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An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States

ABSTRACT: This is an observational study in which data already collected from patients with metastatic colorectal cancer will be studied. Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus) that has spread to other parts of the body. The study drug, regorafenib, is already approved for cancer doctors to prescribe to patients with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. The participants in this study were treated with regorafenib as part of their regular care from their doctors. Some studies have shown that patients with mCRC who took regorafenib had improved survival outcomes, and some of them did well on the treatment for a long time. Cancer doctors have also reported from their routine practice that some patients with mCRC are able to respond to regorafenib for a longer period than others. However, there is limited knowledge about which people this is likely to happen for. To better understand the long-term response of regorafenib treatment, there is a need for a large-scale study in the real world. The main purpose of this study is to learn more about patients who showed a long-term response to regorafenib as a mono treatment for mCRC. To do this, researchers will collect the following information from the participants’ health records: Duration of treatment with regorafenib Percentage of participants who received treatment with regorafenib for at least 5 months and 4 months. Characteristics, including age, sex, race, health condition, and signs and symptoms of mCRC, of participants who received treatment with regorafenib for at least 5 months and 4 months. The data will come from an electronic health records database called the Flatiron Health Data Repository for patients in the United States. The data will be from patients with mCRC who started treatment with regorafenib between July 2013 and December 2022. Researchers will consider the data of the participants collected until May 2023. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 91322 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:This is an observational study using data that has been collected from participants who received their usual treatments. Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus) that has spread to other parts of the body. Regorafenib is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. The combination of anti-cancer drugs trifluridine and tipiracil is called TAS-102. It prevents cancer cells from growing and multiplying. Both regorafenib and TAS-102 are approved treatments for metastatic colorectal cancer and are available for doctors to prescribe to people with mCRC after previous lines of treatment have been unsuccessful. Regorafenib and TAS-102 work in different ways and impact people differently. People might receive one of these drugs first and followed by the other. The best sequence for taking these drugs is still unclear. Researchers have also found that TAS-102, when taken with another anti-cancer drug called bevacizumab, helps people live longer than when taken alone. To better understand the impact of the sequence of taking regorafenib and TAS-102 (with or without bevacizumab), more knowledge is needed about how these work together in people with mCRC in real world settings. The main purpose of this study is to learn more about the characteristics and impact of treatment in people with mCRC who received regorafenib and TAS-102 (with or without bevacizumab) one after the other. This information will be grouped based on their treatment sequence and age group (less or more than 65 years old). In addition, the researchers want to learn about : * how long participants were treated with regorafenib and TAS-102 taken one after the other in a sequential order, * any treatment for mCRC that the participants received after the sequential treatment, * any treatment received for a condition in which the bone marrow cannot make up enough blood cells (a common side effect of cancer treatment), during the sequential treatment, * if and how often white blood cells that fight infection decreased during the sequential treatment, * the number of hospital or testing facility visits that participants had during the sequential treatment, and * how long did participants live (also called overall survival). The participants in this study had already received regorafenib and TS-102 (with or without bevacizumab) as part of their regular care from their doctors. The data will come from the participants’ information stored in an electronic health records database called Flatiron mCRC EDM. Data collected will be from January 2015 to December 2022. Researchers will only look at the health information from adults in the United States of America. In this study, only available data from routine care is collected. No visits or tests will be required as part of this study.

Project description:This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions. Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel or the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is an anti-cancer drug that blocks several proteins called enzymes, which are involved in the development and growth of cancer. A wide range of such enzymes called tyrosine kinases are targeted. In 2013, regorafenib was approved in Europe for doctors to prescribe to people with mCRC who have previously been treated or cannot receive other available treatments. It is known that doctors may change/reduce the amount (the dose) of regorafenib they give (flexible dosing), so that the patients better tolerate the treatment. However, little information is available on the doses of regorafenib given in France, Italy, and Belgium in usual practice. In this study researchers want to learn more about how and in which amount regorafenib is usually given to patients with mCRC in France, Italy, and Belgium: * at the beginning * during, and * at the end of the regorafenib therapy. In addition, the study team will collect data about/if: * the treatment duration at each treatment dose of regorafenib, * the number of people who received reduced initial dosing of regorafenib in real word settings in France, Italy, and Belgium, * reduced (flexible) initial dosing of regorafenib allows patients to stay longer on treatment. To answer these questions, the researchers will look back at cases that have already happened when the study begins. The data will be collected through an online case report form. The doctors will provide case histories of mCRC patients who started regorafenib treatment in most recent 3 years and 4 months (from January 1, 2019 to Apr 30, 2022) or up until 3 months prior to the date of data collection. Besides this data collection, no further tests or examinations are planned in this study. There are no required visits or tests in this study.

Project description:We report the RNA sequencing data from the REPEAT study, in which patients with beyond first-line esophagogastric cancer were treated with regorafenib and paclitaxel. For the RNA sequencing, biopsies from metastatic lesions were obtained on baseline (n=21) and fifteen days following treatment initiation (n=13). PURPOSE: Regorafenib monotherapy, a multikinase-inhibitor of angiogenesis, tumor microenvironment, and oncogenesis, showed promising results in gastric cancer. We aimed to assess the tolerability of regorafenib and paclitaxel in advanced esophagogastric cancer (EGC) patients refractory to first-line treatment, and explore potential biomarkers. METHODS: Patients received paclitaxel (80 mg/m2) on days 1, 8, and 15 of a 28-day cycle and regorafenib (80/120/160 mg) on day 1-21 in the dose-escalation cohort, and the maximum-tolerated dose (MTD) in the dose-expansion cohort. Exploratory, overall- (OS) and progression-free survival (PFS) were compared to a propensity-score matched cohort receiving standard second/third line systemic treatment. Paclitaxel pharmacokinetics were assessed using D1 and D15 samples. We performed ELISA measurements of galectin-1, RNA sequencing and shallow whole-genome sequencing of metastatic tumor biopsies for biomarker analyses. RESULTS: In the dose-escalation cohort (n=14), the MTD of regorafenib was 120 mg. Thirty-four patients were enrolled in the dose-expansion cohort. Most common toxicities (all grades; grade ≥3) were fatigue (79%; 4%) and sensory neuropathy (63%; 4%). Best responses achieved were partial response (28%) and stable disease (54%). Median OS and PFS were 7.8 and 4.2 months, respectively (median follow-up 7.8 months). OS (p=0.08) and PFS (p=0.81) were not significantly improved compared to the matched cohort. Paclitaxel concentrations were significantly increased with regorafenib (D15) compared with paclitaxel only (D1; p<0.05); no associations were observed with toxicity or efficacy. An increase in circulating galectin-1 compared to baseline was associated with shorter OS (p<0.01). Enrichment of angiogenesis-related gene expression was observed in short-survivors measured by RNA sequencing. Chromosome 19q13.12-q13.2 amplification was associated with shorter OS (p=0.02) and PFS (p=0.02). CONCLUSION: Treatment with regorafenib and paclitaxel is tolerable and shows promising efficacy in advanced EGC refractory to first-line treatment. Galectin-1 and chromosome 19q13.12-q13.2 amplification could serve as negative predictive biomarkers for treatment response.

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An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States

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