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A phase II study of tipifarnib and gemcitabine in metastatic breast cancer

Clinton Yam1, Rashmi K Murthy1, Vicente Valero1

  • 1Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Dan L. Duncan Building, CPB5.3542, 1515 Holcombe Blvd., Unit 1354, Houston, TX, 77030, USA.

Investigational New Drugs
|January 28, 2018
PubMed

Insights

The combination of tipifarnib and gemcitabine showed limited efficacy in metastatic breast cancer, with a 16.7% response rate. This novel combination therapy also resulted in high rates of myelosuppression, indicating poor tolerability.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Tipifarnib, a farnesyltransferase inhibitor, shows promise in combination therapies.
  • Previous trials with anti-estrogen therapy were disappointing, but synergy with anthracyclines was observed.

Purpose of the Study:

  • To evaluate the efficacy and safety of tipifarnib combined with gemcitabine in metastatic breast cancer.

Main Methods:

  • A prospective Phase II trial involved 30 postmenopausal women with metastatic breast cancer.
  • Patients received tipifarnib (300 mg PO BID days 1-14) and gemcitabine (1000 mg/m2 IV days 1 and 8) on 21-day cycles.

Main Results:

  • The objective response rate was 16.7% (1 complete response, 4 partial responses).
  • Median progression-free survival was 2.5 months; median overall survival was 13.1 months.
  • Grade 4 neutropenia occurred in 40% of patients.

Conclusions:

  • The combination of tipifarnib and gemcitabine demonstrated poor tolerability due to high rates of myelosuppression.
  • This combination did not show superior efficacy compared to gemcitabine monotherapy for metastatic breast cancer.
Keywords:
GemcitabineMetastatic breast cancerPhase II trialTipifarnib

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