Document Detail


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.
MedLine Citation:
PMID:  23154555     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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 Fregoni; Giovenzio Genestreti; Antonio Rossi; Gianfranco Mancuso; Morena Fasano; Alessandro Morabito; Ming Sound Tsao; Simona Signoriello; Francesco Perrone; Cesare Gridelli;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer     Volume:  7     ISSN:  1556-1380     ISO Abbreviation:  J Thorac Oncol     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-16     Completed Date:  2013-05-07     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  101274235     Medline TA:  J Thorac Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1830-44     Citation Subset:  IM    
Affiliation:
Clinical Trials Unit, National Cancer Institute, Naples, Italy.
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MeSH Terms
Descriptor/Qualifier:
Adenocarcinoma / drug therapy*,  pathology
Aged
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Carcinoma, Large Cell / drug therapy*,  pathology
Carcinoma, Non-Small-Cell Lung / drug therapy*,  pathology
Carcinoma, Squamous Cell / drug therapy*,  pathology
Cisplatin / administration & dosage
Deoxycytidine / administration & dosage,  analogs & derivatives
Female
Follow-Up Studies
Humans
Lung Neoplasms / drug therapy*,  pathology
Male
Neoplasm Recurrence, Local / drug therapy,  pathology
Neoplasm Staging
Prognosis
Quality of Life*
Questionnaires
Quinazolines / administration & dosage
Research Design
Salvage Therapy
Chemical
Reg. No./Substance:
0/Quinazolines; 15663-27-1/Cisplatin; 951-77-9/Deoxycytidine; B76N6SBZ8R/gemcitabine; J4T82NDH7E/erlotinib
Investigator
Investigator/Affiliation:
Vittorio Gebbia / ; Gianfranco Mancuso / ; Antonio Testa / ; Eugenio Bajardi / ; Carlo Arcara / ; Cesare Gridelli / ; Paolo Maione / ; Antonio Rossi / ; Clorinda Schettino / ; Marianna Bareschino / ; Fortunato Ciardiello / ; Floriana Morgillo / ; Flavia Cantile / ; Ferdinando De Vita / ; Morena Fasano / ; Erika Martinelli / ; Michele Orditura / ; Teresa Troiani / ; Ciro Gallo / ; Simona Signoriello / ; Paolo Chiodini / ; Giuseppe Signoriello / ; Giovenzio Genestreti / ; Manuela Monti / ; Carlo Milandri / ; Ruggero Ridolfi / ; Adolfo Favaretto / ; Giulia Pasello / ; Laura Bonanno / ; Paolo Carli / ; Saverio Cinieri / ; Angelo Nacci / ; Pietro Rizzo / ; Palma Fedele / ; Salvatore Siena / ; Mauro Moroni / ; Giovanna Marrapese / ; Giulio Cerea / ; Giampaolo Tortorab / ; Roberto Bianco / ; Roberta Marciano / ; Elide Matano / ; Raffaella Felletti / ; Mercedes Paquali / ; Giorgio Bernabò / ; Ferdinando Riccardi / ; Giacomo Cartenì / ; Chiara De Vitiis / ; Mimma Rizzo / ; Mario Spatafora / ; Gaetana Camarda / ; Vincenzo Bellia / ; Anna Ceribelli / ; Francesco Cognetti / ; Maria Tedeschi / ; Enzo Pasquini / ; Davide Tassinari / ; Maximilian Papi / ; Vittorio Fregoni / ; Anna Milani / ; Lorenzo Pavesi / ; Luigi Cavanna / ; Carmelina Rodinò / ; Elena Zaffignani / ; Manlio Mencoboni / ; Andrea Bruzzone / ; Maria Grazia Covesnon / ; Bruno Daniele / ; Emiddio Barletta / ; Vincenza Tinessa / ; Francesco Rosetti / ; Orazio Vinante / ; Giovanni Luigi Papagallo / ; Giuseppe Valmadre / ; Renzo Epis / ; Fabrizio Artioli / ; Ilaria Bernardini / ; Vincenzo Adamo / ; Tindara Franchina / ; Giuditta di Isernia / ; Marco Ciaparrone / ; Alfonso Maria D'Arco / ; Annamaria Libroia / ; Enzo Veltri / ; Maria Colonna / ; Alessandra Bearz / ; Umberto Tirelli / ; Francesco Carrozza / ; Michela Musacchio / ; Santi Barbera / ; Francesco Renda / ; Michele Maio / ; Luana Calabrò / ; Elena Piazza / ; Virginio Filipazzi / ; Claudio Verusio / ; Raffaella Morena / ; Davide Santeufemia / ; Alessandro Del Conte / ; Daniela Pozzessere / ; Francesca Del Monte / ; Teresa Gamucci / ; Vito Barbieri / ; Stefano Tamberi / ; Elisa Varriale / ; Rodolfo Mattioli / ; Giovanna Antonelli / ; Enrico Aitini / ; David Rossi / ; Francesco Testore / ; Edmondo Terzoli / ; Modesto D'Aprile / ; Domenico Galetta / ; Antonio Ghidini / ; Elvira De Marino / ; Luciana Irtelli / ; Elena Raisi / ; Luca Moscetti / ; Maria Rosaria Valerio / ; Michele Caruso / ; Pietro Masullo / ; Vincenzo Chiuri / ; Sergio Montanara / ; Francesco Perrone / ; Alessandro Morabito / ; Massimo Di Maio / ; Maria Carmela Piccirillo / ; Ermelinda De Maioa / ; Raffaele Costanzo / ; Jane Bryce / ; Roberta D'Aniello / ; Maria Rosaria Salzano / ; Gaetano Rocco / ; Aldo Vecchione / ; Ronald Feld / ; Natasha Leighl / ; Ming Sound Tsao / ; Mauro A Saieg / ; Gilda da Cunha Santos / ; Ni Liu / ; Christine To / ; Olga Ludkovski / ; Rafal Wierzbicki / ; Zeenat Yasmin Alam / ; Sindu Kanjeekal / ; Tarek Elfiki / ; Swati Kulkarni / ; Victor Cohen / ; Jason Agulnik / ; Brian Higgins / ; Robert Myers / ; Mark Rother / ; Richard Gregg / ; Anna Tomiak / ; Mihaela Mates / ; Quincy Chu / ; Anil Joy / ; David Fenton / ; Michael Smylie / ; Randeep Sangha / ; Gary Harding / ; Srisala Navartnam / ; John Goffin / ; Andrew Arnold / ; Donald Morris / ; Desiree Hao / ; Jonathan Noble / ; Ronald Burkes / ; Wojciech Morzycki / ; Cheryl Ho / ; Manuela Florio / ; Federika Crudele / ; Giuliana Canzanella / ; Fiorella Romano / ; Giovanni de Matteis / ; Paolo Russo / ; Valentina Barbato / ; Rita Ambrosio / ; Margherita Cinefra / ; Yves Franzosi / ; Ilaria Carbone / ; Giuliana Drudi / ; Barbara Venturini / ; Camilla di Nunzio / ; Stefania Competiello / ; Giorgia Razzini / ; Giovanni Amato / ; Barbara Barco / ; Alice Ballerio / ; Antonino Ius / ; Filomena Narducci / ; Jansen Janice / ; Patricia Dupis / ; Ricard Ginette / ; Sandy Phillips / ; Christine Maize / ; Jackie Edwards / ; Mary-Linn Gantefoer / ; Sandra Yap / ; Moelker Yvonne / ; Kim Gerat / ; Deb Bertrand / ; Janet Smith / ; Jane Bryce / ; Noemi Giovannini / ; Cristina Magro / ; Liana Letizia Falcone / ; Monica Mina / ; Antonio Messina / ; Silvia Coccato / ; Sergio Speranza / ; Maria Immacolata Morrone / ; Manuela Gardonio / ; Andrea Foster / ; Cathy Pelham / ; Donna Fawdry / ; Robin Rashcovsky / ; Shelina Alarakhia / ; Carole Gallagher / ; Kathi Klapp / ; Theresa Holmes / ; Sharon Holowachuk / ; Faye Gee / ; Ni Liu / ; Chrystal Johnson / ; Christine To / ; James Ho / ; Nhu-An Pham / ; Geoffrey Liu /

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