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C. García-Bernáldez
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-064 - Erlotinib in EGFR-Positive NSCLC: Efficacy, Safety and Feasibility for Rebiopsy (ID 830)
09:30 - 09:30 | Author(s): C. García-Bernáldez
- Abstract
Background:
First-line Erlotinib (E) delays progression in 10-14 months in patients (p) harboring EGFR mutations (EGFRm+). Understanding the resistance mechanisms in order to personalize treatment justify the need for rebiopsy. However, undergoing this procedure could be not feasible on a daily basis. Due to different clinical courses and progression patterns, NCCN guidelines recommend strategies according to symptomatology, extent and site of metastasis in recurrent setting. Nowadays, identifying tumour recurrence patterns and evaluating the potential limitations of rebiopsy are relevant in clinical practice.
Methods:
ASPET is an ongoing, multicentre, observational study. Eligible p are chemonaïve with EGFRm+ advanced NSCLC treated with E (150mg/d, until unacceptable toxicity or progressive disease). Primary endpoint is to correlate PFS and tumour localization/characteristics at progression. The evaluation of potential feasibility of rebiopsy (questionnaires completed by physicians and p at diagnosis) is one of the secondary endpoints.
Results:
Baseline characteristics of 100 p included in this preliminary analysis: mean age 66 yrs; 65% female; 89% adenocarcinoma; 91% stage IV; 69% PS-ECOG 0-1; 60% never smokers; 31% central tumours; 57% Del19, 35% L858R, 8% other mutations. Different metastatic locations according to type of mutation have been reported (Figure 1). Objective Response Rate of 63.33% and Disease Control Rate of 90% (60 p evaluable). Main related grade≥3 toxicities were skin disorders (7%) and diarrhoea (2%). Questionnaires completed by 80 physicians: 81.2% considered technically feasible repeat biopsy, 66.25% believe that p would be willing to undergo rebiopsy and 72.5% would direct changes in therapy with rebiopsy results. Results from questionnaires completed by 69% of p are shown in Table 1. Table 1: Results from patient-reported questionnaires (N=69)
Figure 1Before the biopsy procedure, you thought that it would be N (%) Not uncomfortable 13 (18.84) Uncomfortable 31 (44.93) Painful 22 (31.88) Insufferable 3 (4.35) The punctures of each lesion have been N(%) Not uncomfortable 23 (33.33) Uncomfortable 34 (49.28) Painful 9 (13.04) Insufferable 3 (4.35) Overall, you consider the procedure N(%) Not uncomfortable 20 (28.99) Uncomfortable 37 (53.62) Painful 9 (13.04) Insufferable 3 (4.35) If you would have to repeat another biopsy N(%) I will do it 52 (75.36) I will not repeat it again 4 (5.80) I would need anesthesia 13 (18.84)
Conclusion:
Rebiopsy is considered feasible for physicians in clinical practice and the majority of p would undergo a second biopsy. No new safety data have seen so far and efficacy results in terms of responses match with previously reported data.
