Surveillance des cancers coliques opérés à visée curative : faut-il revoir les recommandations de la conférence de consensus ?

Resume Le cancer colorectal se situe au premier rang des cancers. Le traitement initial reste la resection chirurgicale a visee curative mais pres de la moitie des patients operes presenteront une recidive locoregionale ou a distance. Ce risque eleve de rechute et les possibilites therapeutiques avaient fait recommander une strategie de surveillance lors de la conference de consensus (Paris, 1998) avec un niveau de preuve faible. La question de la strategie de surveillance afin de detecter les recidives plus precocement et a un stade curable n’est toujours pas resolue et les modalites de suivi font toujours l’objet d’un important debat. Les etudes controlees et les meta-analyses publies dep…

FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases: Results of the FFCD 1102 phase II trial

Abstract Aim of the study The optimal therapeutic strategy in patients with rectal cancer and synchronous unresectable metastases remains unknown. We evaluated the efficacy of FOLFIRINOX induction therapy in this setting. Patients and methods Chemotherapy-naive patients received at least 8 cycles of FOLFIRINOX. The primary end-point was the 4-month disease control (4 m DC) rate. Tumour responses were centrally reviewed and assessed by computed tomography scan for metastases (Response Evaluation Criteria in Solid Tumours criteria) and magnetic resonance imaging for rectal tumorus. With a Simon 2-stage design and a targeted (H1) 4 m DC > 75%, 65 patients were enrolled from July 2012 to Februa…

Clinical and economic impact of drug eluting beads in transarterial chemoembolization for hepatocellular carcinoma

Summary What is known and objective Drug eluting beads (DEBs) theoretically improve the efficacy and safety of transarterial chemoembolization (TACE) in hepatocellular carcinoma (HCC). Nonetheless, their economic profile has not been assessed. Our retrospective before/after study aimed to compare efficacy, safety and economic profile of two strategies of TACE without (Period 1) or with the possibility of using DEBs (Period 2). Methods All HCC patients treated by TACE in our hospital between March 2006 and May 2013 were included. Economic analyses were performed from the French Public Health Insurance point of view according to the French Diagnosis-Related Group prospective payment system an…

Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma: results of the IDASPHERE phase I trial

SummaryBackground A phase I dose-escalation trial of transarterial chemoembolisation (TACE) with idarubicin-loaded beads was performed in cirrhotic patients with hepatocellular carcinoma (HCC). Aim To estimate the maximum-tolerated dose (MTD) and to assess safety, efficacy, pharmacokinetics and quality of life. Methods Patients received a single TACE session with injection of 2 mL drug-eluting beads (DEBs; DC Bead 300–500 μm) loaded with idarubicin. The idarubicin dose was escalated according to a modified continuous reassessment method. MTD was defined as the dose level closest to that causing dose-limiting toxicity (DLT) in 20% of patients. Results Twenty-one patients were enrolled, inclu…

The lifelong risk of metachronous colorectal cancer justifies long-term colonoscopic follow-up.

The aim of this study was to calculate the risk of metachronous colorectal cancers, to specify their characteristics and potential risk factors in a well-defined French population over a 27-year period.The 10,801 patients who had colorectal cancers totalled 61,879 person-years of follow-up. The actuarial method was used to obtain crude metachronous colorectal cancer rates. Standardised incidence ratios (SIRs) were calculated.The cumulative rate of metachronous colorectal cancer was 1.8% at 5 years, 3.4% at 10 years and 7.2% at 20 years. The incidence of metachronous colorectal cancer following a first colorectal cancer was higher than expected (SIR: 1.5 [1.3-1.7] p0.001). It remained greate…

Patterns of recurrence of obstructing colon cancers after surgery for cure: a population-based study.

Aim Little is known about patterns of recurrence in obstructing colon cancer (OCC) at a population level. The aim of this study was to determine the risk of recurrence following potentially curative surgery in OCC compared with that in uncomplicated colon cancer (CC). Method Data were obtained from the population-based digestive cancer registry of Burgundy (France). Local and distant failure rates were calculated using actuarial methods. A multivariate analysis was performed using a Cox model. Results Obstructing colon cancer represented 8.5% of all colon cancers resected with curative intent (n = 3375). The 5-year cumulative local recurrence rate was 14.2% for OCC and 7.6% for nonobstructi…

PRODIGE 59-DURIGAST trial: A randomised phase II study evaluating FOLFIRI + Durvalumab ± Tremelimumab in second-line of patients with advanced gastric cancer

International audience; Gastric or gastro-oesophageal junction (GEJ) adenocarcinomas present poor overall survival (OS). First-line chemotherapy regimen for patients with HER2-negative tumours is based on a doublet or triplet of fluoropyrimidine plus platinum salt ± taxane. Second-line chemotherapy (Docetaxel or Irinotecan) improves OS which nonetheless remains poor (around 5 months). The first results of immune checkpoint inhibitors (anti-PD-1) combined with chemotherapy in metastatic gastric and GEJ cancers were discordant in recent phase III trials. Data on dual-blockade (anti-PD-L1 or anti-PD-1 plus anti-CTLA-4) plus chemotherapy are lacking. DURIGAST is a randomised, multicenter, non-c…

French patient-reported experience of diagnosis, management and burden of neuroendocrine tumors

Background: There is a lack of knowledge regarding the experience of patients with neuroendocrine tumors (NET) in France. Materials & methods: A patient survey that captured information on diagnosis, disease impact/management and awareness was conducted. Data of respondents from France were analyzed and compared with US data as a reference. Results: Key topics included delays in diagnosis, negative impact on quality of life, patient access to NET medical experts and treatments, and information on NET and treatments. Significant differences were observed between France and the USA regarding NET diagnosis. Conclusion: This survey highlights the considerable burden experienced by patients…

COVID-19 epidemic: Proposed alternatives in the management of digestive cancers: A French intergroup clinical point of view (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, SFR)

International audience; Introduction - Patients treated for malignancy are considered at risk of severe COVID-19. This exceptional pandemic has affected countries on every level, particularly health systems which are experiencing saturation. Like many countries, France is currently greatly exposed, and a complete reorganization of hospitals is ongoing. We propose here adaptations of diagnostic procedures, therapies and care strategies for patients treated for digestive cancer during the COVID-19 epidemic. Methods - French societies of gastroenterology and gastrointestinal (GI) oncology carried out this study to answer two main questions that have arisen (i) how can we limit high-risk situat…

Low Cross-Reactivity Between Cisplatin and Other Platinum Salts.

Background Hypersensitivity reactions to platinum salts (PS) (cisplatin [CI], carboplatin [CA], and oxaliplatin [OX]) can be severe and their incidence is increasing due to their widespread use in cancer treatment. Objective To determine the rate of cross-reactivity between PS and whether CI can be administered without prior allergy testing in patients with a history of CA or OX hypersensitivity. Methods From September 2002 to April 2016, patients with suspected immediate PS hypersensitivity were tested and cross-reactivity between the 3 PS was evaluated. We then studied patients who were given CI without desensitization after immediate hypersensitivity to other PS. Results A total of 155 p…

A 30-Year, Population-Based Study Shows Improved Management and Prognosis of Hepatocellular Carcinoma

Background & Aims Little is known about the impact of changes in the management of hepatocellular carcinoma (HCC) over time. We assessed trends in the pattern of care and in prognosis at a population level. Methods Data on diagnostic conditions, treatment, and prognosis from 1976–2005 were collected by the population-based digestive cancer registry of Burgundy (France). A nonconditional logistic regression was used to identify factors associated with treatment for cure. A multivariate relative survival analysis was also performed. Results The context of HCC diagnosis has changed; the proportion of asymptomatic patients increased from 5.6% (1976–1985) to 37.2% (1996–2005). The proportion of …

Diagnostic yield of a one sample immunochemical test at different cut-off values in an organised screening programme for colorectal cancer

Abstract Background Quantitative immunochemical faecal occult blood tests have become the recommended tests for colorectal cancer screening. The aim of this study was to complete our knowledge on the performance of one of the quantitative immunochemical tests available, FOB-Gold, and to propose a possible strategy for an organised screening programme. Patients and methods Within the French organised screening programme, 23,231 average-risk individuals, aged 50–74 performed both a 3-day Hemoccult test and a 1-day FOB-Gold test. Performances of the immunochemical test were evaluated at different cut-off levels. Results The positivity rate for the Hemoccult was 2.1% and for the FOB-Gold varied…

Endocrine tumours: epidemiology of malignant digestive neuroendocrine tumours.

Little is known about patients with malignant digestive neuroendocrine tumours (MD-NETs). Although their incidence is increasing, MD-NETs remain a rare cancer, representing 1% of digestive cancers. Most MD-NETs are well-differentiated. MD-NET poorly differentiated carcinomas account for 20% of cases on average. Anatomical localisation of MD-NETs varied according to geographic region. Stage at diagnosis and prognosis for patients with MD-NETs in the general population are considerably worse than often reported from small hospital case series. Prognosis varies with tumour differentiation, anatomic site and histological subtype. There are significant differences in survival from MD-NETs among …

Colorectal cancer survival in the USA and Europe: a CONCORD high-resolution study

Journal Article; OBJECTIVES: To assess the extent to which stage at diagnosis and adherence to treatment guidelines may explain the persistent differences in colorectal cancer survival between the USA and Europe. DESIGN: A high-resolution study using detailed clinical data on Dukes' stage, diagnostic procedures, treatment and follow-up, collected directly from medical records by trained abstractors under a single protocol, with standardised quality control and central statistical analysis. SETTING AND PARTICIPANTS: 21 population-based registries in seven US states and nine European countries provided data for random samples comprising 12 523 adults (15-99 years) diagnosed with colorectal ca…

Epidemiology and risk factors for oesophageal adenocarcinoma.

Oesophageal adenocarcinoma will soon cease to be a rare form of cancer for people born after 1940. In many Western countries, its incidence has increased more rapidly than other digestive cancers. Incidence started increasing in the Seventies in England and USA, 15 years later in Western Europe and Australia. The cumulative risk between the ages of 15 and 74 is particularly striking in the UK, with a tenfold increase in men and fivefold increase in women in little more than a single generation. Prognosis is poor with a 5-year relative survival rate of less than 10%. The main known risk factors are gastro-oesophageal reflux, obesity (predominantly mediated by intra-abdominal adipose tissues)…

Phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients (pts) over 70 with previously treated metastatic colorectal adenocarcinoma (mCRC) FFCD 1404 - REGOLD

Prevalence of patients with colorectal cancer requiring follow-up or active treatment

Abstract Introduction The objective of this study was to estimate prevalence of colorectal cancers requiring care or follow-up. Materials and methods Prevalence was observed in 2005 on the population-based digestive cancer registry of Burgundy (France). Total and 5-year partial prevalences were calculated. The prevalence of patients requiring follow-up was estimated using non-mixture cure models. The prevalence of patients with recurrence was estimated using annual recurrence rates. Results Total prevalence was 262,244 cases in France. The mean variation in 5-year partial prevalence between successive 5-year periods was +8.0%. Time to cure was estimated to be 9.3 years, suggesting that foll…

Epidemiology and prognosis of synchronous and metachronous colon cancer metastases: a French population-based study.

Epidemiological data on synchronous and metachronous metastatic colon cancer are scarce. We assessed epidemiological characteristics and survival in synchronous and metachronous metastatic colon cancer in a French population.Our study included 932 cases of metastatic colon cancer diagnosed in 1999-2010 and registered in a population-based cancer registry; 758 were synchronous colon metastases and 174 metachronous metastases from resected primary colon cancers diagnosed in 1999-2005. Univariate relative survival was calculated and a multivariate model with proportional hazard applied to net survival by interval was used.Mean age at diagnosis was 71.1 years for patients with metachronous meta…

Patients with colorectal tumors with microsatellite instability and large deletions in HSP110 T17 have improved response to 5-fluorouracil–based chemotherapy.

Background & Aims Patients with colorectal tumors with microsatellite instability (MSI) have better prognoses than patients with tumors without MSI, but have a poor response to 5-fluorouracil–based chemotherapy. A dominant-negative form of heat shock protein (HSP)110 (HSP110DE9) expressed by cancer cells with MSI, via exon skipping caused by somatic deletions in the T 17 intron repeat, sensitizes the cells to 5-fluorouracil and oxaliplatin. We investigated whether HSP110 T 17 could be used to identify patients with colorectal cancer who would benefit from adjuvant chemotherapy with 5-fluorouracil and oxaliplatin. Methods We characterized the interaction between HSP110 and HSP110DE9 using su…

Conditional net survival: Relevant prognostic information for colorectal cancer survivors. A French population-based study

Abstract Background Traditionally, survival estimates have been reported as survival from the time of diagnosis. A patient's probability of survival changes according to time elapsed since the diagnosis and this is known as conditional survival. The aim was to estimate 5-year net conditional survival in patients with colorectal cancer in a well-defined French population at yearly intervals up to 5 years. Methods Our study included 18,300 colorectal cancers diagnosed between 1976 and 2008 and registered in the population-based digestive cancer registry of Burgundy (France). We calculated conditional 5-year net survival, using the Pohar Perme estimator, for every additional year survived afte…

HSP110 T17 simplifies and improves the microsatellite instability testing in patients with colorectal cancer

IF 5.65; International audience; Background Every colorectal cancer (CRC) patient should be tested for microsatellite instability (MSI, a marker for defective DNA mismatch repair) as a first screen for Lynch syndrome (LS). In this study, we investigated whether it may be possible to improve the detection of MSI in CRC. We examined whether the HT17 DNA repeat (critical for correct splicing of the chaperone HSP110) might constitute a superior marker for diagnosis of the MSI phenotype in patients with CRC compared with the standard panel of markers (pentaplex).Methods The HT17 polymorphism was analysed in germline DNA from 1037 multi-ethnic individuals. We assessed its sensitivity and specific…

Randomised controlled trial of lipiodol transarterial chemoembolisation with or without amiodarone for unresectable hepatocellular carcinoma.

Abstract Background There is no consensus about the most effective method for transarterial chemoembolisation of hepatocellular carcinoma. Aim The aim of this phase II trial was to compare the efficacy and toxicity of lipiodol transarterial chemoembolisation with amiodarone in association with pirarubicin or doxorubicin versus lipiodol transarterial chemoembolisation with anthracycline alone in a control group. Methods Patients with unresectable hepatocellular carcinoma and Child-Pugh A/B7 were considered eligible for the trial. transarterial chemoembolisation was repeated every 6 weeks for a maximum of 4 sessions. Results Thirteen patients were randomised in the amiodarone group, and 14 we…

Management and prognosis of pancreatic cancer over a 30-year period.

BACKGROUND: The aim of this study was to report on changes in the diagnostic assessment, patterns of care and survival over time for pancreatic cancers. METHODS: A total of 2986 cases of pancreatic cancer from the Digestive Cancer Registry of Burgundy (France) over a 30-year period (1976–2005) were considered. Non-conditional logistic regressions were carried out to identify the factors associated with resection for cure and with the use of chemotherapy. A multivariate relative survival analysis was carried out. RESULTS: Diagnostic procedures have changed. Ultrasonography and computed tomography progressively have become the major diagnostic procedures. There was a slight improvement in sta…

Loss of SMARCB1 expression in colon carcinoma

International audience; SMARCB1 is a tumor suppressor gene, which is part of SWI/SNF complex involved in transcriptional regulation. Recently, loss of SMARCB1 expression has been reported in gastrointestinal carcinomas. Our purpose was to evaluate the incidence and prognostic value of SMARCB1 loss in colon carcinoma (CC). Patients with stage III CC (n = 1695), and a second cohort of 23 patients with poorly differentiated CC were analyzed. Immunohistochemistry for SMARCB1 was performed on tissue microarrays, and cases with loss of expression were controlled on whole sections. Loss of SMARCB1 was compared with the clinico-pathological and molecular characteristics, and the prognostic value wa…

Epidemiology and prognosis of synchronous colorectal cancers

Abstract Background The aim of this population-based study was to report on the incidence, treatment and prognosis of synchronous colorectal carcinomas. Methods Data were obtained from the population-based cancer registry of Burgundy. Results Between 1976 and 2004, 15 562 colorectal cancers were diagnosed. Some 3·8 per cent of patients had synchronous colorectal cancers. The risk of having synchronous cancers was higher in men (odds ratio (OR) 1·41 (95 per cent confidence interval (c.i.) 1·19 to 1·68)), when associated adenomas were present (OR 2·02 (95 per cent c.i. 1·69 to 2·41)), when there were adenomatous remnants on pathological examination (OR 2·10 (95 per cent c.i. 1·73 to 2·55)) an…

Construction of quality of life change patterns: example in oncology in a phase III therapeutic trial (FFCD 0307)

Objective Quality of life data in cancerology are often difficult to summarize due to missing data and difficulty to analyze the pattern of evolution in different groups of patients. The aim of this work was to apply a new methodology to construct Quality of Life (QoL) change patterns within patients included in a clinical trial comparing to regimen of treatment in locally advanced eosogastric cancer. Materials and methods In this trial, QoL was assessed every 2 months by self-reported EORTC QLQ-C30 questionnaire. Physical dimension scores were analyzed. After multiple imputation of missing data, 27 statistical measures aiming to describe the variation of QoL measures among follow-up were c…

Copy number variations inDCC/18q andERBB2/17q are associated with disease-free survival in microsatellite stable colon cancer

We conducted a prospective study to assess the prognostic impact of selected copy number variations (CNVs) in stage II-III microsatellite stable (MSS) colon cancer. A total of 401 patients were included from 01/2004 to 01/2009. The CNVs in 8 selected target genes, DCC/18q, EGFR/7p, TP53/17p, BLK/8p, MYC/8q, APC/5q, ERBB2/17q, and STK6/20q, were detected using a quantitative multiplex polymerase chain reaction of short fluorescent fragment (QMPSF) method. The primary end-point was the impact of the CNVs on the 4-year disease-free survival (DFS). The recurrence rate at 4 years was 20.9%, corresponding to 14% stage II patients vs 31% stage III patients (p<0.0001). The 4-year DFS was significan…

Incidence and survival in late liver metastases of colorectal cancer

Background and Aims Data concerning the risk of long-term liver metastasis following surgery of colorectal cancer in the general population are scarce. The 10-year incidence and prognosis of metachronous liver metastases remain unknown. Methods Among 4584 patients resected for cure for colorectal cancer recorded in two French digestive population-based cancer registries between 1985 and 2000, 602 presented metastases including liver metastases. Results The cumulated incidence of liver metastasis was 15% at 5 years and 17% at 10 years, and was mainly related to stage at diagnosis. The 10-year cumulative incidence was 6% for stage I and 30% for stage III. The hazard ratio was 3.2 [2.4–4.3] fo…

Everolimus after transarterial liver therapy of metastases from gastrointestinal neuroendocrine tumors: The FFCD 1104-EVACEL-GTE phase II study

Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302)

Abstract Background FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin) + aflibercept improves median overall survival (OS) and progression-free survival (PFS) in patients with previously treated metastatic colorectal cancer (mCRC). Our aim was to investigate efficacy and tolerability of this combination in the first line. Patients and Methods Patients with untreated documented mCRC received aflibercept plus FOLFIRI every 14 days until progression or unacceptable toxicity in an open, phase II single-arm, multicenter trial. The primary endpoint was the 6-month PFS rate. Secondary endpoints were OS and tolerability. A 2-step Simon design was used with H0: 55% and H1= 75%. Data were analyzed …

Decision for adjuvant treatment in stage II colon cancer based on circulating tumor DNA:The CIRCULATE-PRODIGE 70 trial

International audience; Background: Adjuvant treatment for stage II colon cancer remains debated. Finding a tool to select patients at risk for disease recurrence may help the clinical decision. Circulating tumor DNA (ctDNA) has been reported recently as a potential predictive marker for disease recurrence. We thus aim to test its ability to better select stage II colon cancer patients for adjuvant therapy.Methods: This national, phase III trial (NCT00002019-000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients. Patients aged 18 to 75 years with ECOG performance status ≤1 wit…

Analyse des infiltrats immunitaires CD3 et CD8 chez 1280 malades atteints de cancers coliques de stade III : approche par intelligence artificielle entièrement automatisée

L’etude retrospective de tumeurs par immunohistochimie constitue un enjeu majeur dans l’amelioration de la prise en charge atteints de pathologies cancereuses. Cependant l’analyse est chronophage pour le pathologiste et reste le plus souvent semi-quantitative pouvant entrainer une perte d’information. L’intelligence artificielle, qui consiste en une approche d’analyse automatisee a haut debit, pourrait permettre de s’affranchir dans ce contexte du pathologiste en apportant de plus une information quantitative. Nous avons ainsi etudie deux parametres immunitaires, CD3 et CD8 sur 1280 lames de malades de la cohorte PETACC8 [1] , une etude europeenne de patients atteints de cancers coliques de…

Hepato-gastroenterologists and oncologists are complementary in the management of digestive cancers

1. Digestive oncology – a changing fieldDigestive cancer accounts for a quarter of all cancers and con-siderable knowledge of the particular features of these disordersis required for correct treatment. Digestive oncology (DO) is amajor field of activity for hepato-gastroenterologists (HGE), whoare involved at all stages, from screening to diagnosis, follow-up,tumour evaluationandpalliativetreatment.HGEhavealsorecentlybeen recruited to multidisciplinary teams, due to their consider-able competence in the management of digestive cancers. OverallDO accounts for more than 50% of all admissions to most gas-troenterology (GI) departments. In Belgium, France and Germany,HGE withspecific,recognizedco…

Survival in patients with primary liver cancer, gallbladder and extrahepatic biliary tract cancer and pancreatic cancer in Europe 1999- 2007: Results of EUROCARE-5

Abstract Background The EUROCARE study collects and analyses survival data from population-based cancer registries (CRs) in Europe in order to provide data on between-country differences in survival and time trends in survival. Methods This study analyses data on liver cancer, gallbladder and extrahepatic biliary tract cancers (“biliary tract cancers”), and pancreatic cancer diagnosed in 2000–2007 from 88 CRs in 29 countries. Relative survival (RS) was estimated overall, by region, sex, age and period of diagnosis using the complete approach. Time trends in 5-year RS over 1999–2007 were also analysed using the period approach. Results The prognosis of the studied cancers was poor. Age-stand…

OC-0284: First results of the French cohort ANABASE : treatment and outcome in non-metastatic anal cancer

IF 4.942 (2017); International audience

Identification of resources and skills developed by partners of patients with advanced colon cancer: a qualitative study

National audience; Les aidants familiaux jouent un rôle central auprès des patients présentant un cancer de stade avancé. Parmi les proches susceptibles d’apporter une aide aux personnes malades, les conjoints, en raison des liens qui les unissent et parce qu’ils partagent leur vie quotidienne, sont sans doute les plus confrontés à la maladie. Ils sont également majoritairement désignés comme étant l’aidant principal. L’irruption de la maladie et le besoin d’accompagnement qu’elle nécessite, viennent bouleverser en profondeur les différents équilibres structurant leur quotidien et leur organisation. Ils viennent aussi questionner la nature des relations qu’ils entretiennent, dans une divers…

Perioperative FOLFOX 4 Versus FOLFOX 4 Plus Cetuximab Versus Immediate Surgery for High-Risk Stage II and III Colon Cancers: A Phase II Multicenter Randomized Controlled Trial (PRODIGE 22).

BACKGROUND Perioperative chemotherapy has proven valuable in several tumors, but not in colon cancer (CC). OBJECTIVE The aim of this study was to evaluate the efficacy and safety of perioperative chemotherapy in patients with locally advanced nonmetastatic CC. METHODS This is a French multicenter randomized phase II trial in patients with resectable high-risk T3, T4, and/or N2 CC on baseline computed tomography (CT) scan. Patients were randomized to receive either 6 months of adjuvant FOLFOX after colectomy (control) or perioperative FOLFOX for 4 cycles before surgery and 8 cycles after (FOLFOX peri-op). In RAS wild-type patients, a third arm testing perioperative FOLFOX-cetuximab was added…

What is the optimal treatment for T1N0 anal squamous cell carcinoma? Analysis of current practices in the prospective French FFCD ANABASE cohort

International audience; Introduction: for localized T1N0 squamous cell carcinoma of the anus (SCCA) standard radiotherapy (RT) may result in overtreatment and alternative strategies are debated. Methods: T1N0M0 SCCA treated between 2015 and 2020 by local excision (LE) or RT were analyzed from the French prospective FFCD ANABASE cohort. Treatment strategies, recurrence-free and colostomy-free survivals (RFS, CFS) and prognostic factors were reported. Results: among 1135 SCCA patients, 99 T1N0M0 were treated by LE(n = 17,17.2%), or RT ( n = 82,82.8%) including RT alone ( n = 65,79.2%) or chemo-RT ( n = 17, 20.7%). Median follow-up was 27.2 months [0.03 and ndash;54.44]. Median tumor size were…

Intratumor CMS Heterogeneity Impacts Patient Prognosis in Localized Colon Cancer

Abstract Purpose: The consensus molecular subtypes (CMS) represent a significant advance in the understanding of intertumor heterogeneity in colon cancer. Intratumor heterogeneity (ITH) is the new frontier for refining prognostication and understanding treatment resistance. This study aims at deciphering the transcriptomic ITH of colon cancer and understanding its potential prognostic implications. Experimental Design: We deconvoluted the transcriptomic profiles of 1,779 tumors from the PETACC8 trial and 155 colon cancer cell lines as weighted sums of the four CMSs, using the Weighted In Silico Pathology (WISP) algorithm. We assigned to each tumor and cell line a combination of up to three …

Everolimus after hepatic arterial embolisation therapy of metastases from gastrointestinal neuroendocrine tumours: The FFCD 1104-EVACEL-GTE phase II study

Abstract Background Hepatic arterial embolisation therapy (HAET) is a treatment of liver metastases of gastrointestinal neuroendocrine tumours (GI-NETs). HAET increases circulating vascular endothelial growth factor levels. Everolimus is a treatment in NETs that may have antiangiogenic activity. Methods This phase II study was conducted in patients with predominant and progressive liver metastases from GI-NETs. Everolimus was initiated 7–30 days after HAET. The hypothesis was that everolimus after HAET would increase hepatic progression-free survival (hPFS) rate at 24 months from 35% to 50%. Results Among the 74 patients included, 88% had small-bowel primary tumour, 43% had grade I and 57% …

Long-term effect of faecal occult blood screening on incidence and mortality from colorectal cancer

Abstract Background Several randomized trials have shown a reduction of colorectal cancer mortality by screening using guaiac-based faecal occult blood tests. However, little is known on the long-term effect of screening at the population level in everyday practice. Methods Small-sized geographic areas including a total of 91,199 individuals were allocated to either biennal screening using the Hemoccult-II test or no screening. The expected mortality and incidence in the cohort invited to screening was determined using mortality and incidence in the non-screened population. Results Colorectal cancer mortality was significantly lower in the population invited to screening than in the non-scr…

Épidémiologie du cancer du pancréas

Actually, pancreatic cancer is a major challenge in digestive oncology. Its prognosis remains very poor with a five-year net survival less than 10%. Although if pancreatic cancer incidence was low, data from French digestive cancer registries show a dramatic increase in recent years, more marked in women (annual variation of +3.6% between 1982 and 2012) than in men (+2.3%). The currently recognized risk factors like tobacco or obesity cannot explain this evolving epidemiology. Moreover, progress in understanding pancreatic carcinogenesis is still insufficient. Except for familial aggregation, systematic screening couldn't be proposed.

Randomized Phase II Trial Evaluating Two Sequential Treatments in First Line of Metastatic Pancreatic Cancer: Results of the PANOPTIMOX-PRODIGE 35 Trial

PURPOSE Metastatic pancreatic cancer (mPC) still harbors a dismal prognosis. Our previous trial (PRODIGE 4—ACCORD 11) demonstrated the superiority of 6-month chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) over gemcitabine for overall survival. The high limiting oxaliplatin-related neurotoxicity supports the evaluation of an oxaliplatin stop-and-go strategy and a sequential strategy in mPC. METHODS In this phase II study, patients were randomly assigned to receive either 6 months of FOLFIRINOX (arm A), 4 months of FOLFIRINOX followed by leucovorin plus fluorouracil maintenance treatment for controlled patients (arm B), or a sequential treatment alternati…

Trends in Frequency and Management of Obstructing Colorectal Cancers in a Well-Defined Population

Few population-based studies investigate obstructing colorectal cancers. This study was designed to describe trends in their frequency and management. Data were obtained for 13,331 colorectal cancers registered by the population-based cancer registry of Burgundy, France, between the years 1976 and 2000. Obstructing cancers represented 8.3 percent of all colorectal cancers. This proportion was stable throughout the study. Resection for cure increased from 54.9 percent (1976–1980) to 71.4 percent (1996–2000; P = 0.011). Using multivariate analysis, site of cancer and period of diagnosis were the only factors significantly associated to a curative resection. Postoperative mortality for obstruc…

444P PRODIGE 25 (FFCD 11-01)-FOLFA: A randomized phase II trial evaluating aflibercept associated with LV5FU2 regimen as first-line treatment of non-resectable metastatic colorectal cancers

Management of rectal cancer in France in a well-defined population.

Objective The aim of this study was to draw a picture of diagnostic assessment and patterns of care for rectal cancer in France using population-based registries data. Methods The study included a random sample of 669 cases of rectal cancers diagnosed in 2005. Results Diagnostic assessment was performed by colonoscopy in 91.4% of the cases. An abdominal computed tomography was performed in 59.4% of the cases and chest computed tomography in 47.8%. An R0 resection was performed in 65.8% of cases and an R1/R2 resection in 16.1%. A rectal endosocography was performed in 40.4% and MRI in 10.4%. The sphincter was preserved in 73.6% of patients aged younger than 75 years of age and in 62.5% of th…

Trends in colorectal cancer incidence: a period and birth-cohort analysis in a well-defined French population.

Abstract Background France stands among high-risk areas for colorectal cancer. Different trends in CRC incidence are reported around the world. The aim of this study was to provide temporal trends in CRC incidence over a 30-year period in a French well-defined population. Methods Between 1976 and 2005, 17,028 new cases were registered by the Burgundy digestive cancer registry. The mean variations in age-standardized incidence rates were estimated using a Poisson regression adjusted for age for each gender and location. The cumulative risk by birth cohort of developing a cancer over the age range 0-74 years was estimated using an age-cohort model. Results Incidence rates for right and left c…

Adjuvant treatments for gastric cancer: From practice guidelines to clinical practice

Abstract Background For gastric cancers, the benefits of adjuvant radiochemotherapy and of perioperative chemotherapy have been demonstrated since 2001 and 2006 respectively. The aim of this study was to evaluate the diffusion of adjuvant treatments in a French population. Methods 334 incident gastric cancers UICC Stage IB, II, III or IVM0 resected for cure and recorded in the Burgundy digestive cancer registry were retrospectively included. Patients were classified as having received an effective adjuvant treatment if they had been treated by adjuvant radiochemotherapy since 2001 or perioperative chemotherapy since 2006. Results The proportion of patients treated with an effective adjuvant…

Immunochemical faecal occult blood tests for colorectal cancer screening: No time to lose

Cancer colorectal : du diagnostic au dépistage

Colorectal cancer fulfils the conditions required for mass screening. Data from controlled studies indicate that it is possible to reduce colorectal cancer mortality at a population level using faecal occult blood testing. Screenings rely on biennial testing in between 50 and 74average risk subjects. Compliance must be over 50%. Colorectal cancer mortality decrease in this case between 15 and 18% in the general population, 33 and 39% among participants to screening. The European Commission, on the basis of available data recommended to organise colorectal cancer screening in the European Union. Generalisation of screening has become a reality in France. Epidemiological studies allow us to d…

Influence of sample return time and ambient temperature on the performance of an immunochemical faecal occult blood test with a new buffer for colorectal cancer screening.

IF 2.415; International audience; The haemoglobin concentration measured by faecal immunochemical tests (FIT) may be decreased in cases of delayed sample return or high temperature. It is an issue of great importance. The aim of this study was to investigate the effects of sample return time and of season on the performance of an FIT (FOB-Gold) with a new buffer. The study included 20 371 participants involved in the French organized colorectal cancer (CRC) screening programme. The probability of a positive screening test, detection rates and positive predictive values for CRC and advanced adenoma were analysed according to sample return time and season of screening. A sample of positive FI…

FOLFIRINEC: a randomized phase II trial of mFOLFIRINOX vs platinum-etoposide for metastatic neuroendocrine carcinoma of gastroenteropancreatic or unknown origin.

Abstract Background Poorly differentiated neuroendocrine carcinomas (NEC) are rare diseases with a poor prognosis. Platinum-etoposide (PE) has been the recommended first-line treatment for decades. FOLFIRINEC (NCT04325425) is a national multicenter randomized phase II study which aims to challenge this standard regimen. Methods The primary objective is to compare the median progression-free survival (PFS) under mFOLFIRINOX versus PE. The secondary objectives are to evaluate the objective response rates (ORR), median overall survival (OS), safety and quality of life. The associated real-time translational study will establish a molecular profile for each patient enrolled. Main inclusion crit…

Predictive factors of transarterial chemoembolisation toxicity in unresectable hepatocellular carcinoma

Abstract Background Transarterial chemoembolisation (TACE) is an effective treatment for unresectable hepatocellular carcinoma (HCC), but can cause severe toxicity. Aim To identify predictive factors of severe TACE-related toxicity in patients with unresectable HCC. Methods All HCC patients who underwent TACE at the Dijon University Hospital between 2008 and 2011 were included in this retrospective study. Severe TACE-related toxicity was defined as the occurrence of any adverse event grade ≥4, or any adverse event that caused a prolongation of hospitalisation of >8 days, or any additional hospitalisation within 1 month after TACE. Factors predicting toxicity were identified using a logistic…

Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high‐risk Stage II and III colon cancers? Three years' follow‐up results of the PRODIGE 22 phase II randomized multicentre trial

International audience; Aim Neoadjuvant chemotherapy has proven valuable in locally advanced resectable colon cancer (CC) but its effect on oncological outcomes is uncertain. The aim of the present paper was to report 3-year oncological outcomes, representing the secondary endpoints of the PRODIGE 22 trial. Method PRODIGE 22 was a randomized multicentre phase II trial in high-risk T3, T4 and/or N2 CC patients on CT scan. Patients were randomized between 6 months of adjuvant FOLFOX (upfront surgery) or perioperative FOLFOX (four cycles before surgery and eight cycles after; FOLFOX perioperative). In wild-type RAS patients, a third arm testing perioperative FOLFOX-cetuximab was added. The pri…

Immunochemical faecal occult blood tests are superior to guaiac-based tests for the detection of colorectal neoplasms

The aim of this study was to compare the performance of a guaiac-based faecal occult blood test (G-FOBT) with that of an immunochemical faecal occult blood test (I-FOBT). A total of 17,215 average risk individuals aged 50 to 74 enrolled in a population-based organised screening programme and performed a 3-day G-FOBT and a 2-day I-FOBT simultaneously. Among participants, 3.1% were found positive for the G-FOBT and 6.9% for the I-FOBT (p<10(-4)). Among the 1205 participants who tested positive and underwent a colonoscopy, the number of detected cancers and advanced adenomas was respectively 2.6 times higher and 3.5 times higher with the I-FOBT than with the G-FOBT. The positive predictive val…

Risk factors for Coronavirus Disease 2019 (COVID-19) severity and mortality among solid cancer patients and impact of the disease on anticancer treatment: A French nationwide cohort study (GCO-002 CACOVID-19).

Background Cancer patients are thought to have an increased risk of developing severe Coronavirus Disease 2019 (COVID-19) infection and of dying from the disease. In this work, predictive factors for COVID-19 severity and mortality in cancer patients were investigated. Patients and Methods In this large nationwide retro-prospective cohort study, we collected data on patients with solid tumours and COVID-19 diagnosed between March 1 and June 11, 2020. The primary endpoint was all-cause mortality and COVID-19 severity, defined as admission to an intensive care unit (ICU) and/or mechanical ventilation and/or death, was one of the secondary endpoints. Results From April 4 to June 11, 2020, 1289…

Digestive Neuroendocrine Neoplasms (NEN): French Intergroup clinical practice guidelines for diagnosis, treatment and follow-up (SNFGE, GTE, RENATEN, TENPATH, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, SFR)

Abstract Introduction This document is a summary of the French Intergroup guidelines regarding the management of digestive neuroendocrine neoplasms (NEN) published in February 2020 ( www.tncd.org ). Methods All French medical societies involved in the management of NEN took part in this work. Recommendations were graded into four categories (A, B, C or D), according to the level of evidence found in the literature until May 2019. Results The management of NEN is challenging because of their heterogeneity and the increasing complexity of diagnostic and therapeutic procedures. Pathological analysis is required for their diagnostic and prognostic characterization, which mainly relies on differ…

Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study

Summary Background Trans-arterial chemoembolization (TACE) is one first-line option therapy for patients with hepatocellular carcinoma (HCC) not suitable for surgical resection. Aims We evaluated the effects of sunitinib plus doxorubicin-TACE on bleeding or liver failure. Methods Seventy-eight patients with HCC were included in this randomized, double-blind study. They received one to three TACE plus either sunitinib or placebo four weeks out of six for one year. The occurrence of severe bleeding or liver failure was assessed during the week after the TACE. The safety and survival outcomes were evaluated. Results No bleeding complication was reported. One and two liver failures were respect…

Are the recommendations of the French consensus conference on the management of colon cancer followed up?

The aim of this study was to determine how the guidelines published after this conference have spread. Pretherapeutic evaluation and treatment were assessed for all colon cancers diagnosed in a well-defined French population in 2000. Patients were classified either as managed according to the recommendations, or as undermanaged or overmanaged. Outside the emergency context, pretherapeutic work-up was classified as in conformity with the consensus in 48.0% of the cases, as undervalued in 21.9% and as overvalued in 30.1%. The resection rate at 90% was not far from the optimum. Pathological data allowed us to classify nearly all cases according to the tumour node metastasis classification; how…

Development of primary early-onset colorectal cancers due to biallelic mutations of the FANCD1/BRCA2 gene

International audience; Fanconi anaemia (FA) is characterized by progressive bone marrow failure, congenital anomalies, and predisposition to malignancy. In a minority of cases, FA results from biallelic FANCD1/BRCA2 mutations that are associated with early-onset leukaemia and solid tumours. Here, we describe the clinical and molecular features of a remarkable family presenting with multiple primary colorectal cancers (CRCs) without detectable mutations in genes involved in the Mendelian predisposition to CRCs. We unexpectedly identified, despite the absence of clinical cardinal features of FA, a biallelic mutation of the FANCD1/BRCA2 corresponding to a frameshift alteration (c.1845_1846del…

Colon cancer molecular subtype intratumoral heterogeneity and its prognostic impact: An extensive molecular analysis of the PETACC-8

Aflibercept in combination with irinotecan, fluorouracil and leucovorin (FOLFIRI) as first-line chemotherapy in metastatic colorectal cancer (mCRC) patients: A phase II multicentric study

Trends in the incidence and management of biliary tract cancer: a French population-based study.

The trends in incidence and management of biliary tract cancer (BTC) were investigated in a well-defined French population over a 30-year period (1976-2005).Data were obtained from the Burgundy digestive cancer registry. Age-standardised incidence rates and trends in incidence were determined. Treatment and stage at diagnosis were also investigated. Five-year survival rates were calculated.Six hundred and fifteen cases of BTC were recorded. There was no significant change in BTC incidence over the 30-year period. For extrahepatic BTC age-standardised incidence rates were 1.1/100,000 for 1976-80 and 2001-2005. These rates were respectively 0.3 and 0.2/100,000 for intrahepatic BTC. The propor…

Chemotherapy of metastatic colon cancer in France: A population-based study

International audience; Aims: to describe, using data from a cancer registry in a well-defined French population, the therapeutic strategies and survival of patients with metastatic colon cancer (mCC).Methods: all patients with synchronous mCC diagnosed within the 2005-2014 period recorded in the digestive cancers registry of Burgundy were included.Results: 1286 mCC patients were included (57% male), of which 34.5% did not receive any antitumor treatment. Both, advanced age (≥75 years) and the Charlson comorbidity score ≥2 were significantly associated with the absence of antitumor treatment. Among the patients treated with chemotherapy, 59 and 33% received at least two and three lines, res…

Epidemiology, Management, and Survival of Peritoneal Carcinomatosis from Colorectal Cancer

Modern chemotherapy aims to improve long-term survival for selected patients with peritoneal carcinomatosis. Publications suggest promising results, but the spread of these new aggressive treatment strategies in the general population is not well known.The aim of this study was to draw a picture of epidemiology, management, and survival in synchronous and metachronous peritoneal carcinomatosis from colorectal cancer.The cumulative risk of metachronous peritoneal carcinomatosis was estimated in patients resected for cure. Net survival rates were calculated for synchronous and metachronous peritoneal carcinomatosis.The study was conducted with the use of the Burgundy Digestive Cancer Registry…

Long-term Net Survival in Patients With Colorectal Cancer in France

Net survival, the survival that might occur if cancer was the only cause of death, is a major epidemiological indicator. Recent findings have shown that the classical methods used for the estimation of net survival from cancer registry data, referred as to "relative-survival methods," provided biased estimates.The aim of this study was to provide, for the first time, long-term net survival rates for colorectal cancer by using a population-based digestive cancer registry.This study is a population-based cancer registry analysis. The recently proposed unbiased nonparametric Pohar-Perme estimator was used.Overall, 14,715 colorectal cancers diagnosed between 1976 and 2005 and registered in the …

Exploratory analyses of 400 patients enrolled in 2 FFCD trials of first line treatment for metastatic pancreatic cancer

Impact of laparoscopy on oncological outcomes after colectomy for stage III colon cancer: A post-hoc multivariate analysis from PETACC8 European randomized clinical trial

Abstract Background In colon cancer (CC), surgery remains the mainstay of treatment with curative intent. Despite several clinical trials comparing open and laparoscopic approaches, data on long-term outcomes for stage III CC are lacking. Methods This post-hoc analysis of the European PETACC8 randomized phase 3 trial included patients from 340 sites between December 2005 and November 2009, with long follow-up (median 7.56 years). Patients were randomly assigned to FOLFOX or FOLFOX+cetuximab after colonic resection. The surgical approach was left to the referring surgeon's discretion. Results Among 2555 patients included, 1796 (70.29%) were operated on by open surgery and 759 (29.71%) by lap…

Cancers du côlon : prise en charge moléculaire

Resume Le demembrement moleculaire des cancers et en particulier des cancers colorectaux conduit a des prises en charge de plus en plus adaptees et de plus en plus complexes. Ce demembrement a abouti a de nombreuses classifications et finalement a une classification moleculaire consensuelle en 2015. Cette classification consensuelle reste pour l’instant non utilisable au quotidien. Plusieurs facteurs moleculaires (statut MSS/MSI, statut BRAF, statut RAS) sont desormais indispensables a la prise en charge du cancer colorectal que ce soit en situation adjuvante ou metastatique. D’autres facteurs tels que le statut HER2 et l’expression de mir-31-3p sont regulierement pris en compte au cas par …

A case report of Muir-Torre syndrome in a woman with breast cancer and MSI-Low skin squamous cell carcinoma.

IF 1.590; International audience; Background: The tumor spectrum in the Lynch syndrome is well defined, comprising an increased risk of developing colonic and extracolonic malignancies. Muir-Torre syndrome is a variant with a higher risk of skin disease. Patients have been described carrying mutations in the mismatch repair genes and presenting tumors with unusual histology or affected organ not part of the Lynch syndrome spectrum. Hence, the real link between Lynch syndrome, or Muir-Torre syndrome, and these tumors remains difficult to assess.Case presentation: We present the case of a 45-year-old-woman, diagnosed with breast cancer at 39 years of age and skin squamous cell carcinoma (SCC)…

Avelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer patients with microsatellite instability: The SAMCO-PRODIGE 54 randomised phase II trial

Abstract Immune checkpoint inhibitors have failed in treating metastatic colorectal cancer (mCRC) patients except those with dMMR/MSI tumors. However, until very recently we had only non-comparative promising data in this population with anti-programmed cell death 1/ programmed cell death ligand 1 (PD1/PD-L1) antibodies alone or combined with anti- cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibodies. This comparative phase II trial (NCT 03186326), conducted in more than 100 centers in France, will include dMMR/MSI mCRC patients with progression after a first-line treatment with chemotherapy ± targeted therapies, to evaluate efficacy and safety of the anti-PDL1 Avelumab versus a s…

Why do results conflict regarding the prognostic value of the methylation status in colon cancers? The role of the preservation method.

Abstract Background In colorectal carcinoma, extensive gene promoter hypermethylation is called the CpG island methylator phenotype (CIMP). Explaining why studies on CIMP and survival yield conflicting results is essential. Most experiments to measure DNA methylation rely on the sodium bisulfite conversion of unmethylated cytosines into uracils. No study has evaluated the performance of bisulfite conversion and methylation levels from matched cryo-preserved and Formalin-Fixed Paraffin Embedded (FFPE) samples using pyrosequencing. Methods Couples of matched cryo-preserved and FFPE samples from 40 colon adenocarcinomas were analyzed. Rates of bisulfite conversion and levels of methylation of …

Improvement in survival of metastatic colorectal cancer: Are the benefits of clinical trials reproduced in population-based studies?

To describe trends in survival of non-resectable metastatic colorectal cancer (MCRC) over a 34-year period in a French population-based registry taking into account major advances in medical therapy.3804 patients with non-resectable metastatic colorectal cancer diagnosed between 1976 and 2009 were included. Three periods (1976-96, 1997-2004 and 2005-09) were considered.The proportion of patients receiving chemotherapy dramatically increased from 19% to 57% between the first two periods, then increased steadily thereafter reaching 59% during the last period (p0.001). Median relative survival increased from 5.9 months during the 1976-96 period to 10.2 months during the 1997-2004 period but, d…

Faecal immunochemical tests: A valuable tool for colorectal cancer screening

Colorectal cancer is a major health problem in industrialized ountries and fulfils the conditions required to justifymass screenng of the general population. Population-based controlled studies erformed in Europe have shown that guaiac faecal occult blood esting (G-FOBT) followed by colonoscopy to detect the cause of leeding can reduce colorectal cancer mortality [1]. Nearly all pubished studies evaluated the Hemoccult II (Beckman Coulter Inc., ea, USA) faecal occult blood test. Screening for colorectal caner using FOBT has, therefore, been included in the European Code gainst Cancer and has been endorsed by the European Commision [2]. Despite its high specificity, Hemoccult has been critic…

Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancérologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX)

Abstract Background Chemotherapy is effective in metastatic pancreatic adenocarcinoma (mPA), but new approaches are still needed to improve patients' survival and quality of life. We have previously published good efficacy and tolerability results on a sequential treatment strategy of gemcitabine followed by an intensified FOLFIRI (5FU+irinotecan) regimen. In the present study, we evaluated the same sequence but replaced gemcitabine by the new gemcitabine + nab-paclitaxel standard first-line combination. Patients and methods We randomised chemotherapy-naive patients with proven mPA, bilirubin levels ≤1.5 upper limit of normal values and performance status 0–2 to alternately receive gemcitab…

The multidisciplinary management of gastro-oesophageal junction tumours

Abstract Background and scope The management of GOJ cancers remains controversial and may vary between countries. Evidence-based attitudes and guidelines are not easy to elaborate since most of the trials and studies reported mixed cases of oesophageal (both adenocarcinoma and squamous cell tumours), GOJ and gastric cancers. The aim of this expert discussion and position paper is to elaborate practical recommendations that integrate evidence-reported literature and experience-based attitude covering all clinical aspects of GOJ cancer across different specialities and countries in Europe. Methodology Opinion leaders, selected on scientific merit were asked to answer to a prepared set of ques…

Hypersensibilité immédiate au carboplatine ou à l’oxaliplatine : réintroduction du cisplatine sans tests cutané ?

International audience; Introduction : L’incidence des réactions d’hypersensibilité immédiate aux sels de platine (cisplatine, carboplatine et oxaliplatine) augmente avec leur large utilisation en cancérologie. Les objectifs de cette étude étaient d’établir la fréquence des sensibilités croisées entre les sels de platine, de déterminer si le cisplatine peut être utilisé sans test allergologique préalable en cas d’allergie immédiate au carboplatine ou à l’oxaliplatine et enfin de proposer une prise en charge simple pour retraiter rapidement les malades.Méthodes : Notre étude rétrospective a porté sur 155 malades ayant présenté une réaction d’hypersensibilité immédiate à un sel de platine. De…

Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 - REGOLD

International audience; BACKGROUND: Regorafenib significantly increases overall survival (OS) in patients with metastatic colorectal cancer previously treated but gives toxicities. OBJECTIVES: to assess the efficacy and safety of regorafenib at it's approved dose in the older population. PATIENTS AND METHODS: This multicenter single-arm phase II enrolled patients ≥70 years old after the failure of fluoropyrimidine-based chemotherapy, anti-VEGF, and anti-EGFR treatment. The primary endpoint was disease control rate (DCR) 2 months after initiation of regorafenib (160 mg/day, 3 weeks on/1 week off). RESULTS: Forty-three patients were enrolled, with a median age of 77 years. The 2 months DCR wa…

Anti-epidermal growth factor receptor therapy in combination with chemoradiotherapy for the treatment of locally advanced anal canal carcinoma: Results of a phase I dose-escalation study with panitumumab (FFCD 0904)

Abstract Background and purpose Standard treatment of epidermoid anal cancer is 5-fluorouracil (5FU) and mitomycin C (MMC) based chemoradiotherapy (CRT). This phase I study aims to evaluate the addition of panitumumab (Pmab) to CRT and to determine the maximum tolerated dose (MTD) of Pmab and 5-FU in combination with CRT. Materials and methods Immunocompetent patients with locally advanced tumour without metastases (Stage T2, T3 or T4, whatever N stage; Stage N1–N3 whatever T stage) followed two RT periods (45 Gy in 5 weeks and 20 Gy in 2 weeks, separated by a 2-week break) with concomitant CT sessions of 5FU/MMC at RT weeks 1, 5 and 8. Pmab was administered on RT weeks 1, 3, 5, 8 and 10 ac…