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局部晚期乳腺癌新辅助吉西他滨、聚乙二醇脂质体多柔比星和多西他赛治疗的 II 期研究。

Phase II study of neoadjuvant gemcitabine, pegylated liposomal doxorubicin, and docetaxel in locally advanced breast cancer.

机构信息

Medical Oncology Department, Istituto Oncologico Veneto/IRCCS, Via Gattamelata 64, 35128 Padova, Italy.

出版信息

Anticancer Res. 2010 Sep;30(9):3817-21.

PMID:20944176
Abstract

AIM

This was a phase II study to assess the activity of a novel neoadjuvant regimen in locally-advanced breast cancer.

PATIENTS AND METHODS

Fifty patients with histological confirmation of locally advanced breast cancer received treatment with gemcitabine 1000 mg/m(2) (day 1) followed by gemcitabine 800 mg/m(2) plus docetaxel 75 mg/m(2) plus pegylated liposomal doxorubicin (PLD) 30 mg/m(2) (day 8) every 3 weeks for at least 4 cycles, plus a final 2 additional cycles. Tumour size was T1 (n=2), T2 (n=32), T3 (n=14), T4 (n=2). All 50 patients underwent surgery.

RESULTS

Clinical complete, partial and no response were observed in 13 (26%), 24 (48%) and 11 (22%) patients, respectively (overall response rate: 74%). The number of chemotherapy cycles was found to be an independent predictor of a pathologic complete response.

CONCLUSION

The combination of gemcitabine-docetaxel-PLD can yield high tumour response rates in patients with locally-advanced breast cancer who undergo a full treatment of 6 cycles.

摘要

目的

这是一项评估新辅助方案治疗局部晚期乳腺癌疗效的 II 期研究。

患者与方法

50 例组织学证实为局部晚期乳腺癌患者接受治疗,方案为吉西他滨 1000mg/m²(第 1 天),随后为吉西他滨 800mg/m²联合多西他赛 75mg/m²联合聚乙二醇化脂质体阿霉素(PLD)30mg/m²(第 8 天),每 3 周为一个周期,至少进行 4 个周期,再加上最后 2 个周期。肿瘤大小为 T1(n=2)、T2(n=32)、T3(n=14)、T4(n=2)。所有 50 例患者均接受了手术。

结果

13 例(26%)、24 例(48%)和 11 例(22%)患者分别观察到临床完全缓解、部分缓解和无缓解(总缓解率:74%)。化疗周期数是病理完全缓解的独立预测因素。

结论

吉西他滨-多西他赛-PLD 联合方案可使接受完整 6 个周期治疗的局部晚期乳腺癌患者获得较高的肿瘤缓解率。

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