STAD Fails to Improve Survival Over Radiotherapy Alone in Prostate Cancer

Article

The addition of short-term androgen deprivation to dose-escalated radiation therapy did not yield a significant difference in quality-of-life outcomes vs radiotherapy alone for those with intermediate-risk prostate cancer, according to an expert from Henry Ford Health Cancer.

The addition of short-term androgen deprivation (STAD) to dose-escalated radiotherapy did not improve overall survival (OS) for patients with intermediate-risk prostate cancer, although the regimen did produce some benefit in metastases rates, prostate cancer death, and prostate-specific antigen (PSA) failures, according to data from the phase 3 NRG Oncology/Radiation Therapy Oncology Group (RTOG) 0815 study (NCT00936390).1

"While there is an initial decline in the hormone and sexual quality of life for [patients who] received short-term hormones in addition to radiation, it is reassuring that this impact was temporary and that quality-of-life outcomes were not clinically meaningfully different between arms by one year," according to an expert from Henry Ford Health Center.

"While there is an initial decline in the hormone and sexual quality of life for [patients who] received short-term hormones in addition to radiation, it is reassuring that this impact was temporary and that quality-of-life outcomes were not clinically meaningfully different between arms by one year," according to an expert from Henry Ford Health Center.

The 5-year and 8-year OS rates for patients receiving radiotherapy alone (arm 1) were 90% and 79% vs 91% and 84% for those receiving radiotherapy plus androgen deprivation in arm 2 (Hazard ratio [HR], 0.85; 95% CI, 0.65-1.11; P = .22; adjusted HR, 0.84; 95% CI, 0.65-1.10). Additionally, 10 patients died of prostate cancer in arm 1 vs 1 patient in arm 2 (cause-specific HR, 0.10; 95% CI, 0.01-0.80; P = .007).

The 5-year and 8-year cumulative distant metastasis incidence rate in arm 1 and arm 2, respectively, were 3.1% and 4.3% vs 0.6% and 1.0% (HR, 0.25; 95% CI, 0.11-0.57; P <.001). The 5-year and 8-year PSA failure rates in each respective arm were 14% and 21% vs 8% and 10% (HR, 0.52; 95% CI, 0.39-0.70; P <.001). Additionally, the 5-year and 8-year salvage androgen deprivation therapy reception rates were 6.1% and 9.8% vs 4.2% and 5.8% in each respective arm (HR, 0.62; 95% CI, 0.41-0.95; P = .025).

Investigators reported no significant differences 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 in arms 1 and 2, respectively, were 2.6% and 3.9% vs 0.6% and 2.0% (HR, 0.44; 95% CI, 0.22-0.90; P = .021). Additionally, the 5-year and 8-year combined rates of clinical or biochemical failure were 14.8% and 22.5% vs 7.9% and 11.4% in each respective arm (HR, 0.52; 95% CI, 0.39-0.70; P <.001).

“While there is an initial decline in the hormone and sexual quality of life for [patients who] received short-term hormones in addition to radiation, it is reassuring that this impact was temporary and that quality-of-life outcomes were not clinically meaningfully different between arms by one year,” study author Benjamin Movsas, MD, medical director of the Henry Ford Health Center, said in a press release on patient-reported outcomes (PROs) in the NRG RTOG 0815 study.2 “[PROs] such as these are incredibly valuable to help individuals make informed decisions when determining their treatment options.”

Investigators of the phase 3 NRG RTOG 0815 study assessed the addition of STAD therapy to radiotherapy for patients with intermediate-risk prostate cancer. Radiotherapy modalities included external-beam radiation alone at 79.2 Gy or 45 Gy with brachytherapy boost. In arm 2, patients also received a luteinizing hormone-releasing hormone agonists or antagonists plus antiandrogen for 6 months beginning 8 weeks before radiotherapy.

The primary end point was OS. Secondary end points included prostate cancer-specific mortality, non-prostate cancer-specific mortality, distant metastases, PSA failure, and incidence of salvage therapy.

Patients who had a diagnosis of intermediate-risk prostate cancer within 6 months of study treatment were eligible for enrollment. Patients also needed to have at least 1 of the following features: stage T2b to T2c disease, a Gleason score of 7, or a pretreatment PSA value above 10 and 20 ng/mL or less.

The study included a total of 1492 patients, 750 of whom received radiotherapy alone and 742 received androgen deprivation plus radiotherapy. Investigators determined that disease characteristics and baseline demographics were comparable between the 2 treatment arms.

In the overall population, most patients were between the ages of 60 and 69 (46%), White (75%), and had a Zubrod performance status of 0 (86%). Additionally, most patients had 1 intermediate-risk factor (67%), received dose-escalated external-beam radiotherapy (89%), and had stage T1 disease (63%).

Multivariate subgroup analyses indicated that STAD therapy plus radiotherapy did not yield superior OS for those with a single intermediate-risk factor, multiple intermediate-risk factors, or a predominant Gleason pattern. Moreover, the addition of STAD yielded improvements in all subgroups for PSA failure and distant metastasis rates except for those who had a Gleason score of 2 to 6.

Acute grade 3 or higher adverse effects (AEs) occurred in 2% of patients in arm 1 and 12% of those in arm 2 (P <.001). The cumulative incidence rates of late grade 3 or higher AEs were 14% and 15% in each respective arm (P = .29).

The rates of late endocrine AEs and neurologic toxicity in arms 1 and 2, respectively, were 3.3% vs 45.0% (P <.001) and 5.3% vs 12.0% (P <.001). Grade 3 sexual or reproductive symptoms occurred in 4.8% and 5.0% of patients in each respective arm.

References

  1. Krauss DJ, Karrison T, Martinez AA, et al. Dose-escalated radiotherapy alone or in combination with short-term androgen deprivation for intermediate-risk rostate cancer: results of a phase III multi-institutional trial. J Clin Oncol. Published online April 27, 2023. doi:10.1200/JCO.22.02390
  2. Patient-reported outcomes form an NRG Oncology study of androgen deprivation therapy with dose-escalated radiotherapy for intermediate-risk prostate cancer show no clinically meaningful differences in scores at one year post-treatment. News release. NRG Oncology. April 27, 2023. Accessed April 28, 2023.
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