每周一次伊立替康联合顺铂治疗既往未治疗的广泛期肺外小细胞癌患者的II期研究
Phase II study of weekly irinotecan plus cisplatin in patients with previously untreated extensive-stage extrapulmonary small cell carcinoma.
作者信息
Jin Shidai, Wang Tongshan, Chen Xiaofeng, Xu Bei, Sun Jing, Guo Renhua, Shu Yongqian
机构信息
Department of Medical Oncology, The First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, P.R. China.
出版信息
Onkologie. 2011;34(7):378-81. doi: 10.1159/000329609. Epub 2011 Jun 24.
BACKGROUND
The regimen of weekly irinotecan plus cisplatin (IP) is used for treatment of small cell lung cancer (SCLC). We conducted a phase II trial to evaluate the efficacy and toxicity of weekly IP in patients with previously untreated extensive-stage extrapulmonary small cell carcinoma (EPSCC).
PATIENTS AND METHODS
15 patients with previously untreated extensive-stage EPSCC were enrolled. They received 60 mg/m2 of irinotecan on days 1, 8 and 15, and 25 mg/m(2) of cisplatin days 1-3. This regimen was given every 28 days, and efficacy was evaluated after 2 cycles.
RESULTS
Objective responses were observed in 10 patients (66.7%), including 3 complete responses (20%) and 7 partial responses (46.7%). The median time to tumor progression was 4.5 months, the median survival time was 11.4 months, and the 1-year survival rate was 46.7%. Toxicities were relatively mild, and there were no treatment-related deaths.
CONCLUSIONS
Weekly IP has significant activity in extensive-stage EPSCC. The regimen was well tolerated, with acceptable myelosuppression and treatment-related diarrhea.
背景
每周一次的伊立替康联合顺铂（IP）方案用于治疗小细胞肺癌（SCLC）。我们进行了一项II期试验，以评估每周一次IP方案对先前未经治疗的广泛期肺外小细胞癌（EPSCC）患者的疗效和毒性。
患者与方法
招募了15例先前未经治疗的广泛期EPSCC患者。他们在第1、8和15天接受60mg/m²的伊立替康，在第1 - 3天接受25mg/m²的顺铂。该方案每28天进行一次，在2个周期后评估疗效。
结果
10例患者（66.7%）观察到客观缓解，包括3例完全缓解（20%）和7例部分缓解（46.7%）。肿瘤进展的中位时间为4.5个月，中位生存时间为11.4个月，1年生存率为46.7%。毒性相对较轻，且无治疗相关死亡。
结论
每周一次的IP方案对广泛期EPSCC具有显著活性。该方案耐受性良好，骨髓抑制和治疗相关腹泻可接受。
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