1.EGFR-TKI Combined with Pemetrexed versus EGFR-TKI Monotherapy in Advanced EGFR-mutated NSCLC: A Prospective, Randomized, Exploratory Study
Weiguang GU ; Hua ZHANG ; Yiyu LU ; Minjing LI ; Shuang YANG ; Jianmiao LIANG ; Zhijian YE ; Zhihua LI ; Minhong HE ; Xiaoliang SHI ; Fei WANG ; Dong YOU ; Weiquan GU ; Weineng FENG
Cancer Research and Treatment 2023;55(3):841-850
Purpose:
We aimed to evaluate whether the addition of pemetrexed is effective in improving progression-free survival (PFS) in epidermal growth factor receptor (EGFR)–mutated patients with or without concomitant alterations.
Materials and Methods:
This multicenter clinical trial was conducted in China from June 15, 2018, to May 31, 2019. A total of 92 non–small cell lung cancer (NSCLC) patients harboring EGFR-sensitive mutations were included and divided into concomitant and non-concomitant groups. Patients in each group were randomly treated with EGFR–tyrosine kinase inhibitor (TKI) monotherapy or EGFR-TKI combined with pemetrexed in a ratio of 1:1. PFS was recorded as the primary endpoint.
Results:
The overall median PFS of this cohort was 10.1 months. There were no significant differences in PFS between patients with and without concomitant and between patients received TKI monotherapy and TKI combined with pemetrexed (p=0.210 and p=0.085, respectively). Stratification analysis indicated that patients received TKI monotherapy had a significantly longer PFS in non-concomitant group than that in concomitant group (p=0.002). In concomitant group, patients received TKI combined with pemetrexed had a significantly longer PFS than patients received TKI monotherapy (p=0.013). Molecular dynamic analysis showed rapidly emerging EGFR T790M in patients received TKI monotherapy. EGFR mutation abundance decreased in patients received TKI combined chemotherapy, which supports better efficacy for a TKI combined chemotherapy as compared to TKI monotherapy. A good correlation between therapeutic efficacy and a change in circulating tumor DNA (ctDNA) status was found in 66% of patients, supporting the guiding role of ctDNA minimal residual disease (MRD) in NSCLC treatment.
Conclusion
EGFR-TKI monotherapy is applicable to EGFR-sensitive patients without concomitant alterations, while a TKI combined chemotherapy is applicable to EGFR-sensitive patients with concomitant alterations. CtDNA MRD may be a potential biomarker for predicting therapeutic efficacy.
2.Effect of enhanced recovery after surgery on the surgical treatment of patients with radiation enteritis and intestinal obstruction
Keying CUI ; Xiaochen QIU ; Jianfeng WENG ; Yingjie ZHAO ; Jianmiao HE
Clinical Medicine of China 2021;37(3):208-213
Objective:To investigate the effect of enhanced recovery after surgery (ERAS) on the surgical treatment of radiation enteritis with intestinal obstruction.Methods:A total of 80 patients with radiation enteritis and intestinal obstruction admitted to the Department of General Surgery, the Eighth Center of Chinese PLA General Hospital from June 2015 to December 2019 were selected and divided into observation group and control group according to the principle of baseline feature matching, with 40 cases in each group.Fourty cases in the control group received conventional surgical treatment combined with conventional rehabilitation intervention, while 40 cases in the observation group received conventional surgical treatment combined with ERAS intervention.According to hemoglobin (HGB), albumin (ALB), prealbumin (PA), transferrin (TRF), the nutritional status of patients in the two groups was compared before and after intervention.According to interleukin-2 (IL-2), interleukin-6 (IL-6), interleukin-8 (IL-8), hypersensitivity C-reactive protein (hs- CRP), tumor necrosis factor-α (TNF-α), the changes of inflammatory factors in the two groups was compared before and after intervention.The immunoglobulin (Ig) A, G and M of the two groups was compared before and after intervention.The postoperative recovery and the incidence of postoperative complications was observed in the two groups.Results:After the intervention, the level of HGB(125.56±11.18) g/L, ALB(42.46±3.95) g/L, PA(0.28±0.03) g/L and TRF(2.60±0.30) g/L in the observation group was higher than that in the control group (102.95±11.12), (36.28±4.25), (0.20±0.05), (2.09±0.27) g/L, respectively, and the differences between the two groups were significant (all P<0.001). After the intervention, the level of IL-2(3.69±0.79) ng/L, IL-6(15.79±7.17) ng/L, IL-8(6.24±1.25) ng/L, hs-CRP(12.51±2.34) ng/L, TNF-α(1.51±0.68) μg/L in the observation group was lower than that in the control group(7.26±1.23) ng/L, (23.82±6.95) ng/L, (9.13±1.71) ng/L, (17.63±2.27) ng/L, (2.02±0.81) μg/L, respectively, and the differences between the two groups were significant ( P<0.001, P<0.001, P<0.001, P<0.001, P=0.003). After the intervention, the level of IgA(1.92±0.63) g/L, IgG(11.36±1.26) g/L, IgM(2.01±0.57) g/L in the observation group was higher than that in the control group (1.62±0.49), (9.58±1.23), (1.60±0.47) g/L, respectively, and the differences between the two groups were significant ( P=0.020, <0.001, =0.001, respectively). In the observation group, the hospital stay(12.1±1.7) d, postoperative ambulation time (1.9±0.6) d and exhaust time (3.1±0.4) d was less than that in the control group(17.2±2.4) d, (2.8±1.0) d, (4.2±0.8) d, respectively, and there were significant differences between two groups(all P<0.001). The postoperative complication rate of 5.0%(2/40) in the observation group was significantly lower than 25.0%(10/40) in the control group (χ 2=6.275, P=0.012). Conclusion:The patients with radiation enteritis and intestinal obstruction treated by conventional surgery were given eras intervention, which improved the nutritional level, immune function and inflammatory stress reaction of the patients, improved the treatment effect of the patients, and shortened the hospitalization time.
3.Clinical effect of intestinal obstruction catheter on tuberculous peritonitis complicated with intestinal obstruction and its influence on inflammatory factors
Keying CUI ; Xiaochen QIU ; Jianfeng WENG ; Jianmiao HE
Clinical Medicine of China 2020;36(6):520-524
Objective:To explore the clinical effect of intestinal obstruction catheter in patients with tuberculous peritonitis complicated with intestinal obstruction and its influence on inflammatory factors.Methods:Sixty-two patients of tuberculous peritonitis with intestinal obstruction were admitted to the general surgery department of the Eighth Medical Center of Chinese PLA General Hospital from June 2015 to January 2020 in this prospective study.According to the method of digital table, cases were randomly divided into control group and treatment group, 31 cases in each group.The control group was given conventional treatment, while the treatment group was treated with intestinal obstruction catheter on the basis of conventional treatment.The clinical indexes such as abdominal pain relief time, antipyretic time, exhaust time, gas-liquid level disappearance time and hospitalization time were compared between the two groups.According to the levels of C-reactive protein(CRP), Interleukin-6(IL-6), Interleukin-8(IL-8) and Interferon-γ(IFN-γ), the inflammatory stress state of the two groups before and after treatment was compared.The changes of gastrin, motilin, vasoactine intrestinal peptide(VIP) were compared between the two groups before and after treatment.Results:The time to relieve abdominal pain(2.08±1.17) d, the time to reduce fever(3.36±1.89) d, the time to exhaust gas(2.12±1.45) d, the time to disappear gas-liquid level(2.58±1.61) d and the time to stay-in-hospital(9.22±2.13) d in the observation group, and those in the control group were (6.26±2.52), (5.68±2.44), (6.18±2.24), (7.34±2.23), (17.49±3.46) d, respectively.The difference between the two groups was statistically significant( P=0.013, 0.024, 0.035, 0.014 and 0.002, respectively). Before treatment, CRP, IL-6, IL-8, IFN-γ in the control group were (105.62±11.96) mg/L, (657.31±49.67) ng/L, IL-8 (463.53±31.74) ng/L and (47.24±9.66) ng/L , and (106.07±12.03) mg/L, (678.46±51.19) ng/L, (471.68±32.03) ng/L and (46.84±9.28) ng/L in the observation group respectively, and there were no significant differences between the two groups before treatment ( P>0.05). After treatment, CRP, IL-6, IL-8, IFN-γ were (86.25±9.16) mg/L, (373.25±24.18) ng/L, (211.26±20.83) ng/L and (35.42±7.52) ng/L in the control group, and (53.72±7.68) mg/L, (184.27±16.92) ng/L, (82.51±11.35) ng/L and (19.65±3.46) ng/L in the observation group, respectively.After treatment, there were significant differences in the indicators between the two groups ( P=0.021, 0.015, 0.029, 0.011, respectively). There was no difference in the levels of gastrin((180.89±21.17) vs(192.32±21.69) ng/L), motilin((336.73±7.23) vs(357.46±7.29) ng/L) and VIP((102.87±13.49) vs(109.31±13.53)pg/L) between the observation and control group before treatment( P>0.05, respectively). After treatment, the levels of gastrin(65.57±8.72) ng/L, motilin(135.71±14.38) ng/L and VIP(55.07±7.15) pg/L in the observation group were lower than those in the control group((110.35±13.86) ng/L, (231.93±21.95) ng/L, (81.56±10.59) pg/L, respectively), and the differences were statistically significant( P=0.013, 0.021 and 0.014, respectively). Conclusion:Intestinal obstruction catheter can effectively improve the clinical effect, reduce the inflammatory stress response, and promote the recovery of gastrointestinal function in patients with tuberculous peritonitis complicated with intestinal obstruction.
4.Clinical significance of serum ALP elevation in patients receiving chemotherapy after radical gastrectomy
Youjun WU ; Jianmiao HE ; Rong QIN ; Zhiyu CAO ; Bo YANG
Chinese Journal of General Surgery 2018;33(6):497-499
Objective To identify the influence of chemotherapy-induced serum alkaline phosphatase (ALP) elevation on the tumor-free survival (TFS) in patients of gastric carcinoma after radical gastrectomy.Methods The clinical data of 189 gastric carcinoma patients receiving radical surgery and postoperative adjuvant chemotherapy between Jan,2010 and Dec,2015 were reviewed and statistically analyzed.Results The TFS of patients with serum ALP elevation was obviously inferior than those without ALP elevation (x2 =5.717,P =0.017),serum ALP elevation was an independent risk factor influencing patients' TFS (HR =2.178,P =0.032),the degree of serum ALP elevation was associated with patients' TFS (x2 =4.627,P =0.031).Conclusion Serum ALP elevation during postoperative chemotherapy indicates the increases of recurrence or metastasis rate of gastric cancer patients after radical gastrectomy.
5.Clinical observation of breast conserving surgery in the treatment of 128 patients with breast cancer
Clinical Medicine of China 2017;33(8):718-721
Objective To analyze the clinical effect and treatment experience of breast conserving surgery.Methods The clinical data of one hundred and twenty-eight cases received breast conserving surgery in 309 Hospital of PLA from April 2006 to April 2011 was analyzed retrospectively.Results The follow-up rate was 95.3%(122/128) and the mean follow-up time was 54 months.The overall survival rate and disease-free survival rate at 5 years were 92.6% and 87.7% respectively.The local recurrence rate was 1.6%.Conclusion Breast conserving surgery is safe and effective for breast cancer treatment.Reasonable surgical indications,clean tumor margin and normative comprehensive treatment are critical for surgical effectiveness.
6.Perioperative risk factors for postoperative pancreatic fistula in patients with gastric cancer
Huazhou ZHAO ; Ting WANG ; Xinhui ZHANG ; Ruijun LIU ; Zhiyu CAO ; Bo YANG ; Jianmiao HE
Clinical Medicine of China 2016;32(10):924-928
Objective To explore perioperative risk factors for postoperative pancreatic fistu?la. Methods Six hundred and forty?three cases patients who underwent radical gastrectomy for gastric cancer from January 2010 to June 2015 in the NO. 309 Hospital of Chinese People’ s Liberation Army were selected and divided into Postoperative Pancreatic Fistula( POPF) group with 53 cases and Non?Postoperative Pancreatic Fis?tula( NPOPF) group with 590 cases. Preoperative,intraoperative and postoperative data were analyzed by statisti?cal analysis of two groups. Results POPF rate was 8. 24%(53/643). There were no significanct differences in terms of gender,age,preoperation with disease,preoperative serum albumin,TNM stage,abdominal surgery,sur?gical procedure,lymph node dissection,digestive tract reconstruction,surgical approach,blood loss and length of time between the POPF group and NPOP group(P>0. 05). The level of BMI of POPF group was higher than that of NPOPF group,the difference was statistically significant((25. 63±2. 54) kg/m2 vs. (21. 11±2. 44) kg/m2,t=2. 245,P=0. 025). The number of lymph node dissection in POPF group was (32. 25±5. 82),in NPOPF group was (27. 06±6. 79),there was significant difference between the two groups(t=2. 093,P=0. 037). The operation time in POPF group was (242. 50±52. 30) min,in NPOPF group was (229. 51±59. 21) min,the difference was statistically significant between the two groups( t=2. 398,P=0. 017) . The serum CRP of 1 d in POPF group was (85. 72±12. 05) mg/L,in NPOPF group was (76. 41±12. 52) mg/L,and there was significant difference between the two groups( t=1. 979,P=0. 048) . The serum albumin of 2?4 d after operation in POPF group was (26. 0±5. 9) g/L,in NPOPF group was (32. 6±6. 8) g/L,the difference between the two groups was statistically significant(t=-10. 185,P=0. 000). The drainage fluid amylase of 1 and 2 d after operation in POPF group was (2094+1444) U/L,in NPOPF group was (746+486) U/L,and there was significant difference be?tween the two groups( t=10. 400,P=0. 000) . Logistic regression analysis results showed that body mass index ( BMI) ,lymph node dissection number,time of operation,postoperative 1,2 d drainage fluid amylase and serum albumin of 2?4 d after operation were postoperative occurred pancreatic fistula risk factors( OR=1. 972,183. 6, 2. 004,0. 150,9. 809,P>0. 05). Conclusion BMI,number of dissected lymph node,duration of surgery,serum albumin of 2?4 d after operation and postoperative 1,2 d drainage fluid amylase have important clinical values for predicted POPF.
7.Rectal cancer surgery for male individuals' sexual and urinary function
Chinese Journal of Tissue Engineering Research 2005;9(14):200-201
BACKGROUND: The occurrence of sexual and urinary dysfunction is higher in patients who have received rectal cancer surgeries. This could most likely be correlated with the age of the patients and the approach applied in the operation. Therefore, how to preserve the sexual and urinary functions has become a hot point in this field.OBJECTIVE: This study was designed to investigate the influence of differences in age and therapeutical approach on the sexual and urinary function in patients with rectal cancer.DESIGN: Investigation study on patients.SETTING: General Surgery Department, the 309 Clinical Division, General Hospital of Chinese PLA.PARTICIPANTS: Some male patients with rectal cancer hospitalized in the General Surgery Department, the 309 Clinical Division, General Hospital of Chinese PLA were involved from January 1999 to October 2000. All of the 79eligible patients had received a radical surgery for rectal cancer by the time of study. Their sexual and urinary function before surgery were normal and an over-2-year follow-up after surgery was conducted on each of them. The two groups, which were classified into two groups according to surgical ap-proaches they received, contained comparable quantity of sampling and age distributions, which prompts the validity of the comparison.METHODS: By distributing follow-up letters, outpatient inquiries and phone call investigations; the follow-up was conducted to evaluate the sexual functions in these patients, including their penile erection and ejaculation. The erectile function was assessed according to the International Index of Erectile Function Questionnaire-5 (IIEF-5). The assessment on ejaculation was based on whether the patients had a sexual climax and whether they can ejaculate. The definition of urinary function consisted of both short-term and long-term urinary functions.MAIN OUTCOME MEASURES: The sexual desire, erectile function, ejaculation and the urinary function in patients within different age brackets.RESULTS: After Miles operation, 81% patients developed sexual dysfunction, 46% got short-term urinary dysfunction(19/41) and 5 % (2/41) had long-term urinary dysfunction. While after Dixon operation, 55% patients had sexual dysfunction, 29% (11/38) had short-term urinary dysfunction, and none of the patients had long-term urinary dysfunction. The difference between the outcomes of the two operations was significant( P < 0. 05) .Sexual dysfunction occurred at a rate of 38% in the less-than-40 age bracket, 60% in the 40-to-59 age bracket, and 96% in the over-60 age bracket. The overall differences between different pairs of age brackets were significantly ( P < 0. 05 ).CONCLUSION: There is a high rate of postoperative sexual and urinary dysfunction in male population. The age of patients and the approach adopted in the surgery are directly correlated with the rate of dysfunction. An autonomic nerve-preserving radical operation for rectal cancer can reduce the occurrence of sexual and urinary dysfunction effectively.
8.Super-selective pump-insertion into the target artery and regional intraarterial infusion chemotherapeutant and immunizator in treatment of the latter gastrointestinal cancer.
Yongdong PU ; Zhidong ZHU ; Jianmiao HE ; Bo YANG ; Liguo DONG ; Gang LIN ; Jun LIU
Chinese Journal of Surgery 2002;40(1):37-39
OBJECTIVETo evaluate the effect of operative selective pump-insertion into the tumorous target artery, postoperative regional infusion chemotherapeutant and immunizator for treatment the latter gastrointestinal cancer.
METHODSThe effect of operative super-selective pump-insertion into the tumorous nutritious artery, postoperative regional infusion chemotherapeutant and immunizator for treatment 88 cases patients suffering from irremovable gastrointestinal cancer was observed. Of them, 45 cases were gastric cancer, 31 cases were rectal cancer, 11cases were colic cancer.
RESULTSComplete response 2 case; Part response 77 cases, 11 cases patients had received secondary resection after intraarterial chemotherapy. Non chang 9 cases; effective rates reach to 89.8%. One, two and three years survival rates were 86.4%, 30.7% and 10.2%. Average survival period were 21.5 mouths.
CONCLUSIONSuper-selective pump-insertion into the artery and regional intraarterial chemotherapy is an efficient way in treatment of the latter gastrointestinal cancer, which can delay the survival period of patients with tumor, and increase the resectable rate.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Catheters, Indwelling ; Combined Modality Therapy ; Female ; Gastrointestinal Neoplasms ; mortality ; therapy ; Humans ; Immunotherapy ; Infusions, Intra-Arterial ; Male ; Middle Aged
9.Double-pump implantation chemotherapy for hepatic metastasis from colorectal cancer.
Jianmiao HE ; Yongdong PU ; Zhidong ZHU ; Zhiyu CAO ; Bo YANG ; Liguo DONG
Chinese Journal of Oncology 2002;24(2):167-169
OBJECTIVETo evaluate the value of infusion chemotherapy by pump implantation via hepatic artery or portal vein or both (double-pump chemotherapy, DPC) for hepatic metastasis from colorectal cancer.
METHODSThirty patients with hepatic metastasis from colorectal cancer were divided into three groups: 1. Group I-DPC (12 patients). 2. Group II-hepatic artery implantation chemotherapy (10 patients) and 3. Group III-portal vein implantation chemotherapy (8 patients).
RESULTSResponse rate was 66.7% in group I, 60% in group II and 37.5% in group III. The 0.5-, 1-, 2-year survival rates were 100.0%, 75.0%, 41.7% in group I, 90.0%, 60.0%, 30.0% in group II and 87.5%, 50.0%, 25.0% in group III.
CONCLUSIONDouble pump implantation chemotherapy is effective in treating hepatic metastasis from colorectal cancer. It is better than hepatic artery or portal vein pump-implantation chemotherapy alone.
Adult ; Aged ; Colorectal Neoplasms ; drug therapy ; pathology ; Drug Therapy ; methods ; Female ; Hepatic Artery ; Humans ; Infusion Pumps, Implantable ; Infusions, Intra-Arterial ; Infusions, Intravenous ; Liver Neoplasms ; drug therapy ; secondary ; Male ; Middle Aged ; Portal Vein ; Therapeutics
10.Diagnosis and treatment of postsurgical gastroparesis syndrome after radical operation of gastric carcinoma:report of 24 cases
Zhiyu CAO ; Yongdong PU ; Jianmiao HE
Medical Journal of Chinese People's Liberation Army 2001;0(12):-
Objective To explore the etiology,diagnosis and treatment of postsurgical gastroparesis syndrome(PGS)after radical gastrectomy for gastric carcinoma.Methods The data of 585 patients who had undergone radical gastrectomy for gastric carcinoma were retrospectively studied.The diagnosis was established with fiberoptic gastroscopy and biopsy before operation in all the patients,and radical subtotal gastrectomy was performed,with antero-colonic Billroth's Ⅱ anastomosis of the remnant stomach and jejunum.Results PGS occurred in 24 patients(age 46-81,mean 58.6 years)among 585 patients,the prevalence was 4.1%.In all the 24 patients,PGS occurred at the period when liquid diet was changed to semifluid diet,with the symptoms of epigastric fullness,nausea,vomiting and intractable hiccup.The vomitus contained large amount of gastric contents and a small amount of bile.The quantity of gastrointestinal decompression was 800-2000 ml/d.Upper gastrointestinal radiography using 38% meglucamine diatrizoate was performed in all the 24 patients,the contrast agent was taken orally or through gastric tube.It showed that the remnant stomach was atonic,gastric peristalsis was weak or absent,and evacuation of contrast agent was delayed.The anastomosis stoma was patent.Gastroscopy was performed in 18 patients,and a large amount of residual gastric content and anatomotic edema of anastomosis stoma were found.Howener,the gastroscope could be introenced into the duodenum or jejunal efferent loop through anastomotic stoma without difficulty,and no signs of mechanical obstruction were found.All the 18 patients were cured within10-38 days by conservative treatment.Conclusion The main causes of PGS may be the loss of gastrointestinal motility and anastomotic edema,while the risk factors may include old age,malnutrition,water-electrolyte imbalance,and peritoneal infection.Gastrointestinal radiography and gastroscopy are important diagnostic methods,and the patients can be cured by conservative treatment.

Result Analysis
Print
Save
E-mail