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Phase I study of Doxil and vinorelbine in metastatic breast cancer.

Publication ,  Journal Article
Burstein, HJ; Ramirez, MJ; Petros, WP; Clarke, KD; Warmuth, MA; Marcom, PK; Matulonis, UA; Parker, LM; Harris, LN; Winer, EP
Published in: Ann Oncol
September 1999

BACKGROUND: Vinorelbine and Doxil (liposomal doxorubicin) are active chemotherapeutic agents in metastatic breast cancer. A phase I study was designed to evaluate combination therapy. PATIENTS AND METHODS: Thirty women with metastatic breast cancer were enrolled. Dose-limiting toxicity was determined through a dose escalation scheme, and defined for the first treatment cycle, only. Pharmacokinetic studies were performed during the first cycle of treatment. RESULTS: In the first cohort of Doxil 30 mg/m2 day 1 and vinorelbine 25 mg/m2 days 1 and 8, patients experienced severe neutropenia. Vinorelbine administration was changed thereafter to days 1 and 15 of each cycle. Dose limiting toxicity was observed at Doxil 50 mg/m2 and vinorelbine 25 mg/m2. Doxil 40 mg/m2 and vinorelbine 30 mg/m2 was defined as the maximally tolerated dose. Few toxicities (principally neutro penia) were seen at this dose level, with the notable absence of significant nausea, vomiting, or alopecia. Though 63% of patients had received prior anthracycline-based chemotherapy, only one patient developed grade 2 cardiac toxicity. Pharmacokinetic studies revealed prolonged exposure to high doxorubicin concentrations for several days following Doxil administration. CONCLUSIONS: Combination chemotherapy with Doxil and vinorelbine affords treatment with two active drugs in women with metastatic breast cancer, and appears to have a favorable toxicity profile. A schedule of Doxil 40 mg/m2 day 1 and vinorelbine 30 mg/m2 days 1 and 15 given every 28 days is recommended for phase II studies.

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Published In

Ann Oncol

DOI

ISSN

0923-7534

Publication Date

September 1999

Volume

10

Issue

9

Start / End Page

1113 / 1116

Location

England

Related Subject Headings

  • Vinorelbine
  • Vinblastine
  • Treatment Outcome
  • Time Factors
  • Oncology & Carcinogenesis
  • Neoplasm Metastasis
  • Middle Aged
  • Humans
  • Female
  • Doxorubicin
 

Citation

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Burstein, H. J., Ramirez, M. J., Petros, W. P., Clarke, K. D., Warmuth, M. A., Marcom, P. K., … Winer, E. P. (1999). Phase I study of Doxil and vinorelbine in metastatic breast cancer. Ann Oncol, 10(9), 1113–1116. https://doi.org/10.1023/a:1008323200102
Burstein, H. J., M. J. Ramirez, W. P. Petros, K. D. Clarke, M. A. Warmuth, P. K. Marcom, U. A. Matulonis, L. M. Parker, L. N. Harris, and E. P. Winer. “Phase I study of Doxil and vinorelbine in metastatic breast cancer.Ann Oncol 10, no. 9 (September 1999): 1113–16. https://doi.org/10.1023/a:1008323200102.
Burstein HJ, Ramirez MJ, Petros WP, Clarke KD, Warmuth MA, Marcom PK, et al. Phase I study of Doxil and vinorelbine in metastatic breast cancer. Ann Oncol. 1999 Sep;10(9):1113–6.
Burstein, H. J., et al. “Phase I study of Doxil and vinorelbine in metastatic breast cancer.Ann Oncol, vol. 10, no. 9, Sept. 1999, pp. 1113–16. Pubmed, doi:10.1023/a:1008323200102.
Burstein HJ, Ramirez MJ, Petros WP, Clarke KD, Warmuth MA, Marcom PK, Matulonis UA, Parker LM, Harris LN, Winer EP. Phase I study of Doxil and vinorelbine in metastatic breast cancer. Ann Oncol. 1999 Sep;10(9):1113–1116.
Journal cover image

Published In

Ann Oncol

DOI

ISSN

0923-7534

Publication Date

September 1999

Volume

10

Issue

9

Start / End Page

1113 / 1116

Location

England

Related Subject Headings

  • Vinorelbine
  • Vinblastine
  • Treatment Outcome
  • Time Factors
  • Oncology & Carcinogenesis
  • Neoplasm Metastasis
  • Middle Aged
  • Humans
  • Female
  • Doxorubicin