Risk of serious toxicity in 1181 patients treated in phase I clinical trials of predominantly targeted anticancer drugs: the M. D. Anderson Cancer Center experience. Ann Oncol 2012 Aug;23(8):1963-1967
Date
03/02/2012Pubmed ID
22377564Pubmed Central ID
PMC4092254DOI
10.1093/annonc/mds027Scopus ID
2-s2.0-84864939835 (requires institutional sign-in at Scopus site) 15 CitationsAbstract
BACKGROUND: This study assessed toxicity in advanced cancer patients treated in a phase I clinic that focuses on targeted agents.
PATIENTS AND METHODS: An analysis of database records of 1181 consecutive patients with advanced cancer who were treated in the phase I program starting 1 January 2006 was carried out.
RESULTS: All patients were treated on at least 1 of the 82 phase I clinical trials. Overall, 56 trials (68.3%) had only targeted agents, 13 (15.9%) only cytotoxics, and 13 (15.9%) targeted and cytotoxic agents. Rates of grade 3 and 4 toxicity that were at least possibly drug related were 7.1% and 3.2%, respectively, and 5 of the 1181 patients (0.4%) died from toxicity that was at least possibly drug related. The most common grade 3 or more toxic effects were neutropenia, thrombocytopenia, anemia, dehydration, infection, altered mental status, bleeding, vomiting, nausea, and diarrhea. Eastern Cooperative Oncology Group (ECOG) performance status greater than zero and use of a cytotoxic agent were selected as independent factors associated with serious toxicity.
CONCLUSION: Phase I trials of primarily targeted agents showed low rates of toxicity, with 10.3% of patients experiencing grade 3 or 4 toxicity and a 0.4% rate of death, at least possibly drug related.
Author List
Wheler JJ, Tsimberidou AM, Hong DS, Naing A, Falchook GS, Fu S, Moulder S, Stephen B, Wen S, Kurzrock RAuthor
Razelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Antineoplastic Agents
Child
Child, Preschool
Clinical Trials, Phase I as Topic
Female
Humans
Male
Middle Aged
Molecular Targeted Therapy
Neoplasms
Retrospective Studies
Young Adult
