Rare esophageal carcinoma-primary adenoid cystic carcinoma of the esophagus: A case report.

BACKGROUND: Esophageal adenoid cystic carcinoma (EACC) is an exceedingly rare malignant tumor of the esophagus, posing significant challenges in the clinic. CASE SUMMARY: This report detailed the case of a 72-year-old male whose diagnosis of EACC was confirmed through postoperative histopathological examination. The patient underwent thoracoscopy-assisted radical resection of the esophageal tumor, coupled with lymph node dissection. Pathological findings revealed an adenoid cystic carcinoma infiltrating the entire layer of the muscularis propria, locally extending into the outer membrane of the esophageal fiber, involving the cardia and exhibiting no lymph node metastasis. The patient's condition was classified as primary EACC, T3N0M0, per the American Joint Committee on Cancer (2017; 8th edition). One month after surgery, the patient received postoperative adjuvant radiation therapy. CONCLUSION: In addressing the rarity and high potential for biopsy misdiagnosis of EACC, this study delved into its diagnostic methods and treatment.

A randomized controlled trial for evaluating pain response in patients with spinal metastases following local versus whole vertebral radiotherapy: study protocol for phase II clinical trial.

BACKGROUND: Patients with bone metastasis often experience severe pain that is difficult to control and seriously affects quality of life. Radiotherapy is an effective way to relieve pain in these patients. Currently, there is no standard recommended range of radiotherapy targets for vertebral metastasis. The effect of radiotherapy on pain relief varies among patients, and some patients with metastases have serious side effects. METHODS: This study aims to verify whether reducing the radiotherapy range for vertebral metastases can achieve the same effect as whole vertebral radiotherapy while minimizing side effects. Sixty-six patients with pain caused by vertebral metastasis were randomly divided into two groups. The study group is receiving partial vertebrae body radiotherapy at the regions of abnormal signal, suspected invasion, and adjacent subclinical focus of vertebral metastasis, and the control group is receiving the same dose of radiotherapy on whole vertebrae body where metastasis occurred. After radiotherapy, along-term follow-up of patients will determine pain relief and side effects. DISCUSSION: The expected results of this study are that local irradiation of vertebral metastases can achieve a palliative effect of pain control not less than total vertebral irradiation with fewer side effects. TRIAL REGISTRATION: This study was registered in the Chinese Clinical Trial Registry (No: ChiCTR1900023401 ).

Anlotinib Combined with S-1 in Third- or Later-Line Stage IV Non-Small Cell Lung Cancer Treatment: A Phase II Clinical Trial.

LESSONS LEARNED: The combination of anlotinib and S-1 exhibited good antitumor activity in third- or later-line treatment for stage IV non-small cell lung cancer (NSCLC). Combination therapy of anlotinib with S-1 has manageable toxicities in patients with NSCLC. BACKGROUND: This study aimed to evaluate the efficacy and safety of anlotinib combined with S-1 as a third- or later-line treatment for patients with stage IV non-small cell lung cancer (NSCLC). Anlotinib was approved in 2018 by the Chinese Food and Drug Administration (FDA) as a third-line treatment for patients with refractory advanced NSCLC and is under study in the U.S. and Europe. METHODS: Simon's phase II clinical trial design with an α error of 5% and a power ß of 80% was used, anticipating a 10% objective response rate (ORR) of anlotinib and a 30% ORR of anlotinib combined with S-1; the required sample size was 29. A total of 29 patients were enrolled in the clinical trial. Patients were treated with anlotinib plus S-1 over a 21-day treatment course until disease progression or unacceptable toxic effects. If the efficacy was assessed as stable disease, partial response, or complete response after six cycles, anlotinib was maintained until disease progression or death. The primary endpoint was the objective response rate. Somatic mutations were not required for study enrollment. RESULTS: The median follow-up time was 11.1 months. Objective responses were observed in 11 of 29 (37.9%) patients making up the intention-to-treat population, which reached the target primary endpoint of 30% ORR. The median overall and progression-free survival were 16.7 and 5.8 months, respectively. The most common grade 3 adverse events (AEs) were gastrointestinal, including nausea, vomiting and diarrhea, fatigue, and hypertension. No grade 4 treatment-related AEs or treatment-related deaths occurred. CONCLUSION: The combination of anlotinib with S-1 in the third- or later-line treatment of stage IV NSCLC shows promising antitumor activity and manageable toxicity in patients with NSCLC; phase III trials will be planned in the future.

Prognostic impact of eosinophils in peripheral blood and tumor site in patients with esophageal squamous cell carcinoma treated with concurrent chemoradiotherapy.

ABSTRACT: To date, no effective biological markers have been identified for predicting the prognosis of esophageal cancer patients. Recent studies have shown that eosinophils are independent prognostic factors in some cancers. This study aimed to identify the prognostic impact of eosinophils in esophageal squamous cell carcinoma patients treated with concurrent chemoradiotherapy (CCRT).This study enrolled 136 patients who received CCRT for locally advanced unresectable esophageal squamous cell carcinoma (ESCC). We evaluated the survival time and clinical pathological characteristics of eosinophils. The Kaplan-Meier method was used to estimate survival data. The log-rank test was used for univariate analysis and the Cox proportional hazards regression model was used to conduct a multivariate analysis.Kaplan-Meier analysis revealed that high eosinophil infiltration correlated with better overall survival (OS) (P = .008) and better progression-free survival (PFS) (P = .015). The increase in absolute eosinophil count after CCRT also enhanced OS (P = .005) and PFS (P = .007). The PFS and OS in patients with high blood eosinophil count before CCRT (>2%) was better than those with low blood eosinophil count(<2%) (P = .006 and P = .001, respectively). Additionally, the multivariate analysis revealed that disease stage and high eosinophil infiltration, increased peripheral blood absolute eosinophil count after CCRT, and high peripheral blood eosinophil count before CCRT were independent prognostic indicators.High eosinophil count of tumor site, increased peripheral blood absolute eosinophil count after CCRT, and high peripheral blood eosinophil count before CCRT are favorable prognostic factors for patients with ESCC treated with CCRT.

Radical radiotherapy for metachronous oligometastasis after initial treatment of esophageal cancer.

BACKGROUND AND PURPOSE: This study aimed to evaluate the efficacy of radical radiotherapy and assess prognostic factors in metachronous oligometastatic esophageal cancer (MOEC) patients after initial treatment with curative-intent surgery and/or chemoradiotherapy. MATERIALS AND METHODS: MOEC Patients during 2009-2018 in Mianyang Central Hospital were retrospectively analyzed. Each patient had ≤5 oligometastatic lesions, and the primary lesions were controlled in this study. Patients were devided into radiotherapy (RT) and non-radiotherapy (NRT) groups. The study endpoints were overall survival (OS) and treatment toxicities. RESULTS: This study included 82 patients who underwent intensity-modulated radiotherapy for MOEC. Median OS were 14 (95% confidence interval [CI], 11.0-17.0) and 7 (95% CI, 4.5-9.5) months for the RT and NRT groups, respectively (P = 0.016). Median OS were 18 (95% CI, 13.6-22.4) and 10 (95% CI, 5.1-14.9) months for lung and bone metastases, respectively (P = 0.010). Median OS were 15 (95% CI, 12.4-17.6) and 10 (95% CI, 7.6-12.4) months for interval time from initial diagnosis to metastasis ≥12 and <12 months, respectively (P = 0.026). Median OS were 16 (95% CI, 12.2-19.8) and 10 (95% CI, 5.0-15.0) months for biological effective dose (BED10) ≥ 60 Gy and BED10 < 60 Gy, respectively (P = 0.033). Cox multivariate regression analysis showed that treatment modality (RT vs. NRT) was an independent prognostic factor for MOEC patients (hazard ratio: 1.8, 95% CI: 1.1-3.0; P = 0.022). No toxic side effects greater than grade 3 were observed in all patients. CONCLUSIONS: Radiotherapy is a feasible and positive treatment for MOEC patients after initial treatment, a radical radiation dose with BED10 ≥ 60 Gy has benefits in extending survival. Radical radiotherapy should thus be considered for MOEC patients.

Clinical Application of Oral Meglumine Diatrizoate Esophagogram in Screening for Esophageal Fistula During Radiotherapy or Chemoradiotherapy for Esophageal Cancer.

Background: This study aimed to investigate the specificity and sensitivity of oral meglumine diatrizoate esophagogram in screening for esophageal fistula during radiotherapy or chemoradiotherapy for esophageal cancer and determine if early detection and intervention could improve the prognosis of esophageal fistulas. Methods: Esophageal cancer patients undergoing radiotherapy or chemoradiotherapy were included. Weekly oral meglumine diatrizoate esophagograms were performed to screen for esophageal fistulas during radiotherapy. When an esophageal fistula was detected, fibroesophagoscopy and computed tomography (CT) were used for confirmation; once confirmed, radiotherapy was discontinued, and the patient received intervention. The esophagogram results were reviewed weekly to assess the recovery of the esophageal fistula. If the fistula was healed, the patient resumed and completed radiotherapy. Results: A total of 206 patients with cancer of the esophagus undergoing chemotherapy/radiotherapy were included. During radiotherapy, 10 cases of esophageal fistula were detected or suspected based on the oral meglumine diatrizoate esophagography findings, and eight of those cases were confirmed by CT and esophagoscopy. All patients with esophageal fistula received intervention; among them, 62.5% (5/8) recovered after 1 to 2 weeks of treatment and continued radiotherapy to completion. The sensitivity and specificity of oral meglumine diatrizoate esophagography in screening for esophageal fistulas during radiotherapy or chemoradiotherapy were 100 and 98.9%, respectively. The median survival period of patients with esophageal fistulas was 6.4 months. Conclusion: Oral meglumine diatrizoate esophagography has high sensitivity and specificity in screening for esophageal fistulas during radiotherapy or chemoradiotherapy with minimal side effects. Early diagnosis and timely intervention can significantly improve the prognosis and prolong the survival period of patients. Trial Registration: Chictr.org.cn, Identifier: ChiCTR-DDD-17012617. Registered on September 7, 2017. The first participant was enrolled on September 25, 2017. http://www.chictr.org.cn/showproj.aspx?proj=21526.

Anlotinib Combined with S-1 in the Third-Line Treatment of Stage IV Non-Small Cell Lung Cancer: Study Protocol for Phase II Clinical Trial.

BACKGROUND: A proportion of patients with stage IV non-small-cell lung cancer (NSCLC) is predicted to receive third-line treatment. However, currently no standard third-line treatment for NSCLC is available. Anlotinib is an oral, multi-targeted tyrosine kinase (TK) receptor inhibitor, which was approved as a third-line treatment for stage IV NSCLC in China on May 9, 2018. Nevertheless, The objective response rate of patients treated with anlotinib was merely 9.2% and the overall survival was only 3 months compared with the patients treated with placebo. Previous studies have shown that cancer treatment with a combination of chemotherapy with TK receptor inhibitors is effective and safe well tolerated. Therefore, the combination of anlotinib with other chemotherapeutic agents may be an effective treatment strategy for patients with stage IV NSCLC. Oral S-1 is a third-generation fluorouracil derivative; it showed good efficacy and caused relatively low toxicity in patients with NSCLC. METHODS: The purpose of this trial is to evaluate the efficacy and safety of anlotinib combined with S-1 as the third-line treatment for patients with stage IV NSCLC. This is a prospective, phase II clinical trial. We will enroll29 patients with stage IV NSCLC treated with anlotinib plus S-1. Tumors will be assessed using computed tomography prior to treatment, after two, four, and six cycles of treatment, and during follow-up every 3 months until disease progression or death. The primary endpoint is the objective response rate (ORR). The secondary endpoints are progression-free survival, duration of response, proportion of disease control, and safety. DISCUSSION: The expected outcome of this study is that anlotinib combined with S-1 has tolerable toxicity and better ORR than anlotinibmonotherapy. The results may indicate additional treatment options for patients with stage IV NSCLC.
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Sera total oxidant/antioxidant status in lung cancer patients.

We investigated oxidative stress parameters in the sera of patients with lung cancer and healthy individuals to evaluate their correlations with lung cancer.Ninety-four lung cancer patients and 64 healthy controls were enrolled after obtaining informed consent. Their sera oxidative stress parameters were measured.Total antioxidant status (TAS), total oxidant status (TOS), and oxidative stress index (OSI) were significantly different between patients and healthy groups (all P < .001). TAS gradually decreased and TOS and OSI gradually increased from stage I to III, but it did not reach statistical significance (all P > .05). TAS and OSI were significantly different between the nonsmoking and smoking groups, radiotherapy and without radiotherapy groups, chemotherapy and without chemotherapy groups (P < .05), but not TOS (P > .05). In a receiver operating characteristic curve analysis comparing patients with lung cancer with healthy controls, the Youden indices of TOS, TAS, and OSI were 0.541, 0.532, and 1, respectively.The oxidative stress may be correlation with lung cancer staging. Smoking, surgery, radiotherapy, and chemotherapy showed correlation with parts oxidative stress parameters.

Safety and efficacy of pulsed low-dose rate radiotherapy for local recurrent esophageal squamous cell carcinoma after radiotherapy: Study protocol for a prospective multi-center phase II trial.

INTRODUCTION: Re-irradiation after radiotherapy is a common treatment for locally recurrent esophageal cancer. However, the side effects of re-irradiation are serious. The most serious adverse reactions of re-irradiation include esophageal perforation and hemorrhage caused by esophageal perforation. Studies have shown that pulsed low-dose rate radiotherapy (PLDR) induces a hypersensitivity effect on tumor tissue and a hyper-repair effect on normal tissue, which can simultaneously reduce damage on the normal tissue and increase the therapeutic effect on the tumor. The objective of this study is to explore whether PLDR can reduce rate of esophageal perforation and improve efficacy in patients with recurrent esophageal squamous cell carcinoma (ESCC) after radiotherapy. METHODS AND ANALYSIS: This study is a prospective, multi-center, open, single-arm clinical trial designed to enroll 27 patients with locally recurrent ESCC after radiotherapy with or without chemotherapy. Re-irradiation will be performed using intensity modulated radiation therapy in 50 Gy/25 fractions. The strategy of PLDR includes dividing 2 Gy into 10 fractions, and administering each irradiating dose of 20 cGy at an interval of 3 minutes before the next low-dose irradiation. The actual dose rate of administration each time will be 16.67 cGy /minute. The primary endpoint in this study is the rate of esophageal perforation. The secondary endpoints are the objective remission rate, the palliative effect on quality of life and pain, and the time of disease progression. The observation time is 2 years after the end of the study. TRIAL REGISTRATION: Clinical trial number: ChiCTR1900020609.

Clinical application of oral meglumine diatrizoate esophagogram in screening esophageal fistula during radiotherapy for esophageal cancer.

INTRODUCTION: Esophageal fistula is a serious and common complication of radiotherapy for esophageal cancer. Therefore, early diagnosis and treatment is necessary. Because of side effect of barium esophagography, it cannot be used to screening esophageal fistula during radiotherapy. Meglumine diatrizoate is an ionic contrast agent, its adverse reactions were rarely seen when it was used in the body cavity. The purpose of this trial is identified the sensitivity and specificity of oral meglumine diatrizoate in an esophagogram for screening esophageal fistula during radiotherapy. METHODS/DESIGN: This trial was a prospective, multicenter, diagnostic clinical trial. A total of 105 patients with esophageal cancer will swallowed meglumine diatrizoate and underwent a radiographic examination weekly during radiotherapy, medical personnel observed the esophageal lesions to determine whether an esophageal fistula formed. If an esophageal fistula was observed, esophagofiberoscopy and/or computer tomography was used to further confirm the diagnosis. And the sensitivity and specificity of meglumine diatrizoate should be calculated for screening esophageal fistula during radiotherapy. DISCUSSION: To our knowledge, this study protocol is the first to identify the sensitivity and specificity of oral meglumine diatrizoate in an esophagogram for screening esophageal fistula during radiotherapy. If oral meglumine diatrizoate can be used to screening esophageal fistula, more patients will benefit from early detection and treatment.