Patient-reported outcome and treatment outcome of Fruquintinib in treating Chinese metastatic colorectal cancer patients: a real world, prospective, multi-center, single-arm, observational study
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ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2716424 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Fruquintinib, also called HMPL-013, was first discovered by Hutchison Whampoa Pharmaceuticals Co. Ltd., Shanghai, China, and it is an oral vascular endothelial growth factor receptor (VEGFR) inhibitor. In clinical trials, fruquintinib has demonstrated a survival benefit in metastatic colorectal cancer (mCRC) patients. The purpose of this study was to retrospectively evaluate the efficacy and toxicity of fruquintinib in real-world patients. We collected data from patients with mCRC treated with oral fruquintinib from 2018 to 2020 in six different institutions. Patients with mCRC initially received 5 mg of oral fruquintinib daily for 3 weeks. Progression-free survival (PFS) was evaluated using the KaplanMeier method. The efficacy and safety of fruquintinib were also assessed. Seventy-five patients were involved in our study, and 29.3% of patients achieved stable disease (SD). Median PFS was 5.4 months (95% CI: 4.8415.959). The treatment-emergent adverse events (TEAEs) with fruquintinib were acceptable with grade 3 TEAEs of 6%. The grade 3 TEAEs were handfoot skin reaction (HFSR), fatigue, and stomatitis. The ECOG performance status was associated with PFS. In this real-world study, the clinical activity of fruquintinib was consistent with what has been reported in previous clinical trials. The level of safety was acceptable, and the side effects were manageable.
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Project description:This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients’ condition.
| 2342564 | ecrin-mdr-crc
Project description:ObjectiveThe objective of this study was to assess the comparative efficacy in third-line setting for metastatic CRC (mCRC) patients using matched population of FRESCO trial with fruquintinib and real-world data with other TKIs.Materials and methodsThe arm of fruquintinib from the FRESCO phase III trial (NCT02314819) included the data of patients with metastatic CRC that progressed after at least two lines of chemotherapy and received fruquintinib treatment. An external control arm was constructed using real-world data (RWD) of patients who received other TKIs based on key eligibility criteria of FRESCO. The baseline characteristics of two arms was balanced by propensity score matching (PSM). The Kaplan-Meier method and Cox proportional hazard model was used to evaluate progression free survival (PFS) and to estimate hazard ratios (HRs) and 95% confidence intervals (CIs), respectively.ResultsOverall, 128 patients were successfully matched by PSM in each, fruquintinib and other TKIs group. The patients in fruquintinib group showed significant increase in median PFS than other TKIs (3.71 vs. 2.49 months, HR = 0.67, 95%CI, 0.48-0.94, p = 0.019). In the subgroup analysis, fruquintinib showed a significant benefit in PFS compared with other TKIs among patients undergoing two or three previous chemotherapy regimens (HR 0.58, 95%CI 0.40-0.84; p=0.004), with rectum as primary disease site (HR 0.52, 95%CI 0.31-0.87; p=0.013), with left sided primary tumor location (HR 0.62, 95%CI 0.42-0.90; p=0.011), with multiple metastasis sites (HR 0.68, 95%CI 0.48-0.97; p=0.034) and with lung metastasis (HR 0.65, 95%CI 0.43-0.98; p=0.042).ConclusionWith the approach of establishing the external control arm from RWD, this study has demonstrated that treatment with fruquintinib significantly prolonged PFS as compared to other TKIs in patients as third-line mCRC treatment.
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Project description:Real-world data indicate disparities in biologic access across Europe. To describe the national structure of PsA care in Poland, with a particular focus on the population of inadequate responders (IRs) and difficulties associated with biologic therapy access. A pool of rheumatologic and dermatologic care centers was created based on National Health Fund contract lists (n = 841), from which 29 rheumatologic and 10 dermatologic centers were sampled randomly and successfully met the inclusion criterium. Additionally, 33 tertiary care centers were recruited. For successful center recruitment, one provider had to recruit at least one patient that met the criteria for one of the four pre-defined clinical subgroups, in which all patients had to have active PsA and IR status to at least 2 conventional synthetic disease-modifying drugs (csDMARDs). Self-assessment questionnaires were distributed among physicians and their patients. Barriers to biologic DMARD (bDMARD) treatment are complex and include stringency of reimbursement criteria, health care system, logistic/organizational, and personal choice factors. For patients who are currently bDMARD users, the median waiting time from the visit, at which the reimbursement procedure was initiated, to the first day of bDMARD admission was 9 weeks (range 2-212; 32% < 4 weeks, 29% 5-12 weeks, 26% 13-28 weeks, 13% with >28 weeks delay). Out of all inadequate responder groups, bDMARD users are the only group with "good" therapeutic situation and satisfaction with therapy. Patient satisfaction with therapy is not always concordant with physician assessment of therapeutic status. Despite the fact that over a decade has passed since the introduction of biologic agents, in medium welfare countries such as Poland, considerable healthcare system barriers to biologic access are present. Out of different IR populations, patient satisfaction with treatment is often discordant with physician assessment of disease status.
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Project description:Background and Objectives Differences in drug prescriptions exist between clinical trials and real-world practice. We evaluated the real-world treatment patterns of sacubitril/valsartan in Korean patients with heart failure (HF). Methods In this retrospective, multicenter cohort study, 600 patients with HF with reduced left-ventricular ejection fraction (LVEF <40%) with ≥1 sacubitril/valsartan prescription were identified by reviewing patient-level medical records at six academic tertiary hospitals in Korea between February 2017 and April 2019. Results At baseline, 59.2%, 28.3%, 4.8%, and 7.7% of the patients received low (50 mg bid), moderate (100 mg bid), target (200 mg bid), and unconventional dose of sacubitril/valsartan, respectively. Patients with low and moderate doses experienced either ‘no-titration’ (39.8%) or ‘stable up-titration’ (41.5%). At 12 months, 31.7%, 28.5%, 24.8%, and 15% received low, moderate, target doses, and unconventional dose, respectively. On follow-up, 31 (5.2%) patients discontinued sacubitril/valsartan. The time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP) level decreased from 879.6 to 406 pg/mL (ratio, 0.5; 95% confidence interval, 0.4–0.5). The mean LVEF increased by 10.4±12.2% from 27.2±5.8 to 36.3±11.1%, whereas LV end-diastolic volume index decreased by 18.7±26.1 mL/m2 from 114.5±37.7 mL/m2 to 98.9±42.3 mL/m2 at baseline and follow-up, respectively. Conclusions In real-world practice, 95% patients started with low and moderate doses of sacubitril/valsartan. Many patients experienced dose up-titration during follow-up; 30% reached the target dose. Cardiac reverse remodelling was reflected by a profound NT-proBNP level and LV size reduction, and LVEF increment. This study confirms the gap in treatment patterns between clinical trials and real-world practice.
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Project description:PurposeTo collect data on diagnosis, treatment, patient's management, and quality of life in patient with bilateral vocal fold paralysis (BVFP).MethodsA retrospective, observational, multicenter registry study was performed. Medical records of 326 adults with permanent BVFP (median age: 61 years; 70% female, 60% after thyroid surgery) generated between 2010 and 2017.ResultsMedian time between BVFP onset and inclusion was 1.2 years. Median post-treatment follow-up was 2 months (range: 0-42). Surgery was treatment of choice in 61.7% of the cases, with a 2-year revision rate of 32.4%. Prior to inclusion, 40.2% of the patients underwent at least one surgery. For tracheotomized patients, decannulation rate was 33.8%. Non-surgical treatments included voice therapy and botulinum toxin injection. Corticosteroid application was the most frequent treatment for post-treatment complications (18%; 1-month after surgery). Older age was an independent predictor for dyspnea (Hazard ratio [HR] = 1.041; CI = 1.005 to 1.079; p = 0.026) and the need for oxygen treatment (HR = 1.098; CI = 1.009 to 1.196; p = 0.031). Current alcohol consumption (HR = 2.565; CI = 1.232 to 5.342; p = 0.012) and a cancer-related etiology (HR = 4.767; CI = 1.615 to 14.067; p = 0.005) were independent factors of higher revision risk.ConclusionsSurgery for BVFP is currently not standardized but highly variable. Postoperative and BVFP-related complications and revision surgery are frequent. Complications are linked to patients' alcohol drinking habits and BVFP etiology. These results shall be confirmed by the upcoming evaluation of the prospective data of this registry.
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Project description:Differently from epidermal growth factor receptor (EGFR) 19Del and L858R mutations, the panoramic description of uncommon EGFR mutations is far from mature. Our understanding of its population characteristics, treatment response, and drug resistance mechanisms needs urgent expansion and deepening. Our study enrolled 437 patients with non-small-cell lung cancer from four clinical centers and who had uncommon EGFR mutations. The clinical characteristics of all patients and the treatment outcomes of 190 advanced patients who received pharmacotherapy were analyzed. Moreover, the acquired resistance mechanisms were explored based on 53 tissue or liquid re-biopsy data in 45 patients. Patients with EGFR 20ins had a shorter survival time compared with patients with non-20ins mutations. In total, 149 cases had received EGFR-tyrosine kinase inhibitors (TKI); afatinib was significantly superior to other EGFR-TKIs both in ORR and mPFS in all uncommon mutations and especially in the L861Q group. The most common acquired drug resistance mechanism was MET amplification, followed by EGFR T790M, which was significantly different from common EGFR mutations.
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Project description:An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
| 2251920 | ecrin-mdr-crc