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
Por:
Irigoyen, A, Gallego, J, Guillen Ponce, C, Vera, R, Iranzo, V, Ales, I, Arevalo, S, Pisa, A, Martin, M, Salud, A, Falco, E, Saenz, A, Manzano Mozo, J, Pulido, G, Martinez Galan, J, Pazo-Cid, R, Rivera, F, Garcia Garcia, T, Serra, O, Fernandez Parra, E, Hurtado, A, Gomez Reina, M, Lopez Gomez, L, Martinez Ortega, E, Benavides, M and Aranda, E
Publicada:
1 abr 2017
Resumen:
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/m2, 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. (C) 2017 Elsevier Ltd. All rights reserved.
Filiaciones:
Irigoyen, A:
Virgen de la Salud Hosp, Toledo, Spain
:
Gen Univ Elche Hosp, Alicante, Spain
Guillen Ponce, C:
Univ Ramon y Cajal Hosp, Madrid, Spain
Vera, R:
Navarra Hosp, Navarra, Spain
Iranzo, V:
Gen Hosp, Valencia, Spain
Ales, I:
Hosp Reg Univ & Virgen de la Victoria, Malaga, Spain
Arevalo, S:
Donostia Hosp, Guipuzcoa, Spain
Pisa, A:
Sabadell Hosp, Corp Sanitaria Parc Tauli, Barcelona, Spain
Martin, M:
Santa Creu & St Pau Hosp, Barcelona, Spain
Salud, A:
Lleida Arnau de Vilanova Hosp, Lerida, Spain
Falco, E:
Fdn Son Llatzer Hosp, Palma De Mallorca, Spain
Saenz, A:
Clin Lozano Blesa Hosp, Zaragoza, Spain
Manzano Mozo, J:
Germans Trias & Pujol ICO Hosp, Barcelona, Spain
Pulido, G:
Univ Cordoba, Reina Sofia Hosp, Maimonides Inst Biomed Res IMIBIC, Spanish Canc Network RTICC,Inst Salud Carlos III, Cordoba, Spain
Martinez Galan, J:
Univ Virgen de las Nieves Hosp, Granada, Spain
Pazo-Cid, R:
Miguel Servet Univ Hosp, Spanish Canc Network RTICC, Inst Salud Carlos 3, Aragon Inst Biomed Res IISA, Zaragoza, Spain
Rivera, F:
Marques de Valdecilla Hosp, Santander, Spain
Garcia Garcia, T:
Morales Meseguer Hosp, Murcia, Spain
Serra, O:
Moises Broggi Hosp, Inst Catala Oncol Hospitalet del Llobregat, Barcelona, Spain
Fernandez Parra, E:
Nuestra Senora Valme Hosp, Seville, Spain
Hurtado, A:
Fdn Hosp Alcorcon, Madrid, Spain
Gomez Reina, M:
Puerta del Mar Hosp, Cadiz, Spain
Lopez Gomez, L:
Virgen de la Salud Hosp, Toledo, Spain
Martinez Ortega, E:
Ciudad Jaen Hosp, Jaen, Spain
Benavides, M:
Hosp Reg Univ & Virgen de la Victoria, Malaga, Spain
Aranda, E:
Univ Cordoba, Reina Sofia Hosp, Maimonides Inst Biomed Res IMIBIC, Spanish Canc Network RTICC,Inst Salud Carlos III, Cordoba, Spain
|