Search results for "Randomized"

Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma

2020

BackgroundWe have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.MethodsThis randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.ResultsAt a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 mont…

The impact of maximal strength training on quality of life among women with breast cancer undergoing treatment.

2019

Cancer rehabilitation programs mainly involve endurance cardio training while little attention has been paid to strength training. Breast cancer (BC) patients lose muscle strength while undergoing adjuvant treatment, thus affecting daily activities and quality of life. Maximal strength training, with an emphasis on velocity in the concentric phase, improves maximal strength and muscle force development characteristics. However, the effect of maximal strength training on quality of life for BC patients undergoing treatment remains elusive. Consequently, the aim of this study was to evaluate the effectiveness of maximal strength training in Health related quality of life in women with newly d…

Does Ligasure(TM) Reduce Fluid Drainage in Axillary Dissection? A Randomised Prospective Clinical Trial

2007

Background: Axillary lymph node dissection (ALND) is an integral part of breast cancer treatment. It is required in about 40–50% of patients. The placement of a drain in the axilla after an operation is current surgical practice. Short surgical stay programmes increase operating efficiency and reduce medical care costs, without compromising quality of care. LigaSureTM is a new haemostatic device that uses bipolar energy to seal vessels. The aim of this study is to determine whether axillary dissection with LigaSureTM reduces the time of wound drainage, the duration of surgical intervention and the volume of drainage after treatment. Patients and methods: This study is a prospective randomiz…

REsect: Blinded assessment of amenability to potentially curative treatment of previously unresectable colorectal cancer liver metastases (CRC LM) af…

2017

3532 Background: Secondary resection and radiofrequency ablation (RFA) of primarily unresectable LM from CRC can prolong survival and cure some patients (pts). Effective downsizing treatments are needed but their impact on secondary amenability to surgery/RFA is difficult to evaluate objectively. The added value of SIRT is not well established. Methods: Baseline (BL) and follow-up (FU) imaging at best response for CRC pts treated with FOLFOX chemotherapy±bevacizumab (bev) (CT) vs. CT+SIRT in the phase III SIRFLOX RCT were reviewed by 3−5 expert HPB surgeons (from a panel of 15) for resectability of LM. Reviewers were blinded to each other and to all clinical information incl. time of imagi…

Wider implications of video-assisted thoracic surgery versus open approach for lung metastasectomy

2015

ABSTRACT  Lung metastasectomy is considered a safe and potentially curative procedure despite there is not a strong evidence that metastasectomy prolongs long-term survival in patients with lung metastases. Moreover, the debate is open regarding the best approach for lung metastasectomy, video-assisted thoracic surgery versus open approach. A systematic review of literature to clarify what is the best approach to prolong survival in patients with lung metastases was performed. Our study confirms that overall survival is equivalent for video-assisted thoracic surgery and thoracotomy, therefore the ‘gold standard’ surgical treatment for lung metastases remains a point of debate. The choice o…

Short- and Long-Term Quality of Life and Bowel Function in Patients With MRI-Defined, High-Risk, Locally Advanced Rectal Cancer Treated With an Inten…

2015

Objective Intensified preoperative treatments have been increasingly investigated in locally advanced rectal cancer (LARC), but limited data are available for the impact of these regimens on quality of life (QoL) and bowel function (BF). We assessed these outcome measures in EXPERT-C, a randomized phase 2 trial of neoadjuvant capecitabine combined with oxaliplatin (CAPOX), followed by chemoradiation therapy (CRT), total mesorectal excision, and adjuvant CAPOX with or without cetuximab in magnetic resonance imaging-defined, high-risk LARC. Methods and Materials QoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR29 questionnaires. Bowel inc…

Lifestyle, nutrition and breast cancer: facts and presumptions for consideration

2015

Breast cancer is the most common cancer in women worldwide, and the high incidence of this cancer coupled with improvements in initial treatments has led to an ever-increasing number of breast cancer survivors. Among the prospective epidemiological studies on diet and breast cancer incidence and recurrence, to date, there is no association that is strong, reproducible and statistically significant, with the exception of alcohol intake, overweight, and weight gain. Nevertheless, many beliefs about food and breast cancer persist in the absence of supporting scientific evidence. After a comprehensive review regarding the role of lifestyle on breast cancer outcomes and a thorough study of the d…

A randomized phase II study of estramustine phosphate versus estramustine phosphate plus etoposide in hormone refractory prostate cancer (HRPC)

2008

20632 Background: Docetaxel-based regimens represent the treatment of choice of HRPC. However, in some patients toxicity may be a concern and the quality of life may be compromised. The aim of this phase II randomized study is to investigate the efficacy and safety of low-dose chemotherapy regimen adopting a combination of EMP and VP16 in patients affected by HRPC. Methods: 54 HRPC patients were randomized between: arm A, daily oral standard dose EMP (10mg/kg) and arm B, low-dose EMP (3mg/kg) plus VP16 (25mg/mq) for 2 weeks followed by 2-weeks’rest. Systemic toxicity and hematologic exams were monitored every 2 weeks. Performance status, pain and analgesic use were evaluated according to WH…

Short fractionated radiotherapy versus multiple fractionated radiotherapy in patients with bone metastases: a meta-analysis of randomized clinical tr…

2003

The sarculator stratified prognosis of patients with high-risk soft tissue sarcomas (STS) of extremities and trunk wall treated with perioperative ch…

2017

11016 Background: Patients with extremity and trunk wall STS with high malignancy grade and size larger than 5cm are considered at high risk of death, but in fact this risk varies broadly depending on histologic subtype and size. The Sarculator, a nomogram for STS, can improve prognostic assessment of these patients. This tool was evaluated for stratifying risk of distant metastasis (DM) and overall survival (OS) in a RCT investigating perioperative chemotherapy. Methods: High-risk STS patients were randomly assigned to receive either three cycles of preoperative chemotherapy with epirubicin (120 mg/m2) and ifosfamide (9 g/m2) or the same three preoperative cycles followed by two further p…