| NEJ002 [12, 23, 30] | IPASS [8, 14, 31] | OPTIMAL [10, 32] | LUX-Lung 3 [15, 33] | LUX-Lung 6 [16, 26] | |
| Questionnaire | Care notebook | FACT-L (incl. LCS/TOI) | FACT-L (incl. LCS/TOI) | EORTC-QLQ C30 and LC13 | EORTC-QLQ C30 and LC13 |
| Assessment until disease progression | Baseline, weekly | Baseline, weeks 1 and 3 Every 3 weeks until week 18, then every 6 weeks | Baseline, every 6 weeks | Baseline, every 3 weeks | Baseline, every 3 weeks |
| Compliance with completing questionnaires+ | Gefitinib: 63% chemotherapy: 69% (at least two time-points) | Gefitinib: 95% chemotherapy: 90% (time-point NR) | Erlotinib: 96%/91% cycle 2/cycle 6 chemotherapy: 100%/50% cycle 2/cycle 6 | Afatinib: 97%/98% cycle 2/cycle 6 chemotherapy: 97%/83% cycle 2/cycle 6 | Afatinib: 96%/85% cycle 2/cycle 6 chemotherapy: 98%/90% cycle 2/cycle 6 |
| Significant and clinically relevant# symptom improvement¶,§ | Loss of appetite (p = 0.014) Constipation (p<0.0001) Pain and shortness of breath (p<0.0001) | Maintaining at least 21 days FACT-L (70% versus 45%), TOI (70% versus 38%), LCS (76% versus 54%) | FACT-L, TOI, LCS | Dyspnoea (64% versus 50%) Pain (59% versus 48%; only significant for individual pain items) | Cough (76% versus 55%) Dyspnoea (71% versus 48%) Pain (64% versus 47%) Global health status (63% versus 33%) Physical (54% versus 29%) Role (50% versus 35%) Social (55% versus 35%) |
| Significant and clinically relevant differences in time to worsening/deterioration | Pain and shortness of breath (0.2 versus 2.1 months) Daily functioning (0.4 versus 3.0 months) | FACT-L (15.6 versus 3.0 months) TOI (16.6 versus 2.9 months) LCS (11.3 versus 2.9 months) | NA | Cough (NE versus 8.0 months) Dyspnoea (10.3 versus 2.9 months) | Cough (NE versus 10.3 months) Dyspnoea (7.7 versus 1.7 months) Pain (6.4 versus 3.4 months) |
| Significant and clinically relevant changes in longitudinal analyses | NA | NA | NA | Cough Dyspnoea | Cough Dyspnoea Pain |
NEJ002: North East Japan 002; IPASS: First Line IRESSA versus Carboplatin/Paclitaxel in Asia; FACT-L: Functional Assessment of Cancer Therapy – Lung; LCS: lung cancer subscale; TOI: trial outcome index; EORTC-QLQ C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30; LC13: lung cancer-specific module; NR: not reported; NA: not available; NE: not evaluable. #: different definitions of “clinically meaningful” were used in the different evaluations; ¶: to date, no quality of life data have been published from the ENSURE trial; +: baseline, cycle 6; §: data are presented as % patients, tyrosine kinase inhibitor versus chemotherapy.