TROPIC Results Validated JEVTANA as a 2nd-Line Treatment After Docetaxel in a Pivotal Phase 3 Trial vs Mitoxantrone1,2
Large, International, Randomized, Open-Label Registration Trial (N=755)
- The trial enrolled patients with mCRPC who previously received docetaxel
- Conducted at 146 sites in 26 countries
Endpoints
- Primary endpoint: OS
- Secondary endpoints: Investigator-assessed tumor response, safety, and pharmacokinetics
N=755
Patients with mCRPC who progressed during or after treatment with a docetaxel-containing regimen
Stratification:
ECOG PS: 0,1 vs 2
Measurable vs nonmeasurable disease
RANDOMIZED 1:1
JEVTANA 25 mg/m2
q3w + oral prednisone 10 mg daily for 10 cycles
(n=378)
mitoxantrone 12 mg/m2
q3w + oral prednisone 10 mg daily for 10 cycles
(n=377)
ECOG PS=Eastern Cooperative Oncology Group performance status; mCRPC=metastatic castration-resistant prostate cancer; OS=overall survival; q3w=every 3 weeks.
Identify Appropriate Patients for JEVTANA in Your Practice
JEVTANA Was Studied in mCRPC Patients With High Disease Burden and Rapid Progression After Docetaxel1-3
TROPIC Trial Included Patients With High Disease
Burden3
Patients Presented With Rapid Progression
After Docetaxel1-3
Summary of Demographics and Patient Characteristics2,3
|
JEVTANA 25 mg/m2 + prednisone (n=378) |
mitoxantrone + prednisone (n=377) |
||
| Age | Median (range) | 68 (46-92) | 67 (47-89) |
| ≥75, No. (%) | 69 (18.3) | 70 (18.6) | |
| ECOG PS, No. (%) | 0,1 | 350 (92.6) | 344 (91.2) |
| 2 | 28 (7.4) | 33 (8.8) | |
| PSA, ng/mL | Median | 143.9 | 127.5 |
|
Disease progression relative to docetaxel administration, No. (%) |
During treatment | 115 (30.4) | 104 (27.6) |
| <3 months from last dose | 158 (41.8) | 181 (48.0) | |
| ≥3 months from last dose | 102 (27.0) | 90 (23.9) | |
| Unknown | 3 (0.8) | 2 (0.5) | |
| Last docetaxel dose to disease progression (months) |
Median (time) | 0.8 (0.0-3.1) | 0.7 (0.0-2.9) |
| Pain at baseline, No. (%) | Pain at baseline* | 174 (46.0) | 168 (44.6) |
|
Measurability of disease (%) |
Measurable disease† | 53.2 | 54.1 |
| Nonmeasurable disease† | 46.8 | 45.9 | |
|
JEVTANA 25 mg/m2 + prednisone (n=378) |
mitoxantrone + prednisone (n=377) |
|
| Age | ||
| Median (range) | 68 (46-92) | 67 (47-89) |
| ≥75, No. (%) | 69 (18.3) | 70 (18.6) |
| ECOG PS, No. (%) | ||
| 0,1 | 350 (92.6) | 344 (91.2) |
| 2 | 28 (7.4) | 33 (8.8) |
| PSA, ng/mL | ||
| Median | 143.9 | 127.5 |
|
Disease progression relative to docetaxel administration, No. (%) |
||
| During treatment | 115 (30.4) | 104 (27.6) |
| <3 months from last dose | 158 (41.8) | 181 (48.0) |
| ≥3 months from last dose | 102 (27.0) | 90 (23.9) |
| Unknown | 3 (0.8) | 2 (0.5) |
| Last docetaxel dose to disease progression (months) |
||
| Median (time) | 0.8 (0.0-3.1) | 0.7 (0.0-2.9) |
| Pain at baseline, No. (%) | ||
| Pain at baseline* | 174 (46.0) | 168 (44.6) |
|
Measurability of disease (%) |
||
| Measurable disease† | 53.2 | 54.1 |
| Nonmeasurable disease† | 46.8 | 45.9 |
More Than 60% of Patients Had 2 or More Sites of Metastases
| Disease site (%) | Bone | 80.2 | 87.0 |
| Distant lymph nodes | 35.2 | 34.5 | |
| Visceral | 24.9 | 24.9 |
| Disease site (%) | ||
| Bone | 80.2 | 87.0 |
| Distant lymph nodes | 35.2 | 34.5 |
| Visceral | 24.9 | 24.9 |
PSA=prostate-specific antigen.
*Pain was assessed with the McGill-Melzack present pain intensity scale, and analgesic score was derived from analgesic consumption (morphine equivalents).2
†Measurable disease was measured by RECIST and nonmeasurable disease was measured by rising PSA levels or appearance of new lesions.1
Explore OS and tumor
response results
See how the recommended dose
of JEVTANA was established