NCT01154140 · OUTCOME
Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)
A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
What was measured
QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.
Analysis population: The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.
Groups in this outcome
Crizotinib
Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
Chemotherapy
Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
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 |
|---|
| Crizotinib | 166 |
|---|
| Chemotherapy | 163 |
|---|
Reported measurements
QLQ-LC13 Alopecia
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -4.4879 | Not reported | -6.99 | -1.99 | Not reported |
|---|
| Chemotherapy | 0.3271 | Not reported | -2.40 | 3.06 | Not reported |
|---|
QLQ-LC13 Coughing
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -16.4819 | Not reported | -18.92 | -14.05 | Not reported |
|---|
| Chemotherapy | -8.0893 | Not reported | -10.83 | -5.35 | Not reported |
|---|
QLQ-LC13 Dysphagia
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | 0.7618 | Not reported | -0.82 | 2.35 | Not reported |
|---|
| Chemotherapy | 0.09660 | Not reported | -1.76 | 1.95 | Not reported |
|---|
QLQ-LC13 Dyspnoea
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -9.2029 | Not reported | -11.20 | -7.20 | Not reported |
|---|
| Chemotherapy | -0.1948 | Not reported | -2.36 | 1.97 | Not reported |
|---|
QLQ-LC13 Haemoptysis
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -3.2197 | Not reported | -3.83 | -2.61 | Not reported |
|---|
| Chemotherapy | -2.3369 | Not reported | -3.05 | -1.62 | Not reported |
|---|
QLQ-LC13 Pain in Arm or Shoulder
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -10.1693 | Not reported | -12.26 | -8.08 | Not reported |
|---|
| Chemotherapy | -4.1218 | Not reported | -6.51 | -1.74 | Not reported |
|---|
QLQ-LC13 Pain in Chest
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -8.1437 | Not reported | -10.31 | -5.98 | Not reported |
|---|
| Chemotherapy | -0.04790 | Not reported | -2.48 | 2.38 | Not reported |
|---|
QLQ-LC13 Pain in Other Parts
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -8.0757 | Not reported | -10.28 | -5.87 | Not reported |
|---|
| Chemotherapy | -1.3040 | Not reported | -3.97 | 1.36 | Not reported |
|---|
QLQ-LC13 Peripheral Neuropathy
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | 3.1779 | Not reported | 1.04 | 5.31 | Not reported |
|---|
| Chemotherapy | -0.1742 | Not reported | -2.60 | 2.25 | Not reported |
|---|
QLQ-LC13 Sore Mouth
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | 2.2472 | Not reported | 0.36 | 4.13 | Not reported |
|---|
| Chemotherapy | 4.3993 | Not reported | 2.27 | 6.53 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -8.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.11
- group Description
- QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0108
- param Type
- Mean Difference (Net)
- param Value
- -4.8149
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -12.06
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -4.72
- group Description
- QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -8.3926
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -1.78
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.11
- group Description
- QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5938
- param Type
- Mean Difference (Net)
- param Value
- 0.6651
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -11.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -6.06
- group Description
- QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -9.0080
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -1.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.06
- group Description
- QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0656
- param Type
- Mean Difference (Net)
- param Value
- -0.8828
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -9.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -2.88
- group Description
- QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0002
- param Type
- Mean Difference (Net)
- param Value
- -6.0475
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -11.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -4.84
- group Description
- QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -8.0959
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -10.24
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -3.31
- group Description
- QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0001
- param Type
- Mean Difference (Net)
- param Value
- -6.7717
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.59
- group Description
- QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0427
- param Type
- Mean Difference (Net)
- param Value
- 3.3521
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -5.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.69
- group Description
- QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1382
- param Type
- Mean Difference (Net)
- param Value
- -2.1521
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -8.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.11
- group Description
- QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0108
- param Type
- Mean Difference (Net)
- param Value
- -4.8149
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -12.06
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -4.72
- group Description
- QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -8.3926
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -1.78
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.11
- group Description
- QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5938
- param Type
- Mean Difference (Net)
- param Value
- 0.6651
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -11.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -6.06
- group Description
- QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -9.0080
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -1.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.06
- group Description
- QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0656
- param Type
- Mean Difference (Net)
- param Value
- -0.8828
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -9.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -2.88
- group Description
- QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0002
- param Type
- Mean Difference (Net)
- param Value
- -6.0475
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -11.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -4.84
- group Description
- QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -8.0959
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -10.24
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -3.31
- group Description
- QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0001
- param Type
- Mean Difference (Net)
- param Value
- -6.7717
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.59
- group Description
- QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0427
- param Type
- Mean Difference (Net)
- param Value
- 3.3521
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -5.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.69
- group Description
- QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1382
- param Type
- Mean Difference (Net)
- param Value
- -2.1521
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -6.99
- upper Limit
- -1.99
- value
- -4.4879
- group Id
- OG001
- lower Limit
- -2.40
- upper Limit
- 3.06
- value
- 0.3271
- title
- QLQ-LC13 Alopecia
- categories
- measurements
- group Id
- OG000
- lower Limit
- -18.92
- upper Limit
- -14.05
- value
- -16.4819
- group Id
- OG001
- lower Limit
- -10.83
- upper Limit
- -5.35
- value
- -8.0893
- title
- QLQ-LC13 Coughing
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.82
- upper Limit
- 2.35
- value
- 0.7618
- group Id
- OG001
- lower Limit
- -1.76
- upper Limit
- 1.95
- value
- 0.09660
- title
- QLQ-LC13 Dysphagia
- categories
- measurements
- group Id
- OG000
- lower Limit
- -11.20
- upper Limit
- -7.20
- value
- -9.2029
- group Id
- OG001
- lower Limit
- -2.36
- upper Limit
- 1.97
- value
- -0.1948
- title
- QLQ-LC13 Dyspnoea
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.83
- upper Limit
- -2.61
- value
- -3.2197
- group Id
- OG001
- lower Limit
- -3.05
- upper Limit
- -1.62
- value
- -2.3369
- title
- QLQ-LC13 Haemoptysis
- categories
- measurements
- group Id
- OG000
- lower Limit
- -12.26
- upper Limit
- -8.08
- value
- -10.1693
- group Id
- OG001
- lower Limit
- -6.51
- upper Limit
- -1.74
- value
- -4.1218
- title
- QLQ-LC13 Pain in Arm or Shoulder
- categories
- measurements
- group Id
- OG000
- lower Limit
- -10.31
- upper Limit
- -5.98
- value
- -8.1437
- group Id
- OG001
- lower Limit
- -2.48
- upper Limit
- 2.38
- value
- -0.04790
- title
- QLQ-LC13 Pain in Chest
- categories
- measurements
- group Id
- OG000
- lower Limit
- -10.28
- upper Limit
- -5.87
- value
- -8.0757
- group Id
- OG001
- lower Limit
- -3.97
- upper Limit
- 1.36
- value
- -1.3040
- title
- QLQ-LC13 Pain in Other Parts
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.04
- upper Limit
- 5.31
- value
- 3.1779
- group Id
- OG001
- lower Limit
- -2.60
- upper Limit
- 2.25
- value
- -0.1742
- title
- QLQ-LC13 Peripheral Neuropathy
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.36
- upper Limit
- 4.13
- value
- 2.2472
- group Id
- OG001
- lower Limit
- 2.27
- upper Limit
- 6.53
- value
- 4.3993
- title
- QLQ-LC13 Sore Mouth
- denoms
- counts
- group Id
- OG000
- value
- 166
- group Id
- OG001
- value
- 163
- units
- Participants
- description
- QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
- id
- OG000
- title
- Crizotinib
- description
- Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEAN
- population Description
- The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.
- reporting Status
- POSTED
- time Frame
- Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
- title
- Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)
- type
- SECONDARY
- unit Of Measure
- units on a scale
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