Phase II study of weekly vinorelbine and 24-h infusion of high-dose 5-fluorouracil plus leucovorin as first-line treatment of advanced breast cancer

Abstract

We prospectively investigated the efficacy and safety of combining weekly vinorelbine (VNB) with weekly 24-h infusion of high-dose 5-fluorouracil (5-FU) and leucovorin (LV) in the treatment of patients with advanced breast cancer (ABC). Vinorelbine 25 mg m À2 30-min intravenous infusion, and high-dose 5-FU 2600 mg m À2 plus LV 300 mg m À2 24-h intravenous infusion (HDFL regimen) were given on days 1 and 8 every 3 weeks. Between June 1999 and April 2003, 40 patients with histologically confirmed recurrent or metastatic breast cancer were enrolled with a median age of 49 years (range: 36 -68). A total of 25 patients had recurrent ABC, and 15 patients had primary metastatic diseases. The overall response rate for the intent-to-treat group was 70.0% (95% CI: 54 -84%) with eight complete responses and 20 partial responses. All 40 patients were evaluated for survival and toxicities. Among a total of 316 cycles of VNB -HDFL given (average: 7.9: range: 4 -14 cycles per patient), the main toxicity was Gr3/4 leucopenia and Gr3/4 neutropenia in 57 (18.0%) and 120 (38.0%) cycles, respectively. Gr1/2 infection and Gr1/2 stomatitis were noted in five (1.6%) and 59 (18.7%) cycles, respectively. None of the patients developed Gr3/4 stomatitis or Gr3/4 infection. Gr2/3 and Gr1 hand -foot syndrome was noted in two (5.0%) and 23 (57.5%) patients, respectively. Gr1 sensory neuropathy developed in three patients. The median time to progression was 8.0 months (range: 3 -25.5 months), and the median overall survival was 25.0 months with a followup of 5.5 to 45 þ months. This VNB -HDFL regimen is a highly active yet well-tolerated first-line treatment for ABC.

Prediction of outcome of patients with metastatic breast cancer: evaluation with prognostic factors and Nottingham prognostic index

“…One study of metastatic breast cancer from Chang Gung Memorial Hospital, Taiwan showed that the 1-year survival rate was 70.5%, and the 2-year survival rate was 32.9% [44]. Another study from the National Taiwan University Hospital showed that the 1-year survival rate was 80.0%, and the 2-year survival rate was 50.0% [86].…”

Molecular Targeted Agents for Gastric Cancer: A Step Forward Towards Personalized Therapy

“…In first-line setting Cetuximab has been evaluated in combination with different regimens of chemotherapy, such as 5FU, folinic acid, irinotecan (iri) (FOLFIRI) [20], docetaxel/cisplatin (cis) [21], FOLFOX [22], (capecitabine (cape), oxaliplatin (ox) (XELOX) [23], weekly iri, infusional 5FU, leucovorin (FUFIRI) [24], continuous infusion high dose 5FU/leucovorin /cis [25], cape/cis [26], and ox/iri [27]. …”

Vinorelbine and fluorouracil plus leucovorin combination (ViFL) in patients with anthracycline and taxane-pretreated metastatic breast cancer: a phase II study

“…In view of its mild toxicity profile, VNB can be easily combined with many other drugs like taxanes, anthracyclines, gemcitabine, 5-fluorouracil, platinum compounds and capecitabine. In comparative studies, combined strategy is not always superior to the optimal sequential therapy and is often more toxic (Mano 2006;Yeh et al 2005;Berruti et al 2000Berruti et al , 2005Campone et al 2009). …”

“…Objective response rate is nearly 45% in first line treatment and 20-30% in previously treated patients. In combination with other chemotherapy agents the most employed schedule was VNB 25 mg/sqm on days 1 and 8 every 3 weeks (Mano 2006;Yeh et al 2005). In view of its mild toxicity profile, VNB can be easily combined with many other drugs like taxanes, anthracyclines, gemcitabine, 5-fluorouracil, platinum compounds and capecitabine.…”