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Clinical Trial
. 2011 Sep 26:6:124.
doi: 10.1186/1748-717X-6-124.

Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival

Lucie Oberic  1 , Frédéric Viret, Charlotte Baey, Marc Ychou, Jaafar Bennouna, Antoine Adenis, Didier Peiffert, Françoise Mornex, Jean-Pierre Pignon, Patrice Celier, Jocelyne Berille, Michel Ducreux
Affiliations
Clinical Trial

Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival

Lucie Oberic et al. Radiat Oncol. .

Abstract

Background: To explore possible improvement in the treatment of locally advanced pancreatic carcinoma (LAPC) we performed a randomized, non-comparative phase II study evaluating docetaxel - plus either daily continuous 5 FU or weekly cisplatin concurrent to radiotherapy. We report here the results of the docetaxel plus 5 FU regimen stopped according to the interim analysis. The docetaxel plus cisplatin arm was continued.

Methods: Forty (40) chemotherapy-naive patients with unresectable LAPC were randomly assigned (1:1) to either continuous fluorouracil (5-FU) 200 mg/m(2)/day (protracted IV) and docetaxel (DCT) 20 mg/m(2)/week or DCT 20 mg/m2 and cisplatin (CDDP) 20 mg/m(2), plus concurrent radiotherapy for a period of 6 weeks. The radiation dose to the primary tumor was 54 Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate (NPR). Secondary endpoints were tolerance, objective response rate, and overall survival. Accrual was to be stopped if at 6 months more than 13 disease progressions were observed in 20 patients.

Results: Eighteen (18) progressions occurred at 6 months in the 5-FU-DCT arm. Six-month NPR was 10% (95%CI: 0-23). Six and 12-month survivals were 85% (95%CI: 64-95) and 40% (95%CI: 22-61); median overall survival was 10.1 months. Median progression-free survival was 4.3 months. We report the case of one patient who was amenable to surgery and has been in complete response (CR) for 5.5 years. Toxicities grade ≥ 3 were reported in 75% of patients; no treatment-related death occurred. Severe toxicities were mainly vomiting (35%), abdominal pain (10%) and fatigue (10%).

Conclusions: Combination of 5-FU, docetaxel and radiotherapy has inadequate efficacy in the treatment of LAPC despite good tolerance for the 5-FU-DCT regimen.

Trial registration: ClinicalTrials.gov: NCT00112697.

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Figures

Figure 1
Figure 1
Treatment schedule: 5-FU + docetaxel + radiotherapy.
Figure 2
Figure 2
Overall and progression-free survival.
See this image and copyright information in PMC

References

    1. Berrino F, Verdecchia A, Lutz JM, Lombardo C, Micheli A, Capocaccia R. Comparative cancer survival information in Europe, EUROCARE Working Group. Eur J Cancer. 2009;45:901–8. doi: 10.1016/j.ejca.2009.01.018. - DOI - PubMed
    1. Garcea Giuseppe. Survival Following Curative Resection for Pancreatic Ductal Adenocarcinoma. A Systematic Review of the Literature. JOP J Pancreas (Online) 2008;9:99–132. - PubMed
    1. Keleg S, Büchler P, Ludwig R, Büchler MW, Friess H. Invasion and metastasis in pancreatic cancer. Molecular Cancer. 2003;2:14. doi: 10.1186/1476-4598-2-14. - DOI - PMC - PubMed
    1. Jacobs NL, Que FG, Miller RC, Vege SS, Farnell MB, Jatoi A. Cumulative morbidity and late mortality in long-term survivors of exocrine pancreas cancer. J Gastroinstestinal Cancer. 2009;40:46–50. doi: 10.1007/s12029-009-9082-y. - DOI - PubMed
    1. Spinelli GP, Zullo A, Romiti A, Di Seri M, Tomao F, Miele E, Spalletta B, Eramo A, Hassan C, Tomao S. Long-Term Survival in Metastatic Pancreatic Cancer. A Case Report and Review of the Literature. JOP J Pancreas (Online) 2006;7:486–491. - PubMed

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