A multicenter, single-armed, prospective phase II study of apatinib combined with chemotherapy neoadjuvant for locally advanced gastric cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15508-e15508
Author(s):  
JianXian Lin ◽  
Changming Huang
Keyword(s):  
Gastric Cancer ◽  
Prospective Study ◽  
Disease Control ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Disease Control Rate ◽  
R0 Resection ◽  
Resection Rate ◽  
Locally Advanced Gastric Cancer

e15508 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 tyrosine kinase inhibitor, 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 (LADG). Methods: This is a multicenter, single-armed, prospective study. Patients with LAGC (cT2-4N+M0) without prior anti-cancer strategies were included. Patients were received 3 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 outcome was safety of the neoadjuvant therapy. The secondary outcomes included R0 resection rate, objective response rate (ORR), and disease control rate (DCR). Results: A total of 30 patients from 7 centers in China were recruited between Sep. 1, 2017 and Aug. 31, 2018. There were 21 males and 9 females. The median age was 66 years (range 41-75 years). There were 25 patients with tumor response evaluation, 18 patients had partial response (PR), 6 patients had stable disease (SD), and 1 patient had progressive disease (PD). The ORR and DCR were 72.0% (18/25) and 96.0% (24/25), respectively. 10 patients discontinued the study (withdrew consent 8 patients, physical deterioration in performance status 1 patient, and Disease progression 1 patient). 20 patients received gastric surgery, the R0 resection rate was 100%, 3 patients had postoperative complication: one had intestinal obstruction and two had pneumonia (all Clavien-Dindo classification less than grade II). All patients were included for safety analysis. The incidence of adverse events (AEs) and grade 3/4 AEs were 56.7% (17/30) and 6.7% (2/30), respectively. The most common AEs were leucopenia (33.3%), liver function damage (6.7%), up-GI hemorrhage (6.7%), and hypertension (6.7%). Conclusions: This prospective study shows that neoadjuvant therapy using apatinib plus SOX brings clinical benefit to LAGC with a high disease control rate and tolerable adverse reactions. This study is registered at ClinicalTrials.gov and carries the following ID number: NCT 03192735. Clinical trial information: NCT 03192735.

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.

Safety and efficacy of neoadjuvant chemotherapy with S-1 and oxaliplatin plus apatinib for locally advanced gastric cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15503-e15503
Author(s):  
Ya'nan Zheng ◽  
Xiao Yang ◽  
Zhentian Ni ◽  
Zhenglun Zhu ◽  
Wei Xu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
R0 Resection ◽  
Resection Rate ◽  
Surgical Morbidity ◽  
Safety And Efficacy ◽  
Locally Advanced Gastric Cancer

e15503 Background: Locally advanced gastric cancer (LAGC) has a poor prognosis. Neoadjuvant chemotherapy can reduce tumor loading, degrade staging and increase possibility of complete resection, thus prolonging the survival of LAGC patients (pts). We conducted a phase II trial to assess the feasibility of SOX regimen in combination with apatinib (an anti-angiogenic agent) as neoadjuvant therapy in LAGC. Methods: This study recruited untreated LAGC pts with pathologically and/or cytologically confirmed adenocarcinoma. Treatment included three 21-day cycles of apatinib (oral, 500 mg qd; discontinued in the last cycle), S-1 (oral, 40-60 mg, bid, day 1-day 14) and oxaliplatin (iv, 130 mg/m2, day 1), followed by radical surgery after 4 weeks. The primary outcome was neoadjuvant therapy related toxicity, and the secondary outcomes included tumor response, R0 resection rate, postoperative pathological evaluation and surgical morbidity. Results: Between December 2, 2016 and August 1, 2018, 31 patients were enrolled. Total 29 patients were eligible for safety and efficacy analyses of SOXA as NAC. During NAC treatment, the incidence of adverse events (AEs, any grade) was 100%, and the incidence of grade 3/4 AEs was 34.48%. No treatment-related death. The ORR of 79.31% (95%CI, 60.28-92.01%) and DCR of 96.55% (95%CI, 82.24-99.91%) were achieved. One patient was evaluated as PD with hepatic metastasis after 3 cycles of preoperative chemotherapy, and this case was inoperable. Resection with curative intent was undertaken in 28 patients with R0 resection rate of 100%. Operative morbidity was observed in 12 of 28 patients including fever (9, 32.14%), anastomotic leakage (1, 3.57%), fat liquefaction of post-surgical incision (1, 3.57%), and gastroparesis (1, 3.57%). Additionally, after surgery 1 patient had pulmonary infection and 1 patient had pleural effusion. The median tumor regression was 90% on pathological findings after surgery. Conclusions: Neoadjuvant therapy with apatinib plus SOX for LAGC showed acceptable toxicity and promising efficacy.

scholarly journals The Safety and Efficacy of Laparoscopic Gastrectomy for Patients with Locally Advanced Gastric Cancer Following Neoadjuvant Chemotherapy

2020 ◽  
Author(s):  
Lihang Liu ◽  
Feng Li ◽  
Shengtao Lin ◽  
Yi Liu ◽  
Changshun Yang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Postoperative Complications ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Laparoscopic Gastrectomy ◽  
Locally Advanced ◽  
R0 Resection ◽  
Resection Rate ◽  
Locally Advanced Gastric Cancer ◽  
Significant Difference

Abstract Background: Limited researches focused on the application of laparoscopic gastrectomy (LG) in locally advanced gastric cancer (LAGC) patients following neoadjuvant chemotherapy (NACT). In this study, we aimed at illustrating the surgical and survival outcome of LG in LAGC patients following NACT.Methods: We performed a retrospective study of patients with LAGC who received either LG following NACT or upfront LG at Fujian Provincial Hospital between March 2013 and October 2018. Perioperative parameters, short-term and long-term outcomes were compared. The Kaplan-Meier estimator was used to describe the survival curves, and the differences were examined by the log-rank test.Results: In total, 76 consecutive patients were enrolled into the NACT-LG (41 patients) and LG (35 patients) group, respectively. There was no significant difference between the two groups for baseline characteristics, including age, sex, BMI, Eastern Clinical Oncology Group performance status, tumor size, location, Borrmann type, Lauren type, differentiation, cT stage, and surgical type (all P>0.05). The surgical trauma in terms of incision length and blood loss, and postoperative recovery in terms of first aerofluxus time, first time on liquid diets, drainage duration, and hospital stays were similar between the two groups (all P>0.05). The operation time was significantly longer for NACT-LG than for LG (286.5 vs. 248.9 min, P=0.008). There was no significant difference in surgical morbidity (19.5% vs. 22.9%, P=0.721) between the two groups. No patient died of postoperative complications in the NACT-LG group, and one patient (1/35, 2.9%) died of postoperative complications in the LG group (P=0.461). After NACT, the R0 resection rate was significantly higher (95.1% vs. 77.1%, P=0.049), and metastatic lymph nodes were less for NACT-LG than for LG (1 vs. 8, P=0.001). Compared with the LG group, the NACT-LG group had a significantly better DFS (59.4% vs. 14.4%, P=0.034) and better OS (69.0% vs. 37.4%, P=0.009) at 3 years.Conclusions: NACT does not decrease safety of LG for patients with LAGC and offer higher R0 resection rate and better disease-free and overall survival. For patients with LAGC, LG following NACT should be the priority treatment.

CPT-11/Cisplatin neoadjuvant therapy downstages locally advanced gastric cancer

2001 ◽  
Vol 120 (5) ◽  
pp. A129-A129
Author(s):  
E NEWMAN ◽  
S MARCUS ◽  
M POTMESIL ◽  
H HOCHSTER ◽  
H YEE ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Locally Advanced Gastric Cancer

scholarly journals Neoadjuvant therapy for locally advanced gastric cancer patients. A population pharmacodynamic modeling

PLoS ONE ◽  
2019 ◽  
Vol 14 (5) ◽  
pp. e0215970 ◽  
Author(s):  
Patricia Martin-Romano ◽  
Belén P. Solans ◽  
David Cano ◽  
Jose Carlos Subtil ◽  
Ana Chopitea ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Locally Advanced ◽  
Pharmacodynamic Modeling ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients

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]

Multicenter phase II study of neoadjuvant chemotherapy consisted with S-1 and oxaliplatin followed by gastrectomy for locally advanced gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS180-TPS180
Author(s):  
Yoshihiro Okita ◽  
Hironaga Satake ◽  
Hiroyuki Okuyama ◽  
Masato Kondo ◽  
Akira Miki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Curative Resection ◽  
Locally Advanced ◽  
Nodal Involvement ◽  
Resection Rate ◽  
Locally Advanced Gastric Cancer ◽  
Large Type ◽  
Type 3

TPS180 Background: Prognosis for locally advanced gastric cancer, such as clinical T4 disease, bulky nodal involvement, type 4 and large type 3 gastric cancer, was not satisfactory even by D2 gastrectomy followed by adjuvant chemotherapy. Neoadjuvant chemotherapy is another promising approach. In our phase I study, neoadjuvant chemotherapy of S-1 and oxaliplatin (SOX) had manageable toxicities and good pathological complete response rate (33%) in patients with locally advanced gastric cancer. Based on the results of this phase I study, we initiate a multi-institutional, single-arm, open label, phase II study (Neo G-SOX PII study). The aim of this study is to evaluate the efficacy and safety of the neoadjuvant chemotherapy of S-1 and oxaliplatin (SOX) followed by gastrectomy with D2/3 lymph node dissection; clinical T4; clinically resectable gastric cancer of type 4 or large type 3 (over 8 cm); bulky nodal involvement around major branched arteries to the stomach Methods: Eligibility criteria include histologically proven adenocarcinoma of the stomach; clinical T4; clinically resectable gastric cancer of type 4 or large type 3 (over 8 cm); bulky nodal involvement around major branched arteries to the stomach; resectable peritoneal dissemination (pathological CY1 or P1, except for clinical CY1 or P1). Patients receive two cycles of neoadjuvant chemotherapy with S-1 (80 mg/m2, p.o., days 1-14 followed by 1 week rest) and oxaliplatin (130 mg/m2 at day 1), followed by D2 or higher surgery with no residual disease. Patients with pathological R0/1 resection received S-1 (80 mg/m2, p.o., days 1-28 followed by 2 week rest) for 1 year as adjuvant chemotherapy. Primary endpoint is curative resection rate. Key secondary endpoints include pathological response, R0/1 resection rate, dose-intensity, overall survival, relapse free survival and safety. We set the threshold curative resection rate at 65% and the expected curative resection rate at 80%. Given a one-sided α of 0.1 and statistical power of 80%, 40 patients was required. Clinical trial information: UMIN000018661 Clinical trial information: UMIN000018661.

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