Lisa S. (2016) ( 1515. Ruef C , Sabol L . Evaluating the On-Body Injector for Neulasta ® as an alternative to manual Neulasta® Injection . Oncology Nursing Forum . 2016 ; 43 ( 2 ): 14 . ) USA |
Test the safety and efficacy of Pegfilgrastim OBI in an infusion center and educate the nursing team to manage the device. |
Pilot study. Nursing team training with a practical demonstration on how to handle the device. Patients received an information leaflet to read, watched a video and were followed up 48 hours after OBI infusion to ensure the success of the injector. Laboratory tests were obtained one week later. |
25 patients on outpatient chemotherapy. |
The injector was successful in all participants. An incomplete dose was delivered to one patient and three patients were hospitalized within a week of Neulasta injection. None of these events were considered injector related. |
Saif et al. (2019) ( 1616. Saif MW , Hackenyos DW , Smith MH , Healey P , Relias V , Wasif K . Racial differences in accepting Pegfilgrastim Onpro Kit (On-Body Injector) use among cancer patients . Clin Oncol . 2019 ; 1 ( 6 ): 1026 . ) USA |
Assess the acceptance of the Onpro kit among patients undergoing chemotherapy. |
Descriptive, retrospective study with patients who received the Onpro kit within 1 hour of completion of systemic chemotherapy. Nursing notes and pharmacy records were reviewed to identify patients who refused the Onpro kit and to discern reasons for refusal, including racial reason. |
Patients with gastrointestinal tumors undergoing G-CSF. |
Five of 68 patients refused the kit (22%), of which 87% were Asian. Reasons for refusal included: aversion to bulky compliance with the skin, understanding about unwitnessed medication administration, fear of reaction, disposal at home, fear of pain, and lack of confirmation of proper dose administration. |
Category 2: Patient and health team experience and opinions regarding Pegfilgrastim OBI use
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Author
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Objective
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Method
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Population
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Results
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Brett Hauber et al. (2018) ( 1717. Brett Hauber A , Mange B , Price MA , Wolin D , Bensink M , Kaye JA , et al . Administration options for pegfilgrastim prophylaxis: patient and physician preferences from a cross-sectional survey . Support Care Cancer . 2018 ; 26 ( 1 ): 251 - 60 . ) Germany |
Estimate patient and physician preferences Pegfilgrastim administration options and the relative importance of the resources associated with these options to to determine systematic variations in physicians’ preferences according to patients’ profile. |
Cross-sectional. Application of a multiple-choice data collection instrument about Pegfilgrastim administration options. |
200 patients and 200 physicians prescribing G-CSF |
Most patients (77.5%) preferred to receive application at the clinic and 16% of patients chose the OBI. Patients generally preferred the administration option with which they had experience: 48.5% of patients who received prior injections at the clinic chose this route and 56.8% with prior OBI administration preferred this option. For the most clinically committed patient with a longer travel distance to the clinic, 37.5% of physicians preferred in-clinic application and 49.5% preferred the OBI. For the less clinically compromised patient and with the shortest travel distance to the clinic, 55.5% of physicians preferred application in the clinic, and 28%, the OBI. |
Metz et al. (2021) ( 1818. Metz M , Semsek D , Rogmans G , Hutzschenreuter U , Fietz T , Harde J , et al . 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 . Support Care Cancer . 2021 ; 29 ( 11 ): 6633 - 43 . ) Germany |
Assess patient, nurse, and physician preferences as well as health care economics, for administering Pegfilgrastim with OBI or manually using a pre-filled syringe (OS). |
Randomized, crossover, non-blinded, two-arm clinical trial. Patients with breast cancer x patients with non-Hodgkin’s lymphoma, 1:1, were randomized to receive Pegfilgrastim for four consecutive cycles of chemotherapy in an alternating sequence, starting with OBI or pre-filled syringe. The primary outcome was patient preference assessed by questionnaires. |
308 patients with early-stage breast cancer receiving anthracycline/cyclophosphamide or taxane-based chemotherapy, and patients with non-Hodgkin’s lymphoma receiving first-line R-CHOP. |
Patients preferred OBI over pre-filled syringe (OBI 43.2%; vs. pre-filled syringe 36.0%), but the difference was not statistically significant. Among patients with preference for OBI, saving time was the main reason for preference. Both arms of the study showed the same results, indicating that patients’ preference is independent of application sequence. Study nurses slightly preferred the pre-filled syringe (n = 19, 46.3%) over the OBI (n = 18, 43.9%) Physicians clearly preferred the pre-filled syringe (n = 24, 58.8%) over the OBI (n = 15, 36.6%). |
Mahler et al. (2017) ( 1919. Mahler LJ , DiBlasi R , Perez A , Gaspard J , McCauley D . On-body injector: an administration device for pegfilgrastim . Clin J Oncol Nurs . 2017 ; 21 ( 1 ): 121 - 22 . ) USA |
Monitor the execution Onpro delivery system in an oncology clinic. |
A satisfaction survey was carried out with patients. |
38 patients with cancer using Pegfilgrastim OBI and nursing staff from the oncology clinic. |
Of 38 participants, 6 reported a problem using the OBI. On a scale of 1 (not satisfied) to 5 (extremely satisfied), 32 patients rated their satisfaction as 4 or 5, and only 2 were dissatisfied with the OBI. Nurses had no difficulties in placing the device. Failed devices were returned by patients and replaced under the Amgen ® refund program. There was an improvement in the clinic’s workflow. |
Yucel et al. (2021) ( 2020. Yucel A , Skalicky A , Eseyin OR , Yucel E , Belani R , Bensink M . Development and content validation of the Satisfaction and Experience Questionnaire for Granulocyte Colony-Stimulating Factor (SEQ-G-CSF) . J Patient Rep Outcomes . 2021 ; 5 ( 1 ): 10 . ) USA |
Develop a Satisfaction and Experience Questionnaire for G-CSF (SEQ-G-CSF) to help understand perspectives and patient satisfaction with different G-CSF options. |
Descriptive study with a qualitative approach. All patients were receiving prophylaxis with G-CSF via injection or OBI. The sample was divided into 2 groups, with group 1 comprising 20 participants with previous experience using Pegfilgrastim OBI and group 2 comprising 20 participants with no prior experience. Both participated in focus groups conducted by video with online calls and semi-structured discussions. |
Three oncology nurses and 40 adult patients with cancer, 10 with breast cancer, 10 with lung cancer, 10 with non-Hodgkin’s lymphoma and 10 with prostate cancer. |
Discussing their experience and satisfaction with the G-CSF, 53% of patients and 29% of participants highlighted the benefits of using the OBI, including convenience, ease of use, available support, and reduced travel and time overhead. The most cited negative experiences were adverse events (lethargy and fatigue) and the need to undergo additional treatment. The SEQ-G-CSF included five domains involving overall satisfaction (one item), treatment burden (four items), travel burden (two items), time burden (four items), and compliance with treatment (two items). Nurses reported that patients tend to tolerate adverse treatment events when they see improvement or if their quality of life is not significantly impacted. |
Category 3 - Workload of patients undergoing cancer treatment
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Author
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Objective
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Method
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Population
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Results
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Cheng et al. (2019) ( 2121. Cheng AC , Levy MA . Measures of treatment workload for patients with breast cancer . JCO Clin Cancer Inform . 2019 ; 3 : 1 - 10 . ) USA. |
Assess dimensions of treatment workload related to outpatient visits, commuting, and admissions. |
Descriptive, quantitative study. The authors developed measures to measure the workload of the days when patients go to the health service for treatment and their displacement. They then applied these methods to two populations of breast patients with cancer to determine whether the measures were sensitive to differences in disease stage and treatment protocols. |
Women at different stages and undergoing treatment for breast cancer. |
Patients with more advanced cancers experienced a greater treatment workload. In the first 18 months after diagnosis, patients with stage III disease spent a median of 81 hours in outpatient clinics, 61 hours in commuting time, and spent $1.432 in commuting costs. In contrast, patients with stage I disease spent an average of 29 hours in the clinic, 34 hours in travel time, and $834 in travel costs. Authors emphasize that Pegfilgrastim OBI was effective in reducing some dimensions of the workload for these patients, such as, for example, the time in days that patients stay in the clinic and the need for additional visits. |
Category 4 - Pegfilgrastim OBI use in clinical practice
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Author
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Objective
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Method
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Population
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Results
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Patel et al. (2019) ( 2222. Patel J , Rainess RA , Benfield MJ , Rogers KM , Moore DC , Larck C , et al . Retrospective analysis of clinical outcomes associated with the use of pegfilgrastim on-body injector in patients receiving chemotherapy requiring granulocyte colony-stimulating factor support . Hosp Pharm . 2021 ; 56 ( 2 ): 77 - 80 . ) USA |
Assess the incidence of febrile neutropenia in patients receiving Pegfilgrastim OBI. |
Observational, descriptive and quantitative study. A retrospective review of electronic medical records of adult patients with cancer who received chemotherapy and Pegfilgrastim OBI was performed. Before a patient receives the OBI device, the nursing staff has been educated and trained. The primary outcome was the development of febrile neutropenia. Secondary outcomes included Pegfilgrastim OBI device failure and treatment delays or dose modifications secondary to febrile neutropenia or neutropenia event. Patients were followed for up to 30 days after the last chemotherapy administration to assess the occurrence of any study parameters. |
28 adult patients with cancer on myelosuppressive chemotherapy. |
Pegfilgrastim OBI were administered during the study period. All patients received Pegfilgrastim OBI as primary prophylaxis and none of the participants developed febrile neutropenia. There were no treatment delays or changes in chemotherapy dose secondary to a febrile neutropenia or neutropenia event. - There were two device failures (1.92%). Failure 1: A patient observed a malfunction in the device’s indicator light, yet received the full dose. Failure 2: The Pegfilgrastim dose was not administered correctly, and it was reported that the Pegfilgrastim leaked down patients’ arm. One case of anaphylaxis has been reported after receiving Pegfilgrastim OBI. |
Mahtani et al. (2022) ( 2323. Mahtani RL , Belani R , Crawford J , Dale D , DeCosta L , Gawade PL , et al . A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis . Support Care Cancer . 2022 ; 30 ( 7 ): 6135 - 44 . ) USA |
Assess the incidence of febrile neutropenia in patients who received treatment with curative intent, patients undergoing chemotherapy with delays or dose reduction and compliance with the device. |
Prospective, multicenter cohort study. Patients were followed from baseline until death, discontinuation of chemotherapy, withdrawal of consent, loss to follow-up, or termination of the study. |
Patients with cancer receiving myelosuppressive chemotherapy treatment and at high risk of developing febrile neutropenia. |
In all cycles, the incidence of febrile neutropenia was lower in patients receiving Pegfilgrastim OBI (4.4% [95% CI, 3.3 5.6%]) compared to those who received other options (7.4% [95% CI 5.3–9.6%]. The OBI group had a lower incidence of febrile neutropenia in each cycle. In patients receiving treatment with curative intent, the incidence of febrile neutropenia in all cycles was lower in those receiving Pegfilgrastim OBI (4.6% [95% CI, 3.4 5.8%]; across all cycles, the percentage of patients on chemotherapy with delays or dose reductions was 4.7% (95% CI, 3.5 5.9%) for the OBI group and 4.7% (95% CI, 2.9-6.4%) for the other group. Adherence to G-CSF was higher in patients receiving Pegfilgrastim OBI (93.8% [CI 95%, 92.5–95.2%]) compared to those receiving other options (69.8% [CI 95 %, 66.1–73.6%]). |
McBride et al. (2021) ( 2424. McBride A , Campbell K , Li E , Schroader B , Campbell D , Wang W . Economic and clinical outcomes of pegfilgrastim via prefilled syringe vs on-body injector: a real-world data analysis . J Manag Care Spec Pharm . 2021 ; 27 ( 9 ): 1230 - 8 . ) USA |
Compare effectiveness and economic outcomes of Pegfilgrastim in pre-filled versus OBI presentations. |
Retrospective cohort study. A propensity score was used to match pre-filled syringe cohort 1:1 to OBI. The results were compared between the matched cohorts using estimation equations. |
3.152 patients with breast diagnosis cancer or non-Hodgkin’s lymphoma that received myelosuppressive chemotherapy and prophylactic use of Pegfilgrastim via pre-filled syringe or OBI. |
1088 patients received prophylaxis with Pegfilgrastim OBI and 2064 received pre-filled syringe. Rates of febrile neutropenia within each Pegfilgrastim cohort were low. During the first cycle of chemotherapy, there was no statistically significant difference in the incidence of febrile neutropenia between the OBI or pre-filled syringe cohorts (1.01% [95% CI = 0.56-1.82] versus 1.48% [95% CI = 0.91-2.39], respectively; p = 0.336). When considering all chemotherapy cycles (total cycles = 7.467), there was also no difference in the incidence of febrile neutropenia between the OBI or pre-filled syringe cohorts (0.91% [95% CI = 0.64-1.30] vs 1.22% [95% CI = 0.90-1.64], respectively; p= 0.214). |