Phase II trial of adjuvant hyperthermic intraperitoneal chemotherapy with three drugs for the prophylactic treatment of carcinomatosis after resection of advanced gastric cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15588-e15588
Author(s):  
S. Murata ◽  
H. Naito ◽  
H. Yamamoto ◽  
E. Mekata ◽  
T. Shimizu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Survival Rate ◽  
Advanced Gastric Cancer ◽  
Intraperitoneal Chemotherapy ◽  
Curative Resection ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Pulmonary Insufficiency ◽  
Serosal Invasion

e15588 Background: This prospective study was performed to assess the efficacy and safety of hyperthermic intraperitoneal chemotherapy (HIPEC) with three drugs in patients with curative resection of T3 or T4 advanced gastric cancer. Methods: Patients with curative resection of clinically T3 or T4 advanced gastric cancer were required to be under 75 years of age and to have adequate organ function. After the curative resection of gastric cancer with D2 lymph node dissection and the reconstruction of the alimentary tract, HIPEC was carried out for 30 minutes with 50mg of CDDP, 10mg of MMC, and 1000mg of 5-FU in 5 L saline maintained at 42–43°C. Patients were given an adjuvant S-1 treatment after surgery. Primary endpoint of this study was overall survival. Results: A total of 29 patients were eligible. Pathologically, 8 patients had sub-serosal invasion (pT2(ss)), 18 patients had serosal invasion (pT3), and 3 patients had adjacent organ invasion (pT4). These patients included pT2(ss)pN0 (n=2), pT2(ss)pN1 (n=6), pT3pN0 (n=4), pT3pN1 (n=9), pT3pN2 (n=5), pT4pN0 (n=1), and pT4pN1 (n=2). Median follow-up period was 44 months (10–72 months). Overall 5- year survival rate in all eligible patients was 89.5%. Overall 5-year survival rate in patients with pT2(ss), pT3, or pT4 was 100%, 82.4%, or 100%, respectively. Three patients with pT3 had recurrence of pleural dissemination (n=1), lymph node metastases (n=1), or pulmonary metastases and peritoneal dissemination (n=1). A total of 7 patients had postoperative complications such as continuous pancreatic juice secretion (13.8%), abdominal abscess (10.3%), leakage of the anastomosis (3.4%), and pulmonary insufficiency (10.3%). Conclusions: The present study suggests that HIPEC with three drugs after curative resection of advanced gastric primary cancer is associated with improved overall survival with an acceptable morbidity. No significant financial relationships to disclose.

Hyperthermic intraperitoneal chemotherapy following gastrectomy for the prevention of carcinomatosis in advanced gastric cancer: Nonrandomized phase II prospective trial.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 116-116
Author(s):  
Satoshi Murata ◽  
Hiroyuki Naito ◽  
Hiroshi Yamamoto ◽  
Tsuyoshi Yamaguchi ◽  
Tohru Miyake ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Advanced Gastric Cancer ◽  
Anticancer Drugs ◽  
Phase Ii ◽  
Intraperitoneal Chemotherapy ◽  
Curative Resection ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Serosal Invasion

116 Background: About half of patients with serosa-invasive gastric cancer develop peritoneal recurrence and die of this disease even if curative resections performed. This prospective phase II study was performed to assess the efficacy and safety of hyperthermic intraperitoneal chemotherapy (HIPEC) with three anticancer drugs in patients with curative resection of clinically T3 or T4 serosa-invasive advanced gastric cancer. Methods: Patients age 75 years or younger with curative resection of clinically T3 or T4 advanced gastric cancer were eligible for this nonrandomized phase II trial. After the curative resection of gastric cancer with D2 lymph node dissection, HIPEC was carried out for 30 minutes with 50mg of CDDP, 10mg of MMC, and 1000mg of 5-FU in 5 L saline maintained at 42-43C°. Patients were given an adjuvant S-1 treatment after surgery. Primary endpoint of this study was overall survival. Second end points included safety and recurrence rate. Results: A total of 50 patients were eligible between January 2002 and December 2010. Pathologically, 12 patients had sub-serosal invasion (pT2(ss)), 35 patients had serosal invasion (pT3), and 3 patients had adjacent organ invasion (pT4). Median follow-up period was 52 months (12-104 months). Overall 5-year survival rate in all eligible patients was 89.9%. Overall 5-year survival rate in patients with stage IB (n=4), stage II (n=12), stage IIIA (n=18), or stage IIIB (n=16) was 100%, 100%, 90.9%, or 76.2%, respectively. Only one patient (2.0%) had peritoneal recurrences. Four patients (8.0%) with pN2 had lymphatic recurrences. A total of 13 patients had postoperative complications such as minor pancreatic fistula (Grade A) (10.0%), abdominal abscess (4.0%), leakage of the anastomosis (8.0%), and pneumonia (6.0%). All patients recovered without any surgical interventions. None of patients needed for the treatment in the Intensive Care Units after HIPEC. Conclusions: Intra-operative HIPEC with three anticancer drugs following curative resection of advanced gastric cancer improves overall survival with an inhibition of peritoneal recurrence and an acceptable morbidity.

scholarly journals Prognosis of Gastric Cancer Patients with Node-Negative Metastasis following Curative Resection: Outcomes of the Survival and Recurrence

2008 ◽  
Vol 22 (10) ◽  
pp. 835-839 ◽  
Author(s):  
Jingyu Deng ◽  
Han Liang ◽  
Dan Sun ◽  
Rupeng Zhang ◽  
Hongjie Zhan ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Survival Rate ◽  
Cancer Patients ◽  
Curative Resection ◽  
Node Negative ◽  
Node Positive ◽  
Lymph Node Positive ◽  
Gastric Cancer Patients

BACKGROUND: The purpose of the present study was to provide valuable prognostic information on lymph node-negative gastric cancer patients following curative resection.METHODS: Data from 112 lymph node-negative gastric cancer patients who underwent curative resection were reviewed to identify the independent factors of overall survival and recurrence.RESULTS: The five-year survival rate of lymph node-negative gastric cancer patients was 85.7%, and recurrence was identified in 25 patients after curative surgery. The five-year survival rate of lymph node-negative gastric cancer patients was higher than that of lymph node-positive gastric cancer patients (P<0.001). Recurrence in lymph node-negative gastric cancer patients was less than that of lymph node-positive gastric cancer patients (P=0.001). The median survival after recurrence of lymph node-negative gastric cancer patients was longer than that of lymph node-positive gastric cancer patients (P=0.021). Using multivariate analyses, the following results were determined for lymph node-negative gastric cancer patients: sex, operative type and the presence of serosal involvement were independent factors of overall survival; and lymphadenectomy, number of dissected nodes and the presence of serosal involvement were independent factors of recurrence.CONCLUSIONS: The prognosis of lymph node-negative gastric cancer patients was better than that of lymph node-positive gastric cancer patients. Male sex, subtotal gastrectomy and nonserosal involvement should be considered to be the favourable predictors of postoperative long-term survival of lymph node-negative gastric cancer patients. Conversely, limited lymphadenectomy, few dissected nodes and serosal involvement should be considered to be risk factors of postoperative recurrence of lymph node-negative gastric cancer patients.

scholarly journals Survival outcomes after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal carcinomatosis from gastric cancer: a systematic review

2016 ◽  
Vol 1 (2) ◽  
pp. 67-77 ◽  
Author(s):  
Claramae Shulyn Chia ◽  
Ramakrishnan Ayloor Seshadri ◽  
Vahan Kepenekian ◽  
Delphine Vaudoyer ◽  
Guillaume Passot ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Peritoneal Carcinomatosis ◽  
Median Survival ◽  
Intraperitoneal Chemotherapy ◽  
Cytoreductive Surgery ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Current Evidence ◽  
Term Survival ◽  
Crs And Hipec

AbstractBackground: The current treatment of choice for peritoneal carcinomatosis from gastric cancer is systemic chemotherapy. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a new aggressive form of loco-regional treatment that is currently being used in pseudomyxoma peritoneii, peritoneal mesothelioma and peritoneal carcinomatosis from colorectal cancer. It is still under investigation for its use in gastric cancer.Methods: The literature between 1970 and 2016 was surveyed systematically through a review of published studies on the treatment outcomes of CRS and HIPEC for peritoneal carcinomatosis from gastric cancer.Results: Seventeen studies were included in this review. The median survival for all patients ranged from 6.6 to 15.8 months. The 5-years overall survival ranged from 6 to 31%. For patients with complete cytoreduction, the median survival was 11.2 to 43.4 months and the 5-years overall survival was 13 % to 23%. Important prognostic factors were found to be a low peritoneal carcarcinomatosis index (PCI) score and the completeness of cytoreduction.Conclusion: The current evidence suggests that CRS and HIPEC has a role to play in the treatment of peritoneal carcinomatosis from gastric cancer. Long term survival has been shown for a select group of patients. However, further studies are needed to validate these results.

Salvage gastrectomy for unresectable advanced gastric cancer after combination chemotherapy with docetaxel, cisplatin, and S-1.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15113-e15113
Author(s):  
Kei Hosoda ◽  
Keishi Yamashita ◽  
Shinichi Sakuramoto ◽  
Hiroaki Mieno ◽  
Katsuhiko Higuchi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Advanced Gastric Cancer ◽  
Univariate Analysis ◽  
Pancreatic Head ◽  
Progression Free Survival ◽  
Hematologic Toxicity ◽  
Primary Tumors ◽  
Free Survival

e15113 Background: The prognosis for patients with unresectable advanced gastric cancer treated with chemotherapy alone is extremely poor. We have evaluated the safety and efficacy of salvage gastrectomy following chemotherapy with docetaxel, cisplatin, and S-1 (DCS) in patients with unresectable advanced gastric cancer. Methods: We evaluated 30 patients with unresectable advanced gastric adenocarcinoma whose lesions were down-staged by DCS chemotherapy and who underwent salvage gastrectomy with lymph node dissection from 2006 to 2012, when visible lesions were judged resectable. We retrospectively reviewed their medical records to identify factors that would influence overall survival. Results: Of the 30 patients, 17 had extra-regional lymph node metastases, 5 had liver metastases, 9 had peritoneal dissemination and 6 had pancreatic head invasion prior to DCS chemotherapy. Of the 30 patients, 23, 3, and 4 underwent R0, R1, and R2 resection, respectively. No in-hospital deaths or reoperations occurred. Pathological evaluation of primary tumors revealed grades 3, 2, 1b, 1a, and 0 tumor regression in 4, 9, 7, 7, and 2 patients, respectively. Median progression-free survival was 19 months.Two-year progression-free survival and overall survival rates were 45% and 65%, respectively. Of 17 patients with target tumors, 15 had partial responses, making the overall response rate 88%. The most common grade 3/4 hematologic toxicity was neutropenia (56%); all treatment-related toxicities were resolved, and no patient died of toxicity-related causes. Univariate analysis showed that R1/2 surgery (p<0.001), diffuse type histology (p=0.054), histological grade 0/1a/1b following chemotherapy (p<0.033), ypN3 (p<0.001) and yply2/3 (p=0.003), were significantly prognostic of reduced overall survival. A multivariate proportional hazard model found that ypN3 (p=0.003) was the sole independent prognostic factor. Conclusions: Salvage gastrectomy after DCS chemotherapy was safe and effective in patients with unresectable advanced gastric cancer. Lymph node metastasis after chemotherapy was significantly prognostic of poor prognosis, suggesting the need for further treatment.

scholarly journals Necessity of prophylactic No.10 lymph node clearance for middle and upper third gastric cancer: a network meta-analysis

2019 ◽  
Author(s):  
Gaozan Zheng ◽  
Jinqiang Liu ◽  
Yinghao Guo ◽  
Fei Wang ◽  
Shushang Liu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Survival Rate ◽  
Complication Rate ◽  
Perioperative Complications ◽  
Meta Analysis ◽  
Cochrane Central Register ◽  
Overall Survival Rate ◽  
The Impact

Abstract Background It remains controversial whether prophylactic No.10 lymph node clearance is necessary for gastric cancer. Thus, the present study aims to investigate the impact of prophylactic No.10 lymph node clearance on the perioperative complications and prognosis of upper and middle third gastric cancer.Methods A network meta-analysis to identify both direct and indirect evidence with respect to the comparison of gastrectomy alone (G-A), gastrectomy combination with splenectomy (G+S) and gastrectomy combination with spleen-preserving splenic hilar dissection (G+SPSHD) was conducted. We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for studies published before September 2018. Perioperative complications and overall survival were analyzed. Hazard ratios (HR) were extracted from the publications on the basis of reported values or were extracted from survival curves by established methods.Results Ten retrospective studies involving 2565 patients were included. In the direct comparison analyses, G-A showed comparable 5-year overall survival rate (HR: 1.1, 95%CI: 0.97-1.3) but lower total complication rate (OR: 0.37, 95%CI: 0.17-0.77) compared with G+S. Similarly, the 5-year overall survival rate between G+SPSHD and G+S was comparable (HR: 1.1, 95%CI: 0.92-1.4), while the total complication rate of G+SPSHD was lower than that of G+S (OR: 0.50, 95%CI: 0.28-0.88). In the indirect comparison analyses, both the 5-year overall survival rate (HR: 1.0, 95%CI: 0.78-1.3) and total complication rate (OR: 0.75, 95%CI: 0.29-1.9) were comparable between G-A and G+SPSHD.Conclusion Prophylactic No.10 lymph node clearance was not recommended for treatment of upper and middle third gastric cancer.

A prospective randomized trial comparing 5-fluorouracil (5-FU), mitomycin-C (MMC), and polysaccharide-K (PSK) versus UFT and PSK as adjuvant chemoimmunotherapy (CITX) for patients with locally advanced gastric cancer with curative resection

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15074-15074
Author(s):  
J. Choi ◽  
S. Kang ◽  
J. Park ◽  
H. Lee ◽  
Y. Cho ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Randomized Trial ◽  
Advanced Gastric Cancer ◽  
Curative Resection ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Target Number ◽  
Stage Ib ◽  
Locally Advanced Gastric Cancer

15074 Background: Adjuvant chemotherapy has demonstrated small but significant survival benefit in locally advanced gastric cancer in several meta-analyses, while adjuvant CITX showed improved outcome of patients (pts) compared to chemotherapy alone in a few trials. However, optimal chemotherapy regimen remains to be determined. We conducted a randomized trial comparing oral (PO) CITX with intravenous (IV) CITX in gastric cancer pts with curative resection. Methods: All enrolled pts underwent radical surgery with at least D2 dissection. After stratification for pathologic stage (IB or II vs. III) and primary tumor size (=5 cm vs. >5 cm), pts were randomized to IV CITX (5-FU 500 mg/m2 weekly for 24 weeks, MMC 8 mg/m2 every 6 weeks x 4) or PO CITX (UFT 400–600 mg/day for 12 months). Pts in both arms received PSK 3 g/day PO for 4 months. The planned target number of pts was 368 to prove the non-inferiority of PO CITX compared to IV CITX in overall survival. Results: A total of 82 pts (stage IB: 6, II: 29, IIIA: 30, IIIB: 17; 44 in IV arm, 38 in PO arm) were enrolled between May 2002 and October 2005, when the trial was closed due to poor accrual. Pts characteristics were well balanced. With a median follow-up of 39 months (14–55 months) in survivors, there were no significant differences in 3-year disease-free survival (82% vs. 61%, p=0.302) and overall survival (84% vs. 79%, p=0.838) between IV and PO arms. No grade 4 toxicity was observed in both arms. IV arm demonstrated higher incidence of grade 2 or 3 neutropenia (79% vs. 52%, p=0.025), thrombocytopenia (19% vs. 0%, p=0.008), and vomiting (36% vs. 9%, p=0.013). Conclusions: Although accrual was well below that planned, the results of this trial suggest that PO CITX with UFT might have similar efficacy with lower toxicity profile compared with 5-FU and MMC CITX in adjuvant treatment for gastric cancer. No significant financial relationships to disclose.

A systematic review and meta-analysis of the randomized controlled trials on adjuvant intraperitoneal chemotherapy for advanced gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4614-4614 ◽  
Author(s):  
T. D. Yan ◽  
D. Black ◽  
P. H. Sugarbaker ◽  
Y. Yonemura ◽  
J. Zhu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Systematic Review ◽  
Overall Survival ◽  
Advanced Gastric Cancer ◽  
Intraperitoneal Chemotherapy ◽  
Data Extraction ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Abdominal Abscess ◽  
Term Survival

4614 Objectives: Despite the use of adjuvant systemic chemotherapy or radiotherapy, the long-term survival in patients with stage III and IV gastric cancer remains limited. The purpose of this systematic review and meta-analysis was to determine the effectiveness and safety of adjuvant intraperitoneal chemotherapy for patients with advanced gastric cancer. Methods: Studies eligible for this systematic review included those in which patients with gastric cancer were randomly assigned to receive surgery combined with intraperitoneal chemotherapy versus surgery without intraperitoneal chemotherapy. All forms of intraperitoneal chemotherapy in addition to surgery were included. There were no language restrictions. Quality of the trials was assessed by a predetermined checklist. The primary end-point of the meta-analysis was overall survival, defined as the time from random assignment to the last follow-up or death. Secondary end-points were the differences in the incidence of recurrence, morbidity and mortality. Results: Thirteen reports of randomised controlled trials (RCTs) were included for appraisal and data extraction. Ten reports were judged fair-quality and subjected to the meta-analysis. A significant improvement in survival was associated with hyperthermic intraoperative intraperitoneal chemotherapy (HIIC) alone (HR = 0.60; 95% CI = 0.43 to 0.83; p = 0.002) or combined with early postoperative intraperitoneal chemotherapy (EPIC) (HR = 0.45; 95% CI = 0.29 to 0.68; p = 0.0002). Survival improvement was marginally significant (HR = 0.67; 95% CI = 0.44 to 1.01; p = 0.06) with normothermic intraoperative intraperitoneal chemotherapy, but not significant with EPIC alone or delayed postoperative intraperitoneal chemotherapy. Intraperitoneal chemotherapy was also found to be associated with higher risks for intra-abdominal abscess (RR = 2.37; 95% CI = 1.32 to 4.26; p = 0.003) and neutropenia (RR = 4.33; 95% CI = 1.49 to 12.61; p = 0.007). Conclusion: The present meta-analysis indicates that HIIC with or without EPIC after resection of advanced gastric primary cancer is associated with an improved overall survival. However, increased risks of intra-abdominal abscess and neutropenia are demonstrated. No significant financial relationships to disclose.

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