Patient, nurse, and physician preferences: final results of the CONVENIENCE study evaluating pegfilgrastim prophylaxis via pre-filled syringe or on-body injector in cancer patients

Abstract

Purpose: The on-body injector (OBI) automatically delivers pegfilgrastim the day after chemotherapy (CTx), thus eliminating the need of return visits to the medical office for guideline-compliant pegfilgrastim administration. The CONVENIENCE study aimed to evaluate patient, nurse, and physician preferences as well as health economics for pegfilgrastim administration either with OBI or manually using a pre-filled syringe (PS).

Methods: Patients with early breast cancer, receiving two or three weekly anthracycline/cyclophosphamide or three weekly taxane-based CTx, and patients with Non-Hodgkin lymphoma (NHL) receiving first-line R-CHOP-14 or -21 were randomized 1:1 to receive both pegfilgrastim application forms for four consecutive CTx cycles in an alternating sequence starting either with OBI or PS. Primary endpoint was patient preference, assessed by questionnaires.

Results: A total of 308 patients were evaluable in the per-protocol analysis. Patients slightly preferred OBI over PS (OBI, n = 133, 43.2%; vs. PS, n = 111, 36.0%; p-value = 0.159), while study nurses slightly preferred PS (n = 19, 46.3%) over OBI (n = 18, 43.9%) and physicians clearly preferred PS (n = 24, 58.8%) over OBI (n = 15, 36.6%). Among patients with preference for OBI, saving of time was their major reason for preference (53.4%). Pegfilgrastim was administered 24-72 h after each CTx cycle in 97.6% of OBI and 63.1% of PS applications.

Conclusion: The OBI was slightly preferred by patients and saving time was the major reason for their preference. PS was physicians' most preferable choice and slightly preferred by nurses. Using OBI, pegfilgrastim was almost always administered within the time period recommended by current guidelines, while it was often not applied as specified using PS.

Trial registration: No: ClinicalTrials.gov No. NCT03619993. Registered on June 25, 2018.

Keywords: Manual injection; On-body injector; Patient/physician/nurse preference; Pegfilgrastim.

Fig. 1

Overall study design. CTX chemotherapy, EBC early breast cancer, NHL Non-Hodgkin lymphoma, OBI on-body injector for pegfilgrastim, R randomization. Patient questionnaires: The questionnaire on patient preference had to be completed by the patient at baseline, prior to the first administration of pegfilgrastim and at the individual end of study after the fourth or last application of pegfilgrastim. The questionnaire on patient’s daily life and cost relevant factors had to be completed by the patient on day 2–4 of each cycle

Fig. 2

CONSORT flow diagram. EBC early breast cancer, EOS end of study, N/n number, NHL Non-Hodgkin lymphoma; PPROT per-protocol set; *Numbers of the listed reasons do not necessarily sum up to the total number of reasons for exclusion from PPROT as for some patients, more than one reason was applicable

Fig. 3

Patient preferences and reasons for their preference at the end of study. a Patient preference by study arms. b Patient preference stratified by subgroups. c Reasons for patient preference stratified by patient preference. OBI on-body injector for pegfilgrastim, PS pre-filled syringe

Fig. 4

Application timepoint, influence on patients’ daily life, and costs. a Time between end of chemotherapy and start of pegfilgrastim application. b Influence of the pegfilgrastim application on patients’ daily life stratified by OBI- or PS-supported cycles. c Cost-related factors (PS-supported cycles only)

Fig. 5

Study nurse and physician preferences and reasons for their preference at the end of study. a Study nurse preference. b Physician preference. c Reasons for preference of the study nurse. d Reasons for preference of the physician. OBI on-body injector for pegfilgrastim; PS pre-filled syringe