Intravenous versus oral vinorelbine plus capecitabine as second-line treatment in advanced breast cancer patients. A retrospective comparison of two consecutive phase II studies

Abstract

Vinorelbine (i.v.) plus capecitabine (oral) combination therapy is active in anthracycline/taxane pretreated patients with metastatic breast cancer. Availability of oral vinorelbine provides this combination in an all-oral formulation. Two consecutive phase II trials differing only in vinorelbine administration routes evaluated their respective activities and tolerabilities in this population. In the i.v. group (n = 38) disease control was 61% (37% PR, 24% SD), median TTP 6.8 months and median survival 11.3 months. In the oral group (n = 38) disease control was 77% (5.4% CR, 34% PR, 38% SD), median TTP 7 months and median survival 10 months. G3-G4 neutropenia was more common in the oral group (p < 0.05); G2-G3 anaemia [5] and G3 thrombocytopenia [1] were observed only in the oral group. Although the comparison between the two regimens was not randomized, the results observed in these two consecutive phase II studies may suggest that oral and iv vinorelbine, in combination with capecitabine, can achieve similar responses in patients with metastatic breast cancer refractory to anthra-taxane combinations.

Efficacy and Safety of the All-Oral Schedule of Metronomic Vinorelbine and Capecitabine in Locally Advanced or Metastatic Breast Cancer Patients: The Phase I-II VICTOR-1 Study

“…Subsequent trials showed that there was a substantial equivalence between the iv and the oral formulations of VRB, even if this latter was characterized by a higher rate of haematological toxicity [3–5]. In all these studies, VRB and CAPE were administered on days 1 and 8, according to the approved standard schedule.…”

A Phase II Study of Combination Chemotherapy with Capecitabine and Intravenous Vinorelbine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes: Efficacy and Tolerance

“…In other phase II trials in which the combination of capecitabine and vinorelbine was administered to patients with breast cancer pretreated with anthracyclines and taxanes Table (4) [25][26][27][28][29][30][31] , the RRs obtained ranged between 33% and 70%. In these studies, the median time to progression (TTP) ranged from 4.5 months to 10 months and the median OS was within 10 months and 30.4 months.…”

A Phase I Study of UFT-Oral Vinorelbine in Metastatic Breast Cancer

“…The only grade 3/4 toxicities were neutropenia (19%) and hand-foot syndrome (9%). The retrospective comparison of two consecutive phase II studies conducted by Lorusso et al [14] demonstrated a similar toxicity profile and response rate for this combination. Interestingly, no hand-foot syndromes were observed in our study despite the use of similar doses of UFT.…”

“…Dose levels were determined based on the results of the previous single-agent and combination chemotherapy trials [11,12,13,14,16,17]. The escalated dose design was based on the Fibonacci ‘3 + 3’ schedule [18].…”

“…It exerts its neoplastic action by preventing tubulin polymerization and arresting mitosis at metaphase. The combination of oral vinorelbine and fluoropyrimidine was previously studied in MBC [11,12,13,14]. As the ultimate goal in MBC management is to prolong the duration of life while maintaining a good quality of life, the choice of UFT and oral vinorelbine combination was particularly attractive.…”