Outcomes of Gemcitabine, Oxaliplatin, and Paclitaxel Salvage Chemotherapy in Japanese Patients With Relapsed or Refractory Germ Cell Tumors.

OBJECTIVES: Gemcitabine, oxaliplatin, and paclitaxel (GOP) therapy has shown antitumor activity as a conventional-dose salvage regimen for relapsed or refractory germ cell tumors (GCTs) in European studies; however, data on Japanese patients remain limited. Therefore, we aimed to evaluate the real-world efficacy and safety of GOP therapy in a multicenter Japanese cohort and explore outcomes according to platinum sensitivity.

METHODS: This retrospective multicenter study included 25 patients with relapsed or refractory GCTs treated with GOP between January 2012 and May 2025 at two institutions in Japan. Treatment response was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1, along with tumor marker evaluations. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method.

RESULTS: Of the 25 patients, 15 (60%) and 10 (40%) had platinum-refractory disease and platinum-non-refractory disease, respectively. The median follow-up was 14.4 months. The overall response rate was 56%, with a complete response rate of 28%. The median PFS and OS were 6.9 and 23.1 months, respectively. The estimated 2-year OS and PFS rates were 48.7% and 36.0%, respectively. Survival outcomes were comparable between patients with platinum-non-refractory and platinum-refractory diseases. Overall, 40% of patients survived for more than 2 years after initiation of GOP therapy. Grades 3-4 hematologic toxicities were common but manageable, with no unexpected safety signals.

CONCLUSIONS: GOP therapy demonstrated clinically meaningful activity and acceptable tolerability in Japanese patients with relapsed or refractory GCTs, supporting GOP as a practical, conventional-dose salvage option for platinum-refractory diseases.