Efficacy and Safety of Fixed-Dose-Rate Infusions of Gemcitabine Plus Erlotinib for Advanced Pancreatic Cancer

Efficacy and Safety of Fixed-Dose-Rate Infusions of Gemcitabine Plus Erlotinib for Advanced Pancreatic Cancer

Authors

  • Alberto Muñoz Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Eider Azkona Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Estíbaliz Iza Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Eluska Iruarrizaga Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Abigail Ruiz de Lobera Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Itziar Rubio Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Joan Manel Mañé Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Sergio Carrera Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Inés Marrodán Ciordia Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain
  • Guillermo López-Vivanco Medical Oncology Department, Hospital Universitario Cruces, Plaza de Cruces, S/N, 48903 Barakaldo, Spain

DOI:

https://doi.org/10.6000/1927-7229.2015.04.01.8

Keywords:

Adenocarcinoma, efficacy, erlotinib, fixed-dose-rate infusion, gemcitabine, pancreas, safety

Abstract

Purpose: To evaluate the efficacy and safety of fixed-dose-rate infusions of gemcitabine in combination with erlotinib for advanced pancreatic cancer.

Methods/Patients: Patients with locally advanced (LAPC) or metastatic pancreatic cancer (MPC) without previous treatment for the advanced disease and Eastern Cooperative Oncology Group performance status received 1500 mg/m2 of gemcitabine in 150-minute infusions (10 mg/m2/minute) on days 1, 8 and 15 in 4-week cycles combined with 100 mg/day of oral erlotinib. The primary endpoint was overall survival (OS).

Results: Sixty-two evaluable patients were enrolled (LAPC, n=16; MPC, n=46). Median OS was 10.0 (95% CI, 7.1-13.0) months. OS was longer in patients with LAPC (p=0.019), females (p=0.010) and patients not receiving opioids (p=0.027). A trend towards longer OS was shown in patients with grade  rash (p=0.078). In multivariate analysis, only gender remained statistically significant (p=0.01). Median PFS was 4.9 (95% CI, 3.1-6.8) months, which was longer in patients with LAPC (p=0.004) and females (p=0.013). Overall response rate was 12.9% (95% CI, 4.7-21.3), with eight patients achieving partial response, and tumour growth control rate was 67.7% (95% CI, 79.3-56.1). The main grade 3/4 adverse events were neutropenia (40.3%), asthenia (22.6%), anaemia (19.4%), thrombocytopenia (17.7%) and infections (14.5%). Three patients died due to septic shock, cholangitis or pulmonary embolism.

Conclusions: The combination of fixed-dose-rate infusions of gemcitabine and erlotinib represents a feasible and active regimen for advanced pancreatic cancer with a manageable safety profile.

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Published

2015-01-09

How to Cite

Alberto Muñoz, Eider Azkona, Estíbaliz Iza, Eluska Iruarrizaga, Abigail Ruiz de Lobera, Itziar Rubio, Joan Manel Mañé, Sergio Carrera, Inés Marrodán Ciordia, & Guillermo López-Vivanco. (2015). Efficacy and Safety of Fixed-Dose-Rate Infusions of Gemcitabine Plus Erlotinib for Advanced Pancreatic Cancer. Journal of Analytical Oncology, 4(1),  44–51. https://doi.org/10.6000/1927-7229.2015.04.01.8

Issue

Vol. 4 No. 1 (2015)

Section

Articles