Table 3.

Phase III studies comparing gefitinib with docetaxel

StudyINTEREST7 (N = 1,499)V-15-328 (N = 489)ISTANA (current; N = 161)
Patient characteristics, n (%)
    Asian ethnicity323 (22.0)489 (100)161 (100)
    Female512 (34.9)187 (38.2)61 (37.9)
    Never smoker298 (20.3)158 (32.3)66 (41.0)
    WHO PS 0 or 11,290 (88.0)468 (95.7)150 (93.2)
    Adenocarcinoma830 (56.6)380 (77.7)110 (68.3)
    Responders (CR/PR) to previous chemotherapy428 (29.2)219 (44.8)58 (36.0)
    Second-line therapy1,229 (83.8)413 (84.5)161 (100)
Treatment outcomes (gefitinib vs docetaxel)
OS; HR, 95% CI (median); mo1.02, 0.91-1.15* (7.6 vs 8.0)1.12, 0.89-1.40 (11.5 vs 14.0)0.87, 0.61-1.24 (14.1 vs 12.2)
PFS; HR, 95% CI (median); mo1.04, 0.93-1.18 (2.2 vs 2.7)0.90, 0.72-1.12 (2.0 vs 2.0)0.73, 0.53-1.0 (3.3 vs 3.4)
ORR, % (P)9.1 vs 7.6 (0.3257)22.5 vs 12.8 (0.009)28.1 vs 7.6 (0.0007)
Quality of life improvement rates (gefitinib vs docetaxel)
FACT-L, % (P)25.1 vs 14.7 (<0.0001)23.4 vs 13.9 (0.023)27.9 vs 27.3 (0.9310)
TOI, % (P)17.3 vs 10.3 (0.0026)20.5 vs 8.7 (0.002)26.5 vs 13.6 (0.0641)
LCS, % (P)20.4 vs 16.8 (0.1329)22.7 vs 20.4 (0.562)39.7 vs 37.9 (0.8282)

Abbreviations: OS, overall survival; HR, hazard ratio; PFS, progression-free survival; ORR, objective response rate; TOI, Trial Outcome Index; LCS, Lung Cancer Subscale.