Risk-Adapted Management for Patients With Clinical Stage I Seminoma: The Second Spanish Germ Cell Cancer Cooperative Group Study Jorge Aparicio, José R. Germa`, Xavier García del Muro, Pablo Maroto, José A. Arranz, Alberto Sa´enz, Agustín Barnadas, Joan Dorca, Josep Guma`, David Olmos, Roma´ Bastu´s, Joan Carles, Daniel Almenar, Miguel Sa´nchez, Luis Paz-Ares, Juan J. Satru´stegui, Begon˜a Mellado, Ana Balil, Marta Lo´pez-Brea, and Alfredo Sa´nchez A B S T R A C T Purpose To assess the efficacy of a risk-adapted treatment policy for patients with stage I seminoma by using universally accepted risk criteria. Patients and Methods Between 1999 and 2003, 314 patients with clinical stage I seminoma after orchiectomy were prospectively included. One hundred patients (31.8%) presented no risk factors and were managed with surveillance. In contrast, 131 patients (41.7%) had tumors larger than 4 cm, 33 patients (10.5%) had rete testis involvement, and 50 patients (15.9%) had both risk factors. All the latter received two courses of adjuvant carboplatin. Results Chemotherapy was well tolerated, as only 17 patients (7.9%) presented grade 3 to 4 toxicity. Relapses were observed in six patients (6.0%) on surveillance and in seven patients (3.3%) treated with carboplatin (0.8% of tumors larger than 4 cm, 9.1% of those involving the rete testis, and 6.0% of patients with both risk criteria). All were located at the retroperitoneum, except for one at the spermatic cord. Median tumor size was 25 mm (range, 11 to 70 mm), and median time to relapse was 9 months (range, 4 to 28 months). All patients were rendered disease-free with chemotherapy (etoposide plus cisplatin). Median follow-up was 34 months (range, 12 to 72 months). The actuarial 5-year disease-free survival rate was 93.4% for patients on surveillance and 96.2% for patients treated with adjuvant chemother- apy. Overall 5-year survival was 100%. Conclusion Adjuvant carboplatin is effective in reducing the relapse rate in patients with stage I seminoma and risk factors. A risk-adapted strategy is safe and feasible and should be considered an alternative to systematic approaches, such as irradiation, chemotherapy, or surveillance. J Clin Oncol 23:8717-8723. © 2005 by American Society of Clinical Oncology INTRODUCTION Stage I seminoma represents approximately 35% of all germ cell testicular cancers. In this clinical setting, definitive cure is the rule, and current therapeutic trials are aiming to maintain these favorable results while re- ducing treatment-related toxicity. 1 Until re- cently, postorchiectomy irradiation to the para-aortic lymph nodes was the standard of care. Reported relapse rates have ranged from 3% to 5%, with seminoma deaths in less than 2%. 2 However, a small but signifi- cant increased risk for second malignancies, cardiovascular morbidity, and peptic ulcer with this treatment approach has been con- firmed. Therefore, new therapeutic options have been investigated in this patient subset. From the Departments of Medical Oncology, Hospital Universitario La Fe; Hospital Universitari Doctor Peset, Valencia; Idibell-Institut Catala´ d’Oncologia Duran i Reynals; Hospital de Sant Pau; Hospital Mutua de Terrassa; Hospital del Mar; Hospital Clinic i Provincial, Barcelona; Hospital General Universitario Gregorio Mara- n˜o´ n; Hospital Universitario 12 de Octubre, Madrid; Hospital Clínico Universitario Lozano Blesa, Zaragoza; Hospital Universitari Germans Trias i Pujol, Badalona; Hospital Universitari Josep Trueta, Girona; Hospital Universi- tari Sant Joan, Reus; Hospital Clínico Universitario Virgen de la Victoria, Ma´ laga; Hospital Donostia; Instituto Oncolo´ gico de Guipu´ zcoa, San Sebas- tia´ n; Hospital Universitari Arnau de Vilanova, Lleida; Hospital Universitario Marqués de Valdecilla, Santander; and Hospital Provincial, Castello´ n, Spain. Submitted March 11, 2005; accepted June 1, 2005. Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA. See online Appendix for other Germ Cell Cancer Cooperative Group members participating in the study. Authors’ disclosures of potential con- flicts of interest are found at the end of this article. Address reprint requests to Jorge Aparicio, MD, Servicio de Oncología Médica, Hospital Universitario La Fe, Avda Campanar 21, E-46009 Valencia, Spain; e-mail: japariciou@seom.org. © 2005 by American Society of Clinical Oncology 0732-183X/05/2334-8717/$20.00 DOI: 10.1200/JCO.2005.01.9810 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T VOLUME 23  NUMBER 34  DECEMBER 1 2005 8717 Downloaded from ascopubs.org by 44.192.20.1 on June 28, 2022 from 044.192.020.001 Copyright © 2022 American Society of Clinical Oncology. All rights reserved.