NCT02125461 · OUTCOME
Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer · Source last updated 2023-10-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
What was measured
The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.
Analysis population: FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≤ 90 were included in the analysis.
Groups in this outcome
Durvalumab (MEDI4736)
Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
Placebo
Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Durvalumab (MEDI4736) | 476 |
|---|
| Placebo | 237 |
|---|
Reported measurements
Dyspnea
Analysis denominator · Participants
| Group | Source count |
|---|
| Durvalumab (MEDI4736) | 467 |
|---|
| Placebo | 230 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 2.8 | Not reported | 1.9 | 3.7 | Not reported |
|---|
| Placebo | 3.7 | Not reported | 2.3 | 4.1 | Not reported |
|---|
Cough
Analysis denominator · Participants
| Group | Source count |
|---|
| Durvalumab (MEDI4736) | 442 |
|---|
| Placebo | 216 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 5.6 | Not reported | 4.5 | 7.3 | Not reported |
|---|
| Placebo | 5.6 | Not reported | 3.7 | 6.0 | Not reported |
|---|
Hemoptysis
Analysis denominator · Participants
| Group | Source count |
|---|
| Durvalumab (MEDI4736) | 472 |
|---|
| Placebo | 232 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | NA | Not reported | NA | NA | The median and 95% CIs could not be calculated as they were not reached. |
|---|
| Placebo | 29.6 | Not reported | 21.2 | NA | Upper limit of 95% CI could not be calculated as it was not reached. |
|---|
Chest pain
Analysis denominator · Participants
| Group | Source count |
|---|
| Durvalumab (MEDI4736) | 463 |
|---|
| Placebo | 229 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Durvalumab (MEDI4736) | 11.1 | Not reported | 7.4 | 18.6 | Not reported |
|---|
| Placebo | 8.3 | Not reported | 5.6 | 13.8 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 0.88
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.29
- group Description
- Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.522
- p Value Comment
- Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.06
- statistical Method
- Log Rank
- ci Lower Limit
- 0.74
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.12
- group Description
- Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.380
- p Value Comment
- Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.91
- statistical Method
- Log Rank
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.00
- group Description
- Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.048
- p Value Comment
- Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.75
- statistical Method
- Log Rank
- ci Lower Limit
- 0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.19
- group Description
- Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.626
- p Value Comment
- Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.94
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.88
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.29
- group Description
- Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.522
- p Value Comment
- Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.06
- statistical Method
- Log Rank
- ci Lower Limit
- 0.74
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.12
- group Description
- Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.380
- p Value Comment
- Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.91
- statistical Method
- Log Rank
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.00
- group Description
- Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.048
- p Value Comment
- Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.75
- statistical Method
- Log Rank
- ci Lower Limit
- 0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.19
- group Description
- Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.626
- p Value Comment
- Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.94
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 3.7
- value
- 2.8
- group Id
- OG001
- lower Limit
- 2.3
- upper Limit
- 4.1
- value
- 3.7
- denoms
- counts
- group Id
- OG000
- value
- 467
- group Id
- OG001
- value
- 230
- units
- Participants
- title
- Dyspnea
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 7.3
- value
- 5.6
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 6.0
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 442
- group Id
- OG001
- value
- 216
- units
- Participants
- title
- Cough
- categories
- measurements
- comment
- The median and 95% CIs could not be calculated as they were not reached.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of 95% CI could not be calculated as it was not reached.
- group Id
- OG001
- lower Limit
- 21.2
- upper Limit
- NA
- value
- 29.6
- denoms
- counts
- group Id
- OG000
- value
- 472
- group Id
- OG001
- value
- 232
- units
- Participants
- title
- Hemoptysis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.4
- upper Limit
- 18.6
- value
- 11.1
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 13.8
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 463
- group Id
- OG001
- value
- 229
- units
- Participants
- title
- Chest pain
- denoms
- counts
- group Id
- OG000
- value
- 476
- group Id
- OG001
- value
- 237
- units
- Participants
- description
- The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
- id
- OG000
- title
- Durvalumab (MEDI4736)
- description
- Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≤ 90 were included in the analysis.
- reporting Status
- POSTED
- time Frame
- At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
- title
- Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)
- type
- SECONDARY
- unit Of Measure
- Months
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