SWOG S1815：一项针对新诊断的晚期胆管癌患者，比较吉西他滨、顺铂和白蛋白结合型紫杉醇与吉西他滨和顺铂疗效的III期随机试验。
SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers.
作者信息
Shroff Rachna T, King Gentry, Colby Sarah, Scott Aaron J, Borad Mitesh J, Goff Laura, Matin Khalid, Mahipal Amit, Kalyan Aparna, Javle Milind M, El Dika Imane, Tan Benjamin, Cheema Puneet, Patel Anuj, Iyer Renuka, Kelley R Katie, Thumar Jaykumar, El-Khoueiry Anthony, Guthrie Katherine A, Chiorean E Gabriela, Hochster Howard, Philip Philip A
机构信息
University of Arizona Cancer Center, Tucson, AZ.
Fred Hutchinson Cancer Center, University of Washington, Seattle, WA.
出版信息
J Clin Oncol. 2025 Feb 10;43(5):536-544. doi: 10.1200/JCO-24-01383. Epub 2024 Dec 13.
PURPOSE
SWOG S1815 was a randomized, open label phase III trial, evaluating gemcitabine, nab-paclitaxel, and cisplatin (GAP) versus gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers (BTCs).
METHODS
Patients with newly diagnosed locally advanced unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), were randomly assigned 2:1 to either GAP (gemcitabine 800 mg/m, cisplatin 25 mg/m, and nab-paclitaxel 100 mg/m intravenously once per day on days 1 and 8 of a 21-day cycle) or GC (gemcitabine 1,000 mg/m and cisplatin 25 mg/m intravenously once per day on days 1 and 8 of a 21-day cycle).
RESULTS
Among 452 randomly assigned participants, 441 were eligible and analyzable, 67% with ICC, 16% with GBC, and 17% with ECC. There was no significant difference in overall survival (OS) between GAP versus GC. Median OS with GAP was 14.0 months (95% CI, 12.4 to 16.1) and 13.6 months with GC (95% CI, 9.7 to 16.6); hazard ratio (HR), 0.91 (95% CI, 0.72 to 1.14); = .41. Median progression-free survival (PFS) was similar between groups with median PFS for GAP being 7.5 months (95% CI, 6.4 to 8.5) versus 6.3 months for GC (95% CI, 4.4 to 8.2); HR, 0.89 (95% CI, 0.71 to 1.12); = .32. In exploratory subset analyses, the OS and PFS benefits of GAP versus GC treatment were greater in locally advanced disease compared with metastatic disease, although not statistically significant (interaction = .14 for OS and = .17 for PFS). Moreover, GAP versus GC showed greater improvement in PFS among participants with GBC than those with ICC or ECC (interaction = .01), but not OS (interaction = .28).
CONCLUSION
The addition of a taxane in the GAP regimen to the standard gemcitabine-cisplatin regimen did not improve OS in newly diagnosed BTC. More toxicity was encountered with GAP versus GC.
目的
SWOG S1815是一项随机、开放标签的III期试验，评估吉西他滨、白蛋白结合型紫杉醇和顺铂（GAP）与吉西他滨和顺铂（GC）用于新诊断的晚期胆管癌（BTC）患者的疗效。
方法
新诊断的局部晚期不可切除或转移性BTC患者，包括肝内胆管癌（ICC）、肝外胆管癌（ECC）和胆囊癌（GBC），按2:1随机分配至GAP组（吉西他滨800mg/m²、顺铂25mg/m²和白蛋白结合型紫杉醇100mg/m²，在21天周期的第1天和第8天静脉注射，每日1次）或GC组（吉西他滨1000mg/m²和顺铂25mg/m²，在21天周期的第1天和第8天静脉注射，每日1次）。
结果
在452名随机分配的参与者中，441名符合条件且可进行分析，其中67%为ICC患者，16%为GBC患者，17%为ECC患者。GAP组与GC组的总生存期（OS）无显著差异。GAP组的中位OS为14.0个月（95%CI，12.4至16.1），GC组为13.6个月（95%CI，9.7至16.6）；风险比（HR）为0.91（95%CI，0.72至1.14）；P = 0.41。两组的中位无进展生存期（PFS）相似，GAP组的中位PFS为7.5个月（95%CI，6.4至8.5），GC组为6.3个月（95%CI，4.4至8.2）；HR为0.89（95%CI，0.71至1.12）；P = 0.32。在探索性子集分析中，与转移性疾病相比，局部晚期疾病中GAP组与GC组治疗的OS和PFS获益更大，尽管无统计学意义（OS的交互作用P = 0.14，PFS的交互作用P = 0.17）。此外，与ICC或ECC患者相比，GAP组与GC组在GBC患者中的PFS改善更大（交互作用P = 0.01），但OS无差异（交互作用P = 0.28）。
结论
在标准的吉西他滨-顺铂方案中加入紫杉烷类药物的GAP方案，并未改善新诊断BTC患者的OS。与GC方案相比，GAP方案的毒性更大。
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