Therapeutic advances in medical oncology · 2025
SALVOVAR: a pragmatic randomized phase III trial comparing the SALVage weekly dose-dense regimen to the standard 3-weekly regimen in patients with poor prognostic OVARian cancers.
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Chator Claire, Yanaihara Nozomu, Chabaud Sylvie, Parma Gabriella Maria, Dima Alexandra L, Clamp Andrew, Ferron Gwenaël, Kroep Judith R, Leary Alexandra, Cibula David, Fiteni Frederic, Bruchim Ilan, Serrier Hassan, Carroll Susannah, Belmont Anne-Sophie, Peron Julien, You Benoit
Аннотация
BACKGROUND: Patients with epithelial ovarian cancer (EOC) receiving neoadjuvant platinum-based chemotherapy (NACT) who remain ineligible for complete interval cytoreductive surgery (ICS) due to poor chemosensitivity (CA-125 KELIM™ score <1.0) have a poor prognosis (~20% 5-year survival). A weekly dose-dense carboplatin-paclitaxel regimen may improve outcomes in this high-risk subgroup.
OBJECTIVES: To demonstrate the superiority of a salvage weekly dose-dense carboplatin-paclitaxel regimen over continuation of the standard 3-weekly regimen in poor-prognosis EOC patients after 3-4 cycles of standard NACT.
DESIGN: SALVOVAR is a pragmatic, open-label, multicenter, international, randomized phase III trial.
METHODS AND ANALYSIS: Patients with stages III-IV high-grade EOC are eligible if they present (1) an unfavorable standardized KELIM score <1.0, and (2) a disease not amenable to complete ICS after 3-4 cycles of standard 3-weekly carboplatin-paclitaxel. Patients are randomized (1:1) to either the experimental arm (dose-dense carboplatin AUC5 day 1 plus paclitaxel 80 mg/m2 on days 1, 8, and 15, every 3 weeks) or the control arm (continuation of the standard regimen) for 3 cycles. Bevacizumab use is allowed at investigator discretion. Stratification factors include planned bevacizumab administration, BRCA mutation status, and KELIM strata. The two co-primary endpoints are (1) improvement in late complete cytoreduction rates (from 5% in the control arm to 20% in the experimental arm), and (2) overall survival (target hazard-ratio, 0.61). Total 250 patients will be randomized. Secondary endpoints include objective response rate, progression-free survival, and safety. Additional planned analyses include quality-of-life, cost-effectiveness, surgical standardization, human sciences, and biology studies.
ETHICS: The protocol was approved by the national ethics committee and health authorities.
DISCUSSION: SALVOVAR will evaluate whether chemotherapy densification improves outcomes in poorly chemosensitive advanced EOC. If positive, this pragmatic strategy could be implemented in large-scale studies, independent of resource setting.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06476184 (June-2024). Available at: https://clinicaltrials.gov/study/NCT06476184.
OBJECTIVES: To demonstrate the superiority of a salvage weekly dose-dense carboplatin-paclitaxel regimen over continuation of the standard 3-weekly regimen in poor-prognosis EOC patients after 3-4 cycles of standard NACT.
DESIGN: SALVOVAR is a pragmatic, open-label, multicenter, international, randomized phase III trial.
METHODS AND ANALYSIS: Patients with stages III-IV high-grade EOC are eligible if they present (1) an unfavorable standardized KELIM score <1.0, and (2) a disease not amenable to complete ICS after 3-4 cycles of standard 3-weekly carboplatin-paclitaxel. Patients are randomized (1:1) to either the experimental arm (dose-dense carboplatin AUC5 day 1 plus paclitaxel 80 mg/m2 on days 1, 8, and 15, every 3 weeks) or the control arm (continuation of the standard regimen) for 3 cycles. Bevacizumab use is allowed at investigator discretion. Stratification factors include planned bevacizumab administration, BRCA mutation status, and KELIM strata. The two co-primary endpoints are (1) improvement in late complete cytoreduction rates (from 5% in the control arm to 20% in the experimental arm), and (2) overall survival (target hazard-ratio, 0.61). Total 250 patients will be randomized. Secondary endpoints include objective response rate, progression-free survival, and safety. Additional planned analyses include quality-of-life, cost-effectiveness, surgical standardization, human sciences, and biology studies.
ETHICS: The protocol was approved by the national ethics committee and health authorities.
DISCUSSION: SALVOVAR will evaluate whether chemotherapy densification improves outcomes in poorly chemosensitive advanced EOC. If positive, this pragmatic strategy could be implemented in large-scale studies, independent of resource setting.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06476184 (June-2024). Available at: https://clinicaltrials.gov/study/NCT06476184.