natelaugh wrote:Hi All,
My dad oncologist email that Regorafenib + Nivolumab is not an approved regimen at Kaiser. We got a pet/ct scan and it shows progression/recurrence. The cancer has spread to his liver, lung and lymph node. 5FU monotherapy didn't work for my dad.
Nate.
Pyro70 wrote:natelaugh wrote:Hi All,
My dad oncologist email that Regorafenib + Nivolumab is not an approved regimen at Kaiser. We got a pet/ct scan and it shows progression/recurrence. The cancer has spread to his liver, lung and lymph node. 5FU monotherapy didn't work for my dad.
Nate.
Regonivo isn’t an approved regimen anywhere.
Rock_Robster wrote:Pyro70 wrote:natelaugh wrote:Hi All,
My dad oncologist email that Regorafenib + Nivolumab is not an approved regimen at Kaiser. We got a pet/ct scan and it shows progression/recurrence. The cancer has spread to his liver, lung and lymph node. 5FU monotherapy didn't work for my dad.
Nate.
Regonivo isn’t an approved regimen anywhere.
Is this quite right? Maybe I’m being semantic but my understanding is that individual drugs get approved, not combinations (I could be wrong though so please correct me!). Oncologists may then choose to use the drugs in combination (and at doses) selected for the patient - eg offering 5FU monotherapy vs FOLFOX. The issue here I think is that nivolumab is an approved drug but not usually funded by insurance for MSS patients due to near-zero response as monotherapy.
Would be interesting to see if the manufacturer is willing to fund or subsidise some regonivo treatment though to get more data out there faster.
Rock_Robster wrote:Thanks Pyro70 for your efforts keeping track of this; it’s incredibly helpful to have in the absence of further trial data.
In REGONIVO, the ORR in MSS CRC patients was 29%, suggesting of your n=7 sample we would expect 2 patients to have had stable disease or regression. This actually doesn’t sound that far from what you’re describing (ie 1 stable, 2 stable or slight increase [which sounds like would likely still meet RECIST criteria for a response]). Whilst it’s disappointing to not see significant reduction of disease burden in your cohort, I’m not sure it could reasonably be expected either if we apply the REGONIVO results to a sample of 7 (even ignoring the reasonable statistical deviation we would expect from such a small sample).
As you say the groups are likely heterogenous as well, ECOG scores may be one area - also pretreatment and response to PD-1 inhibitors seemed to potentially be relevant (though perhaps moreso for gastric cancer than CRC).
So I don’t take this to mean that rego + nivo does or doesn’t work; simply that it can’t be concluded at this point. In short I’m perhaps disappointed but not surprised or discouraged yet
Rob
Pyro70 wrote:Rock_Robster wrote:Thanks Pyro70 for your efforts keeping track of this; it’s incredibly helpful to have in the absence of further trial data.
In REGONIVO, the ORR in MSS CRC patients was 29%, suggesting of your n=7 sample we would expect 2 patients to have had stable disease or regression. This actually doesn’t sound that far from what you’re describing (ie 1 stable, 2 stable or slight increase [which sounds like would likely still meet RECIST criteria for a response]). Whilst it’s disappointing to not see significant reduction of disease burden in your cohort, I’m not sure it could reasonably be expected either if we apply the REGONIVO results to a sample of 7 (even ignoring the reasonable statistical deviation we would expect from such a small sample).
As you say the groups are likely heterogenous as well, ECOG scores may be one area - also pretreatment and response to PD-1 inhibitors seemed to potentially be relevant (though perhaps moreso for gastric cancer than CRC).
So I don’t take this to mean that rego + nivo does or doesn’t work; simply that it can’t be concluded at this point. In short I’m perhaps disappointed but not surprised or discouraged yet
Rob
Yes we can’t draw any definitiv conclusions. But to clarify ORR is the number (or percent of patients) that have had at least 30% tumor shrinkage (sum of PR and CR). It does not include stable patients.
If you include stable patients (growth less than 20% and no new lesions, I think) it’s called the DCR (disease control rate) which for Regonivo was like >80%...
Pyro70 wrote:7 patients that I know of have had their first CT scans or stopped therapy.
4/7 have died or are in hospice and stopped therapy
2/7 are stable with slight increase in tumor size (could be pseudo progression)
1/7 is stable with no change in tumor size
0/7 have had a response (tumor shrinkage)
There is some discussion that the these 7 patients had a lower ECOG than in the Japanese trial where all but one had an ECOG of 0. Like for Regorafenib monotherapy it May be important to start this while the patient is still relatively fit.
. . .
boswind wrote:Here are the two articles from where I drew my statement above.
CORRECT Phase III trial
https://ascopubs.org/doi/abs/10.1200/jc ... suppl.3502
Dominating Caucasian patients
Arm of Regorafenib:
Median PFS: 1.9 months
Median OS: 6.4 months
CONCUR Phase III trial
https://www.ascopost.com/issues/august- ... al-cancer/
Dominating Asian patients
Arm of Regorafenib:
Median PFS: 3.2 months
Median OS: 8.8 months
Regorafenib had a consistent OS benefit in the Japanese and non-Japanese subpopulations, with hazard ratios of 0.81 (95 % confidence interval [CI] 0.43-1.51) and 0.77 (95 % CI 0.62-0.94), respectively. Regorafenib-associated hand-foot skin reaction, hypertension, proteinuria, thrombocytopenia, and lipase elevations occurred more frequently in the Japanese subpopulation than in the non-Japanese subpopulation, but were generally manageable.
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