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

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.

Download Full-text

The Case for Neoadjuvant Therapy in Locally Advanced Gastric Cancer

JAMA Surgery ◽

10.1001/2013.jamasurg.331 ◽

2013 ◽

Vol 148 (4) ◽

pp. 361 ◽

Cited By ~ 1

Author(s):

William G. Hawkins

Keyword(s):

Gastric Cancer ◽

Neoadjuvant Therapy ◽

Advanced Gastric Cancer ◽

Locally Advanced ◽

Locally Advanced Gastric Cancer

Download Full-text

Perioperative Safety and Effectiveness of Neoadjuvant Therapy with Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel Plus Apatinib in Locally Advanced Gastric Cancer

Cancer Management and Research ◽

10.2147/cmar.s304093 ◽

2021 ◽

Vol Volume 13 ◽

pp. 2279-2286

Author(s):

Yonglei Zhang ◽

Bin Zhang ◽

Jinpo Yang ◽

Jindai Zhang ◽

Wei Zhang

Keyword(s):

Gastric Cancer ◽

Neoadjuvant Therapy ◽

Advanced Gastric Cancer ◽

Locally Advanced ◽

Locally Advanced Gastric Cancer ◽

Perioperative Safety

Download Full-text

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

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e15503 ◽

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.

Download Full-text