P-311 A prospective, observational trial to assess the safety and efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice (CORRELATE)

112 Background: Trifluridine/tipiracil (FTD/TPI) significantly improves overall survival (OS) in patients with chemorefractory metastatic colorectal cancer (mCRC). The phase I/II C-TASKFORCE study of FTD/TPI + bevacizumab (Bev) for patients with mCRC who are refractory to standard chemotherapy demonstrated promising efficacy results. FTD/TPI + Bev were linked to significant and clinically relevant improvements in progression-free survival (PFS) and OS compared with FTD/TPI monotherapy and a favorable safety profile in a Danish randomized trial. This retrospective study investigated the safety and efficacy of FTD/TPI alone or in combination with Bev for patients with refractory mCRC in clinical practice. Methods: We reviewed the outcomes of patients with chemorefractory mCRC who received FTD/TPI alone (monotherapy; 35 mg/m2, twice daily on days 1–5 and 8–12 in a 28-day cycle) or FTD/TPI + Bev (combination; 5 mg/kg, days 1 and 15) in our institution since 2014. We compared the safety and efficacy of the monotherapy and combination regimens. Adverse events were evaluated using Common Terminology Criteria for Adverse Eventsv4.0. Median PFS and OS were analyzed using the Kaplan–Meier method. Results: In total, 56 patients received chemotherapy containing FTD/TPI. Twenty-four patients were treated with monotherapy, and 32 patients received the combination regimen. The median PFS was 1.8 months in the monotherapy arm, versus 4.7 months in the combination arm (hazard ratio [HR] = 0.28; 95% confidence interval [CI] = 0.15–0.51; P < 0.0001). The median OS was 6.3 months for the monotherapy arm, versus 11.7 months for the combination arm (HR = 0.25; 95% CI = 0.13–0.48; P < 0.0001). There was no significant difference in the rates of adverse events between the groups excluding neutropenia. Neutropenia (Grade 3 or worse) developed in five patients (20.8%) in the monotherapy arm and 17 patients (53.1%) in the combination arm ( P = 0.030). There were no treatment-related deaths. Conclusions: In patients with chemorefractory mCRC, FTD/TPI + Bev significantly improved PFS and OS versus FTD/TPI monotherapy.

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Prospective, Multicenter Study of 5-Fluorouracil Therapeutic Drug Monitoring in Metastatic Colorectal Cancer Treated in Routine Clinical Practice

Clinical Colorectal Cancer ◽

10.1016/j.clcc.2016.04.001 ◽

2016 ◽

Vol 15 (4) ◽

pp. 381-388 ◽

Cited By ~ 29

Author(s):

Martin Wilhelm ◽

Lothar Mueller ◽

M. Craig Miller ◽

Karin Link ◽

Stefan Holdenrieder ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Practice ◽

Therapeutic Drug Monitoring ◽

Metastatic Colorectal Cancer ◽

Multicenter Study ◽

Drug Monitoring ◽

Routine Clinical Practice ◽

Therapeutic Drug ◽

Prospective Multicenter Study

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Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational CORRELATE study

European Journal of Cancer ◽

10.1016/j.ejca.2019.09.015 ◽

2019 ◽

Vol 123 ◽

pp. 146-154 ◽

Cited By ~ 8

Author(s):

Michel Ducreux ◽

Lone Nørgård Petersen ◽

Leopold Öhler ◽

Francesca Bergamo ◽

Jean-Philippe Metges ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Practice ◽

Metastatic Colorectal Cancer ◽

Routine Clinical Practice

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Effect of starting dose of regorafenib on overall survival of patients with metastatic colorectal cancer: a systematic review and meta-analysis

Modern Oncology ◽

10.26442/18151434.2019.3.190651 ◽

2019 ◽

Vol 21 (3) ◽

pp. 10-15

Author(s):

Mikhail Yu Fedyanin ◽

Elizaveta M Polyanskaya ◽

Alexey A Tryakin ◽

Ilia A Pokataev ◽

Sergei A Tjulandin

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Overall Survival ◽

Clinical Practice ◽

Metastatic Colorectal Cancer ◽

Meta Analysis ◽

Research Data ◽

Routine Clinical Practice ◽

Starting Dose ◽

Review Manager

Aim. To conduct a systematic review and meta-analysis of studies on the effect of starting dose of regorafenib on overall survival (OS) of patients with chemorefractory metastatic colorectal cancer. Materials and methods. We searched for research data in the PubMed. The analysis included all publications till 08.20.2019 which compared OS depending on the starting dose of regorafenib (160 mg or less) in the 1st course of therapy. Meta-analysis was conducted using Review Manager Ver. 5.3. Results. Two studies demonstrated decreased OS at starting dose of less than 160 mg (A. Adenis et al., 2016: risk ratio - RR 1.26, 95% confidence interval - CI 1.01-1.56; A. Aljubran et al., 2019: RR 2.25, 95% CI 0.93-5.43). Two studies showed an improvement in OS with a starting dose of less than 160 mg in the 1st course (T. Bekaii-Saab et al., 2018: RR 0.72, 95% CI 0.47-1,11; J. Gotfrit et al., 2017: RR 0.46, 95% CI 0.17-1.22). In two other studies, there was no effect of a starting dose of regorafenib on OS (K. Yamaguchi et al., 2019: RR 0.95, 95% CI 0.82-1.1; G. Argiles et al., 2019: RR 0,86, 95% CI 0.65-1.13). The meta-analysis did not reveal the effect of starting dose of the drug on OS: RR 0.97, 95% CI 0.78-1.21; p=0.79; I2=64. Conclusions. Reducing the starting dose of regorafenib in the 1st course does not decrease OS and can be recommended for routine clinical practice.

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