Phase II trial of patupilone in patients with brain metastases from breast cancer Journal Article
| Authors: | Peereboom, D. M.; Murphy, C.; Ahluwalia, M. S.; Conlin, A.; Eichler, A.; Van Poznak, C.; Baar, J.; Elson, P.; Seidman, A. D. |
| Article Title: | Phase II trial of patupilone in patients with brain metastases from breast cancer |
| Abstract: | Background. 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/m2 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. © 2014 © The Author(s) 2014. |
| Keywords: | adult; treatment response; aged; major clinical study; overall survival; constipation; fatigue; neutropenia; diarrhea; drug efficacy; drug withdrawal; side effect; cancer patient; chemotherapy; anorexia; progression free survival; multiple cycle treatment; phase 2 clinical trial; breast cancer; anemia; mucosa inflammation; nausea; neuropathy; vomiting; dehydration; weight reduction; abdominal pain; arthralgia; gastrointestinal toxicity; hypokalemia; liver metastasis; multicenter study; brain metastasis; heartburn; dyspepsia; alopecia; epothilone b; epothilone; brain metastases; leptomeninx; patupilone; upper gastrointestinal bleeding; human; female; article |
| Journal Title: | Neuro-Oncology |
| Volume: | 16 |
| Issue: | 4 |
| ISSN: | 1522-8517 |
| Publisher: | Oxford University Press |
| Date Published: | 2014-04-01 |
| Start Page: | 579 |
| End Page: | 583 |
| Language: | English |
| DOI: | 10.1093/neuonc/not305 |
| PROVIDER: | scopus |
| PMCID: | PMC3956359 |
| PUBMED: | 24470546 |
| DOI/URL: | |
| Notes: | Export Date: 1 May 2014 -- CODEN: NEURJ -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work