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Network Meta-Analysis of Chinese Herbal Injections Plus the FOLFOX Regimen for the Treatment of Colorectal Cancer in China.
Zhang, D, Wu, J, Duan, X, Wang, K, Ni, M, Liu, S, Zhang, X, Zhang, B, Zhao, Y
Integrative cancer therapies. 2019;:1534735419827098
Abstract
OBJECTIVE The aim of the present network meta-analysis (NMA) was to explore the comparative effectiveness and safety of different Chinese herbal injections (CHIs) combined with the FOLFOX regimen versus FOLFOX alone for colorectal cancer (CRC). METHODS A comprehensive search for randomized controlled trials (RCTs) was performed with regard to different CHIs for treating CRC in several electronic databases up to July 2016. The quality assessment of the included RCTs was conducted according to the Cochrane risk of bias tool. Standard pair-wise and Bayesian NMA were designed to compare the effectiveness and safety of different CHIs combined with the FOLFOX regimen by utilizing WinBUGS 1.4.3 and Stata 13.1 software, simultaneously. RESULTS Initially, a total of 820 citations were retrieved through comprehensive searching, and 60 eligible articles involving 4849 participants and 14 CHIs were ultimately included. The results of the current evidence indicated that the FOLFOX regimen combined with Delisheng, Kanglaite, Shenqifuzheng, or Aidi injections were associated with the most favorable clinical efficacy compared with the FOLFOX regimen alone. Additionally, the FOLFOX regimen combined with Delisheng, Xiaoaiping, Lentinan, Kangai, Shenqifuzheng, or Aidi injections improved performance status among patients with CRC. CONCLUSIONS The results of cluster analysis demonstrated that the combination of Compound matrine injection and FOLFOX regimen was associated with more preferable and beneficial outcomes than other CHIs groups. Nevertheless, the additional results from multicenter trials and high-quality studies will be pivotal for supporting our findings.
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Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial.
Hao, W, Liu, S, Qin, Y, Sun, C, Chen, L, Wu, C, Bao, Y
Trials. 2017;(1):386
Abstract
BACKGROUND Anthracyclines, alone or in combination with other drugs, are among the most effective chemotherapeutic agents to treat breast cancer both in the adjuvant and neoadjuvant setting. Unfortunately, anthracycline-associated dose-dependent cardiotoxicity is a limiting factor in clinical use. Extensive efforts have been devoted to identifying strategies to prevent anthracycline-induced cardiotoxicity. However, most cardioprotective agents have shown little effect in clinical trials. Herbal medicines are pure, natural substances that have been used for centuries in many countries, including China. This trial aims to evaluate the cardioprotective effects and safety of Platycodon grandiflorum granules compared to placebo granules in patients with early breast cancer receiving anthracycline-based chemotherapy. METHOD/DESIGN This study is a single-center, double-blinded, randomized, placebo-controlled, parallel-group trial. A total of 120 patients will be randomly allocated in a 1:1 ratio to receive either P. grandiflorum granules or placebo granules twice daily for 12 weeks. The primary outcome is heart failure (either clinical or subclinical). The secondary outcomes include all-cause mortality, cardiac death, electrocardiogram (ECG) findings, left ventricular diastolic function, longitudinal systolic strain and velocities measured by tissue Doppler imaging, cardiac biomarkers, such as troponin I (TnI), brain natriuretic peptide (BNP), and creatine kinase isoenzymes (CK-MB). Assessments will be performed at baseline (before randomization) and 3, 6, 9, 12, 16, and 20 weeks after randomization. DISCUSSION This will be the first clinical trial to evaluate the cardioprotective effects and safety of P. grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy. We are also performing this trial to assess the feasibility of a larger-scale clinical trial in the future. TRAIL REGISTRATION Chinese Clinical Trial Registry, ChiCTR-IPR-16009256 . Registered on 23 September 2016.
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Clinical outcomes and biomarker profiles of elderly pretreated NSCLC patients from the BATTLE trial.
Tsao, AS, Liu, S, Lee, JJ, Alden, C, Blumenschein, G, Herbst, R, Davis, SE, Kim, E, Lippman, S, Stewart, D, et al
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2012;(11):1645-52
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Abstract
BACKGROUND Treating elderly non-small-cell lung cancer (NSCLC) patients in the salvage setting is challenging because of concerns of intolerance to therapy. Here we report outcomes (survival and toxicity) of elderly patients on the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial. METHODS Two hundred and fifty-five chemorefractory NSCLC patients received tumor molecular analysis, and were randomized to erlotinib, erlotinib-bexarotene, vandetanib, or sorafenib. Retrospective subgroup analyses were conducted comparing outcomes among age groups (< 65 versus ≥ 65 years; < 70 versus ≥ 70 years; < 75 versus ≥ 75 years), treatments, and sex. RESULTS Median age was 62 years (range, 26-84); 38% were aged 65 years or more. No significant differences among age groups were seen in rates of biopsy-related pneumothorax, treatment-related death, compliance, grade 3 to 4 hematologic toxicities, response rate, nor overall survival. However, older women aged 65 years or more had more grade 3 to 4 nonhematologic toxicities (p = 0.05). Elderly men aged 65 years or more (p = 0.008) had a higher disease-control rate at 8 weeks and a better progression-free survival (PFS) (p = 0.0068). Elderly women aged 70 years or more had a trend toward higher 8-week disease-control rate (p = 0.06). Older men aged 65 years or more treated with vandetanib had a better median PFS (p = 0.03) whereas PFS of older women aged 70 years or more was worse (p = 0.03) compared with younger patients. Elderly men aged 70 years or more treated with sorafenib had a higher overall survival compared with younger men (p = 0.04). Tumor tissue biomarkers show distinct differences by sex and age. CONCLUSION Fit elderly NSCLC patients should be considered for salvage targeted therapy. In this subset of patients, older men seem to have significant clinical benefit from certain agents. Tumor biomarker analysis demonstrates sex and age variations, and is hypothesis-generating.
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Thalidomide improves prevention of chemotherapy-induced gastrointestinal side effects following a modified FOLFOX7 regimen: results of a prospective randomized crossover study.
Liu, Y, Zhang, J, Teng, Y, Zhang, L, Yu, P, Jin, B, Zhao, M, Shi, J, Liu, S, Song, N, et al
Tumori. 2009;(6):691-6
Abstract
AIMS AND BACKGROUND Thalidomide was firstly evaluated for the control of chemotherapy-induced gastrointestinal side effects following a modified FOLFOX7 (mFOLFOX7) regimen. METHODS AND STUDY DESIGN Chemotherapy-naive patients with malignant tumors were randomized into two groups: A-B group (A, 0.3 mg of ramosetron plus 10 mg of dexamethasone on day 1, was given intravenously in the first cycle, and B, 0.3 mg of ramosetron plus 10 mg of dexamethasone on day 1 intravenously plus 150 mg orally twice daily of thalidomide on days 2 through 5, in the second cycle) and B-A group (those drugs were given in the reverse sequence). The primary end point was the efficacy of thalidomide in controlling delayed (days 2 through 5) chemotherapy-induced nausea and vomiting (CINV). The secondary end point was the safety of thalidomide. RESULTS Of 52 patients enrolled, 50 patients (96%) were assessable. Complete response rates of delayed nausea (no nausea) were higher with group B than group A (52% vs 24%, P = 0.004 on day 2; 58% vs 24%, P = 0.001 on day 3; and 60% vs 36%, P = 0.016 on day 4). Complete response rates of delayed emesis (no emetic episodes, no rescue therapy) for group B and A also showed significance (86% vs 66%, P = 0.019 on day 2 and 76% vs 56%, P = 0.035 on day 3). Complete response rates on anorexia for group B were higher than those for group A on days 2 through 5. More patients in group B reported sedation or dizziness than in group A (42% vs 9.6%; P = 0.000). CONCLUSIONS Thalidomide improves prevention of chemotherapy-induced gastrointestinal side effects following the mFOLFOX7 regimen. It is a safe, effective antiemetic.