Safety of ninety-minute daratumumab infusion.

PURPOSE: Daratumumab is the first anti-CD38 monoclonal antibody of the class approved for recurrent and refractory multiple myeloma. Grade 3 and 4 Infusion-Related Reactions (IRRs) are frequent during the first and second infusions. Due to the risks associated with severe IRRs, daratumumab is systematically administered over a period of 3.5 hours.The main objective of this study was to evaluate the safety of a 90-minute daratumumab infusion from the third infusion. PATIENTS AND METHODS: All patients who had received two or more doses of daratumumab in monotherapy or in combination with standard infusion rates were included. We excluded patients enrolled in clinical trials. For the rapid infusion protocol, 20% of the dose was administered over 30 minutes and the remaining 80% over 60 minutes. RESULTS: From April 1 to May 31, 2019, 25 patients received 53 90-minute infusions of daratumumab. Premedication included corticosteroids, antipyretics, antihistamines, and if necessary a leukotriene receptor antagonist. No grade 3 or grade 4 IRRs were observed. CONCLUSION: From the third infusion, we found that a rapid administration of daratumumab (90 vs 210 minutes) was well tolerated and safe. It would be interesting to test this regimen from the second infusion.

Clinical and economic impact of pharmacist interventions in an ambulatory hematology-oncology department.

OBJECTIVES: To evaluate clinical and financial impact of pharmacist interventions in an ambulatory adult hematology-oncology department. METHODS: All cancer patients receiving a first injectable immuno- and/or chemotherapy regimen were included in this prospective study over a one-year period. The clinical impact of pharmacist interventions made by two clinical pharmacists was rated using the Clinical Economic and Organizational tool. Financial impact was calculated through cost savings and cost avoidance. Main results: Five hundred and fifty-eight patients were included. A total of 1970 pharmacist interventions were performed corresponding to a mean number of 3.5 pharmacist interventions/patient. The clinical impact of pharmacist interventions was classified as negative, null, minor, moderate, major and lethal in 0, 84 (4%), 1353 (68%), 385 (20%), 148 (8%) and 0 cases, respectively. The overall cost savings were €175,563. One hundred and nine (6%) of all pharmacist interventions concerned immuno- or chemotherapy regimen for cost savings of €148,032 (84% of the total amount of cost savings). The cost avoidance was €390,480. Cost avoidance results were robust to sensitivity analyses with cost of preventable adverse drug event as main driver of the model. When the cost of employing a pharmacist was subtracted from the average yearly cost savings plus cost avoidance per pharmacist, this yielded a net benefit of €223,021. The cost-benefit ratio of the clinical pharmacist was €3.7 for every €1 invested. Principal conclusions: To have two full-time clinical pharmacists in a 55-bed ambulatory adult hematology-oncology department is both clinically and financially beneficial.

Low Cross-Reactivity Between Cisplatin and Other Platinum Salts.

BACKGROUND: Hypersensitivity reactions to platinum salts (PS) (cisplatin [CI], carboplatin [CA], and oxaliplatin [OX]) can be severe and their incidence is increasing due to their widespread use in cancer treatment. OBJECTIVE: To determine the rate of cross-reactivity between PS and whether CI can be administered without prior allergy testing in patients with a history of CA or OX hypersensitivity. METHODS: From September 2002 to April 2016, patients with suspected immediate PS hypersensitivity were tested and cross-reactivity between the 3 PS was evaluated. We then studied patients who were given CI without desensitization after immediate hypersensitivity to other PS. RESULTS: A total of 155 patients were included. Skin tests were positive in 97 patients (OX: 51, CA: 43, and CI: 3). Cross-reactivity to CA in OX-allergic patients was 45% (23 of 51) (95% confidence interval [CI]: 36% to 66%) and cross-reactivity to OX in CA-allergic patients was 37% (16 of 43) (95% CI: 23% to 53%). In contrast, cross-reactivity to CI was 0% (0 of 51) (95% CI: 0% to 7%) in OX-allergic patients and 7% (3 of 43) (95% CI: 2% to 17%) in CA-allergic patients. All these 3 patients had previously been exposed to CI in previous courses of chemotherapy. CI was initiated in 24 patients with proven hypersensitivity to CA or OX and had no hypersensitivity reactions. CONCLUSION: Initiating CI in patients with proven immediate hypersensitivity to CA or OX appeared to be safe in our study.

[Palifermin in the preventive treatment of oral mucositis in autograft patients: data on efficacy and tolerance following marketing approval]. / Le palifermin dans le traitement préventif de la mucite buccale chez les patients autogreffés: données d'efficacité et de tolérance après autorisation de mise sur le marché

BACKGROUND: Few data are available on the efficacy of and tolerance to palifermin in the preventive treatment of oral mucositis in autograft patients treated with conditioning protocols usually used in France. METHODS: Our retrospective study bears on the first five candidates for autograft who benefited from prophylactic treatment with palifermin (60 microg/kg/day) between December 2005 and March 2006. RESULTS: Despite the prophylactic treatment, 3 patients developed severe oral mucositis. Moreover, in 3 patients, palifermin was found to be responsible for the onset of severe toxidermia, which required, in 2 cases, interruption of the treatment. CONCLUSION: These results need to be confirmed by a larger study that would also make it possible to evaluate the impact of palifermin on morbi-mortality in autograft patients in France, and to determine the safety profile of this drug.

[Economic impact of transarterial chemoembolization with drug eluting beads in the treatment of hepatocellular carcinoma]. / Impact économique de la chimioembolisation avec microsphères chargées dans le traitement du carcinome hépatocellulaire.

Transarterial chemoembolization (TACE) is the standard treatment in patients with unresectable non-metastatic hepatocellular carcinoma (HCC). New drug eluting beads aim at improving efficacy of TACE in retaining as long as possible the anticancer drug within the tumor. Our monocentric study compares direct hospital medical costs, according to two different methods, for a first course of conventional TACE and for a first course of TACE using drug eluting beads in 30 patients with HCC. The average cost of a first course of conventional TACE valued by the analytic accounting system is 4 332 € versus 3 577 € for a first course of TACE using drug eluting beads. The average cost of a first course of conventional TACE valued by the official tariffs from the new French Diagnosis Related Group prospective payment system is 4 507 € (+175 €) versus 2 852 € (-725 €) for a first course of TACE using drug eluting beads. Our study shows that a first TACE using drug eluting beads, valued by the official tariffs from the new French Diagnosis Related Group prospective payment system, is significantly (p  =  0.006) less expensive than a first conventional TACE.