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 language | English |
|---|---|
| Pages (from-to) | e000229 |
| Journal | ESMO Open |
| Volume | 2 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 2017 |
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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 journal › Article
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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 -