Background: Rituximab is used for treatment of follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). A subcutaneous (SC) formulation (Rituxan Hycela™) has recently received FDA approval in the US. Understanding the patient perspective regarding rituximab administration is important as stakeholders make decisions between intravenous (IV) and SC methods of administration. Time for rituximab infusion impacts healthcare team resourcing including chair time and is a burden to patients receiving care at US cancer centers, and their caregivers. This study reports findings on patient-reported impact, as well as the detailed observation of time required for routine IV rituximab infusions in a community oncology setting. Results of this study will lay the groundwork for future comparison with similar data from SC administration upon its availability for use in the US.
Methods: This prospective, observational, time and motion study was conducted in a single US community oncology practice. The sample size for this study was selected in light of case availability and the descriptive aims of the project. Patients were required to be treated with IV rituximab for DLBCL (1st-line), FL or CLL (any line). Direct patient observations and surveys took place from 4/27/2017 to 6/26/2017. Time and motion methodology (continuous recording and momentary time sampling) was used to document detailed time required for various steps of the infusion process (time in waiting room, chair time, time for pre-med, etc.), and for various stakeholders (patient, practitioner, pharmacist, etc.). Additionally, a 19-item patient survey instrument was administered to evaluate patient-reported impact of infusion-visit time on various domains including stress, employment, caregiving, and work-related responsibilities.
Results: The study included 40 patients (median age, 69 years; range 34-88 years). Of these, 29 (72.5%) were male, 34 (85.0%) white, and 6 (15.0%) African American. The most common qualifying diagnosis was FL (47.5%) followed by DLBCL (40.0%) and CLL (12.5%). Five patients had documented ECOG status of ≥2. Of the 25 patients who received rituximab in 1st-line therapy, most (56.0%) were infused with rituximab, cyclophosphamide, doxorubicin, and vincristine. Mean observed total patient time at the infusion center was 319 minutes (SD 95). Of that, the mean time patients spent in the infusion chair was 212 minutes (SD 64) . On infusion day, 35% of patients reported feeling somewhat or extremely stressed, 50% were neutral, while 15% were somewhat or extremely unstressed. Most patients (75%) indicated that reducing chair time by a couple of hours would have a moderate or major positive impact on their infusion day. Patients were generally satisfied (60% somewhat or extremely satisfied, 15% neutral) with wait times before receiving their infusion. The majority (70%) reported usual wait times of 15-60 minutes; however, 25% reported usual wait times of over 60 minutes. There were 7 patients (17.5%) who reported that their employment status changed due to their cancer diagnosis. Of the patients who worked, all had to miss work for every infusion. A caregiver was required for 32.5% of patients, and these caregivers all accompanied the patients on infusion day. Of those caregivers, 38% had to miss work to accompany the patient to their infusion.
Conclusions: This real-world, single-center observational community oncology study shows the detailed time burden of IV rituximab administration, and provides the patient perspective. Detailed time required for each step of the administration was recorded, including a mean patient time of over 5 hours at the infusion center per visit. Many patients reported being stressed by their infusion visit, and most patients reported that reduction in time required for receiving their therapy would have a positive impact. Understanding specific details regarding the burden of administration for rituximab, including the patient-reported perspective, is an important aspect for informed clinical decision making and improving quality of care.
Fisher: Vector Oncology: Employment. Wallick: Genentech: Employment. Miller: Vector Oncology: Employment. Walker: Vector Oncology: Employment. Lash: Genentech: Employment. Dawson: Genentech: Employment, Equity Ownership. Reyes: Genentech Inc.: Employment, Equity Ownership.
Asterisk with author names denotes non-ASH members.