Abstract 437P
Background
Evaluating QoL in oncology clinical studies is becoming increasingly important as a method of understanding treatment benefit from the patient perspective. This study compared patient-reported outcomes (PROs) between previously treated pts with MSI-H or dMMR mCRC who received NIVO monotherapy (3mg/kg) or NIVO (3mg/kg) combined with IPI (1mg/kg) in two non-randomized cohorts of CheckMate 142.
Methods
QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core (EORTC QLQ-C30) questionnaire and the EQ-5D-3L. Mixed models for repeated measurements (MMRM) provided estimates of least squares (LS) mean changes from baseline (BL) on-treatment up to week 199 (≥10 pts per treatment) and differences between treatment groups. The base model controlled for BL PRO score, while BL characteristics with p-values ≤0.2 were added to the base MMRM to control for potential bias.
Results
There were 168 pts (61 NIVO, 107 NIVO + IPI) who had a valid BL and ≥1 post-BL assessment. BL characteristics for both treatment groups were comparable. Patients in both treatment groups had significant improvements from baseline for nearly all subscales. The NIVO + IPI combination had a trend for greater improvements, but these differences were not significant. Table: 437P
| NIVO + IPI | NIVO | |||
| (n=107) | (n=60) | |||
| LS Mean (SE) | 95% CI | LS Mean (SE) | 95% CI | |
| EORTC QLQ-C30 | ||||
| Global Health Status/QoL | 12.6 (1.3) | 10.1, 15.2 | 10.9 (1.9) | 7.1, 14.7 |
| Physical Functioning | 9.1 (1.1) | 7.0, 11.3 | 7.5 (1.7) | 4.2, 10.8 |
| Role Functioning | 12.0 (1.7) | 8.6, 15.4 | 8.6 (2.3) | 3.9, 13.3 |
| Emotional Functioning | 11.2 (1.2) | 8.9, 13.5 | 9.9 (1.6) | 6.6, 13.2 |
| Cognitive Functioning | 1.5 (1.1) | -0.6, 3.6 | 0.6 (1.4) | -2.2, 3.5 |
| Social Functioning | 13.5 (1.4) | 10.7, 16.3 | 10.5 (2.2) | 6.2, 14.9 |
| EQ-5D-3L | ||||
| VAS | 13.5 (1.7) | 10.2, 16.8 | 16.3 (2.4) | 11.5, 21.1 |
| Index (UK) | 0.140 (0.014) | 0.112, 0.169 | 0.128 (0.021) | 0.086, 0.170 |
Conclusions
In previously treated pts with MSI-H or dMMR mCRC, QoL improves with either NIVO monotherapy or in combination with IPI, with a trend towards greater improvement for pts receiving the NIVO + IPI combination.
Clinical trial identification
CA209142 NCT02060188.
Editorial acknowledgement
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
E. Van Cutsem: Financial Interests, Institutional, Advisory Role: Array; Astellas; AstraZeneca; Bayer; Biocartis; Bristol Myers Squibb; Celgene; Daiichi Sankyo; Halozyme; GSK; Pierre Fabre; Incyte; Ispen; Lilly; Merck Sharp & Dohme Corp.; Merck KGaA; Novartis; Roche; Servier; Sirtex; Taiho; Financial Interests, Institutional, Research Grant, Grants to his institution: Amgen; Bayer; Boehringer Ingelheim; Bristol Myers Squibb; Celgene; Ipsen; Lilly; Merck Sharp & Dohme Corp.; Merck KGaA; Novartis; Roche; Servier. M. Dixon: Financial Interests, Institutional, Full or part-time Employment: BMS. F. Taylor: Financial Interests, Institutional, Full or part-time Employment, Adelphi Values is a consulting firm that received payment from BMS for conducting these analyses: Adelphi Values. X. Sun: Financial Interests, Institutional, Full or part-time Employment, Adelphi Values is a consulting firm that received payment from BMS for conducting these analyses: Adelphi Values. C. Yip: Financial Interests, Institutional, Full or part-time Employment, Adelphi Values is a consulting firm that received payment from BMS for conducting these analyses: Adelphi Values. S.I. Blum: Financial Interests, Institutional, Full or part-time Employment: BMS; Financial Interests, Institutional, Stocks/Shares: BMS.