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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.
Wheler, J J; Tsimberidou, A M; Hong, D S; Naing, A; Falchook, G S; Fu, S; Moulder, S; Stephen, B; Wen, S; Kurzrock, R.
Afiliación
  • Wheler JJ; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program. Electronic address: jjwheler@mdanderson.com.
  • Tsimberidou AM; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
  • Hong DS; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
  • Naing A; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
  • Falchook GS; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
  • Fu S; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
  • Moulder S; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program; Breast Medical Oncology.
  • Stephen B; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
  • Wen S; Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, USA.
  • Kurzrock R; Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
Ann Oncol ; 23(8): 1963-1967, 2012 Aug.
Article en En | MEDLINE | ID: mdl-22377564
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.
Asunto(s)

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Terapia Molecular Dirigida / Neoplasias / Antineoplásicos Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Aged80 / Child / Child, preschool / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2012 Tipo del documento: Article

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Terapia Molecular Dirigida / Neoplasias / Antineoplásicos Tipo de estudio: Etiology_studies / Observational_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Aged80 / Child / Child, preschool / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2012 Tipo del documento: Article