Japanese Journal of Clinical Oncology Advance Access originally published online on September 20, 2009
Japanese Journal of Clinical Oncology 2009 39(12):784-790; doi:10.1093/jjco/hyp102
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© The Author (2009). Published by Oxford University Press. All rights reserved
A Phase II Study of Cisplatin and Irinotecan as Induction Chemotherapy Followed by Accelerated Hyperfractionated Thoracic Radiotherapy with Daily Low-dose Carboplatin in Unresectable Stage III Non-small Cell Lung Cancer: JCOG 9510
1 Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Kanagawa
2 Department of Respiratory Medicine, Mitsui Memorial Hospital, Tokyo
3 Department of Internal Medicine, Tochigi Prefectural Cancer Center, Tochigi
4 Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata
5 Japan Clinical Oncology Group Data Center, Center for Cancer Control and Information Services, National Cancer Center
6 Department of Thoracic Oncology, National Cancer Center Hospital Central, Tokyo
7 Department of Medical Oncology, Kinki University School of Medicine, Osaka, Japan
For reprints and all correspondence: Hiroaki Okamoto, Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Yokohama 240-8555, Japan. E-mail: scyooka{at}alles.or.jp
Received May 7, 2009; accepted July 29, 2009
Objective: It is important to find optimal regimens of cisplatin (CDDP)-based third-generation chemotherapy and radiotherapy for patients with unresectable Stage III non-small cell lung cancer (NSCLC).
Methods: This Phase II study was designed to determine the toxicity and efficacy of two courses of chemotherapy (CDDP 80 mg/m2 on day 1 and irinotecan 60 mg/m2 on days 1 and 8) followed by accelerated hyperfractionated thoracic radiotherapy (60 Gy/40 fractions in 4 weeks) combined with daily carboplatin (CBDCA) administration. CBDCA was administered at a target area under the plasma level–time curve of 0.4 x (24 h creatinine clearance + 25), according to Calvert's formula.
Results: Twenty-six patients were enrolled in the study. The patients' median age was 63 years (range 40–74 years) and included 22 males and 4 females. Seven patients were Stage IIIA and 19 were Stage IIIB. Twenty had a performance status (PS) of 1 versus six with a PS of 0. There was one treatment-related death due to sepsis and pneumonia associated with Grade 4 neutropenia and diarrhea during chemotherapy. Grade 3 or 4 neutropenia and diarrhea were observed in 14 and 5 patients, respectively. Toxicity of the radiotherapy was mild. There were 0 complete response and 13 partial responses, giving a response rate of 50.0%. Median survival time and 2-year survival were 16.4 months and 21.5%, respectively. This study was designed with Simon's two-stage design, and the response rate did not meet the criteria to proceed to the second stage and the study was terminated early.
Conclusions: This regimen might be inactive for patients with unresectable Stage III NSCLC.
Key Words: cisplatin • irinotecan • carboplatin • chemoradiotherapy • non-small cell lung cancer