GAMMA: Results from a Phase II Study for Relapsed Germ Cell Tumors using an Oxaliplatin-Based Treatment Regimen

IF 2.4 3区医学 Q3 ONCOLOGY

Clinical genitourinary cancer Pub Date : 2026-02-01 Epub Date: 2025-11-12 DOI:10.1016/j.clgc.2025.102468

Kenrick Ng , Garima Priyadarshini , Aaron Prendergast , Charlotte Ackerman , Susanna Alexander , Sarah Rudman , Han Hsi Wong , Constantine Alifrangis , Daniel Lawrence , Daniel M. Berney , Ewa Nowosinska , Jonathan Shamash

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引用次数: 0

Abstract

Background

Many patients with relapsed germ cell tumors (GCTs) can still be cured with salvage chemotherapy. Oxaliplatin-based therapies may offer reduced toxicity and noncross resistance to cisplatin-based therapies. PET scan response early during therapy may predict long term outcome.

Methods

Eligible patients with GCTs who progressed following cisplatin-based chemotherapy were recruited into this single-arm, phase II clinical trial. Participants received four 21-day cycles of actinomycin D, methotrexate, paclitaxel, and oxaliplatin. The primary endpoint was objective response rate. Secondary endpoints were progression-free survival (PFS), overall survival and toxicity. A survival analysis was performed based on International Prognostic Factors Study Group (IPFSG) classes. The early predictive value of response on PET CT after 1 cycle of treatment was also assessed.

Results

Forty four patients received at least 1 dose of the study medication between 2012 and 2020. The median age was 38, and 70% had intermediate, high or very high-risk disease by IPFSG criteria. The objective response rate of the evaluable population was 59.0%. The median combined radiological or tumor marker PFS was 9.7 months (95% CI, 3.0-22.0 months). At a median follow-up of 26.9 months, the median overall survival was not reached (95% CI, 17.8-NR). Analyses of outcomes based on IPFSG showed relatively favorable outcomes in patients with high and very high-risk disease, with a 2-year combined PFS rates of 33%. PET CT response after 1 cycle of treatment did not predict PFS benefit.

Conclusions

The GAMMA regimen demonstrates encouraging antitumor activity in relapsed GCT, despite recruiting a cohort of patients with predominantly poor risk disease.

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伽玛：使用奥沙利铂治疗复发性生殖细胞肿瘤的II期研究结果。

背景：许多复发性生殖细胞瘤（gct）患者仍然可以通过补救性化疗治愈。以奥沙利铂为基础的治疗可能比以顺铂为基础的治疗提供更低的毒性和非交叉耐药。治疗早期PET扫描反应可以预测长期结果。方法：在顺铂化疗后进展的符合条件的gct患者被招募到这项单臂II期临床试验中。参与者接受4个21天周期的放线菌素D、甲氨蝶呤、紫杉醇和奥沙利铂治疗。主要终点为客观有效率。次要终点是无进展生存期（PFS）、总生存期和毒性。根据国际预后因素研究组（IPFSG）分类进行生存分析。并评估治疗1个周期后PET CT反应的早期预测价值。结果：在2012年至2020年期间，44名患者至少接受了1剂研究药物。中位年龄为38岁，根据IPFSG标准，70%患有中、高或高危疾病。可评价人群的客观应答率为59.0%。中位放射学或肿瘤标志物联合PFS为9.7个月（95% CI, 3.0-22.0个月）。在中位随访26.9个月时，中位总生存期未达到（95% CI, 17.8 nr）。基于IPFSG的结果分析显示，高风险和高危疾病患者的结果相对较好，2年综合PFS率为33%。1个治疗周期后的PET CT反应不能预测PFS的获益。结论：GAMMA方案在复发性GCT中显示出令人鼓舞的抗肿瘤活性，尽管招募了一组主要为低风险疾病的患者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical genitourinary cancer 医学-泌尿学与肾脏学

CiteScore

5.20

自引率

6.20%

发文量

201

审稿时长

54 days

期刊介绍： Clinical Genitourinary Cancer is a peer-reviewed journal that publishes original articles describing various aspects of clinical and translational research in genitourinary cancers. Clinical Genitourinary Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of genitourinary cancers. The main emphasis is on recent scientific developments in all areas related to genitourinary malignancies. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.