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O21 - SCLC II (ID 119)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
O21.02 - Phase III trial comparing irinotecan plus cisplatin (IP) with etoposide plus cisplatin (EP) in Korean patients with extensive disease (ED) small cell lung cancer (SCLC) (ID 2937)
16:15 - 17:45 | Author(s): K.H. Lee
IP showed superior survival outcomes compared with EP in Japanese patients. However, IP failed to show the superiority in subsequent studies in Western population. We conducted a multi-center randomized controlled trial to determine whether IP regimen is superior to EP regimen in Korean patients (ClinicalTrials.gov Identifier: NCT00349492)
Patients were randomly assigned (simple randomization, stratified by ECOG performance status and center) to IP (irinotecan 65 mg/m2 IV on D1&8 plus cisplatin 70 mg/m2 IV on D1, every 3 weeks) or EP (etoposide 100 mg/m2 IV on D1-3 plus cisplatin 70 mg/m2 IV on D1, every 3 weeks) for maximum 6 cycles, until disease progression, or until unacceptable toxicity occurred. The primary objective was to compare overall survival (OS).
A total of 362 patients were randomized to IP (N=173) and EP (N=189) arms. Median OS was 10.9 and 10.3 months (m) for IP and EP, respectively (hazard ratio for death in the IP group, 0.879; 95% one-sided confidence interval, 0 to 1.054; P=0.1207). Objective response rate was higher with IP than with EP (62.4%, 48.2%, P=0.0064), however, there was no significant difference in median progression free survival between IP and EP (6.5 and 5.8 m, P=0.1158). In the pre-planned subgroup analyses, IP was associated with longer OS than with EP in male (11.3 vs 10.1 m, P=0.0361), <65 years old (12.7 vs 11.3 m, P=0.0240), ECOG performance status 0/1 (12.4 vs 10.9 m, P=0.0407) patients group. Grade 3/4 anemia, nausea and diarrhea were more frequent in patients treated with IP. There was no difference in the frequency of grade 3/4 neutropenia, thrombocytopenia, neutropenic fever, infection between both arms.
IP failed to show superiority in overall survival compared to EP in Korean patients with ED SCLC. However, prolongation of OS was observed with IP in pre-defined subgroup of patients with male gender, young age, or good performance status.
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