Champ d’application et objectifs
2018 (Programme de gestion
thérapeutique des
(Society for Immunotherapy of Cancer)
États-Unis AGREE II : 45,7% AGREE II : 43,9 % AGREE II : 47,4 % AGREE II : 58,3 % AGREE II : 55,8 % AGREE II : 55,8 % AGREE II : 58,3 % (Nivolumab has also
been studied in the phase III setting, but is currently not approved for use by Health Canada.)
exposure and therapeutic response.
In support of this strategy, cost analyses have underscored the economic rationale for preferring weight-based dosing in resource-constrained health care systems.
It remains to be seen whether an actual reduction in pharmacy burden from fixed dosing can be translated into reduced costs and how these would compare with the savings afforded by weight-based dosing.
-Dose banding is a refinement of the weight-based approach that proposes the use of round doses, often multiples of vial sizes, for pre-defined weight ranges in order to simplify calculations and preparations. Banding of both pembrolizumab and nivolumab was explored in the literature and was found to be cost-effective.
-Vial rationalization can occur, but as best available practice only allows one drug in the sterile hood at a time, rationalization requires the use of a close system transfer device, which may not be available at all centres. Therefore, wastage and cost savings may vary from site to site based on patient numbers, sterile program procedures and purchasing practices.
2. PRÉCAUTIONS POUR POPULATIONS SPÉCIALES
n.d. n.d. n.d. Patients with prior irAEs
or Pre-existing Autoimmune Conditions - Patients with pre-existing autoimmune conditions or organ transplant recipients may be candidates for immune checkpoint blockade.
-Patients with autoimmune neurologic conditions or
n.d. n.d. The Task Force recognized
that very little is known about contraindications to immunotherapy in patients with NSCLC, and that many of the above examples concern anti-CTLA-4 ipilimumab that hold no approvals for this disease.
-Because patients with autoimmune disease are
Alberta 2015
(Agence canadienne des médicaments et technologies de
la santé) (Programme de gestion
thérapeutique des
(Society for Immunotherapy of Cancer)
États-Unis AGREE II : 45,7% AGREE II : 43,9 % AGREE II : 47,4 % AGREE II : 58,3 % AGREE II : 55,8 % AGREE II : 55,8 % AGREE II : 58,3 %
life-threatening autoimmune disorders, particularly if not controlled with immunosuppressive medications or requiring high doses of
immunosuppression, are unlikely to be suitable candidates for cancer immunotherapy.
-Patients with prior allogenic stem cell transplant may be candidates for immunotherapy.
-Optimization of immunosuppression for pre-existing autoimmune conditions and close cooperation with pertinent subspecialists is recommended. These guidelines suggest a goal of immunosuppressive regimen allowing for prednisone dose of < 10 mg daily (or equivalent) prior to initiating cancer immunotherapy.
-Caution should be exercised when considering resumption of ICI therapy for patients who have experienced a previous treatment-related irAE. A key consideration is the patient’s tumor response. In patients with responding or stable disease, it may be prudent to continue close surveillance and to re-introduce ICI therapy if the patient develops evidence of progression of cancer.
As appropriate, consult with organ-specific specialists prior to resumption. With some exceptions, resumption of
typically excluded from immunotherapy clinical trials, the use of checkpoint inhibitors in these patients is still considered investigational.
-Only 6% of the Task Force felt that a history of multiple sclerosis would be an absolute contraindication.
-Furthermore, in the context of an otherwise fatal illness such as lung cancer there may be greater willingness to accept the risk of toxicity, particularly in the absence of alternative effective therapies.
-Of note, the majority of the Task Force (75%) felt that prior liver transplant was an absolute contraindication to immune checkpoint therapy as some deaths and organ rejection have been described.
-Until further data are available, particularly from real-world clinical settings, close monitoring in conjunction with appropriate specialist care is
recommended to ensure early identification and effective management of irAEs.
Alberta 2015 (Alberta Health
Services) Canada
Alberta 2020 (Alberta Health
Services) Canada
(Agence canadienne des médicaments et technologies de
la santé) Canada
NCCN 2020 (National Comprehensive
Cancer Network) États-Unis
2018 (Programme de gestion
thérapeutique des médicaments)
Canada
pembrolizumab 2018 (Programme de gestion thérapeutique
des médicaments) Canada
(Society for Immunotherapy of Cancer)
États-Unis AGREE II : 45,7% AGREE II : 43,9 % AGREE II : 47,4 % AGREE II : 58,3 % AGREE II : 55,8 % AGREE II : 55,8 % AGREE II : 58,3 %
irAE can be considered once signs and symptoms have resolved to grade 1 or below. Perform close follow-up to monitor for any signs or symptoms of irAE recurrence. If toxicity returns upon ICI rechallenge, permanently discontinue that class of ICI.
-Anti-CTLA4 based therapy has a higher incidence of exacerbating baseline autoimmune conditions relative to anti-PD-1/PD-L1-based approaches.
Organ Transplant Recipients -Consideration of ICI therapy in organ transplant recipients is vey complex and requires
multidisciplinary involvement. Graft failure while on ICI
immunotherapy has been reported, and transplant organ loss may be an outcome of treatment. -Patient with solid organ transplant who have a viable option for alternative therapy if graft rejection occurs (ie, kidney and dialysis) may be candidates for immunotherapy, particularly if there is no prior evidence of graft rejection and patients are on a stable maintenance immunosuppression regimen. The possible consequences of ICI therapy should be discussed with the patient and organ transplant team and there should be a plan
Alberta 2015 (Alberta Health
Services) Canada
Alberta 2020 (Alberta Health
Services) Canada
(Agence canadienne des médicaments et technologies de
la santé) Canada
NCCN 2020 (National Comprehensive
Cancer Network) États-Unis
2018 (Programme de gestion
thérapeutique des médicaments)
Canada
pembrolizumab 2018 (Programme de gestion thérapeutique
des médicaments) Canada
(Society for Immunotherapy of Cancer)
États-Unis AGREE II : 45,7% AGREE II : 43,9 % AGREE II : 47,4 % AGREE II : 58,3 % AGREE II : 55,8 % AGREE II : 55,8 % AGREE II : 58,3 %
in place to seamlessly manage the patient if graft loss occurs.
-Although patients with prior allogeneic stem cell transplant may be candidates for immunotherapy, there is an increased risk of transplant-related complications, including potentially fatal graft-versus-host disease.
Careful discussion with the patient and stem cell transplant physicians should precede initiation of immunotherapy.