© 2006 European Society for Medical Oncology
editorials |
Management of neuromuscular dose limiting toxicity at the early stage of drug development
Service Inter Hospitalier de Cancérologie, Beaujon University Hospital, Clichy, France
(E-mail: Eric.raymond@bjn.aphp.fr, Sandrine.faivre@bjn.aphp.fr)
| The first 150 words of the full text of this article appear below. |
Non-hematological toxicities, including neuromuscular toxicity, occurring during phase I trials may prevent novel compounds from undergoing further drug development. Toxicity may also result in the recommendation of low doses and inappropriate schedules with no antitumor activity, rapidly reducing the interest of clinical investigators, pharmaceutical companies, and/or business investors. In the early stages of drug development a few compounds such as imatinib mesylate [1] and sunitinib malate [2] will provide straightforward evidence of efficacy in well characterized tumor types and good safety profiles, allowing fast-track drug registration. For those drugs, very little support would be sufficient for a convincing and unequivocal demonstration of their potential benefit as anticancer drugs. Many other compounds in development with a narrow spectrum of activity, sporadic activity in a limited number of (often undefined) tumor types, and risky toxicity profile will require deeper clinical tutoring from investigators and sustained support from sponsors