A Pilot Study of Irinotecan Combined with 5-Fluorouracil and Leucovorin for the Treatment of Chinese Patients with Locally Advanced and Metastatic Gastric Cancer

2009 ◽  
Vol 95 (4) ◽  
pp. 432-437 ◽  
Author(s):  
Qiu Li ◽  
Jing Chen ◽  
Xin Zhao ◽  
Xude Yin ◽  
Kai Mei ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Pilot Study ◽  
Partial Response ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Chinese Patients ◽  
Grade 3 ◽  
Anti Tumor Activity ◽  
Comparative Trials

Aims and background The FOLFIRI regimen was evaluated for its anti-tumor activity and toxicity in Chinese patients with locally advanced and metastatic gastric cancer. Methods and study design Treatment consisted of irinotecan, 180 mg/m2 (90-min infusion), leucovorin, 200 mg/m2 (2-h infusion), followed by 5-fluorouracil, 400 mg/m2 (bolus), and then 5-fluorouracil, 600 mg/m2 (22-h continuous infusion) on days 1 and 2, every 14 days. Results Twenty-six patients, of whom 17 were pretreated, were included in the study. Partial response was observed in 9 patients (37.5%). The overall disease control rate was 83.3%. Median progression-free and overall survival was 6.8 and 11.2 months, respectively. Grade 3–4 neutropenia was observed in 6 patients (23.1%) and grade 2–3 diarrhea in 5 (19.2%). No treatment-related deaths occurred. Conclusions The results demonstrate that the FOLFIRI regimen is an active regimen with acceptable toxicity for Chinese patients with advanced and metastatic gastric cancer that merits further investigation in comparative trials.

Docetaxel, oxaliplatin, and capecitabine (TEX regimen) for patients with metastatic gastric cancer: Interim results from a phase II trial by the German AIO Group

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4554-4554 ◽  
Author(s):  
M. H. Moehler ◽  
P. Thuss-Patience ◽  
D. Arnold ◽  
W. Grothe ◽  
A. Stein ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Distant Metastases ◽  
Response Assessment ◽  
Metastatic Gastric Cancer ◽  
Phase Ii Trials ◽  
Grade 3 ◽  
Ecog Ps

4554 Background: Combination regimens of 3 drugs have shown promising activity as treatment for patients (pts) with metastatic gastric cancer (GC). Docetaxel combined with cisplatin and 5-FU (CF) improved overall survival and response rates when compared to standard CF. However, the identification of less toxic and more convenient variants of this regimen is still important. We have previously established a regimen with docetaxel (T) combined with oxaliplatin (E) and capecitabine (X) in a phase I trial [Grothe et al., Proc. ASCO 2006]. Results of a preplanned interim analysis of subsequent multicenter phase II trials of the TEX regimen are presented here. Methods: Pts with metastatic or locally advanced GC, adequate organ function, ECOG PS 0–2, and no prior chemotherapy for advanced disease (adjuvant allowed) were enrolled. TEX regimen was administered as defined: T 35 mg/m2 and E 70 mg/m2 on days (d) 1 and 8, with X 800 mg/m2 bid on d1–14 every 22 days Toxicity assessment was done 3-weekly while CT scans were repeated 9-weekly. Results: 35 of 48 pts were enrolled until 06/08: 28 male / 7 female, median age 59 (36–81) years, ECOG PS 0/1/2 69%/31%/0%, gastric / gastroesophageal cancer 60%/40%, distant metastases 96%, tumor in situ 37%. The most common toxicities reported were (CTC grade [gr] 3/4): diarrhea 20%/3%, vomiting 11%/3%, asthenia and neurotoxicity each 9%/0%. Mucositis and hand-foot-syndrome were observed in (grade 1+2 / grade 3) 29%/0% and 26%/3%, respectively. Hematoxicity was mild with grade 3 anemia in 10% and no other grade 3/4 toxicity except one episode of febrile neutropenia . Of 25 pts evaluable so far, first tumor response assessment revealed (RECIST criteria) partial response in 36% and stable disease in 40% of patients. Conclusions: TEX is a safe and tolerable regimen for patients with metastatic gastric cancer. Preliminary efficacy results indicate promising activity. Mature data including progression free survival will be presented at the meeting. [Table: see text]

PARALLEL 303: Phase 2 randomized study of pamiparib vs placebo as maintenance therapy in patients (pts) with inoperable locally advanced or metastatic gastric cancer that responded to platinum-based first-line (1L) chemotherapy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3109-3109
Author(s):  
Fortunato Ciardiello ◽  
Yung-Jue Bang ◽  
Johanna C. Bendell ◽  
Andres Cervantes ◽  
Mikhail Dvorkin ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Maintenance Therapy ◽  
Primary Endpoint ◽  
Safety Profile ◽  
Statistical Significance ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Phase 2 ◽  
Platinum Based Chemotherapy ◽  
Grade 3

3109 Background: A subset of gastric cancers exhibits platinum sensitivity and genomic instability that is characteristic of homologous recombination deficiency (HRD). Cells with HRD are sensitive to poly (ADP-ribose) polymerase (PARP) inhibition. PARP inhibitor maintenance therapy following platinum-based chemotherapy has been a successful treatment strategy in pts with ovarian cancer. Pamiparib is an orally administered selective PARP protein 1 and 2 (PARP1/2) inhibitor that has shown potent DNA-PARP trapping activity and crosses the blood brain barrier in preclinical studies. In early phase clinical studies (NCT02361723; NCT03333915), pamiparib showed an acceptable safety profile and promising antitumor activity. PARALLEL 303 compared the efficacy and safety of pamiparib vs placebo as maintenance therapy in pts with inoperable locally advanced or metastatic gastric cancer that responded to platinum-based 1L chemotherapy. Methods: The primary endpoint of this double-blind, randomized, global phase 2 study (NCT03427814) was progression-free survival (PFS) as determined by the investigator per RECIST Version 1.1. Key secondary endpoints included time to subsequent treatment, objective response rate, duration of response, time to response, overall survival (OS) and safety. At the time of this analysis, OS data were immature due to the short duration of study. Data presented here will focus on PFS and safety. Results: 136 pts were randomized 1:1 to receive pamiparib 60 mg orally (PO) twice daily (BID) (n=71) or placebo PO BID (n=65) in 28-day cycles. The median PFS was longer with pamiparib vs placebo, but did not reach statistical significance (3.7 months; 95% CI, 1.94–5.26 vs 2.1 months; 95% CI, 1.87–3.75 months); hazard ratio 0.799 (95% CI, 0.534–1.193; P=0.1428). Treatment-emergent adverse events (TEAEs) of ≥ Grade 3 were experienced by 29 pts (40.8%) in the pamiparib arm, and 20 pts (30.8%) in the placebo arm. The most common TEAEs of ≥ Grade 3 were blood and lymphatic system disorders in the pamiparib arm, and gastrointestinal disorders in the placebo arm. TEAEs leading to treatment discontinuation were: 8 pts (11.3%) in the pamiparib arm and 2 pts (3.1%) in the placebo arm. TEAEs leading to death were: 2 pts (2.8%; 1 pneumonia, 1 unexplained) in the pamiparib arm, and 2 pts (3.1%; 1 hepatic rupture, 1 sepsis) in the placebo arm. Conclusions: Although pamiparib did not meet statistical significance for superiority vs placebo for its primary endpoint, it was generally well tolerated with few treatment discontinuations due to TEAEs. No new safety signals were identified with pamiparib, and its safety profile was consistent with that of other PARP inhibitors. Clinical trial information: NCT03427814.

scholarly journals Neoadjuvant Chemotherapy with Fluorouracil plus Leucovorin, Oxaliplatin, and Docetaxel (FLOT) for Gastric Cancer Patients in China

2020 ◽  
Author(s):  
Birendra Kumar Sah ◽  
Xu Wei ◽  
Zhang Benyan ◽  
Zhang Huan ◽  
Yuan Fei ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Tumor Regression ◽  
Chinese Patients ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Grade 3 ◽  
Gastric Cancer Patients

AbstractPurposeNeoadjuvant fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) has shown significant benefits for gastric cancer patients. However, it has not been well accepted in Asian countries, so we conducted a prospective study on the safety and feasibility of this regimen in Chinese patients.MethodsPatients with adenocarcinoma of the stomach or esophagogastric junction received 4 cycles of neoadjuvant chemotherapy (NAC) and 4 cycles of adjuvant chemotherapy (AC) with the FLOT regimen. The completion status of chemotherapy, adverse events, postoperative morbidities and pathological tumor regression were analyzed. The two-year overall survival (OS) and relapse-free survival are presented.ResultsAltogether, 10 patients were enrolled, and all patients completed 4 cycles of neoadjuvant chemotherapy. There were no severe hematological adverse events (grade 3 or above), except for a case of grade 3 anemia. All 10 patients underwent radical gastrectomy. Nine patients had R0 resection, and 3 patients had complete or subtotal pathological tumor regression. Nine patients completed 4 cycles of adjuvant chemotherapy, but only one patient completed the full dose of adjuvant chemotherapy. The dose of adjuvant chemotherapy was reduced by 25% or less in the other patients. The median follow-up time was 23.13 months, 8 patients achieved the overall survival endpoint, and 7 patients had relapse-free survival for this period. Two patients died of disease progression.ConclusionsOur study demonstrates that neoadjuvant chemotherapy with FLOT regimen is safe and effective for Chinese patients. Dose adjustment is necessary for adjuvant chemotherapy. The pathological regression and survival rates need reevaluation in a larger cohort.

scholarly journals Identification of serum proteome signatures of locally advanced and metastatic gastric cancer: a pilot study

2015 ◽  
Vol 13 (1) ◽  
Author(s):  
Agata Abramowicz ◽  
Anna Wojakowska ◽  
Agnieszka Gdowicz-Klosok ◽  
Joanna Polanska ◽  
Pawel Rodziewicz ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Pilot Study ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Serum Proteome

Preliminary results of phase II study of irinotecan and capecitabine combination as first line chemotherapy for advanced and metastatic gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14030-14030 ◽  
Author(s):  
F. Farhat ◽  
M. Bachour ◽  
M. El Seoudi ◽  
J. Kattan ◽  
M. Ghosn ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Partial Response ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Single Agent ◽  
Locally Advanced ◽  
Response Rates ◽  
Metastatic Gastric Cancer ◽  
Tumor Control ◽  
Tumor Control Rate

14030 Background: Chemotherapy has a proven palliative role in advanced gastric cancer. The most widely investigated single-agent chemotherapy is 5-fluorouracil with partial response rates up to 20%. Single-agent irinotecan achieved response rates of 18%-23%. We investigated the combination Irinotecan plus Capecitabine for previously untreated locally advanced or metastatic gastric cancer. Methods: We conducted a phase II study with the combination of Irinotecan 80 mg/m2 on day 1, 8, and 15, and capecitabine 625 mg/m2 twice daily on days 1 to 14 repeated every 4 weeks. Patients were evaluated every second cycle. Previous chemotherapy for metastatic disease was not allowed. Patients must have measurable disease, ECOG PS < 2, life expectancy > 2 months, adequate hematological, liver and renal functions. Response was evaluated according to RECIST and toxicities according to NCI common toxicity criteria 3.0. Results: Between February 2002 and December 2005 31 patients were enrolled (20 male and 11 female). The median age was 57 years [range 37–74 years]. 142 cycles were administered with a median of 4.6 cycles per patient [range 1–10 cycles]. 29 patients were evaluable for response, and two are on ongoing treatment. Partial response rate was 38.5% . 9 patients (29%) had stable disease. Overall tumor control rate was 67.5%. Median time to progression and overall survival were 5.8 months [range- 1–16] and 10.58 months [range- 1–21] respectively. There was no grade III-IV reported toxicity including no hand and foot syndrome. Conclusions: Irinotecan and capecitabine in combination show an interesting tumor control rate (67.5%) with extremely well tolerated toxicity in patients with extensive gastric cancer. No significant financial relationships to disclose.

De Gramont Schedule is a Very Low Toxic and Effective Regimen in Low Performance Status Patients Affected by Metastatic Gastric Cancer: Preliminary Report

2002 ◽  
Vol 88 (4) ◽  
pp. A21-A24 ◽  
Author(s):  
Antonio Rea ◽  
Gennaro Gadaleta Caldarola ◽  
Claudia Sandomenico ◽  
Mauro Colangelo ◽  
Aldo Filice ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Preliminary Report ◽  
Median Overall Survival ◽  
Performance Status ◽  
Metastatic Gastric Cancer ◽  
Hard Choice ◽  
Major Response ◽  
Low Performance ◽  
Grade 3

Summary Treatment of patients affected by metastatic gastric cancer with low performance status (PS) is a very hard choice. It is mandatory to define a very well-tolerated schedule to be employed in these subgroup of patients. Patients and Methods From June 1999 to December 2001, 21 patients (pts) affected by metastatic gastric cancer with low performance status (≥2 ECOG) were treated with bimonthly “de Gramont” schedule. Treatment was planned to perform 6 courses of chemotherapy for each patient plus other 2-4 if a response had been documented. Results A total of 161 courses of de Gramont schedule was administered to the 21 pts enrolled. We observed 8 PD (38%), 8 SD (38%), 5 objective responses (24% – 2 MR, 3 PR). Duration of objective responses (OR) was 5 months, 3 months for 3 PRs and 2 and 1 months for two MRs respectively. At time of observation (June 2002) median overall survival (OS) was 14 months, median survival from the starting de Gramont schedule was 8 months. Toxicity was very mild: grade 3 leukopenia in 1 pt, grade 1-2 anemia and piastrinopenia in 3 pts, grade 1-2 nausea vomiting in 5 pts, grade 1 diarrhea in 4 pts, grade 3 mucositis in 2 pts. No other side effect was renowned. PS ameliorated in 12 (57%) pts, even if a major response was not noted. Conclusions de Gramont schedule can be safely and effectively employed in metastatic gastric cancer pts with very low performance status.

scholarly journals Feasibility and Safety of Perioperative Chemotherapy With Fluorouracil Plus Leucovorin, Oxaliplatin, and Docetaxel for Locally Advanced Gastric Cancer Patients in China

2021 ◽  
Vol 10 ◽  
Author(s):  
Birendra Kumar Sah ◽  
Wei Xu ◽  
Benyan Zhang ◽  
Huan Zhang ◽  
Fei Yuan ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Tumor Regression ◽  
Chinese Patients ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Grade 3 ◽  
Gastric Cancer Patients

BackgroundNeoadjuvant fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) has shown significant benefits for gastric cancer patients. However, it has not been well accepted in Asian countries. We conducted a prospective study on the safety and feasibility of the FLOT regimen in Chinese patients.MethodsPatients with adenocarcinoma of the stomach or esophagogastric junction received four cycles of neoadjuvant chemotherapy (NAC) and four cycles of adjuvant chemotherapy (AC) with the FLOT regimen. The completion status of chemotherapy, adverse events, postoperative morbidities, and pathological tumor regression were analyzed. The 2-year overall survival (OS) and relapse-free survival are presented.ResultsAltogether, 10 patients were enrolled, and all patients completed four cycles of neoadjuvant chemotherapy. There were no severe hematological adverse events (grade 3 or above), except for a case of grade 3 anemia. All 10 patients underwent radical gastrectomy. Nine patients had R0 resection, and three patients had complete or subtotal pathological tumor regression. Nine patients completed four cycles of adjuvant chemotherapy, but only one patient completed the full dose of adjuvant chemotherapy. The dose of adjuvant chemotherapy was reduced by 25% or less in the other patients. The median follow-up time was 23.13 months, eight patients achieved the overall survival endpoint, and seven patients had relapse-free survival for this period. Two patients died of disease progression.ConclusionsOur study demonstrates that the neoadjuvant FLOT regimen is safe and effective for Chinese patients. Dose adjustment is necessary for adjuvant chemotherapy. The pathological regression and survival rates need reevaluation in a larger cohort. The trial is registered with ClinicalTrials.gov (number NCT03646591).

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]

scholarly journals Efficacy of Regional Chemotherapy Approach in Peritoneal Metastatic Gastric Cancer

2021 ◽  
Vol 10 (22) ◽  
pp. 5322
Author(s):  
Kornelia Aigner ◽  
Yogesh Kumar Vashist ◽  
Emir Selak ◽  
Sabine Gailhofer ◽  
Karl Reinhard Aigner
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Median Overall Survival ◽  
Metastatic Gastric Cancer ◽  
Regional Chemotherapy ◽  
Intraarterial Infusion ◽  
Flow Perfusion ◽  
Advanced Stages ◽  
Grade 3 ◽  
Upper Abdominal

Peritoneal spread is frequent in gastric cancer (GC) and a palliative condition. After failure to systemic chemotherapy (sCTx) remaining therapeutic options are very limited. We evaluated the feasibility and efficacy of locoregional chemotherapy (RegCTx) in peritoneal metastatic GC. In total, 38 (23 male and 15 female) patients with peritoneal metastatic GC after failure of previous sCTx and unresectable disease were enrolled in this study. Using the hypoxic abdominal stop-flow perfusion, upper abdominal perfusion and intraarterial infusion technique in total 114 cycles with Cisplatin, Adriamycin and Mitomycin C were applied. No significant procedure related toxicity was noticed- especially no Grade 3 or 4 toxicity occurred. With the RegCTx approach a median overall survival of 17.4 months was achieved. Patients who had undergone previously resection of the GC the median overall survival was even better with 23.5 months. RegCTx is a promising, safe and efficient approach in diffuse metastatic GC. The evaluation of RegCTx in the setting of multimodal treatment approach at less advanced stages is also warranted.

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.

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