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紫杉醇联合顺铂三周方案诱导化疗联合同步放化疗加或不加手术治疗局部晚期非小细胞肺癌的Ⅱ期临床研究

Induction chemotherapy with triweekly docetaxel and cisplatin followed by concomitant chemoradiotherapy with or without surgery in stage III non-small-cell lung cancer: a phase II study.

机构信息

Institute of Oncology, Istanbul University, Turkey.

出版信息

Clin Lung Cancer. 2011 Sep;12(5):286-92. doi: 10.1016/j.cllc.2011.03.030. Epub 2011 May 8.

DOI:10.1016/j.cllc.2011.03.030
PMID:21729649
Abstract

BACKGROUND

The main goal of this study was to evaluate the feasibility and effectivity of triweekly docetaxel/cisplatin followed by weekly docetaxel/cisplatin concomitantly with radiotherapy with or without surgery in locally advanced non-small-cell lung cancer (NSCLC) patients.

MATERIALS AND METHODS

Thirty five patients with locally advanced NSCLC were enrolled. Combination chemotherapy with triweekly docetaxel/cisplatin (75 mg/m(2)) was administered as induction regimen. After induction chemotherapy, patients were evaluated for surgery if their disease subsequently downstaged. Six cycles of weekly docetaxel/cisplatin (20 mg/m(2)) concurrently with radiotherapy up to a 60 Gy were administered after induction chemotherapy with or without surgery. Response, toxicity, time-to-progression and overall survival were evaluated.

RESULTS

Twelve patients with stage IIIA-N2 and 23 patients with stage IIIB-T4N0-2 were evaluated (median age, 54 years). After 94 cycles of induction chemotherapy, partial response was achieved in 20 patients, 9 patients had stable disease and six had progressive disease. After overall treatment, 6 patients achieved complete response, 19 patients had partial response, 8 patients had progressive disease, and 2 patients had stable disease. Two patients experienced grade 3-4 pulmonary toxicity and 1 patient experienced grade 3 esophageal toxicity. Six patients underwent surgery. Median overall survival for all patients was 15 months and time-to-progression was 13 months with a median follow-up of 22 months.

CONCLUSION

Triweekly docetaxel plus cisplatin followed by weekly docetaxel plus cisplatin concomitantly with radiotherapy is effective and feasible and seems to be an alternative option for patients who have locally advanced NSCLC. Surgery may provide additional benefit for patients whose disease adequately downstaged after induction chemotherapy.

摘要

背景

本研究的主要目的是评估在局部晚期非小细胞肺癌(NSCLC)患者中,每周紫杉醇/顺铂联合放疗与或不与手术同时进行的三周紫杉醇/顺铂序贯化疗的可行性和有效性。

材料与方法

共纳入 35 例局部晚期 NSCLC 患者。诱导化疗采用每周紫杉醇/顺铂(75mg/m²)联合方案。诱导化疗后,如果疾病降期,患者可接受手术评估。诱导化疗后,无论是否手术,均给予每周紫杉醇/顺铂(20mg/m²)联合放疗,直至 60Gy。评估反应、毒性、进展时间和总生存期。

结果

12 例 IIIA-N2 期和 23 例 IIIB-T4N0-2 期患者(中位年龄 54 岁)纳入研究。94 个周期的诱导化疗后,20 例患者部分缓解,9 例患者疾病稳定,6 例患者疾病进展。总的治疗后,6 例患者达到完全缓解,19 例患者部分缓解,8 例患者疾病进展,2 例患者疾病稳定。2 例患者发生 3-4 级肺毒性,1 例患者发生 3 级食管毒性。6 例患者接受了手术。所有患者的中位总生存期为 15 个月,进展时间为 13 个月,中位随访时间为 22 个月。

结论

每周紫杉醇联合顺铂序贯三周紫杉醇联合顺铂联合放疗对局部晚期 NSCLC 患者有效且可行,似乎是局部晚期 NSCLC 患者的另一种选择。对于诱导化疗后疾病充分降期的患者,手术可能会带来额外的获益。

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