TY - JOUR
T1 - Safety of trifluridine/tipiracil in an open-label expanded-access program in elderly and younger patients with metastatic colorectal cancer
AU - Mayer, Robert J.
AU - Hochster, Howard S.
AU - Cohen, Steven J.
AU - Winkler, Robert
AU - Makris, Lukas
AU - Grothey, Axel
N1 - Funding Information:
The authors were responsible for all content and editorial decisions and received no honoraria related to the development of this publication. All authors contributed to the research, writing, and reviewing of all drafts of the manuscript and approved the final draft. Editorial support in the preparation of this publication was provided by Madeeha Aqil, Ph.D., at Complete HealthVizion, supported by Taiho Oncology, Inc. This study was funded by Taiho Oncology, Inc. Editorial support in the preparation of this publication was provided by Madeeha Aqil, Ph.D., at Complete HealthVizion, supported by Taiho Oncology, Inc.
Publisher Copyright:
© 2018, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - Purpose: Trifluridine/tipiracil (FTD/TPI; TAS-102, Lonsurf®), a novel form of chemotherapy for metastatic colorectal cancer (mCRC), has shown clinical benefit in the global, phase III RECOURSE trial, regardless of patient age. Here, we report the safety and tolerability profile of FTD/TPI from an expanded-access program (EAP) in the US patients with mCRC whose disease has progressed on the standard therapies. Methods: A total of 549 patients (≥ 18 years) with histologically confirmed mCRC following two or more regimens of standard therapy and an Eastern Cooperative Oncology Group performance status of 0 or 1 participated in this open-label EAP. During the 28-day treatment cycle, patients took FTD/TPI 35 mg/m2 twice daily for 5 days followed by 2 days of rest for 2 weeks, with a 14-day rest period. Data were collected for therapy duration, treatment discontinuation, and adverse events. Age-based post hoc analysis was performed to determine the safety of FTD/TPI in elderly (≥ 65 years) versus younger (< 65 years) patients. Results: FTD/TPI-treated patients in this EAP had a similar therapy duration and time to treatment discontinuation to those in the RECOURSE trial. The safety profile in elderly patients was consistent with that in younger patients, with no unexpected safety concerns. Conclusions: This USA-based, open-label EAP has confirmed a similar safety and tolerability profile for FTD/TPI to that observed in the RECOURSE trial. Furthermore, FTD/TPI is well tolerated and can be considered as a treatment option in elderly patients with mCRC. Trial registration: NCT02286492.
AB - Purpose: Trifluridine/tipiracil (FTD/TPI; TAS-102, Lonsurf®), a novel form of chemotherapy for metastatic colorectal cancer (mCRC), has shown clinical benefit in the global, phase III RECOURSE trial, regardless of patient age. Here, we report the safety and tolerability profile of FTD/TPI from an expanded-access program (EAP) in the US patients with mCRC whose disease has progressed on the standard therapies. Methods: A total of 549 patients (≥ 18 years) with histologically confirmed mCRC following two or more regimens of standard therapy and an Eastern Cooperative Oncology Group performance status of 0 or 1 participated in this open-label EAP. During the 28-day treatment cycle, patients took FTD/TPI 35 mg/m2 twice daily for 5 days followed by 2 days of rest for 2 weeks, with a 14-day rest period. Data were collected for therapy duration, treatment discontinuation, and adverse events. Age-based post hoc analysis was performed to determine the safety of FTD/TPI in elderly (≥ 65 years) versus younger (< 65 years) patients. Results: FTD/TPI-treated patients in this EAP had a similar therapy duration and time to treatment discontinuation to those in the RECOURSE trial. The safety profile in elderly patients was consistent with that in younger patients, with no unexpected safety concerns. Conclusions: This USA-based, open-label EAP has confirmed a similar safety and tolerability profile for FTD/TPI to that observed in the RECOURSE trial. Furthermore, FTD/TPI is well tolerated and can be considered as a treatment option in elderly patients with mCRC. Trial registration: NCT02286492.
KW - Expanded access
KW - FTD/TPI
KW - Metastatic colorectal cancer
KW - Trifluridine/tipiracil
UR - http://www.scopus.com/inward/record.url?scp=85057100317&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85057100317&partnerID=8YFLogxK
U2 - 10.1007/s00280-018-3686-5
DO - 10.1007/s00280-018-3686-5
M3 - Article
C2 - 30350179
AN - SCOPUS:85057100317
SN - 0344-5704
VL - 82
SP - 961
EP - 969
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 6
ER -