Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic Conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105
Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic Conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105
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DOI：
10.1200/jco.2007.14.7371
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发表时间：
2008-05-20
影响因子：
45.3
通讯作者：
Vokes, Everett E.
中科院分区：
文献类型：
--
作者：
Socinski, Mark A.;Blackstock, A. William;Vokes, Everett E.
目的评价74戈伊胸部放疗（TRT）联合诱导化疗治疗IIIA/B期非小细胞肺癌（NSCLC）的疗效。（曲线下面积[AUC]，6;第1天和第22天）（225 mg/m2;第1天和第22天; A组）或卡铂（AUC，5;第1天和第22天）与吉西他滨（1，000 mg/m2;第1、8、22和29天; B组）。在第43天，A组接受每周一次卡铂（AUC，2）和紫杉醇（45 mg/m2），而B组接受每两周一次吉西他滨（35 mg/m2），均与74戈伊TRT同时使用三维治疗计划。主要终点是生存18 months. ResultsForth-three和26例患者分别加入A组和B组。B组由于4 - 5级肺毒性发生率较高而提前关闭。A组和B组的总体缓解率分别为66.6%（95% CI，50.5%-80.4%）和69.2%（95% CI，48.2%-85.7%）。A组和B组的中位生存时间（MST）和1年生存率分别为24.3个月（95% CI，12.3 - 36.4）和66.7%（95% CI，50.3 - 78.7）以及12.5个月（95% CI，9.4 - 27.6）和50.0%（95% CI，29.9 - 67.2）。主要毒性包括食管炎，肺，和fatigue.ConclusionArm A达到的主要终点，估计MST超过18个月，并将与标准剂量的TRT在计划中的随机III期试验在美国合作组。
PurposeTo evaluate 74 Gy thoracic radiation therapy (TRT) with induction and concurrent chemotherapy in stage IIIA/B non-small-cell lung cancer (NSCLC).Patients and MethodsPatients with stage IIIA/B NSCLC were randomly assigned to induction chemotherapy with either carboplatin (area under the curve [AUC], 6; days 1 and 22) with paclitaxel (225 mg/m(2); days 1 and 22; arm A) or carboplatin (AUC, 5; days 1 and 22) with gemcitabine (1,000 mg/m(2); days 1, 8, 22, and 29; arm B). On day 43, arm A received weekly carboplatin (AUC, 2) and paclitaxel (45 mg/m(2)) while arm B received biweekly gemcitabine (35 mg/m(2)) both delivered concurrently with 74 Gy of TRT utilizing three-dimensional treatment planning. The primary end point was survival at 18 months.ResultsForty-three and 26 patients were accrued to arms A and B, respectively. Arm B was closed prematurely due to a high rate of grade 4 to 5 pulmonary toxicity. The overall response rate was 66.6% (95% CI, 50.5% to 80.4%) and 69.2% (95% CI, 48.2% to 85.7%) on arm A and B, respectively. The median survival time (MST) and 1-year survival rate was 24.3 months (95% CI, 12.3 to 36.4) and 66.7% (95% CI, 50.3 to 78.7) and 12.5 months (95% CI, 9.4 to 27.6) and 50.0% (95% CI, 29.9 to 67.2) for arms A and B, respectively. The primary toxicities included esophagitis, pulmonary, and fatigue.ConclusionArm A reached the primary end point with an estimated MST longer than 18 months and will be compared with a standard dose of TRT in a planned randomized phase III trial in the United States cooperative groups.