Abstract | BACKGROUND: 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.
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Authors | David M Peereboom, Conleth Murphy, Manmeet S Ahluwalia, Alison Conlin, April Eichler, Catherine Van Poznak, Joseph Baar, Paul Elson, Andrew D Seidman |
Journal | Neuro-oncology
(Neuro Oncol)
Vol. 16
Issue 4
Pg. 579-83
(Apr 2014)
ISSN: 1523-5866 [Electronic] England |
PMID | 24470546
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents
- Epothilones
- epothilone B
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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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