Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy.

Fumoleau, P.; Delgado, F.M.; Delozier, T.; Monnier, Alain; Delgado, M.; Kerbrat, Pierre; García-Giralt, E; Keiling, R; Namer, M.; Closon, Marie-Thérèse

doi:10.1200/jco.1993.11.7.1245

Cited by 299 publications

(112 citation statements)

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“…vinorelbine has been widely investigated in the treatment of MBC. Response rates of 35 -50% have consistently been demonstrated for first-line single-agent vinorelbine (Fumoleau et al, 1993;Garcia-Conde et al, 1994;Romero et al, 1994;Twelves et al, 1994;Bruno et al, 1995;Weber et al, 1995;Terenziani et al, 1996). The good tolerance profile of i.v.…”

mentioning

confidence: 91%

Vinorelbine alternating oral and intravenous plus epirubicin in first-line therapy of metastatic breast cancer: results of a multicentre phase II study

Serin

Verrill²,

Jones

et al. 2005

Br J Cancer

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The combination of intravenous (i.v.) vinorelbine and epirubicin is highly active in the treatment of metastatic breast cancer (MBC). In an effort to improve patient convenience, we investigated a regimen alternating i.v. and oral vinorelbine in combination with epirubicin as first-line chemotherapy of patients with MBC. In all, 49 patients with MBC received, as first-line treatment, a combination regimen consisting of i.v. vinorelbine 25 mg m À2 plus epirubicin 90 mg m À2 given on day 1, and oral vinorelbine 60 mg m À2 on day 8 (or day 15 if neutrophils o1500 mm À3 ) every 3 weeks, in an open-label, multicentre phase II study. Treatment was to be repeated for a maximum of six cycles. The study population had a median age of 55 years, half of the patients had received prior adjuvant chemotherapy and 86% presented a visceral involvement. In all, 25 responses were documented and validated by an independent panel review, yielding response rates of 51% (95% CI: 36 -66) in the 49 enrolled patients and 54.5% (95% CI: 39 -70) in the 44 evaluable patients. Median durations of progression-free survival and survival were 8 and 20 months, respectively. Neutropenia was the main dose-limiting toxicity, but complications were uncommon, four patients having experienced febrile neutropenia and six having developed neutropenic infection. Other frequently reported adverse events included stomatitis, nausea and vomiting, which were rarely severe. No toxic death was reported. Among patients who received six cycles, global score of quality of life remained stable. This regimen alternating oral and i.v. vinorelbine in combination with epirubicin is effective and safe. Oral vinorelbine on day 8 offers greater convenience to the patient, and decreases the need for i.v. injection and reduces time spent in hospital. Therefore, oral vinorelbine is a convenient alternative to the i.v. form in combination regimens commonly used to treat MBC.

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confidence: 91%

Vinorelbine alternating oral and intravenous plus epirubicin in first-line therapy of metastatic breast cancer: results of a multicentre phase II study

Serin

Verrill²,

Jones

et al. 2005

Br J Cancer

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“…vinorelbine given intravenously at 30 mg/m 2 /week showed an objective response rate of 40 -60% [3][4][5][6][7][8][9][10] and as salvage therapy, 16 -64%. [11][12][13][14][15][16] The dose-limiting toxic effect of weekly vinorelbine is neutropenia.…”

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confidence: 99%

Phase I study of vinorelbine and paclitaxel by 3‐hour simultaneous infusion with and without granulocyte colony‐stimulating factor support in metastatic breast carcinoma

Ibrahim

Buzdar

Valero

et al. 2001

Cancer

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“…Novel derivatives of these compounds, namely vinorelbine and vinflunine, have been shown to display significant antitumour activity (Johnson et al, 1996;Kruczynski et al, 1998a;Hill et al, 1999). Indeed, vinorelbine is a clinically active compound and is currently widely used in the treatment of cancer, especially in nonsmall cell lung cancer and breast cancer (Berthaud et al, 1992;Fumoleau et al, 1993;Le Chevalier et al, 1994;Romero et al, 1994;Fumoleau et al, 1995;Budman, 1997). Vinflunine is currently in Phase I trials in Europe.…”

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confidence: 99%

Anti-vascular effects of vinflunine in the MAC 15A transplantable adenocarcinoma model

2001

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Summary Anti-vascular effects of the novel Vinca alkaloid, vinflunine have been investigated in the MAC 15A transplantable murine colon adenocarcinoma model and compared with those induced by the most recently identified clinically useful third generation Vinca. Administration of the maximum tolerated dose of either vinflunine (50 mg kg -1 ) or vinorelbine (8 mg kg -1 ) resulted in significant tumour growth delay with subsequent histological analysis revealing substantial haemorrhagic necrosis. This suggested possible anti-vascular effects and these were confirmed by Hoechst 33342 perfusion studies. Vinflunine, currently undergoing Phase I trials in Europe, was found to be at least as effective as the clinically active vincristine and vinorelbine in this model and, remarkably, produced anti-vascular effects at doses much lower than the maximum tolerated dose. Although vinflunine caused apoptosis in HUVEC monolayer cultures this event did not occur within the first 8 hours of exposure whereas vascular shutdown in vivo was observed within the first 4 hours.

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Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy.

Abstract: Our data confirm that Navelbine has major single-agent antitumor activity as front-line therapy in advanced breast cancer. Given its excellent tolerance profile and low toxicity, it should be considered for inclusion in first-line combination chemotherapy regimens.

Cited by 299 publications

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Vinorelbine alternating oral and intravenous plus epirubicin in first-line therapy of metastatic breast cancer: results of a multicentre phase II study

Vinorelbine alternating oral and intravenous plus epirubicin in first-line therapy of metastatic breast cancer: results of a multicentre phase II study

Phase I study of vinorelbine and paclitaxel by 3‐hour simultaneous infusion with and without granulocyte colony‐stimulating factor support in metastatic breast carcinoma

Anti-vascular effects of vinflunine in the MAC 15A transplantable adenocarcinoma model

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