safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective observational correlate study

Abstract Background Regorafenib prolonged overall survival (OS) versus placebo in patients with treatment-refractory metastatic colorectal cancer (mCRC) in phase III trials. We conducted an observational study of regorafenib for patients with mCRC in real-world clinical practice. Methods The international, prospective, CORRELATE study recruited patients with mCRC previously treated with approved therapies, for whom the decision to treat with regorafenib was made by the treating physician according to the local health authority approved label. The primary objective was safety, assessed by treatment-emergent adverse events (TEAEs; National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03). Results A total of 1037 patients were treated. The median age was 65 years (range: 24–93); 87% of patients had Eastern Cooperative Oncology Group performance status 0–1, 56% of patients had KRAS, 7% had NRAS and 4% had BRAF mutations. The initial regorafenib dose was 160 mg/day in 57% of patients. The most common grade III or IV drug-related TEAEs were fatigue (9%), hand–foot skin reaction (7%) and hypertension (6%). Drug-related grade V (fatal) TEAEs occurred in 1% of patients. Dose reductions for drug-related TEAEs occurred in 24% of patients. Median OS was 7.7 months (95% confidence interval [CI]: 7.2–8.3), and median progression-free survival (PFS) was 2.9 months (95% CI: 2.8–3.0). Conclusions In this real-world, observational study of patients with mCRC, the regorafenib toxicity profile was similar to that reported in phase III trials. The starting dose for almost half of patients was less than the approved 160-mg dose, and the median OS and PFS were in the range observed in phase III trials. Trial registration: NCT02042144

Actualités thérapeutiques dans le traitement médical du cancer du sein

SCOPUS: re.jinfo:eu-repo/semantics/publishe

Maladie veineuse thromboembolique et survie chez les patients cancéreux. Vers de nouvelles implications du traitement par héparines de bas poids moléculaire?

SCOPUS: cp.jinfo:eu-repo/semantics/publishe

Safety of a diagnostic strategy of pulmonary embolism including pretest probability assessement by junior physicians

info:eu-repo/semantics/publishe

Assessment of pretest probability of pulmonary embolism in the emergency department by physicians in training using the Wells model.

Assessment of pretest probability should be the initial step in investigation of patients with suspected pulmonary embolism (PE). In teaching hospitals physicians in training are often the first physicians to evaluate patients.Journal ArticleResearch Support, Non-U.S. Gov'tSCOPUS: ar.jinfo:eu-repo/semantics/publishe

Thyroid hormones ratio is a major prognostic marker in advanced metastatic colorectal cancer: Results from the phase III randomised CORRECT trial

Free triiodothyronine (FT3)/free thyroxine (FT4) ratio is an index estimating the peripheral activity of thyroid hormones. In a previous experience, we identified a prognostic role for FT3/FT4 ratio in chemorefractory patients treated with regorafenib. Therefore, we planned this post hoc analysis of the phase III CORRECT trial of regorafenib versus placebo