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Phase III Prevention Trial of Fenretinide in Patients with Resected Non–Muscle-Invasive Bladder Cancer

Authors' Affiliations: Departments of ¹ Clinical Cancer Prevention, ² Biostatistics and Applied Mathematics, ³ Urology, ⁴ Pathology, ⁵ Community Clinical Oncology Program, and ⁶ Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center; ⁷ Baylor College of Medicine, Houston, Texas; ⁸ University of Southern California, Los Angeles, California; ⁹ University of Washington and Veteran's Administration Puget Sound Hospital, Seattle, Washington; ¹⁰ University of Michigan, Ann Arbor, Michigan; ¹¹ University of Nebraska Medical Center, Omaha, Nebraska; ¹² Atlanta Regional Community Clinical Oncology Program Research Group, Atlanta, Georgia; ¹³ Louisiana State University, Shreveport, Louisiana; and ¹⁴ National Cancer Institute, Bethesda, Maryland

Requests for reprints: Anita L. Sabichi, 1515 Holcombe Boulevard-Unit 1360, University of Texas M. D. Anderson Cancer Center, P.O. Box 301439, Houston, TX 77230-1439. Phone: 713-745-4928; Fax: 713-794-4403; E-mail: asabichi{at}mdanderson.org.

Purpose: The study aims to evaluate the efficacy and toxicity of fenretinide in preventing tumor recurrence in patients with transitional cell carcinoma (TCC) of the bladder.

Experimental Design: We conducted a multicenter phase III, randomized, placebo-controlled trial of fenretinide (200 mg/day orally for 12 months) in patients with non–muscle-invasive bladder TCC (stages Ta, Tis, or T1) after transurethral resection with or without adjuvant intravesical Bacillus Calmette-Guerin (BCG). Patients received cystoscopic evaluation and bladder cytology every 3 months during the 1-year on study drug and a final evaluation at 15 months. The primary endpoint was time to recurrence.

Results: A total of 149 patients were enrolled; 137 were evaluable for recurrence. The risk of recurrence was considered to be "low" in 72% (no prior BCG) and intermediate or high in 32% (prior BCG) of the evaluable patients. Of the lower-risk group, 68% had solitary tumors and 32% had multifocal, low-grade papillary (Ta, grade 1 or grade 2) tumors. The 1-year recurrence rates by Kaplan-Meier estimate were 32.3% (placebo) versus 31.5% (fenretinide; P = 0.88 log-rank test). Fenretinide was well tolerated and had no unexpected toxic effects; only elevated serum triglyceride levels were significantly more frequent on fenretinide (versus placebo). The Data Safety and Monitoring Board recommended study closure at 149 patients (before reaching the accrual goal of 160 patients) because an interim review of the data showed a low likelihood of detecting a difference between the two arms, even if the original accrual goal was met.

Conclusions: Although well tolerated, fenretinide did not reduce the time-to-recurrence in patients with Ta, T1, or Tis TCC of the bladder.

Commentary

Another Negative Chemoprevention Trial: What Can We Learn?

Frank L. Meyskens, Jr.
Clin. Cancer Res. 2008 14: 2-3. [Full Text] [PDF]

This article has been cited by other articles:

				F. L. Meyskens Jr. Another Negative Chemoprevention Trial: What Can We Learn? Clin. Cancer Res., January 1, 2008; 14(1): 2 - 3. [Full Text] [PDF]