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Phase II trial of patupilone in patients with brain metastases from breast cancer.

AbstractBACKGROUND:
For patients with progressive breast cancer brain metastasis (BCBM) after whole brain radiotherapy (WBRT), few options exist. Patupilone is an epothilone that crosses the blood-brain barrier. We hypothesized that patupilone would produce a 35% 3-month CNS progression-free survival in women with BCBM after WBRT.
METHODS:
This multicenter phase II trial included 2 cohorts. Group A included women with progressive BCBM after WBRT. Group B was an exploratory cohort of patients with either leptomeningeal metastases or untreated brain metastases. The primary goal was to observe a 35% 3-month CNS progression-free survival in Group A. The sample size was 45 for Group A and 10 for Group B. Patients received patupilone 10 mg/m(2) once every 3 weeks until progression. Responses were scored according to the Macdonald criteria.
RESULTS:
Fifty-five patients (45 in Group A, 10 in Group B) enrolled. In Group A, the 3-month CNS progression-free survival was 27%, the median overall survival was 12.7 months, and the overall response rate was 9%. In Group B, which enrolled 5 patients with leptomeningeal disease and 5 with no prior WBRT, no responses occurred and 8 patients had CNS progression before 3 months. Systemic responses occurred in 15% of patients, including a complete response in liver metastases. Diarrhea occurred in 87% of patients; 25% had grade 3 and 4 adverse events.
CONCLUSIONS:
Patupilone in patients with BCBM did not meet the efficacy criteria and had significant gastrointestinal toxicity. Further study of brain-penetrant agents is warranted for patients with CNS metastases from breast cancer.
AuthorsDavid M Peereboom, Conleth Murphy, Manmeet S Ahluwalia, Alison Conlin, April Eichler, Catherine Van Poznak, Joseph Baar, Paul Elson, Andrew D Seidman
JournalNeuro-oncology (Neuro Oncol) Vol. 16 Issue 4 Pg. 579-83 (Apr 2014) ISSN: 1523-5866 [Electronic] England
PMID24470546 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Antineoplastic Agents
  • Epothilones
  • epothilone B
Topics
  • Adult
  • Aged
  • Antineoplastic Agents (therapeutic use)
  • Brain Neoplasms (drug therapy, mortality, secondary)
  • Breast Neoplasms (drug therapy, mortality, pathology)
  • Cohort Studies
  • Epothilones (therapeutic use)
  • Female
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Neoplasm Staging
  • Prognosis
  • Survival Rate

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