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Access and use of immunoglobulins in secondary supportive cancer care: A systematic literature review
Counihan, M., Cervenakova, L., Misztela, D., Van Baelen, M., Naughton, B. D.
The journal of medicine access. 2023;7:27550834231197315
Abstract
BACKGROUND Immunoglobulin replacement therapy (IgRT) benefits patients with primary immuno deficiency (PID) originating from the innate or polygenic defects in the immune system. However, evidence supporting their therapeutic role is not as explicit in secondary immuno deficiency (SID) resulting from the treatment of haematological malignancies. OBJECTIVES This study aimed to (1) create a dataset of relevant research papers, which explore the use of IgRT in SID for analysis, (2) assess the risk of bias within this dataset and (3) study the characteristics of these papers. DESIGN This systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. In addition to the risk of bias, the study characteristics explored in this article included study design, study geographical location and year of publication. DATA SOURCES AND METHODS To identify studies relevant to the research question, EMBASE and PubMed databases were searched. The Population, Intervention, Comparison and Outcome (PICO) framework was used to assess study quality. Risk of bias and quality of studies were assessed in accordance with the study design. As one model was not appropriate to assess bias in all articles, several tools were used. RESULTS A total of 43 studies were identified from the literature search as relevant to the research objective. The most common study design was a retrospective case-control cohort study (n = 16/43), and randomised trials were among the least commonly used approaches (n = 1). Research in this area is occurring around the globe including the United States (n = 7), Italy (n = 7), China, India, Japan and throughout Europe. The annual number of papers in this area has varied from 2012 (n = 1) to 2021 (n = 7). The studies in this article demonstrated a varied risk of bias, with 9 of the 20 cohort studies scoring less than 5 out of 9 stars. CONCLUSIONS Randomised controlled trials are less frequently used to assess access and use of immunoglobulins. More commonly, a retrospective case-control cohort study was used which correlates with the higher risk of bias seen in the studies in this article. Most of the research concerning immunoglobulin use and access occurs in higher-income countries.
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Neuromuscular Complications of Targeted Anticancer Agents: Can Tyrosine Kinase Inhibitors Induce Myasthenia Gravis? Getting Answers From a Case Report up to a Systematic Review
Ziogas DC, Mandellos D, Theocharopoulos C, Lialios PP, Bouros S, Ascierto PA, Gogas H
Frontiers in oncology. 2021;11:727010
Abstract
More than 40 tyrosine kinase inhibitors (TKIs) have received hematological or oncological indications over the past 20 years, following the approval of imatinib, and many others are currently being tested in clinical and preclinical level. Beyond their common toxicities, no certain agent from this large class of molecularly targeted therapies was strongly associated with "off-target" impairment of neuromuscular transmission, and although myasthenia gravis (MG) is a well-characterized autoimmune disorder, only few sporadic events proven by serologically detected causative autoantibodies and/or by positive electrophysiological tests are reported in the literature. Herein, we present the first case of anti-MUSK (+) MG in a woman with metastatic BRAF-mutant melanoma after long-term treatment with dabrafenib (BRAF inhibitor) and trametinib (MEK inhibitor). Triggered by this report, a systematic literature review was conducted, summarizing all other cancer cases that developed MG, after exposure to any type of targeted agent and regardless of the underlying malignancy. All available data on the clinical diagnosis, the potential of administered TKIs to induce a seropositive myasthenic syndrome, the immune and non-immune-mediated pathogenesis of postsynaptic damage, and the challenging management of this neuromuscular toxicity were collected and discussed. In the presented case, MG was confirmed by both autoantibodies and nerve-conduction tests, while its reactivation after TKIs rechallenge supports a more than coincidental association. The following review identified 12 cancer cases with TKI-related MG in six case reports and one case series. In most of them, the myasthenia diagnosis was challenging, since the clinical symptomatology of fatigable weakness was not corroborating with consistent laboratory and electrophysiological findings. In fact, anti-AchR titers were positive in five and anti-MuSK only in the abovementioned individual. The symptomatology corresponded to TKI discontinuation and standard treatment with pyridostigmine and prednisolone; intravenous immunoglobulin was added only in three, and two required mechanical ventilation. In an era where TKIs will be prescribed more frequently for various malignancies, even in combinations with immune-checkpoint inhibitors, this report synthesizes their risk for neuromuscular complications and increases the clinicians' awareness in order to extend the on-treatment and overall survival of TKI-treated cancer patients.
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Pure Red Cell Aplasia and Other Haematological Diseases Associated With Thymoma: A Case Series and Systematic Review
Yen CC, Huang WL, Li SS, Chen YP, Tseng YL, Yen YT, Chu CY, Hsu YT, Chen TY
Frontiers in medicine. 2021;8:759914
Abstract
Background: Thymoma-associated haematological diseases (HDs), such as pure red cell aplasia (PRCA) and Good's syndrome, are extremely rare, and due to the paucity of large-scale studies, the characteristics, remission after thymectomy, and long-term evaluation remain undetermined. Methods: We retrospectively assessed patients with thymoma and associated HDs from Jan 2005 to Dec 2020. All patients received thymectomy and/or additional treatments for HDs. A comparison with thymoma-associated myasthenic gravis (MG), and a systematic review from PubMed/MEDLINE and Embase were conducted. Results: In the median follow-up of 56 months, 130 patients were enrolled. Patients with thymoma-associated MG (n = 46) and HDs [n = 8; PRCA (n = 5), PRCA and Good's syndrome (n = 2) and autoimmune haemolytic anaemia (n = 1)] were evaluated. Patients with MG had a significantly higher remission rate after thymectomy (50 vs. 17%; p = 0.0378) as compared to those with other autoimmune diseases. Two of seven patients with PRCA experienced remission with thymectomy alone, and an additional two patients achieved remission with thymectomy plus immunosuppressive therapy (IST). In the systematic review, 60 studies (case reports, n = 46; case series including the present study, n = 14) were evaluated. Forty-four percent of patients were diagnosed with PRCA after thymoma, and 61% achieved remission with thymectomy plus IST; however, Good's syndrome was unaffected. Conclusions: Our study indicates that patients with thymoma-associated autoimmune diseases other than MG have a lower remission rate than those with MG. Remission of thymoma-associated PRCA can be achieved by thymectomy and IST. This study provides insight into extremely rare but puzzling autoimmune manifestations.
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Potentially Overestimated Efficacy of Nanoparticle Albumin-bound Paclitaxel compared with Solvent-based Paclitaxel in Breast Cancer: A Systemic Review and Meta-analysis
Li BX, Chen XJ, Ding TJ, Liu YH, Ma TT, Zhang GL, Wang XM
Journal of Cancer. 2021;12(17):5164-5172
Abstract
Background: Nanoparticle albumin-bound paclitaxel (nab-PTX) has exhibited clinical efficacy in breast cancer treatment, but toxicities can be yielded more at the same time. We did this meta-analysis aiming to unambiguously compare nab-PTX with conventional solvent-based paclitaxel (sb-PTX) in breast cancer patients of all stages. Method: Pubmed, Embase and Cochrane Library were searched for head-to-head randomized controlled trials of nab-PTX and sb-PTX in breast cancer. Risk ratio (RR) with 95% confidence interval was used for dichotomous variables while Hazard ratio (HR) was used for time-to-event outcomes. Results: Our review finally included 9 studies with 3508 patients. Nab-PTX showed a benefit on objective response rate (ORR) (RR=1.22 [1.04-1.43], P=0.01) as well as non-inferiority compared with sb-PTX in disease control rate (DCR) (RR=1.01 [0.98-1.04], P=0.44), overall survival (OS) (HR=0.99 [0.93-1.05], P=0.81) and disease free survival/progression free survival (DFS/PFS) (HR=0.92 [0.81-1.05], P=0.21). However, when it comes to toxicities (fatigue, nausea or vomiting, peripheral sensory neuropathy and adverse event related discontinuation), results favored sb-PTX (RR=2.89 [1.07-7.8], 3.15 [1.78-5.59], 2.11 [1.32-3.37], 2.02 [1.61-2.53]; P<0.05). Patients with metastatic tumors or undergoing conventional schedule responses better to nab-PTX than the compared groups (RR of ORR in metastatic vs early or locally advanced patients: 1.46 [1.09-1.96] vs 1.01 [0.94-1.08]; conventional vs dose dense group: 1.59 [1.23-2.06] vs 1.01 [0.91-1.12]). Conclusions: Nab-PTX can improve ORR compared with paclitaxel and should be given priority to when aiming to reduce tumor load in breast cancer. Sb-PTX of dose dense schedule is recommended when toxicity of nab-PTX is hard to bear for breast cancer patients.
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Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non-Small-cell Lung Cancer (ABOUND.sqm): A Phase III Randomized Clinical Trial
Spigel DR, Jotte RM, Aix SP, Gressot L, Morgensztern D, McCleod M, Socinski MA, Daniel D, Juan-Vidal O, Mileham KF, et al
Clinical lung cancer. 2020
Abstract
BACKGROUND We evaluated maintenance nanoparticle albumin-bound (nab) paclitaxel in the treatment of advanced squamous non-small-cell lung cancer. PATIENTS AND METHODS Patients with treatment-naive squamous non-small-cell lung cancer received four 21-day cycles of nab-paclitaxel 100 mg/m(2) on days 1, 8, 15 plus carboplatin area under the curve 6 on day 1 as induction therapy. Patients without disease progression after induction were randomized 2:1 to maintenance nab-paclitaxel 100 mg/m(2) (days 1 and 8 every 21 days) plus best supportive care (BSC) or BSC alone. The primary endpoint was progression-free survival (PFS). Secondary endpoints included safety and overall survival (OS). RESULTS Overall, 420 patients had received induction therapy; 202 (nab-paclitaxel plus BSC, 136; BSC, 66) had received maintenance therapy. Enrollment was discontinued after a preplanned interim futility analysis (patients could remain in the study at the investigator's discretion). The median PFS was 3.12 months for nab-paclitaxel plus BSC and 2.60 months for BSC; the difference was not statistically significant (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.19; P = .36). The median OS (median follow-up, 24.2 months) was 17.18 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.70; 95% CI, 0.48-1.02; nominal P = .07). An updated analysis (median follow-up, 28.4 months) revealed a median OS of 17.61 months for nab-paclitaxel plus BSC and 12.16 months for BSC (HR, 0.68; 95% CI, 0.47-0.98; nominal P = .037). The most frequent grade 3 and 4 treatment-emergent adverse events for the entire study were neutropenia (53.1% [nab-paclitaxel plus BSC] vs. 50.0% [BSC]) and anemia (33.1% [nab-paclitaxel plus BSC] vs. 32.3% [BSC]). Only peripheral neuropathy had occurred in ≥ 5% of patients during maintenance therapy (13.1%; nab-paclitaxel plus BSC). CONCLUSIONS The results of the ABOUND.sqm did not meet the primary endpoint of PFS. An updated OS analysis revealed a trend favoring nab-paclitaxel plus BSC.
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Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with solvent-based taxanes for metastatic breast cancer: A meta-analysis
Lee H, Park S, Kang JE, Lee HM, Kim SA, Rhie SJ
Scientific reports. 2020;10(1):530
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Editor's Choice
Abstract
The curative effects of nanoparticle albumin-bound (nab)-paclitaxel in the first-line treatment of metastatic breast cancer (MBC) are still controversial, with even more after the removal of marketing approval of indication of bevacizumab. Five electronic databases and the related resources were searched for eligible randomized clinical trials (RCTs) without year and language restrictions to perform a meta-analysis. The studies were comparing the efficacy and safety between nab-paclitaxel chemotherapy versus solvent-based (sb)-taxanes chemotherapy such as sb-paclitaxel and docetaxel. The primary end points were overall response rate (ORR) and disease control rate (DCR). Secondary end points were progression-free survival (PFS), overall survival (OS), adverse events (AEs), and dose discontinuation rate (DDR). Five RCTs (1,554 patients) were finally identified from 1,902 studies. When compared to sb-paclitaxel, nab-paclitaxel showed significant beneficial effects in terms of ORR (OR 2.39, 95% CI 1.69-3.37, p < 0.001), DCR (OR 1.89, 95% CI 1.07-3.35, p = 0.03), and PFS (HR 0.75, 95% CI 0.62-0.90, p = 0.002). Nab-paclitaxel also showed significantly longer OS (HR 0.73, 95% CI 0.54-0.99, p = 0.04) than docetaxel. AEs and DDR were comparable between the two arms. Using nab-paclitaxel could significantly improve efficacy with comparable toxicities in the treatment of MBC.
PICO Summary
Population
Patients with metastatic breast cancer, (5 studies), (n= 1,554).
Intervention
Nanoparticle albumin-bound (nab)-paclitaxel chemotherapy, (n=774).
Comparison
Solvent-based (sb)-taxanes chemotherapy: sb-paclitaxel, (n=606) and docetaxel, (n=174).
Outcome
When compared to sb-paclitaxel, nab-paclitaxel showed significant beneficial effects in terms of overall response rate (ORR) (OR 2.39), disease control rate (DCR) (OR 1.89), and progression-free survival (PFS) (HR 0.75). Nab-paclitaxel also showed significantly longer overall survival (OS) (HR 0.73) than docetaxel. Adverse events (AEs) and dose discontinuation rate (DDR) were comparable between the two arms.
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Study on the Effect of Nano Albumin Paclitaxel Combined with Carboplatin in the Treatment of Lung Squamous Cell Carcinoma
Wang H, Mou S, Tu M
J Nanosci Nanotechnol. 2020;20(12):7439-7443
Abstract
This study aims to compare the efficacy and side effects of albumin-binding paclitaxel plus carboplatin (NAB PC) and paclitaxel plus carboplatin (PC) in the first-line treatment of advanced non-small cell lung cancer (NSCLC). A total of 60 patients with advanced NSCLC diagnosed by histopathology or cytology were randomly divided into nab PC group (albumin-binding paclitaxel 130 mg/mL, D1, D; carboplatin AUC = 6, D1) and PC group (paclitaxel 175 mg/mL, D1; carboplatin AUC = 6, D1), one cycle every three weeks. RECIST 1.1 standard was used to evaluate the short-term objective efficacy, and who acute and subacute toxicity classification standard was used to evaluate the toxicity. The total effective rate (RR) and disease control rate (DCR) of NAB PC group were 40.0% and 80.0%, respectively, which were higher than 23.3% and 60.0% of the PC group, respectively. This difference was statistically significant (p < 0.05). In squamous cell carcinoma, the RR of NAB PC group and PC group were 57.1% (8/14) and 23.1% (3/13) respectively, with a statistically significant difference (p < 0.05); in non-squamous cell carcinoma, the RR of the two groups were 25.0% (4/16) and 23.3% (4/17) without statistical significance (p > 0.05). The median progression free survival time of the NAB PC group and PC group was 6.5 and 5.9 months, respectively, with no significant difference (p>0.05). No significant difference arose in the incidence of grade III-IV toxicity between the two groups (p > 0.05). The incidence of neutropenia in the NAB PC group was higher than that in the PC group (p < 0.05). The therapeutic effect of paclitaxel combined with carboplatin in the treatment of advanced NSCLC is better, the effect of paclitaxel combined with carboplatin is better, and the side effects can be tolerated, which is worthy of clinical application. Patients are more satisfied with their care.
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Tissue sealants for the prevention of lymphoceles after radical inguinal lymph node dissection in patients with melanoma: A systematic review and individual patient data meta-analysis
Gerken ALH, Dobroschke J, Reissfelder C, Hetjens S, Braun V, Di Monta G, Jakob J, Hohenberger P, Nowak K, Herrle F
Journal of surgical oncology. 2019
Abstract
BACKGROUND AND OBJECTIVES Postoperative lymphoceles and further wound complications occur frequently after radical inguinal lymph node dissection (ILND). In various studies, tissue sealants have shown to reduce the incidence of postoperative morbidity. METHODS A systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effectiveness of tissue sealants in reducing the incidence of postoperative lymphoceles following ILND in patients with melanoma was conducted. Individual patient data was requested to pool the data for meta-analysis appropriately. RESULTS Thousand seven hundred twenty-nine manuscripts were screened for eligibility. Six RCTs published between 1986 and 2012 were identified including 194 patients for ILND. Only four RCTs were included in the meta-analysis. No study properly defined the term "lymphocele." Tissue sealants failed to influence the duration of drain placement (mean difference [MD] = -3.05 days; z = 1.18; P = 0.24), total drainage volume (MD = 598.39 mL; z = 1.49; P = 0.14), the incidence of postoperative seroma, wound infection and skin necrosis. CONCLUSIONS No improvement was identified with the use of tissue sealants, however, a valid comparison of the results of included trials was difficult owing to the lack of a definition of the term "lymphocele." Other surgical techniques and trials using validated endpoint definitions are required to reevaluate these findings.
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Prognostic value of pretreatment albumin to bilirubin ratio in patients with hepatocellular cancer: A meta-analysis
Xu YX, Wang YB, Tan YL, Xi C, Xu XZ
Medicine. 2019;98(2):e14027
Abstract
BACKGROUND Hepatic function is closely associated with prognosis in patients with hepatocellular cancer (HCC). In this study, a meta-analysis of the published studies was performed to assess the prognostic value of ALBI grade in HCC patients. METHODS Databases, including PubMed, EMbase, Web of Science, and Cochrane Library were retrieved up to August 2018. The primary outcome was OS and secondary outcome was DFS, the prognostic impact of which was assessed by using hazard ratio (HRs) with corresponding 95% confidence intervals (CIs). The enrolled studies were analyzed by using STATA version 12.0 software. RESULTS A total of 22,911 patients with HCC in 32 studies were included. Our results demonstrated that high pretreatment ALBI is associated with poor OS (HR = 1.719, 95%CI: 1.666-1.771, P = .000, univariate results; HR = 1.602, 95%CI: 1.470-1.735, P = .000, multivariate results) and poor DFS (HR = 1.411, 95%CI: 1.262-1.561, P = .000, univariate results; HR = 1.264, 95%CI: 1.042-1.485, P = .000, multivariate results). Meanwhile, when the analysis was stratified into subgroups, such as treatment methods, sample size, geographic area, and ALBI grade, the significant correlation in ALBI and poor long-term survival was not altered. CONCLUSION High pretreatment ALBI is closely associated with poor prognosis in HCC, and High ALBI should be treated as an ideal predictor during hepatocellular therapy.
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Intravenous immunoglobulin with prednisone and risk-adapted chemotherapy for children with opsoclonus myoclonus ataxia syndrome associated with neuroblastoma (ANBL00P3): a randomised, open-label, phase 3 trial
de Alarcon P A, Matthay K K, London W B, Naranjo A, Tenney S C, Panzer J A, Hogarty M D, Park J R, Maris J M, Cohn S L
The Lancet Child & Adolescent Health. 2018;2((1)):25-34.
Abstract
Purpose: No previous clinical trial has been conducted for patients with neuroblastoma associated opsoclonus myoclonus ataxia syndrome (OMA), and current treatment is based on case reports. To evaluate the OMA response to prednisone and risk-adapted chemotherapy and determine if the addition of intravenous gammaglobulin (IVIG) further improves response, the Children's Oncology Group designed a randomized therapeutic trial. Patient and Methods: Eligible subjects were randomized to receive twelve cycles of IVIG (IVIG+) or no IVIG (NO-IVIG) in addition to prednisone and neuroblastoma risk-adapted chemotherapy. All low-risk patients were treated with cyclophosphamide. The severity of OMA symptoms was evaluated at 2, 6, and 12 months using a scale developed by Mitchell and Pike and baseline versus best response scores were compared. A single patient who did not undergo neurologic assessment was excluded from OMA response analysis. This study is registered with Clinical Trials.gov (identifier NCT00033293). Results: Of the 53 patients enrolled in the study, 62% (33/53) were female. There were 44 low-risk, 7 intermediate-risk, and 2 high-risk neuroblastoma patients. Twenty-six subjects were randomized to receive IVIG+ and 27 were randomized to NO-IVIG. The neuroblastoma 3-year event-free survival (95% confidence interval (CI)) was 94.1% (87.3%, 100%) and overall survival was 98.0% (94.1%, 100%). Significantly higher rates of OMA response were observed in patients randomized to IVIG+ compared to NO-IVIG [21/26=80.8% for IVIG+; 11/27=40.7% for NO-IVIG (odds ratio=6.1; 95% CI: (1.5, 25.9), p=0.0029)]. For the majority of patients, the IVIG+ OMA regimen combined with cytoxan or other risk-based chemotherapy was well tolerated, although there was one toxic death in a high-risk subject. Conclusion: This is the only randomized prospective therapeutic clinical trial in children with neuroblastoma-associated OMA. The addition of IVIG to prednisone and risk-adapted chemotherapy significantly improves OMA response rate. IVIG+ constitutes a back-bone upon which to build additional therapy.