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Folprecht G.,University Cancer Center | Pericay C.,Corporacio Sanitaria Parc Tauli Institute Universitari | Saunders M.P.,The Christie NHS Foundation Trust | Thomas A.,University of Leicester | And 15 more authors.
Annals of Oncology | Year: 2016

Background: The combination of aflibercept with FOLFIRI has been shown to significantly prolong overall survival in patients with metastatic colorectal cancer (mCRC) after progression on oxaliplatin-based therapy. This trial evaluated the addition of aflibercept to oxaliplatin-based first-line treatment of patients with mCRC. Patients and methods: Patients with mCRC were randomized to receive first-line therapy with mFOLFOX6 plus aflibercept (4 mg/kg) or mFOLFOX6 alone. The primary end point of this phase II study was the progression-free survival (PFS) rate at 12 months in each arm. The analysis of efficacy between the arms was a pre-planned secondary analysis. Results: Of 236 randomized patients, 227 and 235 patients were evaluable for the primary efficacy analysis and safety, respectively. The probabilities of being progression-free at 12 months were 25.8% [95% confidence interval (CI) 17.2- 34.4] for the aflibercept/mFOLFOX6 arm and 21.2% (95% CI 12.2-30.3) for the mFOLFOX6 arm. The median PFS was 8.48 months (95% CI 7.89-9.92) for the aflibercept/mFOLFOX6 arm and 8.77 months (95% CI 7.62-9.27) for the mFOLFOX6 arm; the hazard ratio of aflibercept/mFOLFOX6 versus mFOLFOX6 was 1.00 (95% CI 0.74-1.36). The response rates were 49.1% (95% CI 39.7-58.6) and 45.9% (95% CI 36.4-55.7) for patients treated with and without aflibercept, respectively. The most frequent treatment-emergent grade 3/4 adverse events (AEs) excluding laboratory abnormalities reported for aflibercept/mFOLFOX6 versus mFOLFOX6 were neuropathy (16.8% versus 17.2%) and diarrhea (13.4% versus 5.2%). Neutropenia grade 3/4 occurred in 36.1% versus 29.3%. The most common vascular endothelial growth factor inhibition class-effect grade 3/4 AEs for aflibercept/mFOLFOX6 versus mFOLFOX6 were hypertension (35.3% versus 1.7%), proteinuria (9.2% versus 0%), deep vein thrombosis (5.9% versus 0.9%) and pulmonary embolism (5.9% versus 5.2%). Conclusion: No difference in PFS rate was observed between treatment groups. Adding aflibercept to first-line mFOLFOX6 did not increase efficacy but was associated with higher toxicity. © The Author 2016. Source


Montesinos J.,Clinical Research Unit | Bare M.,Institute Universitari | Dalmau E.,Corporacio Sanitaria Parc Tauli Institute Universitari | Saigi E.,Corporacio Sanitaria Parc Tauli Institute Universitari | And 5 more authors.
Open Respiratory Medicine Journal | Year: 2011

Background: In Europe, approximately 381,500 patients are diagnosed with non-small cell lung cancer (NSCLC) every year. The aim of this study is to analyse the changes in diagnosis, treatment and evolution during the last two decades, using data from a hospital registry. Material and Methods: Patients diagnosed with NSCLC at the Corporació Sanitària Parc Taulí-Sabadell (Catalonia, Spain) during the periods 1990-1997 (n=748) and 2003-2005 (n=311) were included. The hospital tumour registry was used for prospective data collection. Results: Our series shows a significant increase in women diagnosed with NSCLC (6% vs 10.3%; p 0.01) in the latter period; the incidence of adenocarcinomas increased by 20% (31% vs 51.1%), whereas that of squamous cell carcinomas fell (51.3% vs 32.5%; p<0.001). The proportion of patients receiving active treatment also increased significantly, from 56.6% to 76.5% (p<0.001). Disease stage at diagnosis and the number of patients treated by radical surgical resection remained unchanged. Among the favourable independent prognostic factors for survival were: gender (women), age less than 70 years old, Karnofsky index ≥70%, early stage at diagnosis, treatment with chemotherapy, and being diagnosed in the latter period 2003-2005 (HR 0.67). Over this 10-year period, absolute gain in mean survival in our series was 115 days. Conclusions: The absolute gain in mean survival in NSCLC patients in the period studied was 3.8 months, with a 6.75% increase in 5-year survival. Hospital registry data may help the correct assessment of epidemiological changes and the real effectiveness of treatments, which are sometimes overestimated in clinical trials. © Montesinos et al. Source

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