Phase II study of cisplatin plus epirubicin salvage chemotherapy in refractory germ cell tumors

Pablo M. Bedano, Mary J. Brames, Stephen D. Williams, Beth E. Juliar, Lawrence Einhorn

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Purpose: Initial cisplatin (CIS) combination chemotherapy will cure 70% of patients with disseminated testicular cancer. This phase II clinical trial evaluated the combination of CIS plus epirubicin (CIS-EPI) in patients with metastatic germ cell tumors (GCT) not amenable to cure with standard salvage therapy. Patients and Methods: Between March 2001 and August 2005, 30 patients with GCT, who had received at least one previous CIS-based regimen, were enrolled. All patients were males, with median age 36 (range, 24 to 45 years). Twenty-one patients (70%) had experienced late relapses (> 2 years). Patients received EPI 90 mg/m2 on day 1 and CIS 20 mg/m2 on days 1 to 5 every 3 weeks for maximum of four cycles. Results: Nineteen (63%) of 30 patients received all four cycles. Toxicity was primarily hematologic: grade 3/4 neutropenia, four patients (one neutropenic fever); two patients had grade 3 thrombocytopenia, and five patients had grade 3/4 anemia. Nonhematologic toxicity was grade 3 acute renal failure in two patients; grade 3 electrolyte wasting in two patients; grade 3 nausea/vomiting in eight patients; grade 3 elevation of aminotransferases in one patient; and grade 3 diarrhea in one patient. There were no occurrences of severe mucositis, cardiotoxicity, or treatment-related deaths. Nine patients achieved a complete remission; seven of these patients remain without evidence of disease at 25+ , 27+ , 29+, 44+, 45+, 46+, and 48+ months. One patient remains alive with stable pulmonary nodules at 28+ months. Conclusion: CIS-EPI is an active regimen in metastatic GCT, with an acceptable toxicity profile. This regimen offers potential for long-term disease-free survival in this population.

Original languageEnglish
Pages (from-to)5403-5407
Number of pages5
JournalJournal of Clinical Oncology
Volume24
Issue number34
DOIs
StatePublished - Dec 1 2006

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Epirubicin
Germ Cell and Embryonal Neoplasms
Cisplatin
Drug Therapy
Salvage Therapy
Phase II Clinical Trials
Mucositis

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Phase II study of cisplatin plus epirubicin salvage chemotherapy in refractory germ cell tumors. / Bedano, Pablo M.; Brames, Mary J.; Williams, Stephen D.; Juliar, Beth E.; Einhorn, Lawrence.

In: Journal of Clinical Oncology, Vol. 24, No. 34, 01.12.2006, p. 5403-5407.

Research output: Contribution to journalArticle

Bedano, Pablo M. ; Brames, Mary J. ; Williams, Stephen D. ; Juliar, Beth E. ; Einhorn, Lawrence. / Phase II study of cisplatin plus epirubicin salvage chemotherapy in refractory germ cell tumors. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 34. pp. 5403-5407.
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abstract = "Purpose: Initial cisplatin (CIS) combination chemotherapy will cure 70{\%} of patients with disseminated testicular cancer. This phase II clinical trial evaluated the combination of CIS plus epirubicin (CIS-EPI) in patients with metastatic germ cell tumors (GCT) not amenable to cure with standard salvage therapy. Patients and Methods: Between March 2001 and August 2005, 30 patients with GCT, who had received at least one previous CIS-based regimen, were enrolled. All patients were males, with median age 36 (range, 24 to 45 years). Twenty-one patients (70{\%}) had experienced late relapses (> 2 years). Patients received EPI 90 mg/m2 on day 1 and CIS 20 mg/m2 on days 1 to 5 every 3 weeks for maximum of four cycles. Results: Nineteen (63{\%}) of 30 patients received all four cycles. Toxicity was primarily hematologic: grade 3/4 neutropenia, four patients (one neutropenic fever); two patients had grade 3 thrombocytopenia, and five patients had grade 3/4 anemia. Nonhematologic toxicity was grade 3 acute renal failure in two patients; grade 3 electrolyte wasting in two patients; grade 3 nausea/vomiting in eight patients; grade 3 elevation of aminotransferases in one patient; and grade 3 diarrhea in one patient. There were no occurrences of severe mucositis, cardiotoxicity, or treatment-related deaths. Nine patients achieved a complete remission; seven of these patients remain without evidence of disease at 25+ , 27+ , 29+, 44+, 45+, 46+, and 48+ months. One patient remains alive with stable pulmonary nodules at 28+ months. Conclusion: CIS-EPI is an active regimen in metastatic GCT, with an acceptable toxicity profile. This regimen offers potential for long-term disease-free survival in this population.",
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