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大剂量他莫昔芬联合顺铂和依托泊苷治疗晚期不可切除非小细胞肺癌患者

High dose tamoxifen plus cisplatin and etoposide in the treatment of patients with advanced, inoperable nonsmall cell lung carcinoma.

作者信息

Yang C H, Cheng A L, Yeh K H, Yu C J, Lin J F, Yang P C

机构信息

Department of Oncology, National Taiwan University Hospital, Taipei.

出版信息

Cancer. 1999 Aug 1;86(3):415-20. doi: 10.1002/(sici)1097-0142(19990801)86:3<415::aid-cncr9>3.0.co;2-h.

Abstract

BACKGROUND

Tamoxifen sensitizes cancer cells to chemotherapeutic agents. High dose tamoxifen has been tested in the treatment of patients with melanoma and other cancers. The authors conducted a Phase II study of high dose tamoxifen plus cisplatin and etoposide for patients with advanced, inoperable nonsmall cell lung carcinoma.

METHODS

Patients with Stage IIIB, Stage IV, or recurrent disease; good performance status; measurable lesions; and good organ function were eligible. Tamoxifen 150 mg/m2/day, divided into 4 doses, was given for 8 days. Cisplatin 60 mg/m2 was given on Day 4. Etoposide 60 mg/m2/day was given on Days 4-8. Patients were allowed to remain in the study until either intolerable toxicity was observed or disease progression occurred.

RESULTS

Forty patients were accrued and received a total of 191 cycles of treatment. All patients were evaluable for response and toxicity. One patient had a complete remission and 14 had a partial remission (overall response rate, 37.5%). The median survival was 47 weeks. One-year survival was 44%. Increased thrombotic episodes were noted; all were clinically manageable.

CONCLUSIONS

High dose tamoxifen can be administered safely in combination with cisplatin and etoposide to patients with advanced nonsmall cell lung carcinoma. Favorable response rates and survival times were obtained. The value of high dose tamoxifen in the treatment of patients with nonsmall cell lung carcinoma can be evaluated further in randomized Phase III studies.

摘要

背景

他莫昔芬可使癌细胞对化疗药物敏感。高剂量他莫昔芬已在黑色素瘤和其他癌症患者的治疗中进行了试验。作者开展了一项针对晚期、无法手术的非小细胞肺癌患者的高剂量他莫昔芬联合顺铂和依托泊苷的II期研究。

方法

符合条件的患者为IIIB期、IV期或复发性疾病患者;体能状态良好;有可测量病灶;器官功能良好。他莫昔芬150mg/m²/天,分4次给药,共8天。顺铂60mg/m²在第4天给药。依托泊苷60mg/m²/天在第4 - 8天给药。患者可继续留在研究中,直至观察到无法耐受的毒性或疾病进展。

结果

共纳入40例患者,接受了总计191个周期的治疗。所有患者均可评估疗效和毒性。1例患者完全缓解,14例部分缓解(总缓解率为37.5%)。中位生存期为47周。1年生存率为44%。观察到血栓形成事件增加;所有事件在临床上均可处理。

结论

高剂量他莫昔芬可与顺铂和依托泊苷联合安全地用于晚期非小细胞肺癌患者。获得了良好的缓解率和生存时间。高剂量他莫昔芬在非小细胞肺癌患者治疗中的价值可在随机III期研究中进一步评估。

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