一项针对局部晚期直肠癌患者的II期研究:在六周新辅助放化疗后的休息期加用卡培他滨进行四周化疗

A Phase II Study of Additional Four-Week Chemotherapy With Capecitabine During the Resting Periods After Six-Week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer.

作者信息

Lee Kyung Ha, Song Min Sang, Park Jun Boem, Kim Jin Soo, Kang Dae Young, Kim Ji Yeon

机构信息

Department of Surgery, Chungnam National University Hospital, Daejoen, Korea.

出版信息

Ann Coloproctol. 2013 Oct;29(5):192-7. doi: 10.3393/ac.2013.29.5.192. Epub 2013 Oct 31.

Abstract

PURPOSE

The aim of this study is to evaluate the efficacy and the safety of additional 4-week chemotherapy with capecitabine during the resting periods after a 6-week neoadjuvant chemoradiotherapy (NCRT) in patients with locally advanced rectal cancer.

METHODS

Radiotherapy was delivered to the whole pelvis at a total dose of 50.4 Gy for 6 weeks. Oral capecitabine was administered at a dose of 825 mg/m(2) twice daily for 10 weeks. Surgery was performed 2-4 weeks following the completion of chemotherapy.

RESULTS

Between January 2010 and September 2011, 44 patients were enrolled. Forty-three patients underwent surgery, and 41 patients completed the scheduled treatment. Pathologic complete remission (pCR) was noted in 9 patients (20.9%). T down-staging and N down-staging were observed in 32 patients (74.4%) and 33 patients (76.7%), respectively. Grade 3 to 5 toxicity was noted in 5 patients (11.4%). The pCR rate was similar with the pCR rates obtained after conventional NCRT at our institute and at other institutes.

CONCLUSION

This study showed that additional 4-week chemotherapy with capecitabine during the resting periods after 6-week NCRT was safe, but it was no more effective than conventional NCRT.

摘要

目的

本研究旨在评估局部晚期直肠癌患者在接受6周新辅助放化疗(NCRT)后的休息期额外进行4周卡培他滨化疗的疗效和安全性。

方法

对全盆腔进行放疗,总剂量50.4 Gy,为期6周。口服卡培他滨,剂量为825 mg/m²,每日2次,共10周。化疗结束后2 - 4周进行手术。

结果

2010年1月至2011年9月,共纳入44例患者。43例患者接受了手术,41例患者完成了预定治疗。9例患者(20.9%)达到病理完全缓解(pCR)。分别有32例患者(74.4%)和33例患者(76.7%)观察到T分期下降和N分期下降。5例患者(11.4%)出现3至5级毒性反应。pCR率与我院及其他机构采用传统NCRT后获得的pCR率相似。

结论

本研究表明,局部晚期直肠癌患者在6周NCRT后的休息期额外进行4周卡培他滨化疗是安全的,但并不比传统NCRT更有效。

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