Journal of clinical oncology : official journal of the American Society of Clinical Oncology
-
Review Comparative Study
Practical grading system for evaluating cisplatin ototoxicity in children.
We present a new ototoxicity grading system that has clearly defined and frequency-specific audiometric criteria. The purpose of this study was to validate this grading system by assessing its correspondence to audiology treatment recommendations and comparing it with the currently utilized Common Terminology Criteria for Adverse Events (CTCAE). ⋯ This grading system provides robust and clinically useful criteria to represent clinical hearing loss induced by ototoxicity with regard to the impact on speech and language and the need for assistive hearing devices. It is both more specific and more sensitive than the traditional CTCAE criteria for identifying clinically significant ototoxicity.
-
Review Meta Analysis
Choice of starting dose for molecularly targeted agents evaluated in first-in-human phase I cancer clinical trials.
One tenth of the lethal dose to 10% of mice is one of the conventional parameters used to derive a safe starting dose in phase I trials of cytotoxic agents. There is no consensus on which preclinical models and parameters should define the starting dose for molecularly targeted agents. ⋯ The derivation of starting dose for first-in-human phase I trials of molecularly targeted agents in patients with cancer is safe but is based on diverse practices using a variety of preclinical toxicologic parameters.
-
Geriatric issues in cancer are becoming prominent. Depression is a significant concern for both the elderly and patients with cancer, yet identifying depression in these patients is difficult and often leads to under-recognition. We conducted a systematic review to determine which depression instruments are appropriate for use in geriatric patients with cancer. ⋯ The validation evidence for use of common depression instruments in geriatric patients with cancer is lacking. This, and the possibility that these measures may not assess common depressive symptoms in geriatric patients with cancer, questions the adequacy of these scales in this population.
-
To approve a new anticancer drug, the US Food and Drug Administration often requires randomized trials. However, several oncology drugs have been approved on the basis of objective end points without a randomized trial. We reviewed the long-term safety and efficacy of such agents. ⋯ Nonrandomized clinical trials with definitive end points can yield US Food and Drug Administration approvals, and these drugs have a reassuring record of long-term safety and efficacy.