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Enrica Capelletto
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P1.04 - Clinical Design, Statistics and Clinical Trials (ID 690)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.04-002 - Tolerability of Osimertinib and Its Impact on Quality of Life in Advanced Non-Small Cell Lung Cancer Patients: The ARPA Study (ID 8081)
09:30 - 16:00 | Presenting Author(s): Enrica Capelletto
- Abstract
Background:
Osimertinib is a potent Epidermal Growth Factor Receptor (EGFR) inhibitor, conferring a longer survival if compared to platinum-pemetrexed chemotherapy in Non-Small Cell Lung Cancer (NSCLC) EGFR mutated patients who have progressed after first-line Tyrosine Kinase Inhibitor (TKI), with the aquired resistance mutation T790M. The ARPA study is a phase II, single institution observational study aiming to evaluate the tolerability of Osimertinib in a real world population of EGFR-T790M+ NSCLC patients, with special attention to patients' perception of symptomatic Adverse Events (AEs), their impact on health-related quality of life (HRQoL) and psychological issues.
Method:
Before entry into the study, patients have been requested to perform a new tissue or liquid biopsy to confirm the T790M+ status of their tumours. Multiple previous oncologic treatments and asymptomatic brain metastases at baseline were allowed. Patients' perception of symptomatic AEs and the matched medical evaluation were performed every 21 days under continuous treatment with dedicated questionnaires which mainly evaluated the HRQoL, until discontinuation. The psychological assessments include changes in domains related to physical, mental, emotional and social functioning, depression, sleep quality and distress. In case of documented clinical benefit, the study allows to patients to remain on treatment beyond progression.
Result:
From February 2016, a total of 34 patients have been evaluated: 2 of them were registered as screening failures for symptomatic brain metastases and lack of compliance, respectively. The 32 patients enrolled have a median age of 67,6 years (range 40-84 years), are predominantly female (65,6%), with ECOG performance status 0 (68,7%) and a non-smoking history (75,0%). Activating EGFR mutation at diagnosis have been described on exon 19 and 21 in 62,5% and 28,1% of cases, respectively. Only four patients had brain metastases at study entry. Osimertinib has been used as second-line treatment, after failure of first-line TKI, in 78,1% of cases. On the date of 1 June 2017, ten patients have interrupted the treatment for disease progression, with a median duration of therapy equal to 6,69 months (range 2,80-11,20 months).
Conclusion:
Data concerning the tolerability of treatment with Osimertinib in EGFR-T790M+ NSCLC patients, their perception of symptomatic AEs together with the psychological issues evaluated in the ARPA study, are not mature. Great expectations come from this study which reflects a real world population, and the hope of the investigators is to highlight the critical aspects for patients in order to better manage their treatment and the psychological issues.
