The Importance of PRO/HRQoL Measures in
Patient Management and Their Inclusion in
Oncology Clinical Studies
Barbara Melosky, MD, FRCPC
Objectives
• Discuss increasing importance of PRO/QoL measures in influencing the
treatment of patients with cancer
• Discuss the need to include PRO/QoL endpoints in clinical trials
• Highlight QoL outcomes in Lung Cancer Trials
Endpoints and Treatment
Relationships and Role of Patient Reported Outcomes (PROs)
Malignancy
Survival
Quality of Life
Tumour
Response &
Side Effects
Treatment
Quality of Life and PRO Evaluation
Increasing Importance
• Highly Symptomatic Disease
– Survival and response data reveal only part of the results that are important to
patients, families, and health care professionals
• Treatments and Agents Vary in their Side-Effects and Risk Profiles
– Balancing patient-experienced benefit and risk is needed
• Meaningful Survival Differences are Uncommon
Symptom Control Is Important to Patients
68% of patients said they would
choose chemotherapy only if it
improved symptoms
Silvestri G et al. BMJ. 1998;317:771-775.
Quality of Life and PROs: Questions
1. Can we DEFINE quality of life?
2. Can we MEASURE quality of life?
3. Can we agree on how to ANALYSE quality of life results?
4. Can we PRESENT quality of life findings in a clear and useful way?
What Is QoL?
What Is QoL?
“Optimal levels of physical, role and social function, including relationships and
the perception of health, fitness, life satisfaction and well-being.”
– Bowling, 1995
What Is QoL?
• WHO: “Health is not only the absence of infirmity and disease, but also a state
of physical, mental and social well-being.”
• Multiple domains:
– Physical, cognitive, emotional and social functioning, pain, sexual functioning,
health perceptions, and symptoms about nausea and fatigue
What Is QoL?
• “The goodness of life”
• Multi-dimensional
• Includes hope/hopefulness
• As related to health (not housing, income, environment, etc)
• Patient’s perspective
• Fundamental Principle: QoL IS ASSESSED BY THE PATIENT
Why Are We Interested in PRO/QoL in
Clinical Trials?
Why Are We Interested in QoL/PROs?
• PROs following treatment are considered to be important supportive measures
for patients
• PROs should be viewed as components of the total value of a treatment and,
together with other cancer endpoints, provide a comprehensive picture of
the benefits and risks of anticancer therapies
• This has been adopted by the FDA and EMEA
Why Are We Interested in Quality of Life (QOL)?
• The FDA has stated that efficacy with respect to overall survival and/or
improvements in QOL might provide the basis for drug approval
O’Shaughnessy et al. J Clin Oncol. 1991;9:2225-2232.
PROs:
Rationale and Need in Testing Anticancer Agents
• Health care professionals are not accurate in evaluating
subjective or palliative benefits associated with anti-cancer
treatments, when compared with patient self-reports
• PROs are often reported by patients as improved with less
than major responses to treatment—even with only stable
disease…response rates underestimate patient-reported
benefit
• The balance between symptom improvement and toxicity,
or the effects of delayed progression summarised in many
PRO measures, cannot be consistently predicted by other
biomedical endpoints
Why is QOL and Increasingly Frequent Outcome in Clinical Trials?
• Disease-centered outcomes (response rates, cause-specific survival) are not
the only clinically relevant outcomes
• Toxicity has traditionally been assessed from the view-point of medical staff
• Patient-centered outcomes have become an important measure of the patient
experience of their illness and treatment
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How Do You Measure QoL?
Measuring QoL
How are you feeling today?
Happy
Miserable
Measuring QoL
• Hardest part!
• Determine QoL objective
• Choose instrument to measure QoL
– Reliable, valid, responsive, feasible
– Global measures, disease-specific measures, symptom checklists
• Select assessment time points
• Develop analysis plan
Measurement
• Look for measures that are proven to be
– VALID
– RELIABLE
• Validity: does measure actually measure the construct it is intended to
measure?
• Reliability: how much closer does our measure get to the “true” score? (ranges
from 0 to 1)
Validity
• Does the questionnaire really measure QOL?
• Face and content validity
– Do the questions make sense?
– Are they relevant?
– Is the administration and scoring sensible?
– Criterion validity
• Compare to a “Gold Standard”
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Reliability
• Does the questionnaire produce reproducible results?
– Internal consistency (similar items score similarly, eg. Chrobach’s alpha)
– Test-retest reliability (5-7 days) – ideally concordance (ICC) rather than correlation
– Longer questioners are more reliable
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Latent Variables
• QoL is, by definition, a “latent variable”: it cannot be directly measured
• We measure it using “symptoms” of QoL
• Statistical methods help us make inferences about state of QoL via the
symptoms
– Develop models/scales for measuring QoL
– We can maximise reliability and evaluate validity
• Issues to consider:
– What if our “symptoms” are not tapping into QoL like we think?
– What if patients’ perceptions of the questions we ask are different?
– How can we find out about these things????
Latent Variable Depiction
Have you
felt nauseated?
Have you had
problems sleeping?
Quality
of
Life
Have you had pain?
Have you lacked
appetite?
Have you felt
depressed?
Issues to Consider
• The 5W’s: Who, What, When, Where, Why, How
– Who are the patients (cancer type, age, etc)
– What are their concerns or issues
– When & Where will QOL be measured
– Why measure QOL
– How? Self-completed, computerized, interview
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Who and What?
• Consider cancer type, gender, age, level of education, stage, treatment, and
point disease course
• Review literature or interview patients about their issues and concerns
• Are there existing, validated instruments?
• Consider emotional, social, cognitive, role fulfillment and spiritual issues as
well as physical condition
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When and Where?
• Cross-sectional vs. longitudinal design
• Do you want to describe a state, or measure change?
• Beware of pitfalls of missing or untimely data
• Respondents may be more comfortable in their own homes, but the clinic may
be more practical
• Timing with respect to doctor’s visits
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How? Administration
• Self-completion is the gold standard
• Interviews must be standardized
• Use of computers is promising
• Use of proxy information is difficult
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How Important is it to Complete QOL Questionnaires?
• Extremely important!!!
• The biggest problem with analizing QOL information from clinical trials is
missing data
– Are pts whose QOL data are missing different from pts supplying QOL data? Or is
QOL data missing because pts are sicker than those providing info?
• Analysis can try to account for missing data but it is best trying to prevent
missing data
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Example of QOL “Result”
• EORT QLQ-C30 +3 Instrument
• Domain: Global quality of life
• Patient questionnaires items:
How would you rate your overall health during the past week?
1
2
3
4
5
6
7
8
Very Poor
9
10
Excellent
How would you rate your overall quality of life during the past week?
1
Very Poor
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2
3
4
5
6
7
8
9
Excellent
10
Example of QOL “Result”
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Courtesy of Barbara Melosky, MD
Same Data Presented Differently
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Courtesy of Barbara Melosky, MD
Percent of Patients
Same Data Presented Differently
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Courtesy of Barbara Melosky, MD
Choosing Your Instrument
• “Tailor Made” Instruments
– Quick and simple
– Standardised but targeted to disease
– Validated, normed to trial population
– Select subsets of off-the-shelf instruments
• Home-Made Instruments
– Often too long
– Often not validated or ‘normed’ or field-tested in the patient population of interest
Assessment Instruments
a. CARES-SF (Schag 1991) – 59 item scale which measures rehabilitation and
quality of life in patients with cancer. This has been modified to the HIV Overview
of Problems Evaluation Systems (HOPES, Schag 1992).
b. City of Hope Quality of Life, Cancer Patient Version (Ferrell 1995) – a 41 item
ordinal scale representing the four domains of quality of life including physical
well being, psychological well being, and spiritual well being.
c. Daily Diary Card-QOL (Gower 1995) – a self-administered card for use in cancer
clinical trials that has been shown to demonstrate short-term changes in quality of
life related to symptoms induced by chemotherapy.
d. EORTC QOL-30 (Aaronson 1993) – this instrument is composed of modules to
assess quality of life for specific cancers in clinical trials. The current instrument is
30 items with physical function, role function, cognitive function, emotional
function, social function, symptoms, and financial impact.
e. FACT-G (Cella 1993) – a 33 item scale developed to measure quality of life in
patients undergoing cancer treatment.
f. FLIC (Finkelstein 1988) – a 22 item instrument which measures quality of life in
the following domains: physical/occupational function, psychological state,
sociability, and somatic discomfort. This scale was originally proposed as an
adjunct measure to cancer clinical trials.
g. Southwest Oncology Group Quality of Life Questionnaire (Moinpour 1990) –
a scale developed for cancer patients incorporating questions from various
function, symptoms, and global quality of life measures.
QALY
• “QALY” = Quality Adjusted Life Years
• Often interested in whether or not survival with poor quality of life is better than
death without suffering
• Example:
– Cancer: many patients would rather not get toxic therapies and have more
enjoyable end of life
• The general idea is to down-weight time spent in periods of poor quality of life
• Methodologically challenging:
– How to determine the weights?
– Different settings might need different weights
Quality Adjusted Survival
QTWIST: Quality-Adjusted Time Without Symptoms of Disease and Toxicity
• Evaluate therapies based on both quantity and
quality of life through survival analysis
• Based on QALYs
Quality of Life for Individual
– Define QOL health states, including one with good
health (minimal symptoms)
– Patients progress through health states and never
back-track
– Partition the area under the Kaplan-Meier Curve
and calculate the average time spent in each
clinical health state
– Compare treatment regimens using weighted
sums durations, weights are utility based
Example: 5 year survival
0.6  1  08
.  2  0.6  1  0.2  1  3
3 adjusted years of life
Compare the average QTWIST in two treatment groups.
Could be that on treatment A, people live longer, but QOL is worse.
Lung Cancer
Non–Small Cell Lung Cancer
• Quality of life at baseline: Influence on survival
• Prospective analysis of 673 patients at 30 centres
Percent Surviving*
100
80
60
40
20
0
0
2
4
6
8
10
12
14
16
Months
Lower QoL
*P=0.0001, using the LCSS quality of life instrument.
Higher QoL
18
20
22
24
How Do Lung Cancer–Related Symptoms Affect
Patients’ Quality of Life?
• 90% of patients with
advanced NSCLC
experience two or more
disease-related symptoms
and high levels of
associated
psychological distress
Cough
Dyspnoea
(shortness of breath)
General symptoms of
fatigue, pain & anorexia
Tanaka T, Gotay CC. Acad Med. 1998;73:1003-1005; Bottomley A. Oncologist. 2002;7:120-125.
Quality of Life Instruments:
Lung Cancer–Specific
Various Questionnaires Measure PROs
Questionnaire
EORTC Core Quality of Life Questionnaire (QLQ-C30)
EORTC lung cancer supplement (QLQ-LC13)
EuroQol EQ-5D
Functional Assessment of Cancer Therapy – Lung (FACT-L)
Lung Cancer Symptom Scale (LCSS)
- Patient (9 items) & Observer (6 items) Forms
EORTC Core Quality of Life Questionnaire (QLQ-C30)
• Comprises 30 questions
• Five functional scales
– Physical, role, cognitive,
emotional, social
• Three symptom scales
– Fatigue, pain, nausea/vomiting
• A global health status/QoL scale
• A number of single items
– Dyspnoea, loss of appetite,
sleep disturbance, constipation,
diarrhoea, financial impact
• Four-point scale from
1 (not at all) to 4 (very much)
• Takes 11–12 minutes to complete,
on average
Available at: http://groups.eortc.be/qol/eortc-qlq-c30.
EORTC Lung Cancer Supplement (QLQ-LC13)
• Disease-specific modular
questionnaire that should
always be complemented
by the QLQ-C30
• Comprises 13 items across
two domains/categories
– Lung cancer-related
symptoms, treatment
side effects
• Four-point scale from
1 (not at all) to 4 (very
much)
• Takes less than 10 minutes
to complete, on average
Available at: http://groups.eortc.be/qol/sites/default/files/img/specimen_lc13_english.pdf.
EuroQol EQ-5D Questionnaire
• Consists of five domains
and a visual analogue
scale (EQ VAS)
– Mobility, self-care,
usual activity, pain,
anxiety/depression
• Each dimension has
three levels
– No problems
– Some problems
– Extreme problems
• Takes 8 minutes to
complete, on average
Available at: http://www.euroqol.org/eq-5d-products/how-to-obtain-eq-5d.html.
FACT-L (Version 4)
• Comprises 36 items across
five domains/categories
• Category domains
– Physical, social/family,
emotional, and functional
well-being; lung cancer
subscale (symptoms,
cognitive function, regret
of smoking)
• Five-point scale from
0 (not at all) to 4 (very much)
• Takes 11–12 minutes to
complete, on average
Available at: www.facit.org/LiteratureRetrieve.aspx?ID=42271.
Transforming Questionnaire Answers Into Scores
• For each scale/item a linear transformation is applied to standardise the raw
score to a range from 0 to 100
– 100 = best possible function/QoL for functional scales
– 100 = highest burden of symptoms for symptom scales and symptom items
• A 10-point change in an item/domain is perceived to be clinically meaningful
Examples of QoL Results
in Lung Cancer Trials
PRO Assessments in First-Line EGFR Mutation-Positive
Clinical Trials
Trial
Treatments
IPASS
Gefitinib versus
carboplatin +
paclitaxel
Mok T et al. N Engl J Med. 2009;361:947-957
QoL
assessments
FACT-L and
FACT-TOI
Methodology
Outcomes
Randomisation, Week 1,
every 3 weeks until day
127, once every 6 weeks
from Day 128 until disease
progression, and when the
study drug was
discontinued
Significantly more patients in the
gefitinib group than in the
carboplatin/paclitaxel group had a
clinically relevant improvement in
QoL and by scores on the FACT-TOI.
Rates of reduction in symptoms were
similar
PRO Assessments in First-Line EGFR Mutation-Positive
Clinical Trials (cont’d)
Trial
Treatments
EURTAC
Erlotinib versus
cisplatin +
docetaxel or
gemcitabine
QoL
assessments
Completion of
the lung cancer
symptom scale
Rossell R et al. Lancet Oncol. 2012;13:239-246;
Methodology
Outcomes
Baseline, every 3 weeks,
end of treatment visit and
every 3 months during
follow-up
Insufficient data collected for any
analysis to be done – due to low
compliance
PRO Assessments in First-Line EGFR Mutation-Positive
Clinical Trials (cont’d)
Trial
Treatments
QoL
assessments
LUXLung 3
Afatinib versus
cisplatin +
pemetrexed
LUXLung 6
Afatinib versus
gemcitabine +
cisplatin
Methodology
Outcomes
EORTC QLQC30, EORTC
QLQ-LC13
Baseline, every 3 weeks
until disease progression
Afatinib improved lung cancer-related
symptoms and QoL, and delay of
deterioration of symptoms compared
with chemotherapy
EORTC QLQC30, EORTC
QLQ-LC13
Baseline, every 3 weeks
until disease progression
Afatinib improved lung cancer-related
symptoms of cough, dyspnoea and
pain, and global health status/QoL
compared with chemotherapy
Sequist LV et al. J Clin Oncol. 2013;31:3327-3334; Yang JC et al. J Clin Oncol. 2013;31:3342-3350; Geater SL et al. J Clin Oncol. 2013;31(suppl):Abstract/Poster
8061.
IPASS: Rates of Improvement in Scores for Quality of Life and Symptoms
Patients with Sustained Clinically
Relevant Improvement (%)
Gefitinib (N=590)
60
50
Odds ratio, 1.34
(95% CI, 1.06-1.69)
P=0.01
Carboplatin plus paclitaxel (N=561)
Odds ratio, 1.78
(95% CI, 1.40-2.26)
P<0.001
Odds ratio, 1.13
(95% CI, 0.90-1.42)
P=0.30
51.5
48.0
46.4
48.5
40.8
40
32.8
30
20
10
0
Total FACT-L
Mok T et al. N Engl J Med. 2009;361:947-957.
TOI
LCS
All Patients Had Low Baseline Symptom Burden
Patient symptom scores at baseline in LUX-Lung 3 and LUX-Lung 6
LUX-Lung 3
Afatinib
LUX-Lung 6
Pem/Cis
Afatinib
Gem/Cis
EORTC QLQ-LC13 or QLQ-C30
Item/domain
Mean
Score (SD)
n
Mean
Score (SD)
n
Mean
Score (SD)
n
Mean
Score (SD)
n
Cougha (Q1/QLQ-LC13)
35.6 (25.6)
224
32.7 (24.8)
109
37.3 (23.8)
233
29.4 (25.9)
109
Dyspnoeaa (domain: Q3-Q5/QLQ-LC13)
22.1 (19.2)
224
24.9 (24.1)
111
25.3 (19.0)
232
24.0 (20.6)
109
Short of breath (Q8/QLQ-C30)
27.1 (23.8)
224
25.5 (29.1)
111
25.9 (23.1)
229
22.9 (23.0)
109
Paina (domain: Q9, Q19/QLQ-C30)
25.5 (23.5)
224
23.6 (25.6)
111
24.4 (21.8)
232
22.8 (23.1)
109
Pain in chest (Q10/QLQ-LC13)
22.3 (23.6)
224
19.2 (24.0)
111
22.1 (22.2)
231
21.3 (22.5)
108
Pain in arm or shoulder (Q11/QLQ-LC13)
18.9 (24.3)
224
12.3 (19.6)
111
21.7 (25.7)
230
16.8 (21.6)
109
Pain in other parts (Q12/QLQ-LC13)
21.6 (26.4)
213
18.8 (26.0)
101
19.2 (22.9)
220
17.8 (21.3)
103
aPrespecified
NSCLC symptoms.
Data on file. Boehringer Ingelheim.
Sequist et al. ESMO 2012. Abstract 1229PD.
LUX-Lung 3:
All Patients Had Low Baseline Symptom Burden
Patient symptom scores at baseline
EORTC QLQ-LC13 or QLQ-C30
item/domain
Afatinib
Cisplatin/
pemetrexed
Mean score (SD)
n
Mean score (SD)
n
Cough* (Q1/QLQ-LC13)
35.6 (25.6)
224
32.7 (24.8)
109
Dypnoea* (domain: Q3-Q5/QLQLC13
22.1 (19.2)
224
24.9 (24.1)
111
Short of breath (Q8/QLQ-C30)
27.1 (23.8)
224
25.5 (29.1)
111
Pain* (domain Q9, Q19/QLQC30)
25.5 (23.5)
224
23.6 (25.6)
111
Pain in chest (Q10/QLQ-LC13)
22.3 (23.6)
224
19.2 (24.0)
111
Pain in arm or shoulder (Q11/QLQLC13)
18.9 (24.3)
224
12.3 (19.6)
111
Pain in other parts (Q12/QLQLC13)
21.6 (26.4)
213
18.8 (26.0)
101
• Compliance with questionnaires was >85% during the treatment period
*Prespecified non-small cell lung cancer symptoms.
Yang JC et al. J Clin Oncol. 2013;31:3342-3350.
LUX-Lung 3: Percentage of Patients Who Improved
in the Symptoms of Cough, Dyspnoea and Pain
LUX-Lung 31
P
0.244
Cough (Q1 from QLQ-LC13)
0.010
Dyspnoea (Q3-5 from QLQ-LC13)
0.977
Dyspnoea rested (Q3 from QLQ-LC13)
0.266
Dyspnoea walked (Q4 from QLQ-LC13)
0.011
Dyspnoea climbed stairs (Q5 from QLQ-LC13)
Short of breath (Q8 from QLQ-C30)
<0.001
Pain (Q9, Q19 from QLQ-C30)
0.051
0.010
Have pain (Q9 from QLQ-C30)
0.127
Pain affecting daily activities (Q19 from QLQ-C30)
0.018
Pain in chest (Q10 from QLQ-LC13)
Pain in arm/shoulder (Q11 from QLQ-LC13)
0.010
Pain in other parts (Q12 from QLQ-LC13)
0.170
0
20
40
60
Patients (%)
80
Afatinib (n=230)
Cisplatin/pemetrexed (n=115)
*Prespecified NSCLC symptoms. European Organization for Research and Treatment of Cancer scores improved by ≥10 points.
Yang JC et al. J Clin Oncol. 2013;31:3342-3350.
LUX-Lung 3: Afatinib Delayed the Worsening of Cough
Estimated probability
1.0
0.8
Afatinib
N=230
Cis/Pem
N=115
No. of events
78
44
mTTD (mo)
NE
8.0
0.60 (0.41 to 0.87)
P=0.007
HR (95% CI)
0.6
0.4
0.2
Afatinib
Pemetrexed/cisplatin
0
0
3
6
9
12
15
18
21
24
27
8
0
2
0
0
0
Time to deterioration (months)
Number at risk:
Afatinib
230
Pemetrexed/
115
cisplatin
Yang JC et al. J Clin Oncol. 2013;31:3342-3350.
166
62
134
27
104
14
68
5
42
3
26
0
LUX-Lung 3: Afatinib Delayed the Worsening of Dyspnoea
Afatinib
N=230
Cis/Pem
N=115
No. of events
118
67
mTTD (mo)
10.3
2.9
Estimated probability
1.0
0.8
0.6
0.68 (0.50 to 0.93)
P=0.015
HR (95% CI)
0.4
0.2
Afatinib
Pemetrexed/cisplatin
0
0
3
6
9
12
15
18
21
24
27
3
1
1
0
0
0
Time to deterioration (months)
Number at risk:
Afatinib
230
Pemetrexed/
115
cisplatin
Yang JC et al. J Clin Oncol. 2013;31:3342-3350.
128
48
106
20
84
11
58
5
34
3
20
2
LUX-Lung 3: Afatinib Delayed the Worsening of Pain
Estimated probability
1.0
0.8
Afatinib
N=230
Cis/Pem
N=115
No. of events
144
72
mTTD (mo)
4.2
3.1
HR (95% CI)
0.83 (0.62 to 1.10)
P=0.19
0.6
0.4
0.2
Afatinib
Pemetrexed/cisplatin
0
0
3
6
9
12
15
18
21
24
27
4
0
1
0
0
0
Time to deterioration (months)
Number at risk:
Afatinib
Pemetrexed/
cisplatin
Yang JC et al. J Clin Oncol. 2013;31:3342-3350.
230 113
115 49
79
22
55
9
40
3
24
0
17
0
LUX-Lung 3: Time to Deterioration for Individual
Components of Cough, Dyspnoea and Pain-Related Items
HR (95% Cl)
P Value
Cougha (Q1 from QLQ-LC13)
0.60 (0.41-0.87)
0.007
Dyspnoeaa (Q3-5 from QLQ-LC13)
0.68 (0.50-0.93)
0.015
Dyspnoea rested (Q3 from QLQ-LC13)
0.82 (0.55-1.21)
0.304
Dyspnoea walked (Q4 from QLQ-LC13)
0.62 (0.44-0.89)
0.008
Dyspnoea climbed stairs (Q5 from QLQ-LC13)
0.64 (0.46-0.91)
0.011
Short of breath (Q8 from QLQ-C30)
0.48 (0.33-0.68)
<0.001
0.83 (0.62-1.10)
0.191
Have pain (Q9 from QLQ-C30)
0.88 (0.64-1.22)
0.436
Pain affecting daily activities (Q19 from QLQ-C30)
0.94 (0.69-1.28)
0.687
Pain in chest (Q10 from QLQ-LC13)
0.65 (0.45-0.94)
0.023
Pain in arm/shoulder (Q11 from QLQ-LC13)
0.94 (0.65-1.34)
0.721
Pain in other parts (Q12 from QLQ-LC13)
1.09 (0.78-1.52)
0.621
Paina (Q9, Q19 from QLQ-C30)
4/16
Favours afatinib
1
Favours cis/pem
4
Afatinib delayed time to deterioration for the individual items
of dyspnoea and pain, compared with cisplatin/pemetrexed
*Prespecified NSCLC symptoms.
Yang JC et al. J Clin Oncol. 2013;31:3342-3350.
16
LUX-Lung 3: Afatinib Associated With Improved QoL
Difference in mean scores over time (longitudinal analysis)
Mean Treatment
Difference (95% CI)
Mean Treatment
Difference (95% CI)
P Value
Global health status
–3.18 (–5.75 to –0.61)
0.015
Physical (QLQ-C30: Q1-5)
–4.80 (–7.47 to –2.13)
<0.001
Role (QLQ-C30: Q6-7)
–4.40 (–7.40 to –1.40)
0.004
–0.87 (–3.20 to 1.46)
0.462
Cognitive (QLQ-C30: Q20 and 25)
–3.16 (–5.47 to –0.85)
0.007
Social (QLQ-C30: Q26-27)
–1.11 (–3.94 to 1.72)
0.442
Global health status/QoL (QLQ-C30: Q29-30)
Functional scales
Emotional (QLQ-C30: Q21-24)
–10
–8
–6
–4
–2
Favours afatinib
0
2
4
6
8
10
Favours cisplatin/pemetrexed
• Afatinib significantly improved the global health
status/QoL; role, cognitive and physical functioning were
significantly improved compared with cisplatin/pemetrexed
Yang JC et al. J Clin Oncol. 2013;31:3342-3350.
LUX-Lung 6: Percentage of Patients Who Improved
in the Symptoms of Cough, Dyspnoea and Pain
Afatinib
Patients with improvement (%)
80%
80
Gem/Cis
P=0.0003
P<0.0001
70%
70
P=0.0029
P=0.0061
60%
60
P=0.0211
50%
50
P=0.1395
P=0.0924
40%
40
30%
30
20%
20
10%
10
0%
0
Cough
Dyspnoea
Short of
breath
Pain
Pain in chest
Pain in
Pain other
arm/shoulder
• Significantly higher number of patients had symptom improvement with
afatinib for the prespecified symptoms of cough, dyspnoea and pain
Geater SL et al. J Clin Oncol. 2013;31(suppl):Abstract/Poster 8061.
LUX-Lung 6: Percentage of Patients Who Improved
in Global Health Status/QoL and Functional Scales
Afatinib
Patients with improvement (%)
70
Gem/Cis
P<0.0001
60
P=0.0007
P<0.0001
P=0.0129
50
P=0.3828
P=0.1003
40
30
20
10
0
Global health
status
Physical
functioning
Role
functioning
Emotional
functioning
Cognitive
functioning
Social
functioning
• Significantly higher number of patients had an improvement in global health
status/QoL and physical, role and social functioning
Geater SL et al. J Clin Oncol. 2013;31(suppl):Abstract/Poster 8061.