Chemotherapy-induced peripheral neuropathy (CIPN) may necessitate chemotherapy dose reduction, delay, or discontinuation. This pilot study tested feasibility of patient enrollment, CIPN screening, and data collection in cancer patients for a future clinical study that will assess the safety and efficacy of an intervention that may prevent CIPN. This prospective, observational, single-center, pilot study included adults with newly diagnosed lymphoma or multiple myeloma receiving neurotoxic chemotherapy. Patients were enrolled between September 2016 and February 2017. The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire was completed by patients at 3 time points: baseline, week 6, and week 12. The primary outcome was change in the neurotoxicity score between these time points. Of 33 patients approached for consent, 28 (85%) provided consent and were enrolled. The FACT/GOG-Ntx questionnaire was completed by 28 (100%) at baseline, 25 (89%) at week 6, and 24 (86%) at week 12. Average (standard deviation) neurotoxicity scores were 36.5 (6.6) at baseline, 34.0 (8.3) at week 6, and 30.6 (7.6) at week 12. Neurotoxicity scores changed from baseline by − 2.7 points (95% CI − 5.5 to 0.1; p = 0.061) at week 6 and − 6.0 points (95% CI − 5.6 to − 0.8; p = 0.012) at week 12. Clinically meaningful declines (decrease of > 10% from baseline) in neurotoxicity score were detected in 36% (9 of 25) at week 6 and in 67% (16 of 24) at week 12. Sixty-seven percent of patients experienced clinically significant CIPN within 12 weeks of starting chemotherapy. Feasibility metrics for enrollment, consent, CIPN assessment, and follow-up were met.
STUDY OBJECTIVE To evaluate the impact of a pharmacy protocol that converts standard rituximab infusions to a rapid 90-minute infusion on the duration of outpatient infusion center clinic visits.DESIGN Prospective interventional study.SETTING Outpatient infusion clinic at an academic medical center.PATIENTS Sixty-four adults who received at least one rituximab infusion that was eligible for conversion to rapid infusion between August 2010 and July 2011 and who did not receive concurrent chemotherapy or colony-stimulating agents during the same clinic visit. Of the 64 patients, 37 received the rapid infusion (intervention cohort); 27 received the nonrapid infusion (control cohort).INTERVENTION Using a hospital-approved protocol, pharmacists converted rituximab infusions that met eligibility criteria (noninitial rituximab infusion, rituximab given in the previous 90 days, age 18 yrs or older, dose 375 mg/m(2) or less per infusion, dose 1000 mg or less per infusion, and no history of a grade 3 or higher reaction) to a rapid 90-minute infusion.MEASUREMENTS AND MAIN RESULTS The durations of rituximab infusion time and clinic visit time were evaluated and compared between the intervention cohort and the control cohort. Use of the pharmacy protocol to convert standard rituximab infusion to rapid rituximab infusion reduced infusion time by 110.5 minutes/infusion (median 94.5 min [interquartile range (IQR) 90-105 min] for rapid infusion vs 205 min [IQR 138-263 min] for nonrapid infusion; p<0.001) and reduced clinic visit time by 92 minutes/outpatient encounter (median 233 min [IQR 208-277] min for rapid infusion vs 325 min [IQR 275-415 min] for nonrapid infusion; p<0.001). This resulted in a reduction of the duration of outpatient clinic visits by an estimated 255-299 hours in 1 year.CONCLUSION Use of a pharmacist protocol that converted standard rituximab infusions to a rapid 90-minute infusion decreased the duration of outpatient infusion clinic visits for rituximab infusion.
The aim of this study was to determine whether noninitial rituximab doses can be safely administered by a rapid, 90-minute infusion for patients with a CD20-positive B-cell malignancy with or without steroid-containing chemotherapy regimens. Thirteen patients were enrolled in this study for a total of 32 rapid rituximab infusions, all of which were administered in an outpatient setting. The rapid rituximab infusions were well tolerated by 12 of the 13 patients in 31 of 32 infusions. There was one grade 3 reaction of prolonged hypotension, tachycardia, and fever, which resolved within 24 hours. No other symptomatic infusion reactions occurred. These results support previously repor ted data affirming the safety and tolerability of a rapid, 90-minute infusion for noninitial doses of rituximab in patients with CD20-positive B-cell malignancy. Adopting a rapid infusion schedule would benefit patients and the institution by reducing clinic chair time for each dose by 1.5-2 hours, compared with standard infusion times.