Palifermin 6.25mg powder for solution for injection vials

Oral mucositis is a common and most debilitating complication associated with cancer therapy. Despite the significant clinical and economic impact of this condition, there is little to offer to patients with oral mucositis, and the medications used in its management are generally only palliative. Given that mucositis is ultimately a predictable and, therefore, potentially preventable condition, in this study we appraised the scientific literature to evaluate effective methods of prevention that have been tested in randomised controlled trials (RCTs). Published high-level evidence shows that multiple preventative methods are potentially effective in the prevention of oral mucositis induced by radiotherapy, chemotherapy, or both. Anti-inflammatory medications (including benzydamine), growth factors and cytokines (including palifermin), cryotherapy, laser-and-light therapy, herbal medicines and supplements, and mucoprotective agents (including oral pilocarpine) showed some degree of efficacy in preventing/reducing the severity of mucositis with most anticancer treatments. Allopurinol was potentially effective in the prevention of radiotherapy-induced oral mucositis; antimicrobial mouthwash and erythropoietin mouthwash were associated with a lower risk of development of severe oral mucositis induced by chemotherapy. The results of our review may assist in highlighting the efficacy and testing the effectiveness of low-cost, safe preventative measures for oral mucositis in cancer patients.

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Children undergoing antineoplastic treatment often present severe side effects due to the dosage and duration of treatments, with oral mucositis emerging as one of the most prevalent and painful inflammatory conditions. There is a growing body of evidence on therapeutic interventions such as cryotherapy, low-level laser therapy, and natural compounds for this condition. The aim of this systematic review was to identify and compare therapies for the management of cancer treatment-induced oral mucositis in pediatric patients. From 2655 articles obtained in initial searches, 39 articles were considered in this systematic review, after applying inclusion/exclusion criteria. Low-level laser therapy, palifermin, honey, and zinc demonstrated reductions in oral mucositis incidence, duration, severity, and pain reported by the patient. Although there are several therapies in place for the prevention and treatment of oral mucositis in children, evidence of their efficacy is still inconclusive to establish accurate clinical protocols.

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Objective: Oral mucositis (OM) is a debilitating complication of cancer therapies, affecting up to 85% of patients undergoing bone marrow transplantation and nearly all receiving head and neck radiotherapy. Characterized by mucosal inflammation, ulceration, and severe pain, OM significantly impairs oral intake, speech, and quality of life. These disruptions, compounded by complications such as infection, bleeding, and increased healthcare costs, often necessitate treatment delays or modifications, negatively impacting cancer prognosis. Recent insights into nociceptive and neuropathic mechanisms of OM-related pain have led to the development of innovative management strategies. Given the debilitating nature of OM in cancer patients and the critical need for effective pain control, this review aims to examine pharmacological advancements targeting the complex nature of OM-related pain, including agents such as lidocaine, doxepin, benzydamine, methylene blue, opioids, gabapentin, palifermin, caphosol, and ketamine. Methods: A literature search was conducted in the PUBMED, COCHRANE, and MEDLINE databases, covering studies from 2000 to 2024. Studies focusing on OM pathogenesis and pain management strategies were screened. Inclusion criteria encompassed randomized controlled trials, meta-analyses, and systematic reviews involving adult patients treated with lidocaine, doxepin, benzydamine, methylene blue, opioids, gabapentin, palifermin, caphosol, or ketamine for OM-associated pain. Conclusion: OM pain arises from nociceptive and neuropathic pathways involving inflammatory cytokines and neuropeptides. Current interventions, including topical and systemic agents, have shown promise, yet variability in treatment protocols and limited high-quality evidence hinder standardized practices. This review highlights the clinical applicability of emerging therapies, such as avasopasem manganese, which has demonstrated efficacy in mitigating OM progression. Ongoing clinical trials targeting novel pathways that modulate mucosal inflammatory response and limit disease severity offer hope for improved pain relief. Addressing the multifaceted nature of OM-associated pain is essential for enhancing quality of life and optimizing cancer treatment outcomes. Further research is needed to establish robust, evidence-based guidelines for OM pain management.

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Oral mucositis (OM) is one of the most common side effects after hematopoietic stem cell transplantation (HSCT) and palifermin is used for prophylactic use to prevent OM. We conducted a meta-analysis study that evaluates the efficacy of palifermin on OM after HSCT in hematologic malignancy patients. Databases of PubMed/Medline, Web of Science and Cochrane Library for English-language publications were searched for finding the relevant studies. The RevMan 5.3 software with random-effects models (odds ratio (ORs) and 95% confidence intervals (CIs)) was used for to estimate of the efficacy of palifermin in palifermin group compared with control group. Begg's and Egger's tests were used for assessment of bias between the studies. Ten studies were included in the meta-analysis study. The results of the meta-analyses showed that there were significant differences in OM (grade 1-4) [odds ratio (OR) = 0.17; 95%CI= 0.10,0.29; p <0.00001], OM (grade 2-4) [OR= 0.11; 95%CI= 0.05,0.24; p <0.00001], OM (grade 3-4) [OR= 0.22; 95%CI= 0.15,0.33; p <0.00001], after auto-HSCT for OM (grade 1-4) [OR= 0.13; 95%CI= 0.04, 0.35; p <0.0001], OM (grade 2-4) [OR= 0.03; 95%CI= 0.00, 0.21; p =0.0006] or OM (grade 3-4) [OR= 0.25; 95%CI= 0.13, 0.48; p <0.0001], after allo-HSCT for OM (grade 1-4) [OR= 0.23; 95%CI= 0.11, 0.51; p =0.0002], OM (grade 2-4) [OR= 0.14; 95%CI= 0.03, 0.74; p =0.012] or OM (grade 3-4) [OR= 0.19; 95%CI= 0.08, 0.46; p =0.0002] and fever [OR=0.51; 95%CI=0.29, 0.87; p = 0.01], but there were no significant differences in acute graft versus host disease (aGVHD) grades, infection and blood stream infection between two groups. The meta-analysis showed that palifermin was associated with reductions in the incidence and severity of OM and also was effective and safe on OM after allo- or auto-HSCT, but did not seem to effect on the incidence and severity of aGVHD. Peer Review Details Peer review method: Single-Blind (Peer-reviewers: 02) Peer-review policy Plagiarism software screening?: Yes Date of Original Submission: 01 September 2017 Date accepted: 02 October 2017 Peer reviewers approved by: Dr. Lili Hami Editor who approved publication: Dr. Phuc Van Pham

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Purpose: Oral mucositis (OM) is a common, debilitating complication of conditioning regimens for hematopoietic stem cell transplantation (HSCT). Supersaturated calcium phosphate rinse (SCPR) and palifermin have shown efficacy in preventing severe OM. However, whether their efficacy differs is unknown. We aimed to compare the efficacy of SCPR and palifermin in HSCT patients receiving myeloablative conditioning. Methods: A comprehensive review of our institutional database was performed to identify patients who received myeloablative-conditioning therapy over 5 years. All HSCT patients who received radiotherapy-based myeloablative conditioning and received either palifermin or SCPR within the study period were included. Most patients received Fludarabine, Busulfan, and total body irradiation (FBT). Patients were divided into two groups based on the OM prophylactic agent received. The primary outcome is prevalence of severe OM (WHO Grade 3 and 4). The secondary outcomes are a prevalence of all-grade OM and WHO Grade 4 OM. These outcomes were compared between the two groups. Results: We identified 26 patients who received SCPR and 122 patients who received palifermin for OM prophylaxis. The prevalence of World Health Organization (WHO) Grade 3 or 4 OM was significantly lower in the palifermin group (57% vs. 100%, p = 0.01). In addition, the palifermin group had lower WHO Grade 4 OM (22% vs. 62%, p = 0.0006). The overall prevalence of OM was not significantly different between the two groups (86% for palifermin group vs. 100% for SCPR arm, p = 0.15). Subgroup analyses demonstrated improved outcomes with palifermin, regardless of age, sex, disease status, donor type, and primary diagnosis. Conclusion: When compared to SCPR, the use of palifermin is associated reduced severity of OM in HSCT patients receiving radiotherapy-based myeloablative conditioning.

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