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| 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) |