Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study

Autor: Hiroyasu Yamashiro, Koichiro Tsugawa, Kojiro Mashino, Tatsuya Toyama, Tomomi Fujisawa, Shoichiro Ohtani, Uhi Toh, Rikiya Nakamura, Masakazu Toi, Takahiro Nakayama, Naoto Kondo, Masahiro Kashiwaba, Shinji Ohno, Yutaka Yamamoto, Yuichi Tanino, Takashi Ishikawa, Hidetoshi Kawaguchi, Toshimi Takano, Masato Takahashi, Satoshi Morita
Rok vydání: 2020
Předmět:
0301 basic medicine
Oncology
Receptor
ErbB-2
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Clinical endpoint
Locally advanced breast cancer
Overall survival
Pharmacology (medical)
Breast
Prospective Studies
Aged
80 and over
Hazard ratio
General Medicine
Middle Aged
Metastatic breast cancer
Prognosis
Progression-Free Survival
Bevacizumab
Receptors
Estrogen
030220 oncology & carcinogenesis
Original Article
Female
Receptors
Progesterone
medicine.drug
Adult
medicine.medical_specialty
Paclitaxel
Combination therapy
Breast Neoplasms
Neutropenia
Disease-Free Survival
03 medical and health sciences
Breast cancer
Internal medicine
Biomarkers
Tumor
medicine
Humans
Radiology
Nuclear Medicine and imaging
Aged
Second line
Taxane
business.industry
medicine.disease
First line
030104 developmental biology
Neoplasm Recurrence
Local
business
Zdroj: Breast Cancer (Tokyo, Japan)
ISSN: 1880-4233
1340-6868
DOI: 10.1007/s12282-020-01138-4
Popis: Purpose To investigate the effectiveness and safety of bevacizumab–paclitaxel combination therapy as first- or second-line chemotherapy for HER2-negative locally advanced or metastatic breast cancer in daily clinical practice. Methods In this prospective multicenter observational study, bevacizumab–paclitaxel was administered at the discretion of attending physicians. Cohorts A and B had hormone receptor-positive and triple-negative breast cancer (TNBC), respectively. Primary endpoint was overall survival (OS). Multivariate analyses were conducted to identify prognostic factors. Results Between November 2012 and October 2014, 767 patients were enrolled from 155 institutions across Japan. Effectiveness was analyzed in 754 eligible patients (cohort A, 539; cohort B, 215) and safety in 750 treated patients (median observation period, 19.7 months). Median OS (95% CI) was 21.7 (19.8–23.6) months in eligible patients; 25.2 (22.4–27.4) months and 13.2 (11.3–16.6) months in cohorts A and B, respectively; and 24.4 (21.9–27.2) months and 17.6 (15.2–20.0) months in patients receiving first- and second-line therapy, respectively. Factors affecting OS (hazard ratio 95% CI) were TNBC (1.75, 1.44–2.14), second-line therapy (1.35, 1.13–1.63), ECOG performance status ≥ 1 (1.28, 1.04–1.57), taxane-based chemotherapy (0.65, 0.49–0.86), cancer-related symptoms (0.56, 0.46–0.68), and visceral metastasis (0.52, 0.40–0.66). Incidences of grade ≥ 3 AEs hypertension, neutropenia, peripheral neuropathy, proteinuria, and bleeding were 35.7%, 27.2%, 7.2%, 3.7%, and 0.3%, respectively. Conclusions In Japanese clinical practice, combined bevacizumab–paclitaxel was as effective as in previous studies. Factors that independently predicted poor prognosis in the present study are consistent with those identified previously. Trial registration Trial no. UMIN000009086.
Databáze: OpenAIRE
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