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Gemcitabine/paclitaxel improved PFS, OS in metastatic breast cancer
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Maintenance therapy with paclitaxel and gemcitabine improved PFS and OS in women with metastatic breast cancer who initially exhibited disease control after first-line treatment with six cycles of the same combination, according to results of a phase 3 study.
“This strategy may be more valuable to younger patients who are ER-negative and have a higher tumor burden,” Young-Hyuck Im, MD, PhD, head of the division of hematology/medical oncology and director of the Clinical Research Institute at Samsung Medical Center and Sungkyunkwan University School of Medicine, told HemOnc Today.
The prospective, randomized, multicenter study evaluated 231 patients with metastatic breast cancer that demonstrated disease control with six cycles of paclitaxel and gemcitabine. Researchers assigned the women to a maintenance chemotherapy arm (n=116) or observation arm (n=115). Median age was 48 years; median follow-up was 33 months.
Researchers hypothesized that patients would achieve prolonged PFS with maintenance paclitaxel and gemcitabine therapy.
Results indicated median PFS was longer among women assigned maintenance therapy vs. those assigned to the observation arm (7.5 months vs. 3.8 months; P=0.026). Median OS also was longer among patients in the maintenance therapy group (32.3 months vs. 23.5 months; P=0.047).
Patients in the maintenance group had a significantly higher incidence of grade 3 or higher neutropenia compared with those assigned to observation (61% vs. 0.9%; P<.001).
Disclosure: The researchers report no relevant financial disclosures.
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