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Thalidomide combined with chemo-radiotherapy for treating esophageal cancer: A randomized controlled study.

ABSTRACT: The aim of the present study was to investigate the efficiency and safety of a combination of thalidomide and chemo-radiotherapy (CRT) for treating esophageal cancer (EC). Eligible patients received two cycles of chemotherapy using paclitaxel liposome and cisplatin concurrently with three-dimensional radiotherapy. Following radiotherapy, two cycles of maintenance chemotherapy were performed. Patients with elevation of vascular endothelial growth factor (VEGF) during radiotherapy were randomly divided into: i) a test group (n=31), who received a combination of CRT and thalidomide; and ii) a control group (n=30), who received CRT only. Patients with locally advanced EC in the test group demonstrated a significantly improved 3-year overall survival (OS) rate, progression-free survival (PFS) rate, local control and median PFS time compared with the control group (P<0.05). Multivariate analysis indicated that Tumor-Node-Metastasis (TNM) stage was associated with the OS time, while TNM stage and the residence of cancer cells following radiotherapy were associated with PFS time. The present data indicate that thalidomide contributes to an improvement of prognosis for patients with locally advanced EC with elevated serum VEGF levels during radiotherapy. In addition, the toxicities induced by thalidomide were demonstrated to be tolerable.

SUBMITTER: Wang J

PROVIDER: S-EPMC6539441 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Thalidomide combined with chemo-radiotherapy for treating esophageal cancer: A randomized controlled study.

Wang Jian J Yu Jingping J Wang Jianlin J Ni Xinchu X Sun Zhiqiang Z Sun Wei W Sun Suping S Lu Yuting Y

Oncology letters 20190514 1

The aim of the present study was to investigate the efficiency and safety of a combination of thalidomide and chemo-radiotherapy (CRT) for treating esophageal cancer (EC). Eligible patients received two cycles of chemotherapy using paclitaxel liposome and cisplatin concurrently with three-dimensional radiotherapy. Following radiotherapy, two cycles of maintenance chemotherapy were performed. Patients with elevation of vascular endothelial growth factor (VEGF) during radiotherapy were randomly di ...[more]

PMID: 31289557

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Project description:Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery.The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program.This randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies.Trial registration:Netherlands Trial Registry NTR5045 Date of trial registration: January 19th, 2015 Date and version study protocol: February 2017, version 1.

Project description:BACKGROUND:It has been reported that radiation therapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk World Health Organization (WHO) grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide (TMZ) to treat these patients, although large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in high-risk patients with low-grade gliomas (LGGs). METHODS/DESIGN:This is a two-group, randomized controlled trial (RCT) enrolling patients who have LGGs (WHO grade 2) and are aged 40?years or older without regard to the extent of resection or are aged younger than 40?years old with subtotal resection or biopsy. An estimated 250 patients will be enrolled. Eligible participants will be randomly assigned to receive RT alone or RT plus TMZ chemotherapy in a 1:1 ratio. The same RT will be given to all eligible participants regardless of whether they are randomly assigned to the RT group or the chemoradiotherapy (CRT) group. While in the CRT group, patients will receive adjuvant TMZ with or without concurrent radiochemotherapy. The primary outcome of this trial is PFS, and it will be analyzed by the intention-to-treat approach. Secondary outcomes include OS, adverse events, and cognitive function. DISCUSSION:The objective of our research is to assess the effect of radiotherapy coupled with TMZ in high-risk patients with LGGs after surgery, compared with RT alone. Different histological types and molecular subtypes will be examined, and a corresponding subgroup analysis will be conducted. Our data can provide evidence for postoperative adjuvant therapy in patients with high-risk LGGs in China. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR1800015199. Registered on 13 March 2018.

Project description:Background: Locally advanced head and neck cancer is managed either by combined surgery and (chemo) radiotherapy or definitive (chemo) radiotherapy, which may deteriorate nutritional status. Previous data have shown that intensive nutritional intervention by a dietician reduces radiation-induced adverse events including weight loss. Objective: To determine if on-demand nutritional counseling (ODC, control group) would be as efficacious as intensive nutritional counseling (INC, experimental group) in patients undergoing (chemo) radiotherapy. Methods: Fifty-eight patients were randomly assigned to receive INC (n = 26) or ODC (n = 32). Outcome measures were nutritional status (PG-SGA), weight loss, handgrip strength (HGS), body composition, and survival. Results: Weight loss and impaired nutritional parameters during oncological treatment were seen equally in both groups (NS). Leaner patients at baseline maintained their weight, while overweight patients lost both weight and handgrip strength during treatment. Disease-free survival (DFS) (median = 43 months) was not affected by weight loss during treatment. Lower baseline HGS and malnutrition were associated with worse DFS (low vs. normal HGS: 15 vs. 42 months; p = 0.05 and malnutrition vs. good nutrition status: 17 vs. 42 months; p = 0.014, respectively). Survival according to low vs. normal HGS in the INC group was 4 vs. 44 months (p = 0.007) and in the ODC group 28 vs. 40 months (p = 0.944). According to malnutrition vs. good nutritional status in the INC group, DFS was 21 vs. 43 months (p = 0.025) and in the ODC group 15 vs. 41 months (p = 0.03). Conclusions: As for our primary endpoint, individualized on-demand nutritional counseling was as efficacious as intensive counseling in preventing deterioration of nutritional status and incidence of malnutrition during (chemo) radiotherapy. This should be verified with larger number of patients. Additional findings were that overweight patients had more severe weight loss, but not poorer survival. Low HGS and malnutrition at baseline were associated with poor survival. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02159508.

Project description:BackgroundImmunotherapy for GBM is an emerging field which is increasingly being investigated in combination with standard of care treatment options with variable reported success rates.ObjectiveTo perform a systematic review of the available data to evaluate the safety and efficacy of combining immunotherapy with standard of care chemo-radiotherapy following surgical resection for the treatment of newly diagnosed GBM.MethodsA literature search was performed for published clinical trials evaluating immunotherapy for GBM from January 1, 2000, to October 1, 2020, in PubMed and Cochrane using PICOS/PRISMA/MOOSE guidelines. Only clinical trials with two arms (combined therapy vs. control therapy) were included. Outcomes were then pooled using weighted random effects model for meta-analysis and compared using the Wald-type test. Primary outcomes included 1-year overall survival (OS) and progression-free survival (PFS), secondary outcomes included severe adverse events (SAE) grade 3 or higher.ResultsNine randomized phase II and/or III clinical trials were included in the analysis, totaling 1,239 patients. The meta-analysis revealed no statistically significant differences in group's 1-year OS [80.6% (95% CI: 68.6%-90.2%) vs. 72.6% (95% CI: 65.7%-78.9%), p = 0.15] or in 1-year PFS [37% (95% CI: 26.4%-48.2%) vs. 30.4% (95% CI: 25.4%-35.6%) p = 0.17] when the immunotherapy in combination with the standard of care group (combined therapy) was compared to the standard of care group alone (control). Severe adverse events grade 3 to 5 were more common in the immunotherapy and standard of care group than in the standard of care group (47.3%, 95% CI: 20.8-74.6%, vs 43.8%, 95% CI: 8.7-83.1, p = 0.81), but this effect also failed to reach statistical significance.ConclusionOur results suggests that immunotherapy can be safely combined with standard of care chemo-radiotherapy without significant increase in grade 3 to 5 SAE; however, there is no statistically significant increase in overall survival or progression free survival with the combination therapy.

Project description:BackgroundThe role of postoperative radiotherapy in pathological T2-3N0M0 esophageal squamous cell carcinoma is unknown. We aimed to evaluate the efficacy and safety of postoperative radiotherapy in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma.Materials and methodsPatients aged 18-72 years with pathological stage T2-3N0M0 esophageal squamous cell carcinoma after radical surgery and without neoadjuvant therapy were eligible. Patients were randomly assigned to surgery alone or to receive postoperative radiotherapy of 50.4 Gy in supraclavicular field and 56 Gy in mediastinal field in 28 fractions over 6 weeks. The primary endpoint was disease-free survival. The secondary endpoints were local-regional recurrence rate, overall survival, and radiation-related toxicities.ResultsFrom October 2012 to February 2018, 167 patients were enrolled in this study. We analyzed 157 patients whose follow-up time was more than 1 year or who had died. The median follow-up time was 45.6 months. The 3-year disease-free survival rates were 75.1% (95% confidence interval [CI] 65.9-85.5) in the postoperative radiotherapy group and 58.7% (95% CI 48.2-71.5) in the surgery group (hazard ratio 0.53, 95% CI 0.30-0.94, p = .030). Local-regional recurrence rate decreased significantly in the radiotherapy group (10.0% vs. 32.5% in the surgery group, p = .001). The overall survival and distant metastasis rates were not significantly different between two groups. Grade 3 toxicity rate related to radiotherapy was 12.5%.ConclusionPostoperative radiotherapy significantly increased disease-free survival and decreased local regional recurrence rate in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma with acceptable toxicities in this interim analysis. Further enrollment and follow-up are warranted to validate these findings in this ongoing trial.Implications for practiceThe value of adjuvant radiotherapy for patients with node-negative esophageal cancer is not clear. The interim results of this phase III study indicated that postoperative radiotherapy significantly improved disease-free survival and decreased local-regional recurrence rate in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma compared with surgery alone with acceptable toxicities. The distant metastasis rates and overall survival rates were not different between the two groups. Adjuvant radiotherapy should be considered for pathologic T2-3N0M0 thoracic esophageal squamous cell carcinoma. Prospective trials to identify high-risk subgroups are needed.

Dataset Information

Thalidomide combined with chemo-radiotherapy for treating esophageal cancer: A randomized controlled study.

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Thalidomide combined with chemo-radiotherapy for treating esophageal cancer: A randomized controlled study.

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