[Prognosis and Related Factors of Patients with Pathological Complete Response after Neoadjuvant Therapy for Gastric Cancer].

Objective To investigate the related factors of pathological complete response(pCR)of patients with gastric cancer treated by neoadjuvant therapy and resection,and to analyze the risk factors of prognosis. Methods The clinical and pathological data of 490 patients with gastric cancer who received neoadjuvant therapy followed by radical gastrectomy from January to December in 2008 were retrospectively analyzed.Univariate and multivariate analyses were performed to identify the risk factors affecting pCR and prognosis. Results Among the 490 patients,41 achieved pCR,and the overall pCR rate was 8.3%(41/490).The pCR rate was 16.0% in the neoadjuvant chemoradiation group and 6.4% in the neoadjuvant chemotherapy group.The results of multivariate analysis showed that neoadjuvant chemoradiation(OR=4.401,95% CI=2.023-9.574,P<0.001)and preoperative therapeutic response as partial response(OR=40.492,95% CI=5.366-305.572,P<0.001)were independent predictors of pCR after neoadjuvant therapy.Multivariate analysis of prognosis showed that poorly differentiated tumor(HR=1.809,95% CI=1.104-2.964,P=0.019),gastric cardia-fundus-body tumor(HR=2.025,95% CI=1.497-2.739,P<0.001),≤15 intraoperative dissected lymph nodes(HR=1.482,95% CI=1.059-2.073,P=0.022),and postoperative complications(HR=1.625,95% CI=1.156-2.285,P=0.005)were independent risk factors for prognosis,while pCR(HR=0.153,95% CI=0.048-0.484,P=0.001)and postoperative adjuvant chemotherapy(HR=0.589,95% CI=0.421-0.823,P<0.001)were independent protective factors of prognosis. Conclusions Patients who achieved pCR after neoadjuvant therapy for locally advanced gastric cancer might have promising long-term survival,and pCR is an independent predictor for overall survival.Compared with chemotherapy alone,preoperative chemoradiotherapy can significantly improve the pCR rate of patients with locally advanced gastric cancer.

Preoperative prognostic nutritional index predicts long-term outcomes of patients with ampullary adenocarcinoma after curative pancreatoduodenectomy.

BACKGROUND: The prognostic nutritional index (PNI), a marker of immune-nutrition balance, has predictive value for the survival and prognosis of patients with various cancers. AIM: To explore the clinical significance of the preoperative PNI on the prognosis of ampullary adenocarcinoma (AC) patients who underwent curative pancreaticoduodenectomy. METHODS: The data concerning 233 patients diagnosed with ACs were extracted and analyzed at our institution from January 1998 to December 2020. All patients were categorized into low and high PNI groups based on the cutoff value determined by receiver operating characteristic curve analysis. We compared disease-free survival (DFS) and overall survival (OS) between these groups and assessed prognostic factors through univariate and multivariate analyses. RESULTS: The optimal cutoff value for the PNI was established at 45.3. Patients with a PNI ≥ 45.3 were categorized into the PNI-high group, while those with a PNI < 45.3 were assigned to the PNI-low group. Patients within the PNI-low group tended to be of advanced age and exhibited higher levels of aspartate transaminase and total bilirubin and a lower creatinine level than were those in the PNI-high group. The 5-year OS rates for patients with a PNI ≥ 45.3 and a PNI < 45.3 were 61.8% and 43.4%, respectively, while the 5-year DFS rates were 53.5% and 38.3%, respectively. Patients in the PNI- low group had shorter OS (P = 0.006) and DFS (P = 0.012). In addition, multivariate analysis revealed that the PNI, pathological T stage and pathological N stage were found to be independent prognostic factors for both OS and DFS. CONCLUSION: The PNI is a straightforward and valuable marker for predicting long-term survival after pancreatoduodenectomy. The PNI should be incorporated into the standard assessment of patients with AC.

Perioperative chemotherapy improves survival of patients with locally advanced diffuse gastric cancer.

BACKGROUND: Whether patients with diffuse gastric cancer, which is insensitive to chemotherapy, can benefit from neoadjuvant or adjuvant chemotherapy has long been controversial. AIM: To investigate whether perioperative chemotherapy can improve survival of patients with locally advanced diffuse gastric cancer. METHODS: A total of 2684 patients with locally advanced diffuse gastric cancer from 18 population-based cancer registries in the United States were analyzed. RESULTS: Compared with surgery alone, perioperative chemotherapy improved the prognosis of patients with locally advanced gastric cancer. Before stabilized inverse probability of treatment weighting (IPTW), the median overall survival (OS) times were 40.0 months and 13.0 months (P < 0.001), respectively. After IPTW, the median OS times were 33.0 months and 17.0 months (P < 0.001), respectively. Neoadjuvant chemotherapy did not improve the prognosis of patients with locally advanced gastric cancer compared with adjuvant chemotherapy after IPTW. After IPTW, the median OS times were 38.0 months in the neoadjuvant chemotherapy group and 42.0 months in the adjuvant chemotherapy group (P = 0.472). CONCLUSION: Patients with diffuse gastric cancer can benefit from perioperative chemotherapy. There was no significant difference in survival between patients who received neoadjuvant chemotherapy and those who received adjuvant chemotherapy.

A prospective phase II clinical trial of total neoadjuvant therapy for locally advanced gastric cancer and gastroesophageal junction adenocarcinoma.

To investigate the safety and efficacy of the neoadjuvant chemoradiotherapy (NCRT) followed by neoadjuvant consolidation chemotherapy (NCCT) and surgery for locally advanced gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma. Patients diagnosed as locally advanced GC or Siewert II/III GEJ adenocarcinoma with clinical stage T3-4 and/or N positive were prospectively enrolled. Patients underwent NCRT (45 Gy/25 fractions) with concurrent S-1, followed by NCCT (4 to 6 cycles of the SOX regimen) 2 to 4 weeks after NCRT. Gastric cancer radical resection with D2 lymph node dissection was performed 4 to 6 weeks after the total neoadjuvant therapy. The study was conducted from November 2019 to January 2023, enrolling a total of 46 patients. During the NCRT, all patients completed the treatment without dose reduction or delay. During the NCCT, 32 patients (69.6%) completed at least 4 cycles of chemotherapy. Grade 3 or higher adverse events in NCRT (5 cases) were non-hematological. During the course of NCCT, a notable occurrence of hematological toxicities was observed, with grade 3 or higher leukopenia (9.7%) and thrombocytopenia (12.2%) being experienced. A total of 28 patients (60.9%) underwent surgery, achieving R0 resection in all cases. A significant proportion of cases (71.4%) exhibited pathological downstaging to ypT0-2, while 10 patients (35.7%) demonstrated a pathologic complete response (pCR). The total neoadjuvant therapy comprising NCRT followed by NCCT and surgery demonstrates a low severe adverse reactions and promising efficacy, which could be considered as a viable treatment for locally advanced GC or GEJ adenocarcinoma.Trial registration: Clinicaltrials.gov (registration number: NCT04062058); the full date of first trial registration was 20/08/2019.

[Clinical analysis of 17 cases of gastric small cell carcinoma].

OBJECTIVE: To analyze the clinical data and prognosis of gastric small cell carcinoma (GSCC), summarize recent progress in diagnosis and therapy of this disease reported in the literature, and to provide the theoretical basis for its appropriate treatment. METHODS: Clinicopathological data of 17 patients with pathologically confirmed GSCC, treated in our hospital between 1999 to 2012, were retrospectively reviewed. RESULTS: There were 16 males and 1 female, ranged from 46 to 75 years (mean 64.6 years). The tumor was located in the gastric cardia in 13 cases, three in the gastric fundus, and one in the gastric body. All the 17 patients received surgery and 10 of them received postoperative adjuvant chemotherapy, one received preoperative adjuvant chemotherapy. Thirteen patients were followed up. Among them, two 1ived for 40 months all along, the other 3 cases died of recurrence and extensive metastasis in 6 month after operation. The median survival was 13.0 months. The median survival of the patients with and without lymph node metastasis were 42 months and 13 months, respectively. The median survival time of stage II and III patients were 24 months and 14 months, respectively. CONCLUSIONS: It is difficult to make a definite diagnosis before or during the operation for GSCC. Radical operation could be done according to other gastric cancers and lymph node dissection could be simplified. Postoperative chemotherapy with the same scheme as lung small cell carcinoma may help to improve the outcome and prolong the survival of the patients.

[Clinicopathological characteristics and prognostic factors of 27 patients with rectal gastrointestinal stromal tumors].

OBJECTIVE: To explore the clinicopathological characteristics of rectal gastrointestinal stromal tumors (GISTs) and elucidate their associated prognostic factors. METHODS: The clinicopathological data were collected for 27 patients with rectal gastrointestinal stromal tumors at our hospital from January 2000 to December 2011. Univariate analyses were performed to evaluate the prognostic factors. RESULTS: Changed habit of discharge and hematochezia were the most common symptoms. Most GISTs were localized in lower rectum. The 1, 3 and 5-year progression-free survival (PFS) rates were 85.19%, 65.04% and 52.04% respectively. Overall survival (OS) and PFS rates were significantly correlated with incisional margin and invasion of surrounding organs. There was no significant difference in PFS and OS between different resection procedures.Due to the limitation of cases multivariate survival analysis can not be performed. CONCLUSION: Incisional margin and invasion of surrounding organs are two important prognostic factors. And transanal excision is both safe and effective for those properly indicated patients.

[Feasibility of 13th lymph nodes as sentinels for periampullary carcinoma].

OBJECTIVE: To study the feasibility and clinical value of 13th lymph nodes in predicting general lymph nodes metastases for periampullary carcinoma. METHODS: A total of 77 patients with pathologically confirmed periampullary carcinoma were recruited. And 26 (18 males and 8 females, age 38-79 years) of them underwent Whipple procedures during which 1% methylene blue or nanogate carbon was injected into tumor bed. The other 51 patients as controls (33 males, 18 females, age 38-78 years) . The dyed 13th lymph nodes were biopsied. Then routine lymphadenectomy was performed and their pathological results were analyzed. RESULTS: In the experimental group, the lymph node drainage area of cancer was identified. However, in contrast with 51 patients in the control group, the labeling of 13th lymph nodes did not significantly increase the number of cleaned lymph nodes (15.8 (3-54) vs 17.6 (6-40) , P = 0.460). CONCLUSION: 13th lymph nodes are non-suitable as sentinels for predicting general lymph nodes metastases of periampullary carcinoma.

Hepatoid adenocarcinoma of the stomach with neuroendocrine differentiation: A case report and review of literature.

BACKGROUND: Both hepatoid adenocarcinoma of the stomach (HAS) and neuroendocrine differentiation (NED) are rare histological subtypes of gastric cancer with unique clinicopathological features and unfavorable outcomes. HAS with NED is even rarer. CASE SUMMARY: Here, we report a 61-year-old man with HAS with NED, as detected by gastric wall thickening by positron emission tomography/computed tomography for a pulmonary nodule. Distal gastrectomy was performed, and pathological examination led to the diagnosis of HAS with NED. However, liver metastases occurred 6 mo later despite adjuvant chemotherapy, and the patient died 27 mo postoperatively. CONCLUSION: We treated a patient with HAS with NED who underwent adjuvant chemotherapy after radical surgery and still developed liver metastases. We first report the detailed processes of the treatment and development of HAS with NED, providing an important reference for the clinical diagnosis and treatment of this condition.

Dissimilar survival and clinicopathological characteristics of mucinous adenocarcinoma located in pancreatic head and body/tail.

BACKGROUND: Growing evidence shows that pancreatic tumors in different anatomical locations have different characteristics, which have a significant impact on prognosis. However, no study has reported the differences between pancreatic mucinous adenocarcinoma (PMAC) in the head vs the body/tail of the pancreas. AIM: To investigate the differences in survival and clinicopathological characteristics between PMAC in the head and body/tail of pancreas. METHODS: A total of 2058 PMAC patients from the Surveillance, Epidemiology, and End Results database diagnosed between 1992 and 2017 were retrospectively reviewed. We divided the patients who met the inclusion criteria into pancreatic head group (PHG) and pancreatic body/tail group (PBTG). The relationship between two groups and risk of invasive factors was identified using logistic regression analysis. Kaplan-Meier analysis and Cox regression analysis were conducted to compare the overall survival (OS) and cancer-specific survival (CSS) of two patient groups. RESULTS: In total, 271 PMAC patients were included in the study. The 1-year, 3-year, and 5-year OS rates of these patients were 51.6%, 23.5%, and 13.6%, respectively. The 1-year, 3-year, and 5-year CSS rates were 53.2%, 26.2%, and 17.4%, respectively. The median OS of PHG patients was longer than that of PBTG patients (18 vs 7.5 mo, P < 0.001). Compared to PHG patients, PBTG patients had a greater risk of metastases [odds ratio (OR) = 2.747, 95% confidence interval (CI): 1.628-4.636, P < 0.001] and higher staging (OR = 3.204, 95% CI: 1.895-5.415, P < 0.001). Survival analysis revealed that age < 65 years, male sex, low grade (G1-G2), low stage, systemic therapy, and PMAC located at the pancreatic head led to longer OS and CSS (all P < 0.05). The location of PMAC was an independent prognostic factor for CSS [hazard ratio (HR) = 0.7, 95%CI: 0.52-0.94, P = 0.017]. Further analysis demonstrated that OS and CSS of PHG were significantly better than PBTG in advanced stage (stage III-IV). CONCLUSION: Compared to the pancreatic body/tail, PMAC located in the pancreatic head has better survival and favorable clinicopathological characteristics.

CD93 serves as a potential biomarker of gastric cancer and correlates with the tumor microenvironment.

BACKGROUND: The tumor microenvironment (TME) plays an important role in the growth and expansion of gastric cancer (GC). Studies have identified that CD93 is involved in abnormal tumor angiogenesis, which may be related to the regulation of the TME. AIM: To determine the role of CD93 in GC. METHODS: Transcriptomic data of GC was investigated in a cohort from The Cancer Genome Atlas. Additionally, RNA-seq data sets from Gene Expression Omnibus (GSE118916, GSE52138, GSE79973, GSE19826, and GSE84433) were applied to validate the results. We performed the immune infiltration analyses using ESTIMATE, CIBERSORT, and ssGSEA. Furthermore, weighted gene co-expression network analysis (WGCNA) was conducted to identify the immune-related genes. RESULTS: Compared to normal tissues, CD93 significantly enriched in tumor tissues (t = 4.669, 95%CI: 0.342-0.863, P < 0.001). Higher expression of CD93 was significantly associated with shorter overall survival (hazard ratio = 1.62, 95%CI: 1.09-2.4, P = 0.017), less proportion of CD8 T and activated natural killer cells in the TME (P < 0.05), and lower tumor mutation burden (t = 4.131, 95%CI: 0.721-0.256, P < 0.001). Genes co-expressed with CD93 were mainly enriched in angiogenesis. Moreover, 11 genes were identified with a strong relationship between CD93 and the immune microenvironment using WGCNA. CONCLUSION: CD93 is a novel prognostic and diagnostic biomarker for GC, that is closely related to the immune infiltration in the TME. Although this retrospective study was a comprehensive analysis, the prospective cohort studies are preferred to further confirm these conclusions.

Impact of perioperative blood transfusion on oncological outcomes in ampullary carcinoma patients underwent pancreaticoduodenectomy.

BACKGROUND: The effect of perioperative blood transfusion (PBT) on the prognosis of ampullary carcinoma (AC) is still debated. AIM: To explore the impact of PBT on short-term safety and long-term survival in AC patients who underwent pancreaticoduodenectomy. METHODS: A total of 257 patients with AC who underwent pancreaticoduodenectomy between 1998 and 2020 in the Cancer Hospital, Chinese Academy of Medical Sciences, were retrospectively analyzed. We used Cox proportional hazard regression to identify prognostic factors of overall survival (OS) and recurrence-free survival (RFS) and the Kaplan-Meier method to analyze survival information. RESULTS: A total of 144 (56%) of 257 patients received PBT. The PBT group and nonperioperative blood transfusion group showed no significant differences in demographics. Patients who received transfusion had a comparable incidence of postoperative complications with patients who did not. Univariable and multivariable Cox proportional hazard regression analyses indicated that transfusion was not an independent predictor of OS or RFS. We performed Kaplan-Meier analysis according to subgroups of T stage, and subgroup analysis indicated that PBT might be associated with worse OS (P < 0.05) but not RFS in AC of stage T1. CONCLUSION: We found that PBT might be associated with decreased OS in early AC, but more validation is needed. The reasonable use of transfusion might be helpful to improve OS.

Analysis of textbook outcomes for ampullary carcinoma patients following pancreaticoduodenectomy.

BACKGROUND: Textbook outcomes (TOs) have been used to assess the quality of surgical treatment for many digestive tumours but not ampullary carcinoma (AC). AIM: To discuss the factors associated with achieving a TO and further explore the prognostic value of a TO for AC patients undergoing curative pancreaticoduodenectomy (PD). METHODS: Patients who underwent PD at the China National Cancer Center between 1998 and 2020 were identified. A TO was defined by R0 resection, examination of ≥ 12 Lymph nodes, no prolonged hospitalization, no intensive care unit treatment, no postoperative complications, and no 30-day readmission or mortality. Cox regression analysis was used to identify the prognostic value of a TO for overall survival (OS) and recurrence-free survival (RFS). Logistic regression was used to identify predictors of a TO. The rate of a TO and of each indicator were compared in patients who underwent surgery before and after 2010. RESULTS: Ultimately, only 24.3% of 272 AC patients achieved a TO. A TO was independently associated with improved OS [hazard ratio (HR): 0.443, 95% confidence interval (95%CI): 0.276-0.711, P = 0.001] and RFS (HR: 0.379, 95%CI: 0.228-0.629, P < 0.001) in the Cox regression analysis. Factors independently associated with a TO included a year of surgery between 2010 and 2020 (OR: 4.549, 95%CI: 2.064-10.028, P < 0.001) and N1 stage disease (OR: 2.251, 95%CI: 1.023-4.954, P = 0.044). In addition, the TO rate was significantly higher in patients who underwent surgery after 2010 (P < 0.001) than in those who underwent surgery before 2010. CONCLUSION: Only approximately a quarter (24.3%) of AC patients achieved a TO following PD. A TO was independently related to favourable oncological outcomes in AC and should be considered as an outcome measure for the quality of surgery. Further multicentre research is warranted to better elucidate its impact.

Novel prognostic score based on the preoperative total bilirubin-albumin ratio and fibrinogen-albumin ratio in ampullary adenocarcinoma.

BACKGROUND: The preoperative total bilirubin-albumin ratio (TBAR) and fibrinogen-albumin ratio (FAR) have been proven to be valuable prognostic factors in various cancers. AIM: To detect the prognostic value of TBAR and FAR in ampullary adenocarcinoma (AC) patients who underwent curative pancreaticoduodenectomy. METHODS: AC patients who underwent curative pancreaticoduodenectomy in the National Cancer Center of China between 1998 and 2020 were retrospectively reviewed. The prognostic cutoff values of TBAR and FAR were determined through the best survival separation model. Then, a novel prognostic score combining TBAR and FAR was calculated and validated through the logistic regression analysis and Cox regression analysis. RESULTS: A total of 188 AC patients were enrolled in the current study. The best cutoff values of TBAR and FAR for predicting overall survival were 1.7943 and 0.1329, respectively. AC patients were divided into a TBAR-low group (score = 0) vs a TBAR-high group (score = 1) and a FAR-low group (score = 0) vs a FAR-high group (score = 1). The total score was calculated as a novel prognostic factor. Multivariable logistic regression analysis revealed that a high score was an independent protective factor for recurrence [score = 1 vs score = 0: Odds ratio (OR) = 0.517, P = 0.046; score = 2 vs score = 0 OR = 0.236, P = 0.038]. In addition, multivariable survival analysis also demonstrated that a high score was an independent protective factor in AC patients (score = 2 vs score = 0: Hazard ratio = 0.230, P = 0.046). CONCLUSION: A novel prognostic score based on preoperative TBAR and FAR has been demonstrated to have good predictive power in AC patients who underwent curative pancreaticoduodenectomy. However, more studies with larger samples are needed to validate this conclusion.

Laparoscopic endoscopic cooperative surgery for the duodenal neuroendocrine tumor: a single-center case series (How I Do It).

BACKGROUND: Duodenal neuroendocrine tumors (D-NETs) are uncommon. The surgical treatment for D-NETs was in debate. Laparoscopic and endoscopic cooperative surgery (LECS) is a promising approach for treating gastrointestinal tumors. The study aimed to evaluate the feasibility and safety of LECS for D-NETs. Meanwhile, the authors described the details of the LECS technique. METHODS: All patients diagnosed with D-NETs underwent LECS between September 2018 and April 2022 were retrospectively reviewed. The endoscopic procedures were performed with endoscopic full-thickness resection. The defect was manually closed under the surveillance of the laparoscopy. RESULTS: A total of seven patients were enrolled, including three men and four women. The median age was 58 years (ranging from 39-65). Four tumors were located in the bulb and three in the second portion. All cases were diagnosed as NET with grade G1. The tumor depth was pT1 in two cases and pT2 in five cases. The median specimen size and the tumor size were 22 mm (ranging from 10-30) and 8.0 mm (ranging from 2.3-13.0), respectively. En-bloc resection and curative resection rates are 100 and 85.7%, respectively. There were no severe complications. Until 1 June 2022, there was no recurrence. The median follow-up was 9.5 months (range, 1.4-45.1). CONCLUSIONS: LECS with endoscopic full-thickness resection is a reliable surgical procedure. The minimally invasive advantages of LECS enable more individualized treatment options for a specific group. Limited by the length of observation, the long-term performance of LECS for D-NETs requires additional investigation.

[Treatment and prognosis of patients with duodenal gastrointestinal stromal tumors].

OBJECTIVE: To evaluate the clinical characteristics and survival factors of patients with duodenal gastrointestinal stromal tumors (GIST). METHODS: The clinical data of 41 patients with duodenal GIST were analyzed retrospectively at Cancer Hospital and Institute, Chinese Academy of Medical Sciences from June 1996 to August 2011. Kaplan-Meier method was used to calculate the recurrence-free survival rate and the Cox proportional hazard regression model employed for the recurrence-free survival analysis. RESULTS: The lesions of duodenal GIST were predominantly located in the descending (n = 26, 63.4%) and transverse portions (n = 10, 24.4%). Most duodenal GIST presented commonly with upper gastrointestinal bleeding (n = 18, 43.9%) and 12 cases (29.3%) were incidentally detected by physical examinations. Eight patients underwent pancreatoduodenectomy and 27 limited resection. The tumor size varied from 0.6 cm to 30.0 cm (mean: 8.4 cm). The recurrence-free survival rates analyzed by Kaplan-Meier method at 1, 2 and 5-year were 94.1%, 77.5% and 65.0% respectively. The results of Cox proportional hazards regression model indicated that the patients with >10/50 HP mitotic count showed a worse recurrence-free survival than those with ≤ 10/50 HP (HR = 3.7, 95%CI 1.0 - 13.7, P = 0.049). After adjusting other confounding factors, mitotic activity was one significant prognostic factor of recurrence (P = 0.024). There was no significant association between the risk of recurrence and other prognostic factors, including diagnostic age, tumor size, type of operation and the risk of aggressive behaviors (all P > 0.05). CONCLUSIONS: Mitotic activity is one prognostic factor of duodenal GIST. And R(0) resection should be regarded as an optional treatment for duodenal GIST.

Mixed large and small cell neuroendocrine carcinoma of the stomach: A case report and review of literature.

BACKGROUND: Gastric neuroendocrine carcinoma (GNEC) is a rare histological subtype of gastric cancer, which is categorized into small cell and large cell neuroendocrine carcinomas. It is characterized by strong invasiveness and poor prognosis. Mixed large and small cell neuroendocrine carcinoma (L/SCNEC) is an extremely rare pathological type of gastric cancer, and there have been no reports on this situation until now. CASE SUMMARY: Herein, we first present a 57-year-old patient diagnosed with L/SCNEC of the stomach. A 57-year-old Chinese male presented with epigastric discomfort. Outpatient gastroscopic biopsy was performed, and pathological examination revealed that the cardia was invaded by adenocarcinoma. The patient underwent laparoscopic-assisted radical proximal subtotal gastrectomy and was diagnosed with L/SCNEC. He refused adjuvant treatment and was followed up every 3 mo. Eight months after the operation, the patient showed no evidence of local recurrence or distant metastasis. CONCLUSION: We advocate conducting further genomic studies to explore the origin of gastric large cell and small cell neuroendocrine carcinoma and using different chemotherapy schemes according to large or small cell neuroendocrine carcinoma of the stomach for clinical research to clarify the heterogeneity of GNEC and improve the prognosis of patients with GNEC.

Preoperative Concurrent Chemoradiotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: Phase II Randomized Study.

Objective: We evaluated and compared the efficacy and safety of neoadjuvant chemoradiotherapy (NACRT) versus neoadjuvant chemotherapy (NACT) for locally advanced gastric cancer (LAGC) in a single-center randomized phase II trial. Methods: Patients with LAGC were enrolled and received either NACT or NACRT, followed by gastrectomy and adjuvant chemotherapy. The primary endpoint was an R0 resection rate. Results: We enrolled 75 patients: 75.7% (NACT, 28/37 patients) and 76.3% (NACRT, 29/38 patients) underwent surgery; R0 resection rates were 73.0% (27/37) and 73.7% (28/38), respectively. The NACRT group had significantly better major pathological response than the NACT group (37.9% vs 17.9%, p = 0.019). Between-group postoperative complications were not significantly different. The median follow-up was 59.6 months; 5-year overall survival (OS) rate was 50.1% (NACT) and 61.9% (NACRT); neither group reached the median OS; median progression-free survival was 37.3 and 63.4 months, respectively. Conclusions: S-1-based NACRT did not improve the R0 resection rate, although it presented better tumor regression with similar safety to NACT. Trial registration: ClinicalTrial.gov NCT02301481.

Efficacy and toxicity of capecitabine combined with intensity-modulated radiotherapy after D1/D2 lymph node dissection in patients with gastric cancer.

BACKGROUND: Adjuvant chemoradiotherapy (ACRT) with oral capecitabine and intensity-modulated radiotherapy (IMRT) were well tolerated in a phase I study in patients who had undergone partial or total gastrectomy for locally advanced gastric cancer (GC). This phase II study aimed to further determine the efficacy and toxicity of this combination after radical resection and D1/D2 lymph node dissection (LND) for patients with locally advanced GC. AIM: To further determine the efficacy and toxicity of this combination after radical resection and D1/D2 LND for patients with locally advanced GC. METHODS: Forty patients (median age, 53 years; range, 24-71 years) with pathologically confirmed adenocarcinoma who underwent D1/D2 LND were included in this study. The patients received ACRT comprising IMRT (total irradiation dose: 45 Gy delivered in daily 1.8-Gy fractions on 5 d a week over 5 wk) and capecitabine chemotherapy (dose: 800 mg/m² twice daily throughout the duration of radiotherapy). The primary study endpoint was disease-free survival (DFS), and the secondary endpoints were overall survival (OS), toxic effects, and treatment compliance. RESULTS: The 3-year DFS and OS were 66.2% and 75%, respectively. The median time to recurrence was 19.5 mo (range, 6.1-68 mo). Peritoneal implantation (n = 10) was the most common recurrence pattern, and the lung was the most common site of extra-abdominal metastases (n = 5). Nine patients developed grade 3 or 4 toxicities during ACRT. Two patients discontinued ACRT, while eleven underwent ACRT without receiving the entire course of capecitabine. There were no treatment-related deaths. CONCLUSION: The ACRT protocol described herein showed acceptable safety and efficacy for patients with locally advanced GC who received radical gastrectomy and D1/2 LND.

[The role of slow-release 5-fluorouracil implantation in treatment of unresectable pancreatic cancer].

OBJECTIVE: To study the role of slow-release 5-fluorouracil implantation in treatment of unresectable pancreatic cancer. METHODS: 85 cases of untreated patients with locally advanced pancreatic cancer (LAPC) were randomized into two groups: Trial group: slow-release 5-fluorouracil implantation (50 patients) and control group (35 patients). Observing the objective tumor response, clinical benefit response, toxicity, complications and survival of patients of the two groups. RESULTS: In the trial group the overall response rate (PR + NC) was 76.0%, and the clinical benefit response rate was 52.0%. No toxicity was observed. Pancreatic fistula occurred in 2 patients. The median survival time of the two groups was 9.0 months and 4.0 months, respectively. The survival rates of 6- and 12-month were 56.8% vs. 31.4% and 22.9% vs. 2.9% in the two groups, respectively (P = 0.012). CONCLUSION: Slow-release 5-fluorouracil implantation is a simple, safe and effective method in treatment of LAPC.