0000000000038120
AUTHOR
Claudio Verusio
Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial
Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely remov…
Cetuximab and gemcitabine in elderly or adult PS2 patients with advanced non-small-cell lung cancer: The cetuximab in advanced lung cancer (CALC1-E and CALC1-PS2) randomized phase II trials
Background:Two parallel randomized phase 2 trialswere performed to choose the optimal way of combining cetuximab with gemcitabine in the first-line treatment of elderly (CALC1-E) and adult PS2 (CALC1-PS2) patients with advanced NSCLC. Methods: Stage IV or IIIB NSCLC patients, aged ≥70 years with PS 0–2 for CALC1-E or aged <70 with PS2 for CALC1-PS2, not selected for EGFR expression,were eligible. Patients were randomized to concomitant (gemcitabine, for a maximum of 6 cycles, plus cetuximab until progression) or sequential (gemcitabine, for a maximum of 6 cycles, followed by cetuximab) strategy. A selection design, with 1-year survival rate as the primary endpoint, was applied, requiring 58…
Supplementary_Material_-_online_only – Supplemental material for Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG
Supplemental material, Supplementary_Material_-_online_only for Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG by Melissa Bersanelli, Diana Giannarelli, Ugo De Giorgi, Sandro Pignata, Massimo Di Maio, Elena Verzoni, Alberto Clemente, Valentina Guadalupi, Diego Signorelli, Marcello Tiseo, Raffaele Giusti, Marco Filetti, Marilena Di Napoli, Lorenzo Calvetti, Alessandro Cappetta, Paola Ermacora, Diego Zara, Fausto Barbieri, Cinzia Baldessari, Vieri Scotti, Francesca Mazzoni, Antonello Veccia, Pamela Francesca Guglielmini, Marco Maruzzo, Ernesto Rossi, Francesco Grossi, Chiara Casad…
Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors. Prospective analysis from a multicentre observational trial by FICOG
Background:This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events.Patients and methods:Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared …
Effectiveness of a Psychosocial Care Quality Improvement Strategy to Address Quality of Life in Patients with Cancer: The HuCare2 Stepped-Wedge Cluster Randomized Trial
Key Points Question Does an implementation strategy integrating psychosocial care into cancer centers improve at least 1 of 2 domains (emotional or social function) of health-related quality of life? Findings This stepped-wedge cluster randomized clinical trial included 762 patients with cancer at high risk for reduced quality of life. Health-related quality of life score improved from baseline to 3 months among participants in the Humanization in Cancer Care Quality Improvement Strategy arm vs the usual care arm, showing a statistically significant difference for emotional function, but not for social function. Meaning This study suggests the use of an implementation strategy aiming to pro…
Is There Still a Role for Endocrine Therapy Alone in HR+/HER2- Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies
<b><i>Background:</i></b> Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting. <b><i>Methods:</i></b> For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies). <b><i>Res…
Weekly docetaxel vs. docetaxel-based combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer patients
Abstract Background Doublet chemotherapy is more effective than single-agent as first line treatment of advanced non-small-cell lung cancer (NSCLC). No reliable information instead is available on the effect of doublets in second line treatment. The aim of DISTAL-2 study was to compare two doublets containing docetaxel with single agent docetaxel as second line treatment of patients with NSCLC (ClinicalTrials.gov id.:. NCT00345059 ). Methods NSCLC patients, aged 2 on days 1, 8, 15 q 4 weeks); arm B, weekly docetaxel (30 mg/m 2 on days 1, 8, 15) plus gemcitabine (800 mg/m 2 on days 1, 8 q 4 weeks) or plus vinorelbine (20 mg/m 2 on days 1, 8 q 4 weeks) depending on which of the two had been u…
Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX.
IF 6.029; International audience; BackgroundThe prognostic value of lymphocyte infiltration (LI) of colorectal carcinoma (CC) has been demonstrated by several groups. However, no validated test is currently available for clinical practice. We previously described an automated and reproducible method for testing LI and aimed to validate it for clinical use.Patients and methodsAccording to National Institutes of Health criteria, we designed a prospective validation of this biomarker in patients included in the PETACC8 phase III study. Primary objective was to compare percentage of patients alive and without recurrence at 2 years in patients with high versus low LI (#NCT02364024). Associations…