Meeting
2012 ASCO Annual Meeting
Randomized phase III study comparing etoposide and cisplatin (EP) with irinotecan and cisplatin (IP) following EP plus concurrent accelerated hyperfractionated thoracic radiotherapy (EP/AHTRT) for the treatment of limited-stage small-cell lung cancer (LD-SCLC): JCOG0202.
Authors
Kaoru Kubota
National Cancer Center Hospital East, Kashiwa, Japan
Kaoru Kubota , Toyoaki Hida , Satoshi Ishikura , Junki Mizusawa , Makoto Nishio , Masaaki Kawahara , Akira Yokoyama , Fumio Imamura , Koji Takeda , Shunichi Negoro , Masao Harada , Hiroaki Okamoto , Nobuyuki Yamamoto , Tetsu Shinkai , Hiroshi Sakai , Kaoru Matsui , Kazuhiko Nakagawa , Taro Shibata , Nagahiro Saijo , Tomohide Tamura
Organizations
National Cancer Center Hospital East, Kashiwa, Japan, Aichi Cancer Center Hospital, Nagoya, Japan, Department of Radiology,Nagoya City University Graduate School of Medical Sciences, Aichi, Japan, JCOG Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo, Japan, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan, Kinki-Chuo Chest Medical Center, Sakai, Japan, Niigata Cancer Center Hospital, Niigata, Japan, Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan, Osaka City General Hospital, Osaka, Japan, Medical Oncology Division, Hyogo Cancer Center, Akashi, Japan, Hokkaido Cancer Center, Sapporo, Japan, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan, Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan, Saitama Cancer Center, Saitama, Japan, Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan, Department of Medical Oncology, Kinki University School of Medicine, Osaka, Japan, Kinki University Faculty of Medicine, Osaka, Japan, National Cancer Center Hospital, Tokyo, Japan
Research Funding
Other
Background: Four cycles of EP plus AHTRT is the standard treatment for LD-SCLC. IP demonstrated statistically significant overall survival (OS) improvement compared to EP for extensive-stage SCLC (JCOG9511; Noda, et al.NEJM, 2002). EP plus AHTRT followed by 3 cycles of IP is feasible with acceptable toxicities for LD-SCLC (Kubota, et al. CCR,2005). Methods: Eligibility criteria included patients with previously untreated LD-SCLC with measurable lesion, ECOG PS of 0-1, age: 20=<, =<70 years old. Eligible patients received one cycle of EP (etoposide 100 mg/m2 on days 1-3 and cisplatin 80mg/m2 on day 1) plus AHTRT (1.5 Gy b.i.d. total 45 Gy/3 weeks). Patients who achieved CR, good PR, PR or SD with induction EP/AHTRT were randomized to receive either 3 cycles of consolidation EP or IP (irinotecan 60 mg/m2 and cisplatin 60 mg/m2 on days 1, 8, 15). Patients with CR or good PR after consolidation chemotherapy received prophylactic cranial irradiation. The primary endpoint is OS after the randomization. The planned sample size for randomization is 250 with a one-sided alpha of 2.5% and at least 70% power to detect a difference between gruops, 30% in EP versus 42.5% in IP group in 3-year survival. Results: From Sep 2002 to Sep 2006, 281 patients from 36 institutions were registered. After the induction EP/AHTRT, 258 patients were randomized to consolidation EP (n=129) or IP (n=129). Patient demographics were well balanced between the two groups. At the final analysis, the superiority of IP in OS was not demonstrated (hazard ratio of IP to EP, 1.085 [95%CI: 0.80-1.46]; one sided p=0.70, stratifield log-rank test). Grade 3/4 neutropenia (95%/78%), anemia (35%/39%), thrombocytopenia (21%/5%), neutropenic fever (17%/14%), diarrhea (2%/10%) were observed in EP and IP groups, respectively. Conclusions: EP plus AHTRT followed by 3 cycles of IP failed to demonstrate survival advantage over 4 cycles of EP plus AHTRT which still is the standard treatment for LD-SCLC.
| EP | IP | |
|---|---|---|
| Median OS | 3.2 years | 2.8 years |
| 3-year OS | 53% | 47% |
| 5-year OS | 36% | 34% |
| Median PFS | 1.1 years | 1.0 year |
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Abstract Details
Session Type
Poster Discussion Session
Session Title
Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
Track
Lung Cancer
Sub Track
Small Cell Lung Cancer
Clinical Trial Registration Number
C000000095
Citation
J Clin Oncol 30, 2012 (suppl; abstr 7028)
DOI
10.1200/jco.2012.30.15_suppl.7028
Abstract #
7028
Poster Bd #
20
Abstract Disclosures
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