Ipilimumab is a human monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), and it is FDA approved for the treatment of unresectable or metastatic melanoma. Immune-related adverse events (irAEs) of gastrointestinal, dermatologic, and endocrine origin are commonly seen, ranging between 18% and 44%, with immune checkpoint inhibitors (anti-CTLA-4 and anti-PD-1/PD-L1). Rare irAEs include neurological, renal, and hematologic toxicities. Bell's palsy is a form of neurological toxicity that presents as an idiopathic paralysis of the muscles on one side of the face. We report a case of Bell's palsy in a 45-year-old male patient who received 1 dose of both ipilimumab and nivolumab for the treatment of metastatic melanoma. After the resolution of symptoms, ipilimumab was permanently discontinued and single-agent nivolumab administered. The patient has remained free of neurological symptoms. This case suggests that Bell's palsy is an irAE induced by ipilimumab.
Filgrastim-sndz (Zarxio®) was approved by the FDA in March 2015 as a biosimilar product of its reference product, filgrastim (Neupogen®) for all five indications. The NCCN Clinical Practice Guidelines has incorporated filgrastim-sndz into its recommendations as a category 1 recommendation for use in settings of febrile neutropenia, myelosuppressive chemotherapy administration, and post-hematopoietic stem cell transplant (HSCT). As a cost-saving initiative, our institution switched from filgrastim to filgrastim-sndz for all indications starting in March 2016. The purpose of this study was to assess for any difference in clinical or safety outcomes between filgrastim and filgrastim-sndz. This is an IRB-approved, single institution, 1-year retrospective chart review (September 2015 to August 2016) conducted in hospitalized adults who received either filgrastim or filgrastim-sndz either for prophylaxis of chemotherapy-induced myelosuppression or for neutrophil recovery after autologous HSCT. Our data showed no differences in duration of G-CSF therapy (7.96 vs. 8.5 days, P = 0.36), white blood count (WBC) (8.99 vs. 8.04, P = 0.28), absolute neutrophil count (ANC) (7.62 vs. 6.91 × 10/L, P = 0.36) at the time of granulocyte-colony stimulating factor (G-CSF) discontinuation, or safety of filgrastim and filgrastim-sndz. The efficacy and safety of filgrastim and filgrastim-sndz were similar for prophylaxis of chemotherapy-induced neutropenia and neutrophil recovery post-autologous HSCT.
BackgroundLetermovir is a novel antiviral that was approved for cytomegalovirus (CMV) prophylaxis after allogeneic hematopoietic stem cell transplant (allo-HSCT). The objective was to assess the real-world outcomes of CMV prophylaxis with letermovir compared with preemptive therapy (PT) alone.MethodsThis retrospective pre- and post-study evaluated the clinical impact of using letermovir prophylaxis in CMV-seropositive allo-HSCT recipients at our institution. The electronic medical record was used to identify patients that received PT alone from July 2016 to November 2017 and letermovir prophylaxis from November 2017 to March 2019. The primary endpoint was the proportion of patients with CMV infection requiring PT through week 24 after transplant. Secondary endpoints included the proportion of patients with CMV infection requiring PT through week 14 after transplant, time to CMV infection requiring PT, incidence of CMV disease, CMV-related hospitalization and all-cause mortality through week 14 and 24 after transplant. Safety data included incidence and time to engraftment and adverse effects due to letermovir. Chi-squared and t-test were utilized for categorical and continuous data respectively.ResultsThe baseline characteristics were similar (Table 1) and 78.7% of patients were high risk for CMV. Fewer patients in the letermovir group (n = 50) than in the historic control group (n = 100) had CMV infection requiring PT through week 24 after transplant (9 [18%] vs. 63 [63%], P < 0.001). The mean time to CMV infection requiring PT through week 24 after transplant was 93.4 days (28–161) in the letermovir group vs. 37.4 days (11–126) in the historic control group (P < 0.001). The all-cause mortality and incidence of CMV-related hospitalization were not statistically different between the two groups through week 24 after transplant (Table 2). The incidence and time to engraftment were not statistically different between the two groups (Table 3).ConclusionLetermovir prophylaxis in the real-world setting resulted in less CMV infection requiring PT when compared with a historic control of patients receiving PT alone. The majority of patients in the letermovir group experienced delayed-onset CMV reactivation. Letermovir was well-tolerated with no apparent myelosuppressive toxicities. Disclosures All authors: No reported disclosures.
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