Abstract 1085P
Background
Neoadjuvant ipilimumab + nivolumab induces high pathologic response rates with high relapse free survival (RFS). Response appears concordant among nodes in the tumor bed, such that a therapeutic lymph node dissection (TLND) may not be required for patients (pts) achieving a major pathologic response (MPR, ≤10% viable tumor cells) in a single sampled node. In the PRADO trial, TLND was omitted in pts achieving an MPR after resection of just their index lymph node (ILN, the largest LN marked prior to neoadjuvant therapy). We provide 24-week Health Related Quality of Life (HRQoL) results of pts undergoing ILN procedure only versus pts without MPR who underwent TLND.
Methods
HRQoL was assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire-C30 and melanoma surgery specific questions of the Functional Assessment of Cancer Therapy-Melanoma. A generalized estimation equation was used to assess the difference in HRQoL outcomes between pts who underwent TLND versus those who did not. Differences were adjusted for age, gender and follow-up (FU). Pathologic response and additional adjuvant treatment were not included at this stage.
Results
For the 99 pts enrolled in PRADO, questionnaire (QLQ) completion rates were: 91% at baseline and 93%, 90%, 67% at week 6, 12 and 24, respectively. Patients were included if they filled in at least 2 QLQ’s. Median age was 59 (range, 19 – 86) years. Over the FU period of 24 weeks, pts who went on to TLND (n=30) scored significantly lower on global (difference (diff= -6.82; p=.025), physical (diff= -8.74; p<.001), and role functioning (diff=-10.74; p=.012), but higher in symptom burden of insomnia (diff= 17.61; p<.001), pain (diff= 8.60; p=.002), fatigue (diff= 8.98; p=.024), constipation (diff= 8.43; p=.001) and melanoma surgery related symptoms (-2.55; p=.001) than pts who did not (n=61).
Conclusions
Stage 3 melanoma patients with MPR following neoadjuvant immunotherapy who have reduced extent of surgery have significantly better HRQoL scores. By September 2020, the majority of PRADO pts will have reached 36 weeks FU. This data will also be presented.
Clinical trial identification
Clinical trial information OpACIN-neo/PRADO extension cohort NCT02977052.
Editorial acknowledgement
Legal entity responsible for the study
The Netherlands Cancer Institute (NKI).
Funding
BMS.
Disclosure
R.P.M. Saw: Advisory/Consultancy: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Qbiotics; Honoraria (institution): BMS. K.P.M. Suijkerbuijk: Advisory/Consultancy: BMS; Honoraria (institution), Advisory/Consultancy: MSD; Honoraria (institution), Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Honoraria (institution): Roche. E. Kapiteijn: Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy: Novartis; Advisory/Consultancy: Merck; Advisory/Consultancy: Pierre Fabre. A.A.M. Van der Veldt: Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Eisai; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Merck. G.A.P. Hospers: Advisory/Consultancy: Amgen; Advisory/Consultancy: Roche; Advisory/Consultancy: MSD; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabry; Research grant/Funding (institution): Seerave. A.M. Menzies: Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Roche. A.C.J. van Akkooi: Advisory/Consultancy: 4SC; Advisory/Consultancy, Research grant/Funding (institution): Amgen; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy: Merck; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Sanofi. G.V. Long: Advisory/Consultancy: Aduro; Advisory/Consultancy: Amgen; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Mass-Array; Advisory/Consultancy: Merck; Advisory/Consultancy: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: OncoSec medical; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Roche; Advisory/Consultancy: QBiotics; Advisory/Consultancy: Sandoz. C.U. Blank: Honoraria (institution), Research grant/Funding (institution): BMS; Honoraria (institution): MSD; Honoraria (institution): Roche; Honoraria (institution), Research grant/Funding (institution): Novartis; Honoraria (institution): GSK; Honoraria (institution): AZ; Honoraria (institution): Pfizer; Honoraria (institution): Lilly; Honoraria (institution): Genmab; Honoraria (institution): Pierre Fabre; Honoraria (self): Third Rock Ventures; Shareholder/Stockholder/Stock options: Unity Cars; Shareholder/Stockholder/Stock options: Immagene B.V.; Research grant/Funding (institution): NanoString. A.H. Boekhout: Research grant/Funding (institution): Bristol-Myers Squibb. All other authors have declared no conflicts of interest.