Sequential high-dose methotrexate and fluorouracil combined with doxorubicin--a step ahead in the treatment of advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group.

1991 ◽  
Vol 9 (5) ◽  
pp. 827-831 ◽  
Author(s):  
J A Wils ◽  
H O Klein ◽  
D J Wagener ◽  
H Bleiberg ◽  
H Reis ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Multicenter Trial ◽  
Phase Iii ◽  
High Dose ◽  
European Organization ◽  
Dose Methotrexate ◽  
Prospective Phase ◽  
To Receive

In a prospective phase III multicenter trial, 213 patients with advanced measurable or nonmeasurable gastric cancer were randomized to receive methotrexate (MTX), fluorouracil (5-FU), and Adriamycin (doxorubicin; Farmitalia Carlo Erba, Milan, Italy) (FAMTX) or 5-FU, Adriamycin, and mitomycin (FAM). The results show a significantly superior response rate (41% v 9% [P less than .0001]), and survival (median, 42 weeks v 29 weeks [P = .004]) for FAMTX. There was a cumulative thrombocytopenia in FAM and not in FAMTX. The FAMTX protocol should be the reference treatment in future clinical trials that seek to improve the therapeutic outcome in advanced gastric cancer.

An EORTC Gastrointestinal Group phase III evaluation of combinations of methyl-CCNU, 5-fluorouracil, and adriamycin in advanced gastric cancer.

1987 ◽  
Vol 5 (9) ◽  
pp. 1387-1393 ◽  
Author(s):  
A Lacave ◽  
J Wils ◽  
H Bleiberg ◽  
E Diaz-Rubio ◽  
N Duez ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Multicenter Trial ◽  
Phase Iii ◽  
Rank Test ◽  
Short Survival ◽  
Log Rank Test ◽  
Prospective Phase ◽  
To Receive

In a prospective phase III multicenter trial, 189 patients with advanced measurable and nonmeasurable gastric cancer were randomized to receive 5-fluorouracil (5-FU) combined with Adriamycin (FA) or FA plus methyl-CCNU (MeFA). The response rate in patients with measurable disease was 10% (three of 29), and 18% (five of 28), respectively. No difference in the duration of survival was detected (P = .14; log rank test). Median survivals were 21 and 32 weeks, respectively. Toxicity was moderate, but there have been two toxic deaths among the patients who received FA. Because of the low response rate and the short survival, neither regimen can be recommended for the treatment of advanced gastric cancer.

An EORTC Gastrointestinal Group evaluation of the combination of sequential methotrexate and 5-fluorouracil, combined with adriamycin in advanced measurable gastric cancer.

1986 ◽  
Vol 4 (12) ◽  
pp. 1799-1803 ◽  
Author(s):  
J Wils ◽  
H Bleiberg ◽  
O Dalesio ◽  
G Blijham ◽  
N Mulder ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Trial ◽  
Response Rate ◽  
Multicenter Trial ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Group Evaluation ◽  
Dose Methotrexate ◽  
To Receive ◽  
Sequential Methotrexate

In a phase II multicenter trial, 71 patients with advanced measurable gastric cancer were registered to receive sequential high-dose methotrexate (MTX) and 5-fluorouracil (5-FU) combined with Adriamycin (A [Adria Laboratories, Columbus, OH]). The response rate was 33% (22 of 67), including all eligible patients. There were nine complete responders (CRs). The median survival for all patients was 6 months. There has been one toxic death; however, three other patients died from toxicity associated with major protocol violations. It is concluded that this protocol is active in gastric cancer. Toxicity, partly because of nonprotocol adherence, is considerable and is now under further investigation in a randomized trial comparing this schedule with a combination of 5-FU, Adriamycin, and mitomycin C (FAM).

Final Results of a Randomized Phase III Trial of Sequential High-Dose Methotrexate, Fluorouracil, and Doxorubicin Versus Etoposide, Leucovorin, and Fluorouracil Versus Infusional Fluorouracil and Cisplatin in Advanced Gastric Cancer: A Trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group

2000 ◽  
Vol 18 (14) ◽  
pp. 2648-2657 ◽  
Author(s):  
Udo Vanhoefer ◽  
Philippe Rougier ◽  
Hansjochen Wilke ◽  
Michel P. Ducreux ◽  
Angel J. Lacave ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Clinical Efficacy ◽  
Cox Regression ◽  
Tumor Regression ◽  
Phase Iii ◽  
Rank Test ◽  
High Dose ◽  
Survival Times ◽  
European Organization

PURPOSE: To compare the efficacy and tolerability of etoposide, leucovorin, and bolus fluorouracil (ELF) or infusional fluorouracil plus cisplatin (FUP) with that of the reference protocol of fluorouracil, doxorubicin, and methotrexate (FAMTX) in advanced gastric cancer. PATIENTS AND METHODS: A total of 399 patients with advanced adenocarcinoma of the stomach were randomized and analyzed for toxicity, tumor response, and progression-free and overall survival. Only reviewed and confirmed responses were considered. The analysis of remission was based on assessable patients with documented measurable lesions. The intent-to-treat principle, log-rank test, and Cox regression model were used for the statistical analysis of time-to-event end points. RESULTS: The overall response rate for 245 eligible patients with measurable disease was 9% with ELF, 20% with FUP, and 12% with FAMTX, with no significant differences. One hundred twelve patients were eligible for efficacy in assessable, nonmeasurable disease. No change was observed in 66% of patients treated with ELF, 56% with FUP, and 55% with FAMTX. Two patients achieved a complete tumor regression (one each for ELF and FAMTX). With a median follow-up time of 4.5 years, the median survival times were 7.2 months with ELF, 7.2 months with FUP, and 6.7 months with FAMTX, respectively, with no significant differences. Nonhematologic and hematologic toxicities of ELF, FUP, and FAMTX were acceptable, with neutropenia being the major toxicity for all three regimens. Seven treatment-related deaths occurred (two with FUP and five with FAMTX). CONCLUSION: All three investigated regimens demonstrate modest clinical efficacy and should not be regarded as standard treatment for advanced gastric cancer. New strategies should be considered to achieve a better clinical efficacy in the treatment of advanced gastric cancer.

Real-world efficacy and biomarker of nivolumab for advanced gastric cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 388-388
Author(s):  
Ryohei Kawabata ◽  
Yukinori Kurokawa ◽  
Takaomi Hagi ◽  
Takeshi Omori ◽  
Jin Matsuyama ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Predictive Factors ◽  
Real World ◽  
Response Rate ◽  
Performance Status ◽  
Phase Iii ◽  
Tumor Growth Rate ◽  
Positive Score ◽  
Previously Treated

388 Background: Although nivolumab demonstrated survival benefit and a manageable safety profile in previously-treated advanced gastric cancer in a phase III trial (ATTRACTION-2), the efficacy of nivolumab in real-world and predictive factors of responses to nivolumab for advanced gastric cancer remain unclear. We evaluated the efficacy of nivolumab and compared clinicopathological characteristics with responses to nivolumab and long-term survivals in patients with gastric cancer. Methods: 205 patients with unresectable or recurrent gastric cancer who were treated with nivolumab as 3rd or more line treatment were enrolled from 23 institutions. Tissue specimens were collected in 199 patients. PD-L1 expression of tumor specimens defined as tumor positive score (TPS) and combined positive score (CPS) and mismatch repair (MMR) were analyzed by immunohistochemistry. Tumor responses were assessed according to RECIST version 1.1. Hyper progressive disease (HPD) was defined as ≥two folds increase in tumor growth rate. Results: 138 out of 205 enrolled patients had measurable lesions. Response rate and HPD rate were 16.7% (23/138) and 22.0% (29/132), respectively. Response rate was significantly higher in patients with performance status (PS) 0-1, non-peritoneal diseases, CPS ≥10, and MMR deficient patients. On the other hand, PS 2-3 and liver metastases were predictive factors of HPD. Patients with CPS≥10 and MMR deficiency showed significantly better progression-free (P = 0.005, P = 0.001) and overall survivals (P = 0.005, P = 0.002). TPS showed no significant association with any outcomes. Conclusions: Real-world efficacy of nivolumab was shown in previously-treated advanced gastric cancer. CPS and MMR could be the useful biomarkers for the efficacy of nivolumab treatment as well as PS and metastasis site. Clinical trial information: UMIN000032164.

Phase III Study of Docetaxel and Cisplatin Plus Fluorouracil Compared With Cisplatin and Fluorouracil As First-Line Therapy for Advanced Gastric Cancer: A Report of the V325 Study Group

2006 ◽  
Vol 24 (31) ◽  
pp. 4991-4997 ◽  
Author(s):  
Eric Van Cutsem ◽  
Vladimir M. Moiseyenko ◽  
Sergei Tjulandin ◽  
Alejandro Majlis ◽  
Manuel Constenla ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Risk Reduction ◽  
Cancer Patients ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Iii ◽  
First Line Therapy ◽  
Grade 3 ◽  
Gastric Cancer Patients

Purpose In the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, the phase II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel and cisplatin for comparison against cisplatin and fluorouracil (CF; reference regimen) in the phase III part. Patients and Methods Advanced gastric cancer patients were randomly assigned to docetaxel 75 mg/m2 and cisplatin 75 mg/m2 (day 1) plus fluorouracil 750 mg/m2/d (days 1 to 5) every 3 weeks or cisplatin 100 mg/m2 (day 1) plus fluorouracil 1,000 mg/m2/d (days 1 to 5) every 4 weeks. The primary end point was time-to-progression (TTP). Results In 445 randomly assigned and treated patients (DCF = 221; CF = 224), TTP was longer with DCF versus CF (32% risk reduction; log-rank P < .001). Overall survival was longer with DCF versus CF (23% risk reduction; log-rank P = .02). Two-year survival rate was 18% with DCF and 9% with CF. Overall response rate was higher with DCF (χ2 P = .01). Grade 3 to 4 treatment-related adverse events occurred in 69% (DCF) v 59% (CF) of patients. Frequent grade 3 to 4 toxicities for DCF v CF were: neutropenia (82% v 57%), stomatitis (21% v 27%), diarrhea (19% v 8%), lethargy (19% v 14%). Complicated neutropenia was more frequent with DCF than CF (29% v 12%). Conclusion Adding docetaxel to CF significantly improved TTP, survival, and response rate in gastric cancer patients, but resulted in some increase in toxicity. Incorporation of docetaxel, as in DCF or with other active drug(s), is a new therapy option for patients with untreated advanced gastric cancer.

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