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每周一次紫杉醇与每三周一次紫杉醇用于复发性铂耐药上皮性卵巢癌和腹膜癌的疗效比较:一项III期研究

Weekly Paclitaxel Versus Three-Weekly Paclitaxel in Recurrent Platinum-Resistant Epithelial Ovarian and Peritoneal Cancers: A Phase III Study.

作者信息

Osman Mohammed A, Elkady Mohammad S, Nasr Khalid E

机构信息

Consultant, Clinical Oncology, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.

Assistant Professor, Clinical Oncology, Ain Shams University, Cairo, Egypt.

出版信息

Clin Med Insights Oncol. 2016 Apr 25;10:35-41. doi: 10.4137/CMO.S38204. eCollection 2016.

Abstract

INTRODUCTION

Treatment of recurrent platinum-resistant ovarian and peritoneal cancers represents a therapeutic challenge. The aim of this Phase III prospective study was to compare the survival benefits, objective response rate, and toxicities among patients treated by weekly paclitaxel with those who underwent three-weekly paclitaxel in recurrent platinum-resistant ovarian and peritoneal cancers.

METHOD

Patients with recurrent platinum-resistant ovarian and peritoneal cancer were allocated to receive either weekly paclitaxel (arm 1) at 80 m/m(2) or three-weekly paclitaxel (arm 2) at 175 mg/m(2).

RESULTS

Fifty-five patients were enrolled (30 arm 1, 25 arm 2). The mean age was 56.7 years, and the median performance status was 0 (Eastern Cooperative Oncology Group [ECOG]). For arms 1 and 2, the objective response rates were 27% and 16%, the median progression-free survival were 7 and 4.5 months, and the median overall survival were 15.5 and 12.5 months, respectively. Treatments also significantly improved the quality of life. Treatment was associated with mild toxicities, and while neuropathy was slightly higher for weekly paclitaxel over three-weekly paclitaxel, hematological toxicities were significantly lower for the former than the latter.

CONCLUSION

Paclitaxel rechallenge showed antitumor activity in recurrent platinum-resistant ovarian and peritoneal cancers. Weekly paclitaxel achieved better results than three-weekly paclitaxel in terms of survival benefits, quality of life, and toxicities.

摘要

引言

复发性铂耐药卵巢癌和腹膜癌的治疗是一项治疗挑战。这项III期前瞻性研究的目的是比较复发性铂耐药卵巢癌和腹膜癌患者接受每周一次紫杉醇治疗与每三周一次紫杉醇治疗的生存获益、客观缓解率和毒性。

方法

将复发性铂耐药卵巢癌和腹膜癌患者分配接受80mg/m²的每周一次紫杉醇(第1组)或175mg/m²的每三周一次紫杉醇(第2组)。

结果

招募了55名患者(第1组30名,第2组25名)。平均年龄为56.7岁,中位体能状态为0(东部肿瘤协作组[ECOG])。对于第1组和第2组,客观缓解率分别为27%和16%,中位无进展生存期分别为7个月和4.5个月,中位总生存期分别为15.5个月和12.5个月。治疗也显著改善了生活质量。治疗相关毒性较轻,虽然每周一次紫杉醇的神经病变略高于每三周一次紫杉醇,但前者的血液学毒性明显低于后者。

结论

紫杉醇再挑战在复发性铂耐药卵巢癌和腹膜癌中显示出抗肿瘤活性。在生存获益、生活质量和毒性方面,每周一次紫杉醇比每三周一次紫杉醇取得了更好的结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0e0/4847552/a2d42705be20/cmo-10-2016-035f1.jpg

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