Future trends in patient-reported outcomes assessment for patients with advanced-stage lung cancer receiving targeted therapy

Clinical Lung Cancer

Volumn 8, Issue 2, 2006, Pages 99-109

  Eton, David T ^a,b   Yost, Kathleen J ^a,b   Cella, David ^a,b  

^a EVANSTON NORTHWESTERN HEALTHCARE   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Functional assessment of cancer therapy; Hospital anxiety and depression scale; Lung cancer symptom scale; Quality of life; Rotterdam symptom checklist; Symptoms

Indexed keywords

ANTINEOPLASTIC AGENT; BEVACIZUMAB; CARBOPLATIN; CISPLATIN; ERLOTINIB; GEFITINIB; GEMCITABINE; PACLITAXEL; PIVALOYLOXYMETHYL BUTYRATE; PLACEBO; TIPIFARNIB;

ABDOMINAL PAIN; ACNE; ADVANCED CANCER; ALOPECIA; ANEMIA; ANOREXIA; ANXIETY DISORDER; ARTHRALGIA; ASTHENIA; BACKACHE; CANCER RESEARCH; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONSTIPATION; COST EFFECTIVENESS ANALYSIS; COUGHING; DECREASED APPETITE; DEHYDRATION; DERMATITIS; DIARRHEA; DOSE RESPONSE; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRY SKIN; DYSPHAGIA; DYSPNEA; EPISTAXIS; EYE TOXICITY; FATIGUE; FUNCTIONAL ASSESSMENT; GRANULOCYTOPENIA; HAIR LOSS; HEALTH CARE COST; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; INFECTION; INTERMETHOD COMPARISON; LEUKOPENIA; LUNG CANCER; NAUSEA AND VOMITING; NEPHROTOXICITY; NEUROPATHY; NEUTROPENIA; OUTCOME ASSESSMENT; PARESTHESIA; PATIENT COMPLIANCE; PATIENT SATISFACTION; PERCEPTION DEAFNESS; POSTMARKETING SURVEILLANCE; PRURITUS; QUALITY OF LIFE; REVIEW; RHINITIS; STOMATITIS; SYMPTOM; TACHYCARDIA; THORAX PAIN; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT PLANNING; TREND STUDY; WELLBEING;

EID: 33750176007     PISSN: 15257304     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLC.2006.n.037     Document Type: Review

References (65)

1. Johnson ML, Seidman AD. Emerging targeted therapies for breast cancer. Oncology (Williston Park) 2005; 19:611-618.
2. Ross JS, Schenkein DP, Pietrusko R, et al. Targeted therapies for cancer 2004. Am J Clin Pathol 2004; 122:598-609.
3. Sledge GW Jr. What is targeted therapy? J Clin Oncol 2005; 23:1614-1615.
4. Tannock IF, Osoba D, Steckler MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996; 14:1756-1764.
5. Thatcher N, Hopwood P, Anderson H. Improving quality of life in patients with non-small cell lung cancer: research experience with gemcitabine. Eur J Cancer 1997; 33 (suppl 1):S8-S13.
6. Litwin MS, Lubeck DP, Henning JM, et al. Differences in urologist and patient assessments of health-related quality of life in men with prostate cancer: results of the CaPSURE database. J Urol 1998; 159:1988-1992.
7. Fromme EK, Eilers KM, Mori M, et al. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the quality-of-life questionnaire C30. J Clin Oncol 2004; 22:3485-3490.
8. Earle CC, Weeks JC. The science of quality-of-life measurement in lung cancer. In: Lipscomb J, Gotay CC, Snyder C, eds. Outcomes Assessment in Cancer. New York, NY: Cambridge, 2005:160-177.
9. Bottomley A, Efficace F, Thomas R, et al. Health-related quality of life in non-small-cell lung cancer: methodologic issues in randomized controlled trials. J Clin Oncol 2003; 21:2982-2992.
10. Erickson P. Assessing health status and quality of life of cancer patients: the use of general instruments. In: Lipscomb J, Gotay CC, Snyder C, eds. Outcomes Assessment in Cancer. New York, NY: Cambridge, 2005:31-68.
11. Aaronson NK, Ahmedzai S, Bergman B, et al. 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; 85:365-376.
12. 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. EORTC Study Group on Quality of Life. Eur J Cancer 1994; 30A:635-642.
13. Perez-Soler R, Chachoua A, Hammond LA, et al. Determinants of tumor response and survival with erlotinib in patients with non-small-cell lung cancer. J Clin Oncol 2004; 22:3238-3247.
14. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005; 353:123-132.
15. Cella DF, Bonomi AE, Lloyd SR, et al. Reliability and validity of the Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life instrument. Lung Cancer 1995; 12:199-220.
16. Cella D, Eton DT, Fairclough DL, et al. What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 2002; 55:285-295.
17. Kris MG, Natale RB, Herbst RS, et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA 2003; 290:2149-2158.
18. Cella D, Herbst RS, Lynch TJ, et al. Clinically meaningful improvement in symptoms and quality of life for patients with non-small-cell lung cancer receiving gefitinib in a randomized controlled trial. J Clin Oncol 2005; 23:2946-2954.
19. 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.
20. Hollen PJ, Gralla RJ, Kris MG, et al. Quality of life during clinical trials: conceptual model for the Lung Cancer Symptom Scale (LCSS). Support Care Cancer 1994; 2:213-222.
21. Hollen PJ, Gralla RJ, Kris MG, et al. Measurement of quality of life in patients with lung cancer in multi-center trials of new therapies. Psychometric assessment of the Lung Cancer Symptom Scale. Cancer 1994; 73:2087-2098.
22. 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.
23. Bailey AJ, Parmer MK, Stephens RJ. Patient-reported short-term and long-term physical and psychologic symptoms: results of the continuous hyperfiractionated accelerated radiotherapy (CHART) randomized trial in non-small-cell lung cancer. J Clin Oncol 1998; 16:3082-3093.
24. Ranson M, Davidson N, Nicolson M, et al. Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 2000; 92:1074-1080.
25. Moorey S, Greer S, Watson M, et al. The factor structure and factor stability of the hospital anxiety and depression scale in patients with cancer. Br J Psychiatry 1991; 158:255-259.
26. Hopwood P, Stephens RJ. Depression in patients with lung cancer: prevalence and risk factors derived from quality-of-life data. J Clin Oncol 2000; 18:893-903.
27. Cella D, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 1993; 11:570-579.
28. Fukuoka M, Yano S, Giaccone G, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial). J Clin Oncol 2003; 21:2237-2246.
29. Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005; 366:1527-1537.
30. Spigel DR, Hainsworth JD, Burkett ER, et al. Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a Minnie Pearl Cancer Research Network phase II trial. Clin Lung Cancer 2005; 7:127-132.
31. Heymach JV, Johnson DH, Khuri FR, et al. Phase II study of the farnesyl transferase inhibitor R115777 in patients with sensitive relapse small-cell lung cancer. Ann Oncol 2004; 15:1187-1193.
32. de Haes JC, van Knippenberg FC, Neijt JP. Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br J Cancer 1990; 62:1034-1038.
33. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983; 67:361-370.
34. Caponigro F, Basile M, de Rosa V, et al. New drugs in cancer therapy, National Tumor Institute, Naples, 17-18 June 2004. Anticancer Drugs 2005; 16:211-221.
35. Perrone F, Di Maio M, Budillon A, et al. Targeted therapies and non-small cell lung cancer: methodological and conceptual challenge for clinical trials. Curr Opin Oncol 2005; 17:123-129.
36. Silvestri GA, Rivera MP. Targeted therapy for the treatment of advanced non-small cell lung cancer. Chest 2005; 128:3975-3984.
37. Rosen LS. VEGF-targeted therapy: therapeutic potential and recent advances. Oncologist 2005; 10:382-391.
38. Herbst RS, Prager D, Hermann R, et al. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 2005; 23:5892-5899.
39. Herbst RS, Giaccone G, Schiller JH, et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 2. J Clin Oncol 2004; 22:785-794.
40. Giaccone G, Herbst RS, Manegold C, et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1. J Clin Oncol 2004; 22:777-784.
41. Lee DH, Han JY, Lee HG, et al. Gefitinib as a first-line therapy of advanced or metastatic adenocarcinoma of the lung in never-smokers. Clin Cancer Res 2005; 11:3032-3037.
42. Johnson DH, Fehrenbacher L, Novotny WF, et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2004; 22:2184-2191.
43. Reid T, Valone F, Lipera W, et al. Phase II trial of the histone deacetylase inhibitor pivaloyloxymethyl butyrate (Pivanex, AN-9) in advanced non-small cell lung cancer. Lung Cancer 2004; 45:381-386.
44. Adjei AA, Mauer A, Bruzek L, et al. Phase II study of the farnesyl transferase inhibitor R115777 in patients with advanced non-small-cell lung cancer. J Clin Oncol 2003; 21:1760-1766.
45. Cella D. Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System - Version 4. Center on Outcomes, Research & Education (CORE), Evanston Northwestern Healthcare, Evanston, IL, 1997.
46. Ribaudo JM, Cella D, Hahn EA, et al. Re-validation and shortening of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Qual Life Res 2000; 9:1137-1146.
47. Yellen SB, Cella DF, Webster K, et al. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage 1997; 13:63-74.
48. Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol 1997; 34:13-19.
49. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain 1975; 1:277-299.
50. Cleeland C. Measurement of pain by subjective report. In: Chapman C, Loeser J, eds. Advances in Pain Research and Therapy. New York, NY: Raven Press, 1989:391-403.
51. Anderson RT, Rajagopalan R. Development and validation of a quality of life instrument for cutaneous diseases. J Am Acad Dermatol 1997; 37:41-50.
52. Motley RJ, Finlay AY. How much disability is caused by acne? Clin Exp Dermatol 1989; 14:194-198.
53. Morgan M, McCreedy R, Simpson J, et al. Dermatology quality of life scales-a measure of the impact of skin diseases. Br J Dermatol 1997; 136:202-206.
54. Clowes JA, Peel NF, Eastell R. The impact of monitoring on adherence and persistence with antiresorptive treatment for postmenopausal osteoporosis: a randomized controlled trial. J Clin Endocrinol Metab 2004; 89:1117-1123.
55. Waterhouse DM, Calzone KA, Mele C, et al. Adherence to oral tamoxifen: a comparison of patient self-report, pill counts, and microelectronic monitoring. J Clin Oncol 1993; 11:1189-1197.
56. Grunfeld EA, Hunter MS, Sikka P, et al. Adherence beliefs among breast cancer patients taking tamoxifen. Patient Educ Couns 2005; 59:97-102.
57. Fink AK, Gurwitz J, Rakowski W, et al. Patient beliefs and tamoxifen discontinuance in older women with estrogen receptor-positive breast cancer. J Clin Oncol 2004; 22:3309-3315.
58. Perneger TV, Kossovsky MP, Cathieni F, et al. A randomized trial of four patient satisfaction questionnaires. Med Care 2003; 41:1343-1352.
59. Castle NG, Engberg J. Response formats and satisfaction surveys for elders. Gerontologist 2004; 44:358-367.
60. Nadler E, Eckert B, Neumann PJ. Do oncologists believe new cancer drugs offer good value? Oncologist 2006; 11:90-95.
61. Herper M. Cancer's cost crisis. Forbes.com. Available at http://www.forbes.com/technology/2004/06/08/cx_mh_0608costs.html. Accessed April 7, 2006.
62. Ritter J. Cancer drugs can top $100,000 a year. Chicago Sun-Times. Available at http://www.suntimes.com/output/health/cst-nws-cost19.html. Accessed April 7, 2006.
63. Donn J. Costly drugs force life-death decisions. Boston Globe. Available at http://www.boston.com/news/local/massachusetts/articles/2006/08/12/ costly_drugs_force_lifedeath_decisions.html. Accessed August 12, 2006.
64. Fairclough DL, Peterson HF, Chang V. Why are missing quality of life data a problem in clinical trials of cancer therapy? Star Med 1998; 17:667-677.
65. Sneeuw KC, Sprangers MA, Aaronson NK. The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease. J Clin Epidemiol 2002; 55:1130-1143.