RTOG 0937 closed for futility

[Gfunk6]

See here: http://www.rtog.org/LinkClick.aspx?fileticket=RCEM5drudUE=&tabid=290

This was a trial in patients with ES-SCLC with good response to induction chemo, randomized to PCI alone vs. PCI + consolidative XRT to sites of oligometastatic disease.

No OS benefit and significantly higher Grade 4+ toxicities in experimental arm.

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[medgator]

We still have the slotman trial presented at asco last year (along with the older jeremic trial) to offer consolidation thoracic xrt to these pts in addition to pci

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61085-0/abstract

 

[radiaterMike]

We still have the slotman trial presented at asco last year (along with the older jeremic trial) to offer consolidation thoracic xrt to these pts in addition to pci

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61085-0/abstract

The RTOG trial was specifically for limited metastatic disease. Most extensive stage sclc patients have bulky nodal disease in addition to widespread metastases so thoracic radiation is still plausibly beneficial.

 

[medgator]

The RTOG trial was specifically for limited metastatic disease. Most extensive stage sclc patients have bulky nodal disease in addition to widespread metastases so thoracic radiation is still plausibly beneficial.

I think the gist of the situation now is to let chemo take care of extrathoracic disease and allow xrt to consolidate the primary in the chest, as well as sterilize micromets in the brain (sanctuary site)

 

[Palex80]

Well, they randomized something like 79 patients, if I understand correctly.
A randomized trial can easily miss its goal of proving a positive result if it has to be terminated after so few patients have been randomized due to ... bad luck, which means a couple of more patients dying in the experimental arm by chance.

 

[seper]

I wonder what those toxicities an deaths were. Lung?

 

[medgator]

I wonder what those toxicities an deaths were. Lung?

Doesn't make sense considering the other studies I've referenced. Maybe it was hematologic given the chemo and multiple extra-thoracic areas of additional XRT.

 

[seper]

well, the protocol allows 45 Gy/15 or 40/10 to the chest. That's too high, especially after chemo.

 

[medgator]

well, the protocol allows 45 Gy/15 or 40/10 to the chest. That's too high, especially after chemo.

The original induction chemo/radiation studies (Curran RTOG study, Dillman CALGB study) in NSCLC allowed 60 Gy+ to the chest so I am not sure why you think that's high?

 

[Burt Radnolds]

well, the protocol allows 45 Gy/15 or 40/10 to the chest. That's too high, especially after chemo.

The original Jeremic study (http://www.ncbi.nlm.nih.gov/pubmed/10561263) showing a survival advantage for consolidative thoracic RT for ES-SCLC used 54 Gy @ 1.5BID to the chest, which is a pretty whopping dose, and managed to show a survival benefit. I've seen many patients palliated with 45/15 who tolerate it very well. I do not think that this was what fated the trial for failure.

 

[seper]

In SCLC, volumes are usually larger compared to NSCLC. Final report will be an interesting read (surely will take a few years to write though).

 

[medgator]

In SCLC, volumes are usually larger compared to NSCLC. Final report will be an interesting read (surely will take a few years to write though).

They also end up being more central to the mediastinum with lower mean and v20 doses than my typical stage III nsclc pts. Time will tell, but given the positive studies from jeremic and the eortc, I don't think the lung dose was an issue. If anything, it feels a bit on the low side to me for residual gross disease