title: 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.
abstract: BACKGROUND
  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.
authors.affiliation: Clinical Trials Unit, National Cancer Institute, Naples, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Maio
authors.affiliation: Thoraco-Pulmonary Medical Oncology, National Cancer Institute, Naples, Italy.
authors.forename: Natasha B
authors.initials: NB
authors.lastname: Leighl
authors.affiliation: Medical Statistics, Second University, Naples, Italy.
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.affiliation: Medical Oncology, Princess Margaret Hospital/University Health Network, Toronto, Canada.
authors.forename: Ronald
authors.initials: R
authors.lastname: Feld
authors.affiliation: Medical Oncology, Second University, Naples, Italy.
authors.forename: Fortunato
authors.initials: F
authors.lastname: Ciardiello
authors.affiliation: Medical Oncology, Cross Cancer Institute, Edmonton, Canada.
authors.forename: Charles
authors.initials: C
authors.lastname: Butts
authors.affiliation: Medical Oncology, S.G.Moscati Hospital, Avellino, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Maione
authors.affiliation: Medical Oncology, Casa di Cura La Maddalena, Palermo, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.affiliation: Medical Oncology, Second University, Naples, Italy.
authors.forename: Floriana
authors.initials: F
authors.lastname: Morgillo
authors.affiliation: Medical Oncology, Casa di Cura La Maddalena, Palermo, Italy; Oncology Clinical Trials, Durham Regional Cancer Centre, Oshawa, Canada.
authors.forename: Rafal
authors.initials: R
authors.lastname: Wierzbicki
authors.affiliation: Medical Oncology, Istituto Oncologico Veneto, Padova, Italy.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Favaretto
authors.affiliation: Windsor Regional Cancer, Centre, Windsor, Canada; Medical Oncology, A.Perrino Hospital, Brindisi and European Institute of Oncology, Milan, Italy.
authors.forename: Yasmin
authors.initials: Y
authors.lastname: Alam
authors.affiliation: Medical Oncology, Casa di Cura La Maddalena, Palermo, Italy.
authors.forename: Saverio
authors.initials: S
authors.lastname: Cinieri
authors.affiliation: Niguarda Ca' Granda Hospital, Milan, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Siena
authors.affiliation: Medical Oncology, Federico II University, Naples, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Bianco
authors.affiliation: Medical Oncology, Cardarelli Hospital, Naples, Italy.
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Riccardi
authors.affiliation: Pneumology, V.Cervello Hospital, Palermo, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Spatafora
authors.affiliation: Medical Oncology, Civil Hospital, Rimini, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Ravaioli
authors.affiliation: Pneumology, San Martino Hospital, Genova, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Felletti
authors.affiliation: Medical Oncology, Salvatore Maugeri Foundation, Pavia, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Fregoni
authors.affiliation: medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (FO), Italy.
authors.forename: Giovenzio
authors.initials: G
authors.lastname: Genestreti
authors.affiliation: Medical Oncology, S.G.Moscati Hospital, Avellino, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Rossi
authors.affiliation: Medical Oncology, Casa di Cura La Maddalena, Palermo, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Mancuso
authors.affiliation: Medical Oncology, Second University, Naples, Italy.
authors.forename: Morena
authors.initials: M
authors.lastname: Fasano
authors.affiliation: Thoraco-Pulmonary Medical Oncology, National Cancer Institute, Naples, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Morabito
authors.affiliation: Pathology, Princess Margaret Hospital/University Health Network, Toronto, Canada.
authors.forename: Ming Sound
authors.initials: MS
authors.lastname: Tsao
authors.affiliation: Medical Statistics, Second University, Naples, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Signoriello
authors.affiliation: Clinical Trials Unit, National Cancer Institute, Naples, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.affiliation: Medical Oncology, S.G.Moscati Hospital, Avellino, Italy. Electronic address: cgridelli@libero.it.
authors.forename: Cesare
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authors.lastname: Gridelli
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy* / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069347:Erlotinib Hydrochloride; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D011788:Quality of Life; D011799:Quinazolines / Q000008:administration & dosage; D012107:Research Design; D016879:Salvage Therapy; D011795:Surveys and Questionnaires; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D002945:Cisplatin; D000093542:Gemcitabine