The Multicenter, Phase II Prospective Study of Paclitaxel Plus Capecitabine as First-Line Chemotherapy in Advanced Gastric Carcinoma
The Multicenter, Phase II Prospective Study of Paclitaxel Plus Capecitabine as First-Line Chemotherapy in Advanced Gastric Carcinoma
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DOI：
10.1634/theoncologist.2013-0137
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发表时间：
2014-02-01
期刊：
影响因子：
5.8
通讯作者：
Shen, Lin
中科院分区：
文献类型：
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作者：
Gong, Jifang;Hu, Bing;Shen, Lin
背景观察紫杉醇联合卡培他滨（PX）一线治疗晚期胃癌（AGC）的疗效和毒副反应。纳入了既往未接受过治疗的AGC患者。PX每3周给药一次，直至最多6个周期或进展。无疾病进展的患者继续接受卡培他滨单药治疗。主要终点为无进展生存期，次要终点为客观缓解率、总生存期（OS）和安全性。总体而言，194例患者按照方案接受治疗，1例患者因对紫杉醇过敏而被排除。在175例患者中评价了反应，客观反应率为34.8%。中位随访33.2个月后，141例患者出现疾病进展，137例死亡，16例失访，无进展生存期为188天，OS为354天。在多变量考克斯回归分析中，没有任何因素仍然是OS的独立预测因子。45例接受卡培他滨单药治疗的患者在PX后的OS较长（531天）。不良反应轻微（图1），最常见的3-4级毒性反应为白细胞减少和血小板减少。PX作为AGC的一线治疗具有良好的疗效。基于这些数据，已启动III期研究进行进一步调查。
Background. The efficacy and toxicity of paclitaxel plus capecitabine (PX) as first-line treatment in advanced gastric cancer (AGC) was evaluated.Methods. Patients with previously untreated AGC were included. PX was given every 3 weeks until a maximum of six cycles or progression. Capecitabine monotherapy was continued for patients without disease progression. The primary endpoint was progression-free survival, and secondary endpoints were objective response rate, overall survival (OS), and safety.Results. Overall, 194 patients were treated per protocol and one patient was excluded because of allergy to paclitaxel. Response was evaluated in 175 patients, with an objective response rate of 34.8%. After a median follow-up of 33.2 months, disease progression was observed in 141 patients, 137 died, and 16 were lost to follow-up, with progression-free survival of 188 days and OS of 354 days. In multivariate Cox regression analysis, no factor remained an independent predictor of OS. Forty-five patients who received capecitabine monotherapy after PX had longer OS (531 days). Adverse events were mild (Fig. 1), and the most common grade 3-4 toxicities were leucopenia and neutropenia.Conclusion. PX as a first-line treatment has promising efficacy in AGC. Based on these data, a phase III study has been launched for further investigation.