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M.A. Sala
Author of
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ORAL 32 - EGFR WT and MT Targeting (ID 144)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:K.J. O'Byrne, D.R. Gandara
- Coordinates: 9/09/2015, 16:45 - 18:15, Four Seasons Ballroom F3+F4
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ORAL32.02 - Long-Term Survivors with EGFR Wild-Type Advanced NSCLC Treated with Second-Line Erlotinib: Subgroup Analysis from WILT Study (ID 1661)
16:56 - 17:07 | Author(s): M.A. Sala
- Abstract
- Presentation
Background:
The overwhelming majority of advanced NSCLC p worldwide is wild-type (WT) EGFR. The results reported so far are difficult to interpret due to the heterogeneous nature of this large group of p. There is a variation in terms of efficacy considering known prognostic factors; however, other characteristics, as yet undefined, might further explain this variability. In the clinical setting, prolonged second-line treatment with Erlotinib (E) has been identified in a small group of p with WT EGFR leading to a long-term survival. The role of E in this special subset needs to be further determined in order to identify who might be most likely to benefit.
Methods:
WILT is a multicentre, open-label, observational study. WT EGFR (if rarely unknown, both squamous tumour and current/former smoking status as mandatory criteria) advanced NSCLC p treated with second-line E (150mg/d, until unacceptable toxicity/progressive disease) were included. Using a prognostic index model, the aim of this study is to identify subgroups of p with specific clinical and laboratory parameters that are likely to derive clinically meaningful and statistically significant benefit from E. Here we present the results of patients’ subgroups with long-term E treatment in second-line setting (PFS≥6 months and PFS≥9 months).
Results:
355 p were included in the study and preliminary reported data showed an overall median PFS of 2.3 months, finding 40% of p with a median PFS>2.5 months. Baseline subgroups characteristics of 52 p (14.6%) with a PFS≥6 months and 30 p (8.5%) with a PFS≥9 months are shown in Table 1. Efficacy data in PFS≥6 months subgroup: Median PFS of 10.8 months (95% CI: 9.2-12.3). Objective Response Rate of 21.6% and Disease Control Rate of 82.4%. Main related grade≥3 toxicities were rash (1.9%) and diarrhoea (3.8%). Efficacy data in PFS≥9 months subgroup: Median PFS of 13.5 months (95% CI: 12-15). Objective Response Rate of 17.2% and Disease Control Rate of 82.8%. Main related grade≥3 toxicities were rash (3.3%) and diarrhoea (6.7%). Table1: Patient characteristics
*Unknown: Squamous and current/former smokersSLP ≥6 months (N=52) SLP ≥9 months (N=30) Median age ( years) 65 67 Male/Female (%) 69/31 67/33 ECOG 0/1/2 (%) 21/62/17 23/64/13 Histology (%) Adenocarcinoma/Squamous 48/39 43/50 Stage (%) IV 75 67 EGFR status (%) WT Unknown* 85 15 80 20 Smoking status (%) Current/Never/Former 19/17/64 17/16/67 Metastases (%) Yes Lung/Bone/CNS/Pleura/Liver 83 44/21/14/12/9 77 39/22/9/13/13 Prior platinum-based doublet (%) Yes 94 93 Prior Maintenance Treatment (%) Yes 27 17 Best response to first-line (%) CR+PR/SD 48/31 40/37 Weight loss during first-line (%) Yes 22 23 Anaemia (%) Yes 69 63
Conclusion:
Global efficacy results of E, in terms of PFS, match with previously reported data for second-line setting. A long-term survivors group has been identified, whom the administration of E resulted in an extraordinary prolonged response. Highlighting the heterogeneity of this subgroup, it was not possible the identification of standardized prognostic factors. Potentially molecular variables for long-term survival with E in WT EGFR NSCLC could play a role in the determination of different evolutions.
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