The CARD Trial Was the First Comparative, Prospective, Phase 4 Trial Evaluating JEVTANA vs Abiraterone or Enzalutamide1,2
Randomized, Open-Label, Multicenter Trial (N=255)
- The trial enrolled patients with mCRPC who previously received docetaxel and progressed within 12 months on abiraterone or enzalutamide
- Conducted at 62 sites in 13 European countries
Endpoints
- Primary endpoint: rPFS*
- Other efficacy outcomes included OS, tumor response, and safety
N=255
Patients with mCRPC† who had previously received docetaxel (at least 3 cycles before or after abiraterone or enzalutamide) and had disease progression within 12 months on abiraterone or enzalutamide
DOCE
►
ASTI
OR
ASTI
►
DOCE
Stratification:
ECOG PS: 0,1 vs 2
Time to disease progression (<6 months vs >6 to 12 months)
Timing of previous treatment with abiraterone or enzalutamide (before vs after docetaxel)
RANDOMIZED 1:1
JEVTANA 25 mg/m2
q3w + oral prednisone 10 mg daily + G-CSF (n=129)
Oral abiraterone 1000 mg once daily + oral prednisone 5 mg twice daily OR oral enzalutamide 160 mg once daily (n=126)†
Median follow-up was 9.2 months from randomization until the end of the study.2
ASTI=androgen-signaling-targeted inhibitor (abiraterone or enzalutamide); CT=computed tomography; DOCE=docetaxel; ECOG PS=Eastern Cooperative Oncology Group performance status; G-CSF=granulocyte-colony stimulating factor; mCRPC=metastatic castration-resistant prostate cancer; MRI=magnetic resonance imaging; OS=overall survival; PCWG2=Prostate Cancer Clinical Trials Working Group 2; q3w=every 3 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; rPFS=radiographic progression-free survival.
*rPFS is defined as the time from randomization to the occurrence of one of the following events: radiological tumor progression using RECIST 1.1 (except for lymph nodes: if lymph node metastasis is the only evidence of metastasis at baseline, it must be ≥20 mm in diameter when measured by spiral CT or MRI [as defined by PCWG2]), progression of bone lesions according to PCWG2 criteria, or death.3
†Patients had histologically confirmed prostate cancer and castrate levels of serum testosterone (<0.5 ng/mL).2
‡Abiraterone was given to patients who had previously received enzalutamide before trial entry and enzalutamide was given to patients who had previously received abiraterone.2
Identify Appropriate Patients for JEVTANA in Your Practice
JEVTANA Was Studied in a Broad and Diverse Population, Including
Patients With High Disease Burden1
CARD Trial Included Patients With High Disease Burden4
Summary of Demographic and Patient Characteristics at Baseline2,4
|
JEVTANA 25 mg/m2 + prednisone (n=129) |
abiraterone or enzalutamide (n=126) |
||
| Age | Median (range) | 70 (46-85) | 71 (45-88) |
| ≥75, No. (%) | 45 (34.9) | 34 (27.0) | |
| ECOG PS, No. (%) | 0,1 | 123 (95.3) | 119 (94.4) |
| 2 | 6 (4.7) | 7 (5.6) | |
| Disease site, No. (%) | Bone (± lymph nodes) | 74 (57.4) | 76 (60.3) |
| Lymph nodes | 8 (6.2) | 6 (4.8) | |
| Liver | 11 (8.5) | 18 (14.3) | |
| Lung | 10 (7.8) | 7 (5.6) | |
| PSA, ng/mL | Median (range) | 62.0 (1.1-15,000.0) | 60.5 (1.5-2868.0) |
| Type of progression at trial entry, No. (%) |
PSA only | 11 (8.5) | 10 (7.9) |
|
Imaging-based, with or without PSA progression |
23 (17.8) | 16 (12.7) | |
| Pain, with or without PSA or imaging-based progression |
86 (66.7) | 90 (71.4) | |
| Missing data | 9 (7.0) | 10 (7.9) | |
|
JEVTANA 25 mg/m2 + prednisone (n=129) |
abiraterone or enzalutamide (n=126) |
|
| Age | ||
| Median (range) | 70 (46-85) | 71 (45-88) |
| ≥75, No. (%) | 45 (34.9) | 34 (27.0) |
| ECOG PS, No. (%) | ||
| 0,1 | 123 (95.3) | 119 (94.4) |
| 2 | 6 (4.7) | 7 (5.6) |
| Disease site, No. (%) | ||
| Bone (± lymph nodes) | 74 (57.4) | 76 (60.3) |
| Lymph nodes | 8 (6.2) | 6 (4.8) |
| Liver | 11 (8.5) | 18 (14.3) |
| Lung | 10 (7.8) | 7 (5.6) |
| PSA, ng/mL | ||
| Median (range) | 62.0 (1.1-15,000.0) | 60.5 (1.5-2868.0) |
| Type of progression at trial entry, No. (%) |
||
| PSA only | 11 (8.5) | 10 (7.9) |
|
Imaging-based, with or without PSA progression |
23 (17.8) | 16 (12.7) |
| Pain, with or without PSA or imaging-based progression |
86 (66.7) | 90 (71.4) |
| Missing data | 9 (7.0) | 10 (7.9) |
Disease History
| M1 disease at diagnosis, No. (%) | 49 (38.0) | 60 (47.6) | |
| Gleason score 8-10 at diagnosis, No. (%) | 73 (56.6) | 81 (64.3) | |
| First androgen deprivation therapy |
Median duration, months (range) |
13.7 (2-114) | 12.6 (3-179) |
| Previous ASTI, No. (%)§ | Abiraterone | 56 (43.4) | 67 (53.2) |
| Enzalutamide | 72 (55.8) | 59 (46.8) | |
| Timing of previous ASTI, No. (%) |
Before docetaxel | 50 (38.8) | 49 (38.9) |
| After docetaxel | 79 (61.2) | 77 (61.1) | |
| M1 disease at diagnosis, No. (%) | 49 (38.0) | 60 (47.6) |
| Gleason score 8-10 at diagnosis, No. (%) | 73 (56.6) | 81 (64.3) |
| First androgen deprivation therapy |
||
|
Median duration, months (range) |
13.7 (2-114) | 12.6 (3-179) |
| Previous ASTI, No. (%)§ | ||
| Abiraterone | 56 (43.4) | 67 (53.2) |
| Enzalutamide | 72 (55.8) | 59 (46.8) |
| Timing of previous ASTI, No. (%) |
||
| Before docetaxel | 50 (38.8) | 49 (38.9) |
| After docetaxel | 79 (61.2) | 77 (61.1) |
M1 disease=metastatic disease (distant metastases); PSA=prostate-specific antigen.
§One patient (0.8%) had missing data in the JEVTANA group.
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