Phase II Study of Accelerated High-Dose Radiotherapy With Concurrent Chemotherapy for Patients With Limited Small-Cell Lung Cancer: Radiation Therapy Oncology Group Protocol 0239

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• 作者：Ritsuko Komaki ; MD^&lowast ; ; ^{rkomaki@mdanderson.org} ; Rebecca Paulus ; BS^&Dagger ; ; David S. Ettinger ; MD^&sect ; ; Gregory M.M. Videtic ; MD^鈥?/sup> ; Jeffrey D. Bradley ; MD^¶ ; ; Bonnie S. Glisson ; MD^&dagger ; ; Corey J. Langer ; MD^&lowast ; &lowast ; ; William T. Sause ; MD^&dagger ; &dagger ; ; Walter J. Curran Jr. ; MD^&Dagger ; &Dagger ; ; Hak Choy ; MD^&sect ; &sect ;
• 关键词：Concomitant boost thoracic radiation ; Limited-stage small-cell lung cancer ; Cisplatin ; Etoposide
• 刊名：International Journal of Radiation Oncology*Biology*Physics
• 出版年：2012
• 期刊代码：136_03603016
• 类别：med
• 出版时间：15 July, 2012
• 卷：83
• 期：4
• 页码：e531-e536
• 文件大小：216 K

摘要

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Purpose

To investigate whether high-dose thoracic radiation given twice daily during cisplatin-etoposide chemotherapy for limited small-cell lung cancer (LSCLC) improves survival, acute esophagitis, and local control rates relative to findings from Intergroup trial 0096 (47%, 27%, and 64%).

Patients and Methods

Patients were accrued over a 3-year period from 22 US and Canadian institutions. Patients with LSCLC and good performance status were given thoracic radiation to 61.2 Gy over 5 weeks (daily 1.8-Gy fractions on days 1-22, then twice-daily 1.8-Gy fractions on days 23-33). Cisplatin (60 mg/m² IV) was given on day 1 and etoposide (120 mg/m² IV) on days 1-3 and days 22-24, followed by 2 cycles of cisplatin plus etoposide alone. Patients who achieved complete response were offered prophylactic cranial irradiation. Endpoints included overall and progression-free survival; severe esophagitis (Common Toxicity Criteria v 2.0) and treatment-related fatalities; response (Response Evaluation Criteria in Solid Tumors); and local control.

Results

Seventy-two patients were accrued from June 2003 through May 2006; 71 were evaluable (median age 63 years; 52%female; 58%Zubrod 0). Median survival time was 19 months; at 2 years, the overall survival rate was 36.6%(95%confidence interval [CI] 25.6%-47.7%), and progression-free survival 19.7%(95%CI 11.4%-29.6%). Thirteen patients (18%) experienced severe acute esophagitis, and 2 (3%) died of treatment-related causes; 41%achieved complete response, 39%partial response, 10%stable disease, and 6%progressive disease. The local control rate was 73%. Forty-three patients (61%) received prophylactic cranial irradiation.

Conclusions

The overall survival rate did not reach the projected goal; however, rates of esophagitis were lower, and local control higher, than projected. This treatment strategy is now one of three arms of a prospective trial of chemoradiation for LSCLC (Radiation Therapy Oncology Group 0538/Cancer and Leukemia Group B 30610).