Selective bladder preservation with twice-daily radiation plus 5-flourouracil/cisplatin (FCT) or daily radiation plus gemcitabine (GD) for patients with muscle invasive bladder cancer: Primary results of NRG/RTOG 0712—A randomized phase 2 multicenter trial.

Authors

null

John J Coen

21st Century Oncology, Providence, RI

John J Coen , Peixin Zhang , Philip James Saylor , Cheryl T. Lee , Chin-Lee Wu , William Parker , Tim Lautenschlaeger , Anthony L. Zietman , Jason A. Efstathiou , Ashesh B. Jani , Omer Kucuk , Luis Souhami , Joseph P Rodgers , Howard M. Sandler , William U. Shipley

Organizations

21st Century Oncology, Providence, RI, NRG Oncology Statistics and Data Management Center, Philadelphia, PA, Massachusetts General Hospital, Boston, MA, Ohio State University Comprehensive Center, Columbus, OH, NSABP/NRG Oncology/ McGill University Health Centre, Montreal, QC, Canada, Ohio State University, Columbus, OH, Massachusetts General Hospital/ Harvard Medical School, Boston, MA, Emory University, Atlanta, GA, Emory University Winship Cancer Institute, Atlanta, GA, Centre Universitaire de Sante McGill, Montreal, QC, Canada, NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, PA, Cedars-Sinai Medical Center, Los Angeles, CA

Research Funding

NIH

Background: To assess GD or FCT as the chemoradiation (CRT) component of a bladder sparing regimen. Methods: Patients with T2-4a bladder cancer were randomized. Patients had a maximal transurethral resection and induction CRT to 40 Gy followed by cystoscopic assessment. Patients with a complete response (CR) received consolidation CRT to 64 Gy. Others were offered cystectomy and no further CRT. Adjuvant gemcitabine/cisplatin chemotherapy was subsequently administered. The primary endpoint was the rate of distant metastasis at 3 years (DM3). Toxicity and other efficacy related endpoints including CR and bladder intact distant metastasis free survival at 3 years (BI-DMFS3) were also assessed. Using the Clopper-Pearson method, the study required 32 patients per arm, with a benchmark DM3 of 25% and a 1-sided significance level of 0.1. If both arms meet this benchmark, toxicity will be used to select a regimen for future study. This study was not designed to compare arms. Results: From 12/2008 to 4/2014, 70 patients were enrolled; 66 were eligible for analysis (33 per arm). Median follow-up was 4.3 years. DM3 was 22% and 16% for FCT and GD, respectively. BI-DMFS3 was 67% and 72%, respectively. CR rates were 88% and 78%, respectively. Of 33 patients in the FCT group, 32 (97%) completed induction, 27 (93%) completed induction and consolidation, and 18 (55%) completed the entire protocol. Of 33 patients in the GD group, these figures were 31 (94%), 23 (92%), and 16 (49%), respectively. Of 33 patients in the FCT group, 21 (64%) had grade 3-4 toxicity during protocol treatment with 18 (55%), 2 (6%) and 2 (6%) experiencing hematologic, GI and GU toxicity, respectively. For 33 patients in the GD group, these figures were 18 (55%) overall and 14 (43%), 3 (9%) and 2 (6%), respectively. Conclusions: Both regimens are promising, given DM3 rates < 25%. As there was less toxicity in the GD arm, it would be reasonable to consider a gemcitabine based option as well as a cisplatin based regimen for future trials. Daily radiation may be as effective as twice-daily radiation, which may broaden appeal. Clinical trial information: NCT00777491

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2018 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, and Testicular Cancers

Track

Urothelial Carcinoma,Prostate Cancer,Penile, Urethral, and Testicular Cancers

Sub Track

Urothelial Carcinoma

Clinical Trial Registration Number

NCT00777491

Citation

J Clin Oncol 36, 2018 (suppl 6S; abstr 408)

DOI

10.1200/JCO.2018.36.6_suppl.408

Abstract #

408

Poster Bd #

A2

Abstract Disclosures

Similar Abstracts