Quality of life analysis of TORCH, a randomized trial testing first-line erlotinib followed by second-line cisplatin/gemcitabine chemotherapy in advanced non-small-cell lung cancer

Massimo Di Maio, Natasha B. Leighl, Ciro Gallo, Ronald Feld, Fortunato Ciardiello, Charles Butts, Paolo Maione, Vittorio Gebbia, Floriana Morgillo, Rafal Wierzbicki, Adolfo Favaretto, Yasmin Alam, Saverio Cinieri, Salvatore Siena, Roberto Bianco, Ferdinando Riccardi, Mario Spatafora, Alberto Ravaioli, Raffaella Felletti, Vittorio FregoniGiovenzio Genestreti, Antonio Rossi, Gianfranco Mancuso, Morena Fasano, Alessandro Morabito, Ming Sound Tsao, Simona Signoriello, Francesco Perrone, Cesare Gridelli

Research output: Contribution to journalArticlepeer-review

Abstract

INTRODUCTION:: The TORCH (Tarceva or Chemotherapy) trial randomized patients with advanced non-small-cell lung cancer to first-line erlotinib followed by second-line cisplatin/gemcitabine versus. standard inverse sequence. The trial, designed to test noninferiority in overall survival, was stopped at interim analysis because of inferior survival in the experimental arm. Quality of life (QoL), a secondary outcome, is reported here. METHODS:: QoL was assessed at baseline and every 3 weeks during first-line, using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 and QLQ-lung cancer specific module (LC13). Mean changes from baseline within arms were reported. QoL response and time-to-deterioration of QoL using a competing-risk approach were compared between treatment arms. RESULTS:: Six hundred and thirty patients (83%) completed baseline questionnaires. Compliance was affected by differential treatment efficacy, but was similar between arms for patients without progression or death. Significant differences in QoL responses were observed favoring chemotherapy for pain, sleeping, dyspnea, diarrhea, and favoring erlotinib for vomiting, constipation, sore mouth, and alopecia. In the small subset of patients with EGFR-mutated tumors, all selected items (global QoL, physical functioning, cough, dyspnea and pain) improved, whereas worsening or no change was observed in wild-type patients. Improvement was particularly evident in the first-line erlotinib arm as for global QoL and physical functioning. CONCLUSIONS:: QoL was impacted by differential toxicity and efficacy between arms. Functional domains and global QoL did not differ, although some symptoms were better controlled with chemotherapy in unselected non-small-cell lung cancer patients.

Original languageEnglish
Pages (from-to)1830-1844
Number of pages15
JournalJournal of Thoracic Oncology
Volume7
Issue number12
DOIs
Publication statusPublished - Dec 2012

Keywords

  • Advanced non-small-cell lung cancer
  • Chemotherapy
  • EGFR
  • Erlotinib
  • First-line treatment
  • Health-related quality of life
  • Randomized trial

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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