Lung cancer symptom scale outcomes in relation to standard efficacy measures: An analysis of the phase III study of pemetrexed versus docetaxel in advanced non-small cell lung cancer

Journal of Thoracic Oncology

Volumn 3, Issue 1, 2008, Pages 30-36

  De Marinis, Filippo ^a   Pereira, Jose Rodrigues ^b   Fossella, Frank ^c   Perry, Michael C ^d   Reck, Martin ^e   Salzberg, Marc ^f   Jassem, Jacek ^g   Peterson, Patrick ^h   Liepa, Astra M ^h   Moore, Patti ^h   Gralla, Richard J ⁱ  

^a SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^b Instituto do Cancer Dr Arnaldo   (Brazil)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d UNIVERSITY OF MISSOURI   (United States)

^e KRANKENHAUS GROSSHANSDORF   (Germany)

^f UNIVERSITY HOSPITAL BASEL   (Switzerland)

^g MEDICAL UNIVERSITY OF GDANSK   (Poland)

^h ELI LILLY AND COMPANY   (United States)

ⁱ New York Lung Cancer Alliance   (United States)

Author keywords

Docetaxel; Lung Cancer Symptom Scale (LCSS); NSCLC; Pemetrexed; Time to worsening of symptoms (TWS)

Indexed keywords

CYANOCOBALAMIN; DEXAMETHASONE; DOCETAXEL; FOLIC ACID; PEMETREXED;

ADVANCED CANCER; ARTICLE; CANCER INHIBITION; CANCER SURVIVAL; CHEMOTHERAPY; CLINICAL ASSESSMENT TOOL; CLINICAL PRACTICE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CORRELATION ANALYSIS; CORRELATION COEFFICIENT; DISEASE SEVERITY; DRUG EFFICACY; HEMOPTYSIS; HUMAN; LUNG CANCER SYMPTOM SCALE; LUNG NON SMALL CELL CANCER; MULTICENTER STUDY; NONPARAMETRIC TEST; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PARAMETER; PATIENT CARE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RETROSPECTIVE STUDY; STATISTICAL ANALYSIS; SURVIVAL RATE; SYMPTOMATOLOGY; THERAPY EFFECT; TIME TO WORSENING OF SYMPTOM; TREATMENT OUTCOME; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VISUAL ANALOG SCALE;

EID: 37549036328     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e31815e8b48     Document Type: Article

References (20)

1. Barlesi F, Jacot W, Astoul P, et al. Second-line treatment for advanced non-small cell lung cancer: a systematic review. Lung Cancer 2006;51:159-172.
2. Noble J, Ellis PM, Mackay JA, et al. Second-line or subsequent systemic therapy for recurrent or progressive non-small cell lung cancer: a systematic review and practice guideline. J Thoracic Oncol 2006;1:1042-1058.
3. Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004;22:1589-1597.
4. Hollen PJ, Gralla RJ, Kris MG, et al. Quality of life assessment in individuals with lung cancer: testing the Lung Cancer Symptom Scale (LCSS). Eur J Cancer 1993;29A(Suppl 1):S51-S58.
5. Hollen PJ, Gralla RJ, Kris MG, et al. Measurement of quality of life in patients with lung cancer in multicenter trials of new therapies. Psychometric assessment of the Lung Cancer Symptom Scale. Cancer 1994;73:2087-2098.
6. de Marinis F, Pereira JR, Park K, et al. Does second-line therapy for non-small cell lung cancer (NSCLC) result in symptom palliation? Analysis of 484 patients from a randomized trial of pemetrexed vs docetaxel. J Clin Oncol 2004;22(14 Suppl):7035.
7. Bezjak A, Tu D, Seymour L, et al. Symptom improvement in lung cancer patients treated with erlotinib: quality of life analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 2006;24:3831-3837. Erratum: J Clin Oncol 2007;25:3831.
8. Peterson P, Zwitter M, Krzakowski M, et al. Delay in time to worsening of symptoms (TWS) of advanced non-small cell lung cancer (NSCLC) using gemcitabine (gem) maintenance therapy. J Clin Oncol 2006;24(18 Suppl):7140.
9. Green S, Weiss GR. Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria. Invest New Drugs 1992;10:239-253.
10. Hollen PJ, Gralla RJ. Evaluating clinical versus statistical significance with the LCSS quality of life instrument and the Karnofsky Performance Status (KPS). Lung Cancer 2000;29(Suppl 1):107.
11. Guyatt GH, Osoba D, Wu AW, et al. Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002;77:371-383.
12. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582-592.
13. Hollen PJ, Gralla RJ, Rittenberg CN. Quality of life as a clinical trial endpoint: determining the appropriate interval for repeated assessments in patients with advanced lung cancer. Support Care Cancer 2004;12:767-773.
14. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-481.
15. Oakes D. A concordance test for independence in the presence of censoring. Biometrics 1982;38:451-455.
16. Hollen PJ, Gralla RJ, Kris MG, et al. Normative data and trends in quality of life from the Lung Cancer Symptom Scale (LCSS). Support Care Cancer 1999;7:140-148.
17. Dancey J, Shepherd FA, Gralla RJ, et al. Quality of life assessment of second-line docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: results of a prospective, randomized phase III trial. Lung Cancer 2004;43:183-194.
18. Bergman B, Aaronson NK, Ahmedzai S, et al. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. Eur J Cancer 1994;30A:635-642.
19. Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998;16:139-144.
20. Bukowski R, Cella D, Gondek K, et al. Effects of sorafenib on symptoms and quality of life: Results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol 2007;30:220-227.