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改良型每周一次白蛋白结合型紫杉醇与卡铂辅助化疗用于完全切除的非小细胞肺癌的可行性研究:FAST-nab研究

Feasibility study of adjuvant chemotherapy with modified weekly nab-paclitaxel and carboplatin for completely resected non-small-cell lung cancer: FAST-nab.

作者信息

Saji Hisashi, Marushima Hideki, Miyazawa Tomoyuki, Sakai Hiroki, Kimura Hiroyuki, Kurimoto Noriaki, Nakamura Haruhiko

机构信息

Department of Chest Surgery, St Marianna University School of Medicine, Kawasaki, Japan.

出版信息

Anticancer Drugs. 2017 Aug;28(7):795-800. doi: 10.1097/CAD.0000000000000512.

Abstract

The aim of this study was to determine the feasibility of adjuvant administration of nab-paclitaxel (nab-P) plus carboplatin and for completely resected patients with stage IB, II, and IIIA non-small-cell lung cancer (NSCLC) (FAST-nab study, UMIN000011225). Twenty-nine eligible NSCLC patients received surgical resection for pathological stage IB, II, or IIIA, followed by postoperative adjuvant chemotherapy with modified 3-week cycles of either nab-P (100 mg/m) on days 1 and 8, followed by carboplatin area (area under the curve=6) on day 1. Twenty-two (75.9%) of the 29 patients enrolled completed four cycles of this regimen. The most common grade 3 or 4 adverse event experienced during the nab-P plus carboplatin was neutropenia (34.5%), followed by anemia (13.8%). No grade 3 or 4 nonhematologic adverse event was observed during this chemotherapy. The median time to disease recurrence survival was 21 (95% confidence interval: 16-26) months. The administration of modified nab-P plus carboplatin was considered an attractive alternative regimen that was safe and well tolerated as a postoperative adjuvant chemotherapy for completed resected NSCLC.

摘要

本研究的目的是确定在完全切除的ⅠB期、Ⅱ期和ⅢA期非小细胞肺癌(NSCLC)患者中辅助使用白蛋白结合型紫杉醇(nab-P)加卡铂的可行性(FAST-nab研究,UMIN000011225)。29例符合条件的NSCLC患者接受了手术切除,病理分期为ⅠB期、Ⅱ期或ⅢA期,随后接受术后辅助化疗,采用改良的3周周期方案,即第1天和第8天给予nab-P(100mg/m²),然后在第1天给予卡铂曲线下面积(曲线下面积=6)。29例入组患者中有22例(75.9%)完成了四个周期的该方案治疗。在nab-P加卡铂治疗期间,最常见的3级或4级不良事件是中性粒细胞减少(34.5%),其次是贫血(13.8%)。在该化疗期间未观察到3级或4级非血液学不良事件。疾病复发存活的中位时间为21个月(95%置信区间:16-26个月)。改良的nab-P加卡铂给药被认为是一种有吸引力的替代方案,作为完全切除的NSCLC术后辅助化疗,其安全性良好且耐受性佳。

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