Randomized Phase III Study of Irinotecan Plus Cisplatin Versus Etoposide Plus Cisplatin for Completely Resected High-Grade Neuroendocrine Carcinoma of the Lung: JCOG1205/1206

In the referenced clinical trial, investigators sought to pursue the efficacy of irinotecan plus cisplatin versus etoposide plus cisplatin as postoperative adjuvant chemotherapy for patients with pathologic stage I-IIIA completely resected high-grade neuroendocrine carcinoma of the lung. The trial was a randomized, open label, phase 3 study, which randomized patients to receive either etoposide 100 mg/m², days 1-3+ cisplatin, 80 mg/m², day 1 or anemia taken 60 mg/m², days 1, 8, 15+ cisplatin 60 mg/m², day 1 for up to 4 cycles. The primary endpoint was relapse free survival. 221 patient quite well, 111 versus 110 in each arm effectively. Early termination of the trial was recommended because of futility. Had a medium follow-up of 24.1 months, with a 3-year relapse free survival was 65.4% for etoposide plus cisplatin at 69% for him that he can go cisplatin. The hazard ratio was 1.076 (95% CI, 0.666 to 1.738; one-sided log-rank P = .619). Grade 3 and 4 adverse events were more frequent in the etoposide plus cisplatin arm. Febrile neutropenia was reported at 20% versus 4%. Neutropenia was reported at 97 versus 36%. Diarrhea was more common in the irinotecan arm, 8% versus 1%. The authors concluded that the combination of irinotecan and cisplatin is not superior to etoposide plus cisplatin for improving relapse free survival in patients with completely resected high-grade neuroendocrine carcinoma. Etoposide plus cisplatin should remain the standard of care