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Clinical Trial
. 2016 Jun 30;11(6):e0157957.
doi: 10.1371/journal.pone.0157957. eCollection 2016.

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries

Erwin De Cock  1 , Persefoni Kritikou  2 , Mariana Sandoval  3 , Sunning Tao  3 , Christof Wiesner  4 , Angelo Michele Carella  5 , Charles Ngoh  6 , Tim Waterboer  6
Affiliations
Clinical Trial

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries

Erwin De Cock et al. PLoS One. .

Abstract

Background: Rituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings.

Methods: This non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient's first year of treatment (11 rituximab sessions).

Results: Mean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27-58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1-5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53-91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1-5.5 eight-hour days.

Conclusions: Compared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units.

Trial registration: ClinicalTrials.gov NCT01200758.

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Conflict of interest statement

Competing Interests: EDC, PK, MS, ST and AMC declare that they have no competing interests. CW is a current employee and holds share options at Genentech Inc. CN is a current employee and holds share options at F. Hoffmann-La Roche Ltd. TW is a former employee at F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd holds a patent relating to the content of the manuscript. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Chronological listing of tasks measured.
DPA tasks are in red and treatment room tasks are in blue. *Rituximab syringe can be filled either in the pharmacy (43%), or in a special aseptic DPA within the day oncology unit (57%). IV, intravenous; SC, subcutaneous; DPA, drug preparation area.
Fig 2
Fig 2. Active HCP time in treatment room and DPA (per session).
HCP, health care professional; DPA, drug preparation area; IV, intravenous; SC, subcutaneous.
Fig 3
Fig 3. Active HCP time in treatment room and DPA, by task (per session).
The mean country estimate for each task is provided in S4 Table. Total active HCP time for IV administration in the UK was 79.5 minutes. HCP, healthcare professional; DPA, drug preparation area; IV, intravenous; SC, subcutaneous.
Fig 4
Fig 4. Active HCP time in treatment room and DPA, by HCP type (11 sessions).
HCP, healthcare professional; DPA, drug preparation area; IV, intravenous; SC, subcutaneous.
Fig 5
Fig 5. Patient chair time for IV vs. SC administration (per session).
Results derived from the random intercept model: infusion time (France, Russia), injection administration time (France), IV patient chair time (France), SC patient chair time (France). All other results were derived from the standard regression analysis. IV, intravenous; SC, subcutaneous.
Fig 6
Fig 6. Patient chair time for first year of treatment (11 sessions).
Fig 7
Fig 7. Impact of first vs. subsequent infusion on (A) infusion duration and (B) patient chair time.
See this image and copyright information in PMC

References

    1. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JWW, Comber H, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013;49:1374–1403. 10.1016/j.ejca.2012.12.027 - DOI - PubMed
    1. SEER (Surveillance, Epidemiology and End Results Program): Stat Fact Sheets: Non-Hodgkin Lymphoma. 2015. Available: http://seer.cancer.gov/statfacts/html/nhl.html.
    1. Marcus R, Hagenbeek A. The therapeutic use of rituximab in non-Hodgkin's lymphoma. Eur J Haematol. 2007;67(Suppl.):5–14. - PubMed
    1. European Medicines Agency: MabThera. 2009. Available: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici....
    1. Scott SD. Rituximab: a new therapeutic monoclonal antibody for non-Hodgkin’s lymphoma. Cancer Pract. 1998;6:195–197. - PubMed

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