Abstract 1045P
Background
BRAF and MEK inhibitors target therapies (TT) and AntiPD1 immunotherapies (IT) are available first-line treatments for BRAF v600 mutant metastatic melanoma patients (pts). ECOG PS (E), baseline LDH (L), baseline number of metastatic sites (N)are well known clinical prognostic markers that identify different prognostic categories of pts. Direct comparison between first-line TT and IT in different prognostic categories could help in first-line treatment decision.
Methods
This is a retrospective analysis conducted in 14 Italian centers. We analyzed data about 454 metastatic melanoma pts (without brain metastasis), Pts were divided in three different prognostic risk categories: group A: pts with E=0, L within normal range, and N less than 3; group B: pts not included in group A or C; group C: pts with E>0, L over the normal range, and N more than 3. For each prognostic group we compared TT and IT in terms of PFS, OS, DCR.
Results
In the table we report the comparison between TT and IT in groups A, B, C, in terms of PFS, OS, DCR. Table: 1045P
| Group A (better prognosis) | Group B (intermediate prognosis) | Group C(worse prognosis) | ||||
| TT | IT | TT | IT | TT | IT | |
| N° patients | 140 | 36 | 196 | 38 | 41 | 3 |
| mPFS (months) | 36 | 12 | 11,5 | 5 | 6,4 | 1,8 |
| HR (95%IC) p value | 1,949 (1,180-3,217) 0,009 | 1,535 (1,036-2,275) 0.033 | 4,860 (1,399-16) 0,013 | |||
| PFS at 1y (%) | 70 | 48 | 40 | 29 | 18 | nr |
| PFS at 2y (%) | 57 | 43 | 30 | 23 | nr | nr |
| PFS at 3y (%) | 48 | 37 | 22 | 23 | nr | nr |
| PFS at 5y (%) | 43 | nr | 12 | 23 | nr | nr |
| mOS (months) | Not | 55 | 19 | 20,5 | 9 | 5,5 |
| HR (95%IC) p value | Reached 1,195 (0,602-2,373) 0,610 | 0,886 (0,546-1,437) 0,623 | 3,443 (0,991-11,9) 0,052 | |||
| OS at 1y (%) | 88 | 80 | 64 | 75 | 28 | nr |
| OS at 2y (%) | 80 | 77 | 48 | 48 | 10 | nr |
| OS at 3y (%) | 65 | 63 | 36 | 37 | 5 | nr |
| OS at 5y (%) | 55 | 43 | 27 | 30 | nr | nr |
| Disease control rate (CR+PR+SD) (%) P value | 99% | 75% | 85% | 47% | 66% | 33% |
| <0.001 | <0.001 | 0.258 |
Conclusions
In good prognosis group A (baseline ECOG PS 0, LDH within normal range, <3 metastatic sites) TT showed statistically significant better PFS than IT, also in a long term period, suggesting that TT can be a good first-line option for this pts category. Only in Group B we observed a crossing of the survival curves after the 3rd year of observation in favor of IT. Few pts were enrolled in group C, so few conclusion can be made about it, even if TT showed grater efficacy. DCR was better for TT in all groups.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
R. Marconcini: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: La Roche; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Board: Ipsen. M. Bersanelli: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Advisory Board: Pfizer. All other authors have declared no conflicts of interest.