The edition · Oncology
Azacitidine-venetoclax outperformed induction chemotherapy in fit AML patients
PARADIGM randomised 172 induction-eligible adults and more than doubled median event-free survival, from 6.2 to 14.5 months, with fewer serious infections and less bleeding. Plus dose-escalated radiotherapy finally shows a benefit in high-risk prostate cancer, and ivonescimab extends progression-free survival after EGFR-TKI failure.
The edition in brief
The headline result overturns an assumption that has structured acute myeloid leukaemia care for decades. PARADIGM randomised 172 previously untreated adults who were eligible for induction chemotherapy to azacitidine plus venetoclax or to induction. Median age was 64 and 72% had adverse-risk disease by European LeukemiaNet 2022 criteria; patients with core binding factor fusions, FLT3 mutations or NPM1 mutations under 60 were excluded. At a median 21.9 months, median event-free survival was 14.5 months with azacitidine-venetoclax versus 6.2 months with induction (hazard ratio 0.57, 95% CI 0.39 to 0.84, p=0.002). Grade 3 or higher infection occurred in 28% versus 41%, and grade 3 or higher haemorrhage in 2% versus 12%. This is a phase 2 trial and event-free survival is not overall survival. GETUG AFU 18 randomised 505 men with high-risk prostate cancer on long-term androgen deprivation to 80 Gy or 70 Gy. Five-year progression-free survival was 91.4% versus 88.1%, but at ten years the gap widened to 83.6% versus 72.2% (stratified hazard ratio 0.56, 95% CI 0.40 to 0.78). Grade 3 or worse late toxicity was 8% versus 7%. HARMONi randomised 438 patients with EGFR-mutated non-small-cell lung cancer progressing after a third-generation TKI to ivonescimab plus chemotherapy or chemotherapy alone. Median progression-free survival was 6.8 versus 4.4 months (hazard ratio 0.52), with overall survival 16.8 versus 14.0 months (hazard ratio 0.79, 95% CI 0.62 to 1.01) — not yet significant. STAR-TREC found long-course chemoradiotherapy preserved the rectum better than short-course radiotherapy at 12 months. The ACG has published new polyposis guidelines.
PARADIGM: azacitidine-venetoclax beat induction chemotherapy in patients fit enough for induction
In induction-eligible adults with acute myeloid leukaemia outside favourable-risk genotypes, azacitidine-venetoclax more than doubled event-free survival against induction chemotherapy with less infection and bleeding.
GETUG AFU 18: dose escalation to 80 Gy pays off, but only after ten years
Escalating prostate radiotherapy from 70 Gy to 80 Gy alongside long-term androgen deprivation raised ten-year progression-free survival from 72.2% to 83.6% without added late toxicity.
HARMONi: ivonescimab delays progression after EGFR-TKI failure, survival not yet proven
Adding ivonescimab to platinum-pemetrexed after EGFR-TKI failure extends progression-free survival from 4.4 to 6.8 months, at the cost of serious adverse events rising from 15% to 28%, with overall survival benefit not yet proven.
STAR-TREC: long-course chemoradiotherapy preserves more rectums than short-course
For response-adapted organ preservation in early to intermediate rectal cancer, long-course chemoradiotherapy kept 78.5% free of total mesorectal excision at 12 months versus 60.6% with short-course radiotherapy.
No substantive drug regulatory action today; the ACG rewrites polyposis management
No substantive drug regulatory action today; the new ACG polyposis guideline should prompt structured family history taking, timely germline testing, and active cascade testing of relatives.
Say which survival endpoint you are quoting
Name the endpoint aloud when quoting a trial benefit — a progression-free survival gain is not a promise of longer life, and saying so plainly protects the patient later.
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