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Phase II trial of topotecan in patients with cisplatin-refractory germ cell tumors

H S Puc1, D F Bajorin, G J Bosl

  • 1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.

Investigational New Drugs
|January 1, 1995
PubMed

Insights

Topotecan did not show efficacy in treating advanced germ cell tumors (GCT) that were refractory to cisplatin. The study found no responses and significant myelosuppression, indicating it is not a viable treatment option.

Area of Science:

  • Oncology
  • Medical Oncology
  • Clinical Pharmacology

Background:

  • Germ cell tumors (GCT) are a significant group of cancers, particularly in young men.
  • Cisplatin-based chemotherapy is a cornerstone for GCT treatment.
  • Developing effective therapies for cisplatin-refractory GCT remains a clinical challenge.

Purpose of the Study:

  • To evaluate the efficacy and toxicity of topotecan in patients with advanced, cisplatin-refractory germ cell tumors.
  • To determine if topotecan can induce responses in a patient population with limited treatment options.

Main Methods:

  • A phase II clinical trial was conducted.
  • Fifteen patients with advanced, cisplatin-refractory GCT were enrolled.
  • Treatment consisted of topotecan; efficacy and toxicity were assessed in evaluable patients.

Main Results:

  • Out of 14 evaluable patients, none achieved a complete or partial response.
  • The primary toxicity observed was myelosuppression.
  • Median nadir counts included leukocytes (1.75 cells/mm3), neutrophils (1.55 cells/mm3), hemoglobin (8.75 gm/dl), and platelets (20,500 cells/mm3).

Conclusions:

  • Topotecan demonstrated no efficacy in treating cisplatin-refractory germ cell tumors.
  • The drug was associated with significant myelosuppression, limiting its therapeutic potential in this setting.
  • Further investigation of topotecan for GCT is not warranted based on these findings.

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