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SWOG S0124: No survival benefit with irinotecan/cisplatin in extensive SCLC

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SWOG S0124 did not confirm a survival benefit of treatment with the combination irinotecan and cisplatin for extensive small cell lung cancer that was previously demonstrated in a Japanese trial.

Released in 2002, the results of the phase-3 JCOG 9511 study showed superior tumor response and survival for Japanese patients with small cell lung cancer assigned to irinotecan/cisplatin compared with patients assigned to standard treatment with etoposide/cisplatin. The researchers of SWOG S0124, a multicenter phase-3 trial, sought to confirm the survival benefit in North Americans.

The researchers recruited 651 patients and randomly assigned 324 to irinotecan/cisplatin and 327 to etoposide/cisplatin. They found that there was no difference in tumor response for irinotecan/cisplatin compared with etoposide/cisplatin (60% vs. 57%; P=.56).

Median PFS was 5.7 months for the irinotecan/cisplatin group vs. 5.2 for etoposide/cisplatin (P=.07). One-year PFS rates were 7% for irinotecan/cisplatin and 6% for etoposide/cisplatin.

Median OS for irinotecan/cisplatin was 9.9 months compared with 9.1 months for those assigned to etoposide/cisplatin (P=.71). Estimated one-year survival for the irinotecan/cisplatin group was 41% vs. 34% in the etoposide/cisplatin group.

The researchers suggested several explanations between the results of the two studies including the small sample size in JCOG 9511, which involved only 174 total participants, and possible genetic differences between the two populations.

Lara PN. J Clin Oncol. 2009;doi:10.1200/JCO.2008.20.1061.

The combination of cisplatin and CPT-11 was found to be equivalent in efficacy to cisplatin and etoposide in the United States, which is contrary to the findings of Japanese investigators where cisplatin/CPT-11 was found to be superior. Pharmacogenomic differences between the Japanese and U.S. populations may potentially explain the different outcomes between the two similarly designed studies done in the two countries. In the American trial, even though the two regimens were equally effective, the toxicity profiles were different with cisplatin/CPT-11 having more non-hematological toxicities in comparison to cisplatin/VP-16 which had more hematological toxicities, these differences being statistically significant. We therefore now have two equivalent first-line options, with toxicities and physician preference dictating the choice of therapy for extensive stage small cell lung cancer.

– George R. Simon, MD

Director of Thoracic Oncology, Fox Chase Cancer Center, Philadelphia