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PATIENT-REPORTED OUTCOMES

NEW APPROVAL

Global Health Status/Quality of Life and Functioning Scales in ES-SCLC

Patient-reported outcomes in prespecified analyses with IMFINZI + EP1

  • In the CASPIAN study, PROs were assessed at randomization, every 3 weeks during induction, every 4 weeks until disease progression, and every 8 weeks until secondary progression2
  • Time to deterioration of HRQoL/functioning was the time from randomization until the first clinically meaningful confirmed deterioration2
  • Results should be interpreted based on the open-label study design and were not tested for statistical significance1
  • Compliance for PROs was ≥60% up to 84 weeks for the IMFINZI + EP arm and 20 weeks for the EP arm2

Health-related quality of life and functioning were assessed using EORTC QLQ-C302

Time to deterioration in HRQoL and functioning scales2

 

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Time to deterioration in HRQoL and functioning scales
Time to deterioration in HRQoL and functioning scales
  • In the CASPIAN study, global health status/QoL and functioning scores at baseline were comparable between arms2
  • EORTC QLQ-C30 is an integrated questionnaire for assessing HRQoL of cancer patients participating in clinical trials using a scale of 0 to 100 with high scores representing high or healthy levels of functioning/high QoL3
  • Clinically meaningful deterioration in HRQoL/functioning was predefined as a decrease from baseline of ≥10 points2,4,5
  • The QLQ-C30 includes a global health status/QoL scale, 5 functional scales, 3 symptom scales, and 6 single items3

ES-SCLC=extensive-stage small cell lung cancer; PROs=patient-reported outcomes; HRQoL=health-related quality of life; QoL=quality of life; EORTC QLQ=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; HR=hazard ratio; CI=confidence interval; EP=etoposide and either carboplatin or cisplatin.

 

Symptom Scales in ES-SCLC

Patient reported outcomes in prespecified analyses with IMFINZI + EP1

  • In the CASPIAN study, PROs were assessed at randomization, every 3 weeks during induction, every 4 weeks until disease progression, and every 8 weeks until secondary progression2
  • Time to deterioration of symptoms was the time from randomization until the first clinically meaningful confirmed deterioration2
  • Results should be interpreted based on the open-label study design and were not tested for statistical significance1
  • Compliance for PROs was ≥60% up to 84 weeks for the IMFINZI + EP arm and 20 weeks for the EP arm2

Symptoms were assessed using EORTC QLQ-C30 and QLQ-LC132

Time to deterioration in symptom scales2

 

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Time to deterioration symptom scales
Time to deterioration symptom scales
  • In the CASPIAN study, symptom scores at baseline were comparable between arms2
  • EORTC QLQ-LC13 is a validated supplementary questionnaire designed to evaluate symptoms and side effects specifically in lung cancer patients when used in conjunction with the QLQ-C303
  • The QLQ-LC13 and QLQ-C30 use the same 0 to 100 scale, but high scores represent a high level of symptom severity3
  • Clinically meaningful deterioration in symptoms was predefined as an increase from baseline of ≥10 points2,4,5
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