Zhao Xiao-Yin, Liu Xin, Li Wen-Hua, Qiu Li-Xin, Huang Ming-Zhu, Wang Chen-Chen, Chen Zhi-Yu, Zhang Wen, Feng Wan-Jing, Guo Wei-Jian, Zhu Xiaodong
Department of Gastrointestinal Medical Oncology, Shanghai Cancer Center, Fudan University, Shanghai, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Front Oncol. 2022 Oct 26;12:911160. doi: 10.3389/fonc.2022.911160. eCollection 2022.
This research found that the clinical outcomes (PFS, ORR, OS) of the non-platinum-based doublet regimen (docetaxel capecitabine combination) were similar to those of the platinum-based (oxaliplatin capecitabine combination) when used as first line therapy for MGC patients.
Docetaxel, platinum and fluorouracil are the three most important drugs in the treatment of MGC. This study was to compare clinical outcomes of the docetaxel capecitabine combination and the oxaliplatin capecitabine combination as first-line therapy in MGC patients.
In this phase II trial, MGC patients were randomly assigned and treated with either TX (capecitabine 1000 mg/m/twice daily/1-14 days and docetaxel 60/75 mg/m on the 1st day) (because of toxicity, the dose of docetaxel was reduced to 60 mg/m) or XELOX (capecitabine the same dose with TX and oxaliplatin 130 mg/m on the 1st day) as first-line therapy. After progression, patients were crossover to the other group as second-line treatment.
Total 134 MGC patients were randomized (69 in TX, 65 in XELOX). There was no significant difference between the PFS of the two groups (TX vs XELOX, 4.6 months vs 5.1 months, p=0.359), and the SFS (9.3 months vs 7.5 months, p=0.705), OS (13.1 months vs 9.6 months, p=0.261), and ORR (46.4% vs 46.2%) were also similar. Among patients with ascites, the TX group had significantly longer PFS and OS than the XELOX group. A total of 85 patients (48 in TX, 37 in XELOX) received second-line treatment, with overall survival of second-line chemotherapy (OS2) of 8.0 m and 5.3 m (p=0.046), respectively. Grade 3 to 4 treatment-related adverse events of first line treatment occurred more in TX group than that in XELOX group(60.6% vs 55.4%).
TX regimen is an alternative choice of first-line treatment for MGC patients. We still need to explore the large number of cohort to confirm this results.
本研究发现，非铂类双联方案（多西他赛联合卡培他滨）作为一线治疗方案用于MGC患者时，其临床疗效（无进展生存期、客观缓解率、总生存期）与铂类方案（奥沙利铂联合卡培他滨）相似。
多西他赛、铂类和氟尿嘧啶是治疗MGC的三种最重要药物。本研究旨在比较多西他赛联合卡培他滨方案与奥沙利铂联合卡培他滨方案作为MGC患者一线治疗的临床疗效。
在这项II期试验中，MGC患者被随机分组并接受TX方案（卡培他滨1000mg/m²，每日两次，第1 - 14天；多西他赛60/75mg/m²，第１天）（由于毒性反应，多西他赛剂量减至60mg/m²）或XELOX方案（卡培他滨剂量与TX方案相同，奥沙利铂130mg/m²，第１天）作为一线治疗。病情进展后，患者交叉至另一组接受二线治疗。
共134例MGC患者被随机分组（TX组69例，XELOX组65例）。两组的无进展生存期无显著差异（TX组 vs XELOX组，4.6个月 vs 5.1个月，p = 0.359），无病生存期（9.3个月 vs 7.5个月，p = 0.705）、总生存期（13.1个月 vs 9.6个月，p = 0.261）和客观缓解率（46.4% vs 46.2%）也相似。在有腹水的患者中，TX组的无进展生存期和总生存期显著长于XELOX组。共有85例患者（TX组48例，XELOX组37例）接受二线治疗，二线化疗的总生存期（OS2）分别为8.0个月和5.3个月（p = 0.046）。一线治疗中3 - 4级治疗相关不良事件在TX组比XELOX组更常见（60.6% vs 55.4%）。
TX方案是MGC患者一线治疗的替代选择。我们仍需通过大量队列研究来证实这一结果。
