FOLFOX as second-line chemotherapy in patients with pretreated metastatic pancreatic cancer from the FIRGEM study
1 Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, AP-HP, 20 rue Leblanc, 75015 Paris, France
2 University of Paris Descartes, Paris, France
3 Biostatistic and Quality of Life Unit, Georges François Leclerc Center, Dijon, France
4 Department of Hepatogastroenterology, Jean Minjoz Hospital, Besançon, France
5 Department of Hepatogastroenterology, Trousseau Hospital, University of François-Rabelais, Tours, France
6 Department of Gastroenterology and Digestive Oncology, Avicenne Hospital, HUPSSD, AP-HP, University of Paris 13, Sorbonne Paris Cité, Bobigny, France
7 Department of Gastroenterology and Digestive Oncology, Jean Mermoz Hospital, Lyon, France
8 Department of Hepatogastroenterology, Bicêtre Hospital, AP-HP, Kremlin Bicêtre, France
BMC Cancer 2014, 14:441 doi:10.1186/1471-2407-14-441Published: 14 June 2014
FOLFOX second-line treatment seems to be a validated option for patients with pancreatic cancer (PC) progressing after gemcitabine chemotherapy. However, other therapeutics strategy has developed in first-line therapy, as the FIRGEM phase II study that evaluated gemcitabine alone versus FOLFIRI.3 alternating with gemcitabine every two months. The present study assessed the efficacy and safety of FOLFOX after failure of the first-line therapy used in the FIRGEM study.
In this prospective observational cohort study, we analysed all consecutive patients who received second-line chemotherapy with FOLFOX among 98 patients with metastatic PC included in the FIRGEM study. Progression-free survival (PFS) and overall survival (OS) were estimated from the start of second-line chemotherapy using the Kaplan-Meier method.
Among 46 patients who received second-line chemotherapy, 27 patients (male, 55%; median age, 61 years; performance status (PS) 0–1, 44%) were treated with FOLFOX after progression to first-line gemcitabine alone (n = 20) or FOLFIRI.3 alternating with gemcitabine (n = 7). Grade 3 toxicity was observed in 33% of patients (no grade 4 toxicity). At the end of follow-up, all patients had progressed and 25 had died. No objective response was observed, and disease control rate was 36%. Median PFS and OS were 1.7 and 4.3 months, respectively. In multivariate analysis, PS was the only independent prognostic factor. For patients PS 0–1 versus 2–3, median PFS was 3.0 versus 1.2 months (log rank, p = 0.002), and median OS was 5.9 versus 2.6 months (log rank, p = 0.001).
This study suggests that FOLFOX second-line therapy offered interesting efficacy results with an acceptable toxicity profile in metastatic PC patients with a good PS.