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Randomized phase III trial of dose-dense MVAC or 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

  • Pfister C.,
  • Gravis G.,
  • Flechon A.,
  • Soulie M.,
  • Guy L.,
  • Laguerre B.,
  • Mottet N.,
  • Joly F.,
  • Allory Y.,
  • Harter V.,
  • Culine S.,
  • GETUG AFU V05 Investigators

Introduction & Objectives

Neoadjuvant chemotherapy is strongly recommended for patients (pts) with MIUBC, but the optimal perioperative chemotherapy regimen is not defined.

Materials & Methods

Between February 2013 and February 2018, 494 pts were randomized in 28 French centers 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, repectively (p=0.002). In the adjuvant group, 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, 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 asthenia of grade ≥ 3 (p<0.00001). Four deaths (3 in dd-MVAC arm) occured during chemotherapy.
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Conclusions

VESPER preliminary results suggested that the dd-MVAC toxicity was manageable with more severe asthenia and GI side effects than GC in perioperative chemotherapy. Moreover, we observed more frequently complete pathological reponses and organ-confined status in the dd-MVAC arm.