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完全切除的Ⅰ-Ⅲa期小细胞肺癌患者术后辅助顺铂和依托泊苷的Ⅱ期试验:日本临床肿瘤学会肺癌研究组试验(JCOG9101)

Phase II trial of postoperative adjuvant cisplatin and etoposide in patients with completely resected stage I-IIIa small cell lung cancer: the Japan Clinical Oncology Lung Cancer Study Group Trial (JCOG9101).

作者信息

Tsuchiya Ryosuke, Suzuki Kenji, Ichinose Yukito, Watanabe Yoh, Yasumitsu Tsutomu, Ishizuka Naoki, Kato Harubumi

机构信息

Division of Thoracic Surgery, National Cancer Center Hospital, 1-1 Tsukiji 5 cho-me, Chuo-ku, Tokyo 104-0045, Japan.

出版信息

J Thorac Cardiovasc Surg. 2005 May;129(5):977-83. doi: 10.1016/j.jtcvs.2004.05.030.

DOI:10.1016/j.jtcvs.2004.05.030
PMID:15867769
Abstract

OBJECTIVE

Indications for surgical intervention for very limited small cell lung cancer have not yet been determined. The objective of this study is to determine whether resection followed by cisplatin and etoposide is feasible.

METHODS

From September 1991 through December 1996, 62 patients with completely resected small cell lung cancer who were less than 76 years of age from 17 centers were entered in the trial. Of 62 patients, 61 were eligible, with a median follow-up of 65 months. Chemotherapy consisted of 4 cycles of cisplatin (100 mg/m 2 , day 1) and etoposide (100 mg/m 2 , days 1-3). There were 49 (80%) male patients, 44 with clinical stage I disease, 10 with stage II disease, and 6 with stage IIIa disease.

RESULTS

Forty-two (69%) patients received 4 cycles of cisplatin and etoposide. No treatment-associated mortality was noted. Median survival time was not reached in patients with pathologic stage I disease, was 449 days in patients with stage II disease, and was 712 days in patients with stage IIIa disease. Three-year survival was 61% overall, 68% in patients with clinical stage I disease, 56% in patients with stage II disease, and 13% in patients with stage IIIa disease ( P = .02). Recurrence was noted in 26 (43%) patients overall. Local failure was noted in 6 (10%) patients. Locoregional recurrence tends to be found more frequently in patients with stage IIIA disease. Distant failure was found in 21 (34%) patients overall. Brain metastasis was found in 15% of the patients.

CONCLUSION

Major lung resection followed by postoperative cisplatin and etoposide is feasible, with a favorable survival profile. Because nodal metastasis appears to be a major prognostic factor, preoperative evaluation of nodal status remains a major concern.

摘要

目的

极有限的小细胞肺癌手术干预的指征尚未确定。本研究的目的是确定顺铂和依托泊苷治疗后进行手术切除是否可行。

方法

从1991年9月至1996年12月,来自17个中心的62例年龄小于76岁的完全切除的小细胞肺癌患者进入该试验。62例患者中,61例符合条件,中位随访时间为65个月。化疗包括4个周期的顺铂(100mg/m²,第1天)和依托泊苷(100mg/m²,第1 - 3天)。有49例(80%)男性患者,44例临床分期为I期疾病,10例为II期疾病,6例为IIIA期疾病。

结果

42例(69%)患者接受了4个周期的顺铂和依托泊苷治疗。未观察到与治疗相关的死亡。病理I期疾病患者的中位生存时间未达到,II期疾病患者为449天,IIIA期疾病患者为712天。总体三年生存率为61%,临床I期疾病患者为68%,II期疾病患者为56%,IIIA期疾病患者为13%(P = 0.02)。总体26例(43%)患者出现复发。6例(10%)患者出现局部失败。局部区域复发在IIIA期疾病患者中更常见。总体21例(34%)患者出现远处失败。15%的患者发生脑转移。

结论

肺大部切除术后给予顺铂和依托泊苷是可行的,生存情况良好。由于淋巴结转移似乎是一个主要的预后因素,术前评估淋巴结状态仍然是一个主要关注点。

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