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Frontiers in Cellular and Infection... 2022Currently, gastric cancer (GC) and colorectal cancer (CRC) are the most common causes of cancer-related mortality worldwide. Gut microbiota is closely related to the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Currently, gastric cancer (GC) and colorectal cancer (CRC) are the most common causes of cancer-related mortality worldwide. Gut microbiota is closely related to the occurrence of GC and CRC and the efficacy of chemotherapy. This study is aimed at evaluating the efficacy and safety of herbal formulas with the function of gut microbiota regulation (HFGMR) in the treatment of GC and CRC and to assess the quality of the synthesized evidence.
METHODS
A comprehensive search was performed on eight electronic databases, PubMed, EMBASE, CENTRAL, Web of Science, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang database, Chinese Scientific Journals Database, and two registries, Chinese Clinical Trial Registry and ClinicalTrials.gov, from their initiation to January 2022. Randomized controlled trials (RCTs) studying the therapeutic effects of HFGMR were included. We used Stata 16 for data synthesis and Risk of Bias 2 (RoB 2) for methodological quality evaluation and assessed the quality of the synthesized evidence in the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.
RESULTS
Fifty-three RCTs involving 4,478 patients were included. These trials involve seven herbal formulas that could regulate the gut microbiota of , , , , and . The meta-analysis results were subgrouped to three different stages in GC and CRC. 1) For the perioperative stage, HFGMR combined with conventional therapy could shorten the time to bowel sound recovery by 1.63 h [mean difference (MD) = -1.63, 95% confidence interval (CI) (-2.62, -0.65)], the time to first flatus by 9.69 h [MD = -9.69, 95% CI (-10.89, -8.48)], and the duration of hospitalization by 2.91 days [MD = -2.91, 95% CI (-4.01, -1.80)] in GC. There were no significant differences in outcomes of gastrointestinal function recovery and adverse events in CRC. 2) For postoperative patients, combined with adjuvant chemotherapy, HFGMR could decrease the incidence of diarrhea, nausea and vomiting, anorexia, and peripheral neurotoxicity in GC; boost Karnofsky performance status (KPS) improvement rate [risk ratio (RR) = 1.96, 95% CI (1.38, 2.79)]; and decrease the incidence of leucopenia and nausea and vomiting in CRC. 3) For advanced stage, HFGMR can significantly improve the objective response rate (ORR) [RR = 1.35, 95% CI (1.19~1.53)], disease control rate (DCR) [RR = 1.14, 95% CI (1.05~1.23)], and KPS improvement rate [RR = 1.56, 95% CI (1.17, 2.09)] and decrease the incidence of leucopenia, neutropenia, anemia, nausea and vomiting, diarrhea, and fatigue in GC. There were no significant differences in ORR [RR = 1.32, 95% CI (0.94~1.86)] and DCR [RR = 1.22, 95% CI (0.99~1.50)], but they can improve the KPS response rate [RR = 1.62, 95% CI (1.13, 2.32)] and decrease the incidence of myelosuppression, nausea and vomiting, diarrhea, and hepatic and renal dysfunction in CRC.
CONCLUSION
This study indicates that herbal formulas that could regulate the composition and proportion of gut microbiota have a positive effect in three stages (perioperative, postoperative, and advanced) of GC and CRC. They could promote the recovery of postoperative gastrointestinal function, increase tumor response, improve performance status, and reduce the incidence of adverse events. Herbal formulas exerted anti-cancer efficacy through multiple mechanisms and pathways; among them, the regulation of gut microbiota has not been paid enough attention. To further support the conclusion and better understand the role of gut microbiota in the treatment of GC and CRC, more rigorously designed, large-scale, and multicenter RCTs that focus on herbal formulas and gut microbiota are needed in the future.
Topics: Colorectal Neoplasms; Diarrhea; Drugs, Chinese Herbal; Gastrointestinal Microbiome; Humans; Multicenter Studies as Topic; Nausea; Stomach Neoplasms; Vomiting
PubMed: 35992176
DOI: 10.3389/fcimb.2022.875225 -
Efficacy and safety of ruxolitinib in steroid-refractory graft-versus-host disease: A meta-analysis.Frontiers in Immunology 2022Ruxolitinib is an important treatment for steroid refractory graft-versus-host disease (SR-GVHD). Therefore, we reported the updated results of a systematic review and... (Meta-Analysis)
Meta-Analysis
Ruxolitinib is an important treatment for steroid refractory graft-versus-host disease (SR-GVHD). Therefore, we reported the updated results of a systematic review and meta-analysis of ruxolitinib as treatment for SR-GVHD. In addition, we wanted to compare the efficacy and safety between children and adults with SR-GVHD. Overall response rate (ORR) after ruxolitinib treatment was chosen as the primary end point. Complete response rate (CRR), infection, myelosuppression, and overall survival (OS) were chosen as secondary end points. A total of 37 studies were included in this meta-analysis, and 1,580 patients were enrolled. ORR at any time after ruxolitinib treatment was 0.77 [95% confidence interval (CI): 0.68-0.84] and 0.78 (95% CI: 0.74-0.81), respectively, for SR-aGVHD and SR-cGVHD. CRR at any time after ruxolitinib treatment was 0.49 (95% CI: 0.40-0.57) and 0.15 (95% CI: 0.10-0.23), respectively, for SR-aGVHD and SR-cGVHD. The ORRs at any time after treatment was highest in mouth SR-cGVHD, followed by skin, gut, joints and fascia, liver, eyes, esophagus, and lung SR-cGVHD. The incidence rate of infections after ruxolitinib treatment was 0.61 (95% CI: 0.45-0.76) and 0.47 (95% CI: 0.31-0.63), respectively, for SR-aGVHD and SR-cGVHD. The incidence rates of overall (grades I-IV) and severe (grades III-IV) cytopenia were 53.2% (95% CI: 16.0%-90.4%) and 31.0% (95% CI: 0.0-100.0%), respectively, for SR-aGVHD, and were 28.8% (95% CI:13.0%-44.6%) and 10.4% (95% CI: 0.0-27.9%), respectively, for SR-cGVHD. The probability rate of OS at 6 months after treatment was 63.9% (95% CI: 52.5%-75.2%) for SR-aGVHD. The probability rates of OS at 6 months, 1 year, and 2 years after treatment were 95% (95% CI: 79.5%-100.0%), 78.7% (95% CI: 67.2%-90.1%), and 75.3% (95% CI: 68.0%-82.7%), respectively, for SR-cGVHD. The ORR, CRR, infection events, and myelosuppression were all comparable between children and adults with SR-GVHD. In summary, this study suggests that ruxolitinib is an effective and safe treatment for SR-GVHD, and both children and adults with SR-GVHD could benefit from ruxolitinib treatment.
Topics: Adult; Child; Graft vs Host Disease; Humans; Nitriles; Pyrazoles; Pyrimidines; Steroids
PubMed: 35990629
DOI: 10.3389/fimmu.2022.954268 -
Frontiers in Pharmacology 2022Immunosuppressants have been applied in the remedy of idiopathic membranous nephropathy (IMN) extensively. Nevertheless, the efficacy and safety of immunosuppressants...
Immunosuppressants have been applied in the remedy of idiopathic membranous nephropathy (IMN) extensively. Nevertheless, the efficacy and safety of immunosuppressants do not have final conclusion. Thus, a pairwise and network meta-analysis (NMA) was carried out to seek the most recommended therapeutic schedule for patients with IMN. Randomized controlled trials (RCTs) including cyclophosphamide (CTX), mycophenolate mofetil (MMF), tacrolimus-combined mycophenolate mofetil (TAC + MMF), cyclosporine (CsA), tacrolimus (TAC), leflunomide (LEF), chlorambucil (CH), azathioprine (AZA), adrenocorticotropic hormone (ACTH), non-immunosuppressive therapies (CON), steroids (STE), mizoribine (MZB), and rituximab (RIT) for patients with IMN were checked. Risk ratios (RRs) and standard mean difference (SMD) were reckoned to assess dichotomous variable quantities and continuous variable quantities, respectively. Total remission (TR) and 24-h urine total protein (24-h UTP) were compared using pairwise and NMA. Then interventions were ranked on the basis of the surface under the cumulative ranking curve (SUCRA). Our study finally included 51 RCTs and 12 different immunosuppressants. Compared with the CON group, most regimens demonstrated better therapeutic effect in TR, with RR of 2.1 (95% CI) (1.5-2.9) for TAC, 1.9 (1.3-2.8) for RIT, 2.5 (1.2-5.2) for TAC + MMF, 1.9 (1.4-2.7) for CH, 1.8 (1.4-2.4) for CTX, 2.2 (1.0-4.7) for ACTH, 1.6 (1.2-2.1) for CsA, 1.6 (1.0-2.5) for LEF, and 1.6 (1.1-2.2) for MMF. In terms of 24-h UTP, TAC (SMD, -2.3 (95% CI -3.5 to -1.1)), CTX (SMD, -1.7 (95% CI -2.8 to -0.59)), RIT (SMD, -1.8 (95% CI -3.5 to -0.11)), CH (SMD, -2.4 (95% CI -4.3 to -0.49)), AZA (SMD, --4.2 (95% CI -7.7 to -0.68)), and CsA (SMD, -1.7 (95% CI -3 to -0.49)) were significantly superior than the CON group. As for adverse effects (AEs), infections, nausea, emesia, myelosuppression, and glucose intolerance were the collective adverse events for most immunosuppressants. This study indicates that TAC + MMF performed the best in terms of TR, and TAC shows the best effectiveness on 24-h UTP compared with other regimens. On the contrary, there seems to be little advantage on STE alone, LEF, AZA, and MZB in treating patients with IMN compared with CON. [https://www.crd.york.ac.uk/prospero/], identifier [CRD42021287013].
PubMed: 35959430
DOI: 10.3389/fphar.2022.917532 -
Clinical and Experimental Medicine Nov 2022Hyperthermia is a generic term for different techniques using heat in cancer therapies. Temperatures of about 42° Celsius in combination with chemo- or radiotherapy may... (Review)
Review
Hyperthermia is a generic term for different techniques using heat in cancer therapies. Temperatures of about 42° Celsius in combination with chemo- or radiotherapy may improve the effectiveness of those treatments. Clinical benefit is shown in "standard hyperthermia" with tumour temperatures assessed during treatment. This systematic review thoroughly assesses the state of evidence concerning the benefits and side effects of electro hyperthermia or whole-body hyperthermia ("alternative hyperthermia") in oncology. From 26 April 2021 to 09 May 2021, a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsycINFO, CINAHL and Medline) to find studies concerning the use, effectiveness and potential harm of alternative medical hyperthermia therapy on cancer patients. From all 47,388 search results, 53 publications concerning 53 studies with 2006 patients were included in this systematic review. The patients were diagnosed with different types of cancer. The hyperthermic methods included whole-body hyperthermia (WBH) with different methods and electro hyperthermia (EH). The majority of the included studies were single-arm studies, counting in total 32 studies. Six studies were randomized controlled trials (RCT). In addition, one systematic review (SR) was found. The most critical endpoints were tumour response, survival data, pain relief, myelosuppression and toxicities. Outcome was heterogeneous, and considering the methodological limitations, clinical evidence for the benefit of alternative hyperthermia in cancer patients is lacking. Neither for whole-body hyperthermia nor for electro hyperthermia there is any evidence with respect to improvement of survival or quality of life in cancer patients.
Topics: Humans; Neoplasms; Hyperthermia, Induced; Quality of Life
PubMed: 35767077
DOI: 10.1007/s10238-022-00846-9 -
Cancer Medicine Jan 2023This meta-analysis was conducted to evaluate the efficacy and safety of the addition of Traditional Chinese Medicine (TCMs) to capecitabine-based regimens for colorectal... (Meta-Analysis)
Meta-Analysis
This meta-analysis was conducted to evaluate the efficacy and safety of the addition of Traditional Chinese Medicine (TCMs) to capecitabine-based regimens for colorectal cancer (CRC) in term of tumor. The eight electronic databases including Cochrane Library, PubMed, Web of Science (WOS), Excerpt Medica Database (Embase), Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Journals (CQVIP), and Wanfang Database were systematically searched for eligible studies from their inception to March 2021. Thirty-nine randomized controlled trials were involved in this study, and all the data were analyzed by Review Manager 5.3 (Nordic Cochran Centre, Copenhagen, Denmark) and R 4.0.5 software. The meta-analyses suggested that TCMs in combination with capecitabine-based regimens increased objective response rate (ORR) in the palliative treatment of CRC (risk ratio [RR], 1.35 [1.17, 1.55], I = 0%), disease control rate (DCR) (RR, 1.22 [1.12, 1.32], I = 3%), and quality of life (QOL) (RR, 1.71 [1.44, 2.03], I = 0%), with decreased risks of myelosuppression, anemia, thrombocytopenia, liver/renal dysfunction, neurotoxicity, nausea/vomiting, neutropenia, diarrhea, leukopenia, improved the peripheral lymphocyte, reduced the expression of tumor markers, and related factors. Further sensitivity analysis of specific plant-based TCMs found that dangshen, fuling, and gancao had significantly higher contributions to the results of the RR. The results show that capecitabine-based chemotherapy combined with TCM in the treatment of CRC increases the efficiency of ORR and DCR, reduces chemotherapeutic agents-associated adverse reactions, and improves their life quality as compared with chemotherapy alone, but further randomized and large sample of studies are needed.
Topics: Humans; Medicine, Chinese Traditional; Capecitabine; Quality of Life; Drugs, Chinese Herbal; Neutropenia; Colorectal Neoplasms; Randomized Controlled Trials as Topic
PubMed: 35650714
DOI: 10.1002/cam4.4896 -
Frontiers in Oncology 2022Cellular immunotherapy has become a new and promising treatment for patients with liver tumor. However, as most immune cells are delivered by intravenous injection, the...
BACKGROUND
Cellular immunotherapy has become a new and promising treatment for patients with liver tumor. However, as most immune cells are delivered by intravenous injection, the effect is limited and is likely to produce systemic toxicity. Here, the objective was to investigate the efficacy and safety of cellular immunotherapy by local infusion, which seems to be a promising approach and has not been well-studied.
METHODS
The PubMed, Web of Science, Embase, and Cochrane Library databases were searched to obtain literature. The overall response rate (ORR), overall survival (OS) rates, and adverse events were investigated to evaluate the effectiveness and safety of locoregional therapy. The methodological quality of the articles was assessed using the methodological index for non-randomized studies (MINORS) score. The meta-analysis was performed using Stata 15.0.
RESULTS
The eligible 17 studies involved a total of 318 patients. The random-effects model demonstrated that the ORR of local cell infusion therapy was 48% (95% confidence interval [CI]: 26%-70%). The pooled OS rate was 94% (95% CI: 83%-100%) at 6 months, 87% (95% CI: 74%-96%) at 12 months, and 42% (95% CI: 16%-70%) at 24 months. Subgroup analyses suggested that minimally invasive treatment and absence of metastasis were significantly associated with better ORR. Fourteen studies reported a variety of adverse events related to cell therapy by local perfusion. The most common complications after regional infusion of immune cells were myelosuppression (66%), fever (50%), gastrointestinal toxicity (22%), hepatic dysfunction (15%), and pleural effusion and/or ascites (14%).
CONCLUSIONS
Immune cell therapy through local perfusion is effective for patients with liver cancer, with manageable toxicity. It demonstrates better prognosis when combined with minimally invasive therapy. Considering the potential limitations, more randomized controlled trials are needed to provide solid evidence for our findings.
PubMed: 35296019
DOI: 10.3389/fonc.2022.772509 -
Frontiers in Medicine 2022Tuberculous meningitis is difficult to diagnose and is associated with high mortality. Recently, several studies evaluated the intensified regimen containing higher dose...
BACKGROUND
Tuberculous meningitis is difficult to diagnose and is associated with high mortality. Recently, several studies evaluated the intensified regimen containing higher dose rifampin to treat tuberculous meningitis. However, this topic remains to be concluded. Therefore, this systematic review and meta-analysis was conducted to evaluate pharmacokinetics parameters, safety, and survival benefits of high-dose rifampin for tuberculous meningitis.
METHOD
Data were searched from PubMed, EMBASE, The Cochrane Library, and Web of Science for studies describing an antituberculosis regimen including a higher dose of rifampin for patients with tuberculous meningitis. The quality of eligible studies was evaluated The Cochrane Risk of Bias Tool. The meta-analysis was performed by Review Manager 5.3 software, the synthesis of the data was shown in mean difference (MD) or relative risk (RR), and 95% confidence intervals (CIs).
RESULTS
There were six randomized control trails included in this meta-analysis. The results showed that the concentration in plasma and cerebrospinal fluid (CSF) were significantly higher in the intervention group than the standard group [MD = 22.08, 95%CI (16.24, 27.92), < 0.00001; MD = 0.74, 95%CI (0.42, 1.05), < 0.00001], as well as the area under the time concentration curve between 0 and 24 h (AUC) of rifampin [MD 203.56, 95%CI (153.07, 254.05), < 0.00001] in plasma, but the overall survival did not improve [RR = 0.92, 95%CI (0.67, 1.26), = 0.61]. For adverse events, the results showed a statistically significant lower incidence of hypersensitivity compared with the intervention group [RR = 1.72, 95%CI (1.13, 2.62), = 0.01]. Fortunately, other common adverse drug reactions such as liver injury, neurological events, myelosuppression, and cardiotoxicity had no significant increase [RR = 0.98, 95%CI (0.77, 1.26), = 0.90; RR = 1.10, 95%CI (0.94, 1.30), = 0.23; RR = 0.82, 95%CI (0.59, 1.13), = 0.22; RR = 1.11, 95%CI (0.66, 1.86), = 0.70].
CONCLUSION
This meta-analysis suggested that the intensified treatment regimen including a higher dose of rifampin significantly increased the rifampin concentration both in the plasma and CSF, and it was safe in patients with tuberculous meningitis, but resulted in no improvement in survival rates.
PubMed: 35280900
DOI: 10.3389/fmed.2022.822201 -
World Journal of Surgical Oncology Mar 2022The timely and effective treatments are vital to the prognosis of patients with hepatocellular carcinoma, and the role of Apatinib combined with TACE in the treatment of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The timely and effective treatments are vital to the prognosis of patients with hepatocellular carcinoma, and the role of Apatinib combined with TACE in the treatment of hepatocellular carcinoma remains unclear. Therefore, we aimed to conduct a systematic review and meta-analysis to evaluate the efficacy and safety of Apatinib combined with transcatheter arterial chemoembolization (TACE) in the treatment of hepatocellular carcinoma.
METHODS
We searched for randomized controlled trials (RCTs) on Apatinib and TACE use in the treatment of hepatocellular carcinoma. Cochrane Central Register of Controlled Trials, Embase, PubMed, China Biomedical Literature Database, China Knowledge Network, Wanfang Database, and Weipu Chinese Science and Technology Journal Database were searched up to 16 April 2021. Two researchers independently screened the literature and extracted data according to the inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis. This meta-analysis protocol had been registered online (available at: https://inplasy.com/inplasy-2021-6-0047/ ).
RESULTS
A total of 14 RCTs involving 936 hepatocellular carcinoma patients were included. The objective remission rate (OR = 2.93, 95% CI 2.17-3.95), 1-year survival (OR = 2.47, 95% CI 1.65-3.68), 2-year survival (OR = 2.67, 95% CI 1.41-5.04), the incidence of hand-foot syndrome (OR = 32.09, 95% CI 10.87-94.74) and the incidence of proteinuria (OR = 14.79, 95% CI 6.07-36.06) of the Apatinib + TACE group was significantly higher than that of the TACE group (all P < 0.05). There were no significant differences in the incidence of myelosuppression (OR = 1.01, 95% CI 0.61-1.67), the incidence of hypertension (OR = 7.56, 95% CI 0.95-1.67, P = 60.17) between Apatinib + TACE and TACE group (all P > 0.05).
CONCLUSIONS
Apatinib combined with TACE is more effective than TACE alone in the treatment of hepatocellular carcinoma, but it has certain adverse reactions.
Topics: Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Combined Modality Therapy; Humans; Liver Neoplasms; Pyridines; Treatment Outcome
PubMed: 35246145
DOI: 10.1186/s12957-021-02451-8 -
Annals of Palliative Medicine Sep 2021Apatinib in combination with chemotherapy (CT) has been used in the treatment of ovarian cancer (OC), however, the safety and efficacy are unclear. The study aims at... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Apatinib in combination with chemotherapy (CT) has been used in the treatment of ovarian cancer (OC), however, the safety and efficacy are unclear. The study aims at systematic evaluation of the safety and efficacy of the apatinib targeted therapy in combination with CT for the treatment of patients with advanced OC.
METHODS
Literature about randomized controlled clinical trials was searched using search engines such as PubMed, EMBASE, Web of Science, CNKI, the Cochrane Library, CBM, VIP and the Wanfang. We collected the related clinical studies of apatinib in combination with CT in the treatment of OC. The duration of the data retrieval related to clinical studies was from the database establishment to September 2020. Adverse reactions (ADRs) due to treatment, disease control rate (DCR), and that of objective response rate (ORR), were collected as indicators to show treatment outcomes. The literature was independently screened by two researchers. They extracted the data and evaluated the risk of biases of the included studies. Then, Revman 5.4 software was employed for performing the meta-analysis.
RESULTS
Twelve randomized controlled clinical trials with 698 patients having an advanced stage of OC were included. The results revealed that in comparison with the treatment with only CT, apatinib targeted therapy combination with CT showed significant improvement in the patients' ORR [OR =3.19, 95% CI: (2.06, 4.94), P<0.00001] and DCR [OR =4.97, 95% CI: (2.90, 8.52), P<0.00001]. The group that was treated with a combined therapy had shown proteinuria in higher amount (OR =3.08, 95% CI: 51.13-8.42, P<0.00001), while the analyses of other ADRs, such nausea and vomiting (OR =1.10, 95% CI: 0.67-1.79, P=0.71), hand-foot syndrome (OR =1.73, 95% CI: 0.97-3.10, P=0.06), hypertension (OR =1.18, 95% CI: 0.73-1.91, P=0.0.51), diarrhea (OR =1.05, 95% CI: 0.56-1.97, P=0.87), leucopenia (OR =1.22, 95% CI: 0.70-2.12, P=0.48), and myelosuppression (OR =1.00, 95% CI: 0.28-3.62, P=1.00), did not show any significant difference (P>0.05).
DISCUSSION
The effects of apatinib combination with CT for the treatment of OC are significantly better than the CT used alone in ORR and DCR, despite with a relative low incidence of adverse effects. However, due to the very low number of studies available, the results need to be further verified using a high-quality, large sample and long-term studies.
Topics: Female; Humans; Ovarian Neoplasms; Pyridines; Treatment Outcome
PubMed: 34551570
DOI: 10.21037/apm-21-1662 -
BMC Cancer May 2021Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), is commonly used to prevent febrile neutropenia (FN), a potentially life-threatening...
Prophylactic pegfilgrastim to prevent febrile neutropenia among patients receiving biweekly (Q2W) chemotherapy regimens: a systematic review of efficacy, effectiveness and safety.
BACKGROUND
Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), is commonly used to prevent febrile neutropenia (FN), a potentially life-threatening complication, following myelosuppressive chemotherapy. The FDA label for pegfilgrastim specifies that it should not be administered 14 days before or within 24 h of administration of myelosuppressive chemotherapy, precluding the use of pegfilgrastim in biweekly (Q2W) regimens. The National Comprehensive Cancer Network and the European Organisation for Research and Treatment of Cancer guidelines support the use of prophylactic pegfilgrastim in patients receiving Q2W regimens. The objective of this study was to systematically review evidence from randomized clinical trials (RCTs) and observational studies that describe the effectiveness and safety of prophylactic pegfilgrastim in preventing FN among patients receiving Q2W regimens.
METHODS
An Ovid MEDLINE, Embase, and Cochrane Library literature search was conducted to evaluate the evidence regarding efficacy, effectiveness, and safety of prophylactic pegfilgrastim versus no prophylactic pegfilgrastim or prophylaxis with other G-CSF in patients who were receiving Q2W chemotherapy regimens with high (> 20%) or intermediate (10-20%) risk of FN for a non-myeloid malignancy. Studies that addressed absolute or relative risk of FN, grade 1-4 neutropenia, all-cause or any hospitalization, dose delays or dose reductions, adverse events, or mortality were included. Studies where the comparator was a Q3W chemotherapy regimen with primary prophylactic pegfilgrastim were also included.
RESULTS
The initial literature search identified 2258 publications. Thirteen publications met the eligibility criteria, including eight retrospective, one prospective, one phase 1 dose escalation study, and three RCTs. In nine of the 13 studies reporting incidence of FN, and in seven of the nine studies reporting incidence of neutropenia, administration of prophylactic pegfilgrastim in patients receiving Q2W regimens resulted in decreased or comparable rates of FN or neutropenia compared with patients receiving filgrastim, no G-CSF, lipefilgrastim or pegfilgrastim in Q3W regimens. In six of the nine studies reporting safety data, lower or comparable safety profiles were observed between pegfilgrastim and comparators.
CONCLUSIONS
In a variety of non-myeloid malignancies, administration of prophylactic pegfilgrastim was efficacious in reducing the risk of FN in patients receiving high- or intermediate-risk Q2W regimens, with an acceptable safety profile.
TRIAL REGISTRATION
PROSPERO registration no: CRD42019155572 .
Topics: Antineoplastic Combined Chemotherapy Protocols; Chemotherapy-Induced Febrile Neutropenia; Drug Administration Schedule; Filgrastim; Humans; Incidence; Polyethylene Glycols; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment
PubMed: 34044798
DOI: 10.1186/s12885-021-08258-w