Pegfilgrastim for the prevention of chemotherapy-induced febrile neutropenia in patients with solid tumors

Lambertini, Matteo; Ferreira, Arlindo R.; Mastro, Lucia Del; Danesi, Romano; Pronzato, P.

doi:10.1517/14712598.2015.1101063

Cited by 16 publications

(17 citation statements)

References 116 publications

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“…Therefore, because the safety and efficacy of PEGylated G-CSF compared with that of G-CSF for CIN of breast cancer have not been conclusively determined, we conducted an up-to-date systematic review based on RCTs to provide the current best evidence on this topic. Lambertini et al [21,35] suggested that compared with G-CSF, PEGylated G-CSF showed superior efficacy, and for h i g h F N c h e m o t h e r a p y r e g i m e n s , s u c h a s A T (anthracyclines-taxane), resulted in a shorter duration of CIN. However, the results of the present study revealed no significant difference in the efficacy indicators between the two drugs (P > 0.05).…”

Section: Discussionmentioning

confidence: 99%

Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis

Zheng

Mei

et al. 2020

Support Care Cancer

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Background PEGylated granulocyte colony-stimulating factor (G-CSF) is a safe alternative to G-CSF to improve chemotherapyinduced neutropenia (CIN). This superiority has resulted in its increased use by physicians; however, the superiority of PEGylated G-CSF for CIN in breast cancer has not been conclusively determined. Objectives To assess the superiority of PEGylated G-CSF for CIN in breast cancer in terms of effectiveness and safety via a systematic review and meta-analysis. Methods A literature search in PubMed, Embase, Cochrane Library, and Web of Science was performed for eligible studies published from database inception to December 2019. All studies comparing PEGylated G-CSF and G-CSF for CIN of breast cancer were reviewed. After literature selection, data extraction and quality assessment were performed by two reviewers independently. Meta-analysis was conducted using Revman, version 5.2. Results Nine randomized controlled trials were finally identified. The publication bias of these studies was acceptable. For the endpoint of effectiveness, analysis of the incidence/duration of grade ≥ 3 neutropenia, the duration of grade 4 neutropenia, the incidence of febrile neutropenia (FN), and the time to absolute neutrophil count recovery showed no advantage of PEGylated G-CSF over G-CSF for CIN of breast cancer (P > 0.05), with the premise of a sufficient dose of G-CSF according to the guidelines. No significant differences in grade 4 adverse events were observed between the groups (P = 0.29), and PEGylated G-CSF did not increase the incidence of skeletal and/or muscle pain compared with G-CSF (P = 0.32). Conclusion PEGylated G-CSF was as effective and safe as G-CSF to reduce CIN in breast cancer but did not show an obvious superiority. However, in clinical practice, PEGylated G-CSF has an obvious advantage in terms of convenience, which could improve patient's quality of life.

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Section: Discussionmentioning

confidence: 99%

Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis

Zheng

Mei

et al. 2020

Support Care Cancer

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“…Pegfilgrastim use is supported in different length chemotherapy cycles, including fortnightly, albeit data are more limited in patients receiving weekly regimens, where filgrastim might be preferred [9]. For patients on chemotherapy at a high risk of FN (≥ 20%) or intermediate risk of FN (10-20%) plus additional risk factors, pegfilgrastim is generally considered the G-CSF of choice to maintain RDI and avoid the severe complications associated with FN, due to the simplified administration compared with filgrastim supporting higher adherence and, therefore, coverage of the ANC nadir [9,29].…”

Section: G-csf Guidelinesmentioning

confidence: 99%

Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure

et al. 2020

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Febrile neutropenia (FN) is a serious complication of chemotherapy, which can cause significant morbidity and mortality, result in dose delays and reductions and, ultimately, reduce cancer survival. Over the past decade, the availability of biosimilar filgrastim (short-acting granulocyte colony-stimulating factor [G-CSF]) has transformed patient access, with clear evidence of clinical benefit at preventing FN at reduced costs. In 2019, seven biosimilar pegfilgrastims (long-acting G-CSFs) were licensed, creating optimal market conditions and choice for prescribers. FN affects up to 117 per 1000 cancer patients, with mortality rates in the range of 2-21%. By reducing FN incidence and improving chemotherapy relative dose intensity (RDI), G-CSF has been associated with a 3.2% absolute survival benefit. Guidelines recommend primary prophylaxis and that filgrastim be administered for 10-14 days, while pegfilgrastim is administered once per cycle. When taken according to the guidelines, pegfilgrastim and filgrastim are equally effective. However, in routine clinical practice, filgrastim is often under-dosed (< 7 days) and has been shown to be inferior to pegfilgrastim at reducing FN incidence, hospitalisations and maintaining RDI. Once-per-cycle administration with pegfilgrastim might also aid patient adherence. The introduction of biosimilar pegfilgrastim should instigate a rethink of neutropenia management. Biosimilar pegfilgrastim offers countries using biosimilar filgrastim opportunities to improve adherence and thus cancer survival, whilst offering economic benefits for countries using reference pegfilgrastim. These benefits can be realised in full if biosimilar pegfilgrastim becomes part of routine clinical practice supported by drug and therapeutic committees implementing guidelines with multidisciplinary support in the hospital.

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“…Moreover, pegfilgrastim has been reported-in post-hoc analyses of clinical trials, meta-analyses of clinical trials, and realworld evaluations-to be more efficacious and effective than other CSFs in preventing FN [12,15,20,[28][29][30][31][32][33]. Notwithstanding the availability of pegfilgrastim since 2002 and clinical practice guidelines supporting its use, relatively little is known about patterns of pegfilgrastim use across multiple cycles of chemotherapy during the course, the influence of FN on subsequent pegfilgrastim use, and the impact of pegfilgrastim on the incidence of FN [34]. We therefore undertook two retrospective observational cohort studies, the first using data from two large healthcare claims repositories and the second using data from Medicare Claims Research Identifiable Files (RIFs), to examine these issues among patients with non-metastatic breast cancer or non-Hodgkin's lymphoma (NHL) receiving chemotherapy regimens with an intermediate to high risk for FN in US clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Use and effectiveness of pegfilgrastim prophylaxis in US clinical practice:a retrospective observational study

et al. 2019

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Background: Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy. Clinical practice guidelines recommend routine prophylactic coverage with granulocyte colony-stimulating factor (G-CSF)-such as pegfilgrastim-for most patients receiving chemotherapy with an intermediate to high risk for FN. Patterns of pegfilgrastim prophylaxis during the chemotherapy course and associated FN risks in US clinical practice have not been well characterized. Methods: A retrospective cohort design and data from two commercial healthcare claims repositories (01/2010-03/ 2016) and Medicare Claims Research Identifiable Files (01/2007-09/2015) were employed. Study population included patients who had non-metastatic breast cancer or non-Hodgkin's lymphoma and received intermediate/high-risk regimens. Pegfilgrastim prophylaxis use and FN incidence were ascertained in each chemotherapy cycle, and all cycles were pooled for analyses. Adjusted odds ratios for FN were estimated for patients who did versus did not receive pegfilgrastim prophylaxis in that cycle. Results: Study population included 50,778 commercial patients who received 190,622 cycles of chemotherapy and 71, 037 Medicare patients who received 271,944 cycles. In cycle 1, 33% of commercial patients and 28% of Medicare patients did not receive pegfilgrastim prophylaxis, and adjusted odds of FN were 2.6 (95% CI 2.3-2.8) and 1.6 (1.5-1.7), respectively, versus those who received pegfilgrastim prophylaxis. In cycle 2, 28% (commercial) and 26% (Medicare) did not receive pegfilgrastim prophylaxis; corresponding adjusted FN odds were comparably elevated (1.9 [1.6-2.2] and 1.6 [1.5-1.8]). Results in subsequent cycles were similar. Across all cycles, 15% of commercial patients and 23% of Medicare patients did not receive pegfilgrastim prophylaxis despite having FN in a prior cycle, and prior FN increased odds of subsequent FN by 2.1-2.4 times. Conclusions: Notwithstanding clinical practice guidelines, a large minority of patients did not receive G-CSF prophylaxis, and FN incidence was substantially higher among this subset of the population. Appropriate use of pegfilgrastim prophylaxis may reduce patient exposure to this potentially fatal but largely preventable complication of myelosuppressive chemotherapy.

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Pegfilgrastim for the prevention of chemotherapy-induced febrile neutropenia in patients with solid tumors

Cited by 16 publications

References 116 publications

Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis

Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis

Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure

Use and effectiveness of pegfilgrastim prophylaxis in US clinical practice:a retrospective observational study

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