A phase II study using a topoisomerase I-based approach in patients with multiply relapsed germ-cell tumours

Ann Oncol. 2007 May;18(5):925-30. doi: 10.1093/annonc/mdm002. Epub 2007 Mar 12.

Abstract

Background: The outcome of patients with germ-cell tumours (GCTs), who relapse more than once or relapse with a mediastinal primary is poor. We have shown that topoisomerase 1 may be an attractive target in relapsed GCT. We investigated the role of irinotecan, paclitaxel and oxaliplatin (IPO) followed by topotecan-based high-dose therapy in responding patients, in this patient population.

Patients and methods: Twenty-eight patients with multiply relapsed gonadal and mediastinal GCT were recruited to this phase 2 study. All patients received IPO chemotherapy and 12 (43%) went on to receive high-dose therapy. The outcome of these patients was assessed using the Kaplan-Meier method with a median progression-free follow-up of 1 year.

Results: Twenty patients (71%) responded to the therapy including five complete remissions (18%), 13 (46%) marker-negative partial responses and two (7%) marker-positive partial responses. Nine (32%) patients continue to be progression free, and the median survival for the whole group currently measures 17 months. Out of 12 individuals who received subsequent high-dose therapy consolidation, seven (58%) remain progression free. The commonest grade III/IV toxicity was infection (68%) and there were no IPO-related toxic deaths; there was one death from high-dose therapy.

Conclusion: Topoisomerase I-based IPO chemotherapy that lacks etoposide is very active in multiply relapsed GCT. This data merit further investigation.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / adverse effects
  • Camptothecin / analogs & derivatives
  • Follow-Up Studies
  • Humans
  • Irinotecan
  • Male
  • Mediastinal Neoplasms / drug therapy
  • Mediastinal Neoplasms / pathology
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Recurrence, Local / pathology
  • Neoplasms, Germ Cell and Embryonal / drug therapy*
  • Neoplasms, Germ Cell and Embryonal / pathology
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / adverse effects
  • Oxaliplatin
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects
  • Survival Analysis
  • Testicular Neoplasms / drug therapy*
  • Testicular Neoplasms / pathology
  • Time Factors
  • Topoisomerase I Inhibitors*
  • Treatment Outcome

Substances

  • Organoplatinum Compounds
  • Topoisomerase I Inhibitors
  • Oxaliplatin
  • Irinotecan
  • Paclitaxel
  • Camptothecin