Clinical outcome of patients with chemorefractory metastatic colorectal cancer treated with trifluridine/tipiracil (TAS-102): a single Italian institution compassionate use programme

Vincenzo Sforza, Erika Martinelli, Claudia Cardone, Giulia Martini, Stefania Napolitano, Pietro Paolo Vitiello, Pasquale Vitale, Nicoletta Zanaletti, Alfonso Reginelli, Maurizio Di Bisceglie, Tiziana Pia Latiano, AnnaMaria Bochicchio, Fabiana Cecere, Francesco Selvaggi, Fortunato Ciardiello, Teresa Troiani

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Abstract

BACKGROUND: TAS-102 improves overall survival (OS) in patients with metastatic colorectal cancer (mCRC) refractory to standard treatments. However, predictive biomarkers of efficacy are currently lacking.

PATIENTS AND METHODS: We treated a cohort of 43 chemorefractory mCRC patients treated with TAS-102, in a single institution expanded access, compassionate use programme. We stratified patients in two groups according to number of cycles received (<6 cycles and ≥6 cycles). OS, progression-free survival (PFS) and safety were evaluated.

RESULTS: Thirteen out of 43 patients (30%) obtained a clinically relevant disease control with TAS-102 therapy. Eleven of them were treated for ≥6 cycles with TAS-102, reaching a median PFS of 7.5 months (95% CI 5.8 to 9.2 months) and a median OS of 11.2 months (95% CI range not reached yet). A trend towards significance (p=0.08) between a good performance status and response to TAS-102 was observed. Further, 7 out of the 11 TAS-102 long-treated patients achieved a clinical benefit from a previous treatment with regorafenib. A significant correlation between regorafenib and TAS-102 clinical efficacy was observed (p=0.008). Six out 13 regorafenib-naïve patients were treated with regorafenib after progression from TAS-102. All these patients achieved SD with a median duration of treatment with regorafenib of 6.1 months (range, 1.6-6.7).

CONCLUSION: Patients with mCRC in good clinical conditions, even though having been heavily pretreated with all the available treatment options, could obtain a significant clinical benefit from treatment with TAS-102. Moreover, a previous clinical benefit obtained with regorafenib is potentially predictive of clinical efficacy of subsequent TAS-102 treatment.

Original languageEnglish
Pages (from-to)e000229
JournalESMO Open
Volume2
Issue number4
DOIs
Publication statusPublished - 2017

Keywords

  • Journal Article

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    Sforza, V., Martinelli, E., Cardone, C., Martini, G., Napolitano, S., Vitiello, P. P., Vitale, P., Zanaletti, N., Reginelli, A., Bisceglie, M. D., Latiano, T. P., Bochicchio, A., Cecere, F., Selvaggi, F., Ciardiello, F., & Troiani, T. (2017). Clinical outcome of patients with chemorefractory metastatic colorectal cancer treated with trifluridine/tipiracil (TAS-102): a single Italian institution compassionate use programme. ESMO Open, 2(4), e000229. https://doi.org/10.1136/esmoopen-2017-000229