Final Results of an International Retrospective Observational Study in Patients with Advanced Breast Cancer Treated with Oral Vinorelbine-based Chemotherapy

• Published in: Anticancer research Vol. 32; no. 10; pp. 4539 - 4545
• Main Authors: GARCIA PALOMO, Andres, GLOGOWSKA, Iwona, SOMMER, Harald, MALAMOS, Nikolaos, KILAR, Ewa, LOPEZ VEGA, Jose M, TORRECILLAS, Laura, DELOZIER, Thierry, ETTL, Johannes, FINEK, Jindrich
• Format: Journal Article
• Language: English
• Published: Attiki International Institute of Anticancer Research 01-10-2012
• Subjects: Administration, Oral; Adult; Aged; Aged, 80 and over; Anthracyclines - therapeutic use; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Bridged-Ring Compounds - therapeutic use; Capecitabine; Carcinoma - drug therapy; Carcinoma - secondary; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Disease-Free Survival; Female; Fluorouracil - analogs & derivatives; Fluorouracil - therapeutic use; Gynecology. Andrology. Obstetrics; Hematologic Diseases - chemically induced; Humans; Mammary gland diseases; Medical sciences; Middle Aged; Patient Compliance; Retrospective Studies; Severity of Illness Index; Taxoids - therapeutic use; Tumors; Vinblastine - analogs & derivatives; Vinblastine - therapeutic use; Antineoplastic agent; Human; Breast disease; Oral cancer; Stomatology; Breast cancer; Malignant tumor; Retrospective; Mammary gland diseases; Alkaloid; Chemotherapy; Cancerology; Treatment; Advanced stage; Oral cavity disease; Antimitotic; Vinorelbine; Cancer; International
• ISSN: 0250-7005; 1791-7530

Full oral chemotherapy (CT) is an active and convenient therapeutic option for patients with advanced breast cancer (ABC). In this retrospective analysis, we reviewed the characteristics and the outcome of patients treated by oral vinorelbine either as a single-agent or in combination with capecitabine as first- or second-line CT in the metastatic setting.
We analysed 216 patients with ABC who started treatment with a full oral CT at 13 centers and seven countries between 2006 and 2008. To be eligible, patients must have received either as a first-(56%) or second-line (44%) therapy oral vinorelbine as a single-agent (54%) or in combination with capecitabine (46%).
Main patients' characteristics in the full population (n=216): median age (range): 61 (32-87) years; categories of age: <50 years: 18%, 50-65 years: 44%, ≥ 65 years: 38%; hormone receptor-positive: 63%; ≥ 2 metastatic sites: 58%; visceral metastases: 49%; prior CT: 86%; prior CT for ABC: 44%; prior anthracycline treatment: 69%; prior taxane treatment: 43%, prior anthracycline plus taxane: 38%; prior endocrine therapy: 63%. Median number of cycles: 6 (range=1-54); 48% of patients received more than 6 cycles. G3/4 toxicities: neutropenia 8%, anaemia 2%, thrombocytopenia 1%, febrile neutropenia/neutropenic infection 2%, nausea 6%, vomiting 4%, diarrhea 6%, fatigue 6%, hand-foot syndrome 14% (combination with capecitabine), neuropathy 1%, alopecia (grade 2) 1%.
disease control was achieved in 77% of patients [95% confidence interval=71-83%], 74% as single-agent, 81% in combination, 82% in first-line, 71% in second-line. Median progression-free survival was 9.7 months [95% confidence interval=8.2-12.6 months] in first-line and 6.6 months [95% confidence interval=5.5-8.5 months] in second-line therapy. Caregivers described these oral regimens as convenient (81%), well-tolerated (84%) and with a good compliance by patients (76%).
These data from everyday practice confirm, as shown in different clinical trials, that oral vinorelbine is an active and well-tolerated CT for ABC, either as a first- or second-line in patients pre-treated with anthracyclines or taxanes. The convenience of its oral administration in association with its good tolerance profile, allows for continuation of treatment until disease progression without a pre-planned maximum of cycles.