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ESMO 2017

ESMO 2017: Randomized Controlled Trial Comparing Radiotherapy +/- Endocrine Therapy Versus Endocrine Therapy Alone for PSA Failure after Radical Prostatectomy: Japan Clinical Oncology Group Study JCOG0401

Madrid, Spain (UroToday.com) Dr. Yokomizo and colleagues from Japan presented results from their clinical trial comparing radiotherapy +/- endocrine therapy vs endocrine therapy alone among men with PSA failure after radical prostatectomy. Published earlier this year, RTOG 9601 showed that the addition of 24 months of daily bicalutamide to salvage radiation therapy after radical prostatectomy resulted in higher rates of overall survival (OS) and lower rates of metastatic prostate cancer and prostate cancer specific mortality compared to radiation therapy with placebo [1]. As such, the objective of this clinical trial was to confirm the superiority of radiotherapy ± endocrine therapy over endocrine therapy alone for PSA failure after radical prostatectomy.

For this trial, 210 patients from 2004 to 2011 were randomized 1:1 to arm A (endocrine therapy only: bicalutamide monotherapy followed by LH-RH agonist in case of bicalutamide failure), or arm B [64.8 Gy of salvage radiotherapy followed by same regimen of arm A in case of treatment failure of salvage radiotherapy]. The primary endpoint was time to treatment failure of bicalutamide. Secondary endpoints were (i) time to treatment failure of protocol treatment, (ii) clinical relapse-free survival (RFS), (iii) OS, and (iv) adverse events. The sample size of 210 was powered to detect improvement of median time to treatment failure of bicalutamide from 5 years to 8.3 years with one-sided alpha of 5% and power of 80%. The trial found that time to treatment failure of bicalutamide was significantly better in arm B (HR 0.56, 95%CI 0.40–0.77). There were 33 patients (32%) treated with salvage radiotherapy in arm B that had no treatment failure after salvage radiotherapy, resulting in being free from hormonal therapy. In addition, time to treatment failure of protocol treatment was also better in arm B (HR 0.66, 95%CI 0.44-1.00), however clinical RFS (HR 0.90, 95%CI 0.45-1.81) and OS (HR 1.03, 95%CI 0.46-2.29) were similar between the arms. 

The authors concluded that salvage radiation therapy had advantages for both time to treatment failure of bicalutamide and protocol treatment. Although the clinical outcomes of both arms were similar in terms of clinical PFS and OS, salvage radiotherapy was effective in 1/3 of patients, which contributed to avoiding salvage endocrine therapy. However, whether these results translate to improved metastasis free and prostate cancer specific mortality rates remains to be seen with longer follow-up.

Reference: 

1. Shipley WU, Seiferheld W, Lukka HR, et al. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med 2017;376(5):417-428.

Speaker: Akira Yokomizo, Kyushu University, Fukuoka, Japan

Co-Authors: T. Satoh (Sagamihara, Japan) K. Hashine (Matsuyama, Japan) T. Inoue (Kyoto, Japan) K. Fujimoto (Nara, Japan) S. Egawa (Tokyo, Japan) T. Habuchi (Akita, Japan)

K. Kawashima (Utsunomiya, Japan) O. Ishizuka (Matsumoto, Japan) N. Shinohara (Sapporo, Japan) M. Sugimoto (Kagawa, Japan) Y. Yoshino (Nagoya, Japan) M. Wakabayashi (Tokyo, Japan) K. Nihei (Tokyo, Japan) H. Fukuda (Tokyo, Japan) K. Tobisu (Tokyo, Japan) Y. Kakehi (Kagawa, Japan) S. Naito (FUKUOKA, Japan)

Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, Twitter: @zklaassen_md at the European Society for Medical Oncology Annual Congress - September 8 - 12, 2017 - Madrid, Spain