Table 3.
n | 201 [27] | 211 [28] | 221 [29] |
---|---|---|---|
87 (per protocol population) | 269 (eligible population) | 80 (eligible population) | |
Prior chemotherapy | Any prior regimen of chemotherapy with A and T (median 4) | 2–5 prior regimens of chemotherapy with A, T and CAP (median 4) | ≤3 prior regimens of chemotherapy including A and T (median 3) |
Dosing schedule | 1.4 mg/m2 IV inf d1 + 8 + 15 q4w 1.4 mg/m2 IV inf d1 + 8 q3w |
1.4 mg/m2 IV inf d1 + 8 q3w |
1.4 mg/m2 IV inf d1 + 8 q3w |
Tumour response (independent review) | |||
PR (%) | 11.5 [total] | 9.3 | 21.3 |
10.2 [q4w cohort] | |||
14.3 [q3w cohort] | |||
SD (%) | 42.5 [total] | 46.5 | 37.5 |
35.6 [q4w cohort] | |||
57.1 [q3w cohort] | |||
ORRa (%) | 11.5 [total] | 9.3 | 21.3 |
10.2 [q4w cohort] | |||
14.3 [q3w cohort] | |||
CBRb (%) | 17.2 [total] | 17.1 | 27.5 |
11.9 [q4w cohort] | |||
28.6 [q3w cohort] | |||
Median duration of response (months) |
5.6 | 4.1 | 3.9 |
Median PFS (months) | 2.6 | 2.6 | 3.7 |
Median OS (months) | 9.0 | 10.4 | 11.1 |
A anthracycline, CAP capecitabine, CBR clinical benefit rate, d day, IV inf intravenous infusion, ORR objective response rate, OS overall survival, PFS progression-free survival, PR partial response, qXw every X weeks, SD stable disease, T taxane
aObjective response rate = complete response + partial response
bClinical benefit rate = complete response + partial response + stable disease ≥6 months