Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer
Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer
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DOI：
10.1200/jco.20.1.160
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发表时间：
2002-01-01
影响因子：
45.3
通讯作者：
Schulz, JJ
中科院分区：
文献类型：
--
作者：
Cartwright, TH;Cohn, A;Schulz, JJ
目的：确定卡培他滨的安全性和有效性（希罗达; Roche Laboratories，Nutley，NJ）治疗转移性或不可切除的局部晚期胰腺癌患者。42例患者口服卡培他滨1，250 mg/m2，每日2次（2，500 mg/m2/d）作为3周周期的间歇治疗，包括2周治疗，随后1周不治疗。每隔6周（每两个周期后）通过计算机断层扫描或体格检查评估肿瘤病变。在治疗过程中和最后一次给药后28天的研究drug.Results：10（24%）的42例患者经历了临床获益反应（95%置信区间[CI]，12.1%至39.5%）证明疼痛强度，止痛药消耗，和/或Karnofsky性能状态的改善。41例可测量疾病患者中有3例（7.3%）出现客观缓解（部分）。3例缓解患者的中位客观缓解时间为85天（范围：47 - 91天），缓解持续时间分别为208、260和566天。1例患有不可测量但可评估疾病的患者的残留疾病改善，临床获益反应为阳性，42例可评估患者中共有4例缓解，总缓解率为9.5%（90% CI，3.3%-20.5%）。卡培他滨一般耐受良好。结论：治疗与卡培他滨导致临床上显着的有益效果，肿瘤相关症状，并取得了客观的反应活性转移性或局部晚期胰腺癌患者。这些结果连同其一般可耐受的安全性特征和口服给药的额外优势，为在该患者人群中进一步评价卡培他滨作为单药或与其他治疗方式联合使用提供了基础。(C)2001年，美国临床肿瘤学会。
Purpose: To determine the safety and efficacy of capecitabine (Xeloda; Roche Laboratories, Nutley, NJ) in patients with metastatic or unresectable, locally advanced pancreatic cancer.Patients and Methods: Forty-two patients were treated with oral capecitabine 1,250 mg/m(2) administered twice daily (2,500 mg/m(2)/d) as intermittent therapy in 3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment. Tumor lesions were assessed by computed tomography scan or physical examination at 6-week intervals (after every two cycles). Adverse events were monitored continuously during treatment and for 28 days after the last dose of study drug.Results: Ten (24%) of 42 patients experienced a clinical benefit response (95% confidence interval [Cl], 12.1% to 39.5%) as evidenced by improvement in pain intensity, analgesic consumption, and/or Karnofsky performance status. Three (7.3%) of the 41 patients with measurable disease had an objective response (partial). The median time to objective response was 85 days (range, 47 to 91 days) and duration of response was 208, 260, and 566 days for the three responding patients. One patient with nonmeasurable but assessable disease had improved residual disease with a positive clinical benefit response, for a total of four responses among the 42 assessable patients, for an overall response rate of 9.5% (90% Cl, 3.3% to 20.5%). Capecitabine was generally well tolerated.Conclusion: Treatment with capecitabine resulted in clinically significant beneficial effects on tumor-related symptoms and yielded objective response activity in patients with metastatic or locally advanced pancreatic cancer. These results together with its generally tolerable safety profile and the added advantage of oral administration provide the basis for further evaluating capecitabine as a single agent or in combination with other treatment modalities in this patient population. (C) 2001 by American Society of Clinical Oncology.