Lauren Classification Is A Predictor For Pathological Response Of Preoperative Chemoradiotherapy Compared With Preoperative Chemotherapy In Patients With Locally Advanced Gastric Cancer

Author(s):  
Y. Zhang ◽  
Y. Fang ◽  
N. Li ◽  
Y. Ling ◽  
Z.W. Zhou
2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 81-81
Author(s):  
Xiang Wang ◽  
Lin Zhao ◽  
Hongfeng Liu ◽  
Chunmei Bai ◽  
Xiaoyi Li

81 Background: The aim of this study was to evaluate the efficacy and safety of neoadjuvant chemotherapy with the mFOLFOX6 regimen in gastric cancer patients. Methods: This study was a single-arm phase II study. 73 patients with histologically confirmed locally advanced gastric cancer (T2-T4 or N+) were enrolled. The patients were administered the mFOLFOX6 regimen for 3 cycles. Surgery was scheduled 3-4 weeks after the completion of the chemotherapy. Postoperative chemotherapy began 4 weeks after surgery, and the program choice was based on the results of patients’ clinical/pathological evaluations. Perioperative efficacy, toxicity, effects of surgery, postoperative observation, and prognosis were studied. Survival analysis was performed to identify the relationship between the response and outcome and to identify factors predictive of OS. Results: 73 patients received the neoadjuvant chemotherapy, and 67 (91.8%) completed all of the preoperative cycles, with grade 3-4 toxicity arising in 33.0%. Surgery was performed in 71 (97.3%) patients, and radical resection was achieved in 67 (91.8%) patients. Postoperative chemotherapy started in 63 (88.7%) patients. The radiology response rate of chemotherapy was 45.8%. Among the patients who underwent radical surgery, pT downstaging was observed in 22 (32.8%) patients and pN downstaging was observed in 17 (25.4%) patients. All of the patients showed different levels of histological regression of the primary tumour, with a ≥ 50% regression rate of 49.2% and a pCR rate of 3.0%. Univariate analysis identified factors that were associated with OS, including local tumour infiltration, Lauren classification, pre-chemotherapy N stage, ypTNM stage, and pathologic regression rate (GHR)( ≥ 2/3/ < 2/3, ≥ 50%/ < 50%). Multivariate analysis identified both ypTNM stage and Lauren classification as independent predictors of survival. Conclusions: The mFOLFOX6 regimen was very effective and well-tolerated as a neoadjuvant chemotherapy for locally advanced gastric cancer. The ypTNM stage could serve as an independent predictor of survival. GHR ≥ 50% / < 50% could be used as a surrogate marker to guide the selection of a postoperative chemotherapy regimen. Clinical trial information: NCT02226380.


2020 ◽  
Author(s):  
Birendra Kumar Sah ◽  
Benyan Zhang ◽  
Huan Zhang ◽  
Jian Li ◽  
Fei Yuan ◽  
...  

AbstractBackgroundDespite growing trends of neoadjuvant chemotherapy for advanced gastric cancer, there is still no consensus of optimal regimens between East and West countries. Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and Leucovorin (FLOT) regimen has shown promising results in terms of pathological response and survival rate. However, S-1 plus oxaliplatin (SOX) is a more favorable chemotherapy regimen in Eastern countries. We conducted this study to evaluate the safety and efficacy of both regimens, and to explore a suitable regimen for Chinese patients.MethodsPatients with locally advanced gastric cancer(LAGC) were 1:1 randomly assigned to receive either 4 cycles of FLOT or 3 cycles of SOX regimen before curative gastrectomy. The primary endpoint was the comparison of complete or sub-total tumor regression grading (TRG1a+ TRG1b) in the primary tumor.ResultsAltogether 74 cases enrolled between August 2018 and March 2020. All 74 randomly assigned cases were considered as intention-to-treat (ITT) population, and the 55 patients who completed the planned chemotherapy plus surgery were considered as per protocol (PP) population. There was no significant difference in pre-treatment clinicopathological parameters between the FLOT and SOX group(p>0.05). There was no significant difference in adverse effects or postoperative morbidity and mortality between two groups (p>0.05). Similarly, there was no significant difference in the proportion of tumor regression grading between the FLOT and SOX group(p>0.05). In the ITT population, complete or sub-total TRG was 20.0 % in FLOT versus 32.4 % in the SOX group (p>0.05).ConclusionsOur study demonstrates that FLOT and SOX regimens are similarly effective for locally advanced gastric cancer patients in terms of clinical downstaging and pathological response. Both regimens were well-tolerated in this study. A large scale phase 3 randomized controlled trial is necessary to validate this result.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 351-351
Author(s):  
Daisuke Takahari ◽  
Atsuo Takashima ◽  
Takako Eguchi Nakajima ◽  
Naoki Ishizuka ◽  
Manabu Ohashi ◽  
...  

351 Background: TAS-118 is a novel oral agent, containing S-1 and leucovorin. In the SOLAR study (NCT02322593), TAS-118 + oxaliplatin (OHP) significantly improved overall survival compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC). We conducted this open-label study to assess feasibility of perioperative adjuvant chemotherapy with TAS-118 + OHP in pts with locally advanced resectable GC with lymph node metastasis. (Clinical trial information: UMIN000024688). Methods: Eligible pts who had histopathologically confirmed GC with clinical T3-4N1-3M0 on image findings (14th Japanese classification of gastric carcinoma), age 20 to 79 years, were enrolled in this study. The protocol treatment consisted of preoperative 4 courses of TAS-118 (80-120 mg/body, days 1-7) + OHP (85 mg/m2, day 1) every 2 weeks, and gastrectomy with D2 lymphadenectomy, followed by postoperative 12 courses of TAS-118 alone (step1) or 8 cycles of TAS-118 + OHP (step2). The primary endpoints were tolerability of preoperative chemotherapy, gastrectomy and postoperative chemotherapy with TAS-118 plus OHP. Here, we report the feasibility of preoperative chemotherapy and gastrectomy, and pathological response. Results: Between December 2016 and April 2018, 45 pts with a median age of 61 years were enrolled. The numbers of pts with T stage (cT3/4a) and those with N stage (cN1/2/3) were 13/32 and 25/17/3, respectively. The completion rate of preoperative chemotherapy and gastrectomy was 88.9% ( 95% CI 78.0-95.5) and 95.6% (95% CI 86.7-99.2). The relative dose intensity of TAS-118 and OHP was 86.0% and 90.6%. During the 4 cycles of preoperative TAS-118 + OHP, 2 pts discontinued the treatment due to adverse event (AE). Major grade 3-4 AEs were diarrhea (17.8%) and neutropenia (8.9%). R0 resection rate was as high as 95.6%. One pts experienced grade 4 postoperative bleeding, but no treatment-related death was reported. pCR was achieved in 6/45 pts (13.3%) and other 7 pts (28.9%) showed near complete regression (<10 % residual tumor cells). Conclusions: Preoperative TAS-118 + OHP followed by D2 gastorectomy was well tolerated and showed promising efficacy. Clinical trial information: 000024688.


2013 ◽  
Vol 8 (1) ◽  
pp. 6 ◽  
Author(s):  
Joseph M Pepek ◽  
Junzo P Chino ◽  
Christopher G Willett ◽  
Manisha Palta ◽  
Dan G Blazer III ◽  
...  

2020 ◽  
Vol 19 (3) ◽  
pp. 38-46
Author(s):  
V. Yu. Skoropad ◽  
D. D. Kudriavtsev ◽  
L. N. Titova ◽  
S. A. Moserov ◽  
T. A. Agababyan ◽  
...  

The impact of pathological complete response (pCR) on long-term treatment outcomes was analyzed in patients with locally advanced gastric cancer, who received prolonged neoadjuvant chemoradiotherapy.Material and Methods. The study included 45 patients with locally advanced gastric cancer. Neoadjuvant hyperfractionated accelerated radiotherapy at a total dose of 45 Gy was given concurrently with capecitabine and oxaliplatin chemotherapy. There were more men than women. The median age of the patients was 62 years. Tumors were most commonly located in the upper (46 %) and middle (38 %) thirds of the stomach. Low-grade adenocarcinoma and signet-ring cell carcinoma were the most common (65 %). According to a comprehensive examination, including CT and laparoscopy, tumors which invaded the subserous layer of the stomach wall were diagnosed in 17 (37.8 %) patients, and tumors which penetrated the serous layer or surrounding structures were found in 28 (62.2 %) patients. Regional lymph node metastases were detected in 38 (84.4 %) cases.Results. The absolute majority of patients underwent gastrectomy (43 patients, 96 %). Grade IaIb pathological response occurred in almost half of the patients (45.4 % of cases). Peritoneal metastases were found to be the most common mode of cancer dissemination; they were mostly observed in patients with poorly differentiated gastric cancer. Multivariate analysis revealed no effect of any of the factors characterizing the patient, tumor and completeness of treatment on the pathological response grade. However, a correlation between the clinical and morphological assessments of tumor regression was observed. In cases with complete or partial responses of the primary tumor and regional lymph nodes to chemoradiotherapy, 1aIb grades of pathological response were more frequently observed. It was also demonstrated a direct correlation between the pathological response grade and pathomorphological stage of the tumor (yp), as well as ypT and ypN categories. Analysis of long-term treatment outcomes showed that the overall and relapse-free 5-year survival rates were significantly higher in patients with 1a and Ib grades of pathological response. The overall 3-year survival rates were 70 ± 10 % and 41 ± 11 %, respectively (p=0.003). Multivariate analysis using the Cox regression model confirmed a statistically significant independent effect of the pathological response grade on the overall survival (p=0.015).Conclusion. Grade IaIb pathological response was observed in almost half of the patients, who received neoadjuvant chemoradiotherapy for locally advanced gastric cancer. No clinical and morphological factors influencing the pathological response grade were found. A correlation between the clinical and morphological assessments of tumor regression was observed. Patients with Ia-Ib pathological response had significantly higher overall and disease-free survival rates. 


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