Etoposide plus cisplatin, given alongside accelerated hyperfractionated thoracic radiotherapy (AHTRT), remains the gold standard regimen for patients with limited-stage small-cell lung cancer (SCLC), Japanese researchers say.
The phase III Japan Clinical Oncology Group 0202 trial failed to show a significant benefit for treatment with irinotecan plus cisplatin over etoposide plus cisplatin despite promising results for this regimen in patients with extensive-stage SCLC.
Median overall survival was 3.2 years for the 129 patients randomly assigned to receive four cycles of etoposide plus cisplatin with concurrent AHTRT versus 2.8 years for the 129 patients given three cycles of irinotecan plus cisplatin with AHTRTR, after an induction cycle of etoposide plus cisplatin. This gave a nonsignificant hazard ratio of 1.09.
Three- and 5-year overall survival rates were 52.9% and 35.8%, respectively, for patients given the etoposide regime compared with 46.6% and 33.7% for those assigned to receive the irinotecan regimen.
Progression-free survival was also comparable in the two groups, at 1.1 and 1.0 years, respectively.
Grade 3 and 4 adverse events were comparable in the treatment arms, except for a reduced rate of diarrhea in the etoposide plus cisplatin versus irinotecan plus cisplatin groups (2 vs 10%). In all, 90% of etoposide-treated and 86% of irinotecan-treated patients completed treatment.
"Thus, compliance does not explain the negative results in the present study," say Kaoru Kubota (Nippon Medical School, Tokyo) and co-authors in The Lancet Oncology.
Noting that full-dose irinotecan cannot be given alongside AHTRT, the researchers say that future research should focus on other radiosensitizers as it is "unlikely that the addition of irinotecan to radiotherapy improves the outcome of patients with limited-stage SCLC who receive combined chemotherapy and radiotherapy treatment."
They therefore conclude: "At the present time, the results of our study indicate that four cycles of etoposide plus cisplatin plus concurrent AHTRT should continue to be the standard of care in patients with limited-stage SCLC.
"Because SCLC is strongly smoking-related, discouragement and cessation of tobacco use is still the most effective strategy to reduce deaths from SCLC."
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