Annals of Oncology 14:709-714, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Randomized phase II study of cisplatin, irinotecan and etoposide combinations administered weekly or every 4 weeks for extensive small-cell lung cancer (JCOG9902-DI)
1 Department of Internal Medicine, National Cancer Center Hospital, Tokyo; 2 Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa; 3 Division of Internal Medicine, Kanagawa Cancer Center, Yokohama; 4 First Department of Internal Medicine, Osaka City University Medical School, Osaka; 5 Department of Internal Medicine, Kinki University School of Medicine, Osaka; 6 Division of Internal Medicine, Tochigi Prefectural Cancer Center, Utsunomiya; 7 Department of Pulmonary Medicine, Osaka City General Hospital, Osaka; 8 Division of Internal Medicine, Niigata Cancer Center Hospital, Niigata; 9 Department of Internal Medicine, Osaka Prefectural Habikino Hospital, Osaka; 10 First Department of Medicine, Asahikawa Medical College, Asahikawa; 11 Third Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
Received 7 October 2002; revised 9 December 2002; accepted 23 January 2003
Background:
The purpose of this study was to evaluate the toxicity and antitumor effect of cisplatin, irinotecan and etoposide combinations on two schedules, arms A and B, for previously untreated extensive small-cell lung cancer (E-SCLC), and to select the right arm for phase III trials.
Patients and methods:
Sixty patients were randomized to receive either arm A (cisplatin 25 mg/m2 day 1, weekly for 9 weeks, irinotecan 90 mg/m2 day 1, on weeks 1, 3, 5, 7 and 9, and etoposide 60 mg/m2 days 1–3, on weeks 2, 4, 6, 8), or arm B (cisplatin 60 mg/m2 day 1, irinotecan 60 mg/m2 days 1, 8, 15, and etoposide 50 mg/m2 days 1–3, every 4 weeks for four cycles). Prophylactic granulocyte colony-stimulating factor support was provided in both arms.
Results:
Full cycles were delivered to 73% and 70% of patients in arms A and B, respectively. Incidences of grade 3–4 neutropenia, anemia, thrombocytopenia, infection and diarrhea were 57, 43, 27, 7 and 7%, respectively, in arm A, and 87, 47, 10, 13 and 10%, respectively, in arm B. A treatment-related death developed in one patient in arm A. Complete and partial response rates were 7% and 77%, respectively, in arm A, and 17% and 60%, respectively, in arm B. Median survival time was 8.9 months in arm A, and 12.9 months in arm B.
Conclusions:
Arm B showed a promising complete response rate and median survival with acceptable toxicity in patients with E-SCLC, and should be selected for the investigational arm in phase III trials.
Key words: cisplatin, etoposide, irinotecan, randomized phase II, small-cell lung cancer