Abstract 1499P
Background
Neoadjuvant immunotherapy induces high pathologic response (PR) rates with prolonged relapse free survival. The PRADO trial explored omitting lymph node dissection (TLND) in patients (pts) achieving major pathologic response (MPR; ≤10% viable tumor cells) to neoadjuvant Ipilimumab (IPI) + Nivolumab (NIVO) in a single sampled lymph node. Health-Related Quality of Life (HRQoL) outcomes were evaluated in pts with and without MPR.
Methods
HRQoL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life questionnaire-C30 (EORTC-C30) and melanoma (surgery) specific questions of the Functional Assessment of Cancer Therapy-Melanoma. Mean differences in HRQoL between MPR vs non-MPR pts were analyzed over a course of 60 weeks follow-up (FU) according to the intention-to-treat principle. Differences were adjusted for age, sex, and FU.
Results
Of 99 PRADO pts, 95 were analyzed. QLQ completion rates were: 91% at baseline and 97, 89, 88, 93, 85, and 82% at week 6, 12, 24, 36, 48, and 60, respectively. Median FU was 60 weeks (range, 5 – 66) and median age was 61 (range, 19 – 87) years. Preliminary results show that, compared to pts without MPR (n=34), pts with MPR (n=61) reported a significantly higher EORTC-C30 summary score, encouraging us to look closer to other subscales. MPR patients reported higher physical, emotional, role, and social functioning, and had lower symptom burden of fatigue, insomnia, pain, loss of appetite, melanoma related symptoms, and melanoma surgery related symptoms. Differences in mean change were statistically significant (p<0.05) and varied from subtle to unequivocal clinical relevance.
Conclusions
Stage 3 melanoma pts with MPR following neoadjuvant immunotherapy who have reduced extent of treatment have significantly better HRQoL scores than non-MPR pts. An important contributing factor could be the addition of a completion lymph node dissection for the non-MPR group leading to higher rate of surgery related complications and physician- and patient reported lymphedema.
Clinical trial identification
NCT02977052.
Editorial acknowledgement
Legal entity responsible for the study
Antoni van Leeuwenhoek Hospital (AVL/NKI).
Funding
The sponsor is the NKI/AVL and the subsidising party is BMS.
Disclosure
R.P.M. Saw: Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: QBiotics; Financial Interests, Institutional, Invited Speaker: BMS. K. Suijkerbuijk: Financial Interests, Institutional, Advisory Board: Abbvie; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Research Grant: Novartis. E. Kapiteijn: Financial Interests, Institutional, Advisory Role: BMS; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: Merck; Financial Interests, Institutional, Advisory Role: Pierre Fabre; Financial Interests, Institutional, Research Grant: BMS. A.A.M. Van der Veldt: Financial Interests, Institutional, Advisory Role: BMS; Financial Interests, Institutional, Advisory Role: MSD; Financial Interests, Institutional, Advisory Role: Ipsen; Financial Interests, Institutional, Advisory Role: Eisai; Financial Interests, Institutional, Advisory Role: Sanofi; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Advisory Role: Roche; Financial Interests, Institutional, Advisory Role: Pierre Fabre; Financial Interests, Institutional, Advisory Role: Merck. G.A. Hospers: Financial Interests, Institutional, Advisory Role: Amgen; Financial Interests, Institutional, Advisory Role: Roche; Financial Interests, Institutional, Advisory Role: MSD; Financial Interests, Institutional, Advisory Role: BMS; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: Pierre Fabre; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Seerave. A.J. Spillane: Non-Financial Interests, Institutional, Advisory Board: QBiotics; Financial Interests, Institutional, Funding: Stryker. A.M. Menzies: Non-Financial Interests, Institutional, Advisory Board: BMS; Non-Financial Interests, Institutional, Advisory Board: MSD; Non-Financial Interests, Institutional, Advisory Board: Novartis; Non-Financial Interests, Institutional, Advisory Board: Roche; Non-Financial Interests, Institutional, Advisory Board: Pierre Fabre; Non-Financial Interests, Institutional, Advisory Board: QBiotics. A.C.J. van Akkooi: Financial Interests, Institutional, Advisory Board: AMGEN; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: MSD Merck; Financial Interests, Institutional, Advisory Board: Merck Pfizer; Financial Interests, Institutional, Advisory Board: Sanofi; Financial Interests, Institutional, Advisory Board: Sirius Medical; Financial Interests, Institutional, Advisory Board: 4SC; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: Merck Pfizer. G.V. Long: Financial Interests, Institutional, Advisory Role: Aduro Biotech Inc; Financial Interests, Institutional, Advisory Role: Amgen inc; Financial Interests, Institutional, Advisory Role: Array Biopharma inc; Financial Interests, Institutional, Advisory Role: Boehringer Ingelheim International GmbH; Financial Interests, Institutional, Advisory Role: Bristol-Myers Squibb; Financial Interests, Institutional, Advisory Role: Highlight Therapeutics S.L.; Financial Interests, Institutional, Advisory Role: Merck Sharpe & Dohme; Financial Interests, Institutional, Advisory Role: Novartis Pharma AG; Financial Interests, Institutional, Advisory Role: Pierre Fabre; Financial Interests, Institutional, Advisory Role: QBiotics Group Limited; Financial Interests, Institutional, Advisory Role: Regeneron Pharmaceuticals inc. C.U. Blank: Financial Interests, Institutional, Advisory Role: BMS; Financial Interests, Institutional, Advisory Role: MSD; Financial Interests, Institutional, Advisory Role: Roche; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: GSK; Financial Interests, Institutional, Advisory Role: AstraZeneca; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Advisory Role: Lilly; Financial Interests, Institutional, Advisory Role: GenMab; Financial Interests, Institutional, Advisory Role: Pierre Fabre; Financial Interests, Personal, Advisory Role: Third Rock Ventures; Financial Interests, Institutional, Funding: BMS; Financial Interests, Institutional, Funding: Novartis; Financial Interests, Institutional, Funding: NanoString; Financial Interests, Personal, Stocks/Shares, Co-Founder: Immagene BV. A.H. Boekhout: Financial Interests, Institutional, Research Grant: BMS. All other authors have declared no conflicts of interest.