Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: results from a phase I/II study.

Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: results from a phase I/II study.
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DOI:
10.1038/sj.bjc.6603053
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发表时间:
2006-04-10
影响因子:
8.8
通讯作者:
Fietkau, R
Fietkau, R
中科院分区:
医学1区
文献类型:
--
作者:
Klautke, G;Küchenmeister, U;Foitzik, T;Ludwig, K;Prall, F;Klar, E;Fietkau, R

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本研究的目的是探讨使用卡培他滨和伊立替康作为直肠癌患者新辅助治疗的放化疗的疗效和安全性。常规放射剂量为每日 1.8Gy,每周 5 天,总剂量为 55.8 (50.4+5.4)Gy。同时,每周一次给予伊立替康 40mgm−2,并连续给予卡培他滨,剂量水平为 500、650、750 和 825mgm−2,每天两次。放化疗结束后 4-6 周进行手术。共有 28 名患者(3 名 UICC II,25 名 UICC III)入组并全部接受治疗。剂量限制性毒性为 825mgm−2 剂量水平下的 IV 级腹泻和手足综合征。卡培他滨的最大耐受剂量为750mgm−2。腹泻是最常见的毒性:9 名患者为 III 级。两名患者死亡,一名死于肺炎,一名死于心源性猝死。 4 名和 3 名患者 (27%) 获得了完全缓解,仅出现微灶性残留肿瘤病变。总共 28 名接受手术的患者中,有 25 名患者进行了 R0 切除,其中 24 名患者(96%)接受了 R0 切除。基于连续每日卡培他滨和每周伊立替康的术前放化疗对于直肠癌患者似乎是耐受且有效的。
The aim of this study was to investigate the efficacy and safety of chemoradiation using capecitabine and irinotecan as neoadjuvant therapy for patients with rectal cancer. Conventional radiation was given at daily fractions of 1.8 Gy on 5 days a week for a total dose of 55.8 (50.4+5.4) Gy. Concurrently, irinotecan 40 mg m−2 once weekly and capecitabine continuously at dose levels of 500, 650, 750 and 825 mg m−2 twice daily were administered. Surgery was performed 4–6 weeks following completion of chemoradiation. A total of 28 patients (3 UICC II, 25 UICC III) were enrolled and all received treatment. Dose-limiting toxicity was diarrhoea grade IV and hand–foot syndrome at the 825 mg m−2 dose level. The maximum tolerated dose of capecitabine was 750 mg m−2. Diarrhoea was the most common toxicity: grade III in nine patients. Two patients died, one due to pneumonia and one due to sudden cardiac death. A complete response and only microfocal residual tumour disease was achieved in four and three patients (27%). In all, 25 of 28 patients undergoing surgery, 24 (96%) had R0 resection. Preoperative chemoradiation based on continuous daily capecitabine and weekly irinotecan appears to tolerated and effective in patients with rectal cancer.
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