Single agent IV vinflunine (VFL) in the second-line treatment of patients (pts) with advanced gastric cancer (AGC): Initial results of a phase II trial

Kaleta, Remigiusz; Chung, Hyun Cheol; Park, S. R.; Li, R. K.; Kim, Y.; Kim, H.; Langenaeken, J.; George, Ch.; Wit, E. J. de

doi:10.1200/jco.2008.26.15_suppl.15533

“…Preliminary clinical activity has been observed in patients with breast, genitourinary, and lung cancers. [11][12][13][14][15][16]20 The 21-day dosing is relatively more convenient than 5-day dosing with topotecan and is well tolerated and safe.…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9][10] This early efficacy prompted clinical investigation of single agent vinflunine in multiple solid tumor settings, including non-small cell lung cancer and mesothelioma. [11][12][13][14][15][16] Herein, we report on a multicenter phase II trial where vinflunine was administered to patients with relapse-sensitive and refractory SCLC.…”

mentioning

confidence: 99%

Phase II Trial of Vinflunine in Relapsed Small Cell Lung Cancer

Spigel¹,

Hainsworth²,

Lane³

et al. 2010

Journal of Thoracic Oncology

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Background: Vinflunine is a new microtubule inhibitor with preclinical activity in small cell lung cancer (SCLC). In this phase II trial, we evaluated vinflunine in patients with relapse-sensitive and refractory SCLC. Methods: This trial aimed to achieve a 20% objective response rate (ORR) in platinum-sensitive patients. Patients with Eastern Cooperative Oncology Group performance status 0 to 2 and measurable disease received vinflunine (320 mg/m 2 IV) every 21 days (Յ6 cycles; response evaluation every 6 weeks). Results: Patient characteristics (N ϭ 51): median age 63 years (range, 37-85 years); male, 55%; Eastern Cooperative Oncology Group performance status 2, 16%; relapse-sensitive SCLC, 53%. The overall ORR was 19.6% (95% confidence interval [CI] 10 -33%). Twelve (23.5%) patients had stable disease; 18 (35.3%) patients had progressive disease. Among relapse-sensitive patients, ORR was 22.2% (95% CI 9 -42%). Among relapse-refractory patients, ORR was 16.7% (95% CI 5-37%). Median follow-up was 15 months (range, 12-18 months); median progression-free survival (PFS) was 1.6 months (95% CI 1.3-3.9 months); median overall survival (OS) was 4.9 months (95% CI 3.2-6.5 months). Among relapse-sensitive patients, PFS and OS were 1.6 and 4.9 months, respectively. Among relapsed-refractory patients, PFS and OS were 1.4 and 4.0 months, respectively. In general, vinflunine was well tolerated, although neutropenia was a notable toxicity. Grade 3/4 toxicities (Ͼ5%): neutropenia (32%), arthralgia/myalgia (16%), fatigue (16%), hyponatremia (12%), leukopenia (12%), nausea/vomiting (12%), constipation (6%), and thrombocytopenia (6%). The rates of toxicities were relatively well balanced among relapsesensitive and refractory patients; one patient died of sepsis that was possibly treatment related. Conclusions: Vinflunine has activity in relapsed SCLC, including refractory relapsed patients. Neutropenia was common but associated with rare febrile episodes. Additional study in relapse-refractory SCLC is indicated.

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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

Morel¹,

Talbot²

2010

RRU

2

0

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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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“…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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Single agent IV vinflunine (VFL) in the second-line treatment of patients (pts) with advanced gastric cancer (AGC): Initial results of a phase II trial

Cited by 3 publications

References 0 publications

Phase II Trial of Vinflunine in Relapsed Small Cell Lung Cancer

Phase II Trial of Vinflunine in Relapsed Small Cell Lung Cancer

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

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

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