title: Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.
abstract: OBJECTIVE
  The feasibility and utility of assessing quality of life (QoL) and disease-related symptoms in patients with advanced cancer have been evaluated in two Phase I clinical trials of p.o. administered ZD1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced cancer.
  
  
  METHODS
  Functional Assessment of Cancer Therapy (FACT) questionnaires, including disease-specific subscales for lung, head and neck, colorectal, prostate, and ovarian cancer, were completed by patients in two open-label, Phase I, escalating multiple-dose safety and tolerability trials.
  
  
  RESULTS
  In 157 patients, 92% of whom had received prior therapy, compliance in returning FACT questionnaires was 87% (European/Australian trial) and 57% (United States trial). This did not appear to be influenced by dose level or tumor type. For patients with colorectal, prostate, or ovarian cancer, median QoL [FACT and Trial Outcome Index (TOI)] scores deteriorated over time. In contrast, for patients with non-small cell lung cancer (NSCLC) or head and neck cancer, median FACT and TOI scores did not deteriorate significantly, and in the United States trial, head and neck cancer scores improved significantly over time. In patients with NSCLC, symptom-related scores measured by the Lung Cancer Subscale of FACT-L appeared sensitive to clinical change.
  
  
  CONCLUSIONS
  QoL (FACT-L) questionnaires were used successfully in the Phase I clinical trials of ZD1839. They appeared to be a sensitive tool to monitor clinical changes for the five tumor types in these trials and showed that ZD1839 has the potential to improve patients' QoL.
authors.affiliation: Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA.
authors.forename: Patricia M
authors.initials: PM
authors.lastname: LoRusso
authors.forename: Roy S
authors.initials: RS
authors.lastname: Herbst
authors.forename: Danny
authors.initials: D
authors.lastname: Rischin
authors.forename: Malcolm
authors.initials: M
authors.lastname: Ranson
authors.forename: Hilary
authors.initials: H
authors.lastname: Calvert
authors.forename: Eric
authors.initials: E
authors.lastname: Raymond
authors.forename: Dirk
authors.initials: D
authors.lastname: Kieback
authors.forename: Stan
authors.initials: S
authors.lastname: Kaye
authors.forename: Luca
authors.initials: L
authors.lastname: Gianni
authors.forename: Adrian
authors.initials: A
authors.lastname: Harris
authors.forename: Thomas
authors.initials: T
authors.lastname: Bjork
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Maddox
authors.forename: Mace L
authors.initials: ML
authors.lastname: Rothenberg
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Small
authors.forename: Eric H
authors.initials: EH
authors.lastname: Rubin
authors.forename: Andrea
authors.initials: A
authors.lastname: Feyereislova
authors.forename: Anne
authors.initials: A
authors.lastname: Heyes
authors.forename: Steven D
authors.initials: SD
authors.lastname: Averbuch
authors.forename: Judith
authors.initials: J
authors.lastname: Ochs
authors.forename: José
authors.initials: J
authors.lastname: Baselga
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000523:psychology; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011788:Quality of Life; D011799:Quinazolines / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib