EURURO Vol. 71 No. 4

658 692

This is the same cutoff used for age subgroup analysis for COU-AA-302
and COU-AA-301 and is consistent with US regulatory guidance
to define a geriatric population in clinical trials Clinical progression
data were obtained from investigator reports, and data on responses and
subsequent therapy for mCRPC were collected by trial monitors during
site visits. The data were then source-verified and entered into the
database. PSA response rates and post-treatment PSA declines were
summarized using frequency and percentages. The time to PSA
progression (TTPP) was estimated using PCWG2 criteria and included
censored patients. Median TTPP with 95% CI was estimated using the
Kaplan-Meier method.
3. Results
Baseline characteristics for patients who progressed on
AA and received docetaxel as FST were similar to the full
COU-AA-302 intention-to-treat (ITT) population ).
Among patients in the AA arm, 36% (194/546) and 15% (83/
546) had two or more and three or more subsequent
therapies, respectively . Among those in the P arm,
45% (243/542) and 22% (121/542) had two or more and
three or more subsequent therapies, respectively.
[(Fig._1)TD$FIG]
Fig. 1 – CONSORT diagram. a Abiraterone acetate, cabazitaxel, enzalutamide, ketoconazole, or sipuleucel-T.
Table 1 – Baseline characteristics of the ITT population and patients who received docetaxel as FST
COU-AA-302 AA treatment arm
Docetaxel as FST ITT population
Patients (N) 261 546
Median age, yr (range) [n] 69 (44–93) [261] 71 (44–95)
Median time from ID to FD, yr (range) [n] 4.4 (< 1–28) [261] 5.5 (<1–28) [542]
Median PSA at ID, ng/ml (range) [n] 23 (2–5036) [236] 22 (0.4–5036) [470]
Gleason score 8 at ID, n/N (%) 129/244 (53) 263/488 (54)
Extent of disease, n/N (%)
Bone only 132/261 (51) 274/542 (51)
Soft tissue r node 128/261 (49) 267/542 (49)
Other 1/261 (<1) 4/542 (<1)
ECOG PS, n/N (%)
0 206/261 (79) 423/546 (76)
1 55/261 (21) 133/546 (24)
Prior prostate cancer therapy, n/ N (%)
Surgery 125/261 (48) 256/544 (47)
Radiotherapy 138/261 (53) 283/544 (52)
Hormonal 261/261 (100) 544/544 (100)
Other 39/261 (15) 82/544 (15)
Median baseline PSA, ng/ml (range) [n] 48 (1–3266) [261] 42 (0–3927) [546]
Median baseline LDH, IU/l (range) [n] 189 (60–871) [261] 187 (60–871) [543]
Median baseline ALP, IU/l (range) [n] 103 (32–1927) [261] 93 (32–1927) [546]
ITT = intention to treat; FST = first subsequent therapy; AA = abiraterone acetate plus prednisone; ID = initial diagnosis; FD = first dose; ECOG PS = Eastern
Cooperative Oncology Group performance status; PSA = prostate-specific antigen; LDH = lactate dehydrogenase; ALP = alkaline phosphatase.
a Excludes visceral metastases.
E U R O P E A N U R O L O G Y 7 1 ( 2 0 1 7 ) 6 5 6 – 6 6 4 658