ORR by patient characteristics*
Central ALK-testing (n=908)Local ALK-testing (n=158)
n/N**%95% CI n/N**%95% CI
Overall491/9085451 to 5764/1584133 to 49
Number of prior therapies for metastatic disease
 02/2†† 10016 to 1000
 1126/2315548 to 6727/674029 to 53
 2166/3355044 to 5520/494127 to 56
 ≥3197/3405853 to 6317/424126 to 57
Sex
 Male211/3935449 to 5927/723826 to 50
 Female280/5155450 to 5937/864332 to 54
Age‡‡
 <65 years424/7775551 to 5849/1174233 to 51
 ≥65 years67/1315142 to 6015/413722 to 53
Race
 Non-Asian
   White215/4345045 to 5436/983727 to 47
   Black9/165630 to 801/4250.6 to 81
 Asian
   Japanese37/675543 to 679/146435 to 87
   Korean105/1387668 to 833/65012 to 88
   Chinese111/2245043 to 569/283216 to 52
   Other Asian7/135425 to 815/510048 to 100
  Other7/164420 to 701/3330.8 to 91
ECOG PS§
 0127/2145952 to 6615/384024 to 57
 1304/5415652 to 6035/943728 to 48
 252/1254233 to 5111/186136 to 83
 38/282913 to 493/8389 to 76
Smoking status
 Never334/6125551 to 5944/904938 to 60
 Current22/376042 to 751/6170.4 to 64
 Former135/2595246 to 5819/623120 to 44
  • *ORR, DCR, duration of response and time to first response were analyzed in the response1evaluable population (central1testing subgroup) and in the response1evaluablepopulation (local1testing subgroup) (note: numbers of patients in these subgroups were the same as in the as1treated population).

  • †Calculated using the exact method based on the F distribution.

  • ‡Based onBrookmeyer and Crowley method.

  • §Range.

  • ¶Calculated using the normal approximation to the log transformed cumulative hazard rate .

  • **Number with response/total number with patient characteristic.

  • ††Two patients received only adjuvant treatment, but had disease progression within 6 months after adjuvant treatment and were considered eligible for the study.

  • ‡‡At baseline.

  • ALK, anaplastic lymphoma kinase; CI,confidence interval;DCR, disease-control rate (% complete response+partial response+stable disease); ECOG PS, Eastern Cooperative Oncology Group performance status; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.