O-0012 Prognostic Factors of Overall Survival (OS) in Previously Treated Advanced Gastric Cancer (AGC): Analysis of the Phase 3 Granite-1 Trial

215 Background: The purpose of this study is to evaluate significant prognostic factor and compare the cause of death in patients with advanced or recurrent gastric cancer. Methods: We reviewed the medical records of 170 patients who had been diagnosed as advanced or recurrent gastric cancer between January 2006 and September 2013. The patients were divided into two groups. One group (advanced gastric cancer: AC) included 104 patients had undergone chemotherapy for advanced gastric cancer, and the other group (recurrent gastric cancer: RC) 66 for recurrence after surgical treatment. The causes of death and overall survival were compared between two groups, and the significant prognostic factors were investigated by multivariate analysis. Also, subgroup analysis was performed for 18 patients with gastrectomy for curative intent, and they were proved to have unresectable gastric cancer after surgery (non-palliative surgery for advanced gastric cancer: NS). Results: In the comparison for the causes of death, two groups showed no statistical difference, but AC group had more tendency to die because of bleeding ( p = 0.054) and infection ( p = 0.075). Overall survival of AC group did not differ from that of RC ( p = 0.901). In multivariate analysis, bone metastasis ( p = 0.013, HR = 1.923), peritoneal seeding ( p = 0.001, HR = 2.182) and the frequency of chemotherapy ( p < 0.001, HR = 0.887) were significantly associated with the overall survival. In a subgroup analysis, the overall survival of NS was significantly higher than AC ( p = 0.032). Conclusions: In the patients with advanced or recurrent gastric cancer, AC might have more possibility to die because of bleeding and infection than RC. Additionally, the prognosis of patients with advanced or recurrent gastric cancer was affected by the presence of bone metastasis, peritoneal seeding and frequency of chemotherapy. Non-palliative surgery for gastric cancer might show the better prognosis than AC in the specific conditions.

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Prognostic factors for survival in patients with advanced gastric cancer treated with chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.142 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. 142-142

Author(s):

Montserrat Mangas ◽

Alberto Carmona Bayonas ◽

Maria Luisa Sanchez Lorenzo ◽

Avinash Ramchandani ◽

Teresa Garcia ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Prognostic Factors ◽

Advanced Gastric Cancer ◽

Group Performance ◽

Gastroesophageal Junction ◽

Cox Proportional Hazards Model ◽

Her2 Status ◽

Her2 Positive ◽

Ecog Ps

142 Background: A prognostic model in advanced gastric cancer that integrates the Her2 status,histopathological classifications and other patient’s or treatment-dependent parameters is lacking. The aim is to identify clinicopathological factors for overall survival in a cohort of patients with advanced gastric cancer. Methods: 526 consecutive patients with advanced adenocarcinoma of the distal esophagus, gastroesophageal junction or stomach were analyzed. All patients were treated with poly-chemotherapy ( ≥ 2 drugs) at 19 Spanish and one Chilean centers between 2012 and 2015. Characteristics of patients, tumors, therapies and pathological factors, were analyzed by a Cox proportional hazards model. Results: The median overall survival was 10.3 months [95% confidence interval (CI), 9.5-11.1], and the time to progression was 6.7 months (95% CI, 6.1-7.2). Independent prognostic factors associated with overall survival were: distal non-diffuse histopathological subtype (hazard ratio, (HR) 0.73), Her2 positive 3+ (HR 0.54), Her2 positive 2+ with FISH + (HR 0.68), surgery of metastases (HR 0.34), Eastern Cooperative Group performance status (ECOG PS) 2 (HR 2.5), ECOG PS 3 (HR 7.37), and only distant lymph node metastases (HR 0.63) (Table 1). Conclusions: We have identified clinicopathological prognostic factors that could be important to stratify advanced gastric cancer, with potential implications in research and treatment. [Table: see text]

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Phase II study of S-1 monotherapy in taxane, cisplatin refractory gastric cancer

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.4551 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 4551-4551

Author(s):

S. Cho ◽

S. Lee ◽

J. Hwang ◽

W. Bae ◽

H. Shim ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Advanced Gastric Cancer ◽

Clinical Benefit ◽

Phase Ii Study ◽

Progression Free Survival ◽

Salvage Chemotherapy ◽

Free Survival ◽

Previously Treated ◽

Grade 3

4551 Background: S-1 is a fourth-generation oral fluoropyrimidine that was developed to mimic protracted continuous infusion of 5-fluorouracil (5-FU). In previous study, S-1 demonstrated promising activity which is comparable to combination chemotherapy in advanced gastric cancer. This phase II study evaluated the efficacy and safety of S-1 salvage chemotherapy, in patients with taxane and cisplatin refractory gastric cancer. The primary end point was progression free survival and secondary end points were overall survival, safety and clinical benefit. Methods: Patients were eligible if they had histologically documented gastric adenocarcinoma previously treated with taxane (docetaxel or paclitaxel) and cisplatin; age≥18; Eastern Clinical Oncology Group (ECOG) performance status of 2 or less; adequate organ function; no evidence of gastrointestinal obstruction or passage disturbance. S-1 treatment was performed according to BSA as followed; < BSA 1.25, 80 mg/day, 1.25 ≤ BSA < 1.5, 100 mg/day; BSA ≥ 1.5, 120 mg/day. Every dosage was delivered divided two times and administered for 4 weeks followed by 2 weeks of resting period. Treatment continued until progression of disease or life-threatening adverse events were occurred. Results: Fifty-four patients were enrolled in this study and of the patients, forty-eight patients were evaluable. A total 194 chemotherapy cycles were administered and median number of cycles was three. Four (8.3%) patients had a partial response and 18 (37.5%) patients had stable disease. The median progression free survival and overall survival were 3.8 and 10.2 months, respectively. Grade III/IV hematologic toxicities included neutropenia in 6 patients (12.5%) and there was no febrile neutropenia. Most of nonhematologic toxicities were diarrhea, asthenia, and mucositis, and there was no grade 3 or grade 4 except two patients, who developed grade 3 anorexia and diarrhea, respectively. The clinical benefit response was observed in 16 patients (33.3%). Conclusions: This results showed that S-1 monotherapy was active and safe salvage chemotherapy in patients with advanced gastric cancer previously treated with taxane and cisplatin. No significant financial relationships to disclose.

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Efficacy and Outcomes of Intraoperative Extensive Lavage Plus Surgery Versus Surgery Alone in Patients with Advanced Gastric Cancer: A Multicenter Randomized Controlled Trial

10.21203/rs.3.rs-714279/v1 ◽

2021 ◽

Author(s):

Li-xiang Zhang ◽

Chuan-hong Li ◽

Jun Ma ◽

Lei Chen ◽

Zhi-jian Wei ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Prognostic Factors ◽

Advanced Gastric Cancer ◽

Cancer Patients ◽

Survival Curve ◽

Recurrence Free Survival ◽

Abdominal Abscess ◽

Free Survival ◽

Gastric Cancer Patients

Abstract Objective: This randomized study aims to evaluate the efficacy and long-term outcome of advanced gastric cancer patients with extensive intraoperative peritoneal lavage (EIPL). Methods: A total of 150 patients with advanced gastric cancer were enrolled in this study, the patients were randomly allocated to 2 groups: the group of surgery alone (non-EIPL group), the group of surgery plus EIPL (EIPL group). The surviving rate analysis was compared by the Kaplan–Meier method. The prognostic factors were carried out using the Cox appropriate hazard pattern. Results: Symptom of ileus and abdominal abscess appeared more frequently in the non-EIPL group(p<0.05). The overall survival (OS) curve and the recurrence free survival (RFS) curve of the EIPL group was better than the non-EIPL group (p<0.05). The EIPL, tumor size, vascular invasion, N stage and T stage were independent prognostic factors of overall survival. The independent risk factors of recurrence free survival (RFS) include EIPL and tumor size. Conclusions: The present study revealed that EIPL can reduce the possibility of perioperative complications including ileus and abdominal abscess. Besides, the overall survival curve and recurrence free survival curve are better in the EIPL group. This technique is easy and not-expensive, therefore EIPL can benefit advanced gastric cancer patients a lot and would be a promising therapeutic strategy in the future.Trial Registration: Clinical Trials.gov, identifier: NCT02745509, Registered 28 March2016,https://clinicaltrials.gov/ct2/show/NCT02745509?cond=NCT02745509&draw=2&rank=1.

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Nab-paclitaxel versus solvent-based paclitaxel in patients with previously treated advanced gastric cancer (ABSOLUTE): an open-label, randomised, non-inferiority, phase 3 trial

The Lancet Gastroenterology & Hepatology ◽

10.1016/s2468-1253(16)30219-9 ◽

2017 ◽

Vol 2 (4) ◽

pp. 277-287 ◽

Cited By ~ 49

Author(s):

Kohei Shitara ◽

Atsuo Takashima ◽

Kazumasa Fujitani ◽

Keisuke Koeda ◽

Hiroki Hara ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Open Label ◽

Phase 3 ◽

Previously Treated

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Everolimus for Previously Treated Advanced Gastric Cancer: Results of the Randomized, Double-Blind, Phase III GRANITE-1 Study

Journal of Clinical Oncology ◽

10.1200/jco.2012.48.3552 ◽

2013 ◽

Vol 31 (31) ◽

pp. 3935-3943 ◽

Cited By ~ 288

Author(s):

Atsushi Ohtsu ◽

Jaffer A. Ajani ◽

Yu-Xian Bai ◽

Yung-Jue Bang ◽

Hyun-Cheol Chung ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Advanced Gastric Cancer ◽

Safety Profile ◽

Systemic Chemotherapy ◽

Progression Free Survival ◽

Hazard Ratio ◽

Phase Iii ◽

Double Blind ◽

Previously Treated

Purpose The oral mammalian target of rapamycin inhibitor everolimus demonstrated promising efficacy in a phase II study of pretreated advanced gastric cancer. This international, double-blind, phase III study compared everolimus efficacy and safety with that of best supportive care (BSC) in previously treated advanced gastric cancer. Patients and Methods Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were randomly assigned to everolimus 10 mg/d (assignment schedule: 2:1) or matching placebo, both given with BSC. Randomization was stratified by previous chemotherapy lines (one v two) and region (Asia v rest of the world [ROW]). Treatment continued until disease progression or intolerable toxicity. Primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), overall response rate, and safety. Results Six hundred fifty-six patients (median age, 62.0 years; 73.6% male) were enrolled. Median OS was 5.4 months with everolimus and 4.3 months with placebo (hazard ratio, 0.90; 95% CI, 0.75 to 1.08; P = .124). Median PFS was 1.7 months and 1.4 months in the everolimus and placebo arms, respectively (hazard ratio, 0.66; 95% CI, 0.56 to 0.78). Common grade 3/4 adverse events included anemia, decreased appetite, and fatigue. The safety profile was similar in patients enrolled in Asia versus ROW. Conclusion Compared with BSC, everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy. The safety profile observed for everolimus was consistent with that observed for everolimus in other cancers.

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