PROSELICA Results Established JEVTANA 20 mg/m2 as the Recommended Dose1,2
JEVTANA 25 mg/m2 Can Be Used in Select Patients at the Healthcare Provider’s Discretion
Large, Noninferiority, Multicenter, Randomized, Open-Label Trial (N=1200)
- The trial enrolled patients with mCRPC who previously received docetaxel
Endpoints
- The primary endpoint was OS
N=1200
Patients with mCRPC who previously received docetaxel
Stratification:
ECOG PS: 0,1 vs 2
Measurable vs nonmeasurable disease
RANDOMIZED 1:1
JEVTANA 20 mg/m2 + prednisone
(n=598)
JEVTANA 25 mg/m2 + prednisone
(n=602)
ECOG PS=Eastern Cooperative Oncology Group performance status; mCRPC=metastatic castration-resistant prostate cancer; OS=overall survival.
Identify Appropriate Patients for JEVTANA in Your Practice
JEVTANA Was Studied in mCRPC Patients With High Disease Burden and Rapid Progression After Docetaxel2
PROSELICA Trial Included Patients With High
Disease Burden2
Patients Presented With Rapid Progression
After Docetaxel2
Summary of Demographics and Patient Characteristics2,3
|
JEVTANA 20 mg/m2 + prednisone (n=598) |
JEVTANA 25 mg/m2 + prednisone (n=602) |
||
| Age | Median (range) | 68 (45-89) | 69 (45-88) |
| ≥75, No. (%) | 120 (20.1) | 127 (21.1) | |
| ECOG PS, No. (%) | 0,1 | 539 (90.1) | 540 (89.7) |
| 2 | 59 (9.9) | 62 (10.3) | |
| PSA, ng/mL | Median | 159.49 | 170.90 |
|
Disease progression relative to treatment, No. (%) |
During last docetaxel treatment |
153 (25.6) | 154 (25.6) |
|
<3 months since last docetaxel dose |
251 (42.0) | 270 (44.9) | |
|
3-6 months since last docetaxel dose |
110 (18.4) | 96 (15.9) | |
|
>6 months since last docetaxel dose |
69 (11.5) | 61 (10.1) | |
| Missing | 15 (2.5) | 21 (3.5) | |
|
Time from last docetaxel dose to progression, months |
Median | 1.0 | 1.0 |
| Mean (SD) | 2.7 (5.3) | 2.3 (4.1) | |
| Pain at baseline, No. (%) | Pain at baseline* | 248 (41.5) | 284 (47.2) |
|
Measurability of disease (%) |
Measurable disease† | 49.0 | 48.0 |
| Nonmeasurable disease† | 51.0 | 52.0 | |
|
JEVTANA 20 mg/m2 + prednisone (n=598) |
JEVTANA 25 mg/m2 + prednisone (n=602) |
|
| Age | ||
| Median (range) | 68 (45-89) | 69 (45-88) |
| ≥75, No. (%) | 120 (20.1) | 127 (21.1) |
| ECOG PS, No. (%) | ||
| 0,1 | 539 (90.1) | 540 (89.7) |
| 2 | 59 (9.9) | 62 (10.3) |
| PSA, ng/mL | ||
| Median | 159.49 | 170.90 |
|
Disease progression relative to treatment, No. (%) |
||
| During last docetaxel treatment |
153 (25.6) | 154 (25.6) |
|
<3 months since last docetaxel dose |
251 (42.0) | 270 (44.9) |
|
3-6 months since last docetaxel dose |
110 (18.4) | 96 (15.9) |
|
>6 months since last docetaxel dose |
69 (11.5) | 61 (10.1) |
| Missing | 15 (2.5) | 21 (3.5) |
|
Time from last docetaxel dose to progression, months |
||
| Median | 1.0 | 1.0 |
| Mean (SD) | 2.7 (5.3) | 2.3 (4.1) |
| Pain at baseline, No. (%) | ||
| Pain at baseline* | 248 (41.5) | 284 (47.2) |
|
Measurability of disease (%) |
||
| Measurable disease† | 49.0 | 48.0 |
| Nonmeasurable disease† | 51.0 | 52.0 |
PROSELICA Included Patients With Multiple Metastases
| Disease site (%) | Bone | 93.5 | 94.5 |
| Lymph nodes | 49.2 | 49.7 | |
| Lung | 15.6 | 15.9 | |
| Liver | 15.7 | 15.0 |
| Disease site (%) | ||
| Bone | 93.5 | 94.5 |
| Lymph nodes | 49.2 | 49.7 |
| Lung | 15.6 | 15.9 |
| Liver | 15.7 | 15.0 |
PSA=prostate-specific antigen; RECIST=Response Evaluation Criteria in Solid Tumors.
*Pain was assessed with the McGill-Melzack present pain intensity scale, and analgesic score was derived from analgesic consumption (morphine equivalents).
†Measurable disease was measured by RECIST and nonmeasurable disease was measured by rising PSA levels or appearance of new lesions.
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20 mg/m2 vs JEVTANA 25 mg/m2
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