Abstract 1895P
Background
Immunotherapy is associated with different response patterns compared with chemotherapy and targeted therapy, including delayed response and stabilization after disease progression. In clinical practice, immunotherapy can be continued after radiological progression when clinical benefit is observed. Therefore, progression-free survival (PFS), calculated with the first disease progression, may not express the real benefit derived from immunotherapy.
Methods
The Meet-URO 15 study was a multicentric retrospective analysis on 571 pretreated mRCC pts receiving nivolumab. TTF was defined as the time from start of therapy to the definitive disease progression which changed the therapeutic line or death. The comparison between TTF and PFS and the prognostic performance of the Meet-URO score versus (vs) the IMDC score according to TTF and PFS were assessed. Moreover, response and survival outcomes between TBP pts and non-TBP pts were evaluated.
Results
571 pts were included in the analyses (PMID: 34046089). Median TTF was 8.9 months (range: 7.2-10.2) and mPFS was 7.2 months (range: 5.8-8.6). The Meet-URO score performed better than the IMDC score in both TTF (c index: 0.63 vs 0.59) and PFS (0.62 vs 0.59). TBP pts were associated with higher overall response rate (34.4% vs 23.6%; p = 0.035) and disease control rate (61.3% vs 54.8%; p = 0.30). Moreover, TBP pts interestingly correlated with longer TTF (25.0 vs 10.7 months; p<0.001) and OS (42.5 vs 26.7 months; p<0.001), but had similar PFS compared with non-TBP pts. In TBP pts, a mean delay of 13.2 months (range: 6-20.4) from first to definitive disease progression was observed (25 vs 11.8 months), while non-TBP pts had overlapped TTF and PFS (10.8 months).
Conclusions
In pretreated mRCC pts receiving nivolumab, a small difference between mTTF and mPFS (∼2 months) was observed in the overall population. However, TBP pts were associated with significantly better ORR (+10%), TTF (+13 months) and OS (+ 15.8 months). Moreover, the Meet-URO score prognostically performed better with TTF than with PFS and compared with the IMDC score in both survival outcomes.
Clinical trial identification
Regional Ethical Committee of Liguria - registration number 068/2019.
Editorial acknowledgement
Legal entity responsible for the study
G. Fornarini.
Funding
Has not received any funding.
Disclosure
S.E. Rebuzzi: Financial Interests, Personal, Invited Speaker: GSK, BMS, Astellas; Financial Interests, Personal, Other, Travel accommodation: Janssen, MSD. S. Buti: Financial Interests, Personal, Advisory Board: BMS, Pfizer, MSD, MSD, Ipsen, AstraZeneca, Pierre-Fabre, Novartis; Financial Interests, Personal, Invited Speaker: BMS, MSD, Ipsen, AstraZeneca, Novartis; Financial Interests, Institutional, Local PI: BMS, Ipsen, AstraZeneca; Financial Interests, Institutional, Coordinating PI: BMS, MSD; Financial Interests, Institutional, Research Grant: Novartis; Non-Financial Interests, Other, Member of panel for kidney cancer guidelines: AIOM (Italian Association of Medical Oncology); Non-Financial Interests, Other, member and coordinator of the “Rare Tumors” group: Meet-URO group (Italian Network For Research In Urologic-Oncology). U.F.F. De Giorgi: Financial Interests, Personal, Advisory Board: Pfizer, BMS, MSD, PharmaMar, Astellas, Bayer, Ipsen, Novartis, Eisai, Janssen; Financial Interests, Personal, Invited Speaker: Roche, BMS, Clovis Oncology, AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca, Sanofi, Roche. P.A. Zucali: Financial Interests, Institutional, Local PI: Merck, Bayer, Pfizer, BMS Int. Corp. Belgium Branch. M. Soraru: Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen, Ipsen, BMS, Pfizer, Astellas, Sanofi, Roche, Novartis; Financial Interests, Institutional, Research Funding: Roche, Merck, Janssen. C. Masini: Financial Interests, Personal, Speaker, Consultant, Advisor: Ipsen, Astellas, BMS, MSD; Financial Interests, Personal, Advisory Role: BMS, Astellas, Ipsen, MSD, AstraZeneca, Janssen, Merck Serono. G. Fornarini: Financial Interests, Personal, Advisory Board: Amgen, Astellas, BMS, Janssen, Eisai, Ipsen, Pfizer, Bayer; Financial Interests, Personal, Other, ESMO meeting - travel accommodation: Ipsen. All other authors have declared no conflicts of interest.
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