Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-12

AUTHORS

Stefano Kim, Marine Jary, Thierry André, Véronique Vendrely, Bruno Buecher, Eric François, François-Clément Bidard, Sarah Dumont, Emmanuelle Samalin, Didier Peiffert, Simon Pernot, Nabil Baba-Hamed, Farid El Hajbi, Olivier Bouché, Jérôme Desrame, Aurélie Parzy, Mustapha Zoubir, Christophe Louvet, Jean-Baptiste Bachet, Thierry Nguyen, Meher Ben Abdelghani, Denis Smith, Christelle De La Fouchardière, Thomas Aparicio, Jaafar Bennouna, Jean-Marc Gornet, Marion Jacquin, Franck Bonnetain, Christophe Borg

ABSTRACT

BACKGROUND: The squamous cell carcinoma of the anus (SCCA) is a rare disease, but its incidence is markedly increasing. About 15% of patients are diagnosed at metastatic stage, and more than 20% with a localized disease treated by chemoradiotherapy (CRT) will recur. In advanced SCCA, cisplatin and 5-fluorouracil (CF) combination is the standard option but complete response is a rare event and the prognosis remains poor with most disease progression occurring within the first 12 months. We have previously published the potential role of the addition of docetaxel (D). Among 8 consecutive patients with advanced recurrent SCCA after CRT, the DCF regimen induced a complete response in 4 patients, including 3 pathological complete responses. Then, the Epitopes-HPV02 study was designed to confirm the interest of DCF regimen in SCCA patients. METHODS: This multicentre phase II trial assesses the DCF regimen in advanced SCCA patients. Main eligibility criteria are: histologically proven SCCA, unresectable locally advanced recurrent or metastatic disease, Eastern Cooperative Oncology Group-performance status (ECOG-PS) <2, and being eligible for DCF. Patients receive either 6 cycles of standard DCF or 8 cycles of modified DCF depending on age (> vs. ≤ 75 years-old) and ECOG-PS (0 vs. 1). The trial was set up based on a Simon's optimal two-stage design for phase II trials, allowing an early futility interim analysis. The primary endpoint is the observed progression-free survival (PFS) rate at 12 months from the first DCF cycle. A PFS rate below 10% is considered uninteresting, while a PFS rate above 25% is expected. With a unilateral alpha error of 5% and a statistical power of 90%, 66 evaluable patients should be included. Main secondary endpoints are overall survival, PFS, response rate, safety, health-related quality of life, and the correlation of biomarkers with treatment efficacy. DISCUSSION: Since the recommended CF regimen is based in a small retrospective analysis and generates a low rate of complete responses, the Epitopes-HPV02 study will establish a new standard in case of a positive result. Associated biomarker studies will contribute to understand the underlying mechanism of resistance and the role of immunity in SCCA. TRIAL REGISTRATION: NCT02402842 , EudraCT: 2014-001789-81. More... »

PAGES

574

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12885-017-3566-0

DOI

http://dx.doi.org/10.1186/s12885-017-3566-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1091351140

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28841909


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466 https://www.grid.ac/institutes/grid.452436.2 schema:alternateName Institut de Cancérologie de Lorraine
467 schema:name Institut de Cancérologie de Lorraine, Nancy, France
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470 schema:name Centre Hospitalier Universitaire de Besançon, Besançon, France
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474 Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) Oncology Multidisciplinary Group, Besançon, France
475 INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France
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477 https://www.grid.ac/institutes/grid.492693.3 schema:alternateName Hôpital Privé Jean Mermo
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481 schema:name Centre Hospitalier Universitaire de Besançon, Besançon, France
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