PURPOSE:Adjuvant chemotherapy for early stage non-small-cell lung cancer (NSCLC) is now the standard of care, but there is little information regarding its impact on quality of life (QOL). We report the QOL results of JBR.10, a North American, intergroup, randomized trial of adjuvant cisplatin and vinorelbine compared with observation in patients who have completely resected, stages IB to II NSCLC. PATIENTS AND METHODS: QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and a trial-specific checklist at baseline and at weeks 5 and 9 for those who received chemotherapy and at follow-up months 3, 6, 9, 12, 18, 24, 30 and 36. A 10-point change in QOL scores from baseline was considered clinically significant. RESULTS:Four hundred eighty-two patients were randomly assigned on JBR.10. A total of 173 patients (82% of the expected) in the observation arm and 186 (85% of expected) in the chemotherapy arm completed baseline QOL assessments. The two groups were comparable, with low global QOL scores and significant symptom burden, especially pain and fatigue, after thoracotomy. Changes in QOL during chemotherapy were relatively modest; fatigue, nausea, and vomiting worsened, but there was a reduction in pain and no change in global QOL. Patients in the observation arm showed considerable improvements in QOL by 3 months. QOL, except for symptoms of sensory neuropathy and hearing loss, in those treated with chemotherapy returned to baseline by 9 months. CONCLUSION: The findings of this trial indicate that the negative effects of adjuvant chemotherapy on QOL appear to be temporary, and that improvements (with a return to baseline function) are likely in most patients.
RCT Entities:
PURPOSE: Adjuvant chemotherapy for early stage non-small-cell lung cancer (NSCLC) is now the standard of care, but there is little information regarding its impact on quality of life (QOL). We report the QOL results of JBR.10, a North American, intergroup, randomized trial of adjuvant cisplatin and vinorelbine compared with observation in patients who have completely resected, stages IB to II NSCLC. PATIENTS AND METHODS: QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and a trial-specific checklist at baseline and at weeks 5 and 9 for those who received chemotherapy and at follow-up months 3, 6, 9, 12, 18, 24, 30 and 36. A 10-point change in QOL scores from baseline was considered clinically significant. RESULTS: Four hundred eighty-two patients were randomly assigned on JBR.10. A total of 173 patients (82% of the expected) in the observation arm and 186 (85% of expected) in the chemotherapy arm completed baseline QOL assessments. The two groups were comparable, with low global QOL scores and significant symptom burden, especially pain and fatigue, after thoracotomy. Changes in QOL during chemotherapy were relatively modest; fatigue, nausea, and vomiting worsened, but there was a reduction in pain and no change in global QOL. Patients in the observation arm showed considerable improvements in QOL by 3 months. QOL, except for symptoms of sensory neuropathy and hearing loss, in those treated with chemotherapy returned to baseline by 9 months. CONCLUSION: The findings of this trial indicate that the negative effects of adjuvant chemotherapy on QOL appear to be temporary, and that improvements (with a return to baseline function) are likely in most patients.
Authors: Wilson W L Li; T W Lee; Shirley S Y Lam; Calvin S H Ng; Alan D L Sihoe; Innes Y P Wan; Anthony P C Yim Journal: Chest Date: 2002-08 Impact factor: 9.410
Authors: M L G Janssen-Heijnen; S Smulders; V E P P Lemmens; F W J M Smeenk; H J A A van Geffen; J W W Coebergh Journal: Thorax Date: 2004-07 Impact factor: 9.139
Authors: John R Handy; James W Asaph; Laurie Skokan; Carolyn E Reed; Sydney Koh; Gladney Brooks; E Charles Douville; Andrew C Tsen; Gary Y Ott; Gerard A Silvestri Journal: Chest Date: 2002-07 Impact factor: 9.410
Authors: M Di Maio; F Perrone; C Gallo; R V Iaffaioli; L Manzione; F V Piantedosi; S Cigolari; A Illiano; S Barbera; S F Robbiati; E Piazza; G P Ianniello; L Frontini; E Veltri; F Castiglione; F Rosetti; E De Maio; P Maione; C Gridelli; Antonio Rossi; Emiddio Barletta; Maria Luisa Barzelloni; Giuseppe Signoriello; Domenico Bilancia; Angela Dinota; Gerardo Rosati; Domenico Germano; Alfredo Lamberti; Vittorio Pontillo; Luigi Brancacio; Carlo Crispino; Maria Esposito; Ciro Battiloro; Giovanni Tufano; Angela Cioffi; Vincenzo Guardasole; Valentina Angelini; Giovanna Guidetti; Santi Barbera; Francesco Renda; Francesco Romano; Antonio Volpintesta; Sergio Federico Robbiati; Mirella Sannicolò; Virginio Filipazzi; Gabriella Esani; Anna Gambaro; Sabrina Ferrario; Vincenza Tinessa; Maria Grazia Caprio; Sabrina Zonato; Mary Cabiddu; Alberto Raina; Enzo Veltri; Modesto D'Aprile; Giorgio Pistillucci; Gianfranco Porcile; Oliviero Ostellino; Orazio Vinante; Giuseppe Azzarello; Vittorio Gebbia; Nicola Borsellino; Antonio Testa; Giampietro Gasparini; Alessandra Morabito; Domenico Gattuso; Sante Romito; Francesco Carrozza; Sergio Fava; Anna Calcagno; Emanuela Grimi; Oscar Bertetto; Libero Ciuffreda; Giuseppe Parello; Luigi Maiorino; Antonio Santoro; Massimiliano Santoro; Giuseppe Failla; Rosa Anna Aiello; Alessandra Bearz; Roberto Sorio; Simona Scalone; Maurizia Clerici; Roberto Bollina; Paolo Belloni; Cosimo Sacco; Angela Sibau; Vincenzo Adamo; Giuseppe Altavilla; Antonino Scimone; Mario Spatafora; Vincenzo Bellia; Maria Raffealla Hopps; Silvio Monfardini; Adolfo Favaretto; Micaela Stefani; Giuliana Mara Corradini; Gianfranco Pavia; Giorgio Scagliotti; Silvia Novello; Giovanni Selvaggi; Maurizio Tonato; Samir Darwish; Giovanni Michetti; Maria Ori Belometti; Roberto Labianca; Antonello Quadri; Filippo De Marinis; Maria Rita Migliorino; Olga Martelli; Giuseppe Colucci; Dominico Galetta; Francesco Giotta; Luciano Isa; Paola Candido; Nestore Rossi; Antonio Calandriello; Francesco Ferraù; Emilia Malaponte; Sandro Barni; Marina Cazzaniga; Nicola Gebbia; Maria Rosaria Valerio; Mario Belli; Giuseppe Colantuoni; Matteo Antonio Capuano; Michele Angiolillo; Francesco Sollitto; Antonio Ardizzoia; Gino Luporini; Maria Cristina Locatelli; Franca Pari; Enrico Aitini; Tonino Pedicini; Antonio Febbraro; Cesira Zollo; Francesco Di Costanzo; Roberta Bartolucci; Silvia Gasperoni; Fernando Gaion; Giovanni Palazzolo; Enzo Galligioni; Orazio Caffo; Enrico Cortesi; Giuliana D'Auria; Carlo Curcio; Matteo Vasta; Cesare Bumma; Alfredo Celano; Sergio Bretti; Giuseppe Nettis; Annamaria Anselmo; Rodolfo Mattioli; Cecilia Nisticò; Annamaria Aschelter; Paola Foa Journal: Br J Cancer Date: 2003-09-15 Impact factor: 7.640
Authors: Raymond W Jang; Aurélie Le Maître; Keyue Ding; Tim Winton; Andrea Bezjak; Lesley Seymour; Frances A Shepherd; Natasha B Leighl Journal: J Clin Oncol Date: 2009-08-10 Impact factor: 44.544
Authors: Guoan Chen; Sinae Kim; Jeremy M G Taylor; Zhuwen Wang; Oliver Lee; Nithya Ramnath; Rishindra M Reddy; Jules Lin; Andrew C Chang; Mark B Orringer; David G Beer Journal: J Thorac Oncol Date: 2011-09 Impact factor: 15.609