Abstract 1575P
Background
Adjuvant nivolumab is approved and reimbursed for resected patients with esophageal or gastro-esophageal junction (GEJ) cancer with incomplete response to neoadjuvant chemoradiation (nCRT) in the Netherlands since January 2022. This study investigated factors associated with uptake of adjuvant nivolumab in a nationwide population.
Methods
Patients were selected from the Netherlands Cancer Registry based on the EMA indication (non-metastasized esophageal or GEJ cancer treated with nCRT plus surgery and residual pathological disease). Following the Checkmate-577 inclusion criteria, we also investigated a subpopulation using additional criteria: R0 resection and WHO performance status 0-1. Treatment with nivolumab is presented according to time of surgery. The association of not administering nivolumab with patient, disease and treatment characteristics was assessed with multivariable logistic regression.
Results
Of 275 eligible patients in the EMA-indicated population, 177 (64%) were treated with adjuvant nivolumab. Uptake increased from 51% in November-December 2021 to 72%, 68%, and 66% in Q1, Q2 and Q3 of 2022, respectively. According to the Checkmate-577 criteria, 215 patients were eligible, of whom 147 (68%) were treated with nivolumab, with a similar pattern over time (49%, 78%, 67% and 76%, respectively). In the EMA-indicated population, nivolumab was administered less often to patients with ypN0-1 nodal status, irradical resection, post-operative grade 3-4 complications and patients undergoing a gastrectomy (Table).
Table: 1575P
Factors associated with nivolumab treatment
Variable | N | Univariable proportion treated with adjuvant nivolumab | Multivariable odds ratios on not starting with adjuvant nivolumab (95% confidence interval) | P-value |
Age (continuous) | 275 | Not applicable | 1.02 (0.99 – 1.05) | 0.28 |
ypN | ||||
- ypN0 | 130 | 56% | 3.54 (1.57 – 7.98) | <0.01 |
- ypN1 | 92 | 66% | 2.43 (1.04 – 5.69) | 0.04 |
- ypN2-3 | 53 | 79% | Ref | |
Type of surgery | ||||
- Esophagectomy | 267 | 65% | Ref | |
- Total gastrectomy | 8 | 12% | 12.13 (1.41 – 105.6) | 0.02 |
Surgical radicality | ||||
- R0 | 222 | 67% | Ref | |
- R1-2 | 49 | 49% | 2.91 (1.45 – 5.87) | <0.01 |
- Unknown | 4 | 75% | 0.81 (0.08 – 8.83) | 0.86 |
Post-operative grade 3-4 Clavien-Dindo complications | ||||
- No grade 3-4 complication | 217 | 68% | Ref | |
- Grade 3-4 complication | 58 | 50% | 2.11 (1.13 – 3.96) | <0.01 |
Conclusions
Treatment with adjuvant nivolumab has been implemented in the Netherlands, reaching a quarterly maximum of 72-78% of theoretically eligible patients. Small differences in uptake were found between eligible populations based on EMA indicated and Checkmate-577 criteria. Specific disease and treatment characteristics were associated with administration of nivolumab.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
IKNL - Netherlands Comprehensive Cancer Organisation.
Funding
Bristol Myers Squibb.
Disclosure
R.H.A. Verhoeven: Financial Interests, Institutional, Advisory Board, Consultancy: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Non-Financial Interests, Member of Board of Directors, The Dutch Upper-GI Cancer Group is the Dutch multidisciplinary research group regarding Upper-GI cancers.: Dutch Upper-GI Cancer Group; Non-Financial Interests, Member of Board of Directors: International Association of Cancer Registries. N. Haj Mohammad: Financial Interests, Institutional, Research Grant: Servier; Financial Interests, Institutional, Advisory Role: Bristol Myers Squibb, Merck, AstraZeneca, Servier. D. Bertwistle: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. P. Singh: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. M. van Berge Henegouwen: Financial Interests, Institutional, Research Grant: Stryker; Financial Interests, Institutional, Advisory Role: Johnson and Johnson, Alesi Surgical, Viatris, B. Braun, Medtronic. L. Kodach: Financial Interests, Institutional, Other, Received fee for participation in study: Bristol Myers Squibb. B. Mostert: Financial Interests, Institutional, Research Grant: Sanofi, Pfizer, Bristol Myers Squibb; Financial Interests, Personal and Institutional, Advisory Role: Lilly, Bristol Myers Squibb; Financial Interests, Institutional, Advisory Role: Servier, AstraZeneca. M. Slingerland: Financial Interests, Institutional, Advisory Board: Lilly, Bristol Myers Squibb, AstraZeneca. B.P.L. Wijnhoven: Financial Interests, Institutional, Research Grant: Bristol Myers Squibb. H.W.M. van Laarhoven: Financial Interests, Institutional, Advisory Board: BMS, MSD; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Institutional, Invited Speaker: Nordic Pharma, Servier; Financial Interests, Institutional, Research Grant, REPEAT study: Bayer; Financial Interests, Institutional, Research Grant: BMS, Philips; Financial Interests, Institutional, Invited Speaker, FRACTION study: BMS; Financial Interests, Institutional, Research Grant, ACTION study: Celgene; Financial Interests, Institutional, Research Grant, DECO study: Janssen; Financial Interests, Institutional, Invited Speaker, RAINFALL study: Lilly; Financial Interests, Institutional, Invited Speaker, KEYNOTE 062 and KEYNOTE 181 study: Merck/MSD; Financial Interests, Institutional, Research Grant, SOX study: Nordic Pharma; Financial Interests, Institutional, Research Grant, TRAP study, PERFECT study; local PI of JACOB study: Roche; Financial Interests, Institutional, Research Grant, LyRICX study: Servier; Financial Interests, Institutional, Research Grant, TAPESTRY study: Merck; Financial Interests, Institutional, Research Grant, Research money and investigational product: Incyte; Non-Financial Interests, Institutional, Product Samples, For all clinical study mentioned, study medication is provided: See 'research funding'. All other authors have declared no conflicts of interest.
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