2026-06-04

Prostate

MROQC: ARPI recommendations for STAMPEDE M0-eligible pts rose 0% → 23.2% post publication, and facility-level ADT variability persisted after MVA adjustment.

Unclear

MROQC ADT Practice Patterns

ForIntact high-risk M0, N0-1 prostate cancer, definitive RT

TL;DRGuideline-concordant ≥18mo ADT intended in 67.0% of high-risk M0/N0-1 pts receiving definitive RT; ARPI recommended in 23.2% of STAMPEDE-eligible pts post-publication.

Why it mattersRadiation oncology

Facility-level variability in ≥18mo ADT recommendations persisted after adjusting for cN1, grade group and PSA (P<.0001), so treating site, not only tumor features, shapes duration. Among STAMPEDE M0-eligible pts, ARPI recommendations reached only 23.2% after publication, a gap a department can audit directly in its own high-risk RT cohort. The longer read

9 details

Design

Prospective statewide quality-consortium data (MROQC), N=553 across 26 centers, June 2020 to November 2024. Multivariable analysis of predictors, a mixed-effects model with treatment site as random intercept, and ARPI adoption compared before vs after STAMPEDE M0 publication.

Population & inclusion

Intact high-risk M0, N0-1 prostate cancer treated with definitive RT: cT3/4 13.3%, cN1 19.9%, GG 4-5 75.0%, PSA ≥20 ng/mL 40.0%. 27.9% met STAMPEDE M0 criteria (≥2 of cT3/T4, GG 4-5, PSA ≥40 ng/mL, or cN1).

Endpoints

Primary: intended guideline-concordant ADT (GC-ADT, ≥18 months) per 2022 AUA/ASTRO. Also assessed: ARPI recommendation in STAMPEDE-eligible pts and facility-level variability.

Results

91.3% recommended any ADT, 67.0% guideline-concordant. ARPI recommendations in STAMPEDE-eligible pts rose from 0% to 23.2% after publication; facility variability persisted on MVA (P<.0001).

Factor	OR (95% CI)
cN1	2.94 (1.44-5.99)
GG4	6.23 (2.85-13.62)
GG5	9.45 (4.46-20.06)
PSA ≥40 ng/mL	3.64 (1.22-10.87)

Applies to

intact high-risk M0/N0-1 prostate cancer treated with definitive RT

Does not represent post-prostatectomy, intermediate-risk, or metastatic pts, or the ADT duration actually delivered.

vs leading data

Benchmarks practice against the 2022 AUA/ASTRO 18-36 month recommendation and STAMPEDE M0 ARPI intensification criteria. Single-state data, and the source offers no comparison with other practice settings.

Limitations

The abstract gives no reasons for sub-18mo recommendations (comorbidity, pt preference, toxicity), so non-concordance is not necessarily poor care. The ARPI comparison is an uncontrolled before-after design, and no OR is reported for cT3/4.

Discussion

The strongest predictors of a concordant recommendation were grade group (GG5 OR 9.45) and cN1, consistent with shorter courses being offered when high-risk status rests on other features. Residual site variability points to local norms beyond the modelled case mix, though unmeasured covariates could contribute.

Rationale

Practice-patterns study of intended ADT recommendations; no efficacy or outcome endpoint, so nothing here confirms or challenges SOC.

Open questions

Delivered vs intended ADT duration in routine definitive RT practice
Drivers of facility-level variation in ADT duration recommendations
Barriers to ARPI intensification in STAMPEDE M0-eligible pts

Sourced from Dykstra, Michael P. et al.

📚 Sources · 📄 1 paper

📄 PAPER Dykstra, Michael P.; Regan, Samuel N.; Yin, Huiying (Maggie) et al. · JCO Oncology Practice (2025-09)

Androgen Deprivation Therapy Practice Patterns in High-Risk Prostate Cancer Treated With Definitive Radiotherapy: Prospective Results From a Statewide Quality Consortium

doi

Abstract

PURPOSE The 2022 AUA/ASTRO guidelines recommend 18-36 months of androgen deprivation therapy (ADT) with definitive radiotherapy for localized, high-risk prostate cancer. The STAMPEDE M0 trial supports intensification with androgen receptor pathway inhibitors (ARPIs) for patients with ≥2 cT3/T4, Grade Group [GG] 4-5, prostate-specific antigen (PSA) ≥40 ng/mL, or cN1. Given advances in imaging, risk stratification, and treatment delivery, we characterized contemporary practice patterns using prospective data from the Michigan Radiation Oncology Quality Consortium (MROQC). METHODS Patients enrolled in MROQC with intact, high-risk M0/N0-1 prostate cancer were included. Clinical information, including intended ADT duration and ARPI use, was prospectively collected. The primary outcome was intended guideline-concordant ADT (GC-ADT, ≥18 months). Multivariable analyses (MVA) assessed associations between clinical factors and GC-ADT recommendations. We compared the adoption of ARPI with standard therapies before and after the publication of STAMPEDE M0. Facility-level variability was evaluated using a mixed-effects model, with the treatment site as a random intercept. RESULTS Between June 2020 and November 2024, 553 patients across 26 centers were included: cT3/4 (13.3%), cN1 (19.9%), GG 4-5 (75.0%), and PSA ≥20 ng/mL (40.0%). Overall, 91.3% were recommended ADT, with 67.0% being guideline-concordant. On MVA, GC-ADT was significantly associated with cN1 (odds ratio [OR], 2.94 [95% CI, 1.44 to 5.99]), GG (GG4 OR, 6.23 [95% CI, 2.85 to 13.62]; GG5 OR, 9.45 [95% CI, 4.46 to 20.06]), and PSA ≥40 (OR, 3.64 [95% CI, 1.22–10.87]). Facility-level variability persisted in the MVA ( P < .0001). Among the 27.9% who met meeting STAMPEDE criteria, ARPI recommendations increased from 0% prepublication to 23.2% afterward. CONCLUSION Within a statewide quality consortium, guideline-concordant ADT recommendations occurred in two thirds of patients, with ARPI intensification in under 25% among STAMPEDE-eligible patients. These findings highlight the need for individualized ADT strategies and collaborative efforts to standardize high-quality care.

Combined Curative Real-world evidence Unclear

Head & Neck

AREST informs adjuvant RT addition for pN0 OSCC with DOI 5-10mm, PNI, LVE, or poor differentiation: loco-regional gain, no survival gain, RT morbidity unquantified.

Confirmatory

AREST

ForResected pT1-2N0 OSCC, margins ≥5mm, ≥1 intermediate-risk feature

Loco-regional recurrence-free survival local control

HR 0.52

95% CI 0.30-0.91, p=0.02 · 3-yr 89.2% vs 80.9% (ITT)

TL;DR3-yr LRFS 89.2% vs 80.9% (HR 0.52, p=0.02) with adjuvant RT vs observation in resected intermediate-risk pT1-2N0 OSCC; no significant DFS/OS difference.

Why it mattersRadiation oncology

Competing-risk LRF incidence was 10.6% vs 18.9% (HR 0.52) with 60Gy/30fx to tumor bed and at-risk neck. Controls had ≥5mm margins and a level I-III dissection with ≥16 nodes, so this is RT's increment over high-quality surgery alone. It moves adjuvant RT vs observation most for oral tongue, an exploratory subgroup.

Monday clinic

In pT1-2N0 OSCC resected with ≥5mm margins and an adequate level I-III neck dissection but carrying PNI, LVE, poor differentiation or DOI ≥5 to ≤10mm, this supports discussing adjuvant RT for loco-regional control; it does not extend to close-margin, limited-neck or node-positive disease. The longer read

9 details

Design

Multicenter, open-label, phase III RCT from India, 1:1, stratified by oral cavity subsite, PNI/LVE and differentiation. N=392 (191 RT, 201 observation); median follow-up 47.2 mo (IQR 30-59.4). Powered at 80% to detect HR 0.6256, assuming 3-yr LRFS 70% with observation.

Population & inclusion

pT1-T2, pN0 OSCC after adequate surgery: clear margins ≥5mm and at least ipsilateral level I-III neck dissection with ≥16 nodes. Required ≥1 intermediate risk factor: DOI ≥5 to ≤10mm, PNI, LVE, or poor differentiation.

Radiotherapy

60Gy in 30 fractions over 6 weeks to the resected tumor bed and at-risk neck nodal region. Technique and nodal volume definitions not stated in source; no concurrent systemic therapy described.

Endpoints

Primary: loco-regional recurrence-free survival, from randomization to first local and/or regional recurrence. Also reported: cumulative incidence of loco-regional failure with death as competing event, DFS, OS.

Results

LRFS benefit held on PP and competing-risk analyses; DFS and OS not significantly different, with no survival HRs in source.

Endpoint	Adjuvant RT	Observation	HR (95% CI), p
3-yr LRFS, ITT	89.2% (84.3-93.3)	80.9% (74.6-86.1)	0.52 (0.30-0.91), p=0.02
3-yr LRFS, PP	91.1%	80.9%	0.43 (0.23-0.80), p=0.01
LRF cumulative incidence (death competing), ITT	10.6% (6.1-15.1)	18.9% (13.3-24.6)	0.52 (0.30-0.91), p=0.021
LRF cumulative incidence (death competing), PP	8.7% (4.3-13.1)	18.9% (13.3-24.6)	0.43 (0.23-0.79), p=0.007

vs leading data

The abstract describes the evidence for adjuvant RT in this setting as largely retrospective; AREST is the randomised test of that practice. The RTOG and EORTC postoperative trials tested adding concurrent chemo to RT in high-risk resected disease and did not randomise RT itself against observation.

Applies to

pT1-2N0 OSCC with margins ≥5mm, an ipsilateral level I-III neck dissection yielding ≥16 nodes, and ≥1 intermediate-risk feature

Does not represent close or positive margins, pN+ disease, or pts without a formal neck dissection.

Limitations

Control arm beat its design assumption (3-yr LRFS 80.9% vs 70% assumed), so the absolute gain sits against a lower-risk baseline than planned. Oral tongue vs buccal mucosa is an exploratory subgroup with no HR in source, and no result is given per risk factor. Salvage treatment at recurrence is not described, which bears on the OS read.

Discussion

Loco-regional control improved without DFS or OS separation; one explanation is effective salvage of isolated recurrences in observed pts, which the abstract cannot confirm. The decision it moves is adjuvant RT vs observation after adequate resection, weighed against RT morbidity the abstract does not report.

Enrolment

CONSORT flow

Randomized392

↓

Adjuvant RT

allocated 191

3yr LRFS 89.2%

Observation

allocated 201

3yr LRFS 80.9%

Rationale

Randomised phase III hit LRFS primary at 47.2 mo median f/u; DFS/OS not significantly different and no toxicity data in abstract, so supports rather than mandates adjuvant RT.

Open questions

Which intermediate-risk feature (PNI, LVE, DOI, grade) drives the benefit?
Does the oral tongue benefit hold as a prespecified subgroup?
Late RT toxicity and salvage outcomes in the observation arm

Sourced from @DrRishabhOnco, Nair, Sudhir Vasudevan et al.

📚 Sources · 🐦 1 tweet · 📄 1 paper

#ASCO26

🗣️ The AREST trial tackles one of the biggest gray zones in oral cavity cancer.

After adequate surgery in pT1-2N0 OSCC with intermediate-risk features:

✅ Adjuvant RT improved loco-regional control
❌ No OS benefit observed

3-year LRFS:
🔹 89.2% vs 80.9%
🔹 HR 0.52… https://t.co/qsALPFX032 pic.twitter.com/F4XzTMETih
— Dr Rishabh Jain (@DrRishabhOnco) May 27, 2026

📄 PAPER Nair, Sudhir Vasudevan; Gupta, Tejpal; Rane, Swapnil Ulhas et al. · Journal of Clinical Oncology (2026-06)

Adjuvant radiotherapy versus observation following curative surgery for early-stage oral squamous cell carcinoma (AREST; CTRI/2017/07/009114).

doi article →

Abstract

6000 Background: The role of adjuvant radiotherapy (RT) in early-stage, node-negative oral squamous cell carcinoma (OSCC) with one or more intermediate risk factors - such as depth of invasion (DOI) ≥5 to ≤10mm, perineural invasion (PNI), lymphovascular emboli (LVE), or poor differentiation - remains debatable and is largely based on retrospective data. This multicenter, open-label, phase III randomized controlled trial was designed to assess the impact of post-operative adjuvant RT in this setting. Methods: Patients with early-stage (pT1-T2), node-negative (pN0) OSCC undergoing adequate surgery (defined as clear margins ≥5mm and at least ipsilateral level I-III neck dissection with ≥16 nodes) with presence of one or more intermediate risk factors were screened. Eligible patients underwent stratified randomization (oral cavity subsite, PNI/LVE, and differentiation) in 1:1 ratio to either observation or adjuvant RT (60Gy in 30 fractions over 6-weeks) to the resected tumor-bed and at-risk neck nodal region after written informed consent. Primary endpoint was loco-regional recurrence-free survival (LRFS) measured from randomization to first documented event of local and/or regional recurrence from index cancer. All time-to-event outcomes were computed using Kaplan-Meier (KM) method with log-rank test for comparison and expressed as 3-year point estimates with 95% confidence intervals (CI). The planned sample size (N=392) provided 80% power at an α of 0.05 to detect a Hazard Ratio (HR) of 0.6256, assuming 3-year LRFS of 70% in the observation arm. Results: Following curative surgery, a total of 392 patients were randomized (191 to adjuvant RT; 201 to observation). Baseline characteristics were balanced between the two arms. At a median follow-up of 47.2 months (inter-quartile range=30-59.4 months), 3-year KM estimate of LRFS was 89.2% in adjuvant RT arm vs 80.9% in observation arm (HR=0.52, 95%CI=0.30-0.91; p=0.02) in the intention-to-treat (ITT) population and 91.1% vs 80.9% (HR=0.43, 95%CI=0.23-0.80; p=0.01) on per-protocol (PP) analyses. Cumulative incidence of loco-regional failure with death as competing event was 10.6% (95%CI=6.1%-15.1%) with adjuvant RT and 18.9% (95%CI=13.3%-24.6%) with observation (HR=0.52, 95%CI=0.30-0.91; p=0.021) in the ITT population and 8.7% (95%CI=4.3%-13.1%) vs 18.9% (95%CI=13.3%-24.6%) (HR=0.43, 95%CI=0.23-0.79; p=0.007) on PP analyses. Disease-free and overall survival were not significantly different between the two arms. Subgroup analysis identified oral tongue deriving higher benefit of adjuvant RT compared to buccal mucosa. Conclusions: Adjuvant RT significantly reduces risk of loco-regional recurrence for early-stage, node-negative adequately resected OSCC, particularly oral tongue. However, such reduction in loco-regional failure does not translate into significant survival benefit. Clinical trial information: CTRI/2017/07/009114.

📝 https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.6000

Radiation Curative Phase 3 RCT Confirmatory ASCO Annual Meeting 2026