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e-Poster Display Session

149P - First line (1L) osimertinib in EGFR mutant (mut) advanced non-small-cell lung cancer (aNSCLC) patients (pts): progression (PD) pattern and safety in the real-world (RW)

Date

24 Mar 2021

Session

e-Poster Display Session

Presenters

Martina Lorenzi

Citation

Journal of Thoracic Oncology (2021) 16 (suppl_4): S748-S802.

Authors

M. Lorenzi1, A. Dal Maso2, A. Ferro3, V. Polo4, D. Scattolin5, M. Macerelli6, A. Follador6, G. Targato6, S. Indraccolo7, S. Frega7, J. Menis8, L. Bonanno9, V. Guarneri10, P.F. Conte11, G. Pasello12

Author affiliations

  • 1 University of Padua, 35128 - Padua/IT
  • 2 Università degli Studi di Padova, Padova/IT
  • 3 Università degli Studi di Padova, 35128 - Padova/IT
  • 4 AULSS 2 Marca Trevigiana, Ca’ Foncello Hospital, Treviso/IT
  • 5 University of Padua, Padua/IT
  • 6 Azienda Sanitaria Universitaria Integrata of Udine - Santa Maria della Misericordia Hospital, 33100 - Udine/IT
  • 7 Veneto Institute of Oncology IOV – IRCCS, 35128 - Padova/IT
  • 8 University of Padova, 35128 - Padova/IT
  • 9 Istituto Oncologico Veneto IOV - IRCCS, 35128 - Padova/IT
  • 10 Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 11 University of Padova and Oncologia Medica, Padova/IT
  • 12 University of Padova, Padova/IT
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Abstract 149P

Background

RW data on PD pattern and safety of 1L osimertinib in EGFR mut aNSCLC are currently lacking.

Methods

This is an observational, multicenter study enrolling EGFR mut aNSCLC receiving 1L osimertinib between November 2018 and 2020. Primary endpoints were treatment outcomes: median progression free survival (mPFS), time to treatment failure (mTTF) and PD patterns. Safety profile was also recorded as a secondary endpoint. PD was classified as isolated (single lesion PD), oligoprogression (oligoPD; PD in ≤ 3 lesions in ≤ 2 sites), systemic all others.

Results

At data cut-off (January 5, 2021), 82 pts receiving osimertinib were included in 3 centres: 52 (63.4%) were female, 46 (56.1%) never smokers. Baseline EGFR mutations were exon 19 deletion in 39 (47.6%) pts, L858R in 36 (43.9%) pts, others in 7 (8.6%) pts. ECOG performance status was 0–1 in 65 (79.3%) pts. Number (N) of metastatic sites at diagnosis was <3 in 52 (63.4%) pts, ≥ 3 in 30 (35.6%) pts; 27 (32.9%) pts had brain metastases. Median follow-up was 11.2 months (mo). Response rate was 68.3%, disease control rate 86.6%. mPFS was 22.0 mo (95%CI, 11.4–32.5), mTTF 25.3 mo (95%CI, 18.9-not calculable). PD was reported in 28 (34%) pts; median N of PD sites was 2 (range 1–7); the most frequent PD sites were lung (N = 19, 67.9%), bone (N = 11, 39.3%) and brain (N = 7, 25%). New PD sites were present in 11 (39.3%) pts; median N = 1 (range 1–4). Isolated PD was observed in 5 (17.9%) pts, oligoPD in 6 (24.4%) and systemic in 16 (57.1%). 9 cases underwent tissue and/or liquid rebiopsy at PD. Druggable resistance mechanisms were identified in 5 pts: MET amplification (amp) (N = 3), MET amp/EGFR amp (N = 1) and HER2 amp (N = 1). The most frequent any grade (G) adverse events (AEs) were diarrhea (N = 33, 40.2%), rash (N = 32, 39.0%), paronychia (N = 22, 26.8%) and creatinine increase (N = 25, 30.5%). The most frequent G3/4 AEs were thromboembolic events (N = 6, 7.3%), diarrhea (N = 4, 4.9%), arterial thromboembolism (N = 2, 2.4%) and rash (N = 2, 2.4%).

Conclusions

Osimertinib confirmed efficacy and safety in RW. Thromboembolic events were observed more frequently than previously reported. The study is still ongoing in order to recruit a larger patient population.

Legal entity responsible for the study

Veneto Institute of Oncology IOV – IRCCS.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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