Case 2: The CARD Trial for Cabazitaxel in Metastatic CRPC
Patrick G. Pilié, MD, presents data from the phase 3 CARD trial of cabazitaxel in metastatic castration-resistant prostate cancer.
Jorge A. Garcia, MD, FACP: These are the NCCN [National Comprehensive Cancer Network] Guidelines for systemic therapy for M1 CRPC [castration-resistant prostate cancer], and not to our surprise, our discussion is consistent with those recommendations from NCCN Guidelines. You can see first-line therapy again here. Obviously, the sequence of events is completely dictated by the prior therapy rather than patients who receive it as a frontline treatment. We didn’t talk about sipuleucel-T. Most of us recognize that sipuleucel-T is not the ideal treatment choice for this particular patient. As you dissect these guidelines, you can see the first-line therapy on the preferred regimens based on NCCN Guidelines, based on primary therapy upon presentation with de novo metastatic disease.
Let’s have Dr Patrick Pilié review the CARD trial data, and then we’ll have Dr Mary-Ellen Taplin review the importance of the PROfound trial and rucaparib data for patients with DNA-repair deficiencies. Patrick?
Patrick G. Pilié, MD: Here is the CARD trial. This was the first trial that looked at this question of treatment sequence. We have multiple treatments that have been shown to prolong overall survival, but how do we incorporate them into the patients’ care? This trial included patients with metastatic castrate-resistant prostate cancer who had progressed in under 1 year on prior androgen-directed therapy, whether before or after receiving docetaxel chemotherapy.
They were randomized 1:1 to receive cabazitaxel at 25 mg/m2 with growth factor and prednisone vs the alternative androgen receptor signaling-directed agent. The primary end point was radiographic progression-free survival with key secondary end points as listed: overall survival [OS], PFS [progression-free survival], and PSA [prostate-specific antigen] response. Importantly, other secondary end points were also included: quality-of-life measures, pain, and time-to-skeletal events.
Looking at the baseline characteristics, the groups were relatively well matched. It’s important to note that this study population is the population that was relatively highly resistant to androgen receptor signaling-directed therapy, with progression occurring quickly. The primary end points of radiographic progression-free survival favored the patients who received cabazitaxel instead of the alternative androgen receptor–signaling inhibitor with the hazard ratio of 0.54. The median PFS in cabazitaxel is 8 months vs just under 4 months in the alternative androgen receptor–signaling arm. Both the PFS and OS favored cabazitaxel in this patient population with OS benefit, 13.6 vs 11 months in the androgen receptor–signaling targeted cohort. It’s important overall to note that any adverse events were relatively similar. There were slightly more patients in the cabazitaxel arm who had an adverse event leading to their treatment discontinuation vs the abiraterone-enzalutamide.
Transcript edited for clarity.
