Abstract 720P
Background
Sunitinib is approved in mRCC setting at the dose of 50mg daily for 4 weeks followed by 2 weeks rest (4/2 schedule). Due to toxicity, this 4/2 schedule requires often dose modifications. Current recommendation is to reduce the dose to 37.5mg per day. Recent data highlight an alternative schedule: 2 weeks of treatment followed by one-week rest (2/1 schedule). SURF trial is set up to evaluate prospectively schedule 2/1 when toxicity occurs.
Methods
SURF [NCT02689167] is a prospective, non-comparative randomized study. Patients with metastatic clear-cell RCC are included at sunitinib initiation. When a dose adjustment of sunitinib is required, patients are randomized between 4/2 schedule 37.5mg daily and experimental 2/1 schedule 50mg daily. Primary objective is to assess duration of sunitinib treatment (DOT). A futility IA was scheduled after recruitment of the first 33 evaluable patients into experimental arm with a 6-month follow-up.
Results
Overall 222 patients were enrolled, 79 included in this IA. At 6 months, 22 patients (66.7%) of 2/1 schedule were still on treatment (above predefined threshold for futility). Other data can be seen on the table. Safety data were consistent with sunitinib known safety profile. Table: 720P
| overall population n = 79 | control arm (4/2 schedule) n = 46 | experimental arm (2/1 schedule) n = 33 | |
| median duration of treatment (months) [Q1-Q3] | 9.0 [5.0;16.5] | 6.4 [3.8;11.9] | 16.1 [6.7;21.2] |
| median duration of treatment (months) among patients with sunitinb discontinuation [Q1-Q3] | 7.7 [5.0;13.4] | 5.4 [3.7;10.6] | 11.8 [6.4;18.5] |
| median progression free survival (PFS) [CI 95%] | 8.5 [5.5;13.1] | 7.6 [5.3;10.8] | 13.1 [7.7;16.7] |
Conclusions
This IA has confirmed the non-futility of the 2/1 schedule. Promising data on DOT and progression free survival need to be confirmed with more patients and further follow-up at the final analysis.
Clinical trial identification
NCT02689167.
Editorial acknowledgement
Legal entity responsible for the study
Centre Hospitalier Universitaire de Besancon.
Funding
Pfizer, CHRU Besancon.
Disclosure
A. Thiery-Vuillemin: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): pfizer; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Roche. G. Gravis: Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: BMS. F. Rolland: Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: MSD. M. Gross-Goupil: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Pfizer. Y.A. Vano: Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: MSD. P. Barthélémy: Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Eusapharma; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy: JNJ. M. Laramas: Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: BMS. L. Albiges: Advisory/Consultancy: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy: Novartis; Advisory/Consultancy: Amgen; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Roche; Advisory/Consultancy: Astellas; Advisory/Consultancy: Merck; Advisory/Consultancy: MSD; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Corvus Pharmaceuticals; Advisory/Consultancy: Peloton therapeutics. All other authors have declared no conflicts of interest.