Higher-Dose RT Extends Survival in High-Risk Prostate Cancer
For sufferers with high-pains prostate most cancers, medication with prolonged-term androgen deprivation treatment (ADT) and high-dose radiation became connected to vastly better progression-free, most cancers-train, and general survival in comparison with ADT and identical earlier-dose radiation.
The investigators also stumbled on that the sufferers taking prolonged-term ADT and high-dose radiation didn’t skills additional unhurried urinary tract or gastrointestinal toxicities. Christophe Hennequin, MD, PhD, reported these and diverse findings of the Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Most cancers (GETUG-AFU 18) trial, at the 2024 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium.
Amongst 505 sufferers randomly assigned to be treated with radiation treatment (RT) at either the typical 70 Gy dose or a high, 80 Gy dose followed by 3 years of adjuvant ADT, the 10-year progression-free survival (PFS) rate became 83.6% for sufferers who had obtained the 80 Gy dose, vs. 72.2% for sufferers who had obtained the 70 Gy dose. This translated staunch into a hazard ratio (HR) for biochemical or scientific progression of 0.56 (P = .0005).
This PFS income for high-dose radiation became also mirrored by an general survival (OS) income, with 10-year OS rates of 77% vs. 65.9%, respectively, translating staunch into a 39% reduction in pains of death (HR 0.61, P = .0039) for sufferers who had obtained the upper radiation dose, reported Dr. Hennequin, of the Health facility Saint Louis in Paris, France.
“We bask in got now Degree 1 evidence that high-dose RT with prolonged-term ADT ought to be the typical of care in high-pains prostate most cancers sufferers,” he said at the assembly.
Dr. Hennequin illustrious that vastly more sufferers assigned to high-dose RT had been treated with depth modulated radiation treatment (IMRT) in preference to earlier beam radiation, and emphasised that the superior outcomes viewed with the upper dose is seemingly as a consequence of the notify of IMRT.
Prior evidence
Dr. Hennequin pointed to a meta-prognosis printed in The Lancet in 2022 which confirmed that among nearly 11,000 sufferers with a median note-up of 11.4 years the addition of ADT to RT vastly improved metastasis-free survival, and that longer ADT lowered the pains of metastases by 16% in comparison with identical earlier time desk ADT.
He also cited the DART 01/05 trial outcomes, which bask in been printed in 2022 in The Lancet: Oncology, which stumbled on a clinically relevant income for 24 months vs. 4 months of adjuvant ADT following no longer less than 76 Gy radiation in sufferers with high-pains disease, however no longer among sufferers with intermediate-pains disease.
The GETUG-AFU 18 trial became designed to take care of the question of whether 80 Gy of radiation would per chance well beef up outcomes in comparison with 70 Gy in sufferers treated with prolonged-term ADT.
Look for necessary facets and outcomes
The investigators enrolled males with high-pains prostate most cancers outlined as either a prostate-train antigen (PSA) level 20 ng/ml or elevated, Gleason gain 8 or higher, or scientific stage T3 or T4 disease, and after stratification by medication center and lymph node resection randomly assigned them to obtain either 70 Gy or 80 Gy RT followed by 3 years of ADT.
Roughly two-thirds of the sufferers in each realizing arm had one pains ingredient and about one-fourth had two pains factors. The final sufferers had all three high-pains defining factors.
Roughly 16.5% of sufferers in each arm had passed thru lymph node dissection.
The median ADT duration became 33.4 months. In all, 82.9% of sufferers underwent pelvic lymph node radiation; lymph node radiation became no longer performed in these sufferers who had detrimental node dissection outcomes.
Greatly more sufferers assigned to the 80 Gy dose had been treated with IMRT (80.6% vs. 58.6%, P < .001).
The most cancers-train survival rate became also higher for the neighborhood receiving the 80 Gy dose, with a 10 year rate of 95.6% vs. 90% for sufferers treated with 70 Gy. This incompatibility translated staunch into a HR of 0.forty eight (P = .0090).
Similar security
The safety prognosis, which integrated 248 sufferers who obtained 80 Gy and 251 who obtained 70 Gy, confirmed that the incidence rates of each unhurried genitourinary and gastrointestinal toxicities had been low and similar between the groups. Grade 3 or elevated unhurried genitourinary toxicities had been viewed in 2.0% of sufferers treated with 80 Gy and 3.2% of these treated with 70 Gy. In each fingers, handiest 1.6% of sufferers had grade 3 or elevated later GI toxicities.
There bask in been also no differences between the realizing fingers in affected person-reported quality of existence measures connected to either bowel or urinary symptoms.
Invited discussant Neha Vapiwala, MD, FACR, from Penn Remedy in Philadelphia commented that the implications of the GETUG-AFU 18 trial counsel that “at the same time as you had even decrease-dose systemic treatment that the radiation regulate at the local level – local-regional level on this case – can if fact be told make a contribution to the prevention of distant metastases and would per chance well make a contribution to most cancers-train survival.”
She said that with the efficacy outcomes and the similar toxicity and quality of existence measures, dose-escalated radiation treatment and prolonged-term ADT appear to provide a synergistic income.
The outcomes are “practice-asserting for many, maybe practice-altering for some at the same time as you is at risk of be no longer already offering this,” she said.
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