S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC)

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Abstract
7512 Background: The role of irinotecan in SCLC remains controversial. Although J9511 demonstrated a significant survival benefit for IP over EP in Japanese pts with E-SCLC (Noda, et al. NEJM 2002), another small phase III trial did not (Hanna, et al JCO 2006). S0124 was designed to confirm the results of J9511 in a North American & to investigate the association of genetic polymorphisms (SNPs) with outcomes. Methods: Pts with documented E-SCLC, adequate end-organ function & controlled or no brain metastases were stratified by single vs multiple metastases, normal vs elevated LDH, & weight loss ≤ 5% vs > 5%, & randomized to (IP) I-60 mg/m2 days 1, 8, & 15 + P-60 mg/m2 day 1, Q 4 weeks or (IP) E-100 mg/m2 days 1–3 + P-80 mg/m2 day 1, Q 3 weeks. A blood specimen for SNP analysis was collected pre- randomization. Results: From 11/02 through 3/07, 671 pts were accrued, with 645 eligible: IP (N=323) & EP (N=322). Pt demographics: median age 63, 57% males, 76% with multiple metastatic sites, 62% ≤ 5% weight los...

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