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Meta-analysis

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Practice-changing

STAMPEDE (abiraterone ± enzalutamide, high-risk non-metastatic) NCT00268476

ForHigh-risk M0 prostate: node+ or ≥2 of T3-4/Gleason 8-10/PSA≥40

TL;DRMFS HR 0.53 (6yr 82% vs 69%) and OS HR 0.60 adding 2yr abiraterone to ADT in high-risk M0 prostate (85% also had RT).

Why it mattersRadiation oncology

The RT read: abiraterone sits on top of definitive ADT+RT (74Gy/37fx to prostate+SV in the 85% who got RT), not RT vs no-RT. It moves systemic intensification for the high-risk M0 pt you're already irradiating; enzalutamide adds nothing over abiraterone (interaction HR 1.02, p=0.91).

8 details 2 trials watching

Pooled meta-analysis of two open-label phase 3 RCTs within the STAMPEDE platform, 113 UK/Swiss sites, N=1974, randomized 1:1. Median follow-up 72 mo (60-84).

High-risk non-metastatic disease: node-positive, or if node-negative ≥2 of T3/T4, Gleason 8-10, PSA ≥40; or high-risk relapse. Median age 68, median PSA 34; 39% node-positive.

Abiraterone 1000mg + prednisolone 5mg daily for 2yr added to 3yr ADT; the second trial's combination arm also received enzalutamide 160mg. Control = ADT alone.

RT planned in 85% (1684/1974): 74Gy/37fx to prostate + seminal vesicles or hypofractionated equivalent. Mandated if node-negative, encouraged if node-positive.

Primary: metastasis-free survival. Secondary: OS, prostate cancer-specific survival, biochemical failure-free survival, PFS, and toxicity.

Adding enzalutamide to abiraterone gave no extra MFS benefit (interaction HR 1.02, p=0.91), with no between-trial heterogeneity.

high-risk non-metastatic prostate cancer treated with definitive ADT plus radiotherapy
Does not represent metastatic disease, lower-risk localized disease, or patients managed without radiotherapy.

Open-label design, though MFS/OS are hard endpoints less prone to ascertainment bias. Pooled across two platform trials; no radiotherapy-treated subgroup HR reported in the source excerpt.

Two randomised phase 3 trials pooled; MFS primary hit (HR 0.53) with concordant OS benefit at 72mo, applicable high-risk M0 population. Adding enzalutamide gave no extra benefit.

In high-risk M0 prostate (node+, or ≥2 of T3-4/Gleason 8-10/PSA≥40) going to definitive ADT+RT, this supports adding 2yr abiraterone; it does not extend to lower-risk localized disease, and adding enzalutamide buys nothing.

📚 Sources · 📄 1 paper
📄 PAPER Attard, Gerhardt; Murphy, Laura; Clarke, Noel W et al. · The Lancet (2022-01)
Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol
Confirmatory

HYDRA

ForLocalised prostate cancer, definitive EBRT, moderately hypofractionated

TL;DRNo PFS difference vs conventional RT for either MHFRT type, but dose-escalated MHFRT alone raised late G2+ GI + bowel-QoL decrement; isodose 60/20 clean.

Why it mattersRadiation oncology

The split that matters: dose-escalated MHFRT raised late G2+ GI (OR 1.48, p=0.0035) and patient-reported bowel decrement (OR 1.68, p=0.023), while isodose 60/20 stayed clean on every toxicity and QoL axis at equal PFS. Escalating buys no efficacy, so default to isodose MHFRT.

8 details 5 trials watching

IPD meta-analysis of 7 phase 3 RCTs (MARCAP consortium) of CFRT vs MHFRT. Primary efficacy endpoint PFS; co-primary toxicity late G2+ GU and G2+ GI; co-primary PRO urinary/bowel QoL decrement. Two prespecified strata: isodose vs dose-escalated MHFRT.

Localised prostate cancer. CFRT arm required modern dose (≥70 Gy in 2 Gy equivalents); trials lacking published IPD efficacy or late-toxicity data excluded. 3454 pts across 3 isodose trials, 2426 pts across 4 dose-escalated trials.

Isodose MHFRT exemplified by 60 Gy in 20 fractions; dose-escalated MHFRT schedules pooled (specific fractionations not given in source). Median follow-up 5.4 y (isodose) and 7.1 y (dose-escalated).

Efficacy equivalent to CFRT for both strata. The only toxicity separations were in the dose-escalated arm, late G2+ GI and bowel QoL, not isodose (see table).

Reinforces isodose 60/20 (CHHiP-type) as the standard MHFRT regimen and argues against dose-escalating hypofractionated schedules, which buy no efficacy but cost bowel toxicity.

localised prostate cancer treated with definitive EBRT where the control arm used modern-dose CFRT
Does not represent SBRT/ultrahypofractionation, brachytherapy, or node-positive/post-operative settings.

Physician-scored late toxicity carries grading subjectivity, though PRO data corroborate the bowel signal. Dose-escalated stratum pools heterogeneous fractionation; longer follow-up needed to confirm late-toxicity divergence.

IPD meta-analysis of 7 phase 3 RCTs consolidating isodose 60/20 as standard MHFRT; reinforces current practice, no efficacy gained by dose-escalating.

In localised prostate cancer choosing moderate hypofractionation, this supports isodose 60 Gy/20 fx over dose-escalated hypofractionated schedules; it does not speak to SBRT/ultrahypofractionation or node-positive disease.

📚 Sources · 📄 1 paper
📄 PAPER Kishan; Sun; Tree et al. · The Lancet. Oncology (2025-04)
Hypofractionated radiotherapy for prostate cancer (HYDRA): an individual patient data meta-analysis of randomised trials in the MARCAP consortium.
Abstract
BACKGROUND: Trials comparing moderately hypofractionated radiotherapy (MHFRT) to conventionally-fractionated radiotherapy (CFRT) for prostate cancer have varied considerably in intent (non-inferiority vs superiority) and MHFRT dose. We compare the efficacy and toxicity profiles of isodose MHFRT and dose-escalated MHFRT.<br/><br/>METHODS: This was an individual patient data meta-analysis that identified randomised phase 3 trials of CFRT versus MHFRT that had published individual patient-level data on efficacy and late toxicity. A systematic literature search using MEDLINE, Embase, trial registries, the Web of Science, Scopus, and relevant conference proceedings was initially conducted on Dec 15, 2023, and was re-conducted on Jan 8, 2025. Trials that did not publish efficacy data, did not publish late toxicity data, or did not use modern dose radiotherapy (&#x2265;70 Gy in 2 Gy equivalents) in the CFRT group were excluded. Individual patient data were provided to MARCAP by study investigators. Three separate meta-analyses were designed to compare efficacy (primary endpoint was progression-free survival), physician-scored late toxicity (co-primary endpoints were late grade 2 or higher genitourinary and late grade 2 or higher gastrointestinal toxic effects), and patient-reported outcomes (co-primary endpoints were clinically-significant decrements in patient-reported urinary or bowel quality of life) between patients receiving CFRT versus MHFRT.<br/><br/>FINDINGS: We identified 1696 records for review. Seven phase 3 trials comparing MHFRT with CFRT were eligible for inclusion in our analysis. Individual patient data were obtained from these seven studies (3454 patients from three trials comparing CFRT with isodose MHFRT and 2426 patients from four trials comparing CFRT with dose-escalated MHFRT). At a median follow-up of 5&#xb7;4 years (IQR 4&#xb7;6-7&#xb7;2) for isodose MHFRT and 7&#xb7;1 years (5&#xb7;7-8&#xb7;4) for dose-escalated MHFRT, no differences in progression-free survival were detected (hazard ratio 0&#xb7;92, 95% CI 0&#xb7;81-1&#xb7;05; p=0&#xb7;21 and 0&#xb7;94, 0&#xb7;82-1&#xb7;09; p=0&#xb7;43 respectively). No increased odds of grade 2 or higher genitourinary toxic effects were identified for either isodose (odds ratio [OR] 1&#xb7;16, 95 CI% 0&#xb7;86-1&#xb7;57; p=0&#xb7;32) or dose-escalated MHFRT (1&#xb7;20, 0&#xb7;95-1&#xb7;51; p=0&#xb7;13). The odds of grade 2 or higher gastrointestinal toxic effects were significantly higher with dose-escalated (OR 1&#xb7;48, 95% CI 1&#xb7;14-1&#xb7;92; p=0&#xb7;0035) but not isodose MHFRT (1&#xb7;30, 0&#xb7;59-2&#xb7;87; p=0&#xb7;51). Isodose MHFRT was not found to show different odds of urinary quality-of-life decrement (OR 1&#xb7;03, 95% CI 0&#xb7;51-2&#xb7;09; p=0&#xb7;93) or bowel quality-of-life decrement (0&#xb7;76, 0&#xb7;40-1&#xb7;43; p=0&#xb7;39). Dose-escalated MHFRT was associated with greater odds of bowel quality-of-life decrement (OR 1&#xb7;68, 95% CI 1&#xb7;07-2&#xb7;61; p=0&#xb7;023), but no evidence of greater urinary quality-of-life decrement was found (1&#xb7;57, 0&#xb7;87-2&#xb7;85; p=0&#xb7;13).<br/><br/>INTERPRETATION: Isodose MHFRT and dose-escalated MHFRT both have similar efficacy compared with CFRT, but dose-escalated MHFRT is associated with higher physician-scored and patient-reported bowel toxicity. Isodose regimens, eg, 60 Gy in 20 fractions, should be the standard MHFRT regimen for localised prostate cancer.<br/><br/>FUNDING: None.
Confirmatory

WOLVERINE

ForOligometastatic prostate cancer (≤5 mets), predominantly castration-sensitive

TL;DRPFS HR 0.44, rPFS HR 0.60 favor MDT added to SOC in oligomet prostate; OS HR 0.63 non-sig (p=0.051).

Surfaced from a review's discussed trials

Why it mattersRadiation oncology

MDT here is predominantly SBRT, and the RT-attributable read is that benefit held in the sensitivity analysis excluding observation-only-SOC trials (PFS HR 0.46, CRFS HR 0.46), so MDT adds on a systemic backbone, not just vs nothing. OS stayed non-significant (HR 0.63, p=0.051): the gain is delaying progression and castration resistance, not proven survival.

7 details 5 trials watching

IPD meta-analysis (PROSPERO CRD42023479078) of 7 phase 2 RCTs; the primary MDT-efficacy analysis pooled 6 trials randomizing 472 men to MDT+SOC (n=248) vs SOC (n=224). Median follow-up 40.7 mo (IQR 25.6-53.7).

Oligometastatic (up to 5 mets) prostate cancer; 65% castration-sensitive (n=375), ARTO entirely CRPC and EXTEND baskets CRPC-enriched. 85.5% (n=491) had prior definitive local therapy; median PSA 1.9 both arms.

MDT is delivered per each component trial (EXTEND, STOMP, ORIOLE, ARTO, COMET-SABR), predominantly SBRT-based. Dose, fractionation, target volume, and modality breakdown are not reported in this meta-analysis, so the technique-transfer question can't be answered from source.

Coprimary: PFS and OS. Secondary: rPFS and castration resistance-free survival (CRFS).

MDT plus SOC improved PFS, rPFS, and CRFS across both trial- and patient-level analyses; overall survival did not reach significance (effect sizes in the table above).

STOMP and ORIOLE (observation-controlled SBRT trials) drove the early MDT signal; this pooled IPD extends the PFS/CRFS benefit across 6 trials and shows it persists on a systemic-therapy backbone in the observation-excluded sensitivity analysis.

oligometastatic (≤5 mets) prostate cancer, mostly castration-sensitive and post definitive local therapy
Does not represent CRPC-predominant or higher-volume metastatic disease, nor a proven overall-survival benefit.

All 7 component trials are phase 2 with non-blinded randomization ('some concerns' RoB) and open-label PSA-driven endpoints. OS non-significant (p=0.051). SOC arm slightly older (71 vs 68) and more often on 2nd-gen ARPI (59.8% vs 50.4%).

IPD meta-analysis of 6 phase-2 non-blinded RCTs; PFS/rPFS/CRFS clearly hit but OS non-significant. Reinforces the emerging MDT-for-oligomet signal (STOMP, ORIOLE), doesn't establish survival.

In castration-sensitive oligometastatic prostate cancer, up to 5 mets and mostly post definitive local therapy, the pooled evidence supports MDT plus SOC to delay progression and castration resistance; it does not establish a survival benefit nor extend to the CRPC-predominant setting.

📚 Sources · 📄 1 paper
📄 PAPER Tang; Sherry; Hwang et al. · The Lancet. Oncology (2026-02)
Metastasis-directed therapy and standard of care versus standard of care for oligometastatic prostate cancer (WOLVERINE): a systematic review and individual patient data meta-analysis from the X-MET collaboration.
Abstract
BACKGROUND: Oligometastatic disease represents the proximal end of a metastatic spectrum. Metastasis-directed therapy (MDT) is increasingly used to treat oligometastatic disease despite the absence of level 1 evidence. We amalgamated individual patient data across trials to evaluate the effectiveness of MDT for oligometastatic prostate cancer.<br/><br/>METHODS: We conducted a systematic review and individual patient data meta-analysis. We systematically searched Embase, PubMed, CENTRAL, MEDLINE, and ClinicalTrials.gov to identify randomised trials of MDT enrolling patients with oligometastatic prostate cancer. Inclusion criteria were published randomised prospective trials enrolling patients with oligometastatic (up to five metastases) prostate cancer, in which investigators recorded sufficient data to evaluate progression-free survival and overall survival. This systematic review was conducted from database creation to Nov 3, 2023, and was updated on May 4, 2025. Data appraisal was conducted using Covidence with two investigators (CT and ADS) performing independent screens. Studies were evaluated using the Cochrane Collaboration's risk-of-bias assessment (version 2.0). Individual patient data were provided by investigators. Coprimary endpoints were progression-free survival and overall survival. Secondary endpoints were radiographic progression-free survival and castration resistance-free survival. The primary analysis was conducted in the subset of studies in which patients were randomly assigned to MDT plus standard of care (SOC) versus SOC. The primary analysis included a trial-level analysis using a random effects model and a patient-level analysis stratifying by trial. This meta-analysis is registered with PROSPERO (CRD42023479078).<br/><br/>FINDINGS: Of 2975 studies identified for screening, seven phase 2 studies randomly assigning 574 men were included. Six trials randomly assigning 472 patients to MDT plus SOC (n=248) versus SOC (n=224) were used to evaluate MDT and had a median follow-up time of 40&#xb7;7 months (IQR 25&#xb7;6-53&#xb7;7). MDT was associated with improved progression-free survival (trial-level hazard ratio [HR] 0&#xb7;44, [95% CI 0&#xb7;35-0&#xb7;56], p<0&#xb7;0001; patient-level HR 0&#xb7;45 [0&#xb7;35-0&#xb7;57], p<0&#xb7;0001), radiographic progression-free survival (trial-level HR 0&#xb7;60 [0&#xb7;42-0&#xb7;85], p=0&#xb7;0039; patient-level HR 0&#xb7;59 [0&#xb7;46-0&#xb7;76], p<0&#xb7;0001), and castration resistance-free survival (trial-level HR 0&#xb7;58 [95% CI 0&#xb7;37-0&#xb7;92], p=0&#xb7;019; patient-level HR 0&#xb7;58 [95% CI 0&#xb7;37-0&#xb7;91], p=0&#xb7;017). The association between MDT and overall survival showed an HR of 0&#xb7;63 (95% CI 0&#xb7;39-1&#xb7;00, p=0&#xb7;051) in trial-level analyses and 0&#xb7;64 (95% CI 0&#xb7;40-1&#xb7;01, p=0&#xb7;057) in patient-level analyses.<br/><br/>INTERPRETATION: WOLVERINE showed a benefit with MDT for oligometastatic prostate cancer in progression-free survival, radiological progression-free survival, and castration resistance-free survival. Overall survival benefit was not significant and further research is needed.<br/><br/>FUNDING: Philanthropic gift and National Cancer Institute.
📝 Auto-resolved from a review's discussed trials (WOLVERINE).
Caveats dominate

FIRESTORM

ForHigh-risk meningioma: WHO grade 2 STR or recurrent, postop RT

TL;DR5-yr PFS 65.8% vs 38.8% favoring dose-escalated RT (BED ≥79.2 Gy), HR 0.40; OS not improved.

Why it mattersRadiation oncology

The trade-off is the actionable read: escalating to BED ≥79.2 Gy (≈66 Gy/33 fx) roughly doubled 5-yr PFS (65.8% vs 38.8%) but tripled any-grade radionecrosis (33.9% vs 13.2%), with severe RN unchanged (5.1% vs 3.2%) and no OS gain. Benefit was largest after subtotal resection.

9 details 3 trials watching

Individual patient-level meta-analysis pooling 7 institutions, N=248 (59 DE-RT, 189 SD-RT). Retrospective, non-randomized; compared by Kaplan-Meier, Cox multivariable, and IPTW propensity analysis.

High-risk meningioma: 75.8% WHO grade 2, 41.5% recurrent (grade 3 the remainder), 75.2% subtotal resection.

DE-RT defined as biologically effective dose ≥79.2 Gy (equivalent 66 Gy/33 fx); SD-RT comparator conventionally fractionated 59.4 Gy/33 fx or 60 Gy/30 fx. Mixed photon/carbon vs photon-alone DE-RT showed no PFS difference (81.3% vs 92.0% at 3y, P=.34).

Primary: progression-free survival, DE-RT vs SD-RT. Also overall survival and CNS radionecrosis.

OS not improved despite the PFS gain: 5-yr OS 83.8% vs 68.4% (P=.056 UVA), non-significant on MVA (HR 0.66, P=.27) and IPTW (HR 0.77, P=.42).

EndpointDE-RTSD-RT
3-yr PFS86.4%55.6%
5-yr PFS65.8%38.8%
Adjusted HR (MVA)0.40 (0.24-0.69), P=.001ref
IPTW HR0.45 (0.24-0.83), P=.01ref
RadionecrosisDE-RTSD-RT
Any grade33.9% (20/59)13.2% (25/189)
Grade 3+5.1%3.2%

Any-grade radionecrosis higher with DE-RT (33.9% vs 13.2%, P=.001) but grade 3+ similar (5.1% vs 3.2%); most RN was low-grade.

Standard-dose postoperative meningioma RT (RTOG-0539 high-risk 60 Gy, EORTC-22042 60 Gy) sits at/below this cohort's SD-RT arm; the dose-response signal here motivates the ongoing randomized escalation question.

high-risk meningioma (WHO grade 2 subtotally resected or recurrent, plus grade 3) receiving postoperative fractionated RT
Does not represent gross-totally-resected grade 1 disease, upfront observation, or radiosurgery-only management.

Retrospective non-randomized pooling: DE-RT allocation confounded, IPTW mitigates but cannot fully adjust. PFS gain without OS benefit; prior-RT and grade imbalance across arms.

Retrospective non-randomized IPD pooling; DE-RT allocation confounded despite IPTW. PFS-only gain, no OS benefit. Signal supports escalation but needs randomized confirmation.

In high-risk meningioma (WHO grade 2, subtotally resected or recurrent) receiving postoperative RT, this supports a higher dose (BED ≥79.2 Gy) for local control; it does not extend to gross-totally-resected grade 1 disease or establish an OS benefit.

📚 Sources · 📄 1 paper
📄 PAPER Singh, Raj; Koempel, Andrew; French, Beck et al. · International Journal of Radiation Oncology*Biology*Physics (2026-07)
Improved Progression-Free Survival Following Dose-Escalated Versus Standard-Dose Postoperative Radiation Therapy for High-Risk Meningiomas: An International Multicenter Individual Patient–Level Meta-Analysis (FIRESTORM)
Abstract
PURPOSE: We performed an individual patient-level meta-analysis of high-risk meningiomas to compare the outcomes of dose-escalated radiation therapy (DE-RT) versus standard-dose postoperative radiation therapy (SD-RT).<br/><br/>METHODS AND MATERIALS: A total of 7 institutions participated. DE-RT was defined as treatment with a biologically effective dose of &#x2265;79.2 Gy (equivalent of 66 Gy in 33 fractions). We compared progression-free survival (PFS) with DE-RT versus SD-RT via Kaplan-Meier analysis and log-rank t tests, a Cox proportional hazards multivariable model, and propensity score analyses with inverse probability of treatment weighting (IPTW). We also compared incidences of central nervous system radionecrosis (RN) with DE-RT versus SD-RT.<br/><br/>RESULTS: The analysis included 248 patients with high-risk meningioma (59 received DE-RT and 189 received SD-RT). One hundred and eighty-eight cases (75.8%) were World Health Organization grade 2, and 103 cases (41.5%) were recurrent meningiomas. Extent of resection was subtotal resection in 182 of 248 (75.2%). Three- and 5-year PFS rates were 62.8% (95% CI, 55.8%-69.0%) and 45.0% (95% CI, 37.3%-52.3%), respectively. DE-RT was associated with superior PFS rates (P = .0022), with 3-year (86.4% vs 55.6%) and 5-year (65.8% vs 38.8%) PFS rates favoring DE-RT. On multivariable analysis, DE-RT was associated with superior PFS (hazard ratio, 0.40; 95% CI, 0.24-0.69; P = .001). On IPTW, DE-RT continued to be associated with superior PFS (hazard ratio, 0.45; 95% CI, 0.24-0.83; P = .01). A greater incidence of any grade RN was observed following DE-RT (20 of 59; 33.9%) versus SD-RT (25 of 189; 13.2%) (P = .001) but with similar grade 3 or greater RN events (DE-RT 5.1% vs SD-RT 3.2%).<br/><br/>CONCLUSIONS: DE-RT resulted in superior PFS for patients with high-risk meningiomas over SD-RT without an increase in severe toxicities.
Caveats dominate

NRG/RTOG 9804 + E5194 Combined Analysis

ForGood-risk DCIS (low/int grade, ≤2.5cm, ≥3mm margins), lumpectomy without RT

TL;DR15-yr IBR 11.4% vs 19.0% with vs without tamoxifen in RT-omitted good-risk DCIS; MVA HR 0.54, invasive-IBR HR 0.43.

Why it mattersRadiation oncology

Tamoxifen's benefit here concentrates on invasive IBR (HR 0.43, p=0.0042), not DCIS-IBR (p=0.089), offsetting the recurrences that carry survival weight. But 15-yr IBR stays 11.4% even with tamoxifen, and no arm tests RT, so this informs the omit-RT-plus-endocrine path, not RT vs tamoxifen.

7 details 4 trials watching

Ancillary exploratory analysis pooling the non-RT arm of NRG/RTOG 9804 with the good-risk cohort of ECOG-ACRIN E5194. N=878 (317 + 561), median follow-up 14.85 yr.

Good-risk DCIS: low or intermediate grade, ≤2.5 cm, margins ≥3 mm, lumpectomy without RT. Median age 59. Tamoxifen users skewed toward negative re-excision and pathologic size ≤5 mm.

Tamoxifen optional and non-randomized, used by 43.1% overall (65.6% in 9804, 30.3% in E5194).

No RT in either cohort by design; this characterizes the RT-omitted good-risk population, not an RT comparison.

IBR overall, invasive IBR, DCIS-IBR, contralateral breast event, OS. Fine-Gray competing-risk models, univariate plus multivariable.

NSABP B-24 randomized tamoxifen after lumpectomy plus RT and cut breast events; this extends the tamoxifen signal to the RT-omitted good-risk setting, though non-randomized.

good-risk DCIS (low/intermediate grade, ≤2.5 cm, ≥3 mm margins) managed by lumpectomy alone
Does not represent high-grade or RT-treated DCIS, nor a head-to-head of tamoxifen against RT.

Tamoxifen not randomized; users differed on prognostic factors (re-excision, size), so residual confounding is likely. Exploratory combined dataset, not a prespecified endpoint.

EndpointHR (95% CI)p
Any IBR0.54 (0.35-0.83)0.0045
Invasive IBR0.43 (0.24-0.77)0.0042
Group15-yr IBR (95% CI)
Tamoxifen11.4% (7.9-15.5)
No tamoxifen19.0% (15.3-22.9)

Non-randomized optional tamoxifen compared within a post-hoc combined dataset; users differed on prognostic factors. Consistent with randomized NSABP B-24 signal but confounded here.

For good-risk DCIS where RT is already being omitted, this supports endocrine therapy to reduce invasive IBR; it does not test whether tamoxifen substitutes for RT.

📚 Sources · 📄 1 paper
📄 PAPER Wright; Moughan; Woodward et al. · International journal of radiation oncology, biology, physics (2026-05)
Impact of Tamoxifen Only After Lumpectomy for "Good-Risk" Duct Carcinoma In Situ: Combined Analysis of the NRG Oncology/RTOG 9804 and ECOG-ACRIN E5194 Trials.
Abstract
PURPOSE: The NRG Oncology/Radiation Therapy Oncology Group (RTOG) 9804 trial randomized patients with "good-risk" ductal carcinoma in situ (DCIS) to radiation (RT) or no RT following lumpectomy. The Eastern Cooperative Oncology Group-American College of Radiology Imaging Network E5194 trial had a comparable cohort observed without RT. Tamoxifen use was optional in both trials. This ancillary exploratory analysis combining both data sets assessed the effect of tamoxifen on ipsilateral breast recurrence (IBR) in "good-risk" DCIS treated with lumpectomy alone.<br/><br/>METHODS AND MATERIALS: A combined database from the non-RT arm of NRG/RTOG 9804 and the "good-risk" cohort from E5194 (low- or intermediate-grade, &#x2264;2.5 cm, excision margins &#x2265;3 mm) was created, and distributions of patient and DCIS characteristics by tamoxifen use were compared by &#x3c7;2. IBR, invasive IBR, DCIS-IBR, contralateral breast event, and overall survival were estimated, and distributions were compared between tamoxifen use groups. Univariate and multivariable Fine-Gray regression models were used to analyze factors that may be associated with endpoints.<br/><br/>RESULTS: Eight hundred and seventy-eight patients were analyzed (317 from NRG/RTOG 9804 and 561 from E5194). The use of tamoxifen overall was 43.1% (65.6% in NRG/RTOG 9804 and 30.3% in E5194). At a median follow-up of 14.85 years, there were 117 IBRs (65 invasive and 52 DCIS). There was a significant association for reduced IBR with tamoxifen use (P = .001); estimated 15-year IBR with tamoxifen is 11.4% (95% CI, 7.9-15.5) and without is 19.0% (15.3-22.9). Tamoxifen use was significantly associated with reduced invasive IBR (P = .0048) but not DCIS-IBR (P = .089). On multivariable analysis, patients who received tamoxifen were 46% less likely to have any IBR (hazard ratio, 0.54; 95% CI, 0.35-0.83; P = .0045), and 57% less likely to have invasive IBR (hazard ratio, 0.43; 95% CI, 0.24-0.77; P = 0.0042).<br/><br/>CONCLUSION: For patients with "good-risk" DCIS treated with lumpectomy without RT, tamoxifen use was significantly associated with a reduction in IBR overall and invasive IBR, not DCIS-IBR.
📝 https://www.redjournal.org/article/S0360-3016(26)00703-0/abstract
Early signal

INRT-AIR & DARTBOARD pooled analysis

ForOropharynx/larynx/hypopharynx HNSCC, stage I-IVB, excl T1-2N0 larynx

TL;DR5-yr solitary elective nodal recurrence 0% with ENI omission across 117 pts; 5-yr OS 87%, PFS 74%.

Why it mattersRadiation oncology

The failure pattern is what matters: solitary elective nodal recurrence was 0% at 5 yrs while 3-yr local recurrence ran 9.5% and distant 11%, so the residual risk sits in the primary and systemically, not in the uncovered elective levels. Node selection was AI-assisted off PET/CT plus neck CT, which gates whether the volume reproduces outside these trials.

INRT-AIR & DARTBOARD pooled analysis
EndpointTimepointValue
Solitary elective nodal recurrence5-year0%
Local recurrence3-year9.5%
Regional recurrence3-year4.3%
Distant metastasis3-year11%
Overall survival5-year87%
Progression-free survival5-year74%
Composite MDADI (mean)12 months84.9
+1 more figure
INRT-AIR & DARTBOARD pooled analysis
10 details 5 trials watching

Patient-level pooled analysis of two prospective trials of involved nodal RT, INRT-AIR and DARTBOARD. N=117, median follow-up 3.4 years. No randomised ENI comparator arm.

HNSCC of oropharynx, larynx, and hypopharynx, stage I-IVB, excluding T1-2N0 larynx. Completed PET/CT and neck CT required for entry.

INRT omits elective nodal irradiation, treating involved nodes only, with an artificial-intelligence model assisting identification of suspicious lymph nodes. Dose, fractionation, and margin not reported in source.

5-yr solitary elective nodal recurrence 0%. 3-yr cumulative incidence: local 9.5%, regional 4.3%, distant 11%. 5-yr OS 87%, PFS 74%.

Mean composite MDADI 84.9 at 12 months, with no significant decline after treatment. No late G3+ toxicity, xerostomia, or feeding-tube rates reported in source.

PET/CT-staged oropharynx, larynx, and hypopharynx HNSCC, stage I-IVB, treated with definitive INRT on trial
Does not represent T1-2N0 larynx, oral cavity or nasopharynx primaries, or necks staged without PET/CT.

Pooled single-arm data with no ENI control, so the 0% solitary elective recurrence carries no randomised contrast. Median follow-up 3.4 yrs underpins 5-yr estimates, and the AI nodal-selection step is not externally reproduced.

The dosimetric case for INRT rests on OAR sparing, but the only patient-reported outcome here is swallowing (MDADI 84.9), with no xerostomia or dysphagia comparison against ENI. Authors state randomized evidence is required before non-trial implementation.

Pooled single-arm prospective cohorts, N=117, no randomised ENI comparator; presenters explicitly require randomised evidence before non-trial use.

In PET/CT-staged oropharynx, larynx, or hypopharynx HNSCC (excluding T1-2N0 larynx) being planned for definitive chemoRT, this supports enrolling on an INRT trial rather than omitting elective nodal coverage off-protocol, and it does not speak to node-positive necks staged without PET/CT.

📚 Sources · 🐦 1 tweet
Confirmatory

Multinational HCC EBRT IPD Cohort

ForVery early / early-stage HCC (BCLC-0 to A), Child-Pugh A predominant

TL;DRMedian OS 6.8y BCLC-0 and 4.6y BCLC-A across 4,913 EBRT-treated HCC pts, comparable to resection/ablation.

Why it mattersRadiation oncology

The treatment-naive BCLC-0 arm is the RT-relevant cell: median OS not reached (95% CI 8.6 to NR), i.e. first-line EBRT in a truly untreated very-early cohort, not salvage after failed ablation. Ablative dose independently predicted lower mortality, so this moves the dose-selection and BCLC-algorithm-placement decisions.

9 details 3 trials watching

Systematic review (search date December 15, 2022) of EBRT series meeting prespecified HCC technical standards and reporting OS, followed by individual patient data solicitation from corresponding authors. Kaplan-Meier OS and RMST stratified by BCLC stage and treatment status; random-effects Cox for covariates.

N=4,913 EBRT-treated HCC pts across a multinational author network, median follow-up 5.0 years. Stratified as treatment-naive vs treatment-experienced; BCLC stage, tumor burden, performance status, and Child-Pugh class all captured at patient level.

EBRT delivered per each contributing series; the pooling filter was prespecified technical standards for HCC. Ablative dose was independently associated with reduced risk of death, but specific dose/fractionation schedules and the ablative-dose threshold are not reported in the source abstract.

Median OS 6.8 years for BCLC-0 and 4.6 years for BCLC-A; among treatment-naive pts not reached for BCLC-0 and 5.4 years for BCLC-A. On multivariable modeling, advanced BCLC stage, higher tumor burden, worse performance status, and Child-Pugh B/C raised mortality risk; ablative dose and more recent treatment year lowered it.

CohortBCLC-0BCLC-A
All pts6.8 yrs (95% CI 5.7-8.7)4.6 yrs (95% CI 4.1-5.1)
Treatment-naiveNR (95% CI 8.6-NR)5.4 yrs (95% CI 4.5-6.7)

The authors position these OS figures as comparable with resection, thermal ablation, and other ablative locoregional therapies. That comparison is across literatures, not within a trial, so the usual selection differences (lesion location, vascular proximity, comorbidity burden) between an EBRT-referred and a resection-eligible population remain unadjusted.

very early and early-stage HCC (BCLC-0 to A) treated with technically modern EBRT at centers publishing outcomes
Does not represent BCLC-B/C disease, Child-Pugh B-C liver function, or EBRT delivered outside the prespecified technical standards.

No comparator arm: the resection/ablation equivalence claim is a cross-study inference. IPD came only from authors who responded, and the technical-standard filter selects for expert centers, both biasing toward better outcomes. Year-of-treatment effect confounds technique era with staging and systemic-therapy improvements.

The practical argument here is algorithmic placement: BCLC has historically routed early HCC to resection, ablation, or transplant with EBRT absent, and this is the largest patient-level dataset assembled to contest that omission. The treatment-naive BCLC-0 result matters most, since it isolates first-line EBRT from salvage-after-ablation-failure use.

Large multinational prospective-collected IPD across many sites with stage-stratified analyses, but non-randomised and no head-to-head comparator; supports EBRT's guideline-listed role rather than establishing it.

In BCLC-0 or A HCC where ablation or resection is unattractive on lesion location or comorbidity, this supports offering ablative-dose EBRT as a first-line locoregional option rather than a salvage one; it does not speak to BCLC-B/C or Child-Pugh B-C pts, where OS was worse.

📚 Sources · 📄 1 paper
📄 PAPER Moon; Yanagihara; Dawson et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2026-05)
Overall Survival Among Patients With Hepatocellular Carcinoma Treated With External Beam Radiation Therapy: Individual Patient Data Outcomes From a Multinational Cohort.
Abstract
PURPOSE: External beam radiation therapy (EBRT) has gained delayed acceptance as a recommended first-line treatment modality for patients with hepatocellular carcinoma (HCC), given limited evidence that it improves overall survival (OS). We analyzed individual patient data (IPD) from an international cohort to assess OS among patients with HCC treated with EBRT.<br/><br/>METHODS: We performed a systematic review of publications that assessed EBRT, met prespecified technical standards for HCC, and reported OS (search date December 15, 2022). Corresponding authors were invited to submit IPD for the study. We performed Kaplan-Meier survival analyses to determine OS and restricted mean survival time (RMST) stratified by Barcelona Clinic Liver Cancer (BCLC) stage and treatment status (ie, treatment-na&#xef;ve and experienced). We performed random effects Cox proportional hazards modeling to assess clinical characteristics associated with OS.<br/><br/>RESULTS: Data were provided on 4,913 patients treated with EBRT with a median follow-up time of 5.0 years. The median OS was 6.8 years (95% CI, 5.7 to 8.7) for BCLC-0 and 4.6 years (95% CI, 4.1 to 5.1) for BCLC-A. Among treatment-na&#xef;ve patients, the median OS was not reached (95% CI, 8.6 to not reached) for BCLC-0 and was 5.4 years (95% CI, 4.5 to 6.7) for BCLC-A. In multivariable models, more advanced BCLC stage, higher tumor burden, worse performance status, and Child-Pugh class B or C were associated with a higher risk of mortality. Ablative radiation dose and more recent year of treatment were associated with a reduced risk of death.<br/><br/>CONCLUSION: To our knowledge, this study represents the largest multinational cohort of patients with HCC treated with EBRT. OS outcomes with EBRT for very early- and early-stage HCC appear to be comparable with resection, thermal ablation, and other ablative locoregional therapies. These data support the inclusion of EBRT in the BCLC HCC clinical decision-making process.
📝 Moon AM, Yanagihara TK, Dawson LA, Yu JI, Lawrence TS, Kim TH, Yan M, Iwata H, Nabavizadeh N, Apisarnthanarax S, Dunne EM, Lock MI, Chuong MD, Chiang CL, Scorsetti M, Katoh N, Sioshansi S, Numata K, Liu HY, Iwamoto H, Wakatsuki M, Chen Y, Pollom EL, Gkika E, Jabbour SK, Munoz-Schuffenegger P, Dutta D, Hajj C, Ueno M, Hallemeier CL, Feldman AM, Méndèz Romero A, Tan X, Molla M, Tepper JE, Torres F, Reig M; EBRT Collaboration Group. Overall Survival Among Patients With Hepatocellular Carcinoma Treated With External Beam Radiation Therapy: Individual Patient Data Outcomes From a Multinational Cohort. J Clin Oncol. 2026 May 15:JCO2502399.