Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer
Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer
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DOI：
10.1200/jco.2002.02.049
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发表时间：
2002-10-01
影响因子：
45.3
通讯作者：
Frings, S
中科院分区：
文献类型：
--
作者：
Dunst, J;Reese, T;Frings, S
目的：建立并行放疗和卡培他滨的可行性，并确定最大耐受剂量（MTD）在直肠癌patients with rectal cancer.Patients和方法：36例直肠癌患者接受治疗的辅助，新辅助，或姑息性设置与总照射剂量为50.4戈伊与1.8戈伊/d在大约6周。放疗期间，卡培他滨的剂量从250 mg/m2递增至1，250 mg/m2，bid（包括周末）。MTD的定义是当一个队列中的三个或六个患者中有两个或更多的患者出现剂量限制性毒性。结果：在卡培他滨剂量为1，000 mg/m2 bid的六名患者中，有两名患者出现剂量限制性3级手足综合征。其他毒性通常罕见和/或轻度，仅1例非剂量限制性3级腹泻和1例3级皮肤毒性。骨髓抑制主要包括白细胞减少，最大严重程度为2级。因此，825 mg/m2 bid的剂量是进一步评估的推荐剂量水平。一个病理T3 N1肿瘤的完全缓解和9个部分缓解观察到10例患者在新辅助setting.Conclusion治疗：第11期评价的推荐剂量是卡培他滨825 mg/m（2）bid，在约6周的常规放疗期间不间断给药。这种联合治疗方法被证明是一种可行的、耐受性良好的治疗选择，在直肠癌中具有良好的初步疗效。
Purpose : To establish the feasibility of concurrent radiotherapy and capecitabine and define the maximum-tolerated dose (MTD) in patients with rectal cancer.Patients and Methods: Thirty-six patients with rectal cancer received treatment in the adjuvant, neoadjuvant, or palliative setting with a total irradiation dose of 50.4 Gy with 1.8 Gy/d in approximately 6 weeks. Capecitabine was administered at escalating doses from 250 to 1,250 mg/m(2) bid (including weekends) for the duration of radiotherapy. The MTD was defined when two or more patients in a cohort of three or six patients experienced dose-limiting toxicities.Results: Dose-limiting grade 3 hand-foot syndrome was observed in two of six patients treated at a capecitabine dose of 1,000 mg/m(2) bid. Other toxicities were generally rare and/or mild, with only one case of non-dose-limiting grade 3 diarrhea and a single patient with grade 3 skin toxicity. Myelosuppression consisted mainly of leukocytopenia, with a maximum severity of grade 2. Thus, a dosage of 825 mg/m(2) bid is the recommended dose level for further evaluation. One pathologic complete remission of a T3N1 tumor and nine partial remissions were observed in 10 patients treated in the neoadjuvant setting.Conclusion: The recommended dose for phase 11 evaluation is capecitabine 825 mg/m(2) bid, administered without break during a conventional radiotherapy period of about 6 weeks. This combined-modality approach proved to be a feasible and well-tolerated treatment option with promising preliminary efficacy results in rectal cancer.