Gastrointestinal(GI) cancers include esophageal [EC(International Classification of Disease 10^(th) revision: C15)], gastric [GC(C16)], and colorectal [CRC(C18-C21)] cancers. China is a high-incidence country of GI ca...Gastrointestinal(GI) cancers include esophageal [EC(International Classification of Disease 10^(th) revision: C15)], gastric [GC(C16)], and colorectal [CRC(C18-C21)] cancers. China is a high-incidence country of GI cancers.展开更多
Objective:This study evaluated the safety and efficacy of an anti-epidermal growth factor receptor(EGFR)antibody(SCT200)and an anti-programmed cell death 1(PD-1)antibody(SCT-I10A)as third-line or subsequent therapies ...Objective:This study evaluated the safety and efficacy of an anti-epidermal growth factor receptor(EGFR)antibody(SCT200)and an anti-programmed cell death 1(PD-1)antibody(SCT-I10A)as third-line or subsequent therapies in patients with rat sarcoma viral oncogene(RAS)/v-raf murine sarcoma viral oncogene homolog B(BRAF)wild-type(wt)metastatic colorectal cancer(mCRC).Methods:We conducted a multicenter,open-label,phase Ib clinical trial.Patients with histologically confirmed RAS/BRAF wt m CRC with more than two lines of treatment were enrolled and treated with SCT-I10A and SCT200.The primary endpoints were the objective response rate(ORR)and safety.The secondary endpoints included disease control rate(DCR),progression-free survival(PFS),and overall survival(OS).Results:Twenty-one patients were enrolled in the study through January 28,2023.The ORR was 28.57%and the DCR was 85.71%(18/21).The median PFS and OS were 4.14 and 12.84 months,respectively.The treatment-related adverse events(TRAEs)were tolerable.Moreover,compared with the monotherapy cohort from our previous phase I study evaluating SCT200 for RAS/BRAF wt m CRC in a third-line setting,no significant improvements in PFS and OS were observed in the combination group.Conclusions:SCT200 combined with SCT-I10A demonstrated promising efficacy in previously treated RAS/BRAF wt m CRC patients with an acceptable safety profile.Further head-to-head studies with larger sample sizes are needed to validate whether the efficacy and safety of combined anti-EGFR and anti-PD-1 therapy are superior to anti-EGFR monotherapy in the third-line setting.(Registration No.NCT04229537).展开更多
Cancers derived from the gastrointestinal(GI)tract are often treated with radical surgery to achieve a cure.However,recent advances in the management of GI cancers involve the use of a combination of neoadjuvant radia...Cancers derived from the gastrointestinal(GI)tract are often treated with radical surgery to achieve a cure.However,recent advances in the management of GI cancers involve the use of a combination of neoadjuvant radiation and chemotherapy followed by surgical intervention to achieve improved local control and cure.Interestingly,a small proportion of patients with highly sensitive tumors achieved a pathological complete response(pCR)(no residual tumor cells in the resected specimen)to neoadjuvant chemoradiation therapy(nCRT).The desire for organ preservation and avoidance of surgical morbidity brings the idea of a nonoperative management(NOM)strategy.Because of the different nature of tumor biology,GI cancers present diverse responses to nCRT,ranging from high sensitivity(anal cancer)to low sensitivity(gastric/esophageal cancer).There is an increasing attention to NOM of localized GI cancers;however,without the use of biomarkers/imaging parameters to select such patients,NOM will remain a challenge.Therefore,this review intends to summarize some of the recent updates from the aspect of current nCRT regimens,criteria for patient selection and active surveillance schedules.We also hope to review significant sequelae of radical surgery and the complications of nCRT to clarify the directions for optimization of nCRT and NOM for oncologic outcomes and quality of life.展开更多
Objective Radiation mucositis,especially pharyngeal mucositis,severely affects the oral intake of patients of head and neck cancer(HNC)during radiotherapy.Whether the nutritional status affects the severity of pharyng...Objective Radiation mucositis,especially pharyngeal mucositis,severely affects the oral intake of patients of head and neck cancer(HNC)during radiotherapy.Whether the nutritional status affects the severity of pharyngeal mucositis is currently unknown.This study investigated the incidence of malnutrition and radiation pharyngeal mucositis in patients with HNC during radiotherapy and analyzed the impact of the nutritional status on radiation pharyngeal mucositis.Methods Consecutive patients with HNC receiving radiotherapy were recruited for this longitudinal observational study.Data were collected at baseline(T_(1)),midtreatment(T_(2)),and at the end of treatment(T3).The Common Terminology Criteria for Adverse Events version 4.0 and the Global Leadership Initiative on Malnutrition criteria were used to assess pharyngeal mucositis and the nutritional status,respectively.Results There were 348 HNC patients who completed all assessments.The pharyngeal mucositis of patients with HNC was aggravated during radiotherapy(χ^(2)=553.521,P<0.001).At T3,56.0%of patients had moderate or severe pharyngeal mucositis.The proportion of patients with malnutrition increased significantly during treatment(21.3%at T_(1)vs 46.8%at T_(2)vs 76.1%at T3,χ^(2)=209.768,P<0.001).Both a multivariable analysis of generalized estimating equations and a logistic regression analysis showed that pharyngeal mucositis was associated with malnutrition.Conclusions Malnutrition was common in patients with HNC during radiotherapy,and it was closely related to pharyngeal mucositis.Joint interventions targeting nutrition and symptom management should be considered for patients with HNC.展开更多
基金supported by grants from the Clinical Need Oriented Basic Research Project of Inner Mongolia Academy of Medical Sciences (Grant No. 2023GLLH0132)Scientific Research Fund for the Demonstration Project of Public Hospital Reform and Quality Development (Gastrointestinal Tumor) that is approved by Peking University Cancer Hospital [Inner Mongolia Campus (Grant No. 2023SGGZ068)]the Beijing Hospitals Authority Youth Programme (Grant No. QML20211102)。
文摘Gastrointestinal(GI) cancers include esophageal [EC(International Classification of Disease 10^(th) revision: C15)], gastric [GC(C16)], and colorectal [CRC(C18-C21)] cancers. China is a high-incidence country of GI cancers.
基金funded by Tianjin Key Medical Discipline(Specialty)Construction Project(Grant No.TJYXZDXK-009A)National Natural Science Foundation of China(Grant No.82103677)National Science and Technology Major Projects of China(Grant No.2019ZX09732-001)。
文摘Objective:This study evaluated the safety and efficacy of an anti-epidermal growth factor receptor(EGFR)antibody(SCT200)and an anti-programmed cell death 1(PD-1)antibody(SCT-I10A)as third-line or subsequent therapies in patients with rat sarcoma viral oncogene(RAS)/v-raf murine sarcoma viral oncogene homolog B(BRAF)wild-type(wt)metastatic colorectal cancer(mCRC).Methods:We conducted a multicenter,open-label,phase Ib clinical trial.Patients with histologically confirmed RAS/BRAF wt m CRC with more than two lines of treatment were enrolled and treated with SCT-I10A and SCT200.The primary endpoints were the objective response rate(ORR)and safety.The secondary endpoints included disease control rate(DCR),progression-free survival(PFS),and overall survival(OS).Results:Twenty-one patients were enrolled in the study through January 28,2023.The ORR was 28.57%and the DCR was 85.71%(18/21).The median PFS and OS were 4.14 and 12.84 months,respectively.The treatment-related adverse events(TRAEs)were tolerable.Moreover,compared with the monotherapy cohort from our previous phase I study evaluating SCT200 for RAS/BRAF wt m CRC in a third-line setting,no significant improvements in PFS and OS were observed in the combination group.Conclusions:SCT200 combined with SCT-I10A demonstrated promising efficacy in previously treated RAS/BRAF wt m CRC patients with an acceptable safety profile.Further head-to-head studies with larger sample sizes are needed to validate whether the efficacy and safety of combined anti-EGFR and anti-PD-1 therapy are superior to anti-EGFR monotherapy in the third-line setting.(Registration No.NCT04229537).
基金National Natural Science Foundation(No.81773214)Beijing Municipal Administration of Hospital Medicine Development of Special Funding Support(No.ZYLX202116)+2 种基金Beijing Municipal Administration of Hospitals Incubating Program(No.PZ2020027)Beijing Talent Incubating Funding(No.2019-4)Science Foundation of Peking University Cancer Hospital(No.2023-10)。
文摘Cancers derived from the gastrointestinal(GI)tract are often treated with radical surgery to achieve a cure.However,recent advances in the management of GI cancers involve the use of a combination of neoadjuvant radiation and chemotherapy followed by surgical intervention to achieve improved local control and cure.Interestingly,a small proportion of patients with highly sensitive tumors achieved a pathological complete response(pCR)(no residual tumor cells in the resected specimen)to neoadjuvant chemoradiation therapy(nCRT).The desire for organ preservation and avoidance of surgical morbidity brings the idea of a nonoperative management(NOM)strategy.Because of the different nature of tumor biology,GI cancers present diverse responses to nCRT,ranging from high sensitivity(anal cancer)to low sensitivity(gastric/esophageal cancer).There is an increasing attention to NOM of localized GI cancers;however,without the use of biomarkers/imaging parameters to select such patients,NOM will remain a challenge.Therefore,this review intends to summarize some of the recent updates from the aspect of current nCRT regimens,criteria for patient selection and active surveillance schedules.We also hope to review significant sequelae of radical surgery and the complications of nCRT to clarify the directions for optimization of nCRT and NOM for oncologic outcomes and quality of life.
基金This research was supported by the National Key Research and Development Project of China(No.2017YFC1309204)the Medical Nutrition Clinical Research Project of China International Medical Foundation(No.Z-2017-24-2110).
文摘Objective Radiation mucositis,especially pharyngeal mucositis,severely affects the oral intake of patients of head and neck cancer(HNC)during radiotherapy.Whether the nutritional status affects the severity of pharyngeal mucositis is currently unknown.This study investigated the incidence of malnutrition and radiation pharyngeal mucositis in patients with HNC during radiotherapy and analyzed the impact of the nutritional status on radiation pharyngeal mucositis.Methods Consecutive patients with HNC receiving radiotherapy were recruited for this longitudinal observational study.Data were collected at baseline(T_(1)),midtreatment(T_(2)),and at the end of treatment(T3).The Common Terminology Criteria for Adverse Events version 4.0 and the Global Leadership Initiative on Malnutrition criteria were used to assess pharyngeal mucositis and the nutritional status,respectively.Results There were 348 HNC patients who completed all assessments.The pharyngeal mucositis of patients with HNC was aggravated during radiotherapy(χ^(2)=553.521,P<0.001).At T3,56.0%of patients had moderate or severe pharyngeal mucositis.The proportion of patients with malnutrition increased significantly during treatment(21.3%at T_(1)vs 46.8%at T_(2)vs 76.1%at T3,χ^(2)=209.768,P<0.001).Both a multivariable analysis of generalized estimating equations and a logistic regression analysis showed that pharyngeal mucositis was associated with malnutrition.Conclusions Malnutrition was common in patients with HNC during radiotherapy,and it was closely related to pharyngeal mucositis.Joint interventions targeting nutrition and symptom management should be considered for patients with HNC.
