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Table 10. Quality-of-life Outcomes in Patients Undergoing Second-line Treatment for Advanced NSCLC

Study ID No. of patients,
age (median
[range]), sex
Treatment
(dosage/day)
QoL instrument(s) QoL outcomes QoL conclusions
Phase III
Shepherd, et al., 200524,25 731 pts
62 (NR)
35% F
Erlotinib 150 mg TTDS TTDS-cough
TTDS-dyspnea
TTDS-pain
4.9 vs. 3.7 (p = 0.04)
4.7 vs. 2.9 (p = 0.03)
2.8 vs. 1.9 (p = 0.04)
Erlotinib significantly better than placebo for improvement in TTDS-cough, TTDS-dyspnea, and TTDS-pain
Phase II
Kris, et al., 200329 216 pts
61 (30-84)
46% F
Gefitinib 250 mg
Gefitinib 500 mg
LCS of FACT-L
(improved indicates
> or = 2 point
improvement on
28-point scale)
  43% improved
35% improved
In both dosage arms, symptom improvement better in PR (96%)
vs. SD (73%)
vs. PD (17%);
adeno vs. other
(43% vs. 30%)
Fukuoka, et al., 200330 209 pts
61 (28-85)
29% F
Gefitinib 250 mg



Gefitinib 500 mg
LCS of FACT-L
(improved indicates
> or = 2 point
improvement on
28-point scale)
TOI FACT-L
LCS-FACT-L 7d
TOI q28d
FACT-L q28d

LCS-FACT-L 7d
TOI q28d
FACT-L q28d
40.8%
20.9% (11.9-32.6)
23.9% (14.3-25.9)

37%
17.8% (9.8-28.5)
21.9% (13.1-33.1)
Gefitinib at either dose associated with measurable improvements compared with baseline in 3 different QoL measures
Perez-Soler et al., 200431 57 pts
62 (31-83)
60% F
Erlotinib 150 mg EORTC QLQ-C30 and LC13 administered at baseline, every 2 weeks for 2 months, then every month Fatigue subscale
Dyspnea subscale
Cough subscale
67% to 49%
61% to 37%
60% to 39%
Erlotinib associated with measurable improvements compared with baseline in 3 different QoL symptom measures
Comparator studies
Hanna, et al., 200432   Permetrexed
Docetaxel
ASBI of LCSS   21.2% (p = NS)
21.5%
Both arms with similar rates of improvement, stabilization, and worsening of symptoms
Shepherd, et al., 200033
as reported in Dancey et al., 200447
204 pts
61 (28-77)
35% F
BSC
Docetaxel
combined

BSC
Docetaxel
combined
LCSS



EORTC QLQ-C30
instrument
with the LC13 lung
cancer module
Patient (10 items)
Observer (7 items)


Pain/PF/GH
Significant difference for
1 (pain) of 17 items


-19/-27/-27
-12/-19/-21
(change in subscale
scores for pain/PF/GH)
Second-line docetaxel therapy for advanced NSCLC shows a trend (not statistically significant) towards less deterioration in QoL compared with BSC (in this trial that showed a statistically significant survival benefit)

Abbreviations: ASBI = Average Symptom Burden Index; BSC = best supportive care; EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; FACT-L = Functional Assessment of Cancer Therapy-Lung; GH = general health subscale; LCS or LCSS = Lung Cancer Symptom Scale; PF = physical functioning subscale.

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