Adjuvant Immunotherapy in stage IIIA patients

[Lisa Kottschade]

Hi Everyone!

I’m wondering how you all approach the treatment of Stage IIIA patients and do you treat them with adjuvant nivolumab? I’ve found this to be a bit of a difficult area in discussion with patients, in that the study that led to the approval of nivolumab did not include stage IIIA patients, but the FDA approval was a blanket approval for all stage III patients and was not specific. Unfortunately, we will not gain any insight from Checkmate 915 either as stage IIIA patients are excluded from the trial. Looking forward to people’s thoughts.

[Virginia Seery]

Hi Lisa,
Thus far, we have not been offering nivolumab to Stage IIIA patients since the trials have not included that population. However, I hope this can be revisited in the future and I would be very interested in what others are doing at their institutions.

[Lisa Kottschade]

Hi Virginia,

We too have not been offering this to our stage IIIA patients either. I have had patients asking though.

Thanks for your insight-curious what others are doing.
L

[Mollie Reed]

This is certainly an interesting approval given that IIIA patients weren’t included in the trial. While we have yet to encroach this in practice, I think that this will be decided on a case-by-case basis. For example, I think that if you see a younger, healthier patient, oncologists are going to want to be more aggressive in the adjuvant setting. As with everything, it will end up being about weighing risks and benefits. I am happy that more patients than just those eligible for the trial can potentially benefit from this, but it certainly creates some gray areas!

[Kathleen Madden]

We too have been following approval indications, and have been fielding questions from patients. This patient population we have typically been promoting clinical trial options, typically adjuvant vaccines, however some of the adjuvant ICI trials are starting to expanding to include early stage III patients.

On another note, I know that serum marker research is well into development but not ready for release yet. My hope is that advancement with lab markers will assist in evaluating risk for recurrence and help with questions such as this in weighing risks / benefits and lead to other immunologic tests evaluating potentential for irAE’s for all pts but especially early stage adjuvant patients.

[Krista Rubin]

Great question:
We have been taking this on a case-by-case basis. Though IIIA patients have a favorable prognosis, there are some patients that have a more worrisome feature than the “average IIIA”. For those patients, a detailed risk/benefit discussion is essential, and the patient would be made aware of the data (not including IIIA).

[Suzanne McGettigan]

Such an interesting discussion.

Another factor that is influencing this group of patients is the results from the MSLT-II trial which demonstrated no increased benefit on overall survival for patients with microscopic disease undergoing completion lymph node dissection. From a practical standpoint, this potentially means that more patients will be classified as Stage IIIa now than previously. Therefore, it will continue to be a detailed conversation with patients about the role of adjuvant therapy in that setting.

[Rajni Kannan]

I agree that the MSLT-2 trial is going to change who gets completion lymph node dissections, this may influence the use of Adjuvant Nivolumab in high risk IIIA that don’t undergo a completion lymph node dissection. Will be interesting to see how these decisions are made in these patients and of surgeons will have more of influence on the decision.

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