Outcomes by Retrospective Eligibility for Maintenance Therapy of Patients With Advanced Urothelial Carcinoma: Post Hoc Analysis of the Phase 3 KEYNOTE-361 Trial
Ronac Mamtani , Nobuaki Matsubara , Alvaro Montesa Pino , Urbano Anido Herranz , Mehmet A. N. Şendur , Gwenaelle Gravis , Olivier Huillard , Hyo Jin Lee , Rustem Gafanov , Florence Joly , Jens Bedke , Avishay Sella , Yen-Hwa Chang , Kentaro Imai , Blanca Homet Moreno , Jin Zhi Xu , Ajjai Alva , Thomas Powles
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引用次数: 0
Abstract
Introduction
The phase 3 KEYNOTE-361 trial of first-line pembrolizumab with or without chemotherapy versus chemotherapy alone in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) completed enrollment before the approval of postchemotherapy maintenance avelumab for patients without progressive disease. This post hoc analysis evaluated the outcomes of patients who received chemotherapy alone in KEYNOTE-361 by retrospective eligibility for subsequent maintenance therapy.
Patients and Methods
Patients in the chemotherapy alone arm were retrospectively categorized as maintenance eligible (received ≥4 cycles of chemotherapy and did not die or experience disease progression within 10 weeks of chemotherapy completion), maintenance ineligible (received <4 cycles of chemotherapy or had progressive disease or died within 0-10 weeks after completion of ≥4 cycles of chemotherapy), and indeterminate eligibility for maintenance therapy (if neither maintenance eligible or ineligible). End points included progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review and overall survival from randomization (start of chemotherapy).
Results
Median follow-up was 31.7 months (range, 22.0-42.3). Among 342 patients who received chemotherapy alone, 172 (50.3%) were maintenance eligible, 108 (31.6%) were maintenance ineligible, and 62 (18.1%) had indeterminate eligibility for maintenance therapy. The median progression-free survival was 9.0 months (95% CI 8.4-10.4) in maintenance-eligible patients, 5.1 months (4.2-6.0) in maintenance-ineligible patients, and 2.3 months (1.9-3.8) in the indeterminate group; median overall survival was 23.3 months (95% CI 19.4-26.1), 10.2 months (9.1-11.6), and 5.5 months (3.7-8.5), respectively.
Conclusion
This post hoc analysis suggests that a majority of patients with untreated la/mUC who initiated chemotherapy in a clinical trial may have been considered eligible for maintenance therapy and had favorable survival outcomes compared with those considered maintenance ineligible.
简介:局部晚期或转移性尿路上皮癌(la/mUC)患者一线用pembrolizumab联合或不联合化疗与单纯化疗的3期KEYNOTE-361试验在批准对无进展性疾病的患者进行化疗后维持阿维列单抗治疗之前完成了入组。这项事后分析通过回顾后续维持治疗的资格,评估了在KEYNOTE-361中接受单纯化疗的患者的疗效:单纯化疗组的患者被回顾性地分为符合维持治疗条件的患者(接受了≥4个周期的化疗,且在化疗结束后10周内未死亡或疾病进展)、不符合维持治疗条件的患者(接受了≥4个周期的化疗,且在化疗结束后10周内未死亡或疾病进展中位随访时间为 31.7 个月(22.0-42.3 个月)。在342名接受单纯化疗的患者中,172人(50.3%)符合维持治疗条件,108人(31.6%)不符合维持治疗条件,62人(18.1%)不确定是否符合维持治疗条件。符合维持治疗条件的患者的中位无进展生存期为9.0个月(95% CI 8.4-10.4),不符合维持治疗条件的患者为5.1个月(4.2-6.0),不确定组为2.3个月(1.9-3.8);中位总生存期分别为23.3个月(95% CI 19.4-26.1)、10.2个月(9.1-11.6)和5.5个月(3.7-8.5):这项事后分析表明,在临床试验中开始接受化疗的大多数未经治疗的la/mUC患者可能被认为符合接受维持治疗的条件,与那些被认为不符合接受维持治疗条件的患者相比,他们的生存预后较好。
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.