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- W2029029116 abstract "In a Japanese randomized trial, treatment with irinotecan+cisplatin in patients with SCLC-ED was associated with prolonged survival as compared to etoposide+cisplatin. The present trial was undertaken to evaluate the effects of irinotecan+carboplatin compared to etoposide+carboplatin. Patients with SCLC-ED were randomized to receive either etoposide, 120 mg/m2/day, orally, on days 1-5, plus carboplatin, AUC=4 (Chatelut formula) on day 1 (EC), or irinotecan, 175 mg/m2, plus carboplatin (Chatelut AUC=4), both on day 1 (IC). Treatments were repeated every 3 weeks, with 4 cycles planned. Primary endpoint was overall survival (OS), secondary were quality of life (QoL) evaluated by EORTC-QLQ-C30/LC13, and frequency of complete remissions (CR). No upper age nor performance status limits were applied. Between November, 2001 and July, 2005, 220 patients were randomized. 210 were eligible (EC 105, IC 105), while 10 were excluded due to wrong diagnosis (8), limited disease (1) or elevated liver enzymes (1). WHO performance status was: PS0: 20, PS1: 91, PS2: 62, PS3: 29, and PS4: 8 patients. Median age was 67 years (range 39-82). By 1st August, 2006, 192 patients had died (EC 100, IC 92). Median OS was 214 days in the EC group vs. 255 days in the IC group (P=0.04; HR 1.34, 95% CI 1.01-1.79). 1-year survival was 28% vs. 35%. CR was reported in 7 (EC) vs. 18 (IC) patients (P=0.02). There were no significant differences with respect to haematological grade III-IV toxicity, and no severe diarrhea was observed. Minor group differences were seen with regard to patient reported symptom palliation (i.e. sleep disturbance and dyspnea) and hair loss in favour of the IC group, while functioning and global QoL ratings over time were similar in both groups. Irinotecan+carboplatin is superior to oral etoposide+carboplatin with respect to overall survival in SCLC-ED, without compromising QoL." @default.
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- W2029029116 date "2007-08-01" @default.
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- W2029029116 title "D1-03: Treatment with irinotecan plus carboplatin prolongs survival without compromising quality of life in patients with small cell lung cancer, extensive disease (SCLC-ED). Results of a randomized phase III trial" @default.
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