J J Wheler1, A M Tsimberidou2, D S Hong2, A Naing2, G S Falchook2, S Fu2, S Moulder3, B Stephen2, S Wen4, R Kurzrock2. 1. Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program. Electronic address: jjwheler@mdanderson.com. 2. Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program. 3. Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program; Breast Medical Oncology. 4. Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, USA.
Abstract
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.
BACKGROUND: This study assessed toxicity in advanced cancerpatients 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.
Authors: A Schwandt; P J Harris; S Hunsberger; A Deleporte; G L Smith; D Vulih; B D Anderson; S P Ivy Journal: Clin Cancer Res Date: 2014-07-15 Impact factor: 12.531
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Authors: Anita Schwandt; Vivian E von Gruenigen; Robert M Wenham; Heidi Frasure; Susan Eaton; Nancy Fusco; Pingfu Fu; John J Wright; Afshin Dowlati; Steven Waggoner Journal: Invest New Drugs Date: 2014-03-12 Impact factor: 3.850
Authors: Rhodora C Calizo; Smiti Bhattacharya; J G Coen van Hasselt; Chengguo Wei; Jenny S Wong; Robert J Wiener; Xuhua Ge; Nicholas J Wong; Jia-Jye Lee; Christina M Cuttitta; Gomathi Jayaraman; Vivienne H Au; William Janssen; Tong Liu; Hong Li; Fadi Salem; Edgar A Jaimes; Barbara Murphy; Kirk N Campbell; Evren U Azeloglu Journal: Nat Commun Date: 2019-05-03 Impact factor: 14.919