KEY TAKEAWAYS
- The TITAN phase 3 trial aimed to assess patient outcomes based on prior docetaxel chemotherapy before Apa+ADT.
- The results revealed no added benefit from docetaxel before Apa+ADT in patients with mCSPC, citing limited data and analysis.
In the Phase 3 TITAN study, the inclusion of apalutamide (Apa) with androgen deprivation therapy (ADT) notably enhanced overall survival (OS) and other clinical parameters compared to placebo in patients with metastatic castration-sensitive prostate cancer (mCSPC).
Julia Batten and the team aimed to examine patient outcomes based on prior docetaxel chemotherapy before Apa+ADT administration.
Patients received either Apa or placebo alongside ongoing ADT, with some having prior docetaxel with ADT before randomization. The analysis evaluated the influence of prior docetaxel exposure on radiographic progression-free survival (rPFS) at the first interim analysis (median follow-up: 23 months).
At the final analysis (median follow-up: 44 months), the impact of prior docetaxel on OS and time to prostate-specific antigen (PSA) progression was examined. Furthermore, the study analyzed the effect of disease volume at baseline according to adapted CHAARTED criteria, along with matching baseline characteristics.
The results revealed that among 525 patients receiving Apa+ADT in TITAN, 58 (11%) had prior docetaxel treatment in which 76% had high-volume disease, 62% had bone-only metastases, 16% had visceral metastases, and 59% had >10 bone lesions. Analysis showed no significant difference in OS, rPFS, or time to PSA progression with Apa+ADT, regardless of prior docetaxel receipt. This held for both high-volume and low-volume disease subgroups and when baseline characteristics were matched, including PSA levels and time from initial diagnosis to randomization. Safety profiles of Apa were unaffected by prior docetaxel exposure.
The study concluded that prior docetaxel treatment did not enhance the clinical advantages of Apa+ADT in patients with mCSPC patients in TITAN. However, limitations include the small proportion of patients who received prior docetaxel (only 11% of TITAN participants) and the absence of tumor volume data. Additionally, since docetaxel was administered as a prior therapy, information regarding disease characteristics before docetaxel initiation was unavailable.
The trial was sponsored by Aragon Pharmaceuticals, Inc.
Source: https://ons.confex.com/ons/2024/meetingapp.cgi/Paper/15604
Clinical Trial: https://clinicaltrials.gov/study/NCT02489318
Batten J, Chi KN, Given R, et al. (2024). “The Effect of Prior Docetaxel Treatment in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving Apalutamide plus Androgen Deprivation Therapy (TITAN Study).” Presented at ONS 2024 (I20)
