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

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Trifluridine
Compassionate Use Trials
Colorectal Neoplasms
Therapeutics
Disease-Free Survival
Survival
TAS 102
regorafenib

Keywords

  • Journal Article

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Clinical outcome of patients with chemorefractory metastatic colorectal cancer treated with trifluridine/tipiracil (TAS-102) : a single Italian institution compassionate use programme. / Sforza, Vincenzo; Martinelli, Erika; Cardone, Claudia; Martini, Giulia; Napolitano, Stefania; Vitiello, Pietro Paolo; Vitale, Pasquale; Zanaletti, Nicoletta; Reginelli, Alfonso; Bisceglie, Maurizio Di; Latiano, Tiziana Pia; Bochicchio, AnnaMaria; Cecere, Fabiana; Selvaggi, Francesco; Ciardiello, Fortunato; Troiani, Teresa.

In: ESMO Open, Vol. 2, No. 4, 2017, p. e000229.

Research output: Contribution to journalArticle

Sforza, V, Martinelli, E, Cardone, C, Martini, G, Napolitano, S, Vitiello, PP, Vitale, P, Zanaletti, N, Reginelli, A, Bisceglie, MD, Latiano, TP, 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, vol. 2, no. 4, pp. e000229. https://doi.org/10.1136/esmoopen-2017-000229
Sforza, Vincenzo ; Martinelli, Erika ; Cardone, Claudia ; Martini, Giulia ; Napolitano, Stefania ; Vitiello, Pietro Paolo ; Vitale, Pasquale ; Zanaletti, Nicoletta ; Reginelli, Alfonso ; Bisceglie, Maurizio Di ; Latiano, Tiziana Pia ; Bochicchio, AnnaMaria ; Cecere, Fabiana ; Selvaggi, Francesco ; Ciardiello, Fortunato ; Troiani, Teresa. / Clinical outcome of patients with chemorefractory metastatic colorectal cancer treated with trifluridine/tipiracil (TAS-102) : a single Italian institution compassionate use programme. In: ESMO Open. 2017 ; Vol. 2, No. 4. pp. e000229.
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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-na{\"i}ve 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.",
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TY - JOUR

T1 - Clinical outcome of patients with chemorefractory metastatic colorectal cancer treated with trifluridine/tipiracil (TAS-102)

T2 - a single Italian institution compassionate use programme

AU - Sforza, Vincenzo

AU - Martinelli, Erika

AU - Cardone, Claudia

AU - Martini, Giulia

AU - Napolitano, Stefania

AU - Vitiello, Pietro Paolo

AU - Vitale, Pasquale

AU - Zanaletti, Nicoletta

AU - Reginelli, Alfonso

AU - Bisceglie, Maurizio Di

AU - Latiano, Tiziana Pia

AU - Bochicchio, AnnaMaria

AU - Cecere, Fabiana

AU - Selvaggi, Francesco

AU - Ciardiello, Fortunato

AU - Troiani, Teresa

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1136/esmoopen-2017-000229

DO - 10.1136/esmoopen-2017-000229

M3 - Article

C2 - 29018575

VL - 2

SP - e000229

JO - ESMO Open

JF - ESMO Open

SN - 2059-7029

IS - 4

ER -