Randomized phase III trial of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as perioperative chemotherapy for muscle invasive urothelial bladder cancer (MIUBC): Preliminary results of the GETUG/AFU V05 VESPER trial on toxicity and pathological responses.

Authors

null

Stephane Culine

Hospital Saint-Louis, Paris, France

Stephane Culine , Gwenaelle Gravis , Aude Flechon , Michel Soulie , Laurent Guy , Brigitte Laguerre , Nicolas Mottet , Florence Joly , Yves Allory , Valentin Harter , Christian Pfister

Organizations

Hospital Saint-Louis, Paris, France, Institut Paoli-Calmettes, Marseille, France, Departement of Medical Oncology, Centre Léon Bérard, Lyon, France, Centre Hospitalier Universitaire Rangueil, Toulouse, France, Hopital Gabriel Montpied CHU, Clermont-Ferrand, France, Centre Eugène Marquis, Rennes, France, University Hospital Nord, St Etienne Cedex 2, France, Clinical Research Department, Centre François Baclesse, Caen, France, Institut Curie, St-Cloud, France, Centre Francois Baclesse, Caen, France, Centre Hospitalier de Rouen, Rouen, France

Research Funding

Other Government Agency
French Ministry of Health.

Background: The optimal perioperative chemotherapy regimen for patients (pts) with MIUBC is not defined. Methods: Between February 2013 and February 2018, 494 pts were randomized in 28 French centres and received either 4 cycles of GC every 3 weeks or 6 cycles of dd-MVAC every 2 weeks before surgery (neoadjuvant group) or after surgery (adjuvant group). The primary endpoint was the progression-free survival at 3 years. Secondary endpoints included toxicity, pathological responses and overall survival. Results: In the neoadjuvant group, 218 pts received dd-MVAC and 219 pts GC. The median number of cycles was 6 (0-6) and 4 (1-4), respectively. 60% of pts received 6 cycles in the dd-MVAC arm, 84% received 4 cycles in the GC arm. 199 pts (91%) and 198 (90%) pts underwent surgery, respectively. Complete pathologic responses (ypT0pN0) were observed in 84 (42%) and 71 (36%) pts, respectively (p=0.02). An organ-confined status (<ypT3pN0) was obtained in 154 (77%) and 124 (63%) pts, respectively (p=0.002). In the adjuvant group (57 pts), the median number of cycles was 5 (1-6) and 4 (1-4), respectively. 40% of pts received 6 cycles in the dd-MVAC arm, 60% received 4 cycles in the GC arm. Most of CTCAE grade ≥ 3 toxicities concerned hematological toxicities. At least one of these where reported for 125 (50%) pts in the dd-MVAC group and 134 (54%) pts in the GC group (p=NS). Gastrointestinal (GI) grade ≥ 3 disorders were more frequently observed in the dd-MVAC arm (p<0.0001) as well as grade ≥ 3 asthenia (p<0.00001). Four deaths (3 in the dd-MVAC) occurred during chemotherapy. Conclusions: Complete pathological responses and organ-confined status were more frequently observed in the dd-MVAC arm. Toxicity was manageable with more severe asthenia and GI side effects in the dd-MVAC arm. Clinical trial information: 2012-000563-25.

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

General Session

Session Title

Risk Stratification and Management of High-Risk Muscle Invasive Urothelial Carcinoma

Track

Urothelial Carcinoma

Sub Track

Therapeutics

Clinical Trial Registration Number

2012-000563-25

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 437)

Abstract #

437

Abstract Disclosures