Personalized Chemotherapy on the Basis of Tumor Marker Decline in Poor-Prognosis Germ-Cell Tumors: Updated Analysis of the GETUG-13 Phase III Trial

Author:

Fizazi Karim1ORCID,Le Teuff Gwénaël23ORCID,Fléchon Aude4,Pagliaro Lance5,Mardiak Josef6,Geoffrois Lionnel7,Laguerre Brigitte8,Chevreau Christine9,Delva Remy10,Rolland Frederic11ORCID,Theodore Christine12,Roubaud Guilhem13,Gravis Gwenaëlle14ORCID,Eymard Jean-Christophe15,Cancel Mathilde16ORCID,Juzyna Beata17,Reckova Maria6ORCID,Naoun Natacha1ORCID,Logothetis Christopher5,Culine Stephane18ORCID

Affiliation:

1. Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Saclay, Villejuif, France

2. CESP U1018, Oncostat, labeled Ligue Contre le Cancer, University of Paris Saclay, Villejuif, France

3. Department of Biostatistics, Institut Gustave Roussy, Villejuif, France

4. Department of Cancer Medicine, Centre Léon Bérard, Lyon, France

5. UT MD Anderson Cancer Center, Houston, TX

6. National Cancer Institute, Bratislava, Slovakia

7. Department of Cancer Medicine, Centre Alexis Vautrin, Nancy, France

8. Department of Cancer Medicine, Centre Eugène Marquis, Rennes, France

9. Department of Cancer Medicine, Centre Claudius Regaud, Toulouse, France

10. Department of Cancer Medicine, Institut de cancérologie de l’Ouest, Angers, France

11. Department of Cancer Medicine, Institut de cancérologie de l’Ouest, Nantes, France

12. Department of Cancer Medicine, Hopital Foch, Suresnes, France

13. Department of Cancer Medicine, Institut Bergonié, Bordeaux, France

14. Department of Cancer Medicine, Institut Paoli Calmette, Marseille, France

15. Department of Cancer Medicine, Centre Jean Godinot, Reims, France

16. Department of Cancer Medicine, Centre Hospitalo-Universitaire, Tours, France

17. Unicancer, Paris, France

18. Department of Cancer Medicine, Hôpital Saint Louis, Paris, France

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. 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]; P = .036). Five-year overall survival rates were 70.9% and 61.3% (HR, 0.74 [95% CI, 0.46 to 1.20]; P = .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 ( P = .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.

Publisher

American Society of Clinical Oncology (ASCO)

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3