Abstract P3-02-11: First Analysis of the Value of Circulating Epithelial Tumor Cells and Circulating Endothelial Cells (CTCs/CECs) in Patients with HER-2 Negative Recurrent or Metastatic Breast Cancer Treated with Bevacizumab in Combination with Paclitaxel and Gemcitabine as First Line Therapy (AVALUZ Trial)

Purpose To determine the response rate (RR), progression-free survival (PFS), and toxicity in patients with HER-2/neu–negative metastatic breast cancer treated with first-line paclitaxel in a de-escalating dosing schedule. Patients and Methods Between August 1999 and December 2000, 73 patients were enrolled. Paclitaxel was administered on day 1 (175 mg/m2) and on days 8 and 15 (80 mg/m2 each) in each 4-week cycle (1 week of rest). Doses were de-escalated with the aim of reducing toxicity. An Eastern Cooperative Oncology Group performance status of 0, 1, or 2 was found in 55%, 41%, and 4% of patients, respectively. Median age was 59 years (range, 38 to 84 years), and 86% of patients had received prior surgery; 60%, adjuvant chemotherapy; and 59%, radiation therapy. Results Based on an intention-to-treat analysis (N = 73), there were five patients with a complete response (6.8%), 16 with a partial response (21.9%), 17 with stable disease (23.3%), and 23 with progressive disease (31.5%) for an RR of 28.7%. Twelve patients (16.4%) were not assessable for response due to toxicity (seven patients, mainly neuropathy), withdrawal of consent (two patients), early death (two patients), or noncompliance (one patient). Median PFS was 6.5 months (range, < 1 to 36.1 months), median survival was 22.8 months (range, < 1 to 36.1 months), and median duration of response was 8.8 months (range, 3.0 to 31.8 months). Patients (n = 72) were evaluated for toxicity. Grade 3 to 4 treatment-related toxicities occurring in more than 5% of patients included neutropenia (22.2%), neuropathy (18.1%), fatigue (6.9%), and leukopenia (5.6%). Conclusion In a unique de-escalating schedule, this study of single-agent paclitaxel produced a response rate similar to other single-agent paclitaxel schedules, in first-line therapy for metastatic breast cancer, published in the literature. However, this schedule is not recommended for the therapy of metastatic breast cancer because of the higher rate of toxicity.

Download Full-text

482 PUBLICATION Results of intercancer cohort: epidemiologic brazilian data of women with HER-2 positive metastatic breast cancer treated with trastuzumab as first-line therapy

European Journal of Cancer Supplements ◽

10.1016/s1359-6349(05)80778-5 ◽

2005 ◽

Vol 3 (2) ◽

pp. 134

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Metastatic Breast ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Her 2

Download Full-text

Trastuzumab plus capecitabine and docetaxel as first-line therapy for metastatic breast cancer: Phase II results

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.1111 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 1111-1111

Author(s):

C. G. Gennatas ◽

V. Michalaki ◽

S. Gennatas

Keyword(s):

Breast Cancer ◽

Overall Survival ◽

Metastatic Breast Cancer ◽

Adverse Events ◽

Survival Time ◽

Metastatic Breast ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Her 2

1111 Background: In human epidermal growth factor 2 (HER-2)-positive advanced breast cancer, taxanes plus trastuzumab are among the most widely applied options in the first-line setting. The addition of capecitabine to docetaxel significantly improves overall survival in anthracycline-pretreated metastatic breast cancer. We evaluated the efficacy and tolerability of trastuzumab plus capecitabine and docetaxel regimen as first-line therapy. Methods: Patients who had received adjuvant anthracyclines received docetaxel 75 mg/m2 day 1 and capecitabine 950 mg/m2 twice daily, days 1–14, every 3 weeks until disease progression or unacceptable toxicity. Trastuzumab was administered at a dose of 6 mg/kg every 3 weeks. Time to progression (TTP) was defined as primary end point. Results: Twenty eight patients were evaluable (median age 52 years, range 34–70). The regimen achieved objective responses in 11 patients (39%), including complete response in three patients (11%) and partial response in eight patients (28.5%). The median overall survival time was 25.5 months, and the median progression-free survival time was 7.8 months. The safety profile of the combination was favorable and predictable, with a low incidence of grade 3/4 adverse events. The most common adverse events were hand-foot syndrome, and GI toxicities. Severe myelosuppression was rare and cardiac toxicity did not occur. Conclusions: These data confirm that the combination of trastuzumab plus capecitabine and docetaxel is highly active in patients with HER-2-overexpressing anthracycline-pretreated breast cancer, and is well tolerated. No significant financial relationships to disclose.

Download Full-text