A Phase I Study of an All-Oral Combination of Vinorelbine/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes

Kellokumpu-Lehtinen, Pirkko-Liisa; Sunela, Kaisa; Lehtinen, Ilari; Joensuu, Heikki; Sjöström-Mattson, Johanna

doi:10.3816/cbc.2006.n.057

Cited by 17 publications

(6 citation statements)

References 29 publications

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“…Three phase I trials have evaluated the combination of oral vinorelbine and capecitabine in MBC (Kellokumpu-Lehtinen et al, 2006;Nole et al, 2006;Anton et al, 2008). In all these studies, the recommended dose of capecitabine for phase II trials was 1000 mg m À2 twice daily, on days 1 -14.…”

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confidence: 99%

All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial

et al. 2009

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BACKGROUND: This multicentre, international phase II trial evaluated the efficacy and safety profile of a first-line combination of oral vinorelbine plus capecitabine for women with metastatic breast cancer (MBC). METHODS: Patients with measurable, HER2-negative disease received, as a first line in metastatic setting, 3-weekly cycles of oral vinorelbine 80 mg m À2 (after a first cycle at 60) on day 1 and day 8, plus capecitabine 1000 mg m À2 (750 if X65 years of age) twice daily, on days 1 -14. Treatment was continued until progression or unacceptable toxicity. RESULTS: A total of 55 patients were enrolled and 54 were treated (median age: 58.5 years). Most (78%) had visceral involvement and 63% had received earlier (neo)adjuvant chemotherapy. The objective response rate (RECIST) in 49 evaluable patients was 51% (95% confidence interval (CI), 36 -66), including complete response in 4%. The clinical benefit rate (response or stable disease for X6 months) was 63% (95% CI, 48 -77). The median duration of response was 7.2 months (95% CI, 6.4 -10.2). After a median follow-up of 41 months, median progression-free survival was 8.4 months (95% CI, 5.8 -9.7) and median overall survival was 29.2 months (95% CI, 18.2 -40.1). Treatment-related adverse events were manageable, the main grade 3 -4 toxicity was neutropaenia (49%); two patients experienced febrile neutropaenia and three patients had a neutropaenic infection (including one septic death). A particularly low rate of alopaecia was observed. CONCLUSION: These results show that the all-oral combination of oral vinorelbine and capecitabine is an effective and well-tolerated first-line regimen for MBC.

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confidence: 99%

All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial

et al. 2009

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“…In two phase I dose-escalation studies, a regimen of C 1,000 mg/m 2 bid for 14 days every 3 weeks combined with oral VI 60 mg/m 2 , days 1 and 8, was identified for further evaluation [44,45]. In single-arm, phase II studies, this combination (most commonly utilising C at 1,000 mg/m 2 bid days 1-14 and VI 60-80 mg, days 1 and 8 every 3 weeks) has demonstrated RRs of 26-61% in an unselected population (prevalently first-line setting).…”

Section: Oral VI In Combination Therapymentioning

confidence: 99%

Oral vinorelbine: its role in advanced breast cancer pre-treated with anthracycline and taxane chemotherapies

Petrelli

Barni

2010

Oncol Rev

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Metastatic breast cancer (BC) remains an incurable disease and clinical benefit and prolongation of time to progression are the main end-points in advanced setting. A safe and feasible schedule of administration is the principal option in pre-treated and symptomatic patients, as in the elderly too. Oral vinorelbine represents a good choice for its toxicity profile and activity in anthracycline and taxane-pre-treated BC patients. A 20-30% response rate (RR) can be obtained when used as single agent. In phase II trials, involving fit patients, and when oral vinorelbine is used in combination with other agents (e.g., capecitabine) a RR of 50-60% has been observed. In HER2-positive BC a combination of oral vinorelbine and trastuzumab has a dramatic activity in first-line therapy and is a reasonable choice in trastuzumab pre-treated patients. In conclusion, oral vinorelbine represents a pivotal choice in advanced and pre-treated BC both as single agent and in combination with others.

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“…Nevertheless, neither of them was an optimal drug delivery system for vinorelbine. An injectable formulation of vinorelbine (Navelbine ® IV) developed by Pierre Fabre Medicament France has been widely used in the world [5][6][7][8][9]. However, vinorelbine has a vesicant action and this could cause venous irritation and phlebitis when directly administered intravenously as an aqueous solution [10].…”

Section: Introductionmentioning

confidence: 99%

Green, Rapid and Facile HPMo-Assisted Synthesis of Silver Nanoparticles

Ahmadpour

Tanhaei²,

Bamoharram³

et al. 2012

CNANO

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Vinorelbine tartrate is a semi-synthetic drug with a broad-spectrum anti-tumor activity. An injectable formulation of vinorelbine (Navelbine ® IV) has been widely used in the world, despite existing some disadvantages. In this study, in order to improve the efficacy of vinorelbine injection metabolism with minimal side effects, rHSA nanoparticles entrapping VLBT were prepared by a desolvation procedure, and subsequently decorated by folic acid. A central composite design was applied for modeling the process. To some extent, the drug release rate could be adjusted by cross-linking with different amount of glutaraldehyde. In this paper, Fa-rHSANPs-VLBT with three degrees (25%, 50% and 75%) of cross-linking were obtained under the optimum conditions for preparing the nanoparticles. Then we carried out a further study to compare the characteristics of the nanoparticles, such as drug entrapment efficiency (DEE), drug-loading efficiency (DLE), surface morphology, surface chemistry, physical status of VLBT in Fa-rHSANPs-VLBT, amount of folate conjugation, and release kinetics in vitro. The experiment results displayed that as the degree of cross-linking increased, both the zeta potential (ZP) and folate content associated with the VLBT-rHSANPs showing a reduced tend. Moreover, the increasing glutaraldehyde concentration made the rate of release of the VLBT from these nanoparticles decrease.

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A Phase I Study of an All-Oral Combination of Vinorelbine/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes

Cited by 17 publications

References 29 publications

All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial

All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial

Oral vinorelbine: its role in advanced breast cancer pre-treated with anthracycline and taxane chemotherapies

Green, Rapid and Facile HPMo-Assisted Synthesis of Silver Nanoparticles

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