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It seems that our experiences thus far have been variable with the 480mg q 4 wk dosing, and certainly seems that the low grade flu like sx can an education point that we can all cover with our patients whether they are just starting tx or transitioning from another dosing regminen. Fortunately, in our observations, they have been short lived (usually several days) and respond to no intervention or supportive care such as acetaminophen or ibuprofen.
We have transitioned about 8 patients from other braf / mek agents to the Braf-tovi & Mek-tovi & they are doing very well in regard to tolerablitliy and not having reoccurrences of the AE’s that were dlt’s & drug holds on prior therapies.
Have you transitioned any patients?
How are patients doing on BRAFtovi & Mektovi?
Thoughts on how you will proceed with starting BRAF/ Mek therapies as we move forward?I spoke with our BMS reimbursement liaison earlier today and per the company July 1 the reimbursement should have gone through for Medicare.
we have had a couple of patients with hemolytic anemia all from combination ipi/nivo, 1 was hospitalized at an outside hospital & our team was in touch with the hosptial team, the pt made a full recovery. another was close to our center so we were able to avoid a hospitalization, through use of oral high dose steroids& close oversight & she is fully recovered.
We were so excited to hear about the approval! We have had several patients who have been waiting for the approval due to intolerability with Dabrafenib and Tramatenib. We just now need to wait for insurance to update their system to be able to get access to these drugs. The main issue is going to be the same as we see with the other targeted therapies which is high copays for our patients with Medicare part D. Finding sources or assistance programs to help with patients donut holes is always difficult.
We were just discussing this last week. After years of ASCO having huge announcements of positive very influential findings things have slowed down. With the discovery of Ipilimumab and Nivolumab and the BRAF/MEK inhibitors we are almost at a plateau when it comes to new innovations. I am sure there are many more to come but at the moment especially front line clinical trials seems to be limited.
We don’t routinely check our IIB pts or primary lesions, we will check the primary lesion if the tissue from nodes is QNS and there is no other source of sampling or if safety is an issue wtih a new issue in sampling.
Although primary tumors may possess BRAF mutations, they don’t always 100% of the time correlate to metastatic sites, so checking new advanced disease against a high risk primary result would be prudent. As Rajni mentioned a quick 24 hour turn around with tissue IHC for BRAF can be conducted while conducting a full genetic analysis, especially if the start of treatment is urgent. I agree Krista, we will be seeing more sampling in earlier high risk disease, thank you for sharing your routine practice.Great question, tough topic, we have a few patients who have had varient mutations and when they failed immunotherapies we have utilized either a braf or a mek inhibitor to try and slow or arrest their disease. The inhibition is not as robust as with a true BRAF V600 E, K or M variant but the pt may receive some term of benefit. Approval of inhibotors for variant mutations, can either go smoothly or a letter of medical necessity may be required with a peer reviewed journal article &/ or a peer to peer may also be necessary.
Such an important topic, as many supplements are OTC and unregulated. In our practice, we first explore if supplements being used were recommended by a HCP who has training and experience with supplements, herbals, homeopathy or essential oils or if a pt has added “supplements” themselves.
We investigate the intent of the “supplements” and evaluate which may safely remain in a patients’ regimen in relation to treatment. Sometimes, pts make choices of supplements based on what they think they need without real guidance or input as to how the supplements may interact with one another or prescribed medications. As Mollie pointed out some supplements especially poly supplements can interfere with oral targeted therapies or set up a renal or hepato –toxic situation in respect to immune checkpoint inhibitors. Additionally, the growing access to CBD (cannabidiol) oil and ingestion of CBD which is a powerful CYP450 3A 4&5 inhibitor can interfere with other oral agents causing toxicity with prescribed medications.Tissue availability is a large barrier for BRAF testing especially in patients with microscopic foci in a single lymph node. Often times there isn’t enough tissue to test. In these patients we often have to wait and see and if they end up with progressio. Of disease, they have to undergo procedure to procure more tissue. Patient often find distress in this process for they just have found out they have recurrent disease and now have to undergo a procedure for tissue for BRAF testing. If we can we try to at least do a IHC on tissue to see if we can get BRAF results.
I think we are more likely to give immunotherapy adjuvantly. The side affects of dabrafenib especially the pyrexia are very difficult for patients to maintain their normal lifestyle. I think that dabrafenib and tramatenib do have a place adjuvantly with patients who can’t recieve immunotherapy such as those with precious history of colitis or other autoimmune conditions or organ transplant patients.
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.
Rumor mill update- hearing that early June is when the new combo therapy will be available. Behind the scenes sounds very ready for launch and immediate availability of meds for pts. That’s what I am hearing.
We do not routinely premedicate either unless with the first or a subsequent dose there have been adverse events experienced. When we do premed and manage post injection sx we typically use tylenol or ibuprofen and benadryl 25mg since the gmcsf component often creates a cytokine release which causes the elevated temps and chills / flu-like sx.
We will have a patient premed day of, then remedicate every 8 hours for up to 48 hours as needed, but definitely the first 24 hours. On a very rare occassion we have use low dose dex for a pt who atypically went up to 105, he was on concurrent pembro.Suzanne, great spotlight on ICI induced AI- thank you for that reminder!
I have had 1 patient in the past with sensitive skin ( no rash or itching) as you have described, steroids were not helpful however gabapentin was helpful, pt remained on it until the sx resolved, If I recall it was a couple of months.
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