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The Cochrane Database of Systematic... Mar 2021Epidermal growth factor receptor (EGFR) mutation positive (M+) non-small cell lung cancer (NSCLC) is an important subtype of lung cancer comprising 10% to 15% of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Epidermal growth factor receptor (EGFR) mutation positive (M+) non-small cell lung cancer (NSCLC) is an important subtype of lung cancer comprising 10% to 15% of non-squamous tumours. This subtype is more common in women than men, is less associated with smoking, but occurs at a younger age than sporadic tumours.
OBJECTIVES
To assess the clinical effectiveness of single-agent or combination EGFR therapies used in the first-line treatment of people with locally advanced or metastatic EGFR M+ NSCLC compared with other cytotoxic chemotherapy (CTX) agents used alone or in combination, or best supportive care (BSC). The primary outcomes were overall survival and progression-free survival. Secondary outcomes included response rate, symptom palliation, toxicity, and health-related quality of life.
SEARCH METHODS
We conducted electronic searches of the Cochrane Register of Controlled Trials (CENTRAL) (2020, Issue 7), MEDLINE (1946 to 27th July 2020), Embase (1980 to 27th July 2020), and ISI Web of Science (1899 to 27th July 2020). We also searched the conference abstracts of the American Society for Clinical Oncology and the European Society for Medical Oncology (July 2020); Evidence Review Group submissions to the National Institute for Health and Care Excellence; and the reference lists of retrieved articles.
SELECTION CRITERIA
Parallel-group randomised controlled trials comparing EGFR-targeted agents (alone or in combination with cytotoxic agents or BSC) with cytotoxic chemotherapy (single or doublet) or BSC in chemotherapy-naive patients with locally advanced or metastatic (stage IIIB or IV) EGFR M+ NSCLC unsuitable for treatment with curative intent.
DATA COLLECTION AND ANALYSIS
Two review authors independently identified articles, extracted data, and carried out the 'Risk of bias' assessment. We conducted meta-analyses using a fixed-effect model unless there was substantial heterogeneity, in which case we also performed a random-effects analysis as a sensitivity analysis.
MAIN RESULTS
Twenty-two trials met the inclusion criteria. Ten of these exclusively recruited people with EGFR M+ NSCLC; the remainder recruited a mixed population and reported results for people with EGFR M+ NSCLC as subgroup analyses. The number of participants with EGFR M+ tumours totalled 3023, of whom approximately 2563 were of Asian origin. Overall survival (OS) data showed inconsistent results between the included trials that compared EGFR-targeted treatments against cytotoxic chemotherapy or placebo. Erlotinib was used in eight trials, gefitinib in nine trials, afatinib in two trials, cetuximab in two trials, and icotinib in one trial. The findings of FASTACT 2 suggested a clinical benefit for OS for participants treated with erlotinib plus cytotoxic chemotherapy when compared to cytotoxic chemotherapy alone, as did the Han 2017 trial for gefitinib plus cytotoxic chemotherapy, but both results were based on a small number of participants (n = 97 and 122, respectively). For progression-free survival (PFS), a pooled analysis of four trials showed evidence of clinical benefit for erlotinib compared with cytotoxic chemotherapy (hazard ratio (HR) 0.31; 95% confidence interval (CI) 0.25 to 0.39 ; 583 participants ; high-certainty evidence). A pooled analysis of two trials of gefitinib versus paclitaxel plus carboplatin showed evidence of clinical benefit for PFS for gefitinib (HR 0.39; 95% CI 0.32 to 0.48 ; 491 participants high-certainty evidence), and a pooled analysis of two trials of gefitinib versus pemetrexed plus carboplatin with pemetrexed maintenance also showed evidence of clinical benefit for PFS for gefitinib (HR 0.59; 95% CI 0.46 to 0.74, 371 participants ; moderate-certainty evidence). Afatinib showed evidence of clinical benefit for PFS when compared with chemotherapy in a pooled analysis of two trials (HR 0.42; 95% CI 0.34 to 0.53, 709 participants high-certainty evidence). All but one small trial showed a corresponding improvement in response rate with tyrosine-kinase inhibitor (TKI) compared to chemotherapy. Commonly reported grade 3/4 adverse events associated with afatinib, erlotinib, gefitinib and icotinib monotherapy were rash and diarrhoea. Myelosuppression was consistently worse in the chemotherapy arms; fatigue and anorexia were also associated with some chemotherapies. Seven trials reported on health-related quality of life and symptom improvement using different methodologies. For each of erlotinib, gefitinib, and afatinib, two trials showed improvement in one or more indices for the TKI compared to chemotherapy. The quality of evidence was high for the comparisons of erlotinib and gefitinib with cytotoxic chemotherapy and for the comparison of afatinib with cytotoxic chemotherapy.
AUTHORS' CONCLUSIONS
Erlotinib, gefitinib, afatinib and icotinib are all active agents in EGFR M+ NSCLC patients, and demonstrate an increased tumour response rate and prolonged PFS compared to cytotoxic chemotherapy. We found a beneficial effect of the TKI compared to cytotoxic chemotherapy in adverse effect and health-related quality of life. We found limited evidence for increased OS for the TKI when compared with standard chemotherapy, but the majority of the included trials allowed participants to switch treatments on disease progression, which will have a confounding effect on any OS analysis. Single agent-TKI remains the standard of care and the benefit of combining a TKI and chemotherapy remains uncertain as the evidence is based on small patient numbers. Cytotoxic chemotherapy is less effective in EGFR M+ NSCLC than erlotinib, gefitinib, afatinib or icotinib and is associated with greater toxicity. There are no data supporting the use of monoclonal antibody therapy. Icotinib is not available outside China.
Topics: Afatinib; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Bias; Carboplatin; Carcinoma, Non-Small-Cell Lung; Cetuximab; Crown Ethers; ErbB Receptors; Erlotinib Hydrochloride; Female; Gefitinib; Humans; Lung Neoplasms; Male; Middle Aged; Mutation; Paclitaxel; Pemetrexed; Progression-Free Survival; Protein Kinase Inhibitors; Quality of Life; Quinazolines; Randomized Controlled Trials as Topic
PubMed: 33734432
DOI: 10.1002/14651858.CD010383.pub3 -
Frontiers in Medicine 2021Immune checkpoint inhibitors (ICIs) have previously been reported to have a promising potential in terms of the improvement of outcomes in non-small cell lung cancer...
Immune checkpoint inhibitors (ICIs) have previously been reported to have a promising potential in terms of the improvement of outcomes in non-small cell lung cancer (NSCLC). Fatal adverse events (FAEs) of ICIs are relatively uncommon, and the incidence and risk in NSCLC remain unclear. In the present study, we conducted a systematic review and meta-analysis to evaluate the risk of FAEs in NSCLC patients administered with ICIs. Potentially relevant studies were identified in PubMed, EMBASE, and Cochrane library database from inception to September 16, 2020. The systematic review and meta-analysis included randomized controlled trials that reported treatment-related FAEs in NSCLC. The pooled incidence and risk ratios (RRs) were calculated to evaluate prospective risk. Twenty clinical trials that included a total of 13,483 patients were selected for the meta-analysis. The overall incidence of FAEs was 0.65% [95% confidence interval (CI) = 0.31-1.07, = 50.2%] in ICI monotherapy, 1.17% (95% CI = 0.74-1.69, = 56.3%) in chemotherapy, and 2.01% (95% CI = 1.42-2.69, = 5.9%) in the combination therapy (ICI and chemotherapy). ICI monotherapy was associated with lower incidence of FAEs caused by blood system disorders (RR = 0.23, 95% CI = 0.07-0.73, = 0.013, = 0%) and infectious diseases (RR = 0.29, 95% CI = 0.13-0.63, = 0.002, = 0%). The incidence of pneumonitis significantly increased in immunotherapy (RR = 5.72, 95% CI = 1.14-28.80, = 0.03, = 0%). The results of the present study demonstrate that ICI monotherapy decreases the risk of FAEs, whereas the combined regimens with chemotherapy have the opposite tendency as compared to conventional chemotherapy. While the patients who received chemotherapy suffered the risks of death mainly from myelosuppression and infection, those who received immunotherapy were mainly threatened by immune-related pneumonitis.
PubMed: 33659263
DOI: 10.3389/fmed.2021.627089 -
Frontiers in Oncology 2020Chemotherapy usually induces a variety of side-effects in cancer treatment as it cannot tell normal cells apart from cancer cells and kills both. Chinese herbal medicine...
BACKGROUND
Chemotherapy usually induces a variety of side-effects in cancer treatment as it cannot tell normal cells apart from cancer cells and kills both. Chinese herbal medicine (CHM) has been regarded as a potential effective intervention for relieving the side-effects of chemotherapy in breast cancer patients.
OBJECTIVE
This study aims to conduct a comprehensive systematic review and meta-analysis to evaluate the efficacy of CHM as adjuvant therapy for reducing the chemotherapy-induced side-effects in the treatment of breast cancer.
METHODS
Main electronic databases were searched up to May 2020 for Randomized Controlled Trials (RCTs) evaluating the effect of CHM on breast cancer patients with chemotherapy. The PRISMA statement was adopted in this study and meta-analyses were performed.
RESULTS
The included studies showed unsatisfied quality. Results based on available literature indicated that the adjunctive use of CHM with chemotherapy may reduce the chemotherapeutic agents-associated adverse events, including nausea and vomiting, diarrhea, alopecia, myelosuppression, and impaired immune function.
CONCLUSION
A confident conclusion could not be have due to the lack of large scale and high quality trials.
PubMed: 33363030
DOI: 10.3389/fonc.2020.599073 -
BMC Cancer Oct 2020Both intermittent intravenous (IIV) infusion and continuous intravenous (CIV) infusion of Endostar are widely used for NSCLC in China. We aimed to compare the efficacy... (Comparative Study)
Comparative Study Meta-Analysis
Endostar continuous versus intermittent intravenous infusion combined with chemotherapy for advanced NSCLC: a systematic review and meta-analysis including non-randomized studies.
BACKGROUND
Both intermittent intravenous (IIV) infusion and continuous intravenous (CIV) infusion of Endostar are widely used for NSCLC in China. We aimed to compare the efficacy and safety of CIV of Endostar versus IIV in combination with first-line chemotherapy for patients with advanced NSCLC.
METHODS
RCTs, NRCTs and cohort studies which compared CIV of Endostar with IIV in advanced NSCLC patients and reported efficacy or safety outcomes were eligible. Two reviewers independently screened records, extracted data and assessed risk of bias. Pooled risk ratios (RRs) with 95% confidence intervals were calculated using random effects meta-analysis for short-term efficacy and safety outcomes, and hazard ratios (HRs) for survival outcomes.
RESULTS
Finally nine studies involving 597 patients were included, containing two RCTs, three NRCTs and four cohort studies. For short-term efficacy, moderate quality of evidence showed that there were no significant differences between CIV of Endostar and IIV in objective response rate (ORR; RR 1.34, 95% CI 0.91-1.98, P = 0.14) and disease control rate (DCR; RR 1.11, 95% CI 0.94-1.30, P = 0.21). Very low quality of evidence indicated that CIV of Endostar significantly improved both overall survival (OS; HR 0.69, 95% CI 0.48-0.99, P = 0.046) and progression-free survival (PFS; HR 0.71, 95% CI 0.55-0.93, P = 0.01) compared with IIV. As for safety outcomes, moderate quality of evidence found that CIV of Endostar significantly reduced the risk of myelosuppression (RR 0.55, 95% CI 0.32-0.96, P = 0.03) and cardiovascular toxicity (RR 0.21, 95% CI 0.06-0.78, P = 0.02) compared with IIV.
CONCLUSIONS
In advanced NSCLC, compared with IIV, CIV of Endostar had similar short-term efficacy, and substantially lower risk of myelosuppression and cardiovascular toxicity. Although very low quality of evidence supported the survival benefit of CIV compared with IIV, large RCTs with long-term follow-up are needed to demonstrate survival benefits. Caution should be given for off-label use of CIV of Endostar.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; China; Drug Therapy; Endostatins; Humans; Infusions, Intravenous; Lung Neoplasms; Non-Randomized Controlled Trials as Topic; Recombinant Proteins; Survival Analysis; Treatment Outcome
PubMed: 33087103
DOI: 10.1186/s12885-020-07527-4 -
Evidence-based Complementary and... 2020Cinobufacin is a Chinese patent medicine widely used for breast cancer in China. However, no systematic review and meta-analysis have been published to validate its...
BACKGROUND
Cinobufacin is a Chinese patent medicine widely used for breast cancer in China. However, no systematic review and meta-analysis have been published to validate its effects in breast cancer treatment. We, therefore, summarize the efficacy and safety of Cinobufacin combined with chemotherapy in order to provide rigid evidence for its clinical application.
METHODS
By searching multiple databases incepted to December 2019, the RCTs of breast cancer patients treated with Cinobufacin were screened according to the inclusion criteria, and the meta-analysis and sensitivity analysis were conducted using RevMan5.3.
RESULTS
A total of 1163 articles were retrieved, and 16 studies were included. The total sample size was 1331 cases, including 666 cases in the treatment group receiving Cinobufacin combined with chemotherapy and 665 cases in the control group receiving chemotherapy alone. Our study found that the ORR (overall response rate) (RR = 1.35, 95% CI: [1.23, 1.49], < 0.00001), CBR (clinical benefit rate) (RR = 1.14, 95% CI: [1.08, 1.21], < 0.00001), KPS scores (RR = 1.98, 95% CI: [1.45, 2.68], < 0.0001), and pain relief rate (RR = 1.34, 95% CI: [1.01, 1.78] =0.04 of the Cinobufacin combined with chemotherapy group were better than those of the chemotherapy group, and the difference was statistically significant. Our study also discovered that the tumor markers (CA125, CA153, and CEA) in the Cinobufacin combined with chemotherapy group were lower than those in the chemotherapy group, which heterogeneity was derived from the low-quality literature included in the study, but the results were robust. In addition, in terms of safety, we found that the incidences of gastrointestinal reactions (RR = 0.58, 95% CI: [0.48, 0.70], < 0.00001), liver and kidney damage (RR = 0.57, 95% CI: [0.38, 0.84], =0.004), and hair loss (RR = 0.61, 95% CI: [0.40, 0.92], =0.02) in the Cinobufacin combined chemotherapy group were lower than those in the chemotherapy group, and the difference was statistically significant, but the incidences of peripheral neurotoxicity (RR = 0.69, 95% CI: [0.26, 1.85], =0.46) and myelosuppression (RR = 0.78, 95% CI: [0.46, 1.34], =0.37) in the combined group were similar to those of the chemotherapy group, and the difference was not statistically significant.
CONCLUSIONS
Cinobufacin combined with chemotherapy can improve the clinical efficacy of breast cancer patients, enhance the quality of life of the patients, reduce the value of tumor markers such as CA125, CA153, and CEA, and lower the occurrence of adverse reactions such as gastrointestinal reactions, liver and kidney damage, and hair loss.
PubMed: 33014106
DOI: 10.1155/2020/4953539 -
Evidence-based Complementary and... 2020Aidi injection (ADI) is being used widely for breast cancer in China. However, the efficacy and safety of it need to be summarized. We conducted a systematic review and... (Review)
Review
BACKGROUND
Aidi injection (ADI) is being used widely for breast cancer in China. However, the efficacy and safety of it need to be summarized. We conducted a systematic review and meta-analysis to compare ADI and non-ADI treatment for advanced breast cancer.
METHODS
We searched PubMed, EMBASE, CNKI, SinoMed, and CENTRAL from inception to Jan 2020 for randomized controlled trials (RCTs) with diagnosis of advanced breast cancer that compared the efficacy of ADI with non-ADI treatment. Two researchers screened the literature, extracted data, and evaluated risk of bias separately. The primary outcomes were overall response rate (ORR) and disease control rate (DCR). The secondary outcomes included the QOL, immune cells, and adverse events. Review Manager software was used for estimating risks of bias of included studies, data analysis, and plotting. The sensitivity analysis and the publication bias test were performed using the language. and chi-square tests were used to estimate heterogeneity. If > 0.1 or < 40%, the fixed-effect model meta-analysis was performed. A random or fixed-effect analysis was used depending on the heterogeneity testing. Weighted mean difference (WMD) or standard mean difference (SMD) was used for analysis of continuous data, and the rate ratio (RR) was calculated for the dichotomous variable, respectively.
RESULTS
We included 14 studies with 1006 patients diagnosed as advanced breast cancer in total. The pooled effect showed that ADI increased ORR in advanced BC patients as an add-on therapy with little heterogeneity ( = 1.14, 95% CI 1.03-1.27). DCR in BC patients could not be improved by ADI. ADI improved the KPS score in BC patients compared with chemotherapy alone (MD = 3.26, 95% CI 1.74-4.78). There were no improvements on immune markers except CD4/CD8 and NK%. Serum tumor markers CEA and CA153 were decreased while treated with ADI, but only one trial was involved. ADI decreased the numbers of myelosuppression in advanced BC patients, and AST, ALT, -GT, and CK-MB were all decreased. The sensitivity evaluation indicated that the result of the pooled effect size had good stability.
CONCLUSION
This meta-analysis suggested that based on the existing evidence, treatment with ADI significantly changed the ORR of patients with advanced BC and improved their quality of life with few side effects. However, more randomized trials involving larger samples should be considered, and detailed mechanisms are needed to be uncovered.
PubMed: 32904623
DOI: 10.1155/2020/2871494 -
Bioscience Reports Aug 2020Huaier Granule, a type of traditional Chinese biomedical preparation (TCBP), is considered to be a promising adjuvant therapy for breast cancer. Although an analysis of... (Meta-Analysis)
Meta-Analysis
Huaier Granule, a type of traditional Chinese biomedical preparation (TCBP), is considered to be a promising adjuvant therapy for breast cancer. Although an analysis of the published literature has been performed, the exact effects and safety of Huaier Granule remains controversial. Therefore, a wide-ranging systematic search of electronic databases from which to draw conclusions was performed. Data from 27 trials, including 2562 patients with breast cancer were analyzed. The results indicated that, compared with conventional treatment alone, the combination of conventional treatment and Huaier Granule markedly improved patients' overall response (P=0.02) and quality of life (P<0.00001), and significantly prolonged 2-year (P=0.02), 3-year (P<0.0001) and 5-year (P=0.004) overall survival rates, and 1-year (P=0.003), 2-year (P<0.00001), 3-year (P<0.00001) and 5-year (P=0.03) disease-free survival. The immune function of patients was also significantly enhanced after combined intervention treatment, indicated by clearly increased percentages of CD3+ (P=0.05), CD4+ (P<0.00001) and natural killer cells (P<0.0001), and CD4+/CD8+ ratio (P<0.00001). The incidence of myelosuppression (P=0.001) and hepatotoxicity (P=0.05) was lower in breast cancer patients treated with Huaier Granule, whereas other adverse events did not differ significantly between the two groups (P>0.05). In summary, results of this meta-analysis suggest that the combination of conventional treatment and Huaier Granule is more effective for the treatment of breast cancer than conventional treatment alone.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Complex Mixtures; Controlled Clinical Trials as Topic; Female; Humans; Middle Aged; Time Factors; Trametes; Treatment Outcome
PubMed: 32789470
DOI: 10.1042/BSR20202509 -
Frontiers in Pharmacology 2020Patients with advanced cancer often undergo myelosuppression after receiving chemotherapy. However, severe myelosuppression results in treatment delay, and some can even...
Patients with advanced cancer often undergo myelosuppression after receiving chemotherapy. However, severe myelosuppression results in treatment delay, and some can even be life-threatening. At present, cancer patients undergoing chemotherapy urgently need effective intervention strategies to prevent myelosuppression. Fortunately, ginsenoside Rg3 has shown promise as an anti-myelosuppression agent. Therefore, this study was conducted to evaluate the effectiveness of ginsenoside Rg3 in preventing chemotherapy-induced myelosuppression in cancer patients. The PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Weipu (VIP), and Wanfang databases were searched in this study. A total of 18 trials which reported on 2,222 subjects were identified. All trials concerning the use of ginsenoside Rg3 for the prevention of chemotherapy-induced myelosuppression (the decline of leukocyte, hemoglobin, platelet, and neutrophil counts) were randomized-controlled trials. Dichotomous data were expressed as odds ratio (OR) with their respective 95% confidence intervals (CI). The Cochrane evidence-based medicine systematic evaluation was used to evaluate the methodological quality of the included trials. The Review Manager 5.3 and Stata 12.0 software were used to perform the statistical analyses. The trial sequential analysis (TSA) was used to evaluate information size and prevention benefits. The results revealed obvious ginsenoside Rg3-induced improvement in the leukocyte (OR, 0.46; 95% CI, 0.37-0.55), hemoglobin (OR, 0.64; 95% CI, 0.53-0.77), platelet (OR, 0.60; 95% CI, 0.48-0.75) and neutrophil (OR, 0.62; 95% CI, 0.43-0.90) counts at toxic grades I-IV, and leukocyte (OR, 0.39; 95% CI, 0.28-0.54) counts at toxic grades III-IV. The sensitivity analysis revealed that the results were robust. The Egger's test indicated that there was no publication bias in the results. Overall, this study suggested that ginsenoside Rg3 is beneficial for alleviating the chemotherapy-induced decrease in leukocyte, hemoglobin, platelet, and neutrophil counts. However, the confirmation of the ginsenoside Rg3 can be recommended for myelosuppression patients was limited due to poor methodological quality. Thus, more rigorously designed randomized-controlled trials (RCTs) are required to assess the efficacy of ginsenoside Rg3 for myelosuppression.
PubMed: 32477128
DOI: 10.3389/fphar.2020.00649 -
Medicine Apr 2020The digestive tract malignancies are a series of malignant tumor with high morbidity and mortality. Traditional Chinese medicine (TCM) combined with chemotherapy drugs... (Meta-Analysis)
Meta-Analysis
Kanglaite injection plus fluorouracil-based chemotherapy on the reduction of adverse effects and improvement of clinical effectiveness in patients with advanced malignant tumors of the digestive tract: A meta-analysis of 20 RCTs following the PRISMA guidelines.
BACKGROUND
The digestive tract malignancies are a series of malignant tumor with high morbidity and mortality. Traditional Chinese medicine (TCM) combined with chemotherapy drugs interventions have been applied for the treatment of malignant tumors in Asian countries for dacades. This study aimed to assess the effectiveness and safety on the combination of Kanglaite injection and fluorouracil-based chemotherapy for treating digestive tract malignancies.
PURPOSE
To assess the effectiveness and safety on the combination of Kanglaite injection and fluorouracil-based chemotherapy for digestive tract malignancies.
METHODS
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed when conducting the meta-analysis. Randomized controlled trials (RCTs) of Kanglaite injection combined with fluorouracil-based chemotherapy in the treatment of digestive tract malignant tumors were selected and assessed for inclusion. RevMan 5.3 software (Cochrane Collaboration, Oxford, UK) was used for meta-analysis. The objective response rate (ORR) was defined as the primary endpoint, and the disease control rate (DCR), quality of life (QoL), and toxicities were the secondary outcomes.
RESULTS
20 RCTs enrolling 1339 patients with advanced digestive tract malignancies were included. The methodological quality of most included trials was low to moderate. Compared with fluorouracil-based chemotherapy alone, Kanglaite injection plus fluorouracil-based chemotherapy can improve DCR (risk ratio (RR) = 1.18, 95% confidence interval (CI) 1.11-1.25, P < .00001), ORR (RR = 1.35, 95% CI 1.18-1.54, P < .00001), QoL (RR = 1.58, 95% CI 1.35-1.85, P < .00001), and can reduce adverse drug reactions (ADRs) such as myelosuppression (RR = 0.33, 95% CI 0.25-0.43, P < .00001), leukopenia (RR = 0.31, 95% CI 0.22-0.43, P < .00001), thrombocytopenia (RR = 0.6, 95% CI 0.38-0.49, P = .03), neutropenia (RR = 0.26, 95% CI 0.12-0.55, P = .0005), anemia (RR = 0.41, 95% CI 0.23-0.75, P = .004), gastrointestinal reaction (RR = 0.35, 95% CI 0.27-0.46, P < .00001), nausea/vomiting (RR = 0.41, 95% CI 0.28-0.61, P < .00001), diarrhea (RR = 0.34, 95% CI 0.18-0.62, P = .0004), hepatotoxicity (RR = 0.28, 95% CI 0.17-0.47, P < .00001), neurotoxicity (RR = 0.58, 95% CI 0.41-0.82, P = .002), mucositis (RR = 0.59, 95% CI 0.29-1.21, P = .15).
CONCLUSION
Kanglaite injection combined with fluorouracil-based chemotherapy could remarkably improve the clinical effectiveness and reduce the adverse effects in patients with advanced malignant tumors of the digestive tract which may provide evidence to judge whether TCM is an effective and safe intervention for the digestive tract malignancies.
Topics: Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Digestive System Neoplasms; Drugs, Chinese Herbal; Fluorouracil; Neoplasm Staging; Odds Ratio
PubMed: 32332600
DOI: 10.1097/MD.0000000000019480 -
Cancer Biology & Therapy Jul 2020Up to now, no proven effective medical therapy for surgery and radiation-refractory anaplastic meningioma (AM) exists. Patients with vascular endothelial growth factor...
UNLABELLED
Up to now, no proven effective medical therapy for surgery and radiation-refractory anaplastic meningioma (AM) exists. Patients with vascular endothelial growth factor receptor 2 (VEGFR-2) positive meningiomas showed significantly shorter progression-free survival. Apatinib is a small-molecule antiangiogenic agent that selectively inhibits VEGFR-2. We report three cases of recurrent AM (VEGFR-2 positive) treated with apatinib. After apatinib treatment, the best outcome for all three patients was the partial response. The Progression-free survival was 17.3 months, 10.3 months, and 14+ months, respectively. The third patient lost follow-up after the last review. The overall survival was 28.5 months and 18 months, respectively. The main adverse events were hypertension, hand-foot syndrome, and myelosuppression. Apatinib is active in recurrent AM patients and this is the first report in the world. It is promising to launch a Phase II clinical trial of apatinib to further evaluate its efficacy on AM.
BACKGROUND
Anaplastic meningioma (AM) are rare and aggressive tumors with high recurrence rates despite optimal surgical or medical management. Up to now, no proven effective medical therapy, surgery, or radiation-refractory for AM exist. The progression-free survival (PFS) of patients with vascular endothelial growth factor receptor 2 (VEGFR-2)-positive meningiomas was significantly low. Apatinib (YN968D1) is a small-molecule antiangiogenic agent that selectively inhibits VEGFR-2.
CASE #1
A 47-year-old Asian female patient with malignant meningioma underwent four operations and three radiotherapies. She was given a 500 mg apatinib daily oral treatment, and the dosage was halved to 250 mg 3 months into the treatment. According to the Response Assessment in Neuro-Oncology (RANO) evaluation criteria, the best outcome during treatment was the partial response (PR) 6 months after the treatment. The PFS was 17.3 months, whereas the overall survival (OS) was 28.5 months. The best change in the Karnofsky performance scale (KPS) was a 10-point increase. The main adverse events included anemia (grade II), thrombocytopenia (grade II), and proteinuria (grade I).
CASE #2
A 71-year-old Asian woman with AM underwent two operations and two gamma knife stereotactic radiotherapies. She was given a 500 mg apatinib daily oral treatment with a follow-up period of 18 months. apatinib was taken orally for 10 months. According to the RANO evaluation criteria, the best outcome during treatment was PR. The PFS was 10.3 months, whereas the OS was 18 months. The best change in KPS was a 20-point increase. The main adverse events included hypertension (grade II), hand-foot syndrome (grade II), and fecal ocular blood (grade II). Case #3: A 16-year-old Asian girl with AM underwent two operations and two radiotherapies. She was given a 250 mg apatinib daily oral treatment with a follow-up period of 16 months. Apatinib was taken orally for 8 months. The patient did not follow-up after the last review of the brain-enhanced magnetic resonance imaging. According to the RANO evaluation criteria, the best outcome during treatment was PR. The PFS was 14+ months, and the best change in KPS was a 10-point increase. The main adverse events included hypertension (grade I) and hand-foot syndrome (grade I).
CONCLUSION
Apatinib is actively used in treating patients with recurrent AM. A randomized trial and phase II clinical trial of this inhibitor should be performed to further evaluate its efficacy in treating malignant meningioma.
Topics: Adolescent; Aged; Antineoplastic Agents; Female; Humans; Meningioma; Middle Aged; Pyridines; Retrospective Studies
PubMed: 32212907
DOI: 10.1080/15384047.2020.1740053