Abstract 1215P
Background
Osimertinib is licensed as adjuvant treatment for resected EGFR mutated stage IB-IIIA non-small cell lung cancer. In the ADAURA trial, it improved disease-free and overall survival (Tsuboi et al, 2023). Real-world dose compliance with oral anti-cancer agents is less than that in clinical trials (Greer et al, 2016). Establishing real-world adjuvant Osimertinib compliance is therefore important.
Methods
A multi-centre retrospective study, from 32 UK hospitals, of patients who received adjuvant Osimertinib since November 2021. Primary outcome: dose acceptability rates, defined as remaining on 80mg at point of data collection (irrespective of interruptions). Secondary outcomes assessed dose tolerability, including reductions, interruptions and cessations. SPSS was used for univariate and multivariate analysis and Kaplan-Meier discontinuation curves.
Results
Of 206 patients offered adjuvant osimertinib, 182 (88.3%) started treatment. Median duration of follow-up was 17.1 months. The dose acceptability rate was 54.4% (99/182), compared to 74.8% (252/337) in ADAURA. At univariate and multivariate analysis neither demographic variables, mutation type, nor surgical resection type affected dose acceptability. Osimertinib dose reduction, interruption and cessation rates were 33.5%, 39.0% and 18.7% respectively. The commonest reason for these were treatment adverse events (AE). All-grade AE were similar to those in ADAURA, the commonest were diarrhoea (42.9%), fatigue (40.1%) and rash (38.5%). The median time to dose reduction or cessations was 69 days, and was affected by type of AE (Table). 60.0% reduced or stopped Osimertinib by 100 days, and 89.2% by 1 year. Table: 1215P
Treatment related adverse events and dose acceptability, in patients who dose-reduced or stopped osimertinib
TOTAL | Number of patients n (%) | G1 | G2 | G3 | G4 | Median time to dose reduction/ cessation (Days) | Median time to follow-up (Days) |
Cardiac toxicity | 5 (6.8%) | 1 | 3 | 1 | 28 | 575 | |
Rash | 14 (19.2%) | 9 | 5 | 38.5 | 663 | ||
Other | 15 (20.5%) | 4 | 7 | 4 | 49 | 311 | |
Fatigue | 11 (15.1%) | 2 | 8 | 1 | 69 | 379.5 | |
Diarrhoea | 19 (26.0%) | 6 | 11 | 1 | 1 | 71 | 391 |
Paronychia | 3 (4.1%) | 1 | 2 | 133 | 133 | ||
Respiratory toxicity | 6 (8.2%) | 1 | 3 | 2 | 277 | 893 | |
Totals (averages for medians) | 73 | 15 | 40 | 16 | 2 | 69 | 433 |
Conclusions
Dose reduction and cessation rates of adjuvant osimertinib are higher in the real-world than were found in ADAURA, primarily due to treatment AEs. These results should be considered when discussing adjuvant Osimertinib with patients in routine clinical practice.
Clinical trial identification
Not Applicable
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1131P - A phase II study of pembrolizumab combination with temozolomide as 1L treatment for Chinese metastatic acral melanoma patients
Presenter: Ya Ding
Session: Poster session 04
1132P - Regorafenib in Caucasian patients with pretreated advanced KIT-mutant melanoma: A dual center case series
Presenter: Iris Dirven
Session: Poster session 04
1133P - Only early adjuvant radiotherapy, particularly of the tumor bed rather than the lymph node region, improves prognosis in Merkel cell carcinoma: Results from the prospective German MCC registry
Presenter: Juergen Becker
Session: Poster session 04
1134P - Avelumab in metastatic Merkel cell carcinoma (mMCC): Conditional survival and long-term safety in patients treated for ≥1 or ≥2 years in JAVELIN Merkel 200
Presenter: Celeste Lebbe
Session: Poster session 04
1135P - Multi-modal and longitudinal characterization of the tumor and immune microenvironment of Merkel cell carcinoma
Presenter: Maximilian Haist
Session: Poster session 04
1136P - Cosibelimab in advanced cutaneous squamous cell carcinoma (CSCC): Longer-term efficacy and safety results from pivotal study
Presenter: Eva Muñoz-Couselo
Session: Poster session 04
1137P - Efficacy of LNS8801 in melanoma patients with prior immune-related adverse events from immune-checkpoint inhibitors
Presenter: Justine Cohen
Session: Poster session 04
1138P - A prospective study of patients with immune checkpoint inhibitor-induced hepatitis: Management outcome and association with liver injury subtype, immune infiltration, and clinical parameters
Presenter: Rikke Holmstroem
Session: Poster session 04
1139TiP - IDE196 (darovasertib) in combination with crizotinib versus investigator’s choice of treatment as first-line therapy in HLA-A2 negative metastatic uveal melanoma
Presenter: Marcus Butler
Session: Poster session 04
1140TiP - Safe stop IPI-NIVO trial: Early discontinuation of nivolumab upon achieving a complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
Presenter: Joséphine Janssen
Session: Poster session 04