Results from the phase 3 NRG Oncology/Radiation Therapy Oncology Group (RTOG) 0815 study (NCT00936390) show that the addition of short-term androgen deprivation therapy (STAD) to escalating-dose radiation therapy improves overall survival (OS ) showed no improvement. prostate cancer; however, the addition of STAD improved secondary endpoints such as metastasis rate, prostate cancer-specific mortality, and PSA failure.1
Multivariate subgroup analysis showed that patients with a single intermediate-risk factor, multiple intermediate-risk factors, or a predominant Gleason pattern did not have superior OS with the combination of STAD and RT. was done.
Patients who received radiotherapy alone (arm 1) had 5- and 8-year OS rates of 90% and 79%, compared with 91% and was 84% (hazard ratio [HR]0.85; 95% CI, 0.65–1.11; P. = .22; adjusted HR, 0.84. 95% CI, 0.65–1.10). In addition, 10 patients died of prostate cancer in arm 1 compared to 1 patient in arm 2 (cause-specific HR, 0.10; 95% CI, 0.01-0.80; P. = .007).
The 5- and 8-year cumulative incidence of distant metastasis in arms 1 and 2 was 3.1% and 4.3% vs. 0.6% and 1.0%, respectively (HR, 0.25; 95% CI, 0.11-0.57; P. <.001). His 5- and 8-year PSA failure rates for each arm were 14% and 21% versus 8% and 10% (HR, 0.52; 95% CI, 0.39–0.70; P. <.001). In addition, rates of receiving 5- and 8-year salvage androgen deprivation therapy were 6.1% and 9.8% versus 4.2% and 5.8% in the respective arms (HR, 0.62; 95% CI, 0.41-0.95; P. = .025).
Investigators reported no significant difference in non-prostate cancer-specific mortality between arms 1 and 2 (HR, 0.92; 95% CI, 0.70-1.21; P. = .56). The 5-year and 8-year local recurrence rates for arms 1 and 2 were 2.6% and 3.9%, respectively, compared with 0.6% and 2.0% (HR, 0.44; 95% CI, 0.22-0.90; P. = .021). Furthermore, the combined 5- and 8-year rates of clinical or biochemical failure were 14.8% and 22.5% versus 7.9% and 11.4% in the respective groups (HR, 0.52; 95% CI, 0.39 -0.70; P. <.001).
“Although there is an early decline in hormones and quality of sexual life, [patients who] It is encouraging to note that this effect was temporary as a result of receiving short-term hormone therapy in addition to radiation, and that QOL outcomes were not clinically significant between the two groups by 1 year. Ford Health Center said in a press release regarding the patient-reported outcomes (PROs) of the NRG RTOG 0815 study.2 “[PROs] These can be very helpful in helping individuals make informed decisions when deciding on treatment options. ”
Investigators in the phase 3 NRG RTOG 0815 study evaluated the addition of STAD therapy to radiation therapy for patients with intermediate-risk prostate cancer. Radiotherapy modalities included 79.2 Gy or 45 Gy external beam radiation alone and brachytherapy boost. In arm 2, the patient also received a luteinizing hormone-releasing hormone agonist or antagonist and an antiandrogen for 6 months starting 8 weeks before her radiotherapy.
The primary endpoint was OS. Secondary endpoints included prostate cancer-specific mortality, non-prostate cancer-specific mortality, distant metastasis, PSA failure, and incidence of salvage therapy.
Patients diagnosed with intermediate-risk prostate cancer within 6 months of study treatment were eligible for enrollment. Patients also had to have at least 1 of the following characteristics: stage T2b to T2c disease, a Gleason score of 7, or >10 and ≤20 ng/mL pretreatment her PSA level.
The study included a total of 1492 patients, of whom 750 received radiotherapy alone and 742 received androgen deprivation plus radiotherapy. The investigators determined that disease characteristics and baseline demographics were comparable between her two treatment arms.
In the overall population, most patients were 60-69 years old (46%), Caucasian (75%), and had a Zubrod performance status of 0 (86%). In addition, most patients he had 1 intermediate risk factor (67%), received escalating dose external beam radiotherapy (89%), and had stage T1 disease (63%).
Multivariate subgroup analyzes showed that patients with a single intermediate-risk factor, multiple intermediate-risk factors, or a predominant Gleason pattern did not have superior OS with the combination of STAD and RT. was done. Moreover, the addition of STAD improved PSA failure and distant metastasis rates in all subgroups except those with a Gleason score of 2–6 for her.
Acute Grade ≥3 adverse reactions (AEs) occurred in 2% of Arm 1 patients and 12% of Arm 2 patients (P. <.001). The cumulative incidence of late grade ≥3 AEs was 14% and 15% in each group (P. = .29).
The incidence of late endocrine AEs and neurotoxicity in arms 1 and 2 was 3.3% vs 45.0%, respectively (P. <.001) and 5.3% vs 12.0% (P. <.001). Grade 3 sexual or reproductive symptoms occurred in her 4.8% and 5.0% of patients in each group.
References
1. Escalating-dose radiotherapy alone or with short-term androgen deprivation therapy for intermediate-risk prostate cancers such as Klaus DJ, Callison T, and Martinez AA: results from a multicenter phase III trial. J Clin Oncol. Published online April 27, 2023. doi:10.1200/JCO.22.02390
2. Patient-reported outcomes from the NRG Oncology study of androgen ablation with escalating-dose radiation therapy for intermediate-risk prostate cancer show no clinically meaningful score differences at 1 year after treatment. News release. NRG Oncology. April 27, 2023. Accessed April 28, 2023.