scholarly journals Can pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O+) be added to standard treatment for resectable high-risk gastric cancer patients? a study protocol

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Jessica L. Reid ◽  
Harsh A. Kanhere ◽  
Peter J. Hewett ◽  
Timothy J. Price ◽  
Guy J. Maddern ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Multimodal Treatment ◽  
Pilot Trial ◽  
Preventive Measure ◽  
Treatment Regime ◽  
Open Label ◽  
Treatment Pathway ◽  
Perioperative Morbidity ◽  
Post Surgery ◽  
Gastric Cancer Patients

Abstract Objectives Gastric cancer remains one of the most fatal cancers, despite an intensive treatment regime of chemotherapy–surgery–chemotherapy. Peritoneal metastatic disease is commonly diagnosed post treatment regime and once established, patients are likely to die in 3–9 months. Systemic chemotherapy does not increase survival for these patients due to the poor vascularisation of this area. We are proposing the addition of pressurised intraperitoneal aerosol chemotherapy (PIPAC) to the treatment regime for curative patients as a preventive measure to reduce the risk of peritoneal metastases occurring. Methods This is a prospective, single centre, non-randomised, open-label pilot trial evaluating the addition of PIPAC to the standard multimodal treatment pathway. Patients will undergo standard neoadjuvant chemotherapy with four cycles of fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT), then PIPAC, followed by gastrectomy. Four cycles of FLOT will be administered post-surgery. Primary outcome is safety and feasibility, assessed by perioperative morbidity and possible interruptions of the standard multimodal treatment pathway.

scholarly journals A PHASE II TRIAL EXPLORING THE EXTENSIVE INTRA-OPERATIVE PERITONEAL LAVAGE (EIPL) AS A PROPHYLACTIC STRATEGY FOR PERITONEAL RECURRENCE IN LOCALLY ADVANCED GASTRIC CANCER: reporting postoperative morbidity and mortality after early closure

2015 ◽  
Vol 52 (2) ◽  
pp. 161-164 ◽  
Author(s):  
Thales Paulo BATISTA ◽  
Mário Rino MARTINS ◽  
Euclides Dias MARTINS-FILHO ◽  
Rogerio Luiz dos SANTOS
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Peritoneal Lavage ◽  
Locally Advanced ◽  
Open Label ◽  
Safety And Efficacy ◽  
Intention To Treat ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients

Background The Extensive Intraoperative Peritoneal Lavage (EIPL) has been proposed as a practical prophylactic strategy to decrease the risk of peritoneal metastasis in gastric cancer. Objective To explore the safety and efficacy of the EIPL in our locally advanced gastric cancer patients. Methods This study is an open-label, double-center, single-arm phase II clinical trial developed at two tertiary hospitals from Recife (Pernambuco, Brazil). Results The study protocol was prematurely closed due to slow accrual after only 16 patients had been recruited to participate. Eight of them were excluded of the protocol study during the laparotomy, whereas four cases were also excluded from the per-protocol analysis. Two patients had died in hospital before 30 days and six were alive with no evidence of cancer relapses after a follow-up ranging from five to 14,2 months (median of 10.6 months). In the intention-to-treat analysis, three of eight patients suffered of gastrointestinal leakages and two of them had died. On a per-protocol basis, two of four patients presented this type of postoperative complication and one of them had died. All deaths occurred as a somewhat consequence of gastrointestinal leakages. Conclusion We could not make any conclusion about the safety and efficacy of the EIPL, but the possibility of this approach might increase the rate of gastrointestinal leakage is highlighted.

A prospective cohort study to reduce operative risk in stage I gastric cancer patients with metabolic syndrome: Preoperative exercise versus surgery alone.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15112-e15112
Author(s):  
Haruhiko Cho ◽  
Akira Tsuburaya ◽  
Naoki Hirabayashi ◽  
Junya Shirai ◽  
Toru Aoyama ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Abdominal Obesity ◽  
Exercise Group ◽  
Operative Risk ◽  
Intraoperative Blood Loss ◽  
Perioperative Morbidity ◽  
Preoperative Exercise ◽  
Surgical Difficulty ◽  
Gastric Cancer Patients

e15112 Background: Although obesity influences the technical difficulty of surgery, a reasonable marker of abdominal obesity is not confirmed and effective intervention has never been applied to reduce the operative risk in patients with abdominal obesity. Methods: To reduce the surgical difficulty and risk in gastric cancer patients with abdominal obesity, a preoperative exercise protocol was designed for stage I gastric cancer patients who were diagnosed to have metabolic syndrome (MetS). Results: In total, 51 patients (33 who underwent surgery alone, 18 who were treated with preoperative exercise) were registered in this study. Visceral fat areas (VFA) were estimated by CT scan, and they were associated most strongly with waist, followed by HDL cholesterol, and BMI. In the exercise group, all patients completed protocol treatment, without disease progression and > grade2 exercise-associated adverse events. VFA of the exercise group were larger than that of the surgery alone group at registration (221cm2 /180cm2, p=0.028), then reduced after exercise to non-significant level with surgery alone group (201cm2 /180cm2, p=0.264). There were no significant differences of intraoperative blood loss (262mL/201mL: p=0.465) and incidence of perioperative morbidity (27.7%/29%, p=1.000) between exercise and non-exercise groups. Multivariate logistic regression analysis detected intraoperative blood loss (> 380mL) as significant risk factor (p=0.023) for perioperative morbidity. Conclusions: Waist was surrogate marker for VFA in this study, thus can be a candidate of simple indicator of abdominal obesity. Preoperative interventional exercise did not directly reduce operative risk of gastric cancer with MetS; however, it was associated indirectly with risk reduction by improving surgical difficulty.

Value of FGFR2 expression for advanced gastric cancer patients receiving pazopanib plus CapeOX (capecitabine and oxaliplatin).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 65-65
Author(s):  
Seung Kim ◽  
Young-Woong Won ◽  
Jung Hoon Kim ◽  
Joon Ho Park
Keyword(s):  
Gastric Cancer ◽  
Treatment Outcomes ◽  
Advanced Gastric Cancer ◽  
Complete Response ◽  
Open Label ◽  
Prognostic Analysis ◽  
Tumor Tissues ◽  
Significant Difference ◽  
Open Label Phase ◽  
Gastric Cancer Patients

65 Background: The aim of this study was to use immunohistochemistry (IHC) to determine the effect of FGFR2 and VEGFR2 expression on treatment outcomes for patients with metastatic or recurrent advanced gastric cancer (AGC) receiving a combination of pazopanib with CapeOx (capecitabine and oxaliplatin). Methods: We conducted a single-arm, open-label phase II study to determine the efficacy and toxicity of the combination of pazopanib with CapeOx in 66 patients with metastatic or recurrent AGC (ClinicalTrials.gov NCT01130805). IHC analysis of FGFR2 and VEGFR2 was possible in 54 patients (81.8%). Results: Among 54 patients, the median age was 51.5 years (range, 23–72 years). Most patients were men (59.3%). Seven patients (13.5%) had tumor tissues that expressed FGFR2 by IHC. No patients had tumors that expressed VEGFR2. Among 7 patients with tumors with FGFR2 expression, 6 achieved partial response (PR) with a 85.7% response rate and one patient with stable disease. Among 47 patients with tumors without FGFR2 expression, one had complete response and 27 had PR (59.5%). A significant difference in PFS was seen between patients who were positive and negative for FGFR2 using IHC (8.5 vs. 5.6 months, p = 0.050). By prognostic analysis for PFS, only FGFR2 status by IHC (positive vs. negative) had significant prognostic value for predicting PFS. Conclusions: FGFR2 expression by IHC might be a useful biomarker for predicting treatment outcomes of patients with metastatic or recurrent AGC treated with a combination of pazopanib and CapeOx.

scholarly journals Impact of perioperative treatment on survival of resectable gastric cancer patients after D2 lymphadenectomy: a single European centre propensity score matching analysis

2019 ◽  
Vol 53 (2) ◽  
pp. 245-255
Author(s):  
Tomaz Jagric ◽  
Bojan Ilijevec ◽  
Vaneja Velenik ◽  
Janja Ocvirk ◽  
Stojan Potrc
Keyword(s):  
Gastric Cancer ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Cancer Patients ◽  
Long Term Results ◽  
Perioperative Chemotherapy ◽  
D2 Lymphadenectomy ◽  
Perioperative Treatment ◽  
Perioperative Morbidity ◽  
Gastric Cancer Patients

Abstract Background To determine the effects of perioperative treatment of gastric cancer patients, we conducted an analysis with propensity score matched patient groups to determine the role of perioperative chemotherapy in patients after D2 lymphadenectomy. Patients and methods From our database of 1563 patients, 482 patients were selected with propensity score matching and divided into two balanced groups: 241 patients in the surgery only group and 241 patients in the perioperative group. The long-term results of treatment were compared between the two groups. Results Most of the included patients received radio-chemotherapy with capecitabine (n = 111; 46%) and perioperative chemotherapy with epirubicin, oxalliplatin and capecitabine (n = 91; 37.7%). 92.9% of the patients received a D2 lymph node dissection. Perioperative morbidity was similar between surgery only (18.3%) and perioperative treatment groups (20.7%) (p = 0.537). The perioperative mortality was not influenced by perioperative treatment. A pathological response was observed in 12.5% of patients. The overall 5-year and median survivals were significantly higher in the perioperative treatment group (50.5%; 51.7 moths) compared to surgery only group (41.8%; 34.9 months; p = 0.038). The subgroup analysis revealed that only patients with the TNM stages T3 (p = 0.028), N2 (p = 0.009), N3b (p = 0.043), and UICC stages IIIb (p = 0.003) and IIIc (p = 0.03) significantly benefit from perioperative treatment. Conclusions Perioperative treatment in radically resected gastric cancer patients after D2 lymphadenectomy was beneficial in stages IIIb and IIIc. The effects of perioperative treatment in lower stages could be negated by the effects of the radical surgery in lower stages and in higher stages by the biology of the disease.

Randomized phase II study of nimotuzumab, an anti-EGFR antibody, plus irinotecan in patients with 5-fluorouracil–based regimen-refractory advanced or recurrent gastric cancer in Korea and Japan: Preliminary results.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 87-87 ◽  
Author(s):  
Y. H. Kim ◽  
Y. Sasaki ◽  
K. H. Lee ◽  
S. Y. Rha ◽  
S. Park ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Skin Toxicity ◽  
Metastatic Gastric Cancer ◽  
Hazard Ratio ◽  
Open Label ◽  
Efficacy Analysis ◽  
Grade 3 ◽  
Gastric Cancer Patients ◽  
Ecog Ps

87 Background: Nimotuzumab is a humanized IgG1 anti-EGFR monoclonal antibody. In previous studies, nimotuzumab has demonstrated efficacy associated with an absence of severe skin toxicity, commonly caused by other EGFR-targeting therapies. Methods: This is a Korea and Japan collaborative, multi-center, randomized, open-label study of nimotuzumab (400 mg, IV q1 week) plus irinotecan (150 mg/m2 IV q2 weeks) (N+I) versus irinotecan (I) in patients with advanced or metastatic gastric cancer refractory to 5-fluorouracil-based regimen. The primary endpoint was PFS with an external review and the secondary endpoints included safety, ORR, OS, PK, and a biomarker. Results: Eighty-two eligible patients (ECOG PS 0-1, one prior regimen) were treated with N+I (n = 40) or I (n = 42). Baseline characteristics were balanced between both arms. Archival tumor tissues collected from 48 patients (N+I arm: 26, I arm: 22) were analyzed for EGFR and K-ras. EGFR status, 0/1+/2+/3+, examined by immunohistochemistry was 44%/25%/13%/17%, respectively. Two patients in N+I arm had a K-ras mutation in codon 12 or 13. The efficacy analysis was conducted 6 months after completion of randomization with median follow-up period of 197 days. Median PFS was 73.0 days in N+I arm compared with 85.0 days in I arm (HR 0.860; 95% CI, 0.516, 1.435). MST was 293.0 days in N+I arm compared with 227.0 days in I arm (HR 0.717; 95% CI, 0.420, 1.224). In the sub-analysis, the hazard ratio in PFS for patients with EGFR +1/2+/3+ was 0.463 (95%CI, 0.177, 1.212) and that of EGFR 2+/3+ was 0.341 (95% CI, 0.080, 1.457) and the hazard ratio in OS was 0.584 (95% CI, 0.242, 1.409) and 0.295 (95% CI, 0.077, 1.129), respectively. The incidence of adverse events was similar between both arms. No adverse events of grade 3 skin rash or grade 3 infusion-related reaction were reported. Conclusions: These results didn't demonstrate clear benefit at this sample size. However, EGFR-positive patients treated nimotuzumab showed a potential improvement of PFS and OS. This study supports the selection of gastric cancer patients by molecular status for future study of nimotuzumab. [Table: see text]

Postoperation chemotherapy with S1 and docetaxel in curatively resected gastric cancer of stage III (POST trial).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4142-TPS4142
Author(s):  
Minkyu Jung ◽  
Seok Yun Kang ◽  
Bong-Seog Kim ◽  
Ki Hyang Kim ◽  
Kyung Hee Lee ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Open Label ◽  
Post Trial ◽  
Gastric Cancer Patients

TPS4142 Background: Complete surgical resections remains the only chance for cure in patients with gastric cancer, but approximately from 40% to 80% of patients still have recurrences and most patients ultimately die from their disease. The recent adjuvant trials in gastric cancer showed significantly improved survival in patients with adjuvant chemotherapy than those with surgery alone. However, further studies need for the effect of adjuvant chemotherapy following D2 dissected gastric cancer patients, especially in advanced gastric cancer. S-1 is an oral anticancer drug, a prodrug of fluorouracil, very effective in gastric cancer. Docetaxel is the first drug that showed survival benefits when added to the two drugs in advanced gastric cancer patients. And docetaxel is also synergistic anti-cancer effect with S-1 in advanced gastric cancer. Base on this background, the aim of this study is to detect a significant increase in 3 –year disease free survival (DFS) of adjuvant chemotherapy with docetaxel and S-1(DS) relative to those with S-1 and cisplatin (SP) in patients with stage III gastric cancer Methods: This study is an open-label, phase 3, randomized controlled trial, multicenter in South Korea. Patients with stage III (AJCC 7th edition) gastric cancer who had had curative D2 gastrectomy is randomly assigned to receive adjuvant chemotherapy of eight 3-week cycles of intravenous docetaxel (35 mg/m2 on day 1 and 8 of each cycle) plus oral S-1 (35 mg/m2 twice daily on days 1 to 14 of each cycle) for 6 months (DS) or chemotherapy of eight 3-week cycles of oral S1 plus intravenous cisplatin (60 mg/m2). After satisfying the screening criteria, patients have been randomized to the SD or SP arm in a 1:1 ratio. The randomization is stratified by institution and stage of disease (IIIA vs. IIIB vs. IIIC). The each stratum has been randomized by using the method of randomly permuted block. The primary endpoint is 3 year DFS, will analyze by intention to treat. A total of 290 patients will be enrolled, 67 patients have been treated to day, with continuing accrual. The trial is registered at ClinicalTrials.gov (NCT01283217).

PS02.166: OESOPHAGO-GASTRIC CANCER PATIENTS OPERATED ON IN THE PRIVATE SECTOR SURVIVE LONGER THAN NHS PATIENTS

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 168-169
Author(s):  
Abraham Botha ◽  
S Heymans ◽  
William Knight ◽  
Rebecca Bott ◽  
Nick Maisey ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Private Sector ◽  
Conflicts Of Interest ◽  
Definitive Treatment ◽  
Term Survival ◽  
Treatment Pathway ◽  
Study Protocols ◽  
Neo Adjuvant Chemotherapy ◽  
Gastric Cancer Patients

Abstract Background In the UK, national directives have resulted in centralisation of oesophago-gastric cancer in large National Health Service (NHS) centres. NHS cancer centres have treatment pathway targets of 30 and 60 days to complete staging and start treatment. We have treated patients with oesophago-gastric cancer both in the NHS and private sector. The purpose of this study was to assess whether the treatment and outcome was different for patients treated in the private sector. Methods Data was collected prospectively of consecutive oesophago-gastrectomies for OGJ cancer performed by a single surgeon from 2003–2013. After diagnosis all cases were discussed in a multi-disciplinary meeting. Neo-adjuvant chemotherapy was offered to all patients deemed to have N1 or T3 disease according to MAGIC and OEO5 study protocols. Patients in these stage groups who declined neo-adjuvant chemotherapy were offered adjuvant chemotherapy or chemo-radiation. During the first 2 years oesophago-gastrectomy was performed by open surgery, where-after laparoscopic and thoracoscopic techniques were introduced. Data analysis was by logistic regression using SPSS software. Results 204 resections for OGJ cancer were performed during. The average age was 63 years (range 41–82), 85% had adenocarcinoma, and 78% of patients received neo-adjuvant chemotherapy. The pathological staging was pN1 64%, pT0 5%, pT1 17%, pT2 32%, pT3 42%, pT4 3%. The median hospital stay was 14 days (range 6–210), and the in-hospital mortality was 2.5%. 40 patients had their treatment in private hospitals. There was no difference in the demographics, histology, tumour stage, percentage receiving chemotherapy, type of chemotherapy or surgery between private and NHS patients. Private patients completed their staging tests within 9 days (range 126) of endoscopy and started definitive treatment within 10 days (range 2–59) of the last staging test. 26 of the 40 patients (65%) operated on in the private sector survived 5 years which was more than the 39% of NHS patients who survived 5 years (P = 0.0084). Conclusion Treatment for oesophago-gastric cancer is evolving. Patients with oesophago-gastric cancer treated in the private sector have better long-term survival than NHS patients which might be related to their shorter treatment pathway. Further studies will elucidate the changes in treatment required to improve survival for all UK patients with oesophago-gastric cancer. Disclosure All authors have declared no conflicts of interest.

scholarly journals Naples Prognostic Score Predicts Tumor Regression Grade in Resectable Gastric Cancer Treated with Preoperative Chemotherapy

Cancers ◽  
2021 ◽  
Vol 13 (18) ◽  
pp. 4676
Author(s):  
Eva Lieto ◽  
Annamaria Auricchio ◽  
Giuseppe Tirino ◽  
Luca Pompella ◽  
Iacopo Panarese ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Preoperative Chemotherapy ◽  
Multimodal Treatment ◽  
Tumor Regression ◽  
Prognostic Score ◽  
Tumor Regression Grade ◽  
Term Survival ◽  
Gastric Cancer Patients ◽  
Regression Grade

Despite recent progresses, locally advanced gastric cancer remains a daunting challenge to embrace. Perioperative chemotherapy and D2-gastrectomy depict multimodal treatment of gastric cancer in Europe, shows better results than curative surgery alone in terms of downstaging, micrometastases elimination, and improved long-term survival. Unfortunately, preoperative chemotherapy is useless in about 50% of cases of non-responder patients, in which no effect is registered. Tumor regression grade (TRG) is directly related to chemotherapy effectiveness, but its understanding is achieved only after surgical operation; accordingly, preoperative chemotherapy is given indiscriminately. Conversely, Naples Prognostic Score (NPS), related to patient immune-nutritional status and easily obtained before taking any therapeutic decision, appeared an independent prognostic variable of TRG. NPS was calculated in 59 consecutive surgically treated gastric cancer patients after neoadjuvant FLOT4-based chemotherapy. 42.2% of positive responses were observed: all normal NPS and half mild/moderate NPS showed significant responses to chemotherapy with TRG 1–3; while only 20% of the worst NPS showed some related benefits. Evaluation of NPS in gastric cancer patients undergoing multimodal treatment may be useful both in selecting patients who will benefit from preoperative chemotherapy and for changing immune-nutritional conditions in order to improve patient’s reaction against the tumor.

scholarly journals An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202)

2020 ◽  
Vol 12 ◽  
pp. 175883592090542
Author(s):  
Xiang Wang ◽  
Ruixing Zhang ◽  
Nan Du ◽  
Mudan Yang ◽  
Aimin Zang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Progression Free Survival ◽  
High Dose ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Grade 3 ◽  
Gastric Cancer Patients ◽  
Noninterventional Study

Background: Apatinib has been proved to be effective and well tolerated among patients in phase II and III studies. Here, we evaluated the safety and effectiveness of apatinib in advanced gastric cancer patients in a real-world setting. Methods: This study enrolled advanced gastric cancer patients who had progressed or relapsed despite systemic chemotherapy. The primary outcome was safety and the secondary outcomes included overall survival (OS) and progression-free survival (PFS). Results: A total of 337 patients were included. In total, 62 (18.4%), 102 (30.3%), and 173 (51.3%) patients received first, second, and third or higher line apatinib therapy, respectively. Grade 3/4 treatment-emergent adverse events (AEs) were infrequent (<5%), with hypertension (6.8%) being the only grade 3/4 AE occurring in more than 5% of the patients and across the low-dose (250 mg, 7.3%), mid-dose (425–500 mg, 6.1%), and high-dose group (675–850 mg, 2/15, 13.3%). The median OS and PFS were 7.13 months (95% CI, 6.17–7.93) and 4.20 months (95% CI, 4.60–4.77), respectively, and were comparable among the low-, mid-, and high-dose groups. Conclusion: Lower daily doses of apatinib achieved comparable OS and PFS versus higher daily doses of apatinib while maintaining a more benign safety profile in advanced gastric cancer patients. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT02668380.

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