Randomized, placebo-controlled phase II trial (MAJA): Efficacy results of maintenance vinflunine after cisplatin chemotherapy (CT) in patients with advanced urothelial carcinoma (UC)—SOGUG 2011-02.

Font, Albert; Pérez-Valderrama, Begoña; Virizuela, Juan Antonio; Polo, Susana Hernando; Climent, Miguel Ángel; Arija, José Ángel Arranz; Guzmán, José Carlos Villa; Llorente, M.; Laínez, Núria; Mellado, Begoña; Alba, Aránzazu Gonzalez del; Díaz, Enrique; Castellano, Daniel; Herranz, Urbano Anido; Domènech, Montserrat; Muro, Xavier García del; Puente, Javier; Morales, Rafael; García-Donás, Jesús; Bellmunt, Joaquim; Sogug,

doi:10.1200/jco.2016.34.15_suppl.4529

Cited by 3 publications

(4 citation statements)

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“…The MAJA trial has shown favorable outcomes comparing VIN maintenance with BSC with 59% disease progression and 43% patient death in the treatment arm versus 81% and 62%, respectively, in the BSC control arm. 10 Survival analysis in this trial is pending; however, this response benefit was demonstrated in the context of favorable tolerability.…”

Section: Discussionmentioning

confidence: 95%

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Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract: an evidence-based review of safety, efficacy, and place in therapy

Brousell¹,

Fantony²,

Noord³

et al. 2018

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BackgroundA systematic review and meta-analysis of the use of systemic vinflunine (VIN) in the treatment of urothelial carcinoma (UC) was performed to evaluate its efficacy based on current available clinical data.MethodsThis review was prospectively registered at the International Prospective Register of Systematic Reviews, PROSPERO (registration CRD42016049294). Electronic databases including MEDLINE®, Embase®, Cochrane Central Register of Controlled Trials, and Web of Science were searched through December 2016. We performed a meta-analysis of the published data. Primary end points were progression-free survival (PFS) and overall survival (OS). Numerous secondary clinical outcomes were analyzed including response and toxicity data.ResultsWe identified 382 publications, of which 35 met inclusion criteria for this review representing 29 unique studies. A total of 2,255 patients received VIN for the treatment of UC in the included studies. OS and PFS were analyzed in a pooled Kaplan–Meier analysis. Response data were available for 1,416 VIN-treated patients with random effects proportion of complete response in 1%, partial response in 18%, and overall response rate of 21%. Toxicity analysis revealed fatigue (40.1%), nausea (33.9%), constipation (34.1%), and alopecia (26.0%) as the most prevalent overall non-hematologic adverse events (AEs). Most prevalent grade 3–4 AEs were fatigue (10.2%), abdominal pain (8.2%), myalgias (2.5%), and nausea (2.3%). Most common hematologic AEs of all grades were anemia (56.6%), neutropenia (46.0%), thrombocytopenia (25.5%), and febrile neutropenia (6.6%). Grade 3–4 hematologic AEs had the following pooled rates: neutropenia, 24.6%; anemia, 10.2%; febrile neutropenia, 5.4%; and thrombocytopenia, 3.0%.ConclusionVIN has been explored as a combination first-line treatment as well as a single-agent second-line, third-line, and maintenance therapy for advanced and metastatic UC. In first-line treatment of UC, either as a maintenance agent after cisplatin or as a primary combination therapy, VIN may be a promising alternative to current treatments. Further studies are needed to compare first-line combination VIN regimens to the current standard of care in order to assess long-term survival outcomes. Second- and third-line VIN monotherapy does provide a proven, although limited, survival benefit in platinum-refractory patients.

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Section: Discussionmentioning

confidence: 95%

“… 9 MAJA, a placebo-controlled Phase II trial, examined maintenance VIN versus BSC in a larger cohort (88) of patients with platinum-responsive advanced UC and found improved PFS of 6.5 months in the VIN arm versus 4.6 months in BSC arm (HR 0.56, 95% CI 0.34–0.93, p =0.024). 10 …”

Section: Introductionmentioning

confidence: 99%

Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract: an evidence-based review of safety, efficacy, and place in therapy

Brousell¹,

Fantony²,

Noord³

et al. 2018

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“…In mUC, a satisfactory response rate was observed in patients with high PD-L1 expression treated in second-line with pembrolizumab and durvalumab, or in first-line with avelumab. However, no correlation was found between PD-L1 expression and OS in patients receiving second-line nivolumab and pembrolizumab [13,[15][16][17]66,[68][69][70][71][72][73]. PD-L1 expression detected by immunohistochemistry does not necessarily correlate with response to treatment.…”

Section: Pd-l1mentioning

confidence: 94%

“…The role of other agents has not yet been established in the maintenance setting. Indeed, vinflunine, a third-generation bifluorinated semi-synthetic vinca alkaloid, has shown progression-free, but not OS benefit in randomized phase II trials [66].…”

Section: Maintenance Therapymentioning

confidence: 99%

Immune Checkpoint Inhibitors in Urothelial Bladder Cancer: State of the Art and Future Perspectives

Roviello

Catalano

Santi

et al. 2021

Cancers

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Bladder cancer (BC) is the most common malignancy of the genitourinary tract, with high morbidity and mortality rates. Until recently, the treatment of locally advanced or metastatic urothelial BC was based on the use of chemotherapy alone. Since 2016, five immune checkpoint inhibitors (ICIs) have been approved by the Food and Drug Administration (FDA) in different settings, i.e., first-line, maintenance and second-line treatment, while several trials are still ongoing in the perioperative context. Lately, pembrolizumab, a programmed death-1 (PD-1) inhibitor, has been approved for Bacillus Calmette–Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC), using immunotherapy at an early stage of the disease. This review investigates the current state and future perspectives of immunotherapy in BC, focusing on the rationale and results of combining immunotherapy with other therapeutic strategies.

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Vinflunine in Metastatic Urothelial Carcinoma of the Bladder in Progression after a Platinum-Containing Regimen

et al. 2019

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Background: Vinflunine is a microtubule inhibitor of the vinca alkaloid class approved for the treatment of urothelial bladder carcinoma after a platinum-containing regimen. Methods: To evaluate the effectiveness of vinflunine, we enrolled 80 subjects with a histologically confirmed diagnosis of metastatic urothelial bladder carcinoma that had previously undergone chemotherapy with a platinum-containing regimen and had measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST). The patients (n = 80) received vinflunine (Javlor®) every 3 weeks at 320 mg/m2 via 20-min intravenous infusion. The endpoints were progression-free survival (PFS), objective response rate, overall survival (OS), and tolerability. The cumulative survival of the patients was analyzed using the Kaplan-Meier method. Results: In this retrospective study, vinflunine treatment was well tolerated and resulted in a good level of disease control (complete response + partial response + stable disease >50%), with a manageable toxicity profile. The median PFS and OS were 3.2 and 6.8 months, respectively. A significant correlation between pain and PFS was also noted. The major hematologic adverse event was neutropenia, observed in 47% of the patients. The most common nonhematologic adverse events were constipation in 48% of the patients and fatigue in 26%. Discussion: In this real-word non-randomized clinical trial setting, the data showed that vinflunine is an efficacious and safe therapeutic option for second-line treatment of patients with metastatic urothelial carcinoma of the bladder after a platinum-containing regimen.

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Randomized, placebo-controlled phase II trial (MAJA): Efficacy results of maintenance vinflunine after cisplatin chemotherapy (CT) in patients with advanced urothelial carcinoma (UC)—SOGUG 2011-02.

Cited by 3 publications

References 0 publications

Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract: an evidence-based review of safety, efficacy, and place in therapy

Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract: an evidence-based review of safety, efficacy, and place in therapy

Immune Checkpoint Inhibitors in Urothelial Bladder Cancer: State of the Art and Future Perspectives

Vinflunine in Metastatic Urothelial Carcinoma of the Bladder in Progression after a Platinum-Containing Regimen

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