Oral capecitabine in gemcitabine-pretreated patients with advanced pancreatic cancer
Oral capecitabine in gemcitabine-pretreated patients with advanced pancreatic cancer
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DOI：
10.1159/000127413
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发表时间：
2007-01-01
期刊：
影响因子：
3.5
通讯作者：
Heinemann, Volker
中科院分区：
文献类型：
--
作者：
Boeck, Stefan;Wilkowski, Ralf;Heinemann, Volker
目的：到目前为止，晚期胰腺癌（PC）患者在吉西他滨（Gem）失效后，还没有确定挽救性化疗的标准方案。口服卡培他滨（Cap）在PC患者的一线化疗试验中显示出有希望的活性。方法：在一项前瞻性单中心研究中，Cap被提供给已经接受过至少一种先前含有全剂量Gem的治疗方案的患者（作为单一药物，作为联合化疗方案的一部分，或在放化疗方案中顺序）。Cap以1,250 mg/m(2)的剂量口服，每天两次，连续14天，然后休息7天。研究终点为客观肿瘤显像率（根据RECIST）、碳水化合物抗原19-9 （CA19-9）肿瘤标志物反应、进展时间、总生存期和毒性。结果：39例患者接受了中位3个治疗周期（范围1-36）。中位随访6.6个月后，27例患者可评估缓解：未观察到完全或部分缓解，但15例患者（39%）病情稳定。6例患者（15%）在2个Cap周期后，CA19-9降低了20%。中位进展时间为2.3个月（范围0.5-45.1），中位总生存期（自Cap治疗开始）为7.6个月（范围0.7-45.1）。主要的2级和3级毒性（每个患者分析）是手足综合征28%(3级13%)；贫血23%;腿部水肿15%；腹泻13%;恶心/呕吐10%，白细胞减少10%。结论：单药Cap是gem预处理晚期PC患者的安全治疗选择。建议在gem预处理的晚期PC患者的对照临床试验中进一步评估Cap。版权所有2008 S. Karger AG，巴塞尔
Objective: To date, no standard regimen for salvage chemotherapy after gemcitabine (Gem) failure has been defined for patients with advanced pancreatic cancer (PC). Oral capecitabine (Cap) has shown promising activity in first-line chemotherapy trials in PC patients. Methods: Within a prospective single-center study, Cap was offered to patients who had already received at least 1 previous treatment regimen containing full-dose Gem (as a single agent, as part of a combination chemotherapy regimen or sequentially within a chemoradiotherapy protocol). Cap was administered orally at a dose of 1,250 mg/m(2) twice daily for 14 days followed by 7 days of rest. Study endpoints were objective tumor response rate by imaging criteria (according to RECIST), carbohydrate antigen 19-9 (CA19-9) tumor marker response, time to progression, overall survival and toxicity. Results: A median of 3 treatment cycles (range 1-36) was given to 39 patients. After a median follow-up of 6.6 months, 27 patients were evaluable for response: no complete or partial responses were observed, but 15 patients (39%) had stable disease. A CA19-9 reduction of >20% after 2 cycles of Cap was documented in 6 patients (15%). Median time to progression was 2.3 months (range 0.5-45.1) and median overall survival (since start of Cap treatment) was 7.6 months (range 0.7-45.1). Predominant grade 2 and 3 toxicities (per patient analysis) were hand-foot syndrome 28% (13% grade 3); anemia 23%; leg edema 15%; diarrhea 13%; nausea/vomiting 10%, and leukocytopenia 10%. Conclusion: Single-agent Cap is a safe treatment option for Gem-pretreated patients with advanced PC. Further evaluation of Cap in controlled clinical trials of Gem-pretreated patients with advanced PC is recommended. Copyright (C) 2008 S. Karger AG, Basel.