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ORIGINAL ARTICLE
Year : 2014  |  Volume : 10  |  Issue : 2  |  Page : 330-336

Concurrent chemo-irradiation with weekly cisplatin and paclitaxel in the treatment of locally advanced squamous cell carcinoma of cervix: A phase II study


1 Department of Radiation Oncology Unit I, Christian Medical College, Vellore, Tamil Nadu, India
2 Department of Radiology, Christian Medical College, Vellore, Tamil Nadu, India
3 Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India

Correspondence Address:
Sunitha Susan Varghese
Department of Radiation Oncology Unit I, Christian Medical College, Vellore, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0973-1482.136621

Clinical trial registration CTRI/2008/091/000029

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Background: Cervical cancer is the most common gynecological cancer in Indian women. This study was initiated to assess whether the combination of paclitaxel and cisplatin with radiation was feasible in Indian women. Aims and Objectives: The aim of this study was to assess the immediate tumor response and toxicity of weekly cisplatin and paclitaxel along with radiotherapy in the treatment of cervical cancer. Materials and Methods: Women with primary untreated squamous cell carcinoma of the cervix with FIGO stages IB2 to IIIB were treated with weekly injections of cisplatin 30 mg/m2and paclitaxel 40 mg/m2 for 4 weeks along with radiotherapy. A total of 25 patients were enrolled in this study. Disease was assessed prior to treatment by pelvic examination and contrast enhanced computed tomography scan of the abdomen and pelvis. Response was assessed 6 weeks after completion of treatment using the same parameters. Clinical and radiological response was documented. The toxicity was assessed and was graded using the common toxicity criteria Version 3.0. Intention to treat analysis was used when reporting results. Results: A total of 23 patients completed the intended treatment. There was a complete response rate of 88%, 12% were not available for response assessment. The major toxicity was Grade 3 diarrhea (48%). The mean duration of treatment was 58 days. Conclusions: Combination chemotherapy with cisplatin and paclitaxel along with radiotherapy in patients with locally advanced squamous cell carcinoma of cervix had a high incidence of acute toxicity. There was no increase in immediate tumor response and progression free survival with this treatment regimen. Hence, this regimen offers no added benefit when compared to the chemo radiation with cisplatin alone.

Abstract in Chinese

局部晚期鳞状细胞宫颈癌顺铂和紫杉醇同步放化疗II期研究 摘要 背景:在印度宫颈癌是女性最常见的妇科肿瘤。本研究评估是否在印度妇女的紫杉醇联合顺铂与放疗相结合是可行的。 目的:本研究的目的是评估每周顺铂和紫杉醇同步放疗对于宫颈癌的疗效及毒性反应。 材料和方法:25例未经治疗的原发性FIGO分级IB2到IIIB期的宫颈鳞状细胞癌的妇女,每周注射顺铂3030 mg/m2,紫杉醇30 mg/m2,共4周,同步放射治疗。治疗前用CT扫描腹部和盆腔进行疾病的评估。6周的治疗完成后,使用相同的参数。临床和放射学的反应被记录。使用通用毒性标准版本3.0对毒性进行了评估和分级。 结果:共有23例完成预期的处理。完全缓解率88%,12%反应评估无法得到。不良反应主要为3级腹泻(48%)。平均治疗时间为58天。 结论:宫颈局部晚期鳞状细胞癌患者用顺铂和紫杉醇的联合化疗加放疗的急性毒性反应发生率高,而且对肿瘤治疗的有效率和无进展生存没有增加。因此,联合化疗加放疗相比单药顺铂联合放疗并未能提供更多获益。 关键词:宫颈癌,顺铂,紫杉醇,化疗,放疗



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