0000000000142990
AUTHOR
Alexander Schmittel
A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer.
Superiority of irinotecan/cisplatin over etoposide/cisplatin was suggested in small-cell lung cancer (SCLC). This trial investigated irinotecan/carboplatin (IP) versus etoposide/carboplatin (EP).The interim analysis at the phase II/phase III transition point of the multicenter trial is reported. Extensive disease SCLC patients were randomized to receive carboplatin AUC 5 mg x min/ml either in combination with 50 mg/m2 of irinotecan on days 1, 8 and 15 (IP) or with etoposide 140 mg/m2 days 1-3 (EP). The primary end point was response rate and the secondary end points were toxicity and progression-free survival.Seventy patients were randomized. Significant differences in grade 3 and 4 thrombo…
A German multicenter, randomized phase III trial comparing irinotecan-carboplatin with etoposide-carboplatin as first-line therapy for extensive-disease small-cell lung cancer.
Background This trial was designed to prove superiority of irinotecan over etoposide combined with carboplatin in extensive-disease small-cell lung cancer. Patients and methods Patients were randomly assigned to receive carboplatin area under the curve 5 mg x min/ml either in combination with irinotecan 50 mg/m2 on days 1, 8, and 15 (IP) or etoposide 140 mg/m2 on days 1-3 (EP). Primary end point was progression-free survival (PFS) at 6 months. Secondary end points were overall survival (OS), response rate, and toxicity. Results Of 226 patients, 216 were eligible. Median PFS was 6.0 months [95% confidence interval (CI) 5.0-7.0] in the IP arm and 6.0 months (95% CI 5.2-6.8) in EP arm (P = 0.0…
Quantitation of antigen-reactive T cells in peripheral blood by IFNgamma-ELISPOT assay and chromium-release assay: a four-centre comparative trial
The ELISPOT assay is increasingly being used for the monitoring of the induction of antigen-reactive T cells in cancer vaccination trials. In order to evaluate the reliability of T cell frequency analysis with the ELISPOT assay, a comparative study was performed in four European laboratories. Six samples from healthy subjects were analyzed for the frequency of influenza-reactive CD8+ T cells in peripheral blood mononuclear cells (PBMC) by IFNgamma-ELISPOT assay. In addition, one laboratory determined cytotoxic T cell precursor (CTL) frequencies in these samples by limiting dilution chromium-release assay (LDA), and three laboratories performed a variant of the LDA, the multiple microculture…
Catumaxomab: a bispecific trifunctional antibody.
The trifunctional bispecific monoclonal antibody catumaxomab has two binding specificities directed at epithelial cell adhesion molecule (EpCAM) and the T-cell antigen CD3. With its Fc-fragment, catumaxomab additionally binds accessory cells such as dendritic cells, macrophages and natural killer cells. The trifunctional approach thus leads to unrestricted but specific killing of epithelial tumor cells by major histocompatibility complex without the need for preactivation or external costimulation. The tumor-associated antigen EpCAM is strongly expressed in carcinomas of various origins including colon, rectum, ovarian, gastric, esophagus, lung, pancreas, breast and head and neck. Expressio…
Brain metastases following interleukin-2 plus interferon-alpha-2a therapy
Abstract This study analyses the frequency and therapy of brain metastases in 94 stage IV melanoma patients after treatment with high-dose interleukin-2 (IL-2) and interferon-α (IFN-α) within three subsequent trials between 1990 and 1995. Central nervous system (CNS) metastases occurred in 28 patients (30%) during the potential follow-up period of 6 years. Time to occurence of brain metastases varied between 1 and 53 months, with a median of 10 months. Of 28 patients, 19 had
Dermatux: Phase IV trial of C-FOLFIRI in 1st-line metastatic colorectal cancer receiving a pre-defined skin care.
e15048Background: Dose- and treatment limiting cetuximab-induced skin rash ≥ 3° occur in 18% of colorectal cancer (CRC) patients. Survival, response and toxicity parameters were re-evaluated under a pre-defined skin prophylaxis consistent of vitamin K1 ointment and oral doxycycline. Methods: This is a national, phase IV, multicenter, 1st-line CRC trial (N = 165, KRAS wt, EGFR +, ECOG 0/1) in UICC stage 4 patients. Patients received irinotecan 180 mg/m² (d1) , folinic acid 400 mg/m² (d1), and 5-FU 400 mg/m² (d1, d2) and cetuximab ( 400 mg² (d1), then 250 mg/m² qw). Concurrently, patients received 0.1% vitamin K1 ointment qd and oral doxycycline 100 mg bid. Upon occurrence of rash ≥ 3°, an ad…
Deterioration in quality of life (QOL) in patients with malignant ascites : Results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone
Background: Malignant ascites (MA) is associated with poor prognosis and limited palliative therapeutic options. Therefore, quality of life (QoL) assessment is of particular importance to demonstrate new treatment value. Following the demonstration of the superiority of catumaxomab and paracentesis over paracentesis on puncture-free survival, this analysis aimed at comparing deterioration in QoL between both the treatment options. Patients and methods: In a randomised, multicentre, phase II/III study of patients with MA due to epithelial cell adhesion molecule (EpCAM) positive cancer, the QoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life …
A nonrandomized, phase IV trial of FOLFIRI and cetuximab in first-line treatment of metastatic colorectal cancer receiving a predefined skin care and skin prophylaxis aiming to prevent a skin rash.
e20724 Background: Anti-EGFR empowered chemotherapeutic regimens resulted in increased overall survival (OS) and response rates (RR). Anti-EGFR induced skin rash occurs in ~ 70% patients, and ~18% ...
Long-term freedom from recurrence in 2 stage IV melanoma patients following vaccination with tyrosinase peptides.
We report here on 2 patients who received adjuvant vaccination with an HLA-A2- or HLA-A24-restricted tyrosinase peptide, respectively, and GM-CSF for frequently relapsing stage IV melanoma. Following resection of metastases and irradiation of brain metastases in 1 patient, both patients were without evidence of disease when receiving the first vaccination. While the patients had had 9 and 12, respectively, mostly s.c., relapses during the 3 years before vaccination, they experienced freedom from relapse for more than 2 years after vaccination. We found a T-cell response to the vaccine peptide in both patients in the peripheral blood by ex vivo IFN-gamma ELISPOT assay. The T-cell population …