A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (A Vanderbilt cancer center affiliate network study)
A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (A Vanderbilt cancer center affiliate network study)
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DOI：
10.1016/s0360-3016(00)00420-x
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发表时间：
2000-07-01
影响因子：
7
通讯作者：
Johnson, DH
中科院分区：
文献类型：
--
作者：
Choy, H;Devore, RF;Johnson, DH
目的:我们进行了一项前瞻性II期研究，以确定同时每周紫杉醇、卡铂和超分割放疗（紫杉醇/卡铂/HFX RT）的反应率、毒性和生存率，随后进行2个周期的紫杉醇和卡铂治疗局部晚期不可切除的非小细胞肺癌（NSCLC）。每周紫杉醇和卡铂方案旨在优化紫杉醇在并发治疗期间的放射增敏特性。方法和材料：从1996年6月至1997年5月，来自范德比尔特癌症中心和附属网络（VCCAN）机构的43例不可切除的IIIA期和IIIB期非小细胞肺癌患者进入研究，每周静脉注射（IV）紫杉醇（50mg /m(2)/l-小时）和每周卡铂（AUC 2）加同期超分割胸部RT (1.2 Gy/BID/69.6 Gy)，持续6周，随后2个周期紫杉醇（200mg /m(2)）和卡铂（AUC 6）。结果：42例患者的反应和毒性可评估，3例患者达到完全缓解（7.2%），30例患者达到部分缓解（71.4%），总缓解率为78.6% [95% C.I.(66.2%-91.0%)]。43例患者的1年和2年总生存率和无进展生存率分别为61.6%和35%，中位生存时间为14.3个月。中位随访时间为14个月。食管炎是主要的毒性反应。11例（26%）患者发生3级或4级食管炎，3级和4级肺毒性分别为7%和9.5%。结论：每周紫杉醇、卡铂加同期高分割放疗是一种耐受性良好的门诊治疗方案。该方案的反应率令人鼓舞，似乎至少与毒性更大的放化疗试验相当。这些发现支持在一项III期研究中进一步对每周紫杉醇/卡铂/HFX放疗进行临床评估。(C) 2000 Elsevier Science Inc.；
Purpose: We conducted a prospective phase II study to determine the response rate, toxicity, and survival rate of concurrent weekly paclitaxel, carboplatin, and hyperfractionated radiation therapy (paclitaxel/carboplatin/HFX RT) followed by 2 cycles of paclitaxel and carboplatin for locally advanced unresectable non-small cell lung cancer (NSCLC), The weekly paclitaxel and carboplatin regimen was designed to optimize the radiosensitizing properties of paclitaxel during the concurrent phase of treatment.Methods and Materials: Forty-three patients with unresectable stage IIIA and IIIB NSCLC from the Vanderbilt Cancer Center and-Affiliate Network (VCCAN) institutions were entered onto the study from June 1996 until May 1997, Weekly intravenous (IV) paclitaxel (50 mg/m(2)/l-hour) and weekly carboplatin (AUC 2) plus concurrent hyperfractionated chest RT (1.2 Gy/BID/69.6 Gy) were delivered for 6 weeks followed by 2 cycles of paclitaxel (200 mg/m(2)) and carboplatin (AUC 6).Results: Forty-two patients were evaluable for response and toxicities, Three patients achieved a complete response (7.2%) and 30 patients achieved a partial response (71.4%), for an overall response rate of 78.6% [95% C.I. (66.2%-91.0%)]. The 1- and 2-year overall and progression-free survival rates of all 43 patients were 61.6% and 35% respectively, with a median survival time of 14.3 months. The median follow-up time was 14 months. Esophagitis was the principal toxicity. Grade 3 or 4 esophagitis occurred in 11 patients (26%), There was an incidence of 7% grade 3 and 9.5% grade 4 pulmonary toxicities.Conclusions: Weekly paclitaxel, carboplatin, plus concurrent hyperfractionated RT is a well-tolerated outpatient regimen. The response rate from this regimen is encouraging and appears to be at least equivalent to the more toxic chemoradiation trials. These findings warrant further clinical evaluation of weekly paclitaxel/carboplatin/HFX RT in a phase III study. (C) 2000 Elsevier Science Inc.