Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Saclay, Villejuif, France.
CESP U1018, Oncostat, labeled Ligue Contre le Cancer, University of Paris Saclay, Villejuif, France.
J Clin Oncol. 2024 Oct;42(28):3270-3276. doi: 10.1200/JCO.23.01960. Epub 2024 Aug 21.
JCO GETUG-13 established that switching patients with poor-prognosis nonseminomatous germ-cell tumors with an unfavorable marker decline to intensified chemotherapy resulted in improved outcomes. Here, we report the GETUG-13 long-term efficacy and toxicity. Two hundred and sixty-three patients with International Germ Cell Cancer Consensus Group poor prognosis received one cycle of bleomycin, etoposide, and cisplatin (BEP): 51 with a favorable tumor marker decline continued with three cycles of BEP (Fav-BEP) and 203 with an unfavorable decline were randomly treated with three BEP (Unfav-BEP) cycles or a dose-dense regimen (Unfav-dose-dense; two cycles of paclitaxel-BEP-oxaliplatin + two cycles of cisplatin, ifosfamide, and bleomycin). The median follow-up was 7.1 years (range, 0.3-13.3). Five-year progression-free survival (PFS) rates were 58.9% in the Unfav-dose-dense arm and 46.7% in the Unfav-BEP arm (hazard ratio [HR], 0.65 [95% CI, 0.44 to 0.97]; = .036). Five-year overall survival rates were 70.9% and 61.3% (HR, 0.74 [95% CI, 0.46 to 1.20]; = .22). Side effects evolved favorably, with only three patients in the Unfav-dose-dense arm reporting grade 3 motor neurotoxicity at 1 year and no reported toxicity over grade 1 after year 2. Salvage high-dose chemotherapy plus a stem-cell transplant was used in 8% in the Unfav-dose-dense arm and 17% in the Unfav-BEP arm ( = .035). Long-term outcomes suggest a sustained benefit of intensified chemotherapy in terms of PFS and numerically better survival, with a minimal toxicity and reduced use of salvage high-dose chemotherapy plus stem-cell transplant.
JCO GETUG-13 研究表明，对于预后不良的非精原细胞瘤生殖细胞肿瘤患者，如果标志物下降不良，转换为强化化疗可改善预后。在此，我们报告 GETUG-13 的长期疗效和毒性。263 名国际生殖细胞瘤癌症共识组预后不良的患者接受了一个周期的博来霉素、依托泊苷和顺铂（BEP）治疗：51 名标志物下降良好的患者继续接受三个周期的 BEP（Fav-BEP）治疗，203 名标志物下降不良的患者随机接受三个周期的 BEP（Unfav-BEP）治疗或剂量密集方案（Unfav-dose-dense；两个周期紫杉醇-BEP-奥沙利铂+两个周期顺铂、异环磷酰胺和博来霉素）。中位随访时间为 7.1 年（范围，0.3-13.3 年）。Unfav-dose-dense 组的 5 年无进展生存率（PFS）为 58.9%，Unfav-BEP 组为 46.7%（风险比[HR]，0.65 [95%CI，0.44 至 0.97]；=.036）。5 年总生存率分别为 70.9%和 61.3%（HR，0.74 [95%CI，0.46 至 1.20]；=.22）。副作用表现良好，仅有 3 名 Unfav-dose-dense 组患者在 1 年内出现 3 级运动神经毒性，且在第 2 年以后无报告 1 级以上毒性。在 Unfav-dose-dense 组和 Unfav-BEP 组，挽救性大剂量化疗加干细胞移植的使用率分别为 8%和 17%（=.035）。长期结果表明，强化化疗在 PFS 和生存方面具有持续的获益，毒性最小，挽救性大剂量化疗加干细胞移植的使用率降低。
