Clinical breast cancer
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Clinical breast cancer · Aug 2005
Hormone receptor status does not affect the clinical benefit of trastuzumab therapy for patients with metastatic breast cancer.
Hormone receptor (HR) and HER2 signaling pathways are involved in the regulation of breast cancer proliferation. The impact of HR status on the clinical outcome of patients with HER2-overexpressing disease treated with the monoclonal antibody trastuzumab is unknown. ⋯ Hormone receptor status did not affect the clinical benefit of trastuzumab given as a single agent or combined with chemotherapy. The addition of trastuzumab to chemotherapy provides an improved clinical benefit compared with chemotherapy alone, regardless of HR status.
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Clinical breast cancer · Jun 2005
Multicenter Study Clinical TrialWeekly epoetin alfa during adjuvant chemotherapy for breast cancer: effect on hemoglobin levels and quality of life.
Anemia, fatigue, and diminished quality of life (QOL) often are associated with chemotherapy. In a previous study of patients with early-stage breast cancer and a mean baseline hemoglobin (Hb) level of 12.1 g/dL, Hb decreased by 2.0 g/dL after 4 cycles of adjuvant chemotherapy. The current open-label, nonrandomized, multicenter, prospective, community-based study evaluated the effects of 12-24 weeks of epoetin alfa (40,000 U subcutaneously once weekly initiated at the start of standard adjuvant chemotherapy) in patients with stage I-III breast cancer and baseline Hb levels > or =10 g/dL to < or =14 g/dL on Hb level, transfusions, and QOL. ⋯ Controlled studies are warranted to confirm the safety and efficacy of epoetin alfa therapy in patients with mild anemia receiving chemotherapy.
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Clinical breast cancer · Oct 2004
Randomized Controlled Trial Comparative Study Clinical TrialSurvival benefit with capecitabine/docetaxel versus docetaxel alone: analysis of therapy in a randomized phase III trial.
In a large phase III trial of 511 patients with anthracycline-pretreated advanced/metastatic breast cancer, capecitabine/docetaxel combination therapy was shown to have significantly superior efficacy compared with single-agent docetaxel, including superior progression-free and overall survival and objective response rate. An updated survival analysis with >/= 27 months follow-up shows that patients receiving combination therapy maintained significantly superior survival (hazard ratio [HR], 0.777 [95% CI, 0.645-0.942]; P < 0.01; median survival, 14.5 months vs. 11.5 months) compared with those receiving single-agent docetaxel. Following the failure of docetaxel monotherapy, 35% of patients did not receive additional cytotoxic chemotherapy. ⋯ Among patients randomized to combination therapy, discontinuing docetaxel of capecitabine has a similar effect on survival (HR, 0.720; P = 0.20; median survival, 15.8 months vs. 18.3 months, respectively). Median survival was 18.3 months in patients who discontinued docetaxel and continued to receive capecitabine versus 15.8 months in patients who discontinued capecitabine and continued to receive docetaxel, with a trend toward improved survival in patients continuing to receive capecitabine. Although this is a retrospective analysis, these data suggest that the sequential administration of docetaxel followed by capecitabine is associated with prolonged survival in patients who are candidates for sequential single-agent therapy.
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Clinical breast cancer · Oct 2004
Randomized Controlled Trial Clinical TrialEffect of cardiac dysfunction on treatment outcomes in women receiving trastuzumab for HER2-overexpressing metastatic breast cancer.
Trastuzumab improves time to disease progression (TTP) and survival when added to chemotherapy for HER-positive metastatic breast cancer (MBC), but it is associated with infrequent cardiac dysfunction (CD). We analyzed data from a previous pivotal randomized trial of 469 women with HER2-overexpressing MBC. The aim was to determine the benefit of adding trastuzumab to chemotherapy in terms of TTP that was free of CD, including all CD, moderate or severe (New York Heart Association class III/IV) CD only, or moderate or severe CD that did not improve with cardiac therapy. ⋯ Outcomes improved with trastuzumab despite CD. In particular, the benefit from trastuzumab/paclitaxel outweighed the potential risk of CD in patients with MBC. These types of analyses will be critical for trials assessing trastuzumab as adjuvant therapy.