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Clinical Trial
. 2017 Apr:75:73-82.
doi: 10.1016/j.ejca.2016.12.032. Epub 2017 Mar 7.

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

Antonio Irigoyen  1 , Javier Gallego  2 , Carmen Guillén Ponce  3 , Ruth Vera  4 , Vega Iranzo  5 , Inmaculada Ales  6 , Sara Arévalo  7 , Aleydis Pisa  8 , Marta Martín  9 , Antonieta Salud  10 , Esther Falcó  11 , Alberto Sáenz  12 , José Luis Manzano Mozo  13 , Gema Pulido  14 , Joaquina Martínez Galán  15 , Roberto Pazo-Cid  16 , Fernando Rivera  17 , Teresa García García  18 , Olbia Serra  19 , Eva Ma Fernández Parra  20 , Alicia Hurtado  21 , Ma José Gómez Reina  22 , Luis Jesús López Gomez  23 , Esther Martínez Ortega  24 , Manuel Benavides  6 , Enrique Aranda  14 ; Spanish Cooperative Group of Treatment of Digestive Tumors (TTD)
Affiliations
Clinical Trial

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

Antonio Irigoyen et al. Eur J Cancer. 2017 Apr.

Abstract

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/m2, 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.

Keywords: Capecitabine; Erlotinib; First-line; Gemcitabine; Metastatic pancreatic cancer.

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