scholarly journals A Novel Bedside HIPEC as Adjuvant Therapy for Stage III Gastric Cancer Patients after D2 Radical  Gastrectomy

Author(s):  
Lili Liu ◽  
Li Sun ◽  
Ning Zhang ◽  
Cheng-gong Liao ◽  
Haichuan Su ◽  
...  

Abstract Background To investigate the efficacy and safety of a novel bedside prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of advanced gastric cancer after radical D2 gastrectomy.Methods Total 114 patients with stage III gastric cancer were randomly assigned to bedside HIPEC or control treatment groups two weeks after radical D2 gastrectomy. HIPEC group was treated with cisplatin (60 mg/m2) through HIPEC, which was given on day 1 and 3 (30 mg/m2 each time), plus oral administration of S-1 twice daily at 40–60 mg/time for 14 days. Control group was treated with cisplatin (60 mg/m2), which was administered intravenously once, plus oral administration of S-1 twice daily, 40–60 mg/time, for 14 days. Patients in either group were given 6–8 cycles of the therapy.Results Median of disease-free survival (DFS) was 21.0 months in the HIPEC group, which was significantly longer than that in the control group (14.0 months, P = 0.039). The rate of 2-year DFS in the HIPEC group was higher than that in the control group although it was not statistically significant (47.3% vs 29.4%). In contrast, incidence of peritoneal metastasis was lower in the HIPEC (6/57, 10.5%) in comparison to that in the control group (12/57, 21.1%, P = 0.198). Patients in both groups completed an average of 5.9 cycles of the therapy with no significant difference in the incidence of adverse effects (except thrombocytopenia).Conclusion HIPEC with cisplatin plus oral S-1 is a safe and effective adjuvant therapy for the patients with advanced gastric cancer following radical D2 gastrectomy.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 82-82
Author(s):  
Jae Gyu Kim ◽  
Beom Jin Kim ◽  
Kyong-Choun Chi ◽  
Jung Min Park ◽  
Mi Kyoung Kim ◽  
...  

82 Background: Radical gastrectomy followed by adjuvant chemotherapy for advanced gastric cancer brings about serious nutritional impairment. Recent studies have shown an association between body mass index (BMI) and perioperative outcomes of gastric cancer. However, little is known about the association between BMI and long-term outcomes of advanced gastric cancer. Our study evaluated the clinical impact of BMI on the long-term outcomes of gastric cancer staged at II and III, treated by radical gastrectomy followed by adjuvant chemotherapy. Methods: We analysed a total of 211 cases of advanced gastric cancer stage II and III between January 2005 and December 2010 at Chung-Ang University Hospital. The patients were divided into 4 groups according to BMI; underweight, normal, overweight, and obese. In addition, they were divided into two groups (BMI-High vs BMI-Low). We assessed age, sex, tumor location, lymph node involvement, operation method, initial cancer stage, recurrence, and survival (overall survival and disease free survival) between two groups. Results: We classified them into 4 groups according to BMI; underweight, normal, overweight, and obese. There was no difference in overall survival between normal, overweight, and obese group. However, there was significant difference between underweight group and the other groups. As for disease free survival, similar findings were observed. Among 211 patients, 154 patients (72.9%) were included in BMI-L (body mass index < 25), whereas 57 patients (27.1%) in BMI-H (body mass index ≥ 25). There was no difference in age, sex, tumor location, stage, lymph node involvement, operation method, recurrence, and cancer-related death between two groups. When classified into 4 groups as stage II in BMI-H, stage II in BMI-L, stage III in BMI-H, and stage III in BMI-L, overall survival showed significant difference in stage, however, no difference between BMI-H and BMI-L. Disease free survival showed no significant difference in stage and BMI, especially, no significant difference between stage II in BMI-L and stage III in BMI –H. Conclusions: Our findings suggest that preoperative BMI may predict the long term outcomes of advanced gastric cancer after radical surgery and chemotherapy.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4142-TPS4142
Author(s):  
Minkyu Jung ◽  
Seok Yun Kang ◽  
Bong-Seog Kim ◽  
Ki Hyang Kim ◽  
Kyung Hee Lee ◽  
...  

TPS4142 Background: Complete surgical resections remains the only chance for cure in patients with gastric cancer, but approximately from 40% to 80% of patients still have recurrences and most patients ultimately die from their disease. The recent adjuvant trials in gastric cancer showed significantly improved survival in patients with adjuvant chemotherapy than those with surgery alone. However, further studies need for the effect of adjuvant chemotherapy following D2 dissected gastric cancer patients, especially in advanced gastric cancer. S-1 is an oral anticancer drug, a prodrug of fluorouracil, very effective in gastric cancer. Docetaxel is the first drug that showed survival benefits when added to the two drugs in advanced gastric cancer patients. And docetaxel is also synergistic anti-cancer effect with S-1 in advanced gastric cancer. Base on this background, the aim of this study is to detect a significant increase in 3 –year disease free survival (DFS) of adjuvant chemotherapy with docetaxel and S-1(DS) relative to those with S-1 and cisplatin (SP) in patients with stage III gastric cancer Methods: This study is an open-label, phase 3, randomized controlled trial, multicenter in South Korea. Patients with stage III (AJCC 7th edition) gastric cancer who had had curative D2 gastrectomy is randomly assigned to receive adjuvant chemotherapy of eight 3-week cycles of intravenous docetaxel (35 mg/m2 on day 1 and 8 of each cycle) plus oral S-1 (35 mg/m2 twice daily on days 1 to 14 of each cycle) for 6 months (DS) or chemotherapy of eight 3-week cycles of oral S1 plus intravenous cisplatin (60 mg/m2). After satisfying the screening criteria, patients have been randomized to the SD or SP arm in a 1:1 ratio. The randomization is stratified by institution and stage of disease (IIIA vs. IIIB vs. IIIC). The each stratum has been randomized by using the method of randomly permuted block. The primary endpoint is 3 year DFS, will analyze by intention to treat. A total of 290 patients will be enrolled, 67 patients have been treated to day, with continuing accrual. The trial is registered at ClinicalTrials.gov (NCT01283217).


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4090-4090
Author(s):  
J. Xu ◽  
Y. Zhong ◽  
W. Niu ◽  
X. Qin ◽  
Y. Wei ◽  
...  

4090 Background: To investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving curative colorectal cancer resection. Methods: Patients with Stage II or Stage III colorectal cancer (CRC) were randomly assigned to receive preoperative hepatic and regional arterial chemotherapy (PHRAC group, n=256) or surgery alone (control group, n=253). The primary endpoint was disease-free survival, whereas the secondary endpoints included liver metastasis-free survival and overall survival. Results: There were no significant differences in overall morbidity between PHRAC and Control groups. During the follow-up period (median, 42 months), the median liver metastasis time for patients with stage III CRC was significantly longer in the PHRAC group (16±3 months v.s. 8±1 months, P=0.01). In stage III patients, there was also significant difference between the two groups with regard to the incidence of liver metastasis (18.9% vs 27.3%, P=0.01), 5-year disease-free survival (70.2% vs 52.0%, P=0.0076), 5-year overall survival (80.3% vs 69.5%, P=0.020) and the median survival time (40.1± 4.6 months vs 36.3 ± 3.2 months, P=0.03). In the PHRAC arm, the risk ratio of recurrence was 0.63 (95% CI, 0.51–0.79, P=0.0001), of death was 0.50(95% CI, 0.32–0.67; P=0.005), and of liver metastasis was 0.70 (95% CI, 0.52–0.86; p=0.01). In contrast, PHRAC seemed to be no benefit for stage II patients. Toxicities, such as hepatic toxicity and leucocyte decreasing, were mild and could be cured with medicine. Conclusions: Preoperative hepatic and regional arterial chemotherapy, in combination with surgical resection, could be able to reduce and delay the occurrence of liver metastasis and therefore improve survival rate in patients with stage III colorectal cancer. No significant financial relationships to disclose.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. TPS190-TPS190
Author(s):  
Daxing Xie

TPS190 Background: In our previous research, laparoscopic D2 lymphadenectomy plus Complete Mesogastrium Excision (D2+CME) has been proven to be an optimal surgical approach for advanced gastric cancer (AGC). However, there is a lack of evidence regarding its oncologic safety. Here, we conducted a single-centre, prospective, randomized controlled trial comparing the morbidity and mortality of laparoscopic D2+CME with conventional D2 gastrectomy in AGC. Methods: Patients eligibly criteria were pathologically-proven adenocarcinoma, 18 to 75 years old, cT2-4N0-3M0 at preoperative evaluation, expected curative resection via laparoscopic distal gastrectomy, no history of other cancers, chemotherapy or radiotherapy, no history of upper abdominal operation and perioperative ASA class I, II or III. The primary end-point was 3-year disease-free survival. The morbidity and mortality were compared to evaluate the safety of this trial. We hypothesized that the morbidity of this study was not significantly different from that of previous reports on laparoscopic distal gastrectomy (5.7%-15.5%). This study is registered at ClinicalTrials.gov, ID number is NCT01978444. Clinical trial information: NCT01978444.


2020 ◽  
Author(s):  
Ji-Hyun Kim ◽  
Kyonghwa Jun ◽  
Hyung-Min Chin

Abstract Background: To evaluate the prognostic value of tumor volume in gastric cancer, we assess calculated tumor volume (cTV) based on pathologic reviews and investigate its correlation with long-term outcome of patients who underwent curative gastrectomy.Methods: In total, 574 gastric cancer patients who underwent curative gastrectomy in a single institution between January 2012 and December 2015 were enrolled and divided into subgroups (cTV group) according to cTV using pathologic tumor size and depth. The cutoff values of calculated cTV for subgroups were designated as 0-160.0 for the cTV1 group, 160.1-468.0 for the cTV2 group, and ≥ 468.1 for the cTV3 group.Results: Among enrolled patients, 403 (70.2%) were in the cTV1 group, 116 (20.2%) were in the cTV2 group, and 55 (9.6%) were in the cTV3 group. The 5-year overall survival rate of V groups were significantly different: 94.4% in cTV1, 86.2% in cTV2, and 69.3% in cTV3. In the univariate analysis, the cTV groups were associated with poor overall survival (OS) and disease-free survival (DFS) with age, tumor location, histologic type, Lauren classification, T stage, and N stage. In the multivariate analysis, the cTV group was an independent prognostic factor for OS (HR 2.50, P=0.049) and DFS (HR 2.25, P=0.044). In the subgroup analysis, there was a significant difference according to the cTV group in both OS and DFS in T4 and N3 gastric cancers. Conclusions: Tumor volume plays an additive role in predicting survival in patients with gastric cancer. Moreover, the calculated tumor volume is significant parameter associated with poor prognosis in T4 and N3 advanced gastric cancer regardless of TNM stage.


2021 ◽  
Vol 11 ◽  
Author(s):  
Xingyu Feng ◽  
Xin Chen ◽  
Zaisheng Ye ◽  
Wenjun Xiong ◽  
Xueqing Yao ◽  
...  

BackgroundGiven the great technical difficulty and procedural complexity of laparoscopic total gastrectomy (LTG), the technical and oncologic safety of LTG versus open total gastrectomy (OTG) in the field of advanced gastric cancer (AGC) is yet undetermined.ObjectiveThis multicenter cohort study aimed to compare the surgical and oncological outcomes of LTG with those of OTG in AGC patients.Patients and MethodsIn total, 588 patients from 3 centers who underwent primary total gastrectomy with D2 lymphadenectomy, by well-trained surgeons with adequate experience, for pathologically confirmed locally AGC (T2N0–3, T3N0–3, or T4N0–3) between January 1, 2011, and December 31, 2015, were identified, and their clinical data were collected from three participating centers. After 1:1 propensity score matching (PSM), 450 cases (LTG, n = 225; OTG, n = 225) were eligible and assessed.ResultsNo significant difference in the number of retrieved lymph nodes, 5-year disease-free survival (DFS) rates, or 5-year overall survival (OS) rates between both surgical groups were observed. Although LTG had significantly longer surgical time (262 vs. 180 min, p &lt; 0.001), LTG was associated with fewer postoperative complications [relative risk (RR) 0.583, 95% CI 0.353–0.960, p = 0.047), less intraoperative bleeding (120 vs. 200 ml, p &lt; 0.001), longer proximal margin resection (3 vs. 2 cm, p &lt; 0.001), and shorter postoperative hospitalization (11 vs. 13 days, p &lt; 0.001). The mortality rate was comparable in both groups.ConclusionsLTG was not inferior to OTG in terms of survival outcomes and was associated with shorter surgical and postoperative hospitalization time and fewer postoperative complications, suggesting LTG with D2 lymphadenectomy as an important alternative to OTG for patients with AGC, but to be carried out in highly experienced centers.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yanrui Liang ◽  
Liying Zhao ◽  
Hao Chen ◽  
Tian Lin ◽  
Tao Chen ◽  
...  

Abstract Background The benefits of adjuvant chemotherapy for elderly patients with gastric cancer (GC) remain unknown because elderly patients are underrepresented in most clinical trials. This study aimed to evaluate the effectiveness and complications of adjuvant chemotherapy in patients > 65 years of age after laparoscopic D2 gastrectomy. Methods This was a single-center retrospective cohort study of elderly patients (> 65 years) with stage II/III GC who underwent curative laparoscopic D2 gastrectomy with R0 resection between 2004 and 2018. The adjuvant chemotherapy regimens included monotherapy (oral capecitabine) and doublet chemotherapy (oral capecitabine plus intravenous oxaliplatin [XELOX] or intravenous oxaliplatin, leucovorin, and 5-fluorouracil [FOLFOX]). The data were retrieved from a prospectively registered database maintained at the Department of General Surgery in Nanfang Hospital, China. The patients were divided as surgery alone and surgery plus adjuvant chemotherapy (chemo group). The overall survival (OS), disease-free survival (DFS), chemotherapy duration, and toxicity were examined. Results There were 270 patients included: 169 and 101 in the surgery and chemo groups, respectively. There were 10 (10/101) and six (6/101) patients with grade 3+ non-hematological and hematological adverse events. The 1−/3−/5-year OS rates of the surgery group were 72.9%/51.8%/48.3%, compared with 90.1%/66.4%/48.6% for the chemo group (log-rank test: P = 0.018). For stage III patients, the 1−/3−/5-year OS rates of the surgery group were 83.7%/40.7%/28.7%, compared with 89.9%/61.2%/43.6% for the chemo group (log-rank test: P = 0.015). Adjuvant chemotherapy was significantly associated with higher OS (HR = 0.568, 95%CI: 0.357–0.903, P = 0.017) and DFS (HR = 0.511, 95%CI: 0.322–0.811, P = 0.004) in stage III patients. Conclusions This study suggested that adjuvant chemotherapy significantly improves OS and DFS compared with surgery alone in elderly patients with stage III GC after D2 laparoscopic gastrectomy, with a tolerable adverse event profile.


2003 ◽  
Vol 13 (4) ◽  
pp. 395-404 ◽  
Author(s):  
B. Winter-Roach ◽  
L. Hooper ◽  
H. Kitchener

A systematic review and meta analysis has been undertaken in order to evaluate the effectiveness of adjuvant therapy following surgery for early ovarian cancer. Trials reported since 1990 have been of a higher quality enabling a meta analysis of adjuvant chemotherapy vs adjuvant radiotherapy and a meta analysis of adjuvant chemotherapy vs observation. There was no significant difference between radiotherapy and chemotherapy, though these comprised studies which demonstrated considerable heterogeneity. Chemotherapy did confer significant benefit over observation in terms of both overall and disease free survival. Except for women in whom adequate surgical staging has revealed well differentiated disease confined to one or both ovaries with intact capsule, platinum chemotherapy should be offered to reduce risk of recurrence.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 205-205
Author(s):  
Daisuke Takahari ◽  
Manabu Ohashi ◽  
Atsuo Takashima ◽  
Takuro Mizukami ◽  
Naoki Ishizuka ◽  
...  

205 Background:TAS-118 (S-1 and leucovorin) + oxaliplatin (L-OHP) improved overall survival (OS) compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC) (Kang, Lancet Oncol. 2020). This study investigated the feasibility of peri (pre and post)-operative (op) chemotherapy (chemo) with TAS-118 ± L-OHP in pts with locally advanced resectable GC. While it was reported that pre-op TAS-118 + L-OHP followed by D2 gastrectomy was well tolerated and showed promising efficay (Takahari, ASCO-GI. 2020), the recommended post-op chemo regimen, TAS-118 or TAS-118 + L-OHP, has yet to be determined. Methods:Eligible pts with GC of clinical T3-4N1-3M0 were enrolled. The protocol treatment consisted of pre-op chemo with 4 courses of TAS-118 (40-60 mg/body, orally, twice daily, 7 days) + L-OHP (85 mg/m2, intravenously, day 1) in a 2-week cycle, and gastrectomy with D2 lymphadenectomy, followed by post-op chemo with 12 courses of TAS-118 (step 1) and 8 courses of TAS-118 + L-OHP (step 2). Step 2 was started if the dose-limiting toxicity (DLT) occurred in < 6 of 10 pts in step 1. Up to 20 pts were included in the analysis of feasibility after a recommended regimen was determined. Results:Between December 2016 and February 2019, 45 pts were enrolled. The numbers of pts with cT3/4a and cN1/2/3 were 13/32 and 25/17/3, respectively. Excluding 14 pts (4 achieving pathological complete response, 4 not satisfying the criteria for post-op chemo, 3 physician judgement or pt withdrawal, 2 progressive disease, 1 adverse event [AE]), 31 pts (11/20 in step 1/2) received the post-op chemo. No DLT was observed in either step. The post-op chemo completion rate was 90.9% (95% CI, 63.6-99.5) in step 1 and 80.0% (95% CI, 59.9-92.9) in step 2. The median relative dose intensity of TAS-118 in step 1 was 83.3%, and those of TAS-118 and L-OHP in step 2 were 69.9% and 74.3%, respectively. One pt in step 2 discontinued post-op chemo due to AE. Grade ³ 3 AEs observed in ≥ 10% of pts were weight loss in both step 1 and step 2 (2 in each), and hypokalemia (n = 3) and neutropenia (n = 2) in step 2. At 1-year follow-up after the last pt was enrolled, recurrence-free survival and OS rates were 91.1% (95% CI, 78.0-96.6) and 100%, respectively at 12 months, and 69.1% (95% CI, 49.6-82.3) and 95.5% (95% CI, 71.9-99.3), respectively at 24 months. Conclusions:Taken together with the feasibility and efficacy of pre-op chemo, peri-op chemo with TAS-118 + L-OHP with D2 gastrectomy was well tolerated and showed promising efficacy. Clinical trial information: UMIN000024688.


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