In this French study, patients with bladder cancer that had grown into the muscle wall received one of two cisplatin-based chemotherapy regimens around the time of surgery. In those who had chemotherapy before surgery, six cycles of dd-MVAC, compared with four cycles of gemcitabine-cisplatin, raised the chance of being alive after 5 years from 57% to 66%.
Cisplatin-eligible MIBC cT2 to T4a N0 M0 before cystectomy (in VESPER: creatinine clearance ≥40 mL/min, WHO performance status 0 to 1, left ventricular ejection fraction ≥50%)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Methotrexate | 30 mg/m² | IV | Day 1 |
| Vinblastine | 3 mg/m² | IV | Day 2 |
| Doxorubicin | 30 mg/m² | IV | Day 2 |
| Cisplatin | 70 mg/m² | IV | Day 2 |
| G-CSF | — | — | Days 3 and 9 (per the trial registration) |
VESPER trial regimen as registered on ClinicalTrials.gov.
Cisplatin-eligible MIBC before cystectomy; adjuvant cisplatin-based chemotherapy is also recommended for pT3/4 or N+ disease without prior neoadjuvant therapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Gemcitabine | 1250 mg/m² | IV | Days 1 and 8 |
| Cisplatin | 70 mg/m² | IV | Day 1 |
Doses from the VESPER trial registration; place in therapy per EAU. In cisplatin-ineligible patients, neoadjuvant non-cisplatin chemotherapy is not recommended.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
dd-MVAC every 2 weeks for 6 cycles: methotrexate 30 mg/m² day 1; vinblastine 3 mg/m², doxorubicin 30 mg/m² and cisplatin 70 mg/m² day 2; G-CSF on days 3 and 9 (per the ClinicalTrials.gov record).
Gemcitabine 1250 mg/m² days 1 and 8 + cisplatin 70 mg/m² day 1, every 3 weeks for 4 cycles.
Source of the regimen details: ClinicalTrials.gov NCT01812369
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Adults aged 18 to 80 years with primary bladder cancer and muscle-invasive urothelial carcinoma (cT2 to T4a N0 M0 for neoadjuvant treatment; pT3/pT4 or pN+ for adjuvant treatment), WHO performance status 0 or 1, haemoglobin above 11 g/dL, neutrophils ≥1500, platelets ≥100,000, creatinine clearance ≥40 mL/min and left ventricular ejection fraction ≥50%; 89% received neoadjuvant chemotherapy.
Secondary endpoints: overall survival and time to death from bladder cancer at 5 years (the primary endpoint, 3-year progression-free survival, was reported earlier).
Of 190 deaths, 83% were due to bladder cancer progression and 2% (four cases) were related to chemotherapy toxicity.
VESPER supports preferring six cycles of dd-MVAC over four cycles of GC for neoadjuvant chemotherapy in suitable patients; both regimens are guideline-endorsed cisplatin-based combination chemotherapy.
The survival benefit in the overall perioperative population was not significant, and the neoadjuvant subgroup finding should be interpreted with caution; the trial was open-label and limited to France, and patients over 80 years were not enrolled.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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