ARAMIS IS THE LARGEST PHASE III STUDY IN nmCRPC TO DATE1-3nmCRPC
- Treatment continued until radiographic disease progression as assessed by conventional imaging (CT, MRI, 99mTc bone scan) by blinded independent central review, discontinuation due to adverse reactions, or withdrawal of consent
*All patients received concurrent ADT (treatment with GnRH analog or previous bilateral orchiectomy).
†Lymph nodes located below the aortic bifurcation as measured by the short axis.
CRPC=castration-resistant prostate cancer; PSADT=prostate-specific antigen doubling time; PSA=prostate-specific antigen; ECOG PS=Eastern Cooperative Oncology Group performance status; ADT=androgen deprivation therapy; CT=computed tomography; MRI=magnetic resonance imaging; GnRH=gonadotropin-releasing hormone.
- Metastasis-free survival
- Overall survival
- Time to pain progression*
- Time to first cytotoxic chemotherapy
- Time to first symptomatic skeletal event
- Progression-free survival
- Time to first prostate cancer–related procedure
- Time to initiation of subsequent chemotherapy
- PSA progression and response
- Deterioration in ECOG PS
- Quality of life†
*Time to pain progression was defined as at least a 2-point worsening from baseline of pain score on BPI-SF (a validated health-related quality-of-life instrument) or initiation of opioids
and reported in 28% of all patients on study.
†Tools used to prespecify quality-of-life exploratory endpoints are the EQ-5D-3L, a preference-based instrument, and the FACT-P, BPI-SF, and EORTC-QLQ-PR25 prostate-specific questionnaires.
PSA=prostate-specific antigen; ECOG PS=Eastern Cooperative Oncology Group performance status; EQ-5D-3L=EuroQol Group 5-dimension 3-level; FACT-P=Functional Assessment of Cancer
Therapy–Prostate; BPI-SF=Brief Pain Inventory Short Form; EORTC-QLQ-PR25=European Organization for Research and Treatment of Cancer quality of life questionnaire, a 25-item questionnaire.
The majority of patients (68%) had an ECOG PS of 0 at baseline, defined as fully active and able to carry on all pre-disease performance without restriction4,6
- 43% of patients were on an antithrombotic, such as apixaban, clopidogrel, rivaroxaban, or warfarin5
- More than a third of patients were on a statin (34.5%), such as atorvastatin, pravastatin, or rosuvastatin5
Bone-sparing agents included bisphosphonates, denosumab, vitamin D and analogs, calcium and calcium combinations, fluorides, and calcitonins.5
ECOG PS is graded according to the following criteria: 0: Fully active,
able to carry on all pre-disease performance without restriction;
1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light housework, office work.6
ECOG PS=Eastern Cooperative Oncology Group performance status; ADT=androgen deprivation therapy; PSA=prostate-specific antigen; DDIs=drug-drug interactions.
DELAY METASTASIS, HELP PATIENTS LIVE LONGER WITHOUT PROGRESSION1,4nmCRPC
Men lived 2X longer without cancer spreading1,4
Significant increase in MFS vs ADT alone
HR: 0.41; 95% CI: 0.34-0.50; P<0.0001 (intent to treat)
- Consistent results for MFS across patient subgroups4:
- PSADT (≤6 months or >6 months)
- Prior use of bone-targeting agents (yes or no)
*95% CI: 34.3-NE. †95% CI: 15.5-22.3.