Assessment of quality of life in advanced breast cancer. An overview of randomized phase III trials

Cancer Treatment Reviews

Volumn 38, Issue 5, 2012, Pages 554-558

  Adamowicz, Krzysztof ^a   Jassem, Jacek ^b   Katz, Artur ^c   Saad, Everardo D ^d  

^a Regional Oncology Center of Gdansk   (Poland)

^b MEDICAL UNIVERSITY OF GDANSK   (Poland)

^c HOSPITAL SÍRIO LIBANÊS   (Brazil)

^d Dendrix Research   (Brazil)

Author keywords

Breast neoplasms; Drug therapy; Quality of life

Indexed keywords

ANASTROZOLE; BEVACIZUMAB; CAPECITABINE; CARBOPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; EXEMESTANE; FLUOROURACIL; FULVESTRANT; GEMCITABINE; LETROZOLE; MEGESTROL ACETATE; MITOMYCIN C; MITOXANTRONE; NAVELBINE; PACLITAXEL; TAMOXIFEN; TESMILIFENE; VINBLASTINE; VOROZOLE;

BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER HORMONE THERAPY; CANCER PROGNOSIS; DRUG DOSE COMPARISON; HUMAN; MEDLINE; PHASE 3 CLINICAL TRIAL (TOPIC); QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SCORING SYSTEM; SYSTEMIC THERAPY;

ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CLINICAL TRIALS, PHASE III AS TOPIC; FEMALE; HUMANS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84861187971     PISSN: 03057372     EISSN: 15321967     Source Type: Journal    
DOI: 10.1016/j.ctrv.2011.07.002     Document Type: Review

References (59)

1. Garcia M., Jemal A., Ward E.M., et al. Global cancer facts & figures 2007 2007, American Cancer Society, Atlanta, GA.
2. Berry D.A., Cronin K.A., Plevritis S.K., et al. Effect of screening and adjuvant therapy on mortality from breast cancer. N Engl J Med 2005, 353:1784-1792.
3. Hortobagyi G.N. Treatment of breast cancer. N Engl J Med 1998, 339:974-984.
4. Bernard-Marty C., Cardoso F., Piccart M.J. Facts and controversies in systemic treatment of metastatic breast cancer. Oncologist 2004, 9:617-632.
5. Saad E.D., Katz A., Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol 2010, 28:1958-1962.
6. Smith I. Goals of treatment for patients with metastatic breast cancer. Semin Oncol 2006, 33:2-5.
7. Greenfield S., Nelson E.C. Recent developments and future issues in the use of health status assessment measures in clinical settings. Med Care 1992, 30:23-41.
8. Michael M., Tannock I.F. Measuring health-related quality of life in clinical trials that evaluate the role of chemotherapy in cancer treatment. CMAJ 1998, 158:1727-1734.
9. Goodwin P.J., Black J.T., Bordeleau L.J., Ganz P.A. Health-related quality-of-life measurement in randomized clinical trials in breast cancer-taking stock. J Natl Cancer Inst 2003, 95:263-281.
10. Minasian L.M., O'Mara A.M., Reeve B.B., et al. Health-related quality of life and symptom management research sponsored by the National Cancer Institute. J Clin Oncol 2007, 25:5128-5132.
11. Bottomley A., Aaronson N.K. International perspective on health-related quality-of-life research in cancer clinical trials: the European Organisation for Research and Treatment of Cancer experience. J Clin Oncol 2007, 25:5082-5086.
12. Bottomley A., Therasse P. Quality of life in patients undergoing systemic therapy for advanced breast cancer. Lancet Oncol 2002, 3:620-628.
13. Mandelblatt J., Armetta C., Yabroff K.R., Liang W., Lawrence W. Descriptive review of the literature on breast cancer outcomes: 1990 through 2000. J Natl Cancer Inst Monogr 1990, 2004:8-44.
14. Montazeri A. Health-related quality of life in breast cancer patients: a bibliographic review of the literature from 1974 to 2007. J Exp Clin Cancer Res 2008, 27:32.
15. Saad E.D., Katz A. Progression-free survival and time to progression as primary end points in advanced breast cancer: often used, sometimes loosely defined. Ann Oncol 2009, 20:460-464.
16. Pacini P., Rinaldini M., Algeri R., et al. FEC (5-fluorouracil, epidoxorubicin and cyclophosphamide) versus EM (epidoxorubicin and mitomycin-C) with or without lonidamine as first-line treatment for advanced breast cancer. A multicentric randomised study. Final results. Eur J Cancer 2000, 36:966-975.
17. Berruti A., Bitossi R., Gorzegno G., et al. Time to progression in metastatic breast cancer patients treated with epirubicin is not improved by the addition of either cisplatin or lonidamine: final results of a phase III study with a factorial design. J Clin Oncol 2002, 20:4150-4159.
18. Seidman A.D., Berry D., Cirrincione C., et al. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol 2008, 26:1642-1649.
19. Chan S., Romieu G., Huober J., et al. Phase III study of gemcitabine plus docetaxel compared with capecitabine plus docetaxel for anthracycline-pretreated patients with metastatic breast cancer. J Clin Oncol 2009, 27:1753-1760.
20. Albain K.S., Nag S.M., Calderillo-Ruiz G., et al. Gemcitabine plus Paclitaxel versus Paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 2008, 26:3950-3957.
21. Chia S., Gradishar W., Mauriac L., et al. Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT. J Clin Oncol 2008, 26:1664-1670.
22. Cassier P.A., Chabaud S., Trillet-Lenoir V., et al. A phase-III trial of doxorubicin and docetaxel versus doxorubicin and paclitaxel in metastatic breast cancer: results of the ERASME 3 study. Breast Cancer Res Treat 2008, 109:343-350.
23. Miller K., Wang M., Gralow J., et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007, 357:2666-2676.
24. Gennari A., Amadori D., De Lena M., et al. Lack of benefit of maintenance paclitaxel in first-line chemotherapy in metastatic breast cancer. J Clin Oncol 2006, 24:3912-3918.
25. Gradishar W.J., Tjulandin S., Davidson N., et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005, 23:7794-7803.
26. Jones S.E., Erban J., Overmoyer B., et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 2005, 23:5542-5551.
27. Feher O., Vodvarka P., Jassem J., et al. First-line gemcitabine versus epirubicin in postmenopausal women aged 60 or older with metastatic breast cancer: a multicenter, randomized, phase III study. Ann Oncol 2005, 16:899-908.
28. Miller K.D., Chap L.I., Holmes F.A., et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005, 23:792-799.
29. Keller A.M., Mennel R.G., Georgoulias V.A., et al. Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer. J Clin Oncol 2004, 22:3893-3901.
30. Fountzilas G., Kalofonos H.P., Dafni U., et al. Paclitaxel and epirubicin versus paclitaxel and carboplatin as first-line chemotherapy in patients with advanced breast cancer: a phase III study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol 2004, 15:1517-1526.
31. Conte P.F., Guarneri V., Bruzzi P., et al. Concomitant versus sequential administration of epirubicin and paclitaxel as first-line therapy in metastatic breast carcinoma: results for the Gruppo Oncologico Nord Ovest randomized trial. Cancer 2004, 101:704-712.
32. Winer E.P., Berry D.A., Woolf S., et al. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol 2004, 22:2061-2068.
33. Howell A., Pippen J., Elledge R.M., et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials. Cancer 2005, 104:236-239.
34. Reyno L., Seymour L., Tu D., et al. Phase III study of N,N-diethyl-2-[4-(phenylmethyl) phenoxy]ethanamine (BMS-217380-01) combined with doxorubicin versus doxorubicin alone in metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA.19. J Clin Oncol 2004, 22:269-276.
35. Nabholtz J.M., Falkson C., Campos D., et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol 2003, 21:968-975.
36. Sledge G.W., Neuberg D., Bernardo P., et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 2003, 21:588-592.
37. Heidemann E., Stoeger H., Souchon R., et al. Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial. Ann Oncol 2002, 13:1717-1729.
38. Howell A., Robertson J.F., Quaresma Albano J., et al. Fulvestrant, formerly ICI 182, 780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol 2002, 20:3396-3403.
39. Osborne C.K., Pippen J., Jones S.E., et al. Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol 2002, 20:3386-3395.
40. O'Shaughnessy J., Miles D., Vukelja S., et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002, 20:2812-2823.
41. Buzdar A., Douma J., Davidson N., et al. Phase III, multicenter, double-blind, randomized study of letrozole, an aromatase inhibitor, for advanced breast cancer versus megestrol acetate. J Clin Oncol 2001, 19:3357-3366.
42. Jassem J., Pienkowski T., Pluzanska A., et al. Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trial. J Clin Oncol 2001, 19:1707-1715.
43. Norris B., Pritchard K.I., James K., et al. Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA8. J Clin Oncol 2000, 18:2385-2394.
44. Kaufmann M., Bajetta E., Dirix L.Y., et al. Exemestane is superior to megestrol acetate after tamoxifen failure in postmenopausal women with advanced breast cancer: results of a phase III randomized double-blind trial. The Exemestane Study Group. J Clin Oncol 2000, 18:1399-1411.
45. Paridaens R., Biganzoli L., Bruning P., et al. Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer Randomized Study with cross-over. J Clin Oncol 2000, 18:724-733.
46. Bishop J.F., Dewar J., Toner G.C., et al. Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer. J Clin Oncol 1999, 17:2355-2364.
47. Chan S., Friedrichs K., Noel D., et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999, 17:2341-2354.
48. Goss P.E., Winer E.P., Tannock I.F., Schwartz L.H. Randomized phase III trial comparing the new potent and selective third-generation aromatase inhibitor vorozole with megestrol acetate in postmenopausal advanced breast cancer patients. North American Vorozole Study Group. J Clin Oncol 1999, 17:52-63.
49. Nabholtz J.M., Senn H.J., Bezwoda W.R., et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group. J Clin Oncol 1999, 17:1413-1424.
50. Joensuu H., Holli K., Heikkinen M., et al. Combination chemotherapy versus single-agent therapy as first- and second-line treatment in metastatic breast cancer: a prospective randomized trial. J Clin Oncol 1998, 16:3720-3730.
51. Pierga J.Y., Jouve M., Asselain B., et al. Randomized trial comparing protracted infusion of 5-fluorouracil with weekly doxorubicin and cyclophosphamide with a monthly bolus FAC regimen in metastatic breast carcinoma (SPM90). Br J Cancer 1998, 77:1474-1479.
52. Dombernowsky P., Smith I., Falkson G., et al. Letrozole, a new oral aromatase inhibitor for advanced breast cancer: double-blind randomized trial showing a dose effect and improved efficacy and tolerability compared with megestrol acetate. J Clin Oncol 1998, 16:453-461.
53. Bottomley A., Biganzoli L., Cufer T., et al. Randomized, controlled trial investigating short-term health-related quality of life with doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: European Organization for Research and Treatment of Cancer Breast Cancer Group, Investigational Drug Branch for Breast Cancer and the New Drug Development Group Study. J Clin Oncol 2004, 22:2576-2586.
54. Coates A., Gebski V., Signorini D., et al. Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer. Australian New Zealand Breast Cancer Trials Group. J Clin Oncol 1992, 10:1833-1838.
55. Dancey J., Zee B., Osoba D., et al. Quality of life scores: an independent prognostic variable in a general population of cancer patients receiving chemotherapy. The National Cancer Institute of Canada Clinical Trials Group. Qual Life Res 1997, 6:151-158.
56. Coates A.S., Hurny C., Peterson H.F., et al. Quality-of-life scores predict outcome in metastatic but not early breast cancer. International Breast Cancer Study Group. J Clin Oncol 2000, 18:3768-3774.
57. Montazeri A. Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008. Health Qual Life Outcomes 2009, 7:102.
58. Liu J., Tu D., Dancey J., et al. Quality of life analyses in a clinical trial of DPPE (tesmilifene) plus doxorubicin versus doxorubicin in patients with advanced or metastatic breast cancer: NCIC CTG Trial MA.19. Breast Cancer Res Treat 2006, 100:263-271.
59. Biganzoli L., Cufer T., Bruning P., et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 Multicenter Phase III Trial. J Clin Oncol 2002, 20:3114-3121.