ESPAC-3(v2): A multicenter, international, open-label, randomized, controlled phase III trial of adjuvant 5-fluorouracil/folinic acid (5-FU/FA) versus gemcitabine (GEM) in patients with resected pancreatic ductal adenocarcinoma

Neoptolemos, J. P.; Büchler, M. W.; Stocken, D. D.; Ghaneh, Paula; Smith, Douglas D.; Bassi, C.; Moore, Malcolm J.; Cunningham, David; Dervenis, C.; Goldstein, David

doi:10.1200/jco.2009.27.18_suppl.lba4505

Cited by 46 publications

(28 citation statements)

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“…This was statistically non-significant that may be because 55% of cases were in stage IIB and 27.5% with positive safety margin 15 . The ESPAC-3 trial resulted in median OS of 23 months in cases treated with fluorouracil/folinic acid, while those treated with gemcitabine had a median OS of 23.6 months 16 . The aforementioned, both were less than OS obtained in our CTH group attributed to advanced stage of disease as 55% of cases with stage IIB, 27.5% with positive margin and 30% with elevated CA19-9.…”

Section: Discussionmentioning

confidence: 99%

Adjuvant Chemo-Radiotherapy versus Chemotherapy in Pancreatic Carcinoma

Attia

Awad

Elkholy

et al. 2017

Kasr-Al-Aini J.of Clin. Onc. and Nuc. Med.

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Background: Pancreatic carcinoma has the worst prognosis of all gastrointestinal solid tumors. Only 15-20% of cases present at a resectable stage and the rate of local recurrence is high. Aim: To assess tolerability and efficacy of adjuvant chemo-radiotherapy (CRT) for pancreatic carcinoma compared to chemotherapy (CTH) alone. Methods: This was a prospective study with historical control group. The intervention group involved patients who underwent a 3-phases protocol following Whipple surgery. In the first phase, weekly gemcitabine was administered at a dose of 1 gm/m 2 for 3 weeks. The second was a CRT phase whereas capecitabine (800 mg/m 2 ) used twice daily for 5-6 weeks concurrent with 3 dimensional conformal radiotherapy. Finally, the maintenance phase in which gemcitabine administered at a dose of 1 gm/m 2 weekly for 3 weeks with 1 week rest for 3 cycles. The historical group included patients who received gemcitabine only within the preceding 2 years. Results: From 50 patients with pancreatic cancer in the intervention group, 41 completed the treatment protocol versus 40 patients in the control group. The estimated median disease-free survival was 15 months in the CRT group versus 10 months in the CTH group, and the estimated mean was 19.4 versus 13.2 (p = 0.041). The estimated median overall survival was not reached in both treatment arms. The estimated mean overall survival was 27.9 months in the CRT group compared to 19.2 months in the CTH group (p = 0.023). The relapse rate was 29% in the CRT group versus 65% in the CTH group (p= 0.001). CRT was associated with more toxicity which was tolerated with no interruption of treatment. Conclusions: Adjuvant gemcitabine before and after capecitabine concurrent with 3D conformal radiotherapy was tolerated with better survival and local control in pancreatic cancer patients.

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Section: Discussionmentioning

confidence: 99%

Adjuvant Chemo-Radiotherapy versus Chemotherapy in Pancreatic Carcinoma

Attia

Awad

Elkholy

et al. 2017

Kasr-Al-Aini J.of Clin. Onc. and Nuc. Med.

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“…Recent trials supported the use of chemotherapy in radically resected patients, but the most effective regimen (gemcitabine or 5-fluorouracil/leucovorin) remains unclear (7,8). Similarly a phase 3 trial showed that a cisplatin-epirubicin-5-fluorouracil-gemcitabine regimen obtained a 1-year survival rate of 38.5%, which was significantly better than single-agent gemcitabine (6).…”

Section: Discussionmentioning

confidence: 99%

“…Although several attempts have been made to increase the survival using combinations of chemotherapy and targeted therapy, only a marginal success was achieved with gemcitabine combined with capecitabine or erlotinib, and with a four-drug regimen (4)(5)(6). According to the results of CONKO-001 and ESPAC-3 trials (7,8), gemcitabine also increased the disease-free survival (DFS) and overall survival (OS) in the adjuvant setting. However, the most effective adjuvant chemotherapy remains unclear, and the 5-year survival in patients undergoing resection still hovers between 10% and 20% (1).…”

Section: Introductionmentioning

confidence: 99%

MicroRNA-21 in Pancreatic Cancer: Correlation with Clinical Outcome and Pharmacologic Aspects Underlying Its Role in the Modulation of Gemcitabine Activity

et al. 2010

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MicroRNA-21 (miR-21) was reported to be overexpressed and contributes to invasion and gemcitabine resistance in pancreatic ductal adenocarcinoma (PDAC). The aim of this study was to evaluate whether miR-21 expression was associated with the overall survival (OS) of PDAC patients treated with gemcitabine and to provide mechanistic insights for new therapeutic targets. miR-21 expression was evaluated in cells (including 7 PDAC cell lines, 7 primary cultures, fibroblasts, and a normal pancreatic ductal cell line) and tissues (neoplastic specimens from 81 PDAC patients and normal ductal samples) isolated by laser microdissection. The role of miR-21 on the pharmacologic effects of gemcitabine was studied with a specific miR-21 precursor (pre-miR-21). Patients with high miR-21 expression had a significantly shorter OS both in the metastatic and in the adjuvant setting. Multivariate analysis confirmed the prognostic significance of miR-21. miR-21 expression in primary cultures correlated with expression in their respective tissues and with gemcitabine resistance. Pre-miR-21 transfection significantly decreased antiproliferative effects and apoptosis induction by gemcitabine, whereas matrix metalloproteinase (MMP)-2/MMP-9 and vascular endothelial growth factor expression were upregulated. Addition of inhibitors of phosphoinositide 3-kinase and mammalian target of rapamycin resulted in decrease of phospho-Akt and prevented pre-miR-21-induced resistance to the proapoptotic effects of gemcitabine. miR-21 expression correlated with outcome in PDAC patients treated with gemcitabine. Modulation of apoptosis, Akt phosphorylation, and expression of genes involved in invasive behavior may contribute to the role of miR-21 in gemcitabine chemoresistance and to the rational development of new targeted combinations. Cancer Res; 70(11); 4528-38. ©2010 AACR.

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“…The ESPAC group recently reported data from ESPAC-3 in their latest abstract, showing equivalence of gemcitabine and 5-FU plus leucovorin as adjuvant therapy, with a better safety profile in favor of gemcitabine [53]. ESPAC-4 has now been launched comparing gemcitabine with gemcitabine plus capecitabine in the adjuvant setting because the assessment of the ESPAC group is that CRT offers no benefit in this setting.…”

Section: Adjuvant Crt In Pancreatic Adenocarcinomamentioning

confidence: 99%

Chemoradiation in Pancreatic Adenocarcinoma: A Literature Review

Roy

Maraveyas

2010

The Oncologist

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Adenocarcinoma of the exocrine pancreas has an annual incidence of 7,400 cases in the U.K. In comparison with other common cancers of solid organs, namely, breast, colorectal, and prostate cancer, pancreatic cancer has a high morbidity and mortality. Radical resection is possible in only 15%-20% of patients, and only 3%-4% of all patients presenting with this condition achieve long-term control and cure. Various strategies in the form of neoadjuvant and adjuvant treatment have been employed over the years to improve outcome, with limited success. Systemic chemotherapy remains the gold standard in the metastatic setting in good performance status patients, and adjuvant chemotherapy after resection of localized and locally advanced cancer has been found to improve outcome. The role of radiotherapy, however, remains controversial and is an area that merits further investigation in well-conducted multicenter trials at various stages of the disease in combination with systemic agents and exploiting recent advances in the delivery of radiotherapy. In this article, we review the published literature on the use of chemoradiation as a modality in various stages of pancreatic adenocarcinoma and highlight areas that future trials in this field should target for a way forward in this malignancy. The Oncologist 2010;15:259 -269

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ESPAC-3(v2): A multicenter, international, open-label, randomized, controlled phase III trial of adjuvant 5-fluorouracil/folinic acid (5-FU/FA) versus gemcitabine (GEM) in patients with resected pancreatic ductal adenocarcinoma

Cited by 46 publications

References 0 publications

Adjuvant Chemo-Radiotherapy versus Chemotherapy in Pancreatic Carcinoma

Adjuvant Chemo-Radiotherapy versus Chemotherapy in Pancreatic Carcinoma

MicroRNA-21 in Pancreatic Cancer: Correlation with Clinical Outcome and Pharmacologic Aspects Underlying Its Role in the Modulation of Gemcitabine Activity

Chemoradiation in Pancreatic Adenocarcinoma: A Literature Review

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