Abstract 803P
Background
COMBI-APlus, an open-label, phase 3b study, met its primary endpoint of significant reduction in composite pyrexia events compared with a historical control from COMBI-AD. Here, we report the patient-reported outcomes (PROs) during the 12-month adjuvant dabrafenib plus trametinib (D + T) treatment in patients (pts) with stage III BRAF V600+ melanoma after complete resection.
Methods
Eligible pts aged ≥18 years with resected stage III BRAF V600E/K–mutant melanoma received oral adjuvant D (150 mg twice daily) + T (2 mg once daily) for up to 12 months (mo). A 16-item melanoma subscale of the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) tool was used to assess the quality of life (QOL). Respondents were asked to score the statements related to their QoL with melanoma, based on a four-point response scale, with 4 being the best response. The FACT-M scores were assessed at baseline and at every month up to month 12. Time to first deterioration, which was defined as the time from inclusion in the study to the first decrease in QoL scores according to baseline score, and effect of age, stage, baseline score, visit, and status visit on PRO using a mixed-effect model were also evaluated.
Results
A total of 552 pts were enrolled and included in this analysis. The mean (SD) FACT-M score at baseline for all pts was 57.44 (5.203), which changed to 55.31 (7.392) at 6 months, and 56.02 (7.324) at 12 months. Overall, data of individual questions showed that pts were at their best state at most of the visits, with non-relapsed pts showing better change in scores than relapsed pts. The minimal point of worsening was observed at point 5, and the median time for minimal worsening of melanoma-related symptoms was 5.55 mo. The mixed-effect model showed that the disease stage at baseline had a significant effect on the change in PRO score.
Conclusions
PRO data from COMBI-APlus study showed no clear worsening of QOL during the treatment unless there was a relapse. This implies that disease evolution but not treatment affects the QOL, supporting use of D + T as adjuvant treatment in pts with stage III BRAF V600+ melanoma after complete resection.
Clinical trial identification
NCT03551626.
Editorial acknowledgement
Medical writing and editorial support was provided by Faizan Farooqui, Novartis Healthcare Pvt Ltd (Hyderabad, India).
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
J.J. Grob: Financial Interests, Personal, Other, Consulting Fee: Novartis, BMS; Financial Interests, Personal, Advisory Board: Novartis, BMS, MSD, Philogen, Pierre Fabre, Sanofi, Roche, Amgen. M. Del Vecchio: Financial Interests, Personal, Other, Consulting Fee: Novartis, BMS, Merck, Pierre Fabre; Financial Interests, Personal, Invited Speaker: Novartis, BMS, Merck, Pierre Fabre. B. Ryll: Financial Interests, Institutional, Other, Support for MPNE yearly activities for 2019 and 2020, projects are always multi-sponsored and support never gives rights to any influence wrt content, program, speakers or other; this reflects MPNE’s total budget: Amgen, Delcath, MSD, Pierre Fabre, Roche; Financial Interests, Institutional, Other, Support for MPNE yearly activities for 2019, 2020 and 2021, projects are always multi-sponsored and support never gives rights to any influence wrt content, program, speakers or other; this reflects MPNE’s total budget: BMS, Novartis; Financial Interests, Personal, Advisory Board, Ethics Board for EAP programs: Clinigen; Financial Interests, Personal, Advisory Board, Access to medicines AD board: AstraZeneca; Financial Interests, Personal, Invited Speaker, Patient Summit: Pfizer; Financial Interests, Personal, Advisory Board, Histology-agnostic ad board: Roche; Financial Interests, Personal, Advisory Board, Patient Expert Ad board: Amgen; Financial Interests, Personal, Invited Speaker, Patient Ad board, internal meeting: Novartis Sweden; Financial Interests, Personal, Invited Speaker, Baltic Oncology Summit, webinars: MSD SE; Financial Interests, Personal, Other, Fee for Service- organisation of a workshop for PA at ESMO 2019: MSD; Financial Interests, Personal, Invited Speaker, WIN symposium: Roche; Financial Interests, Personal, Advisory Board, Melanoma Academy: Novartis; Financial Interests, Personal, Advisory Board, IQVIA Oncology Ad board: IQVIA; Financial Interests, Personal, Advisory Board, Patient AD board: BMS; Financial Interests, Personal, Advisory Board, Advisor for a research project 2021: Pierre Fabre; Financial Interests, Personal, Advisory Board, Member of clinical trial steering committee COMBI-Aplus: Novartis; Financial Interests, Personal, Other, Member of the ASC Oncology Advisory Board: ASC Oncology. C. Robert: Financial Interests, Personal, Advisory Board: BMS, Roche, Pierre Fabre, Novartis, Sanofi, MSD, AstraZeneca, Pfizer. H.J. Gogas: Financial Interests, Personal, Advisory Board: MSD, BMS, PIERRE FABRE; Financial Interests, Personal, Invited Speaker: MSD, BMS, NOVARTIS, PIERRE FABRE, SANOFI; Financial Interests, Invited Speaker: AMGEN, REPLIMUNE; Financial Interests, Institutional, Invited Speaker: AMGEN, MSD, BMS, REPLIMUNE, IOVANCE; Financial Interests, Institutional, Research Grant: BMS, PFIZER. A.M. Menzies: Financial Interests, Personal, Advisory Board, advisory board: BMS, MSD, Novartis, Roche, Pierre-Fabre, QBiotics. A. Gupta: Financial Interests, Personal, Funding: Novartis, BMS; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Advisory Role: Novartis. H. Banerjee: Financial Interests, Personal, Full or part-time Employment: Novartis. M.R. Lau: Financial Interests, Personal, Stocks/Shares: Novartis Pharma AG; Financial Interests, Personal, Full or part-time Employment: Novartis Pharma AG. V.G. Atkinson: Financial Interests, Personal, Advisory Board: BMS, MSD, Nektar, Novartis, Pierre Fabre, QBiotics; Financial Interests, Personal, Invited Speaker: BMS, MSD, Novartis, Pierre Fabre, Limbic; Financial Interests, Personal, Other, Travel Support: BMS. All other authors have declared no conflicts of interest.