Abstract
Understanding of how to analyse and interpret quality of life (QoL) data from clinical trials in patients with advanced cancer is limited. In order to increase the knowledge about the possibilities of drawing conclusions from QoL data of these patients, data from 2 trials were reanalysed. A total of 113 patients with pancreatic, biliary or gastric cancer were included in 2 randomised trials comparing chemotherapy and best supportive care (BSC) with BSC alone. Patient benefit was evaluated by the treating physician (subjective response) and by using selected scales and different summary measures of the EORTC QLQ-C30 questionnaire. An increasing number of drop-outs (mainly due to death) with time did not occur in a random fashion. Therefore, the mean scores in the different subscales of the QLQ-C30 obtained during the follow-up of interviewed patients did not reflect the outcome of the randomised population. The scores of the patient-provided summary measure, ‘Global health status/QoL’, were stable in a rather high proportion of the patients and could not discriminate between the 2 groups. 3 other summary measures revealed greater variability, and they all discriminated between the 2 groups. A high agreement was also seen between the changes in the summary measures and the subjective response. A categorisation of whether an individual patient had benefited or not from the intervention could overcome the problem with the selective attrition. © 2001 Cancer Research Campaign
Keywords: quality of life, advanced gastrointestinal cancer, palliation, EORTC QLQ-C30
Full Text
The Full Text of this article is available as a PDF (84.7 KB).
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Aaronson N. K., Ahmedzai S., Bergman B., Bullinger M., Cull A., Duez N. J., Filiberti A., Flechtner H., Fleishman S. B., de Haes J. C. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365–376. doi: 10.1093/jnci/85.5.365. [DOI] [PubMed] [Google Scholar]
- Bergman B., Sullivan M., Sörenson S. Quality of life during chemotherapy for small cell lung cancer. I. An evaluation with generic health measures. Acta Oncol. 1991;30(8):947–957. doi: 10.3109/02841869109088248. [DOI] [PubMed] [Google Scholar]
- Bernhard J., Cella D. F., Coates A. S., Fallowfield L., Ganz P. A., Moinpour C. M., Mosconi P., Osoba D., Simes J., Hürny C. Missing quality of life data in cancer clinical trials: serious problems and challenges. 1998 Mar 15-Apr 15Stat Med. 17(5-7):517–532. doi: 10.1002/(sici)1097-0258(19980315/15)17:5/7<517::aid-sim799>3.0.co;2-s. [DOI] [PubMed] [Google Scholar]
- Bernhard J., Hürny C., Maibach R., Herrmann R., Laffer U. Quality of life as subjective experience: reframing of perception in patients with colon cancer undergoing radical resection with or without adjuvant chemotherapy. Swiss Group for Clinical Cancer Research (SAKK) Ann Oncol. 1999 Jul;10(7):775–782. doi: 10.1023/a:1008311918967. [DOI] [PubMed] [Google Scholar]
- Bjordal K., Kaasa S. Psychometric validation of the EORTC Core Quality of Life Questionnaire, 30-item version and a diagnosis-specific module for head and neck cancer patients. Acta Oncol. 1992;31(3):311–321. doi: 10.3109/02841869209108178. [DOI] [PubMed] [Google Scholar]
- Breetvelt I. S., Van Dam F. S. Underreporting by cancer patients: the case of response-shift. Soc Sci Med. 1991;32(9):981–987. doi: 10.1016/0277-9536(91)90156-7. [DOI] [PubMed] [Google Scholar]
- Campbell S., Whyte F. The quality of life of cancer patients participating in phase I clinical trials using SEIQoL-DW. J Adv Nurs. 1999 Aug;30(2):335–343. doi: 10.1046/j.1365-2648.1999.01079.x. [DOI] [PubMed] [Google Scholar]
- Cassileth B. R., Lusk E. J., Tenaglia A. N. A psychological comparison of patients with malignant melanoma and other dermatologic disorders. J Am Acad Dermatol. 1982 Dec;7(6):742–746. doi: 10.1016/s0190-9622(82)70155-0. [DOI] [PubMed] [Google Scholar]
- Cella D. F., Tulsky D. S., Gray G., Sarafian B., Linn E., Bonomi A., Silberman M., Yellen S. B., Winicour P., Brannon J. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570–579. doi: 10.1200/JCO.1993.11.3.570. [DOI] [PubMed] [Google Scholar]
- Curran D., Fossa S., Aaronson N., Kiebert G., Keuppens F., Hall R., Keuppens E. Baseline quality of life of patients with advanced prostate cancer. European Organization for Research and Treatment of Cancer (EORTC), Genito-Urinary Tract Cancer Cooperative Group (GUT-CCG) Eur J Cancer. 1997 Oct;33(11):1809–1814. doi: 10.1016/s0959-8049(97)00187-1. [DOI] [PubMed] [Google Scholar]
- Detmar S. B., Aaronson N. K., Wever L. D., Muller M., Schornagel J. H. How are you feeling? Who wants to know? Patients' and oncologists' preferences for discussing health-related quality-of-life issues. J Clin Oncol. 2000 Sep 15;18(18):3295–3301. doi: 10.1200/JCO.2000.18.18.3295. [DOI] [PubMed] [Google Scholar]
- Fayers P. M., Hopwood P., Harvey A., Girling D. J., Machin D., Stephens R. Quality of life assessment in clinical trials--guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience. MRC Cancer Trials Office. Eur J Cancer. 1997 Jan;33(1):20–28. doi: 10.1016/s0959-8049(96)00412-1. [DOI] [PubMed] [Google Scholar]
- Glimelius B., Ekström K., Hoffman K., Graf W., Sjödén P. O., Haglund U., Svensson C., Enander L. K., Linné T., Sellström H. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997 Feb;8(2):163–168. doi: 10.1023/a:1008243606668. [DOI] [PubMed] [Google Scholar]
- Glimelius B., Graf W., Hoffman K., Påhlman L., Sjödén P. O., Wennberg A. General condition of asymptomatic patients with advanced colorectal cancer receiving palliative chemotherapy. A longitudinal study. Acta Oncol. 1992;31(6):645–651. doi: 10.3109/02841869209083847. [DOI] [PubMed] [Google Scholar]
- Glimelius B., Hoffman K., Graf W., Påhlman L., Sjödén P. O. Quality of life during chemotherapy in patients with symptomatic advanced colorectal cancer. The Nordic Gastrointestinal Tumor Adjuvant Therapy Group. Cancer. 1994 Feb 1;73(3):556–562. doi: 10.1002/1097-0142(19940201)73:3<556::aid-cncr2820730310>3.0.co;2-8. [DOI] [PubMed] [Google Scholar]
- Glimelius B., Hoffman K., Olafsdottir M., Påhlman L., Sjödén P. O., Wennberg A. Quality of life during cytostatic therapy for advanced symptomatic colorectal carcinoma: a randomized comparison of two regimens. Eur J Cancer Clin Oncol. 1989 May;25(5):829–835. doi: 10.1016/0277-5379(89)90128-4. [DOI] [PubMed] [Google Scholar]
- Glimelius B., Hoffman K., Sjödén P. O., Jacobsson G., Sellström H., Enander L. K., Linné T., Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593–600. doi: 10.1093/oxfordjournals.annonc.a010676. [DOI] [PubMed] [Google Scholar]
- Gunnars B., Nygren P., Glimelius B., SBU-group. Swedish Council of Technology Assessment in Health Care Assessment of quality of life during chemotherapy. Acta Oncol. 2001;40(2-3):175–184. doi: 10.1080/02841860151116222. [DOI] [PubMed] [Google Scholar]
- Guyatt G. H., Veldhuyzen Van Zanten S. J., Feeny D. H., Patrick D. L. Measuring quality of life in clinical trials: a taxonomy and review. CMAJ. 1989 Jun 15;140(12):1441–1448. [PMC free article] [PubMed] [Google Scholar]
- Hopwood P., Stephens R. J., Machin D. Approaches to the analysis of quality of life data: experiences gained from a medical research council lung cancer working party palliative chemotherapy trial. Qual Life Res. 1994 Oct;3(5):339–352. doi: 10.1007/BF00451726. [DOI] [PubMed] [Google Scholar]
- Juniper E. F., Guyatt G. H., Willan A., Griffith L. E. Determining a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol. 1994 Jan;47(1):81–87. doi: 10.1016/0895-4356(94)90036-1. [DOI] [PubMed] [Google Scholar]
- Kaasa S., Mastekaasa A., Stokke I., Naess S. Validation of a quality of life questionnaire for use in clinical trials for treatment of patients with inoperable lung cancer. Eur J Cancer Clin Oncol. 1988 Apr;24(4):691–701. doi: 10.1016/0277-5379(88)90301-x. [DOI] [PubMed] [Google Scholar]
- Labianca R., Pancera G., Luporini G. Factors influencing response rates for advanced colorectal cancer chemotherapy. Ann Oncol. 1996 Nov;7(9):901–906. doi: 10.1093/oxfordjournals.annonc.a010791. [DOI] [PubMed] [Google Scholar]
- Lydick E., Epstein R. S. Interpretation of quality of life changes. Qual Life Res. 1993 Jun;2(3):221–226. doi: 10.1007/BF00435226. [DOI] [PubMed] [Google Scholar]
- Matthews J. N. A refinement to the analysis of serial data using summary measures. Stat Med. 1993 Jan 15;12(1):27–37. doi: 10.1002/sim.4780120105. [DOI] [PubMed] [Google Scholar]
- Moinpour C. M., Sawyers Triplett J., McKnight B., Lovato L. C., Upchurch C., Leichman C. G., Muggia F. M., Tanaka L., James W. A., Lennard M. Challenges posed by non-random missing quality of life data in an advanced-stage colorectal cancer clinical trial. Psychooncology. 2000 Jul-Aug;9(4):340–354. doi: 10.1002/1099-1611(200007/08)9:4<340::aid-pon466>3.0.co;2-f. [DOI] [PubMed] [Google Scholar]
- Morris J., Perez D., McNoe B. The use of quality of life data in clinical practice. Qual Life Res. 1998 Jan;7(1):85–91. doi: 10.1023/a:1008893007068. [DOI] [PubMed] [Google Scholar]
- O'Boyle C. A., McGee H., Hickey A., O'Malley K., Joyce C. R. Individual quality of life in patients undergoing hip replacement. Lancet. 1992 May 2;339(8801):1088–1091. doi: 10.1016/0140-6736(92)90673-q. [DOI] [PubMed] [Google Scholar]
- Osoba D., Rodrigues G., Myles J., Zee B., Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139–144. doi: 10.1200/JCO.1998.16.1.139. [DOI] [PubMed] [Google Scholar]
- Ross P. J., Webb A., Cunningham D., Prendiville J., Norman A. R., Oates J. Infusional 5-fluorouracil in the treatment of gastrointestinal cancers: the Royal Marsden Hospital experience. Ann Oncol. 1997 Feb;8(2):111–115. doi: 10.1023/a:1008274522483. [DOI] [PubMed] [Google Scholar]
- Rothenberg M. L., Moore M. J., Cripps M. C., Andersen J. S., Portenoy R. K., Burris H. A., 3rd, Green M. R., Tarassoff P. G., Brown T. D., Casper E. S. A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. Ann Oncol. 1996 Apr;7(4):347–353. doi: 10.1093/oxfordjournals.annonc.a010600. [DOI] [PubMed] [Google Scholar]
- Sanders C., Egger M., Donovan J., Tallon D., Frankel S. Reporting on quality of life in randomised controlled trials: bibliographic study. BMJ. 1998 Oct 31;317(7167):1191–1194. doi: 10.1136/bmj.317.7167.1191. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Schag C. A., Ganz P. A., Heinrich R. L. CAncer Rehabilitation Evaluation System--short form (CARES-SF). A cancer specific rehabilitation and quality of life instrument. Cancer. 1991 Sep 15;68(6):1406–1413. doi: 10.1002/1097-0142(19910915)68:6<1406::aid-cncr2820680638>3.0.co;2-2. [DOI] [PubMed] [Google Scholar]
- Sigurdardóttir V., Bolund C., Sullivan M. Quality of life evaluation by the EORTC questionnaire technique in patients with generalized malignant melanoma on chemotherapy. Acta Oncol. 1996;35(2):149–158. doi: 10.3109/02841869609098495. [DOI] [PubMed] [Google Scholar]
- Sprangers M. A., Schwartz C. E. Integrating response shift into health-related quality of life research: a theoretical model. Soc Sci Med. 1999 Jun;48(11):1507–1515. doi: 10.1016/s0277-9536(99)00045-3. [DOI] [PubMed] [Google Scholar]
- Sprangers M. A., Van Dam F. S., Broersen J., Lodder L., Wever L., Visser M. R., Oosterveld P., Smets E. M. Revealing response shift in longitudinal research on fatigue--the use of the thentest approach. Acta Oncol. 1999;38(6):709–718. [PubMed] [Google Scholar]
- Sprangers M. A., te Velde A., Aaronson N. K. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Eur J Cancer. 1999 Feb;35(2):238–247. doi: 10.1016/s0959-8049(98)00357-8. [DOI] [PubMed] [Google Scholar]
- Troxel A. B., Fairclough D. L., Curran D., Hahn E. A. Statistical analysis of quality of life with missing data in cancer clinical trials. 1998 Mar 15-Apr 15Stat Med. 17(5-7):653–666. doi: 10.1002/(sici)1097-0258(19980315/15)17:5/7<653::aid-sim812>3.0.co;2-m. [DOI] [PubMed] [Google Scholar]
- Wilke H., Preusser P., Stahl M., Harstrick A., Meyer H. J., Achterrath W., Schmoll H. J., Seeber S. Etoposide, folinic acid, and 5-fluorouracil in carboplatin-pretreated patients with advanced gastric cancer. Cancer Chemother Pharmacol. 1991;29(1):83–84. doi: 10.1007/BF00686342. [DOI] [PubMed] [Google Scholar]
- de Haes J. C., van Knippenberg F. C., Neijt J. P. Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br J Cancer. 1990 Dec;62(6):1034–1038. doi: 10.1038/bjc.1990.434. [DOI] [PMC free article] [PubMed] [Google Scholar]