Oxaliplatin and irinotecan chemotherapy in advanced gastric cancer. Final results of a multicenter phase II trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4070-4070 ◽  
Author(s):  
E. Woell ◽  
T. Kühr ◽  
W. Eisterer ◽  
K. Gattringer ◽  
R. Greil ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Treatment Options ◽  
Locally Advanced ◽  
Sensory Neuropathy ◽  
Metastatic Gastric Cancer ◽  
Female Ratio ◽  
Multiple Metastases ◽  
Grade 3 ◽  
Gastric Cancer Patients

4070 Background: There are only limited treatment options for advanced gastric cancer. Development of new treatment options is therefore warranted. The aim of this study was to evaluate the safety, feasibility and efficacy of an outpatient Oxaliplatin/Irinotecan combination in patients suffering from unresectable, locally advanced and/or metastatic gastric cancer. Methods: The combination of Oxaliplatin 85 mg/m2 biweekly with Irinotecan 125 mg/m2 biweekly was chosen since it has been shown in colorectal cancer that a biweekly dose of at least 85 mg/m2 oxaliplatin is superior to a lower dose and toxicity of Irinotecan is much lower if given fractionated into two doses. Furthermore the Irinotecan dose below MTD considers concerns about increased toxicity in gastric cancer patients. Results: 43 patients with histologically proven unresectable and/or metastatic gastric adenocarcinoma and no previous palliative chemotherapy and/or immunotherapy were selected. Median age: 61 years (range 32–81 years), male/female ratio: 24/19, PS 0:11 patients, PS <3:32 patients, locally advanced cancer 5 patients, single metastatic site: 19 patients, multiple metastases: 19 patients, previously adjuvant radiochemotherapy: 4 patients. This outpatient regimen was generally well tolerated. Frequently reported adverse events (more than 20% of patients) were grade 1 or 2 and included neutropenia (44% of patients), thrombocytopenia (30%), anemia (77%), nausea 67%), diarrhea (51%), alopecia (35%). Grade 3 and 4 toxicities included neutropenia in 2/43 pts., anemia in 3/43 pts., nausea in 2/43 pts., and diarrhea in 4/43pts. 5 patients were taken off-study due to toxicity (asthenia, nausea, reversible renal failure, diarrhea). Sensory neuropathy occurred only as grade 2 in 14%, no grade 3/4 neurotoxicity was observed. For response 38 patients are assessable with 3 pts. (8%) showing a CR, PR in 19 pts. (50%), SD in 11 pts. (29%), PD in 5 pts. (13%). Median TTP was 5.3 months and median OS 9.5 months. Conclusions: The outpatient combination of a biweekly Oxaliplatin/Irinotecan chemotherapy is well tolerated and shows a response rate within the range of other combination therapies. The favourable toxicity profile makes it an alternative 1st line regimen. [Table: see text]

Oxaliplatin, irinotecan, and cetuximab in advanced gastric cancer. First efficacy results of a multicenter phase II trial (AGMT Gastric-2) of the Arbeitsgemeinschaft Medikamentoese Tumortherapie (AGMT)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4538-4538
Author(s):  
E. Woell ◽  
R. Greil ◽  
W. Eisterer ◽  
M. Fridrik ◽  
B. Grünberger ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Treatment Options ◽  
Objective Response ◽  
Sensory Neuropathy ◽  
Multicenter Phase ◽  
Grade 3 ◽  
Line Setting

4538 Background: Patients (pts.) suffering from advanced gastric cancer have still a poor prognosis and treatment options are limited. In our previous phase II trial (AGMT-Gastric-1) we could show that the combination of oxaliplatin and irinotecan was well tolerated and showed an objective response rate of 58% (Anticancer Res 28:2901–2906, 2008). This chemotherapy regimen was tested in combination with cetuximab in a multicenter phase II trial. Methods: Oxaliplatin 85 mg/m2 biweekly and irinotecan 125 mg/m2 biweekly were combined with cetuximab 400 mg/m2 loading dose and subsequently weekly 250 mg/m2. 51 patients with histological proven unresectable and/or metastatic gastric adenocarcinoma were treated in a first line setting. Median age: 62 years (range 19–79 years), PS 0: 25 patients, PS 1+2 26 patients, single metastatic site: 24 patients, multiple metastases: 27 patients. Results: Frequently reported adverse events (more than 20% of pts.) were predominantly grade 1 or 2 and included neutropenia (35% of pts.), thrombocytopenia (33%), anemia (73%), nausea (45%), diarrhea (57%), alopecia (22%), and fatigue (37%). Grade 3 and 4 toxicities included neutropenia in 9/1 pts., thrombocytopenia in 1/0 pts., anemia in 3/1 pts., nausea in 2/0 pts., and diarrhea in 7/2 pts. Sensory neuropathy occurred mostly as grade 1 and 2 in 37% of pts., in 7 pts. grade 3 neurotoxicity was observed. Acneiform skin rash grade 1 / 2 / 3 / 4 was reported in 31% / 20% / 6% / 2% of pts. respectively. 16 pts. went off-study due to neutropenia (n=5), nausea/vomiting (n=1), diarrhea (n=1), progressive disease (n=3), toxic colon (n=2), and allergic reaction to cetuximab at first (n=2), second (n=1) or third infusion (n=1). 35 patients are assessable for response with 1 pt. (3%) showing a CR, 21 pts. (60%) a PR, 7 pts. (20%) a SD and PD in 6 pts. (17%). A disease control rate was achieved in 83%. Median time to progression was 24.8 weeks (n=29), median overall survival 38.1 weeks (n=32). Conclusions: The combination of oxaliplatin and irinotecan with cetuximab is feasible, safe and active in advanced gastric cancer. [Table: see text]

Weekly nanoparticle albumin-bound paclitaxel(nab-PTX) as second-or later-line treatment for unresectable or recurrent gastric cancer in practice.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 168-168
Author(s):  
Masataka Yagisawa ◽  
Susumu Sogabe ◽  
Ichiro Iwanaga ◽  
Tomohiro Oshino ◽  
Takahiro Yamamura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
Line Treatment ◽  
Safety And Efficacy ◽  
Recurrent Gastric Cancer ◽  
Common Grade ◽  
Grade 3 ◽  
Gastric Cancer Patients

168 Background: Nanoparticle albumin-bound paclitaxel (nab-PTX) is a novel, solvent polyoxyethylated castor oil-free, biologically interactive form of paclitaxel (PTX). Nab-PTX allows shorter infusion schedules and needs no premedication for hypersensitivity reactions, so nab-PTX will be used as the alternative to PTX for more patients. In Japan, nab-PTX was approved as tri-weekly regimen (210mg/m2 every 3weeks) for gastric cancer. On the other hands, weekly PTX (80mg/m2 on day1, 8, and 15, every 4weeks) is mostly used as PTX regimen as 2nd or later line treatment for gastric cancer in Japan. So in practice, nab-PTX would be used by weekly regimen same as weekly PTX. However, the safety and efficacy of weekly nab-PTX for gastric cancer had not been reported yet. Methods: Unresectable or metastatic gastric cancer patients who began receiving weekly nab-PTX as 2nd or later line chemotherapy in our two facilities from February 2013 to August 2014 were retrospectively analyzed for the safety and efficacy. Written informed consent about the treatment of weekly nab-PTX was obtained from all patients before treatment. Results: A total of 32 patients were assessed, retrospectively. The dose and schedule of nab-PTX was 100mg/m2 on day1, 8, and 15, every 4weeks in all patients. Patients characteristics were as follows: median age 67.5(37-84); Male/female: 24/8; PS 0/1/2/3:15/8/7/2; treatment line 2/3/4/5: 12/14/5/1. The overall response rate was 9.3% (CR/PR/SD/PD/NE: 1/2/12/15/2). The median progression-free survival (mPFS) and median overall survival (mOS) were 2.99 months and 5.95 months, in all patients. In 23 patients whose PS were 0 or 1, mPFS and mOS were 4.14 months and 8.44 months. Most common grade 3/4 hematological toxicities were anemia (46.9%), neutropenia (40.6%), febrile neutropenia (15.6%). About the sensory neuropathy, grade 3 was 9.3%, grade2 was 21.9%, and grade1 was 3.1%. There were no treatment-related deaths. Conclusions: Weekly nab-PTX showed promising efficacy against previously treated unresectable or recurrent gastric cancer especially for good PS patients, The Common toxicities of weekly nab-PTX were well-tolerated.

Phase II Study of Oxaliplatin, Fluorouracil, and Folinic Acid in Locally Advanced or Metastatic Gastric Cancer Patients

2002 ◽  
Vol 20 (23) ◽  
pp. 4543-4548 ◽  
Author(s):  
C. Louvet ◽  
T. André ◽  
J.M. Tigaud ◽  
E. Gamelin ◽  
J.Y. Douillard ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Folinic Acid ◽  
Performance Status ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Curative Intent ◽  
Suitable Alternative ◽  
Best Response ◽  
Grade 3 ◽  
Gastric Cancer Patients

PURPOSE: To evaluate the efficacy and safety of an oxaliplatin, fluorouracil (5-FU), and folinic acid (FA) combination in patients with metastatic or advanced gastric cancer (M/AGC). PATIENTS AND METHODS: Of the 54 eligible patients with measurable or assessable M/AGC, 53 received oxaliplatin 100 mg/m2 and FA 400 mg/m2 (2-hour intravenous infusion) followed by 5-FU bolus 400 mg/m2 (10-minute infusion) and then 5-FU 3,000 mg/m2 (46-hour continuous infusion) every 14 days. RESULTS: Patients (69% male, 31% female) had a median age of 61 years (range, 31 to 75 years), 89% had a performance status of 0 or 1, 70% had newly diagnosed disease, and 87% had metastatic disease. All had histologically confirmed adenocarcinoma. With a median of three involved organs, disease sites included the lymph nodes (67%), stomach (65%), and liver (61%). A median of 10 cycles per patient and 468 complete cycles were administered. Best responses in the 49 assessable patients were two complete responses and 20 partial responses, giving an overall best response rate of 44.9%. Eight patients underwent complementary treatment with curative intent (six with surgery and two with chemoradiotherapy). Median follow-up, time to progression, and overall survival were 18.6 months, 6.2 months, and 8.6 months, respectively. Grade 3/4 neutropenia, leukopenia, thrombocytopenia, and anemia occurred in 38%, 19%, 4%, and 11% of patients, respectively, and febrile neutropenia occurred in six patients (one episode each). Grade 3 peripheral neuropathy occurred in 21% of patients (oxaliplatin-specific scale). Seven patients withdrew because of treatment-related toxicity. CONCLUSION: This oxaliplatin/5-FU/FA regimen shows good efficacy and an acceptable safety profile in M/AGC patients, and may prove to be a suitable alternative regimen in this indication.

Feasibility study of TAS-118 plus oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 205-205
Author(s):  
Daisuke Takahari ◽  
Manabu Ohashi ◽  
Atsuo Takashima ◽  
Takuro Mizukami ◽  
Naoki Ishizuka ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Complete Response ◽  
Free Survival ◽  
D2 Gastrectomy ◽  
Locally Advanced Gastric Cancer ◽  
Grade 3

205 Background:TAS-118 (S-1 and leucovorin) + oxaliplatin (L-OHP) improved overall survival (OS) compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC) (Kang, Lancet Oncol. 2020). This study investigated the feasibility of peri (pre and post)-operative (op) chemotherapy (chemo) with TAS-118 ± L-OHP in pts with locally advanced resectable GC. While it was reported that pre-op TAS-118 + L-OHP followed by D2 gastrectomy was well tolerated and showed promising efficay (Takahari, ASCO-GI. 2020), the recommended post-op chemo regimen, TAS-118 or TAS-118 + L-OHP, has yet to be determined. Methods:Eligible pts with GC of clinical T3-4N1-3M0 were enrolled. The protocol treatment consisted of pre-op chemo with 4 courses of TAS-118 (40-60 mg/body, orally, twice daily, 7 days) + L-OHP (85 mg/m2, intravenously, day 1) in a 2-week cycle, and gastrectomy with D2 lymphadenectomy, followed by post-op chemo with 12 courses of TAS-118 (step 1) and 8 courses of TAS-118 + L-OHP (step 2). Step 2 was started if the dose-limiting toxicity (DLT) occurred in < 6 of 10 pts in step 1. Up to 20 pts were included in the analysis of feasibility after a recommended regimen was determined. Results:Between December 2016 and February 2019, 45 pts were enrolled. The numbers of pts with cT3/4a and cN1/2/3 were 13/32 and 25/17/3, respectively. Excluding 14 pts (4 achieving pathological complete response, 4 not satisfying the criteria for post-op chemo, 3 physician judgement or pt withdrawal, 2 progressive disease, 1 adverse event [AE]), 31 pts (11/20 in step 1/2) received the post-op chemo. No DLT was observed in either step. The post-op chemo completion rate was 90.9% (95% CI, 63.6-99.5) in step 1 and 80.0% (95% CI, 59.9-92.9) in step 2. The median relative dose intensity of TAS-118 in step 1 was 83.3%, and those of TAS-118 and L-OHP in step 2 were 69.9% and 74.3%, respectively. One pt in step 2 discontinued post-op chemo due to AE. Grade ³ 3 AEs observed in ≥ 10% of pts were weight loss in both step 1 and step 2 (2 in each), and hypokalemia (n = 3) and neutropenia (n = 2) in step 2. At 1-year follow-up after the last pt was enrolled, recurrence-free survival and OS rates were 91.1% (95% CI, 78.0-96.6) and 100%, respectively at 12 months, and 69.1% (95% CI, 49.6-82.3) and 95.5% (95% CI, 71.9-99.3), respectively at 24 months. Conclusions:Taken together with the feasibility and efficacy of pre-op chemo, peri-op chemo with TAS-118 + L-OHP with D2 gastrectomy was well tolerated and showed promising efficacy. Clinical trial information: UMIN000024688.

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.

scholarly journals FEATURES OF EMERGENCY SURGERY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER

2020 ◽  
pp. 108-112
Author(s):  
V. V. Boyko ◽  
I. V. Krivorotko ◽  
V. A. Lazirsky
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Surgical Intervention ◽  
Locally Advanced ◽  
Postoperative Mortality ◽  
Surgical Interventions ◽  
Second Stage ◽  
Locally Advanced Gastric Cancer ◽  
Surgical Tactics ◽  
Gastric Cancer Patients

Summary. Materials and methods. The work is based on an analysis of the results of surgical treatment of 418 patients with complicated locally advanced gastric cancer. Patients are divided into two groups: comparisons — 212, and the main — 206 patients who were treated from 2006 to 2010. and from 2011 to 2015 respectively. The complications rating was: bleeding in 252 (60.3 %) patients, stenosis in 89 (21.3 %), perforation in 15 (3.5 %), and their combination in 62 (14.8 %). Results and discussion. Radical operations were performed in 212 (50.7 %) patients, in 145 (34.6 %) — palliative and symptomatic. Postoperative complications occurred in 82 patients (19.6 %), postoperative mortality was 7.2 % (30 patients). A two-stage surgical tactics has been developed, which involves the implementation of minimally invasive endoscopic and endovascular surgical interventions at the first stage with the implementation of a delayed or planned surgical intervention at the second stage. Conclusions. Urgent operations decreased from 21.7 to 6.3 %, which reduced the number of palliative and symptomatic operations from 50.4 to 18.4 %.

scholarly journals Second-Line Irinotecan, Leucovorin, and 5-Fluorouracil for Gastric Cancer Patients after Failed Docetaxel and S-1

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Joo Young Jung ◽  
Min-Hee Ryu ◽  
Baek-Yeol Ryoo ◽  
Boram Han ◽  
Ji Woong Cho ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Response Rate ◽  
Response Rate ◽  
Antitumour Activity ◽  
Metastatic Gastric Cancer ◽  
Second Line ◽  
First Line ◽  
Previously Treated ◽  
Grade 3 ◽  
Gastric Cancer Patients

Background.This retrospective study aimed to assess the efficacy and toxicities of second-line chemotherapy with irinotecan, leucovorin, and 5-fluorouracil (5-FU) in metastatic gastric cancer (MGC) patients previously treated with docetaxel and S-1 with or without oxaliplatin (DS/DOS).Patients and Methods.We reviewed the data of patients who had previously been treated with first-line DS/DOS and received biweekly irinotecan-based chemotherapy (FOLFIRI/IFL) between October 2004 and November 2011.Results.A total of 209 cycles were administered to 35 patients, with a median of 4 (range, 1–22) cycles each. The overall response rate in 29 response-assessable patients was 17.2%, including 2 complete and 3 partial responses. The median progression-free and overall survivals were 3.81 (95% confidence interval [CI], 1.82–5.80) months and 6.24 (95% CI, 1.44–11.04) months, respectively. The major grade 3/4 toxicity was neutropenia (8.6%).Conclusion.FOLFIRI/IFL chemotherapy showed modest antitumour activity and tolerable toxicities in DS/DOS-treated MGC patients.

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

Oxaliplatin/CF/5-FU versus paclitaxel/CF/5-FU in patients with advanced gastric cancer: A phase II clinical trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14014-14014
Author(s):  
T. Lin ◽  
F. Xu ◽  
S. Wang ◽  
Y. He ◽  
W. Tian ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Time ◽  
Advanced Gastric Cancer ◽  
Median Survival ◽  
Median Survival Time ◽  
Performance Status ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Tumor Control ◽  
Tumor Control Rate

14014 Background: Although many randomized trials of chemotherapy for advanced gastric cancer have been reported during the past two decades, no standard regimens worldwide have been established yet. Now Paclitaxel and Oxaliplatin have shown promising activity in advanced gastric cancer. We prospectively evaluated toxicity, efficacy and survival of Oxaliplatin /CF/5-FU versus Paclitaxel/CF/5-FU. Methods: Metastatic or locally advanced gastric cancer; performance status (PS) 0–2. Patients (pts) were enrolled and randomized into arm A with Oxaliplatin 100mg/m2, 5-FU 400 mg/m2 bolus, FA 200 mg/m2 2h, 5-FU 2500 mg/m2 46h, q2w or into arm B with Paclitaxel 80 mg/m2, 5-FU 400 mg/m2 bolus, FA 200 mg/m2 2h, 5-FU 2500 mg/m2 46h, q2w. Results: From 2000 to 2005, (A/B) 46/43 pts were enrolled into this study. Median age (52/50 y), gender, PS, localization and numbers of metastatic sites were comparable for both arms. Pts who were not chemotherapy naive in A/B (% of pts) were 41.3/33.3. All pts were eligible and evaluable for toxicity and response. Overall response (CR+PR) rate for A/B (% of pts): 37.0/47.2 (p<0.05), tumor control rate (CR+PR+SD) 76.1/69.4(p<0.05). Median time to progression (TTP) were for A/B: 6.0 and 3.2 months. And median survival time for A/B were 13.4 and 13.8 months. Grade 3/4 toxicities were for A/B (% of pts): neutropenia 10.9/5.6, thrombocytopenia 4.3/2.8, anemia 0/2.8, vomiting 8.7/2.8, neurotoxic 0/2. No treatment-related death occurred in A/B. Conclusions: Oxaliplatin /CF/5-FU and Paclitaxel/CF/5-FU are both effective and safe in advanced or metastatic gastric cancer. Though Oxaliplatin /CF/5-FU had better tumor control rate and median TTP, there was no difference between the arms in the median survival time. No significant financial relationships to disclose.

Sign in / Sign up

Export Citation Format

Share Document