The lancet oncology
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The lancet oncology · Jan 2015
Randomized Controlled Trial Multicenter StudyThe cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study.
Palbociclib (PD-0332991) is an oral, small-molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6 with preclinical evidence of growth-inhibitory activity in oestrogen receptor-positive breast cancer cells and synergy with anti-oestrogens. We aimed to assess the safety and efficacy of palbociclib in combination with letrozole as first-line treatment of patients with advanced, oestrogen receptor-positive, HER2-negative breast cancer. ⋯ Pfizer.
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The lancet oncology · Jan 2015
Review Historical ArticleOutcomes and endpoints in trials of cancer treatment: the past, present, and future.
Cancer treatment should allow patients to live better or longer lives, and ideally, both. Trial endpoints should show clinically meaningful improvements in patient survival or quality of life. ⋯ Many stakeholders are affected, including regulatory agencies, industry partners, clinicians, and most importantly, patients. In an accompanying Review, reflections from individual stakeholders are incorporated into a discussion of what the future holds for clinical trial endpoints and design.
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The lancet oncology · Jan 2015
Randomized Controlled Trial Multicenter StudyTamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial.
Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first 10 years of follow-up. We report the long-term follow-up of the IBIS-I trial, in which the participants and investigators remain largely masked to treatment allocation. ⋯ Cancer Research UK (UK) and the National Health and Medical Research Council (Australia).
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The lancet oncology · Jan 2015
ReviewAssessment of the quality of surgery within randomised controlled trials for the treatment of gastro-oesophageal cancer: a systematic review.
Multicentre, randomised, controlled trials (RCTs) provide level 1 evidence for surgery in the treatment of gastro-oesophageal cancer. This systematic review investigated whether standardisation of surgical techniques in RCTs reduces the variation in lymph-node harvest, in-hospital mortality, and locoregional cancer recurrence. ⋯ Factors that reduced adjusted in-hospital mortality included credentialing surgeons through procedural volume and operative reports, and standardisation of surgical techniques. Future RCTs should include an assessment of surgical performance as an important aspect of study design to reduce variation in clinical outcomes.
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The lancet oncology · Jan 2015
Anamorelin for patients with cancer cachexia: an integrated analysis of two phase 2, randomised, placebo-controlled, double-blind trials.
Cancer anorexia-cachexia syndrome is associated with increased morbidity and mortality. Anamorelin is an oral ghrelin-receptor agonist with appetite-enhancing and anabolic activity. We assessed the effects of anamorelin on body composition, strength, quality of life, biochemical markers, and safety in patients with cancer anorexia-cachexia. ⋯ Helsinn Therapeutics (US), Helsinn Healthcare SA.