Phase I study of neoadjuvant chemoradiotherapy as an outpatient setting for patients with resectable advanced gastric cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 84-84 ◽  
Author(s):  
Tsunehiro Takahashi ◽  
Yoshiro Saikawa ◽  
Norihito Wada ◽  
Hirofumi Kawakubo ◽  
Hiroya Takeuchi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Therapeutic Effect ◽  
Dose Range ◽  
Neoadjuvant Chemoradiotherapy ◽  
Chylous Ascites ◽  
High Rate ◽  
Recommended Dose ◽  
R0 Resection ◽  
Number Of Patients

84 Background: The prognosis for advanced gastric cancer remains poor because of a high rate of metastasis or recurrence. Therefore, treatment options that might improve the prognosis are needed. Radiation is expected to improve the rate of curable resection and local recurrence. To that end, neoadjuvant chemoradiotherapy with S-1 and cisplatin (CDDP) was investigated. Methods: Advanced gastric cancer patients with regional lymph nodes metastases enrolled in this study. The chemoradiotherapy consisted of S-1 on days 1–14 and CDDP on days 1 and 15. The dose range of CDDP in the study was 15 mg/m2 to 30 mg/m2. Radiation therapy was started concurrently with chemotherapy and repeated daily on days 1–5, 8–12, 15–19, and 22–26. After the initial chemoradiation therapy, the chemotherapy was repeated within 2 weeks after the termination of radiotherapy. Surgery was scheduled to take place within 6 weeks after completion of the second cycle of chemotherapy. Results: A total of 9 patients were recruited. There was no dose-limiting toxicity (DLT) in patients both 15 mg/m2 and 20 mg/m2. In the next three patients at 25 mg/m2, there were two cases with DLTs. Therefore, the recommended dose (RD) of CDDP was 20 mg/m2. Eight patients underwent surgery and all had an R0 resection. Postoperative complications occurred in two cases (pancreatic fistula and chylous ascites). However, there was no treatment-related death. The grades of histological therapeutic effect were Grade 1a in two patients, Grade 1b in one patient and Grade 2 in four patients. One patient had no viable cancer cells, which is classified as a Grade 3 histological therapeutic effect and represented a pathological CR. Conclusions: The recommended dose of CDDP is 20mg/m2 bi-weekly and its safety and feasibility as a preoperative therapy are supported in this study. Neoadjuvant chemoradiotherapy can provide remarkable shrinkage of tumors and increases in curability rate would be expected. Further clinical trials in a larger number of patients are recommended to evaluate the validation of neoadjuvant chemoradiotherapy with S-1 and CDDP as a standard treatment strategy for resectable advanced gastric cancer. Clinical trial information: UMIN000008941.

Neoadjuvant chemoradiotherapy plus postoperative adjuvant XELOX chemotherapy versus postoperative adjuvant chemotherapy with XELOX regimen for local advanced gastric cancer-A randomized, controlled study

2021 ◽  
pp. 20201088
Author(s):  
Fuli Wang ◽  
Aizhong Qu ◽  
Yinping Sun ◽  
Jifeng Zhang ◽  
Benzun Wei ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Postoperative Complications ◽  
Advanced Gastric Cancer ◽  
Neoadjuvant Chemoradiotherapy ◽  
Regional Recurrence ◽  
R0 Resection ◽  
Resection Rate ◽  
Postoperative Adjuvant Chemotherapy ◽  
Local Advanced

Objective: The aim of this study was to compare the clinical efficacy of neoadjuvant chemoradiotherapy (NACRT) combined with postoperative adjuvant XELOX (Oxaliplatin +Capecitabine) chemotherapy and postoperative adjuvant chemotherapy (ACT) with XELOX for local advanced gastric cancer (LAGC). Methods: In this prospectively randomized trial, we investigated the effect of NACRT combined with postoperative ACT for LAGC. 60 patients were randomly divided into NACRT group and ACT group, with 30 patients in each group. Patients in NACRT group were given three-dimensional conformal radiotherapy (45 Gy/1.8 Gy/f) accompanied by synchronous XELOX of two cycles, followed by surgery, and then postoperative adjuvant XELOX chemotherapy of four cycles was performed. Patients in ACT group received surgery in advance, and then XELOX chemotherapy of six cycles was given. Results: The objective response rate of NACRT was 76.7%. The overall incidence of postoperative complications in NACRT group was not significantly different from that in ACT group (23.1% vs 30.0%, p = 0.560). The 1 year, 2 years, and 3 years progression-free survival (PFS）and overall survival (OS) in NACRT and ACT groups were 80.0% vs 56.7%, 73.3% vs 46.7%, 60.0% vs 33.3%, and 86.7% vs 80.0%, 76.7% vs 66.7%, 63.3% vs 50.0%, respectively. Patients in NACRT group showed a significantly higher R0 resection rate (84.6% vs 56.7%, p = 0.029),lower loco-regional recurrence rate (36.7% vs 11.5%, p = 0.039), longer PFS (p = 0.019) and freedom from locoregional progression(FFLP) (p = 0.004) than patients in ACT group, while there was no difference in OS (p = 0.215) and in toxicity incidence (p > 0.05). Conclusions: NACRT combined with postoperative adjuvant XELOX chemotherapy can improve R0 resection rate, reduce loco-regional recurrence, prolong PFS and FFLP without increasing the incidence of postoperative complications in patients with LAGC. Advances in knowledge: Compared with postoperative adjuvant chemotherapy, locally advanced gastric cancer patients may benefit from neoadjuvant chemoradiotherapy, and toxicity associated with chemoradiotherapy was tolerant and manageable.

Impact of preoperative treatment with chemoradiotherapy or chemotherapy in patients with locally advanced or irresecable gastric cancer (LAGC).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 167-167
Author(s):  
C Diaz Romero ◽  
G Calderillo Ruiz ◽  
Marytere Herrera ◽  
E Ruiz Garcia ◽  
H Lopez Basave ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Pathologic Response ◽  
High Rate ◽  
Gastric Disease ◽  
R0 Resection ◽  
Preoperative Treatment ◽  
Post Surgery

167 Background: The only curative treatment for gastric cancer remains surgery neoadjuvant chemoradiotherapy (NACRT) has shown decrease of staging and improve survival. La NACRT has been studied in esophagus cancer and Gastroesophagic Junction cancer but this trials did not include advanced gastric disease. The aim of our study was to investigate the role of Chemoradiotherapy (CTR) and chemotherapy (CT) in the treatment of LAGC. Methods: We retrospectively reviewed the medical records of 108 patients who were treated between December 2010 and January 2015, with preoperatory CRT or chemotherapy preoperatory (CT). Evaluating parameters of resectability, pathological response complete, prognostic with a 3-year follow-up. Results: 108 patients were analyzed, 61 man and 47 women, with median age 55 years, 83 (76.8%) with diffuse, 25 (23.2%) intestinal histology, however 83 patients (76.8%) had component of signet ring cells. Of the 108 patients, 41 (38%) received chemotherapy and 67 (62%) received CRT preoperative. R0 radical surgery was possible in 41 patients of which 24.3% (10/41) were in the group of CT and 46% (31/67) CRT group. Radiological progression was documented in 8 (19.5%) patients with CT and 11 (16.4%) with CRT. 7 patients were considered inoperable and 17 unresectable at the end of the preoperative treatment. The carcinomatosis was documented during the surgery in 11 and 12 patients in the CT or CRT group respectively. 10 patients developed complications gastrointestinal and hematologic to the treatment with CT and 23 patients with CRT, which 4 patients in CRT needed reoperation post-surgery. Any patient in the chemotherapy group reached complete pathologic response while of the CRT group achieved 5 complete pathological responses. Medium-3 years follow-up survival rate was 11% in the group treated with CT and 23% with CRT. Conclusions: Our revision showed a high rate of pathologic response and survival in patients with LAGC that received CRT preoperative followed by gastrectomy. On the other hand R0 resection has been reported to be a predictive factor for survival in this study were found more patients with resectable tumor after CRT preoperative.

scholarly journals Long-term outcomes of omentum-preserving versus resecting gastrectomy for locally advanced gastric cancer with propensity score analysis

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Yusuke Sakimura ◽  
Noriyuki Inaki ◽  
Toshikatsu Tsuji ◽  
Shinichi Kadoya ◽  
Hiroyuki Bando
Keyword(s):  
Gastric Cancer ◽  
Propensity Score ◽  
Advanced Gastric Cancer ◽  
Missing Values ◽  
Propensity Score Analysis ◽  
Locally Advanced ◽  
R0 Resection ◽  
Significant Difference ◽  
First Recurrence ◽  
The Impact

Abstract Omentectomy is conducted for advanced gastric cancer (AGC) patients as radical surgery without an adequate discussion of the effect. This study was conducted to reveal the impact of omentum-preserving gastrectomy on postoperative outcomes. AGC patients with cT3 and 4 disease who underwent total or distal gastrectomy with R0 resection were identified retrospectively. They were divided into the omentum-preserved group (OPG) and the omentum-resected group (ORG) and matched with propensity score matching with multiple imputation for missing values. Three-year overall survival (OS) and 3-year relapse-free survival (RFS) were compared, and the first recurrence site and complications were analysed. The numbers of eligible patients were 94 in the OPG and 144 in the ORG, and after matching, the number was 73 in each group. No significant difference was found in the 3-year OS rate (OPG: 78.9 vs. ORG: 78.9, P = 0.54) or the 3-year RFS rate (OPG: 77.8 vs. ORG: 68.2, P = 0.24). The proportions of peritoneal carcinomatosis and peritoneal dissemination as the first recurrence site and the rate and severity of complications were similar in the two groups. Omentectomy is not required for radical gastrectomy for AGC.

A single-arm, phase II feasibility study of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy in potentially resectable gastric or gastroesophageal junction adenocarcinoma.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 96-96
Author(s):  
M. Ryu ◽  
Y. Choi ◽  
B. Kim ◽  
Y. Park ◽  
H. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Residual Disease ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Phase Iii ◽  
R0 Resection ◽  
Locally Advanced Gastric Cancer ◽  
Grade 3

96 Background: The aim of this study was to evaluate feasibility and safety of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy in patients with potentially resectable adenocarcinoma of stomach or gastroesophageal junction. Methods: Forty-one patients with clinical stage T3-4N0M0 or T2-4N+M0 determined by CT, endoscopic ultrasonography, and laparoscopy were enrolled between DEC 2008 and MAR 2010. Gastrectomy with D2 lymph node dissection was conducted after 3 cycles of DOS chemotherapy. DOS chemotherapy consists of docetaxel 50 mg/m2 iv (day1), oxaliplatin 100 mg/m2 iv (day1), and S-1 40 mg/m2 po bid (days1-14) at 3 weeks interval. After curative gastrectomy, the patients were given 1 year of adjuvant chemotherapy with S-1 (40 mg/m2 D1-28, every 6 weeks). Results: All patients finished the planned neoadjuvant chemotherapy. Twenty-three (56%) patients achieved a partial response, and the remaining 18 patients had stable disease by CT scan after 3 cycles of DOS chemotherapy. No disease progression was observed during the neoadjuvant chemotherapy. A median 4.7 weeks (range, 4.0-7.6) after the start of the 3rd cycle of DOS chemotherapy, 39 (95%) patients underwent R0 resection with no pathologic residual disease in 4 (10%) patients. Hematologic toxicities were common including grade 4 neutropenia (32%), grade 3 thrombocytopenia (17%), and febrile neutropenia (10%). However, hematologic toxicities were generally transient and manageable. There were no grade 3 or 4 non-hematologic toxicities with frequency > 5% of patients. With all toxicities taken together, 21 (51%) patients experienced grade 3 or 4 toxicities (except grade 3 neutropenia). There was no treatment-related death, and surgical complications included only mild wound problem in 4 (10%) patients. Conclusions: In this study, neoadjuvant DOS chemotherapy could induce a sufficient down-staging and R0 resection of locally advanced gastric cancer with mild and manageable toxicities. A phase III randomized trial is planned for evaluating the benefit of neoadjuvant DOS chemotherapy in patients with locally advanced gastric cancer. [Table: see text]

Apatinib combined with SOX neoadjuvant therapy for locally advanced gastric cancer: A multicenter, single-armed, prospective study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 367-367
Author(s):  
Jian-Xian Lin ◽  
Changming Huang
Keyword(s):  
Gastric Cancer ◽  
Prospective Study ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Gastric Surgery ◽  
R0 Resection ◽  
Resection Rate ◽  
Locally Advanced Gastric Cancer ◽  
Tumor Response Evaluation

367 Background: Molecular targeted therapy has made great progress in the treatment of gastric cancer. In some previous studies, apatinib, an oral small molecular of VEGFR-2 TKI, had been confirmed can improve OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. However, there is limited evidence about the safety and feasibility of apatinib combined with SOX regimen as neoadjuvant therapy for locally advanced gastric cancer (AGC). Methods: This is a multicenter, single-armed, prospective study. Patients with AGC (cT2-4N+M0) without prior anti-cancer strategies were included. Patients were received 2 to 5 cycles (21 days a cycle) of neoadjuvant therapy using S-1 (po, 40-60 mg bid, day1-day14), oxaliplatin (iv, 130 mg/m2, day1), and apatinib (po, 500 mg qd). Apatinib was prohibited in the last cycle. The operation should be performed 2 to 4 weeks later of the neoadjuvant therapy. The primary endpoint was R0 resection rate. The secondary endpoint included safety, ORR, and DCR. Results: A total of 56 patients from 10 centers in China were recruited. There were 43 males and 13 females. The median age was 63.04 years (range 41-75 years). There were 43 patients with tumor response evaluation, 29 patients (67.4%) had partial response (PR), 12 patients (27.9%) had stable disease (SD), and 2 patient (4.6%) had progressive disease (PD). The ORR and DCR were 67.4% (29/43) and 95.3% (41/43), respectively. 36 patients received gastric surgery, the R0 resection rate was 97.2%, 3 patients had postoperative complication: one had intestinal obstruction and 2 had pneumonia (all Clavien-Dindo classification less than grade II). 46 patients were included for safety analysis. The incidence of adverse events (AEs) and grade 3/4 AEs were 84.8% (39/46) and 17.4% (8/46), respectively. The most common AEs were neutropenia (40%), low platelet count (40%), leucopenia (32.6%), vomit (13%). Conclusions: This prospective study shows that neoadjuvant therapy using apatinib plus SOX brings clinical benefit to AGC with a high disease control rate and tolerable adverse reactions. Clinical trial information: NCT 03192735.

scholarly journals Neoadjuvant Chemotherapy with FOLFOX4 Regimen to Treat Advanced Gastric Cancer Improves Survival without Increasing Adverse Events: A Retrospective Cohort Study from a Chinese Center

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Zhen Sun ◽  
Rui-Juan Zhu ◽  
Gui-Fang Yang ◽  
Yan Li
Keyword(s):  
Gastric Cancer ◽  
Cohort Study ◽  
Neoadjuvant Chemotherapy ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
R0 Resection ◽  
Ki 67 ◽  
Lymph Nodes Dissection

Background/Aim. To evaluate the clinical efficacy of FOLFOX4 (5-fluomumcil/leucovorin combined and oxaliplatin) neoadjuvant chemotherapy for advanced gastric cancer (AGC).Patients and Methods. Fifty-eight AGC patients were enrolled in this retrospective cohort study, 23 in the neoadjuvant group and 35 in the adjuvant group. R0 resection, survival, and adverse events were compared.Results. The two groups were well-matched, with no significant differences in R0 resection rate (82.6% versus 82.0%) and number of lymph nodes dissection (16 (0–49) versus 13 (3–40)) between the two groups(P>0.05). The number of lymph node metastases in the neoadjuvant group (3 (0–14)) was significantly fewer than that in the adjuvant group (6 (0–27))(P=0.04). The neoadjuvant group had significantly better median overall survival (29.0 versus 22.0 months) and 3-year survival rate (73.9% versus 40.0%) than the adjuvant group(P=0.013). The positive expression rate of Ki-67 in the neoadjuvant group (40.0%, 8/20) was lower than that in the adjuvant group (74.2%, 23/31;P=0.015).Conclusion. The FOLFOX4 neoadjuvant chemotherapy could improve survival without increasing adverse events in patients with AGC.

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