The lancet oncology
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The lancet oncology · Nov 2016
Randomized Controlled Trial Multicenter StudyCombined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.
Results from phase 2 and 3 trials in patients with advanced melanoma have shown significant improvements in the proportion of patients achieving an objective response and prolonged progression-free survival with the combination of nivolumab (an anti-PD-1 antibody) plus ipilimumab (an anti-CTLA-4 antibody) compared with ipilimumab alone. We report 2-year overall survival data from a randomised controlled trial assessing this treatment in previously untreated advanced melanoma. ⋯ Bristol-Myers Squibb.
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The lancet oncology · Nov 2016
Randomized Controlled Trial Multicenter StudyHealth-related quality of life in patients with high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study.
Temozolomide chemotherapy versus radiotherapy in patients with a high-risk low-grade glioma has been shown to have no significant effect on progression-free survival. If these treatments have a different effect on health-related quality of life (HRQOL), it might affect the choice of therapy. We postulated that temozolomide compromises HRQOL and global cognitive functioning to a lesser extent than does radiotherapy. ⋯ Merck Sharp & Dohme-Merck & Co, National Cancer Institute, Swiss Cancer League, National Institute for Health Research, Cancer Research UK, Canadian Cancer Society Research Institute, National Health and Medical Research Council, European Organisation for Research and Treatment of Cancer Cancer Research Fund.
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Biosimilars are considered to be one of the solutions to combat the substantially increasing costs of cancer treatment, and its imminent introduction is expected to expand affordability worldwide. However, biosimilar monoclonal antibodies provide many challenges compared with first-generation biosimilars, growth factors, and hormones, because they have shown only a modest clinical effect, and are often used in combination with other more toxic therapies, making it difficult to design studies that allow appropriate efficacy and safety assessments compared with the original products. The value of comparative clinical trials for showing clinical equivalence of biosimilars that demonstrate a high degree of similarity in physical, chemical, structural, and biological characteristics with the original product is increasingly being questioned, and advances in analytical methods that provide robust non-clinical data might reduce the need for extensive clinical comparisons. In this Series paper, the third of three papers on drug safety in oncology, we review the safety and efficacy of biosimilars in oncology, assessing biosimilar monoclonal antibodies in relation to first-generation biosimilars, the issues surrounding interchangeability and extrapolation of biosimilars to other disease and patient indications, and reassessing the safety approval pathway in light of 10 years worth of biosimilar experience.