Prostate cancer is one of the leading cause of death in men globally and Dr. Reddy’s is committed to accelerate the access to affordable and innovative medicines as well as sharing the insights among the thought leaders. With this aim, webinar on the topic “Important Updates on Prostate Cancer from ASCO-20 & ASCO-GU 20” was organized by Dr. Reddy’s Laboratories Limited on August 1, 2020. The webinar was conducted by Dr. Reddy’s with over 100 oncologists, clinical oncologists and urologists on-board from Vietnam.
Non-metastatic castration-resistant prostate cancer
- SPARTAN, PROSPER, and ARAMIS are phase III trials, randomized placebo-controlled trials, evaluating Apalutamide, enzalutamide, and darolutamide respectively.
- Patients with a PSADT ≤ 10 months were included in all trials, these patients are at significant risk of metastases or death.
- All trials randomized patients 2:1 and metastasis-free survival was primary end point and Overall survival secondary endpoint.
- SPARTAN: Median follow-up at the time of data cut-off was 52 months. Median OS was significantly longer among men receiving apalutamide than placebo (73.9 vs 59.9 months), corresponding to a relative reduction of 21.6% in the risk of death (HR 0.78; P=0.0161).
- PROSPER: Median OS was 67.0 months in the enzalutamide group and 56.3 months in the placebo group (HR 0.73; 95% CI 0.61–0.89; P=0.001). An unplanned analysis indicated 3-year OS of 80% versus 73%. The benefit of enzalutamide was generally consistent across prespecified subgroups, with the potential exception of the small group of patients receiving bone-sparing agents.
- ARAMIS: With a median follow-up of approximately 29 months, the 3-year OS rates were 83% and 77% on the darolutamide and placebo arms, respectively (HR 0.69; 95% CI 0.53-0.88; P=0.003). Notably, darolutamide significantly delayed time to pain progression, with a median 40.3 months versus 25.4 months with placebo (HR 0.65; 95% CI 0.53-0.79; P<0>
- The safety profile of all 3 agents was consistent with prior analyses of the androgen receptor inhibitors.
- the incidence of treatment-associated adverse events, including fatigue, bone fracture, decreased weight, rash, hypertension, and hot flash were not found to be statistically different between the agents.
Recent advances in mHSPC
- Docetaxel in men with metastatic (M1) disease: Results from three trials CHAARTED, GETUG-15, STAMPEDE trials (2992 [93%] of 3206 men randomised) showed that the addition of docetaxel to standard of care improved survival. T
- The HR of 0·77 (95% CI 0·68-0·87; p<0>
- LATITUDE clinical trial: Newly diagnosed patients with high-risk mHSPC, defined as having ≥2 of the following criteria: Gleason score ≥8, ≥3 lesions on bone scan and Measurable visceral lesion were enrolled. 1199 men were randomized to receive ADT with abiraterone and prednisone, versus ADT with dual placebos.
- Final analysis was conducted after a median follow-up of 51.8 months, AA+P treatment continued to show significant OS benefits compared to placebo alone 53.3 months vs. 36.5 months in the placebo, HR: 0.66, 95% CI: 0.56-0.78; p<0>
- OS benefit was consistent across subgroup analyses.
- Adding abiraterone to androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: based on 2,201 men OS analysis results from LATITUDE and STAMPEDE, showed a highly significant 38% reduction in the risk of death with AAP plus ADT (HR = 0.62, 95% CI= 0.53- 0.71, p= 0.55X1010, that translates into a 14