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RESEARCH PRODUCT
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.
M Di MaioNb LeighlC GalloR FeldF CiardielloC ButtsP MaioneV GebbiaF MorgilloR WierzbickiA FavarettoY AlamS CinieriS SienaR BiancoF RiccardiM SpataforaA RavaioliR FellettiV FregoniG GenestretiA RossiV FregoniG GenestretiA RossiG MancusoM FasanoA MorabitoMs TsaoS SignorielloF PerroneC GridelliInvestigators TorchL Calabro'subject
OncologyMaleerlotinibLung NeoplasmsHealth-related quality of lifeNSCLCchemotherapyDeoxycytidinelaw.inventionRandomized controlled trialQuality of lifelawCarcinoma Non-Small-Cell LungSurveys and QuestionnairesAntineoplastic Combined Chemotherapy ProtocolsSurveys and QuestionnaireQuality of life analysis of TORCHErlotinib HydrochloridePrognosishumanitiesOncologyResearch DesignAdvanced non–small-cell lung cancerCarcinoma Squamous CellFemaleErlotinibRandomized trialmedicine.drugHumanPulmonary and Respiratory Medicinemedicine.medical_specialtyPrognosiEGFRFirst-line treatmentfirst-line erlotinibsecond-line cisplatin/gemcitabine chemotherapyAdenocarcinomaNOFollow-Up StudieErlotinib HydrochlorideInternal medicineadvanced non-small-cell lung cancermedicineHumansLung cancerAdvanced non-small-cell lung cancer; Chemotherapy; EGFR; Erlotinib; First-line treatment; Health-related quality of life; Randomized trialQuality of life analysis of TORCH first-line erlotinib second-line cisplatin/gemcitabine chemotherapy advanced non-small-cell lung cancer.AgedNeoplasm StagingSalvage TherapyAntineoplastic Combined Chemotherapy Protocolbusiness.industryQuestionnaireCancerQuinazolinemedicine.diseaseInterim analysisGemcitabineGemcitabineSurgeryLung Neoplasmquality of lifeQuinazolinesCarcinoma Large CellCisplatinNeoplasm Recurrence LocalbusinessFollow-Up Studiesdescription
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. © 2012 by the International Association for the Study of Lung Cancer.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2012-12-01 |