Phase II Trial of Biweekly Infusional Fluorouracil, Folinic Acid, and Oxaliplatin in Patients With Advanced Gastric Cancer

Al‐Batran, Salah‐Eddin; Atmaca, Akin; Hegewisch‐Becker, Susanna; Jaeger, Dirk; Hahnfeld, S.; Rummel, Mathias; Seipelt, G.; Rost, Andreas; Orth, J.; Knuth, Alexander; Jaeger, E.

doi:10.1200/jco.2004.07.042

Cited by 162 publications

(119 citation statements)

References 30 publications

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“…This represents the typical treatment facilities for cancer patients in Germany. As in three studies on oxaliplatin plus 5-FU/FA in gastric cancer previously published by the French group (Louvet et al, 2002a), the Taiwan group (Chao et al, 2004) and the Frankfurt group (Al-Batran et al, 2004), the majority of patients in our study presented with a good performance status and the median age of 62 years was in the same range as in the three previous trials. Of note, all patients included in our study presented with metastatic disease.…”

Section: Efficacysupporting

confidence: 68%

“…In advanced gastric cancer, two previously published phase II studies have shown consistent results regarding the activity of biweekly oxaliplatin-5 -FU/FA combinations. These regimens induced objective tumour responses in 43 and 45% of patients, respectively, and were associated with a median survival of 9.6 and 8.6 months, respectively (Louvet et al, 2002a;Al-Batran et al, 2004). A study from Taiwan assessed the activity of oxaliplatin-5-FU/FA given on days 1 and 8, repeated every 3 weeks.…”

Section: Efficacymentioning

confidence: 99%

“…Therefore, in many countries this combination forms the new standard of care in the first-line treatment of metastatic disease. In advanced gastric cancer, biweekly oxaliplatin plus 5-FU/FA has shown considerable antitumour activity in phase II trials (Louvet et al, 2002a;Al-Batran et al, 2004). Oxaliplatin shows a better toxicity profile than cisplatin.…”

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confidence: 99%

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Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

et al. 2005

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Oxaliplatin plus fluorouracil/folinic acid (5-FU/FA) every 2 weeks has shown promising activity in advanced gastric cancer. This study assessed the efficacy and safety of weekly oxaliplatin plus 5-FU/FA (FUFOX regimen) in the metastatic setting. Patients with previously untreated metastatic gastric cancer received oxaliplatin (50 mg m À2 ) plus FA (500 mg m À2 , 2-h infusion) followed by 5-FU (2000 mg m À2 , 24-h infusion) given on days 1, 8, 15 and 22 of a 5-week cycle. The primary end point of this multicentre phase II study was the response rate according to RECIST criteria. A total of 48 patients were enrolled. Median age was 62 years and all patients had metastatic disease, with a median number of three involved organs. The most common treatment-related grade 3/4 adverse events were diarrhoea (17%), deep vein thrombosis (15%), neutropenia (8%), nausea (6%), febrile neutropenia (4%), fatigue (4%), anaemia (4%), tumour bleeding (4%), emesis (2%), cardiac ischaemia (2%) and pneumonia (2%). Grade 1/2 sensory neuropathy occurred in 67% of patients but there were no episodes of grade 3 neuropathy. Intent-to-treat analysis showed a response rate of 54% (95% CI, 39 -69%), including two complete responses. At a median follow-up of 18.1 months (range 11.2 -26.2 months), median survival is 11.4 months (95% CI, 8.0 -14.9 months) and the median time to progression is 6.5 months (95% CI, 3.9 -9.2 months). The weekly FUFOX regimen is well tolerated and shows notable activity as first-line treatment in metastatic gastric cancer.

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Section: Efficacysupporting

confidence: 68%

Section: Efficacymentioning

confidence: 99%

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Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

et al. 2005

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“…To our knowledge, this is the largest phase II study in this patient population. Indeed, the other two phase II trials of oxaliplatin, 5-FU and FA combination in chemotherapynaive AGC patients enrolled 54 (49 patients were assessable for response) and 41 (37 patients were assessable for response) patients, respectively (Louvet et al, 2002;Al-Batran et al, 2004). Table 3 summarises the results of our study in comparison with the two previously published phase II trials of oxaliplatin, FA and 5-FU as first-line therapy in AGC patients.…”

Section: Discussionmentioning

confidence: 96%

A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients

et al. 2005

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The aim of the study was to assess the toxicity and the clinical activity of biweekly oxaliplatin in combination with infusional 5-fluorouracil (5-FU) and folinic acid (FA) administered every 2 weeks (FOLFOX-4 regimen) in patients with advanced gastric cancer (AGC). A total of 61 previously untreated AGC patients were treated with oxaliplatin 85 mg m À2 on day 1, FA 200 mg m À2 as a 2 h infusion followed by bolus 5-FU 400 mg m À2 and a 22 h infusion of 5-FU 600 mg m À2 , repeated for 2 consecutive days every 2 weeks. All patients were assessable for toxicity and response to treatment. Four (7%) complete responses and 19 partial responses were observed (overall response rate, 38%). Stable disease was observed in 22 (36%) patients, with progressive disease in the other six (10%) patients. Median time to progression (TTP) and median overall survival (OS) were 7.1 and 11.2 months, respectively. National Cancer Institute Common Toxicity Criteria grade 3 and 4 haematologic toxicities were neutropenia, anaemia and thrombocytopenia in 36, 10 and 5% of the patients, respectively. Grade 3 peripheral neuropathy was recorded in three (5%) patients. FOLFOX-4 is an active and well-tolerated chemotherapy. Response rate (RR), TTP and OS were comparable with those of other oxaliplatin-based regimens, suggesting a role for this combination in gastric cancer.

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“…In 2005, there were approximately 400 000 new cases and 300 000 deaths from gastric cancer (Yang, 2006). There is currently no established standard regimen for advanced gastric cancer; however, biweekly oxaliplatin plus 5-fluorouracil (5-FU) and folinic acid (FOLFOX) was well tolerated and yielded median survival times of 9.6 -11.4 months in five phase II studies (Louvet et al, 2002;Al-Batran et al, 2004;Chao et al, 2004;De Vita et al, 2005;Lordick et al, 2005). Considerable published evidence suggests that interindividual variation in response to 5-FU results from variations in the thymidylate synthase (TS) mRNA expression levels of the tumour (Longley et al, 2003).…”

mentioning

confidence: 99%

ERCC1 mRNA levels and survival of advanced gastric cancer patients treated with a modified FOLFOX regimen

et al. 2008

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Molecular markers involved in DNA repair can help to predict survival in gastric cancer patients treated with 5-FU plus platinum chemotherapy. Excision repair cross-complementing 1 (ERCC1) and thymidylate synthase (TS) mRNA expression levels were assessed in advanced gastric cancer tumour samples using real-time quantitative PCR in 76 patients treated with a modified FOLFOX (biweekly oxaliplatin plus 5-FU and folinic acid) regimen. Median survival time in patients with low ERCC1 levels was significantly longer than in those with high levels (15.8 vs 6.2 months; Po0.0001). Patients with high TS levels had longer survival than those with low levels (12.2 vs 10.1 months; P ¼ 0.01). Forty-eight patients with low ERCC1 and high TS levels had a median survival of 16.1 months (Po0.0001). The hazard ratio for patients with high ERCC1 expression was 9.4 (Po0.0001). In patients with high mRNA levels of ERCC1, alternative chemotherapy regimens should be considered.

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Phase II Trial of Biweekly Infusional Fluorouracil, Folinic Acid, and Oxaliplatin in Patients With Advanced Gastric Cancer

Cited by 162 publications

References 30 publications

Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients

ERCC1 mRNA levels and survival of advanced gastric cancer patients treated with a modified FOLFOX regimen

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