Abstract 1088P
Background
DT combination has shown efficacy in the adjuvant setting for BRAF mutated melanoma (BMM) patients (pts) in clinical trials. However, 26% of pts discontinued treatment (tt) due to unacceptable toxicity. DESCRIBE-AD study aims to collect real-world evidence on the discontinuation of adjuvant DT in Spain.
Methods
An observational retrospective study was carried out in 23 GEM sites in Spain. Histologically confirmed and resected BMM pts previously treated with DT in the adjuvant setting were included. Only surgical resection was allowed as a prior tt to DT. DT discontinuation rate and time to treatment discontinuation was the primary objective. Secondary objectives included safety and efficacy of the combination.
Results
From 10/2020 to 03/2021, 65 pts were included. Median age was 58y, 55% were male and 60%/25%/14% had an ECOG PS 0/1/Uk respectively. Allocation of stage IIIA, IIIB and IIIC according to TNM AJCC 7th edition was 26%, 22% and 28%, respectively. Ulceration was present in 40%, Breslow ≥2 mm in 71%, and nodes were microscopically and macroscopically affected in 39% and 22% of pts, respectively. DT discontinuation rate due to treatment-related adverse events (TRAEs) of any grade happened in 6 pts (9%). Other discontinuation reasons included patient´s decision (6%), physician decision (6%), DT unrelated AEs (3%), PD (5%) and other (5%). The median time to DT discontinuation was 9 m (95%CI: 5-11). 76.9% of pts presented at least 1 TRAE. Most frequent grade ≥3 TRAEs were pyrexia (3%), asthenia (3%) and diarrhea (3%). Unscheduled hospitalizations and extra clinical tests occurred in 4 (6%) and 14 (22%) pts respectively. After a median follow up of 20 m (95%CI: 18-22), 6 pts (9%) were exitus due to disease progression, with a 12-month overall survival rate of 100%.
Conclusions
TRAEs and DT discontinuation rate in our study were less frequent than previously reported in clinical trials. DT proved effectiveness during treatment and a manageable toxicity profile in the real world that did not differ from previous reports in clinical trials and led to low incidence of unscheduled medical visits and tests.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Grupo Español Multidisciplinar de Melanoma (GEM).
Funding
Novartis.
Disclosure
J. Martín-Liberal: Financial Interests, Personal, Other, Lecture fees: Astellas; Financial Interests, Personal, Other, Lecture fees, advisory fees: Bristol-Myers Squibb; Financial Interests, Personal, Other, Lecture fees: MSD; Financial Interests, Personal, Other, Lecture fees, advisory fees: Novartis; Financial Interests, Personal, Other, Lecture fees, advisory fees: Pierre Fabre; Financial Interests, Personal, Other, Lecture fees, advisory fees: Pfizer; Financial Interests, Personal, Other, Lecture fees, advisory fees: Roche; Financial Interests, Personal, Other, Lecture fees, advisory fees: Sanofi; Non-Financial Interests, Personal, Affiliate: ASCO; Non-Financial Interests, Personal, Affiliate: ESMO; Non-Financial Interests, Personal, Affiliate: SEOM; Non-Financial Interests, Personal, Affiliate: GEM; Non-Financial Interests, Personal, Affiliate: EORTC; Non-Financial Interests, Personal, Affiliate: SOGUG; Non-Financial Interests, Personal, Affiliate: GEIS. L.A. Fernandez-Morales: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Pierre-Fabre; Financial Interests, Personal, Invited Speaker: ROCHE; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Role: Novartis. G. Benítez: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Other, Conferences: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Roche. J. Medina: Financial Interests, Personal, Other, Honoraria you have directly received for any speaker, consultancy or advisory role or similar: Novartis; Financial Interests, Personal, Other, Honoraria you have directly received for any speaker, consultancy or advisory role or similar: Roche; Financial Interests, Personal, Other, Honoraria you have directly received for any speaker, consultancy or advisory role or similar: Pierre Fabre; Financial Interests, Personal, Other, Honoraria you have directly received for any speaker, consultancy or advisory role or similar: BMS; Financial Interests, Personal, Other, Honoraria you have directly received for any speaker, consultancy or advisory role or similar: MSD; Financial Interests, Personal, Other, Honoraria you have directly received for any speaker, consultancy or advisory role or similar: Sanofi. M. Quindós: Financial Interests, Personal, Other, Speaker, consultancy and advisory: AstraZeneca; Financial Interests, Personal, Other, Speaker, consultancy and advisory: GSK; Financial Interests, Personal, Other, Speaker, consultancy and advisory: Merk Sharp & Dohme; Financial Interests, Personal, Other, Speaker, consultancy and advisory: Novartis; Financial Interests, Personal, Other, Speaker, consultancy and advisory: PharmaMar; Financial Interests, Personal, Other, Speaker, consultancy and advisory: Roche; Financial Interests, Personal, Other, Speaker, consultancy and advisory: Bristol-Myers Squibb; Financial Interests, Personal, Other, Speaker, consultancy and advisory: Pierre Fabre; Financial Interests, Institutional, Other, Clinical trials: Merk Sharp & Dohme; Financial Interests, Institutional, Other, Clinical trials: Roche; Financial Interests, Institutional, Other, Clinical trials: Bristol-Myers Squibb. O. Fernández: Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: EUSA Pharma; Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Role: Astellas; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Advisory Role: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Role: EUSA Pharma; Financial Interests, Personal, Advisory Role: Sanofi; Non-Financial Interests, Personal, Member, Board member: SOGUG. R. Vilchez Simo: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: Novartis. M. Majem: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Other, Honororia and speaker: MSD; Financial Interests, Personal, Other, Honororia and speaker: Roche; Financial Interests, Personal, Other, Honororia and speaker: AstraZeneca; Financial Interests, Personal, Other, Honororia and speaker: Boehringer I; Financial Interests, Personal, Other, Honoraria: Takeda; Financial Interests, Personal, Other, Honoraria: Sanofi; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Other, Honoraria: Janssen; Financial Interests, Institutional, Other, Financial Support: BMS; Non-Financial Interests, Personal, Advisory Board: SEOM; Non-Financial Interests, Personal, Advisory Board: ICAPEM. L. Bellido Hernández: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Boehringer. B. Campos: Financial Interests, Personal, Other, Speaker and advisory role: Roche; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Other, Speaker and advisory role: Sanofi; Financial Interests, Personal, Other, Speaker and advisory role: Novartis; Financial Interests, Personal, Invited Speaker: Merk; Financial Interests, Personal, Invited Speaker: Pierre Fabre. E. Espinosa: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Stocks/Shares: Biomedica Molecular Medicine; Financial Interests, Personal, Project Lead, translational investigation in breast cancer: Roche. J.A. Macías Cerrolaza: Financial Interests, Personal, Other, Conference in webinar: MSD; Financial Interests, Personal, Advisory Board: Bristol MB; Financial Interests, Personal, Other, Conference in webinar: Roche; Financial Interests, Personal, Other, Conference in webinar: AstraZeneca. I. Gil-Arnaiz: Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal, Advisory Role: PharmaMar; Financial Interests, Personal, Invited Speaker: Bristol; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Expert Testimony: Bristol; Financial Interests, Personal, Expert Testimony: AECC; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Expert Testimony: KYOWA KIRIN; Non-Financial Interests, Personal, Member: GEM; Non-Financial Interests, Personal, Member: GECP; Non-Financial Interests, Personal, Member: SOGUG; Non-Financial Interests, Personal, Member: SEOM. D. Lorente: Financial Interests, Personal, Other, Advisory, speaker, travel fees: Janssen; Financial Interests, Personal, Other, Advisory, speaker, travel fees: Sanofi; Financial Interests, Personal, Other, Speaker fees: Bayer; Financial Interests, Personal, Other, Advisory, speaker, travel fees: Astellas; Financial Interests, Personal, Other, Consultancy, speaker, travel fees: BMS; Financial Interests, Personal, Other, Advisory, speaker fees: AstraZeneca; Financial Interests, Personal, Other, Speaker, travel fees: Pfizer. A. Martínez-Fernández: Financial Interests, Personal, Full or part-time Employment: Novartis. E. Martín-Sánchez: Financial Interests, Personal, Full or part-time Employment: Novartis. P. Cerezuela-Fuentes: Financial Interests, Personal, Other, Participation in speaker`s bureau: BMS; Financial Interests, Personal, Other, Participation in speaker`s bureau: MSD; Financial Interests, Personal, Other, Participation in speaker`s bureau: Sanofi; Financial Interests, Personal, Other, Participation in speaker`s bureau: Novartis; Non-Financial Interests, Personal, Member: GEM. All other authors have declared no conflicts of interest.