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

2019 ◽  
Vol 123 ◽  
pp. 146-154 ◽  
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

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

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.

Capecitabine in early-stage colon cancer and metastatic colorectal cancer: Results from an Austrian noninterventional trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14103-e14103
Author(s):  
Wolfgang Eisterer ◽  
Bjoern Jagdt ◽  
Christa Haeusler ◽  
Markus Krenn
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Clinical Practice ◽  
Adjuvant Therapy ◽  
Metastatic Colorectal Cancer ◽  
Treatment Duration ◽  
Early Stage ◽  
Routine Clinical Practice ◽  
Line Therapy ◽  
Early Stage Colon Cancer

e14103 Background: Capecitabine (Cap) is approved for adjuvant therapy in stage III colon cancer and for metastatic colorectal cancer (mCRC) in Austria. Methods: In this open-label, multicenter, single-arm non-interventional trial, Cap-based therapy in patients with early-stage colon cancer and mCRC was observed at 30 sites. Cap was prescribed at the physician’s discretion and according to drug labelling. 409 patients were included between 2008 and 2011. Safety of Cap in routine clinical practice was the primary study endpoint. All adverse events (AEs) were documented in an online CRF by participating investigators. Progression-free survival (PFS), defined as the time from study entry until tumour progression or death, and treatment duration were also assessed. Results: Most of the 409 patients were ≥65 years old (72.6%; n=297). 249 (60.9%) patients were male and 160 (39.1%) were female. 221 (54.0%) patients received Cap as adjuvant therapy; 111 (50.2%) of these received Cap alone, and 110 (49.8%) were treated with Cap plus oxaliplatin. 188 (46.0%) patients were treated for mCRC; 105 (55.9%) received first-line therapy, 48 (25.5%) second-line therapy and 35 (18.6%) third-line or later lines of therapy with different Cap-containing regimens. 163 mCRC patients were eligible for PFS evaluation. The median PFS was 8.1 (range 1.0–28.5) months. Patients who received Cap-based therapy for at least 8 cycles (n=97) had a profound increase in PFS to 9.4 months. The longest treatment duration with Cap was 47 cycles. The median duration of treatment for all patients was 8 cycles (range 1–47) at a median daily dose of 1944 mg/m2 (range 833–3055 mg/m²) for Cap alone and 1862 mg/m2 (range 1111–4166 mg/m²) as part of a combination regimen. The most common grade 3/4 AEs included diarrhoea (2.2%), hand-foot syndrome (2.0%), nausea (0.7%), neuropathy (0.7%), and leukopenia (0.2%). Conclusions: Cap therapy is well tolerated in routine clinical practice. The median number of 8 cycles correlates well with the suggested treatment duration. AEs included only known and previously documented safety reactions. Prolonged treatment with Cap in patients with mCRC leads to a meaningful increase in PFS.

Liquid biopsy-driven anti-EGFR rechallenge in patients with metastatic colorectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3577-3577
Author(s):  
Stefano Mariani ◽  
Marco Puzzoni ◽  
Nicole Liscia ◽  
Valentino Impera ◽  
Andrea Pretta ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Practice ◽  
Metastatic Colorectal Cancer ◽  
Liquid Biopsy ◽  
Selection Criteria ◽  
Wild Type ◽  
Braf Mutations ◽  
Previous Response ◽  
Clinical Variables ◽  
Ct Dna

3577 Background: The rechallenge with EGFR inhibitors represents an emerging strategy for anti-EGFR pre-treated patients with RAS wild type colorectal cancer (CRC). Unfortunately definitive selection criteria for anti-EGFR rechallenge in this setting are lacking. Very recently RAS wild type status on circulating tumor DNA (ct-DNA) at the time of rechallenge along with already known clinical criteria emerged as a potential watershed for this strategy. In the present study we explored liquid biopsy-driven anti-EGFR rechallenge strategy in the clinical practice for patients with metastatic colorectal cancer. Methods: Ct-DNA from RAS and BRAF wild type metastatic CRC patients previously treated with an anti-EGFR containing therapy was analyzed for RAS/BRAF mutations with the aim to evaluate the rechallenge strategy with anti-EGFR. The ct-DNA was analyzed for RAS-BRAF mutations using pyro-sequencing (PyroMark Q24 MDx Workstation) and nucleotide sequencing (Genetic Analyzer ABI3130) assays. Real-time PCR (Idylla) and droplet digital PCR (QX200 System) were performed to confirm the RAS-BRAF mutation status. Several clinical variables including previous response to anti EGFR containing therapy, tumor sidedness and anti-EGFR free interval were evaluated in relation to outcome. Tumor response evaluation was performed according to RECIST 1.1. Differences between categorical variables were evaluated using the Fisher’s exact test. Survival probability over time was estimated by the Kaplan–Meier method. Significant differences in the probability of survival between the strata were evaluated by log-rank test. Results: Twenty patients were included in the study. All patients were tested for RAS-BRAF mutations in ct-DNA. Fourteen patients (70%) showed a RAS-BRAF WT molecular profile, six patients (30%) showed a KRAS mutation. All the patients with ct-DNA RAS-BRAF WT profile underwent rechallenge with anti-EGFR. In details 11 patients (78.6%) underwent irinotecan+ cetuximab treatment, whereas 3 patients (21.4%) underwent panitumumab monotherapy. As for the outcome results to the rechallenge strategy, the median OS was 7 months (95% CI 5.0 to 13.0), the median PFS was 3 months (95% CI 2.0 to 6.0), the ORR was 27.3% with a DCR of 54.5%. Among the clinical variables evaluated as putative predictive/prognostic factors, previous response to anti-EGFR treatment was related to a not statistically significant improved OS (12 months vs 5 months HR:0.19 p: 0.06) and to a statistically significant improved ORR (75% vs 0% p:0.03). Conclusions: The rechallenge strategy with anti-EGFR confirmed to be feasible in clinical practice. The clinical outcome resulted consistent with the literature data. In addition to the molecular selection through the analysis of ct-DNA for RAS, previous response to anti EGFR treatment is confirmed as a prospective selection criteria for this therapeutic option.

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