Giordano K F, Jatoi A, Stella P J, Foster N, Tschetter L K, Alberts S R, Dakhil S R, Mailliard J A, Flynn P J, Nikcevich D A
Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
Ann Oncol. 2006 Apr;17(4):652-6. doi: 10.1093/annonc/mdl005. Epub 2006 Feb 23.
Previous studies suggest that the combination of docetaxel and capecitabine are worthy of further testing in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. We therefore undertook this phase II study to test this combination in a multi-institutional, first-line clinical trial.
Forty-four eligible patients with histologic or cytologic confirmation of the above malignancy were recruited. The cohort had Eastern Cooperative Oncology Group performance scores of 0, 1 and 2 in 59%, 39% and 2% of patients, respectively. Median age was 57 years (range 32-77 years). Adequate organ function was a requirement for study entry. All patients were prescribed docetaxel 75 mg/m2 intravenously on day 1 and capecitabine 825 mg/m2 orally twice a day on days 1-14 of a 21-day cycle.
The tumor response rate was 39% [95% confidence interval (CI) 23% to 55%]. There were two complete responses and the rest were partial. Median survival was 9.4 months (95% CI 6.3-10.7 months) and median time-to-tumor progression was 4.2 months (95% CI 3.6-5.6 months). There was one treatment-related death from a myocardial infarction and dysrhythmia. Commonly occurring grade 3 adverse events included neutropenia (11 patients), infection (five patients), constipation (three patients), thrombosis (three patients), dyspnea (three patients) and hand-foot syndrome (three patients). In addition, 24/45 patients developed grade 4 neutropenia.
The regimen docetaxel and capecitabine shows activity in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. This regimen merits further study.
既往研究表明，多西他赛与卡培他滨联合应用在转移性胃腺癌和胃食管交界腺癌患者中值得进一步试验。因此，我们开展了这项II期研究，在一项多机构一线临床试验中对该联合方案进行测试。
招募了44例经组织学或细胞学确诊为上述恶性肿瘤的合格患者。该队列中，东部肿瘤协作组体能状态评分为0、1和2的患者分别占59%、39%和2%。中位年龄为57岁（范围32 - 77岁）。研究入组要求器官功能良好。所有患者在21天周期的第1天静脉注射多西他赛75 mg/m²，在第1 - 14天口服卡培他滨825 mg/m²，每日两次。
肿瘤缓解率为39% [95%置信区间（CI）23%至55%]。有2例完全缓解，其余为部分缓解。中位生存期为9.4个月（95% CI 6.3 - 10.7个月），中位至肿瘤进展时间为4.2个月（95% CI 3.6 - 5.6个月）。有1例与治疗相关的死亡，死于心肌梗死和心律失常。常见的3级不良事件包括中性粒细胞减少（11例患者）、感染（5例患者）、便秘（3例患者）、血栓形成（3例患者）、呼吸困难（3例患者）和手足综合征（3例患者）。此外，45例患者中有24例发生4级中性粒细胞减少。
多西他赛与卡培他滨联合方案在转移性胃腺癌和胃食管交界腺癌患者中显示出活性。该方案值得进一步研究。
