TY - JOUR
T1 - 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
AU - Di Maio, Massimo
AU - Leighl, Natasha B.
AU - Gallo, Ciro
AU - Feld, Ronald
AU - Ciardiello, Fortunato
AU - Butts, Charles
AU - Maione, Paolo
AU - Gebbia, Vittorio
AU - Morgillo, Floriana
AU - Wierzbicki, Rafal
AU - Favaretto, Adolfo
AU - Alam, Yasmin
AU - Cinieri, Saverio
AU - Siena, Salvatore
AU - Bianco, Roberto
AU - Riccardi, Ferdinando
AU - Spatafora, Mario
AU - Ravaioli, Alberto
AU - Felletti, Raffaella
AU - Fregoni, Vittorio
AU - Genestreti, Giovenzio
AU - Rossi, Antonio
AU - Mancuso, Gianfranco
AU - Fasano, Morena
AU - Morabito, Alessandro
AU - Tsao, Ming Sound
AU - Signoriello, Simona
AU - Perrone, Francesco
AU - Gridelli, Cesare
PY - 2012/12
Y1 - 2012/12
N2 - 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.
AB - 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.
KW - Advanced non-small-cell lung cancer
KW - Chemotherapy
KW - EGFR
KW - Erlotinib
KW - First-line treatment
KW - Health-related quality of life
KW - Randomized trial
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U2 - 10.1097/JTO.0b013e318275b327
DO - 10.1097/JTO.0b013e318275b327
M3 - Article
C2 - 23154555
AN - SCOPUS:84870327842
VL - 7
SP - 1830
EP - 1844
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
SN - 1556-0864
IS - 12
ER -