LU-002 closed and will not move to phase III as it did not meet prescribed PFS criteria

[drowsy12]

is the abscopal effect in the room with us now?

(Sorry I had to)

But LU002 was testing a specific question - whether ablation of oligometastases improves outcomes (in the immunotherapy era). Not the abscopal effect. Every clinical trial looking for the abscopal effect has been dead negative. This was not the intent of LU002.

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[communitydoc13]

Not the abscopal effect.

My general take on COMET is that the statistics are so bad, the cases so mixed, that it likely provides a number of red herrings.

First, prostate CA is it's own beast, with the best data for local management impacting metastatic outcomes of any malignancy.

The presentation of data in COMET was a bit weird, and it would have been nice to see overlying graphs of treated lesion progression vs new lesion progression on a per patient basis.

But, even in COMET, it doesn't seem to be that prevention of new lesions was the major driver of any disparity in survival.

It may be as prosaic as this:

https://www.sciencedirect.com/science/article/abs/pii/S0360301622032631

Lesional control matters for pain and maintenance of performance status. Maintenance of performance status keeps people alive.

 

[drowsy12]

Huge believer in outcomes potentially improving by use of RT for maintaining/improving PS, allowing more systemic therapy.

 

[evilbooyaa]

They did lower doses on LU-002 (and subsequent trials) to avoid the deaths seen in OG SABR-COMET. 5% G5 tox is not acceptable to radiation oncologists or their referring doctors.

 

[temujim]

They did lower doses on LU-002 (and subsequent trials) to avoid the deaths seen in OG SABR-COMET. 5% G5 tox is not acceptable to radiation oncologists or their referring doctors.

5%+ Gr5 from surgery or systemic therapy and other specialties don't blink an eye.

 

[theradiator]

Please keep in mind that 5% grade 5 toxicity was only seen in SABR COMET but not in other randomized or prospective oligometastasis trials.

 

[evilbooyaa]

5%+ Gr5 from surgery or systemic therapy and other specialties don't blink an eye.

5% Gr5 from systemic therapy? Only flak I've seen systemic catch is the 10% G5 in CAR-T, and that is a burgeoning area of concern....

5% Gr5 from surgery seems high too, but most aren't doing surgery for what is essentially a palliative indication...

Please keep in mind that 5% grade 5 toxicity was only seen in SABR COMET but not in other randomized or prospective oligometastasis trials.

Yes, and most of those other trials had a lower Rx dose than trying to take para-aortic or mediastinal nodes to 50/5.