Efficacy and Safety of Regorafenib Monotherapy among Patients with Previously Treated Metastatic Colorectal Cancer in a Chinese Population: A Real-World Exploratory Study

639 Background: Trifluridine/tipiracil (FTD/TPI) is indicated and recommended for the treatment of previously treated metastatic colorectal cancer (mCRC). Previous evaluations used pooled clinical evidence from the Phase III (RECOURSE) and Phase II trials to model cost-effectiveness, but FTD/TPI specific utilities were not available and alternative data sources were used. The aim of this study was to utilize EQ-5D data from an ongoing Phase IIIb trial (PRECONNECT) within an updated cost-effectiveness model to validate health-related quality of life (HRQoL) outcomes for mCRC patients receiving FTD/TPI. Methods: EQ-5D-3L data from PRECONNECT trial were analyzed with UK utility tariff applied. Pre- and post-progression health state utilities were estimated using a linear mixed effects regression model. Indirect comparison versus regorafenib was based on evidence from the CORRECT trial. Utilities and UK costs (GBP, 2018) were then implemented into the existing economic model. Results: Mean pre-progression and post-progression utilities were 0.72 and 0.59, respectively, with discounted incremental quality adjusted life years gain of 2.1 months versus best supportive care (BSC) and 0.8 versus regorafenib. Use of FTD/TPI based on PRECONNECT data, as in the previous analysis, was associated with improved mean survival pre-progression (by 1.8 months) and post-progression (by 1.4 months) for the total OS gain of 3.2 months versus BSC. The mean OS gain versus regorafenib was 1.4 months. Updated cost-effectiveness analysis using PRECONNECT derived inputs showed that results remained broadly unchanged with a negligible increase in ICER from £51,589 to £51,792 (£51,101 in the probabilistic sensitivity analysis) when compared to BSC, while FTD/TPI remained dominant (more effective and less costly) versus regorafenib. Conclusions: New HRQoL data from the PRECONNECT study collected in a real-world setting validated previous HRQoL inputs used to model cost-effectiveness of FTD/TPI in previously treated metastatic colorectal cancer. Clinical trial information: NCT03306394.

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Efficacy and safety of the combination of aflibercept with fluorouracil, leucovorin, and irinotecan in patients aged 70 years and older with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen in Spain: A retrospective multicenter cohort study.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.124 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 124-124 ◽

Cited By ~ 1

Author(s):

Laura Gutiérrez Sainz ◽

Sergio Martínez-Recio ◽

Oliver Higuera ◽

Ismael Ghanem ◽

Ana López-Alfonso ◽

...

Keyword(s):

Colorectal Cancer ◽

Adverse Events ◽

Metastatic Colorectal Cancer ◽

Therapeutic Option ◽

Efficacy And Safety ◽

Multicenter Cohort Study ◽

Discontinuation Of Treatment ◽

Previously Treated ◽

Grade 3 ◽

Retrospective Multicenter Study

124 Background: Colorectal cancer is currently the third most common cancer worldwide. The results of the VELOUR study showed that the addition of aflibercept to Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) produced an advantage in both progression-free and overall survival (PFS and OS) in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-based regimen. The purpose of this study was to evaluate the efficacy and safety of the combination of aflibercept with FOLFIRI in patients aged 70 years and older with mCRC. Methods: We conducted a retrospective multicenter study, which included all patients aged 70 years and older with mCRC treated with Aflibercept plus FOLFIRI between May 2013 and March 2019 in 5 centers in Spain. Data regarding clinical and pathological characteristics, treatment response and survival were collected. Results: We selected 69 patients, of whom the majority (n = 48, 69.6%) were males with a median age of 75 years (range 70 to 84 years). Patients received an average of nine courses of aflibercept with FOLFIRI overall. Regarding response rates, 17 patients (24.6%) achieved a partial response, 37 (53.6%) had stable disease and 15 (21.7%) experienced disease progression. The median PFS was 6.1 months (CI 95%: 4.4–7.8), and the median OS was 13.9 months (CI 95%: 11.1–16.7). Treatment adverse events grade 3 and 4 were reported in 42 patients (60.9%). The most frequently reported treatment adverse events grade 3 and 4 were asthenia (24.6%), diarrhea (18.8%), stomatitis and ulceration (18.8%) and neutropenia (14.5%). Adverse events grade 3 and 4 typically associated with anti-VEGF therapy were infrequent. Adverse events led to permanent discontinuation of treatment in 26.1% of patients. Conclusions: In our sample the combination of aflibercept with FOLFIRI in patients aged 70 years and older with mCRC was effective and safe. Aflibercept plus FOLFIRI is a good therapeutic option for the treatment of mCRC in patients aged 70 years and older previously treated with oxaliplatin.

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The regorafenib issue: focus on efficacy and safety in pre-treated metastatic colorectal cancer from a real world experience

Annals of Oncology ◽

10.1093/annonc/mdx422.044 ◽

2017 ◽

Vol 28 ◽

pp. vi15-vi16 ◽

Cited By ~ 1

Author(s):

F. Daniel ◽

E. Bannò ◽

L. Belluomini ◽

L.R. Martella ◽

F. Lancia ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Real World ◽

Efficacy And Safety

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2131 Efficacy and safety of nab-paclitaxel (nab-P) in patients (pts) with previously treated metastatic colorectal cancer (mCRC): The phase II COLO-001 trial

European Journal of Cancer ◽

10.1016/s0959-8049(16)31053-x ◽

2015 ◽

Vol 51 ◽

pp. S376

Author(s):

M. Ducreux ◽

J. Bennouna ◽

A. Adenis ◽

T. Conroy ◽

A. Lievre ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Phase Ii ◽

Efficacy And Safety ◽

Previously Treated

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4CPS-275 Efficacy and safety of trifluridine/tipiracil in patients with metastatic colorectal cancer: real world data

10.1136/ejhpharm-2021-eahpconf.107 ◽

2021 ◽

Author(s):

I Patier ◽

FF Fernando ◽

MG Maria ◽

DF Raul ◽

MG Teresa

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Real World ◽

Efficacy And Safety ◽

Real World Data ◽

World Data

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Regorafenib plus FOLFIRI with irinotecan dose escalated according to uridine diphosphate glucuronosyltransferase 1A1 genotyping in previous treated metastatic colorectal cancer patients: study protocol for a randomized controlled trial

10.21203/rs.2.11809/v3 ◽

2019 ◽

Author(s):

Cheng-Jen Ma ◽

Tsung-Kun Chang ◽

Hsiang-Lin Tsai ◽

Wei-Chih Su ◽

Ching-Wen Huang ◽

...

Keyword(s):

Colorectal Cancer ◽

Monoclonal Antibodies ◽

Growth Factor ◽

Metastatic Colorectal Cancer ◽

Dose Adjustment ◽

Uridine Diphosphate ◽

Efficacy And Safety ◽

Uridine Diphosphate Glucuronosyltransferase ◽

Previously Treated ◽

Irinotecan Dose

Abstract Background Regorafenib is an oral multi-kinase inhibitor for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidines, irinotecan, oxaliplatin, monoclonal antibodies targeting vascular endothelial growth factor (VEGF), and monoclonal antibodies targeting epidermal growth factor receptor (EGFR). A dose reduction from 160 mg to 120 mg regorafenib reduces regorafenib-associated adverse events (AEs). Dose adjustment of irinotecan in FOLFIRI regimen on basis of individual uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype provides optimal oncological outcomes with acceptable AEs. This study is trying to address the efficacy and safety of dose adjusted combination of regorafenib and FOLFIRI for patients with mCRC. Methods A prospective, multicenter, randomized in a 2:1 ratio, controlled, clinical trial with two parallel arms will be conducted to compare irinotecan dose escalated FOLFIRI according to UGT1A1 genotyping plus 120 mg regorafenib with 120 mg regorafenib alone in previously treated patients with mCRC. The primary endpoint is progression-free survival (PFS) and the secondary endpoints are overall survival (OS), disease control rate (DCR), time to progression (TTP), and duration of treatment (DoT). Safety assessments are recorded as well. Discussion Dose adjustment for regorafenib and irinotecan makes treatment-related AEs tolerable and makes the concomitant treatment practicable. This study will provide initial evidences regarding the efficacy and safety of a new combination of chemotherapy and a targeted agent for mCRC.

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