ABSTRACT
BACKGROUND: Chimeric antigen receptor (CAR) T-cells are an important new third-line treatment option for large B-cell lymphoma (LBCL). The objective response rates in pivotal early phase clinical trials with CAR T-cells were very promising. The objective of this study was to describe the efficacy results obtained with CAR T-cells infusions in our institution and to compare the toxicities of our cohort with those of pivotal trials and studies conducted in a real-life setting. PATIENTS AND METHODS: Efficacy and safety data were retrospectively collected from 25 patients with LBCL treated with CAR T-cells therapy at CHU de Québec-Université Laval. A literature search was then performed to identify other efficacy or safety data from a real-life setting. RESULTS: At 3 months post infusion, the objective response rate (ORR) in our population with tisagenlecleucel and axicabtagene-ciloleucel were 20% and 47%, respectively. Bulky disease was the only negative predictor of poor response at 3 months (0% vs. 53%, P = .03). Bulky disease was associated with a median PFS of 2 months compared to 5 months for non-bulky disease (P = .0009). Grade ≥ 3 hematological toxicities were greater in patients treated with axi-cel (60% vs. 20%, P = .048), without bone marrow involvement (55% vs. 0%, P =.046), without stage IV disease (72% vs. 21%, P =.02), with refractory disease (67% vs. 10%, P =.01) or having been affected by cytokine release syndrome (58% vs. 0%, P =.02). CONCLUSION: The poor response rate at 3 months after infusion in our cohort was influenced mainly by bulky disease. Further studies are needed to better characterize the loss of efficacy of CAR T-cells because the majority of patients will relapse over time.
Subject(s)
Lymphoma, Large B-Cell, Diffuse , Neoplasm Recurrence, Local , Humans , Retrospective Studies , Canada , Neoplasm Recurrence, Local/drug therapy , Lymphoma, Large B-Cell, Diffuse/pathology , Immunotherapy, Adoptive/methods , T-Lymphocytes , Antigens, CD19ABSTRACT
Trastuzumab is a monoclonal antibody used to treat human epidermal growth receptor 2 positive (HER2+) breast cancers either by itself or in combination with other chemotherapy medication. Marketing authorization was granted for a subcutaneous form of the antibody in 2014. In this case report, we discuss our experience with a patient who took part in a therapeutic education program on self-administration of trastuzumab. We demonstrate that these types of self-administered injections are not only possible but also are toxicity-free. Based on the tolerance data and our patient's experience, we propose that the current regulations be relaxed regarding the availability of trastuzumab subcutaneous form in order to develop a cheaper "city scheme," i.e. self-administered injections.
Subject(s)
Antineoplastic Agents, Immunological/administration & dosage , Breast Neoplasms/drug therapy , Patient Education as Topic/methods , Trastuzumab/administration & dosage , Adult , Breast Neoplasms/genetics , Female , Humans , Injections, Subcutaneous , Receptor, ErbB-2/genetics , Self AdministrationABSTRACT
Herceptin(®) injected by intravenous (IV) is one of the key treatment of breast cancer HER2+. The improvement of galenic form allowed a new way of administration, the sub-cutaneous way (SC), authorized by EMEA in 2013. This new way enables a 5-minute infusion, a fixed dose and a fixed volume of preparation. On 2012, saving-time and financial impacts were calculated by extrapolation of the IV way in a cancer treatment center. The study showed a preparing time-saving of 7.5min/loading dose and of 6.5min/maintenance dose, and a nurse time-saving of 4.5min/loading dose and 4.25min/maintenance dose. Moreover, it can be added a saving of consumable of 13,31 per injection in case of monotherapy. The SC leads to a new adaptation and reorganization in the preparation of monoclonal antibodies and day hospitals.
