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Efficacy of infusional 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) in the treatment of patients with gemcitabine-pretreated pancreatic cancer and analysis of prognostic factors in a salvage setting

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Abstract

Purpose

In gemcitabine-pretreated pancreatic cancer, salvage chemotherapy has not been established, and the prognostic factors are not completely known. The purpose of this study was to determine the efficacy and safety of infusional 5-fluorouracil (5-FU), doxorubicin, and mitomycin-C (iFAM) in patients with gemcitabine-pretreated pancreatic cancer and to elucidate the prognostic factors.

Methods

Study eligibility was as follows: (1) 18–75 years of age; (2) relapse within 6 months after adjuvant gemcitabine-based chemotherapy (GBC) or previously treated with palliative GBC; and (3) an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2. iFAM consisted of a 5-FU (800 mg/m2) infusion over 10 h on days 1–5, doxorubicin (30 mg/m2) on day 1, and mitomycin-C (8 mg/m2) on day 1 every 4 weeks.

Results

Sixty patients were enrolled. The responses to iFAM included a partial response in 6 patients (10.0%) and stable disease in 8 patients (13.3%). The median progression-free survival (PFS) and overall survival (OS) were 2.4 months (95% confidence interval [CI], 2.0–2.8 months) and 6.1 months (95% CI, 4.2–8.0 months), respectively. The 6- and 12-month survival rates were 50.4 and 26.4%, respectively. Grade 3/4 hematologic toxicities included neutropenia (3.3%) and thrombocytopenia (3.3%). The ECOG PS was a significant prognostic factor for PFS (P < 0.001) and OS (P = 0.022). An elevated CA 19-9 at the time of initiating iFAM (P = 0.011) was a poor prognostic factor for OS.

Conclusions

iFAM is an effective and well-tolerated in patients with gemcitabine-pretreated pancreatic cancer, even patients with an ECOG PS of 2. ECOG PS and CA 19-9 were shown to be significant prognostic factors in this salvage setting.

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None of the authors have a financial relationship with a commercial entity that has an interest in the subject of this manuscript.

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  1. Kyu-Hyoung Lim

    Present address: Department of Internal Medicine, Kangwon National University Hospital, 17-1 Hyoja 3-dong Chuncheon-si, Gangwon-do, 200-722, Korea

Authors and Affiliations

  1. Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 28 Yongon dong, Chongno-gu, Seoul, 110-744, Korea

    Kyu-Hyoung Lim, Tae-Yong Kim, Kyung-Hun Lee, Sae-Won Han, Do-Youn Oh, Seock-Ah Im, Tae-You Kim & Yung-Jue Bang

  2. Cancer Research Institute, Seoul National University College of Medicine, 28 Yongon dong, Chongno-gu, Seoul, 110-744, Korea

    Sae-Won Han, Do-Youn Oh, Seock-Ah Im, Tae-You Kim & Yung-Jue Bang

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Lim, KH., Kim, TY., Lee, KH. et al. Efficacy of infusional 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) in the treatment of patients with gemcitabine-pretreated pancreatic cancer and analysis of prognostic factors in a salvage setting. Cancer Chemother Pharmacol 68, 1017–1026 (2011). https://doi.org/10.1007/s00280-011-1584-1

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