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Triplet regimen yielded high complete response rate in testicular germ cell tumors
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In patients with a recurrence of metastatic germ cell tumors, four cycles of a three-drug regimen consisting of gemcitabine, ifosfamide and cisplatin appears to deliver a high complete response rate, according to recent findings.
Additionally, the gemcitabine, ifosfamide and cisplatin (GIP) regimen minimized neurotoxicity and achieved high survival rates.
In a prospective, multicenter, phase 2 trial, researchers enrolled 37 patients with relapsed testicular germ cell tumors, who previously had a complete response to chemotherapy for metastatic cancer. The researchers utilized a two-stage Simon design, and the complete response rate was defined as the study’s primary endpoint.
Patients underwent a GIP regimen entailing gemcitabine 1,000 mg/m2 on days 1 and 5, ifosfamide 1,200 mg/m2/day on days 1 to 5, and cisplatin 20 mg/m2/day on days 1 to 5, and granulocyte colony–stimulating factor 263 mcg/day on days 7 to 15. This regimen was repeated every 3 weeks for a total of four cycles.
Researchers found that among those who received the GIP regimen, 29 (78%) of the 37 patients attained positive responses, including a complete response in 20 (54%) of the patients and a partial response with tumor marker normalization in nine (24%) of the patients.
The study had a median follow-up of 53 months, and the researchers found that the 2-year OS rate was 73%. The continuous PFS rate was 51%.
The most commonly observed toxicity in the patients was myelosuppression, including febrile neutropenia in eight (22%) patients and a need for platelet infusion in 18 (50%) of cases. There were no grade 3 or 4 peripheral neurotoxicities or renal toxicities, although two patients died of treatment-related toxicities, and one of these patients showed cancer progression.
“As gemcitabine consistently displayed activity in patients with advanced germ cell tumors and as synergy with cisplatin was reported, we integrated this drug into the salvage triplet regimen and assessed its activity,” the researchers wrote. “In a multicenter context, four cycles of the GIP regimen achieved a high [complete response] rate in patients with relapsed testicular germ cell tumors.”
Disclosure: The researchers report no relevant financial disclosures.
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