Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113
Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113
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DOI：
10.1200/jco.2008.16.6918
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发表时间：
2008-10-01
影响因子：
45.3
通讯作者：
Willett, Christopher G.
中科院分区：
文献类型：
--
作者：
Ajani, Jaffer A.;Winter, Kathryn;Willett, Christopher G.
目的比较两个中心采用诱导化疗和确定性放化疗的两种非手术方法（一种不用氟尿嘧啶）治疗局限性食管癌（LEC）的效果。主要终点是评估任何方法是否能达到≥ 77.5%的1年生存率，超过放射治疗肿瘤组（RTOG）9405方案的历史66%的生存率。患者和方法在多机构合作组中，患有不可切除癌症的LEC患者，不愿意接受手术，或医学上不适合手术的患者被随机分配接受氟尿嘧啶，顺铂，紫杉醇+氟尿嘧啶+紫杉醇+50.4戈伊放疗（A组）或紫杉醇+顺铂诱导化疗+50.4戈伊放疗（臂B）。安全性和生存率进行了assessed.ResultsA共84例患者被随机分配（A组，n = 41;臂B，n = 43），和72个评估（A组，n = 37;臂B，n = 35）。A组患者的中位生存时间为28.7个月，B组患者为14.9个月（RTOG 9405中的患者为18.8个月）。A组的1年生存率为75.7%，接近但未达到或超过77.5%的目标。A组的2年生存率为56%，B组为37%。3级（A组= 54%，B组= 43%）和4级毒性（A组= 27%，B组= 40%）较为常见。治疗相关性死亡发生在3%的患者在A组和6%的患者在手臂B。ConclusionBoth武器的RTOG 0113与高发病率，研究没有达到其1年生存终点。
PurposeTwo nonoperative approaches (one without fluorouracil) using induction chemotherapy and then definitive chemoradiotherapy developed at two centers were compared in patients with localized esophageal cancer (LEC). The primary end point was to assess whether any approach would achieve a >= 77.5% 1-year survival rate, surpassing the historical 66% rate from the Radiation Therapy Oncology Group (RTOG) protocol 9405.Patients and MethodsIn a multi-institutional cooperative group setting, patients with LEC who had unresectable cancer, were unwilling to undergo surgery, or were medically unfit for surgery were randomly assigned to receive either induction with fluorouracil, cisplatin, and paclitaxel and then fluorouracil plus paclitaxel with 50.4 Gy of radiation (arm A) or induction with paclitaxel plus cisplatin and then the same chemotherapy with 50.4 Gy of radiation (arm B). Safety and survival rates were assessed.ResultsA total of 84 patients were randomly assigned (arm A, n = 41; arm B, n = 43), and 72 were assessable (arm A, n = 37; arm B, n = 35). The median survival time was 28.7 months for patients in arm A and 14.9 months for patients in arm B (18.8 months for patients in RTOG 9405). The 1-year survival rate of 75.7% in arm A was close to, but did not meet or surpass, the 77.5% goal. The 2-year survival rate was 56% for arm A and 37% for arm B. Grade 3 (arm A = 54%, arm B = 43%) and grade 4 toxicities (arm A = 27%, arm B = 40%) were frequent. Treatment-related death occurred in 3% of patients in arm A and 6% of patients in arm B.ConclusionBoth arms of RTOG 0113 were associated with high morbidity, and the study did not meet its 1-year survival end point.