Navelbine (NVB) and Doxorubicin (DX) both at 25 mg/m2, on days 1 &amp; 8 for the management of advanced breast cancer (ABC)

Anelli, Agnaldo; Hegg, R.; Costa, M. Angeles Andreu; Correa, Mariangela; Yamaguchi, Natsu; Novaes, Nedda Maria Vasconcelos; Andrade, Cláudia; Rodrigues, Thenner Silva; Malzyner, A.; Altino, J.; Caponero, Ricardo; Cabral-Filho, S.; Perdicans, M.; Delgado, Gilson Luchezi; Pizzanelli, Michela; Delgado, F.M.

doi:10.1016/s0959-8049(97)85254-9

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“…However, a comparable analysis of patients treated with NA reveals that this distinction is much smaller, with a response rate of 78% (29 of 37 patients; 95% CI, 61–89%) in patients with nonvisceral sites of disease and 71% (34 of 48 patients; 19% CI, 58–84%) in those with involvement of visceral sites ( P = 0.636). Similar results have been reported in previous trials of vinorelbine/doxorubicin12, 18–20 but, in this study, it is associated with improvements in the survival of these patients compared with those treated with FAC, and, although this observation is based on a small number of patients, it is of sufficient interest to require confirmation in a larger study.…”

Section: Discussionsupporting

confidence: 90%

A prospective, randomized phase III trial comparing combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil with vinorelbine plus doxorubicin in the treatment of advanced breast carcinoma

Blajman¹,

Balbiani²,

Block³

et al. 1999

Cancer

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BACKGROUND A prospective, multicenter, randomized, Phase III trial comparing the efficacy of combination chemotherapy with 5‐fluorouracil, doxorubicin, and cyclophosphamide (FAC) with a combination of vinorelbine and doxorubicin (NA) in the treatment of patients with advanced breast carcinoma was undertaken. METHODS One hundred and seventy‐seven patients who previously were untreated for recurrent or metastatic breast carcinoma were entered into the study; 7 patients could not be assessed. The final analysis relates to 85 patients who were treated with FAC and 85 patients who were treated with NA, of whom 21 (25%) and 44 (52%), respectively, had received prior adjuvant chemotherapy. RESULTS The overall response rates were similar for the two treatments and were unaffected by prior exposure to adjuvant therapy; overall response rate (ORR) for FAC was 74% (95% confidence interval [95% CI], 65–83%), and the ORR for NA was 75% (95% CI, 66–84%). The activity of NA in patients with liver involvement was greater than that of FAC in terms of survival. Overall survivals were similar, with a median of 17.3 months for patients receiving FAC and 17.8 months for patients receiving NA. Severe toxicity was uncommon with World Health Organization Grade 3–4 neutropenia affecting only 7% of patients in each arm of the study. NA was associated with a higher incidence of mild to moderate constipation, neurotoxicity, and phlebitis, whereas FAC produced a slight excess of mild cardiotoxicity. CONCLUSIONS The efficacy of these two regimens is very similar, although NA may be more active in a subset of patients with visceral metastatic disease, particularly liver involvement. It is clear that, in a direct comparison with an established three‐drug regimen, the newer two‐drug combination of NA demonstrated equivalent activity with no significant excess of Grade 3–4 toxicity. Cancer 1999;85:1091–7. © 1999 American Cancer Society.

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Section: Discussionsupporting

confidence: 90%