In-depth analysis of practice-changing oncology research, one article at a time.
The Step 2 randomization of NRG Oncology/RTOG 0848, a phase III trial of 354 patients with resected pancreatic head adenocarcinoma, found that adding chemoradiotherapy (CXRT) to adjuvant chemotherapy did not significantly improve overall survival across the full study population.
A retrospective cohort study of 16,924 men with prostate cancer, drawn from the Epic Cosmos national electronic health record dataset, found that new-onset metabolic syndrome developed in nearly 40% of patients within 12 months of starting concurrent androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI).
In a correlative biomarker analysis of the HCRN GU16-260 trial, non-exhausted CD8+ T cells were linked to higher response rates and longer progression-free survival in treatment-naive metastatic clear-cell RCC treated with first-line nivolumab.
Paired ctDNA profiling of 44 patients with RAS-mutant metastatic pancreatic cancer who progressed on daraxonrasib monotherapy found acquired RAS pathway alterations in 26 of 44 patients (59%), with mutant KRAS amplification the dominant mechanism (36%, 16 of 44).
In a prognostic analysis nested within the phase 2 c-TRAK TN trial, a tissue-free ctDNA assay detected molecular residual disease in 54 of 159 patients (34.0%) with early triple negative breast cancer, and detection was strongly associated with recurrence risk (HR, 27.2).
The Phase II FLARE-RT trial used mid-treatment FDG-PET response to selectively boost radiation dose (to 74 Gy, peak >90 Gy) only in the roughly one-third of unresectable NSCLC patients whose tumors were not responding, while treating responders with standard 60 Gy chemoradiation.
Long-term follow-up (median exceeding 10 years) of NRG Oncology RTOG 0539 validates a risk-adapted meningioma strategy: observation after gross total or subtotal resection for low-risk (WHO grade 1) disease, and radiotherapy for intermediate- and high-risk disease.
A first-cycle "adaptive therapy score," derived from a mathematical model of competing drug-sensitive and drug-resistant tumor cell populations, more strongly predicted time to progression than any standard PSA metric across two independent prostate cancer cohorts (n=53 total).
The FDA approved retifanlimab, a PD-1-targeting checkpoint inhibitor, in combination with carboplatin and paclitaxel for first-line treatment and as a single agent for second-line treatment of squamous cell carcinoma of the anal canal (SCAC) — the first checkpoint inhibitor approval in this disease.
The multicenter PRO B trial randomized 924 patients with metastatic breast cancer across 52 German centers to weekly alert-based electronic patient-reported outcome (ePRO) monitoring or usual quarterly PRO monitoring, with fatigue at 6 months as the primary endpoint.
A post-hoc analysis of the phase III PACIFIC trial (660 of 713 originally randomized patients; 449 durvalumab, 211 placebo) examined whether baseline exposure to proton pump inhibitors (PPIs) or antibiotics was associated with worse outcomes after consolidation durvalumab for unresectable stage III NSCLC, at a median follow-up of 62.4 months.
The phase III STELLAR trial (NCT02533271) randomly assigned 591 patients with distal or middle-third locally advanced rectal cancer to a short-course radiotherapy-based total neoadjuvant therapy regimen (SCRT-TNT) or standard long-course chemoradiotherapy (CRT); this update reports 5-year outcomes at a median follow-up of 68.7 months.
A single-center, investigator-initiated Phase II trial using a Simon two-stage design tested sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, in 50 evaluable patients with recurrent or persistent endometrial cancer who had progressed after platinum-based chemotherapy, enrolled between March 2020 and December 2024.
A single-center, investigator-initiated Phase Ib/II trial (NCI protocol 18-C-0110, NCT03554473) tested bintrafusp alfa — a bifunctional PD-L1/TGF-β fusion protein — alone or with chemotherapy in 37 patients with relapsed small cell lung cancer treated between 2019 and 2022.
A Phase 2 arm of the adaptive I-SPY2 platform trial (78 patients treated 2020-2021, compared against 350 historical controls) tested adding cemiplimab (anti-PD-1) and fianlimab (anti-LAG-3) to neoadjuvant chemotherapy in high-risk, stage II-III, ERBB2 (HER2)-negative breast cancer.
Phase 3 TORCH trial (241 patients, two tertiary centers in China, enrolled 2015-2024) randomized adults with unresectable, liver-confined, intermediate-stage (BCLC stage B) hepatocellular carcinoma 1:1 to transarterial chemoembolization (TACE) plus sequential radiofrequency ablation versus TACE alone.
A systematic review and trial-level meta-analysis of 21 randomized trials (9,165 pooled patients) in HR+/HER2-negative metastatic breast cancer compares investigator (local site)-assessed progression-free survival against blinded independent central review (BICR), asking whether the added cost and complexity of BICR is actually needed.
Randomized phase 3 comparison, from the maintenance ("R2") randomization of the ECOG-ACRIN ENDURANCE (E1A11) trial, of indefinite-duration versus fixed 2-year lenalidomide maintenance in 516 standard-risk multiple myeloma patients who did not undergo up-front autologous stem-cell transplantation.
A pooled, secondary mixture-cure-model analysis of three mature Phase III trials (HIMALAYA, CheckMate 9DW, RATIONALE-301) plus a large real-world cohort estimates how many patients with advanced hepatocellular carcinoma (HCC) achieve durable, cure-like outcomes on first-line immune checkpoint inhibitor (ICI) regimens.
Single-center, nonrandomized Phase 1 dose-exploration trial of META 10-19 — a CD19 CAR T-cell product engineered to also express interleukin-10 — delivered at ultralow cell doses to 13 heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Phase 1, first-in-human dose-escalation trial of DYP688 — an antibody-drug conjugate that targets the melanocyte antigen PMEL and delivers a Gq/11 signaling inhibitor payload — in 66 patients with metastatic uveal melanoma and other GNAQ/GNA11-mutant melanomas, a population largely excluded from the only approved therapy for this disease.
Retrospective, single-center biomarker cohort study of 39 patients with dMMR metastatic colorectal cancer treated with anti-PD-1 monotherapy at Mayo Clinic, using integrated exome, transcriptome, and immune-repertoire profiling to test whether quantitative MSI burden — not just binary MSI-high status — predicts benefit from checkpoint blockade
Randomized (2:1), open-label, international phase II trial of ceralasertib (an oral ATR inhibitor) plus durvalumab versus ceralasertib monotherapy in 151 patients with advanced melanoma that had progressed on prior anti-PD-(L)1 therapy
Open-label, single-center phase I dose-escalation and dose-expansion trial of IM96, an autologous GUCY2C-targeted CAR T-cell product, in 20 treated patients with microsatellite-stable, third- or later-line metastatic colorectal cancer — a population with very few remaining options
Open-label, multicenter phase 1 trial (Adult Brain Tumor Consortium, ABTC 1501) of the anti-LAG-3 antibody relatlimab, alone or combined with the anti-PD-1 antibody nivolumab, in 46 patients with first-time recurrent glioblastoma (GBM)
Open-label, single-arm phase 1b/2 trial of HRS-4642 — an intravenous, liposomal-nanoparticle KRAS-G12D inhibitor — added to gemcitabine and nab-paclitaxel (the "AG" backbone) in advanced KRAS-G12D-mutant pancreatic ductal adenocarcinoma (PDAC); 68 patients screened, 31 treated, 30 treatment-naive
Final post hoc analysis of the global, double-blind, placebo-controlled phase 3 TOPAZ-1 trial (685 patients randomized 1:1) reporting the longest published follow-up — approximately 4 years — of an immunotherapy-plus-chemotherapy regimen in first-line advanced biliary tract cancer (aBTC)
Multicenter, open-label, randomized phase 2 trial (TREASURE, AIO-TRK-0320) at 20 sites in Germany and Austria testing whether adding consolidative thoracic radiotherapy (TRT, 30 Gy in 10 fractions) to atezolizumab maintenance improves overall survival in extensive-stage small cell lung cancer (ES-SCLC) after induction chemoimmunotherapy; 96 patients screened, 68 randomized 1:1
Pooled analysis of the phase III CARES program (CAEL101-301 and CAEL101-302, n=406) testing whether adding the antifibril monoclonal antibody anselamimab to standard anti-plasma cell dyscrasia therapy improves a composite mortality/hospitalization endpoint in advanced (Mayo stage IIIa/IIIb) AL amyloidosis
Retrospective subset analysis of the CIRCULATE-Japan GALAXY registry (298 patients with resected colorectal liver metastases) testing whether ctDNA-defined molecular residual disease (MRD) status can identify who actually benefits from adjuvant chemotherapy (ACT) after liver resection
Randomised, double-blind, phase 3 study of 1,402 patients with surgically resected stage IIB–IV cutaneous melanoma across 205 global sites
VIKTORIA-1 is a Phase 3, open-label, randomized, global trial enrolling 392 PIK3CA wild-type patients with HR+/HER2- metastatic or locally advanced breast cancer who had progressed on prior CDK4/6 inhibitor plus nonsteroidal aromatase inhibitor therapy
Phase 3 randomized trial of 909 patients with previously untreated CLL across 174 sites in 13 countries
The Phase III OptiTROP-Lung04 trial randomized 376 patients with EGFR-mutated advanced NSCLC that progressed after EGFR-TKI therapy to sacituzumab tirumotecan (sac-TMT) monotherapy or platinum-based chemotherapy