Randomized phase II study evaluating oxaliplatin alone, oxaliplatin combined with infusional 5-FU, and infusional 5-FU alone in advanced pancreatic carcinoma patients

Ducreux, Michel; Mitry, Emmanuel; Ould-Kaci, Mahmoud; Boige, Valérie; Seitz, Jean François; Bugat, R.; Breau, J. L.; Bouché, Olivier; Etienne, Pierre-Luc; Tigaud, Jean-Marie; Morvan, F.; Cvitkovic, Esteban; Rougier, Philippe

doi:10.1093/annonc/mdh098

Cited by 93 publications

(46 citation statements)

References 33 publications

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“…Median follow-up is 18.1 months (range 11.2 -26.2 months). (Louvet et al, 2002b;Ducreux et al, 2004) and biliary tract adenocarcinoma (André et al, 2004b). In combination with radiation therapy, oxaliplatin and fluoropyrimidines result in promising tumour remissions in locally advanced oesophageal and rectal cancer (Freyer et al, 2001;Khushalani et al, 2002;Rödel et al, 2003).…”

Section: Efficacymentioning

confidence: 99%

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: Efficacymentioning

confidence: 99%

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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“…For the combination of a fluoropyrimidine and oxaliplatin, efficacy has been observed in gastrointestinal tumors such as pancreatic or biliary tract cancer [11][12][13][14] and in several other tumor entities. In advanced breast cancer, capecitabine is one of the standard drugs for anthracycline-pretreated patients [15,16].…”

Section: Discussionmentioning

confidence: 99%

Phase II Trial of Capecitabine and Oxaliplatin in Patients with Adeno- and Undifferentiated Carcinoma of Unknown Primary

et al. 2009

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Background: Carcinomas of unknown primary (CUP) account for approximately 2–5% of all cancer diagnoses. Except for some subsets with favorable prognosis, for most of these patients treatment options are limited, and no standard first-line regimen has been identified. We performed a phase II study with oxaliplatin (OX) and capecitabine (CAP) as first-line treatment for patients with histo-or cytologically proven adeno- or undifferentiated CUP. Patients and Methods: Protocol treatment in this multicenter trial consisted of CAP 1,000 mg/m² twice daily orally (days 1–14) and OX 130 mg/m² intravenously (day 1), repeated every 21 days at a maximum of 6 cycles. The primary endpoint was the response rate (RR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Results: 51 patients with CUP (71% with poorly differentiated adenocarcinoma; 41% ECOG performance status (PS) 0, 39% PS 1, 10% PS 2, 55% with elevated lactate dehydrogenase (LDH), and 39% with liver metastases) were enrolled in this study. We observed an objective RR of 11.7% and a median PFS of 2.5 months as well as an OS of 7.5 months with a good toxicity profile. Conclusion: CAP/OX did not reach higher RR compared to a standard regimen with paclitaxel/carboplatin, which discourages further investigation of this schedule in CUP.

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“…i tym samym przewyższa monoterapię 5-FU [76]. Natomiast połączenie 5-FU z cisplatyną [77][78][79] oraz 5-FU z cisplatyną i interferonem [80] nie zwiększa przeżycia w porównaniu z samym 5-FU.…”

Section: Terapia łąCzona Z Zastosowaniem 5-fluorouracylu W Zaawansowaunclassified

Randomized trials in exocrine pancreatic cancer

Andrén‐Sandberg¹,

Hedberg²,

Winter³

et al. 2011

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StreszczenieLeczenie raka trzustki jest poważnym problemem współczes -nej medycyny. Rak ten stanowi ok. 3% nowotworów wykrywanych corocznie na świecie i zajmuje 4. miejsce pod względem śmiertelności wśród nowotworów złośliwych. Agresywny przebieg, późne rozpoznanie oraz oporność na stosowane leczenie powoduje, że 5-letnie przeżycie nie przekracza 5%. Podstawową metodą terapii wczesnych postaci nowotworu jest radykalny zabieg, jednak w chwili rozpoznania u 80-90% chorych proces nowotworowy jest zaawansowany, a guz nieoperacyjny. Jedną z możliwości poprawy wyników leczenia raka trzustki jest stosowanie terapii uzupełniającej. W niniejszym artykule przedstawiono przegląd aktualnych badań z randomizacją dotyczących leczenia adiuwantowego, neoadiuwantowego, monoterapii, terapii skojarzonej oraz leczenia bólu czy roli odżywiania w terapii raka trzustki. AbstractTreatment of pancreatic cancer is a major oncological challenge. Pancreatic cancer remains a highly lethal disease and is the 4 th leading cause of cancer-related deaths in the United States, with a 5-year survival of less than 5%. The poor prognosis of this cancer is due to its propensity for early local invasion and metastasis. Most patients present with advanced disease, precluding curative surgical resection, which remains the only potential curative approach. The adjuvant treatment may improve the prognosis in pancreatic cancer. This article presents a review of randomized clinical trials including adjuvant and neoadjuvant treatment, monotherapy and combination therapy, pain relief and the role of nutrition in pancreatic cancer treatment. WstępLeczenie raka trzustki jest poważnym problemem współczesnej medycyny. Stanowi on ok. 3% nowotworów wykrywanych corocznie na świecie i zajmuje 4. miejsce pod względem śmiertelności wśród nowotworów złośli-wych. Agresywny przebieg, późne rozpoznanie oraz oporność na stosowane leczenie powoduje, że 5-letnie przeżycie nie przekracza 5%, a większość chorych umiera w ciągu 3-6 mies. od rozpoznania. Podstawową metodą terapii wczesnych postaci nowotworu jest radykalny zabieg, jednak w chwili rozpoznania u 80-90% chorych proces nowotworowy jest zaawansowany, a guz nieoperacyjny [1]. Jedną z możliwości poprawy wyników leczenia raka trzustki jest stosowanie terapii uzupełniającej.W niniejszym artykule przedstawiono przegląd aktualnych badań z randomizacją dotyczących leczenia adiuwantowego, neoadiuwantowego, monoterapii, terapii skojarzonej oraz leczenia bólu czy roli odżywiania w terapii raka trzustki.

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Randomized phase II study evaluating oxaliplatin alone, oxaliplatin combined with infusional 5-FU, and infusional 5-FU alone in advanced pancreatic carcinoma patients

Abstract: With a 10% response rate, median overall survival of 9 months and an encouraging safety profile, the OXFU combination is effective, appears superior to infusional 5-FU and warrants further studies in APC patients.

Cited by 93 publications

References 33 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

Phase II Trial of Capecitabine and Oxaliplatin in Patients with Adeno- and Undifferentiated Carcinoma of Unknown Primary

Randomized trials in exocrine pancreatic cancer

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