San Francisco, California (UroToday.com) The survival outcomes of the CARD trial, a practice-informing study of men with pre-treated metastatic castration-resistant prostate cancer (mCRPC), have previously been reported. However, there were a number of pre-planned quality of life (QoL) outcomes that importantly influence the clinician’s and the patient’s decision regarding choosing chemotherapy versus potent hormonal therapy, that are closely awaited. In his rapid abstract talk, Prof Karim Fizazi presented QoL outcomes of the study and importantly, elaborated on the importance of these findings to the clinical care of men with mCRPC.
The CARD trial was a multicenter, randomized, open-label study that enrolled men with mCRPC between 2015 and 2018. Patients were eligible if they had evidence of progressive disease within 12 months of prior androgen receptor targeted agent (ARTA), before or after prior docetaxel. Men were randomized in a 1:1 fashion to cabazitaxel versus abiraterone or enzalutamide with a primary endpoint of radiographic progression-free survival (rPFS). In the results previously presented, rPFS and overall survival (OS) were significantly prolonged with cabazitaxel, compared with abiraterone or enzalutamide.
The objective of this QoL was directed at three particular domains: pain response and time to pain progression; symptomatic skeletal events and patient-reported outcomes (FACT-P tool). Firstly, pain response was significantly greater in patients who have received cabazitaxel (45% vs 19.3%, p<0.0001) and furthermore, the probability of ‘no’ pain progression was greater with cabazitaxel at sequential time points: 3 months, 6 months, 9 months, 12 months. Taken together, cabazitaxel was associated with more frequent pain response and a greater chance of having ‘no pain’ progression, compared with abiraterone/enzalutamide.
Secondly, time to first symptomatic skeletal event was prolonged in the cabazitaxel arm (median NR versus 16.7 months, HR 0.58, 95%CI 0.35-1.01, p=0.05). Similarly, the probability of ‘no’ symptomatic skeletal events was greater in the cabazitaxel arm than the abiraterone/enzalutamide arm. Thirdly, using the FACT-P tool, the probability of no deterioration at 3 months in multiple physical, emotional, function, pain and prostate-specific domains was consistently greater in the cabazitaxel arm. Plotted per cycle, prostate-specific concerns and pain-related symptoms appeared to have more favorable QoL scores than hormonal therapy.
Prof Fizazi concluded that in the CARD trial, cabazitaxel not only improved rPFS and OS, it was associated with improved pain, time to pain progression and time to symptomatic skeletal events. Therefore, these results support the use of cabazitaxel over ARTA therapy in men with mCRPC previously treated with docetaxel and who progressed within 12 months of ARTA. Taken together, these QoL findings are an important part of discussing the known benefit of cabazitaxel chemotherapy in this patient population.
Presented by: Karim Fizazi, MD, PhD, Head of the Department of Cancer Medicine, Institut Gustave Roussy, Villejuif, France and Professor of Oncology at the University of Paris.
Written by: Anis Hamid, MBBS, Medical Oncology Research Fellow at Dana-Farber Cancer Institute and Medical Oncologist, PhD candidate, University of Melbourne, Australia (Twitter: @anis_a_hamid) at the 2020 Genitourinary Cancers Symposium, ASCO GU #GU20, February 13-15, 2020, San Francisco, California
Watch: Cabazitaxel Improves Pain and Health-Related Quality of Life Analysis in Patients with mCRPC, Results from the CARD Study - Karim Fizazi