ADT + tx intensification w/ chemo or ARSI is SOC based on lots of RCTs
No OS diff seen in STAMPEDE from ADT+Abi vs ADT+doce (FFS difference as ARSI suppress PSA = FFS).
No clear role of triplet therapy in low volume (ARASENS)
Thus, SOC is ADT+doce or ARSI for low volume
2/n
RT to primary for low volume improved FFS and OS in STAMPEDE arm H, and in IPD meta-analysis w/ HORRAD RCT.
18% of men received ADT+doce on STAMPEDE arm H, and no interaction of differential effect noticed.
Thus, ADT+doce+RT in low volume was the SOC at this point.
3/n In countries like US majority use an ARSI instead of doce, esp in low volume.
Given doce and abi have similar long-term OS (post-hoc in STAMPEDE), and recent data in cN1 disease shows RT+ADT +/- Abi, that Abi improves OS, many adopted RT+ADT+RT to primary. @AttardLab
4/n Now, some argued that we have no clean trial of ADT+RT +/- Abi, or ADT+Abi +/- RT.
However, if one were to add only 1 therapy to ADT it is undeniable that the value based option would be RT to the primary and not Abi.
Thus, SOC is ADT+RT +/- tx intensification at this point
5/n Here is where PEACE-1 comes in.
Only in hindsight we know know it would need to be 2-3 times the size to answer all the questions it sought out to if the co-primary endpoints were truly to include rPFS and OS.
This is because of the introduction of doce into the SOC arms
6/n PEACE-1 enrolled 1173 men.
-43% were low volume = 505 men
-50% of low volume got doce
-About half of these got ADT alone and not ADT+Abi
Thus, only ~125 men were randomized to ADT+Abi +/- RT for low volume!
STAMPEDE arm H low volume ~1000 men!
7/n Thus, the trial turned out testing triplet systemic therapy, which already reviewed not needed in low volume and adds even more cost and toxicity.
Despite this, RT to primary on top of excessive systemic tx improve rPFS!!!
8/n And as noted on it is underpowered for OS for low volume, it still showed important trends: 1. OS for SOC+RT was numerically superior to SOC+Abi (STAMPEDE predicted RT and abi have similar HR of benefit) 2. SOC+Abi+RT had numerically best OS but subsets are tiny
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Fallacy #1:
Dr. Ehdaie et al begin their reply by stating it is invalid to compare outcomes from pts treated 20-30 yrs ago.
Yet they cited data on positive post tx bx from data 30-40 years ago with low dose 2D and 3D RT.
#1 continued.
They ignored their very own MSKCC reference from Dr. Zelefsky's trial showing <10% post-tx bx positive rates that we referenced in our letter even...I am puzzled why someone of your standing would mislead people this way.
@ParikhSimul@SprakerMDPhD Been absent on SDN and twitter mostly lately. Thanks for the good read. Here is my thoughts on COI as I have evolved over time and struggle given I have seen 1st hand when COIs cloud judgement. I also have seen those without expertise make incorrect interpretations.
Here we go...
@ParikhSimul@SprakerMDPhD 1/n I started my career declining all COIs. Was taught from med school they make you biased & pharma/industry were evil. I felt like I was pure & proud to have no COIs. Then I got to know people who worked for industry and those who transitioned from academics to industry...
@ParikhSimul@SprakerMDPhD 2/n I realized if my goal was to impact cancer patients lives, get access to practice changing data, educate ppl from around the world, run practice changing trials, you MUST work with industry. The degree however you work with them matters.
@aj2279@NicholasZaorsky and myself wrote a quick commentary to @TheLancet for the @NRGonc RTOG 0534/SPPORT trial. Didnt make the cut so figured I would just post here if of interest to anyone.
Their word limit is crazy short.
Would be great to see RMST analysis of time to salvage ADT, ideally with associated testosterone data to determine if this is merely delay vs increased cure.
1st read up on the 1st RCT of SRT +/- hormone therapy (HT), RTOG 9601, and why men getting early SRT at low pre-SRT PSAs should NOT get ADT: jamanetwork.com/journals/jamao…
1/n I write this without knowing where to start, but what I know is I have a voice and that voice may reach people where other voices may not, or at least reinforce the voices of others.
After reading, listening, talking with those effected, here is what I know and what I dont
2/n Staying quiet, respectful, and polite is not enough. I need to actively be anti-racist. I need to actively be willing to relinquish power, and encourage others to as well to accelerate equality in America. Although some of that power was earned, much was also born into
3/n This problem has been here before I was born, and black people have every right to be annoyed that people are now trying to step up when it has been going on for hundreds of years.
1/
TWEETORIAL of GETUG-16 and hormone therapy with SRT
I have been asked many times to discuss this paper and my views on the topic now that the GETUG-16 was updated. It is a great trial with numerous strengths. So here we go… @MCWardMD@RTendulkarMD@subatomicdoc#PCSM
Sample size was increased to be powered for OS, which was not met. So the endpoint the trial was actually powered for was not met = negative.
@MCWardMD@RTendulkarMD@subatomicdoc 3/
PFS should really not be used for ph3 trials. PFS basically equals BCR, which will near always be improved w/ ADT as you are inhibiting the PSA-based endpoint you are measuring. Even in RTOG 9408 low risk pts have a BCR benefit. Signal finding not practice changing.