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This website is intended for UK Healthcare professionals only. Other UK residents please visit astrazeneca.co.uk
HRQoL data complements clinical outcomes by providing a more holistic picture of what your patients are likely to experience in their daily lives. This information can provide important clinical information that can support clinicians in making treatment decisions. HRQoL can include the impact on their physical and mental wellbeing, daily activities, and relationships. When patients are informed on both the clinical benefits and the day-to-day realities of treatment, it helps patients make informed choices and they are more likely to adhere to treatment plans.1,2
HRQoL is centered on two essential principles: subjectivity and multidimensionality; it is the patient’s perception of the impact of their disease and its treatment(s) on their daily life, looking at physical, functional, emotional and social functioning and well-being.1,3
Regulatory agencies have recommended inclusion of patient-reported outcomes (PROs) in clinical trials since 20051; and in 2024 the regulatory body in the US included HRQoL in the core set of PROs for oncology clinical trials.4 The patient’s perspective is now recognised as essential for regulatory decisions, including evaluating treatment effects, benefit–risk assessments, and supporting information in Section 5.1 of the SmPC.5,6
If you want to read more on the use of PROs in anticancer medicinal products in Europe, click HERE.1
There are a number of different QOL measures available which focus on different aspects; not all quality of life (QoL) measures are equal and each tool varies in its focus and sensitivity, capturing different aspects of patient experience depending on their design and intended use.
The pivotal Phase Ill, global FLAURA and FLAURA2 trials demonstrated the efficacy and safety profile of TAGRISSO in patients with metastatic or locally advanced EGFRm NSCLC, while capturing the lived experiences of patients using validated, cancer-specific PROMs.7,8 FLAURA and FLAURA2 collected health-related quality of life (HRQoL) data using validated, widely established measures at multiple time points throughout the treatment period.7,8
Between the two trials, the scales used are EORTC QLQ-LC13, EORTC QLQ-C30, and PRO-CTCAE:9-11
Want a recap on the FLAURA trial data? Click HERE
PRO methods: patients (N=556) completed the EORTC QLQ-LC13 weekly for 6 weeks, then every 3 weeks, and the QLQ-C30 every 6 weeks for up to 114 weeks or until treatment discontinuation. Questionnaire completion rates were on average >70%.
Some patients experienced improvements from baseline in key symptoms in both treatment arms; however, overall mean changes from baseline did not meet the threshold for clinical relevance and were not significantly different between groups.
Adapted from Leighl NB, et al. 2020.7
The symptom improvement rate was based on a decrease in score from baseline ≥10 at two consecutive assessments ≥21 days apart.
No significant difference in odds of improvement of prespecified key symptoms detected.
Improvements in cough were seen as early as week 1 in both treatment arms and were maintained throughout the study period.7
Adapted from Leighl NB, et al. 2020.7
Statistically significant improvement in emotional and social functioning with TAGRISSO vs gefitinib/erlotinib (8.79 vs. 4.91; P=0.004), (7.66 vs. 1.74; P<0.001), respectively.7
Stable cognitive functioning with TAGRISSO but deterioration with gefitinib / erlotinib (0.03 vs. 3.91; P=0.005).7
While the mean changes did not reach the 10-point improvement threshold for clinical relevance, patients reported HRQoL improvements, with emotional and social functioning favouring TAGRISSO treatment.7
Want a recap on the FLAURA trial data? Click HERE
Adapted from Lee CK, et al. 2024.8
LSM (least squared means, shown on the y-axis) change in GHS/QoL scores from baseline over all visits was 3.32 (95% CI 1.67, 4.98) with TAGRISSO with chemotherapy and 7.38 (95% CI 5.70, 9.07) with TAGRISSO monotherapy.8
There was a non-clinically meaningful worsening in appetite loss with TAGRISSO and chemotherapy.8
Overall compliance rates for completion of QLQ-C30 and QLQ-LC13 were high in both treatment arms at BL (>91%) and remained high (>80%) to week 82; overall compliance rates for PRO-CTCAE visits were relatively high in both treatment arms at BL (>85%) and remained relatively high (≥75%) to week 82.
Reassure patients that addition of chemotherapy to TAGRISSO may not diminish HRQoL.
Adapted from Lee CK, et al. 2024.8
LSM change in cough from baseline was -13.23 (95% CI -14.85, -11.62) with TAGRISSO with chemotherapy and -11.19 (95% CI -12.83, -9.55) with TAGRISSO monotherapy.8
Overall compliance rates for completion of QLQ-C30 and QLQ-LC13 were high in both treatment arms at BL (>91%) and remained high (>80%) to week 82; overall compliance rates for PRO-CTCAE visits were relatively high in both treatment arms at BL (>85%) and remained relatively high (≥75%) to week 82.
Reassure patients that addition of chemotherapy to TAGRISSO may not diminish HRQoL.
Adapted from Lee CK, et al. 2024.8
The relative proportions of severe/very severe grades of nausea, vomiting and dry skin reduced from the end of induction, through the maintenance period, for the TAGRISSO and chemotherapy arm.
The PRO-CTCAE exploratory endpoint here looked at nine symptoms relevant to this trial; these were mouth / throat sores, nausea, vomiting, diarrhoea, abdominal pain, loss of bowel movement control, dry skin, hair loss, and numbness / tingling in the hands / feet.
Overall compliance rates for completion of QLQ-C30 and QLQ-LC13 were high in both treatment arms at BL (>91%) and remained high (>80%) to week 82; overall compliance rates for PRO-CTCAE visits were relatively high in both treatment arms at BL (>85%) and remained relatively high (≥75%) to week 82.
Together with significant efficacy benefit, patient-reported outcomes support TAGRISSO with chemotherapy as a beneficial first-line treatment option in eligible patients.
Want a recap on the ADAURA trial data? Click HERE
PCS, physical component summary; SF-36, 36-Item Short Form Health Survey; SD, standard deviation.
Adapted from Majem M, et al. 2022.12
Maintained HRQoL with no clinically meaningful differences* vs placebo in physical health:12
-1.18 (-2.02 to -0.34) PCS TAGRISSO vs. placebo ±2
-0.86 (95% CI -1.76 to 0.04) Physical functioning ±3
-1.80 (95% CI -2.90 to -0.71) Role-physical ±3
-0.57 (95% CI -1.64 to 0.50) Bodily pain ±3
-1.50 (95% CI -2.53 to -0.47) General health ±2
-1.93 (95% CI -3.02 to -0.84) Vitality ±2
TTD of PCS and MCS was similar whether patients received TAGRISSO or placebo; HR 1.17 (95% CI, 0.82, 1.67) and HR 0.98 (95% CI, 0.70, 1.39), respectively.
*Clinically meaningful difference based on definitions from the 3rd edition of the SF-36 scoring manual. Differences in HRQoL improvements as assessed by SF-36 were not clinically meaningful.
Compliance rates for completion of SF-36 ranged from 85% to 99% for the overall population from baseline through to week 156; during this time SF-36 compliance rates were similar in both the osimertinib (87-99%) and placebo (85-99%) arms.
Help maintain your patients’ HRQoL with TAGRISSO after surgery.
MCS, mental component summary; SF-36, 36-Item Short Form Health Survey; SD, standard deviation.
Adapted from Majem M, et al. 2022.12
Maintained HRQoL with no clinically meaningful differences* vs placebo in physical health:12
-1.34 (-2.40 to -0.28) MCS TAGRISSO vs. placebo ±3
-1.46 (95% CI -2.65 to -0.28) Role-emotional ±4
-1.11 (95% CI -2.13 to -0.08) Social functioning ±3
-0.88 (95% CI -1.92 to 0.17) Mental health ±3
TTD of PCS and MCS was similar whether patients received TAGRISSO or placebo; HR 1.17 (95% CI, 0.82, 1.67) and HR 0.98 (95% CI, 0.70, 1.39), respectively.
*Clinically meaningful difference based on definitions from the 3rd edition of the SF-36 scoring manual. Differences in HRQoL improvements as assessed by SF-36 were not clinically meaningful.
Compliance rates for completion of SF-36 ranged from 85% to 99% for the overall population from baseline through to week 156; during this time SF-36 compliance rates were similar in both the osimertinib (87-99%) and placebo (85-99%) arms.
Help maintain your patients’ HRQoL with TAGRISSO after surgery.
Want a recap on the LAURA trial data? Click HERE
Health-related quality of life (HRQoL) was maintained during the study treatment for patients with unresectable (UR) stage III EGFRm NSCLC after definitive CRT as part of the LAURA trial:13,14
Together with a significant progression-free survival (PFS) benefit and safety results from the LAURA trial consistent with the known profiles of both TAGRISSO and chemoradiation,14 these PRO data support the use of osimertinib to treat patients with UR stage III EGFRm NSCLC following definitive CRT.
BL, baseline; CI, confidence interval; CRT, chemoradiotherapy; E/G, erlotinib/gefitinib; EORTC, European Organisation for Research and Treatment of Cancer; EORTC QLQ, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; EMA, European Medicines Agency; FDA, United States Food and Drug Administration; GHS, General Health Score; HR, hazard ratio; HRQoL, health-related quality of life; LSM, least squared means; MCS, mental component summary; NSCLC, non-small cell lung cancer; OS, overall survival; Osi, osimertinib; Osi + ctx, osimertinib and platinum based pemetrexed chemotherapy; PCS, physical component summary; PFS, progression-free survival; PROs, patient reported outcomes; PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; QLQ, quality of life questionnaire; SD, standard deviation; SmPC, Summary of Product Characteristics; UR, unresectable.
GB-63995 | DOP: August 2025
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This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.
