Abstract 1745P
Background
Neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) is standard for patients with muscle-invasive bladder cancer (MIBC). When previous western studies using retrospective or phase II studies showed that dd-MVAC (dose dense methotrexate, vinblastine, doxorubicin and cisplatin) for NAC was beneficial, while none was reported in Asian population. Also, there has been no study related with dd-MVAC in locally advanced urothelial carcinoma (UC). This prospective phase II study aimed to evaluate efficacy and safety of dd-MVAC in Korean MIBC or locally advanced UC patients.
Methods
Patients with MIBC (cT2-4aN0M0) or locally advanced UC (cTanyN1-3M0) eligible for RC were prospectively enrolled. The participants were treated with four cycles of dd-MVAC with pegfilgrastim every 2 weeks. The primary end point was pathologic partial response (pPR, < ypT2N0). Secondary end points were relapse-free survival (RFS) and overall survival (OS).
Results
Of 24 enrolled patients between DEC 2019 and AUG 2021, 23 were evaluable (12% cT2N0, 44% cT3-4aN0, and 44% cTanyN1-3). Eighteen patients (78%) completed four cycles of dd-MVAC, while remaining 5 patients showed early discontinuation. Dose modification (91%) and dose delay (70%) were occurred, finally, dose intensity of dd-MVAC was 79%. Nineteen patients underwent RC except 4 patients who declined. Among 19 patients, 13 (68%) were neobladder as urinary diversion, and case of 90-days readmission was none. Seven patients [37% (95% CI, 16-58)] achieved < ypT2N0. With median follow-up of 22.8 months (95% CI, 7.1-38.5), RFS was 13.5 months and OS was 23.1 months (95% CI, 17.1-29.1). According to pPR, RFS showed numerical trend (pPR, not reached, non-pPR, 11.8 months, P = 0.059) and OS showed significant difference (pPR, not reached, non-pPR 22.2 months, P=0.034).
Conclusions
Our study showed substantial efficacy and safety, despite of including patients with locally advanced UC. Patients with < ypT2N0 showed improved OS. Considering that NAC regimen using immune check-point inhibitors do not have robust evidence, dd-MVAC could still be a promising option as NAC in Asian patients with UC.
Clinical trial identification
NCT04047693, Initial release: 08-May-2019.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.