Abstract 712P
Background
Response of primary tumor in mRCC has been described in the TKI era but remain unknown with immune checkpoint inhibitors (ICI). Since the CARMENA study, upfront cytoreductive nephrectomy (CN) is no longer recommended for metastatic patients requiring first systemic therapy. We aimed to describe the response of the primary tumor in patients who did not undergo CN and received nivolumab within the GETUG-AFU-26 NIVOREN study.
Methods
Patients who did not undergo CN, and for whom the primary tumor was evaluated as a target lesion, were included. Response rate (ORR), progression-free survival (PFS) and overall survival (OS) were prospectively assessed. Best response in primary tumor size from baseline was considered as pPR (shrinkage > 30%), pSD (between -30% and +20%) and pPD (growth >20%).
Results
Among 720 patients treated with nivolumab in the NIVOREN GETUG-AFU -26 study, 111 did not undergo CN including 84 patients evaluable for response on their primary tumor. This population was represented by men (78.6%) with a median age of 64 yo and poor IMDC prognosis (53%). IMDC was favorable in 2.4% of pts, intermediate in 44.6%. Nivolumab was used in 2nd line for 62% of patients, 3rd line or more in 38%. With a median follow-up of 26 months [CI95%: 21.5;27.1] The ORR was 9% (7/84) patients). Median PFS was 2.7 months [CI95%: 2.4;3.0] and OS 11.3 months [CI95%: 6.4;19.3]. The median size of the primary renal tumor at nivolumab start was 79.5mm and consisted in >50% of the measured tumor burden (median sum of target lesion diameters 147mm). Median best change in primary tumor size was 5% (range: -51% to +68%). Four patients experienced pPR (5%), 14 pPD (17%). Median PFS for the primary tumor was 11.3 months [CI95%: 5.2;NE] and only 1 patient had pPD before progression on other lesions. Comparison between the response of the primary and other lesions showed a linear correlation at first, which became uncertain with successive evaluations.
Conclusions
Patients who did not undergo CN had adverse baseline characteristics but most achieved pSD or pPR as well as prolonged primary tumor control with nivolumab. Study of exceptional responders may provide insights on subsets of patients who may benefit from delayed CN.
Clinical trial identification
NCT03013335.
Editorial acknowledgement
Legal entity responsible for the study
UNICANCER.
Funding
Has not received any funding.
Disclosure
B. Laguerre: Honoraria (self), Travel/Accommodation/Expenses: pfizer; Honoraria (self): AstraZeneca; Honoraria (self): Janssen; Honoraria (self): Astellas; Honoraria (self): Ipsens; Honoraria (self): MDS; Honoraria (self): Roche; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: BMS. S. Ladoire: Honoraria (self): BMS. P. Barthélémy: Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Travel/Accommodation/Expenses: Janssen; Honoraria (self), Travel/Accommodation/Expenses: IPSEN; Honoraria (self), Travel/Accommodation/Expenses: MSD; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: Astellas; Honoraria (self): Novartis; Honoraria (self): EusaPharma. S. Oudard: Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Astellas Pharma; Honoraria (self), Advisory/Consultancy: Janssen; Advisory/Consultancy: MSD; Advisory/Consultancy: Roche; Advisory/Consultancy: Boehringer Ingelheim. F. Joly: Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Tesaro; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy: Pfizer; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Bristol-Myers Squibb; Research grant/Funding (self): Astellas Pharma. G. Gravis Mescam: Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Janssen Oncology; Travel/Accommodation/Expenses: Bristol-Myers Squibb; Travel/Accommodation/Expenses: Astellas Pharma; Travel/Accommodation/Expenses: Pfizer. C.M. Chevreau: Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: MSD Oncology; Travel/Accommodation/Expenses: AstraZeneca. L. Geoffrois: Honoraria (self), Travel/Accommodation/Expenses: BMS. E. Deluche: Honoraria (institution): Fresenius kabi; Travel/Accommodation/Expenses: Novartis. F. Rolland: Advisory/Consultancy: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Janssen; Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: Astellas Pharma. S. Culine: Advisory/Consultancy: Ferring; Advisory/Consultancy: Roche; Advisory/Consultancy: Bayer; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Astellas Pharma; Travel/Accommodation/Expenses: Merck; Travel/Accommodation/Expenses: Janssen. S. Négrier: Honoraria (self): Pfizer; Honoraria (self): Ipsen; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): EUSA Pharma; Honoraria (self): Novartis. H. Mahammedi: Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Travel/Accommodation/Expenses: Janssen Oncology; Honoraria (self): Sanofi/Aventis; Honoraria (self): Ipsen; Travel/Accommodation/Expenses: Roche; Honoraria (self), Travel/Accommodation/Expenses: Bayer; Travel/Accommodation/Expenses: Sanofi; Travel/Accommodation/Expenses: Astellas Medivation. B. Escudier: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy: EUSA Pharma; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Genentech; Advisory/Consultancy: AVEO. R. Flippot: Travel/Accommodation/Expenses: Pfizer. L. Albiges: Advisory/Consultancy: Astellas Pharma (Inst); Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Amgen (Inst); Advisory/Consultancy: Novartis; Advisory/Consultancy: Merck (Inst); Advisory/Consultancy: Bristol-Myers Squibb (Inst); Advisory/Consultancy: Ipsen (Inst); Advisory/Consultancy: Roche (Inst); Advisory/Consultancy: Novartis (Inst); Advisory/Consultancy: Pfizer (Inst). All other authors have declared no conflicts of interest.