The edition · Oncology
Azacitidine-venetoclax beat intensive induction on event-free survival in fit AML
PARADIGM, a randomised phase 2 trial in 172 induction-eligible adults, found event-free survival of 14.5 versus 6.2 months with less severe infection and bleeding. Also: ivonescimab after EGFR-TKI progression, 80 Gy for high-risk prostate cancer, an FDA supplement for abemaciclib, and supervised exercise for men on ADT.
The edition in brief
PARADIGM randomised 172 previously untreated adults with AML who were fit for intensive induction, excluding core-binding-factor, FLT3 and most NPM1-mutated disease, to azacitidine plus venetoclax or induction chemotherapy. Median event-free survival was 14.5 versus 6.2 months (HR 0.57, 0.39 to 0.84); grade 3 or worse infection (28% vs 41%) and haemorrhage (2% vs 12%) were less common. Seventy-two per cent had adverse-risk disease. As a phase 2 trial it points towards, but does not yet establish, a new standard. HARMONi found ivonescimab with chemotherapy improved progression-free survival after third-generation EGFR-TKI progression (6.8 vs 4.4 months, HR 0.52), without a significant overall survival gain (HR 0.79, 0.62 to 1.01) and with more serious adverse events. GETUG AFU 18 found 80 Gy rather than 70 Gy with long-term ADT improved 10-year progression-free survival in high-risk prostate cancer (83.6% vs 72.2%), a post hoc time point, with similar toxicity. STAMINA, in 700 men on ADT across 15 NHS trusts, found 12 months of supervised exercise and dietary support improved prostate cancer quality of life and fatigue. FDA's database lists a supplement to the abemaciclib (Verzenio) application; its content is not stated.
PARADIGM: azacitidine-venetoclax versus induction in fit AML
In fit adults with adverse-risk AML, azacitidine-venetoclax is a credible alternative to induction, but await phase 3 survival data before making it routine.
HARMONi: ivonescimab after EGFR-TKI progression improves PFS, not clearly OS
Ivonescimab plus chemotherapy extends progression-free survival after EGFR-TKI failure, but a survival benefit is not yet shown.
80 Gy with long-term ADT improves 10-year PFS in high-risk prostate cancer
For high-risk prostate cancer on long-term ADT, 80 Gy is a reasonable choice that reduces progression without adding late toxicity.
FDA lists a supplement to the abemaciclib (Verzenio) application
An FDA supplement to the Verzenio application is listed; wait for the revised label before changing anything.
Prescribing exercise for a man starting ADT
Start a supervised aerobic and resistance exercise plan on the day ADT begins, after a bone and falls check.
STAMINA: supervised exercise improves quality of life on ADT
Refer every man starting ADT to a supervised exercise and diet programme; it measurably improves quality of life and fatigue.
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