Oncology Clinical Trials

[DavidFR, BSN, MSN, RN]

Is anybody else working in oncology clinical trials?

Interested to know what people's experiences are with the newer immunotherapies and how you all manage strong cytokine reactions? What are your policies on giving paracetamol and at what point do you give an antedote (Toclizumab or or Siltuximab)?

[OncologyCat, BSN, RN]

I work with phase I and phase II clinical trials. Depending on each protocol, the principal investigator will specify in the protocol which drugs to give in case of hypersensitivity reactions. Some meds require premeds per the sponsor, and the most common premeds/rescue meds are tylenol, benadryl, zyrtec/allegra, solu-medrol/decadron, pepcid, and singulair. I have never personally given tocilizumab as a rescue meds for reactions, though I have given it as part of a protocol for newer melanoma tx and for grade 2 CRS in CAR-T cell patients. I’m sure CRS intervention will depend on the sponsor/principal investigator for each protocol and the physician’s judgment of the pt’s clinical picture.

[DavidFR, BSN, MSN, RN]

On 5/31/2021 at 4:46 AM, OncologyCat said:

I work with phase I and phase II clinical trials. Depending on each protocol, the principal investigator will specify in the protocol which drugs to give in case of hypersensitivity reactions. Some meds require premeds per the sponsor, and the most common premeds/rescue meds are tylenol, benadryl, zyrtec/allegra, solu-medrol/decadron, pepcid, and singulair. I have never personally given tocilizumab as a rescue meds for reactions, though I have given it as part of a protocol for newer melanoma tx and for grade 2 CRS in CAR-T cell patients. I’m sure CRS intervention will depend on the sponsor/principal investigator for each protocol and the physician’s judgment of the pt’s clinical picture.

I'm just interested because our gudelines change all the time at present. The latest thng from some sponsors is to avoid paracetamol/tylenol at all costs unless absolutely necessary as there are now some theories that the efficacity of the immunotherapy agent could be compromised. Have you ever heard that?

I have twice gven tocilizumab as an antedote. Extreme reactions seem to be getting more frequent.

[OncologyCat, BSN, RN]

18 hours ago, DavidFR said:

I'm just interested because our gudelines change all the time at present. The latest thng from some sponsors is to avoid paracetamol/tylenol at all costs unless absolutely necessary as there are now some theories that the efficacity of the immunotherapy agent could be compromised. Have you ever heard that?

I have twice gven tocilizumab as an antedote. Extreme reactions seem to be getting more frequent.

I haven’t heard anything about avoiding tylenol for immunotherapy. For standard of care immunotherapy such as Daratumumab or Rituxan we still give tylenol as premed. The policy in our workplace for hypersensitivity reactions also allow to use tylenol if patients have fever/pain/chills/rigors. Again, depending on each protocol the PI might have different directions on what to do for reactions, but tylenol, at least for my institute, is still commonly used.

[C_AlexanderRN, BSN, RN]

I work in an inpatient setting where we routinely administer clinical trials and monitor patients after some phase 1 drugs. Each protocol is very different in terms of which rescue meds are "allowed" and even the grading system used. There is a flowsheet built into EPIC that we use called IEC score. We routinely check ICANS/ICE scores in patients, especially those receiving CAR-T cell therapy. Attached are a few CRS grading tables with associated interventions. Tocilizumab is usually given if patients have Grade 2 CRS refractory to other supportive care measures (I.e. NS bolus for HoTN). Giving Toci sooner rather than later can save the patient a lot of unnecessary discomfort in my opinion. Toci has not been shown to decrease the efficacy of CAR-T cells. Toci has the potential for hypersensitivity reaction, so it is good practice to have an anaphylactic kit at the bedside when you are giving it.

[DavidFR, BSN, MSN, RN]

Interesting, we have a similar system and yes, it's the Car-T cell patients that seem to get Toci sooner than the others.