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Vinflunine for the Treatment of Metastatic Transitional Cell Carcinoma: Recent Evidence from Clinical Trials and Observational Studies

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Vinflunine for the Treatment of Metastatic Transitional Cell Carcinoma: Recent Evidence from Clinical Trials and Observational Studies Review: Clinical Trial Outcomes Vinflunine for the treatment of metastatic transitional cell carcinoma: recent evidence from clinical trials and observational studies The microtubule inhibitor vinflunine is currently the only cytotoxic drug approved Camille Serrate1,2, Damien in Europe for the treatment of patients with metastatic transitional cell carcinoma Pouessel1, Hélène Gauthier1,2, 1 who failed first-line platinum-based chemotherapy. Indeed, the only Phase III trial Christine le Maignan , 1,2 ever conducted in this setting demonstrated a benefit in progression-free and Luis Teixeira & Stéphane Culine*1,2 overall survival for patients receiving vinflunine plus best supportive care compared 1Department of Medical Oncology, with best supportive care alone. Recent data from European studies performed in Hôpital Saint-Louis, Paris, France real life confirmed the efficacy of the drug, even in patient populations exhibiting 2Paris Diderot University – Paris 7, Paris, adverse prognostic factors. Side effects were manageable, provided gastrointestinal France prophylaxis is performed. The potential role of vinflunine in first-line treatment as *Author for correspondence: maintenance therapy or as a partner in combination chemotherapy for patients unfit Tel.: +33 1 42 49 42 47 Fax: +33 1 42 49 98 95 for cisplatin is currently being investigated. [email protected] Keywords: metastatic disease • platinum-resistant disease • second-line chemotherapy • transitional cell carcinoma • urothelial carcinoma • vinflunine Bladder cancer is a major global health prob- refractory disease. Most studies evaluating lem with an estimated 386,000 new cases other single-agent or combination regimens worldwide resulting in 150,000 deaths in in this setting have included few patients 2008 [1] . Transitional cell carcinoma (TCC) and heterogeneous populations, limiting val- is the predominant histological type. Diag- idation of standard second-line treatment. nosis is often made at early stage of the Modest RR of 10–20% and median OS of disease but 50% of patients in advanced 6–9 months were reported [3]. Vinflunine stages (>T2) experience metastatic relapse. was approved in Europe in recent years based Untreated metastatic TCC is associated on results of the first completed Phase III with a median survival times rarely exceed- trial in the second-line setting [4]. This ing 3–6 months. Following cisplatin-based review provides an update of vinflunine data front-line schedules including methotrex- in metastatic TCC. ate, vinblastine, doxorubicin and cisplatin or gemcitabine plus cisplatin, high response Preclinical & early clinical data rates (RR) of 40–70% are observed along Vinflunine is a microtubule-inhibiting bif- with different toxicity profiles. However luorinated vinca alkaloid. In vivo, vinflunine median progression-free survival (PFS) of showed greater antitumor activity than vino- approximately 8 months and median overall relbine because of differences in its tubu- survival (OS) of 14–15 months are disap- lin-properties and inhibitory effects on micro- pointing, even though some long survivors tubule dynamics during mitosis. By inhibit- have been reported [2]. ing tubulin, vinflunine prevents microtubule After failure of first-line chemotherapy, assembly and induces apoptosis. Three Phase I more than half of patients are unfit for cis- trials were conducted between 1998 and platin, due to renal dysfunction, cumulative 2003 in patients with refractory solid tumors neurotoxicity, poor performance status or (Table 1). Three administration schedules were part of 10.4155/CLI.14.15 © 2014 Future Science Ltd Clin. Invest. (2014) 4(4), 305–311 ISSN 2041-6792 305 Review: Clinical Trial Outcomes Serrate, Pouessel, Gauthier, le Maignan, Teixeira & Culine Table 1. Results of Phase I studies with vinflunine in solid tumors. Study Patients (n) Administration schedule Recommended dose (mg/m2) PR Ref. Delord et al. 34 D1 weekly 120–150 0 [5] Bennouna et al. 31 D1 three weekly 350 3 [6] Johnson et al. 16 D1–D8 three weekly 170 0 [7] D: Days; PR: Partial response. studied [5–7]. The three weekly (10 min intravenous In total, 64 patients (42%) achieved stable disease. infusion) regimen was retained for subsequent develop- Median PFS was 2.8 months while median OS was 2 ment, with a recommended dose of 350 mg/m . Dose 8.2 months [9]. limiting toxicities included mucositis, constipation and neutropenia [6]. Phase III trial A total of 370 metastatic TCC patients were randomly Phase II studies in patients with assigned to vinflunine plus best supportive care (BSC) platinum-refractory metastatic TCC or to BSC alone between May 2003 and August 2006 The results of the two Phase II studies were quite sim- [4,10]. Patients with Eastern Cooperative Oncology ilar (Table 2). In the European trial, the initial dose Group performance status (ECOG PS) of 0 and with- of 350 mg/m2 every 3 weeks was reduced to 320 mg/ out previous pelvic irradiation were treated at 320 mg/ m2 after the occurrence of significant hematologic m2 every 3 weeks. The initial dose was reduced to toxicities in the first six patients. RR was 18% with a 280 mg/m2 in patients with ECOG PS of 1 or with median duration of response of 9 months while 50% of previous pelvic irradiation but a third of them subse- patients had stable disease. Better disease control was quently experienced dose escalation to full dose. After observed in patients who had previously experienced a median follow-up time of 21 months, the objective response to first-line chemotherapy or had a long inter- of a median 2-month survival advantage was achieved val from prior platinum treatment. Median PFS was but the difference was not statistically significant. In 3 months whereas median OS was 6.6 months [8]. The the eligible population excluding 13 patients with at American trial confirmed these results in 151 patients least one major protocol deviations, median OS was with more pejorative prognostic factors. About 80% significantly longer for vinflunine plus BSC compared of patients had developed a disease progression within with BSC alone (Table 3). Safety was acceptable. The 6 months after prior chemotherapy. A large proportion most frequent grade 3–4 toxicity was neutropenia of patients (40%) presented with renal dysfunction (50%), with neutropenic fever occurring in 6% of (creatinine clearance between 20 and 60 ml/min). patients. Severe constipation (grade 3–4) was reported Most of them had comorbidities accounting for a in 16% of patients, mainly observed during the first lower initial dose of 280 mg/m2 since only 26% of and second cycles and easily managed by prophylaxis. patients received an initial dose of 320 mg/m2. Dose Long-term results were recently published with a escalation to 320 mg/m2 was still possible for 37% of median follow-up duration of 42 months for the vin- patients while 20% had a dose reduction. The RR was flunine arm and 45 months for the control arm [10] . 15% with a median duration of response of 6 months. In the eligible population, the addition of vinflunine Table 2. Results of Phase II studies with vinflunine in patients with platinum-refractory metastatic transitional cell carcinoma. Study n Age (years) PS (n, %) RI† PR SD PD PFS (months; OS (months; Ref. (n, %) (n, %) (n, %) 95% CI) 95% CI) Mean < 65 ≥ 65 0 1 2 (n, %) (n, %) European 51 63 31 20 28 22 1 11 9 25 14 3 6.6 [8] (60.8) (39.2) (54.9) (43.1) (2.0) (21.6) (18) (49) (28) (2.4–3.8) (4.8 –7.6) American 151 66 70 81 103 48 – 61 22 64 49 2.8 8.2 [9] (46.4) (53.6) (68.2) (31.8) (40.4) (15) ‡ (42)‡ (32.5)‡ (2.6–3.8) (6.8–9.6) †Creatinine clearance between 20 and 60 ml/min. ‡According to the independent response review committee. OS: Overall survival; PD: Progressive disease; PFS: progression-free survival; PR: Partial response; PS: Performance status; RI: Renal impairment; SD: Stable disease. 306 Clin. Invest. (2014) 4(4) future science group tivariate ana significantly associated PFS mulwith OS and in that shorter time chemotherapy from prior was and liver involvement in the Phase Data from chemotherapy. patientsprior included investigateto the prognostic value time of from tive trials including 570 A second-line setting in factors Prognostic reduced 23%. by independent effect OS with on arisk death of lation, the addition vinflunine of hadsignificant a prespecifiedprognostic factorson the ITT popu chemotherapy model patients for who failed after platinum-based study was indefine to order done prognostic a preplanned multivariate ana tion-to-treat (ITT) in population. the However, efit (CR). The median was PFS 4.2 RR was 22% with 5% responses complete of and anemia (8.2%).penia (17.2%) The objective 3–4 effects side asthenia were (20.9%), neutro at least dose reduction. one Most frequent grade patients.of In patients total, of experienced 16% OS varied from 14.2 retrospective ana three risk a factors recently, More (p< 0.001). anyout risk factor 1.7 to vs and hemoglobin (<10 identified: ECOGPS 1), (0 liver vs involvement uary December to 2011 This survey included 134 The French retrospective CURVE study to BSCto median prolonged 2.6 OS by t w 1–23). The starting dose was 280 the median number cycles of was five (range: <10 an ECOG 2, of PS 24% abaseline hemoglobin centage adverse of prognostic factors: 23% had The study populationapy. exhibited ahigh per receiveda platinum salt as first-line chemother median duration treatment of was 3 effectiveness and safety vinflunine of vational studies have recently investigated the prospectiveOne and two retrospective obser experiences Vinflunine in routine practice:European reated with vinflunine in 20 Jan centers from ith statistical significance post hocpost was not g/dl and 10% hepatic liver dysfunction. The , observational ana l statistically significant in the inten ysis, such as ECOG PS, hemoglobin III trial with vinflunine confirmed [11] ly .
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