Abstract 201P
Background
In the LAURA study (NCT03521154), treatment with osi after definitive CRT significantly improved PFS vs placebo (pbo): HR 0.16; 95% CI 0.10, 0.24; p < 0.001. Based on these results, osi is now approved for UR stage III EGFRm NSCLC after definitive CRT. The impact of osi treatment after CRT on patients’ health-related quality of life (HRQoL) is an important clinical consideration. We report PROs from LAURA.
Methods
HRQoL, functioning and symptoms were measured using EORTC QLQ-C30/LC13 questionnaires from baseline (BL) to 32 wks post-disease progression. Score changes from BL (analysed by mixed model for repeated measures) and time to symptom deterioration were analysed. A clinically meaningful within-patient change was defined as ≥10-point change from BL. Tolerability was assessed using the PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE v1).
Results
EORTC questionnaire completion was >90% at BL, remaining >70% to Wk 24 post-BL. BL EORTC scale scores were comparable between treatment arms. No meaningful differences were observed between treatment arms for risk of confirmed deterioration in key scales (HR [95% CI]: global health status/QoL 1.14 [0.74, 1.78]; physical function 1.06 [0.65, 1.71]; fatigue 1.23 [0.85, 1.80]; appetite loss 1.00 [0.63, 1.58]; dyspnoea 1.30 [0.91, 1.86]; coughing 1.17 [0.81, 1.71]; pain in chest 1.46 [0.95, 2.23]). Over 40 wks, minimal changes from BL were observed for these key functions and symptoms in both treatment arms, with maintenance of, or non-clinically meaningful worsening from, the BL score. No clinically meaningful differences were seen between arms. PRO-CTCAE proportions were similar across treatment arms, indicating similar tolerability of osi and pbo in terms of symptom frequency and severity, except for dry skin, for which most osi-treated patients reported mild severity (vs “none” reported by most pbo-treated patients).
Conclusions
QoL was maintained during osi treatment of patients with UR stage III EGFRm NSCLC after definitive CRT. Together with significant PFS survival benefit, the PRO data further support osi treatment in this setting. Clinical trial identification: NCT03521154.
Editorial acknowledgement
The authors would like to acknowledge Neil R. Smith, PhD, of Ashfield MedComms, an Inizio company, for medical writing support that was funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
E. Arriola Aperribay: Financial Interests, Personal, Advisory Board: Roche, Pfizer, Lilly, AstraZeneca, Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: AstraZeneca, Roche, MSD, BMS, Takeda, Amgen, Pfizer, Janssen; Financial Interests, Personal, Full or part-time Employment: Department of Medical Oncology, Hospital del Mar-CIBERONC; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, Roche, Merck Sharp & Dohme, Pfizer, Lilly, AstraZeneca, Boehringer Ingelheim, Takeda, Janssen; Non-Financial Interests, Personal, Member: ESMO, IASLC; Financial Interests, Personal and Institutional, Other, Financial co-founder: Training Health S.L.; Financial Interests, Personal, Principal Investigator: Roche, Merck Sharp & Dohme, Pfizer, Lilly, AstraZeneca, Boehringer Ingelheim, Janssen, Amgen; Financial Interests, Institutional, Research Grant: Roche, Pfizer, AstraZeneca, Bristol Myers Squibb; Financial Interests, Personal,Writing Engagements: Pfizer.M. Ozguroglu: Financial Interests, Personal, Advisory Board: MSD Oncology, Regeneron, Sanofi, Astellas; Financial Interests, Personal, Advisory Role: MSD Oncology, AstraZeneca; Non-Financial Interests, Personal, Invited Speaker: Regeneron; Financial Interests, Personal, Principal Investigator, Local PI: MSD, AstraZeneca, Regeneron, BMS, Pfizer, BeiGene, Daiichi Sankyo, Roche; Non-Financial Interests, Personal, Member: ESMO, ASCO; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Other, Steering Committee Member: AstraZeneca; Financial Interests, Personal, Other, Travel, accommodations, expenses: AstraZeneca; Financial Interests, Personal, Other, Honoraria: Astellas Pharma, Novartis, Janssen Oncology. T. Takahashi: Financial Interests, Personal and Institutional, Research Grant: AstraZeneca KK, Eli Lilly Japan K.K, Chugai Pharmaceutical Co., Ltd., MSD K. K., Pfizer Japan Inc., Amgen Inc., Merck Biopharma Co., Ltd., Janssen Pharmaceutical K.K., AnHeart Therapeutics Inc.; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca KK, Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Ono Pharmaceutical Co., Ltd., MSD K.K., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., BMS Japan, Amgen K.K., Novartis. K. Goto: Financial Interests, Institutional, Funding, Commissioned research/joint research expenses: AstraZeneca; Financial Interests, Personal, Other, Lecture fee: AstraZeneca; Financial Interests, Personal, Other, Steering Committee Member: AstraZeneca. K. Maneenil: Financial Interests, Personal, Advisory Role: AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pfizer, Roche, ZP Therapeutics, Johnson & Johnson; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, ZP Therapeutics, Johnson & Johnson. K.H. Lee: Financial Interests, Personal, Advisory Role: Pfizer, AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, J&J, Eli Lilly, Boehringer, Daiichi Sankyo, Amgen, Takeda, Yuhan; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb, Merck Sharp & Dohme, AstraZeneca, Pfizer, Eli Lilly, Yuhan Corporation. M.A. Cobo Dols: Financial Interests, Personal, Advisory Role: Novartis, AstraZeneca, Boehringer Ingelheim, Roche, BMS, Lilly, MSD, Takeda, Pfizer, Kyowa, Sanofi, Janssen; Financial Interests, Personal, Speaker’s Bureau: Novartis, AstraZeneca, Boehringer Ingelheim, Roche, BMS, Lilly, MSD, Takeda, Kyowa, Pierre-Fabre, Novocure, Sanofi, Janssen. N.I. Valdiviezo Lama: Financial Interests, Personal, Other, Travel support to ELCC 2023: AstraZeneca. A.L. Evans: Financial Interests, Personal and Institutional, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. A.L. Bolanos: Financial Interests, Personal and Institutional, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. X. Huang: Financial Interests, Personal and Institutional, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. R. Lai: Financial Interests, Personal and Institutional, Full or part-time Employment: AstraZeneca (Evinova); Financial Interests, Personal, Stocks/Shares: AstraZeneca. S.S. Ramalingam: Financial Interests, Institutional, Funding, Research Funding: Amgen, AstraZeneca, GSK, Pfizer, BMS; Financial Interests, Personal, Other, Travel, accommodations, expenses: AbbVie. All other authors have declared no conflicts of interest.