Irinotecan Plus Carboplatin Prolongs Survival in Patients with Extensive Small-Cell Lung Cancer

PHASE III

German researchers sought to confirm the results of a previous Japanese trial that found patients with extensive-disease small—cell lung cancer (ED SCLC) treated with irinotecan plus cisplatin lived longer than subjects given therapy with etoposide plus cisplatin.

Hermes et al enrolled 220 patients with ED SCLC to receive one of two therapies. One group received carboplatin plus irinotecan (175 mg/m²) intravenously on day 1 while the other group was given carboplatin plus etoposide (120 mg/ m²/d) orally on days 1 to 5. The courses were repeated every 3 weeks for 4 cycles. Doses were reduced by one-third for patients with a World Health Organization performance status score of 3 to 4 or aged >70 years.

Of the initial 220 enrollees, 209 were eligible for analysis, consisting of 105 in the irinotecan group and 104 in the etoposide group. Clinicians noted that at the onset of the study, 47% of patients had a performance status score of 2 to 4 and 35% were aged >70 years. Prognostic factors were similar in both groups of patients.

Patients in the carboplatin plus etoposide cohort demonstrated shorter overall survival than those in the carboplatin plus irinotecan arm (HR = 1.41; P = .02). Median survival time was 8.5 months for the irinotecan group, which had a 34% rate of 1-year survival. The etoposide group had median survival time of 7.1 months and a 24% rate of 1-year survival. Additionally, 18 patients in the irinotecan group achieved complete response versus 7 patients in the group that received therapy with etoposide (P = .02).

The rate of hematologic grade 3 and 4 toxicity was not statistically different between the two groups, although the incidence of grade 3 and grade 4 diarrhea was higher in the irinotecan cohort. The researchers observed small quality-of-life differences between patients in the 2 arms, and those in the irinotecan group had a tendency toward extended symptom relief.

Overall findings supported those of the Japanese study, and researchers concluded that irinotecan treatment prolonged survival in patients with ED SCLC and slightly improved patients’ quality-of-life scores.

Hermes A, Bergman B, Bremnes R, et al. Irinotecan plus carboplatin versus oral etoposide plus carboplatin in extensive small—cell lung cancer: A randomized phase III trial.

2008;26(26):4261-4267.

J Clin Oncol.