Phase 2 Study of Single-Agent IV Vinflunine as Third-Line Treatment of Metastatic Breast Cancer After Failure of Anthracycline-/Taxane-Based Chemotherapy

Fumoleau, P.; Cortés, Javier; Taleb, Amina; Chan, Sy; Campone, Mario; Pouget, Jean-Christophe; Tubiana-Hulin, M.; Slabber, C F; Caroff-Paraïso, Isabelle; Alberts, A. S.; Ayed, Farhat Ben

doi:10.1097/coc.0b013e31818f2d2f

Cited by 31 publications

(10 citation statements)

References 28 publications

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“…VinXunine single agent has shown signiWcant antitumour activity as second-line or third-line treatment of anthracycline-taxane-pretreated patients with MBC [8,14]. VinXunine in association with other cytotoxics is currently investigated in MBC and in other indications: doxorubicin [34], gemcitabine [5] carboplatin [32] and cisplatin [28].…”

Section: Discussionmentioning

confidence: 98%

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A phase I study of vinflunine in combination with capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes

Campone

Isambert

Bourbouloux

et al. 2011

Cancer Chemother Pharmacol

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Section: Discussionmentioning

confidence: 98%

“…Among 56 patients treated in third-line, a response rate of 13% (95% CI: 5-24), a median progression-free survival of 2.6 months and a median survival of 11.4 months were reported [14].…”

Section: Introductionmentioning

confidence: 98%

A phase I study of vinflunine in combination with capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes

Campone

Isambert

Bourbouloux

et al. 2011

Cancer Chemother Pharmacol

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“…In the largest phase II study of vinflunine at 320 mg/m 2 in patients with advanced transitional cell carcinoma of the bladder, 67% experienced grade 3 or 4 neutropenia, and 10% had febrile neutropenia [4]. Similar rates of grade 3/4 neutropenia (65% and 71%), but lower rates of febrile neutropenia (5% and 0%) were seen in the phase II refractory breast cancer experience [3, 13]. Neutropenia was less common in a phase III study of vinflunine at 320 mg/m 2 compared with docetaxel for second line therapy of nonsmall cell lung cancer in which grade 3/4 neutropenia occurred in 32% of patients, and only 3% had an episode of febrile neutropenia [6].…”

Section: Discussionmentioning

confidence: 99%

Phase I trial of vinflunine and pemetrexed in refractory solid tumors

et al. 2009

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Summary Background Vinflunine is a novel vinca alkaloid with promising single agent clinical activity. Pemetrexed has at least additive activity with other vincas. A phase I trial was undertaken to assess the safety of vinflunine and pemetrexed in patients with refractory solid tumors. Methods A standard 3-patient cohort dose escalation scheme was used to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the vinflunine/pemetrexed combination. Pemetrexed 500 mg/m2 was given with vinflunine 280 mg/m2 (cohort 1), 300 mg/m2 (cohort 2) or 320 mg/m2 (cohort 3) on day 1 of a 21-day cycle. Results 19 patients were enrolled, median age 58 years (range 32 to 77) and had a median of 3 (range 1–6) prior therapies. DLT occured 1 of 6 pts in cohort 1 (thrombocytopenia, hyponatremia), 2 of 10 pts in cohort 2 (febrile neutropenia, hyponatremia, hyperbilirubinema; febrile neutropenia), and 2 of 3 pts in cohort 3 (febrile neutropenia, hypokalemia; febrile neutropenia). 1 pt in cohort 2 died prior to completion of cycle 1 likely from disease progression. Most common grade 3/4 adverse events were neutropenia (7), leukopenia (5). Febrile neutropenia occurred in 4 patients (21%). No objective responses were seen. Two patients (breast and lung) had prolonged stable disease for 25 and 20 cycles respectively. Conclusions Based on this experience we recommend vinflunine 300 mg/m2 and pemetrexed 500 mg/m2 in combination every 3 weeks for future study. At these doses, the combination of vinflunine and pemetrexed was tolerable in this heavily pretreated population. Hematologic toxicity, including febrile neutropenia, was prominent.

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“…Because of its broader spectrum of activity and advantages over other Vinca alkaloids, VFL has been evaluated as monotherapy and as combination chemotherapy in a number of different cancers, including breast cancer, [60][61][62][63][64][65][66] NSCLC, [67][68][69][70][71] small cell lung cancer (SCLC), 72,73 prostate cancer, 74 gastric cancer, 75 malignant pleural mesothelioma [76][77][78] and renal cell carcinoma. 79 The recommended dose for clinical studies is 320 mg/m 2 administered intravenously every 21 days.…”

Section: Clinical Trialsmentioning

confidence: 99%

Critical evaluation of vinflunine in the treatment of refractory metastatic urothelial carcinoma

Talbot¹,

Morel²

2010

OAJU

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Urothelial carcinoma (UC) accounts for 5% to 10% of malignancies in men in Europe and the United States. For locally advanced or metastatic disease, there are two standard firstline chemotherapy regimens: MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) and gemcitabine/cisplatin. For refractory disease, there is currently no standard treatment. Vinflunine, a second-generation Vinca alkaloid, is the first chemotherapeutic agent to be evaluated in a large UC second-line population. This review discusses the pre-clinical and clinical data published, and compares vinflunine to alternative single agents and combination regimens tested in this setting. Based on the results of the phase II and III clinical trials, there appears to be sufficient evidence to support the use of vinflunine in the second-line setting.

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Phase 2 Study of Single-Agent IV Vinflunine as Third-Line Treatment of Metastatic Breast Cancer After Failure of Anthracycline-/Taxane-Based Chemotherapy

Abstract: Vinflunine is an active and well-tolerated agent as third-line treatment of patients with MBC after failure of anthracycline- and taxane-based therapy. These results warrant further investigation of vinflunine monotherapy or in combination for the treatment of MBC.

Cited by 31 publications

References 28 publications

A phase I study of vinflunine in combination with capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes

A phase I study of vinflunine in combination with capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes

Phase I trial of vinflunine and pemetrexed in refractory solid tumors

Critical evaluation of vinflunine in the treatment of refractory metastatic urothelial carcinoma

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