Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression

Authors

Debu Tripathy, University of Texas MD Anderson Cancer Center, USA
Mansoor Saleh, Aga Khan UniversityFollow
Dennis Slamon, University of California, USA
Melody Cobleigh, Rush University Medical Center, USA
Andrew Arnold, University of Connecticut Health Center, USA
Joanne Mortimer, City of Hope Comprehensive Cancer Center, USA
George Sledge, Stanford University School of Medicine, USA

Document Type

Article

Department

Haematology and Oncology, East Africa

Abstract

Purpose: In a pivotal phase III trial, the addition of trastuzumab to chemotherapy significantly improved response rate, time to disease progression, and overall survival in women with HER2 overexpressing metastatic breast cancer. We conducted an extension study to this trial to obtain additional safety information and to provide trastuzumab following disease progression.

Patients and Methods: A total of 247 patients with documented disease progression received weekly intravenous trastuzumab in the extension study. Concurrent therapies were administered at the discretion of the treating physician. Patient groups were based on initial study treatment: chemotherapy alone (group 1, n = 154) or chemotherapy plus trastuzumab (group 2, n = 93).

Results: Sixty-eight percent of group 1 and 76% of group 2 received chemotherapy plus trastuzumab in the extension trial; the remainder received trastuzumab alone or combined with palliative radiotherapy or hormonal therapy. Seventy-six percent of group 1 and 55% of group 2 experienced at least one adverse event, similar to effects observed in the pivotal trial. Symptomatic or asymptomatic cardiac dysfunction occurred in 9% of group 1 and 2% of group 2 patients. Overall objective response rates were 14% in group 1 and 11% in group 2; median durations of response exceeded 6 months in both groups.

Conclusion:Our results suggest that prolonged use of trastuzumab therapy is safe and well tolerated. Longer durations of therapy did not appear to increase the risk of cardiac dysfunction. Patients progressing on trastuzumab-containing therapy demonstrate some response to a second trastuzumab-containing regimen. The independent contribution of trastuzumab in this setting merits further study.

Comments

This work was published before the author joined Aga Khan University.

Publication (Name of Journal)

Journal of Clinical Oncology

DOI

https://doi.org/10.1200/JCO.2004.06.557

Recommended Citation

Tripathy, D., Saleh, M., Slamon, D., Cobleigh, M., Arnold, A., Mortimer, J., Sledge, G. (2004). Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression. Journal of Clinical Oncology, 22(6), 1063-1070.
Available at: https://ecommons.aku.edu/eastafrica_fhs_mc_haematol_oncol/56