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Clinical Trial
. 2018 Apr;23(2):281-286.
doi: 10.1007/s10147-017-1195-x. Epub 2017 Sep 27.

MMC/UFT/LV in refractory colorectal cancer: phase II study and analysis of predictive variables of progression

Chiara Baratelli  1 , Marco Tampellini  1 , Massimo Di Maio  1 , Azzurra Ottone  1 , Maria Pia Brizzi  1 , Laura Forti  1 , Irene Alabiso  1 , Cristina Sonetto  2 , Oscar Alabiso  1 , Giorgio Vittorio Scagliotti  1
Affiliations
Clinical Trial

MMC/UFT/LV in refractory colorectal cancer: phase II study and analysis of predictive variables of progression

Chiara Baratelli et al. Int J Clin Oncol. 2018 Apr.

Abstract

Background: The treatment of refractory metastatic colorectal cancer (rmCRC) and the lack of predictive variables are matters of debate.

Patients and methods: We conducted a multicentre phase II trial assessing the disease control rate (DCR) of the combination of tegafur/uracil and mitomycin C in rmCRC. The number of previous lines of chemotherapy, carcinoembryonic antigen (CEA) levels, progression-free survival of the last chemotherapy regimen (PPFS), and the neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio at the time of study entry were evaluated as indicators of early progression.

Results: We enrolled 42 patients. The combination was well tolerated with a DCR of 26.2% and median overall survival of 6.9 months. Low CEA levels, PPFS >6 months and low NLR were significantly associated with better prognosis.

Conclusion: The study failed its primary endpoint. However, some putative indicators of early progressive patients have been described.

Keywords: Colorectal cancer; Mitomycin C; Predictive markers; UFT.

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