Gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in the first-line treatment of patients with metastatic pancreatic cancer: Efficacy and safety results of a phase IIb randomised study from the Spanish TTD Collaborative Group.

Autor:	Irigoyen A; Virgen de la Salud Hospital, Toledo, Spain. Electronic address: antonioirigoyen@yahoo.com., Gallego J; General Universitario de Elche Hospital, Alicante, Spain., Guillén Ponce C; Universitario Ramón y Cajal Hospital, Madrid, Spain., Vera R; Navarra Hospital, Navarra, Spain., Iranzo V; General Hospital, Valencia, Spain., Ales I; Hospital Regional Universitario y Virgen de la Victoria, Málaga, Spain., Arévalo S; Donostia Hospital, Guipúzcoa, Spain., Pisa A; Sabadell Hospital, Corporación Sanitaria Parc Tauli, Barcelona, Spain., Martín M; Santa Creu i Sant Pau Hospital, Barcelona, Spain., Salud A; Lleida Arnau de Vilanova Hospital, Lérida, Spain., Falcó E; Fundación Son Llatzer Hospital, Palma de Mallorca, Spain., Sáenz A; Clínico Lozano Blesa Hospital, Zaragoza, Spain., Manzano Mozo JL; Germans Trias i Pujol-ICO Hospital, Barcelona, Spain., Pulido G; Maimonides Institute of Biomedical Research (IMIBIC), Reina Sofía Hospital, University of Córdoba, Spanish Cancer Network (RTICC), Instituto de Salud Carlos III, Córdoba, Spain., Martínez Galán J; Universitario Virgen de las Nieves Hospital, Granada, Spain., Pazo-Cid R; Aragon Institute of Biomedical Research (IISA), Miguel Servet University Hospital, Spanish Cancer Network (RTICC), Instituto de Salud Carlos III, Zaragoza, Spain., Rivera F; Marqués de Valdecilla Hospital, Santander, Spain., García García T; Morales Meseguer Hospital, Murcia, Spain., Serra O; Moisés Broggi Hospital, Institut Català Oncologia - Hospitalet del Llobregat, Barcelona, Spain., Fernández Parra EM; Nuestra Señora de Valme Hospital, Sevilla, Spain., Hurtado A; Fundación Hospital de Alcorcón, Madrid, Spain., Gómez Reina MJ; Puerta del Mar Hospital, Cádiz, Spain., López Gomez LJ; Virgen de la Salud Hospital, Toledo, Spain., Martínez Ortega E; Ciudad de Jaén Hospital, Jaén, Spain., Benavides M; Hospital Regional Universitario y Virgen de la Victoria, Málaga, Spain., Aranda E; Maimonides Institute of Biomedical Research (IMIBIC), Reina Sofía Hospital, University of Córdoba, Spanish Cancer Network (RTICC), Instituto de Salud Carlos III, Córdoba, Spain.
Jazyk:	angličtina
Zdroj:	European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2017 Apr; Vol. 75, pp. 73-82. Date of Electronic Publication: 2017 Mar 07.
DOI:	10.1016/j.ejca.2016.12.032
Abstrakt:	Background: Gemcitabine and erlotinib have shown a survival benefit in the first-line setting in metastatic pancreatic cancer (mPC). The aim of this study was to assess whether combining capecitabine (C) with gemcitabine + erlotinib (GE) was safe and effective versus GE in patients with mPC. Patients and Methods: Previously untreated mPC patients were randomised to receive G (1000 mg/m 2 , days 1, 8, 15) + E (100 mg/day, days 1-28) + C (1660 mg/m 2 , days 1-21) or GE, q4 weeks, until progression or unacceptable toxicity. Primary end-point: progression-free survival (PFS); secondary end-points: overall survival (OS), response rate, relationship of rash with PFS/OS and safety. Results: 120 patients were randomised, median age 63 years, ECOG status 0/1/2 33%/58%/8%; median follow-up 16.5 months. Median PFS in the gemcitabine-erlotinib-capecitabine (GEC) and GE arms was 4.3 and 3.8 months, respectively (hazard ratio [HR]: 0.88, 95% confidence interval [CI]: 0.58-1.31; p = 0.52). Median OS in the GEC and GE arms was 6.8 and 7.7 months, respectively (HR: 1.09, 95% CI: 0.72-1.63; p = 0.69). Grade 3/4 neutropenia (GEC 43% versus GE 15%; p = 0.0008) and mucositis (GEC 9% versus GE 0%; p = 0.03) were the only statistically significant differences in grade 3/4 adverse events. PFS and OS were significantly longer in patients with rash (grade ≥1) versus no rash (grade = 0): PFS 5.5 versus 2.0 months (HR = 0.39, 95% CI: 0.26-0.6; p < 0.0001) and OS: 9.5 versus 4.0 months (HR = 0.51, 95% CI: 0.33-0.77; p = 0.0014). Conclusion: PFS with GEC was not significantly different to that with GE in patients with mPC. Skin rash strongly predicted erlotinib efficacy. The study was registered with ClinicalTrials.gov: NCT01303029. (Copyright © 2017 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Full Text from ScienceDirect