A Phase II Trial of Fixed-Dose Rate Gemcitabine plus Capecitabine in Metastatic/Advanced Biliary Tract Cancer Patients

Antonio Russo, Giuseppe Bronte, Enrico Vasile, Vincenzo Catalano, Bruno Vincenzi, Gianluca Masi, Alfredo Falcone, Francesco Graziano, Giuseppe Tonini, Daniele Santini, Vladimir Virzi

Risultato della ricerca: Articlepeer review

10 Citazioni (Scopus)

Abstract

Background: This phase II trial was conducted to determine the activity and safety of the combination of fixed-dose rate (FDR) gemcitabine and capecitabine in metastatic biliary tract cancer (BTC) patients. Methods: Patients with unresectable BTC who had pathologically confirmed adenocarcinoma, no prior chemotherapy, Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and measurable disease were enrolled. Treatment consisted of FDR gemcitabine at 800 mg/m 2 on days 1 and 8 every 21 days with capecitabine administered orally b.i.d. in equal doses (650 mg/m 2 b.i.d.) for 14 days (28 doses). Results: Between May 2005 and February 2009, 30 patients were enrolled. The median age was 67 years (45-76) and there were 14 males. Thirty patients were evaluable for response and toxicity. A total of 221 cycles were administered (median 7, range 2-16). One patient achieved complete response and 7 patients achieved partial response, giving an overall response rate of 26.7% in the intention-to-treat population. Twelve patients (40.0%) had stable disease. The median progression-free survival was 6.33 months. The median overall survival was 10.8 months. Grade 3/4 neutropenia and thrombocytopenia were noted in 13 and 7% of the patients, respectively. Grade 2/3 nonhematologic toxicities were asthenia (54% of patients), diarrhea (17%), stomatitis (23%) and hand-foot syndrome (7%). There was no treatment-related death. The drugs taken were skipped at least once in 45% of the patients and the dose was reduced in 26% of them. Conclusions: The combination of FDR gemcitabine and capecitabine in this 3-week cycle is safe and seems to have a good activity in advanced biliary cancer.
Lingua originaleEnglish
pagine (da-a)75-82
Numero di pagine8
RivistaOncology
Volume82
Stato di pubblicazionePublished - 2012

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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