Concurrent chemoradiation therapy with oral etoposide and cisplatin for locally advanced inoperable non-small-cell lung cancer: Radiation therapy oncology group protocol 91-06
Concurrent chemoradiation therapy with oral etoposide and cisplatin for locally advanced inoperable non-small-cell lung cancer: Radiation therapy oncology group protocol 91-06
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DOI：
10.1200/jco.1996.14.4.1055
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发表时间：
1996-04-01
影响因子：
45.3
通讯作者：
Curran, WJ
中科院分区：
文献类型：
--
作者：
Lee, JS;Scott, C;Curran, WJ
目的：局部晚期不可手术的非小细胞肺癌（NSCLC）患者的临床结局较差。我们进行了一项前瞻性研究，以评估的优点，化疗管理同时与超分割胸部放疗。患者和方法：79例不能手术的非小细胞肺癌患者参加了一个多中心的II期临床试验的同时放化疗。治疗包括两个周期的口服依托泊苷100 mg/d（50 mg，每日两次），第1 - 14天，28天为一个周期（如果体表面积[BSA] < 1.70 m2，则为75 mg/d），第1天和第8天静脉注射顺铂50 mg/m2，每周超分割放射治疗5天（1.2戈伊，每日两次，间隔> 6小时;共69.6戈伊）.结果：对76例Karnofsky体力状态≥ 60，且既往未接受治疗的器官功能良好的可评估患者进行了临床结局和毒性反应评价。在至少21个月的随访时间后，1年和2年生存率和中位生存时间分别为67%、35%和18.9个月;体重减轻≤ 5%的患者分别为70%、42%和21.1个月。毒性显著; 57%发生4级血液学毒性，53%发生3级或4级食管炎，25%发生3级或4级肺毒性。然而，只有6.6%的患者发生了4级或致死性非血液学毒性，其中包括3例治疗相关性死亡（2例肺炎和1例肾衰竭）。结论：口服依托泊苷和顺铂联合超分割放射治疗同步放化疗是可行的。该方案的生存结局优于其他放化疗试验，甚至包括手术在内的多模式试验。(C)1996年，美国临床肿瘤学会。
Purpose: Patients with locally advanced inoperable non-small-cell lung cancer (NSCLC) have a poor clinical outcome. We conducted a prospective study to evaluate the merit of chemotherapy administered concurrently with hyperfractionated thoracic radiation therapy.Patients and Methods: Seventy-nine patients with inoperable NSCLC were enrolled onto a multicenter phase II trial of concurrent chemoradiation therapy. Treatment consisted of two cycles of oral etoposide 100 mg/d (50 mg twice daily) on days 1 to 14 of a 28-day cycle (75 mg/d if body-surface area [BSA] < 1.70 m(2)), intravenous cisplatin 50 mg/m(2) on days 1 and 8, and hyperfractionated radiation therapy 5 days per week (1.2 Gy twice daily > 6 hours apart; total, 69.6 Gy).Results: Seventy-six assessable patients with a Karnofsky performance status greater than or equal to 60 and adequate organ function who had received no prior therapy were evaluated for clinical outcome and toxic effects. After a minimum follow-up duration of 21 months, the 1- and 2-year survival rates and median survival duration were 67%, 35%, and 18.9 months overall; they were 70%, 42%, and 21.1 months for patients with weight loss of less than or equal to 5%. Toxicity was significant; 57% developed grade 4 hematologic toxicity, 53% grade 3 or 4 esophagitis, and 25% grade 3 or 4 lung toxicity. However, only 6.6% of patients had grade 4 or lethal nonhematologic toxicity, which included three treatment-related deaths (two of pneumonitis and one of renal failure).Conclusion: Concurrent chemoradiation therapy with oral etoposide and cisplatin plus hyperfractionated radiation therapy is feasible. The survival outcome from this regimen compares favorably with that of other chemoradiation trials and even of multimodality trials that have included surgery. (C) 1996 by American Society of Clinical Oncology.