Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients ≥65 years of age: an NCCTG study

Baweja, Mansoina; Suman, Vera J.; Fitch, Tom R.; Mailliard, James A.; Bernath, Albert M.; Rowland, Kendrith M.; Alberts, Steven R.; Kaur, Judith S.; Perez, Edith A.

doi:10.1093/annonc/mdj130

Cited by 38 publications

(12 citation statements)

References 37 publications

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“…[28][29][30] A phase I study of oral vinorelbine and capecitabine has established a recommended dose of vinorelbine 60 mg/m 2 per week and capecitabine 2000 mg/m 2 days 1-14 every 3 weeks 31 and recently a phase II study of the oral combination in pretreated MBC has shown a response rate of 39%. 32 Although it Leucopenia 25 19 3 1 Neutropenia 16 19 15 1 Anemia 13 2 0 0 Thrombocytopenia 2 0 0 0 Non hematological Nausea 12 4 1 0 Emesis 6 3 0 0 Diarrhea 16 2 2 0 Dehydration 1 0 1 0 Stomatitis 12 0 1 0 Hand-foot syndrome 8 2 0 0 Neuropathy 7 0 1 0 Fatigue 19 12 2 0 Other 34 12 2 0 NCI CTC, National Cancer Institute Common Toxicity Criteria.…”

Section: Discussionmentioning

confidence: 99%

Multicenter phase II study of combination chemotherapy with capecitabine and intravenous vinorelbine in patients with pretreated metastatic breast cancer

Davis

Brew

Gebski

et al. 2007

Asia-Pac J Clncl Oncology

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Background: Capecitabine and i.v. vinorelbine are both active in metastatic breast cancer with nonoverlapping toxicities. This study examined the efficacy and safety of the combination of these agents in patients with pretreated metastatic breast cancer. Methods: Patients previously treated for breast cancer, maximum of one prior metastatic regimen, received capecitabine 1000 mg/m 2 b.d. for days 1-14 and vinorelbine 25 mg/m 2 i.v. days 1 and 8 every 21 days. All patients had measurable disease and adequate baseline organ function. The primary endpoint was response and secondary endpoints time to progression, duration of response, survival and safety. Results: Twenty-two patients (median age 56 years) received a median of six cycles. All patients had received anthracyclines and 64% taxanes. Objective responses were seen in 7/21 (33%, 95% confidence interval [CI] 18-57%), with two complete responses; stable disease was seen in 5/21 (24%, 95% CI 8-42%). Median duration of response was 6.9 months (95% CI 4.7-13.1), time to progression was 5.8 months (95% CI 2.8-6.8) and survival was 13.5 months (95% CI 6.9-19.9). The median dose intensity of vinorelbine was 75% of the intended dose and of capecitabine 85% of intended dose. The main toxicity was myelosuppression including 16 episodes of G3-4 neutropenia in 11 patients (50%). Other toxicities were generally mild to moderate. Conclusion: The combination of capecitabine and i.v. vinorelbine is active and well tolerated in patients with pretreated metastatic breast cancer. The recent availability of oral vinorelbine provides an opportunity to explore a fully oral combination.

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Section: Discussionmentioning

confidence: 99%

Multicenter phase II study of combination chemotherapy with capecitabine and intravenous vinorelbine in patients with pretreated metastatic breast cancer

Davis

Brew

Gebski

et al. 2007

Asia-Pac J Clncl Oncology

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“…The treatment was fairly well tolerated with G3 neutropoenia in 12.5%, fatigue in 12.5% of the patients, and G2 neuromotor and neurosensory toxicities in 12.5 and 8.3%, respectively. Overall, the activity of this drug in first-or second-line therapies in the elderly population is low [50].…”

Section: Oral VI In the Elderlymentioning

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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“…5 Many studies have put effort into maintaining the vinorelbine concentration surrounding tumor cells in order to improve the anticancer activity of vinorelbine. 6,7 Liposomal encapsulation is practical for vinorelbine to extend its circulation time and to increase its accumulation in tumor tissue.…”

Section: Introductionmentioning

confidence: 99%

Correlation between radioactivity and chemotherapeutics of the 111In-VNB-liposome in pharmacokinetics and biodistribution in rats

Lee¹,

Chang²,

Huang³

et al. 2012

IJN

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Background The combination of a radioisotope with a chemotherapeutic agent in a liposomal carrier (ie, Indium-111-labeled polyethylene glycol pegylated liposomal vinorelbine, [ 111 In-VNB-liposome]) has been reported to show better therapeutic efficiency in tumor growth suppression. Nevertheless, the challenge remains as to whether this therapeutic effect is attributable to the combination of a radioisotope with chemotherapeutics. The goal of this study was to investigate the pharmacokinetics, biodistribution, and correlation of Indium-111 radioactivity and vinorelbine concentration in the 111 In-VNB-liposome. Methods The VNB-liposome and 111 In-VNB-liposome were administered to rats. Blood, liver, and spleen tissue were collected to determine the distribution profile of the 111 In-VNB-liposome. A liquid chromatography tandem mass spectrometry system and gamma counter were used to analyze the concentration of vinorelbine and radioactivity of Indium-111. Results High uptake of the 111 In-VNB-liposome in the liver and spleen demonstrated the properties of a nanosized drug delivery system. Linear regression showed a good correlation ( r = 0.97) between Indium-111 radioactivity and vinorelbine concentration in the plasma of rats administered the 111 In-VNB-liposome. Conclusion A significant positive correlation between the pharmacokinetics and biodistribution of 111 Indium radioactivity and vinorelbine in blood, spleen, and liver was found following administration of the 111 In-VNB-liposome. The liposome efficiently encapsulated both vinorelbine and Indium-111, and showed a similar concentration-radioactivity time profile, indicating the correlation between chemotherapy and radiotherapy could be identical in the liposomal formulation.

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Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients ≥65 years of age: an NCCTG study

Abstract: Oral vinorelbine as a single agent at these dose and schedule in this population of women > or = 65 years is well tolerated but has a low level of objective efficacy for the treatment of metastatic breast cancer.

Cited by 38 publications

References 37 publications

Multicenter phase II study of combination chemotherapy with capecitabine and intravenous vinorelbine in patients with pretreated metastatic breast cancer

Multicenter phase II study of combination chemotherapy with capecitabine and intravenous vinorelbine in patients with pretreated metastatic breast cancer

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

Correlation between radioactivity and chemotherapeutics of the 111In-VNB-liposome in pharmacokinetics and biodistribution in rats

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