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ESMO 2017: Do patients with advanced nonseminomatous germ cell tumors and unfavorable time to normalization of tumor markers benefit with prolongation of 1-st line chemotherapy?

Madrid, Spain (UroToday.com) At the afternoon poster session at ESMO 2017, Dr. Tryakin and colleagues from Russia presented findings from their study assessing whether patients with advanced nonseminomatous germ cell tumors (NSGCT) and unfavorable time to normalization of tumor markers would benefit from prolongation of first-line chemotherapy. Three-four cycles of BEP chemotherapy are commonly recognized as a standard first-line treatment in advanced NSGCT. However, there are no trials studying optimal cycle numbers in this setting, especially in cases of unfavorable time to normalization of tumor markers. The author’s objective for this study was to perform a retrospective single center analysis to evaluate if patients with unfavorable time to normalization of tumor markers may benefit with prolongation of induction chemotherapy.

Patient inclusion was from 1987-2011, and key inclusion criteria for this study included: (i) chemotherapy-naïve advance NSGCT patients treated with etoposide- and cisplatin-based chemotherapy; (ii) AFP and hCG levels available at days 0 and 18-22 of cycle 1 to calculate time to normalization [1]. Patients who received less than “standard” number of cycles (3xBEP or 4xEP for IGCCCG good risk, 4xBEP for intermediate and poor risk) for any reason were excluded from the analysis. The number of cycles was increased to 5-6 in patients if the first cycle was administered with dose reduction by 40-60%, and in patients with slow recovery of tumor marker levels. The primary outcome was overall survival (OS) and Cox regression multivariate analysis was performed.

There were 952 patients with advanced NSGCT that received first-line chemotherapy, of which 584 matched the inclusion criteria. There were 24 (11%) patients with unfavorable time to normalization with good IGCCCG risk, 61 (41%) patients with intermediate risk, and 122 (84%) patients with poor risk. Among these 584 patients, 199 (34%) received more than the standard number of cycles. Unfortunately, prolongation of chemotherapy did not result in significant improvement of OS in any IGCCCG prognostic groups irrespective of time to normalization.

In conclusion, prolongation of first-line chemotherapy beyond standard number of cycles did not improve OS for patients with unfavorable time to normalization of tumor markers in this single institutional study. It is likely that since OS was the primary outcome, the low event rate is a limitation of this study, which should potentially be assessed in a high-volume, multi-center setting.

Speaker: Alexey Tryakin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation

Co-Authors: M. Fedyanin (Moscow, Russian Federation) J. Sergeev (Moscow, Russian Federation) A. Bulanov (Moscow, Russian Federation) B. Akhmedov (Moscow, Russian Federation) T. Zakharova (Moscow, Russian Federation) V. Matveev (Moscow, Russian Federation) I. Fainstein (Moscow, Russian Federation) A. Garin (Moscow, Russian Federation) S. Tjulandin (Moscow, Russian Federation)

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

References:

Fizazi K, Culine S, Kramar A, et al. Early predicted time to normalization of tumor markers predicts outcome in poor prognosis nonseminomatous germ cell tumors. J Clin Oncol 2004;22(19):3868-3876.