Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): A combined analysis of two phase 3 randomised trials

The Lancet Oncology

Volumn 16, Issue 7, 2015, Pages 848-858

  Bernhard, Jürg ^a   Luo, Weixiu ^b   Ribi, Karin ^c   Colleoni, Marco ^d   Burstein, Harold J ^b   Tondini, Carlo ^e   Pinotti, Graziella ^f   Spazzapan, Simon ^g   Ruhstaller, Thomas ^h   Puglisi, Fabio ⁱ   Pavesi, Lorenzo ^j   Parmar, Vani ^k   Regan, Meredith M ^l   Pagani, Olivia ^m   Fleming, Gini F ⁿ   Francis, Prudence A ^o,t   Price, Karen N ^p   Coates, Alan S ^q   Gelber, Richard D ^p   Goldhirsch, Aron ^d,r   Walley, Barbara A ^s   more..

^a UNIVERSITY OF BERN   (Switzerland)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c International Breast Cancer Study Group Coordinating Center   (Switzerland)

^d EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^e PAPA GIOVANNI XXIII HOSPITAL   (Italy)

^f OSPEDALE DI CIRCOLO   (Italy)

^g CENTRO DI RIFERIMENTO ONCOLOGICO   (Italy)

^h CANTONAL HOSPITAL ST GALLEN   (Switzerland)

ⁱ UNIVERSITY HOSPITAL OF UDINE   (Italy)

^j IRCCS   (Italy)

^k TATA MEMORIAL HOSPITAL   (India)

^l HARVARD MEDICAL SCHOOL   (United States)

^m ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND   (Switzerland)

ⁿ UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^o UNIVERSITY OF MELBOURNE   (Australia)

^p FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^q UNIVERSITY OF SYDNEY   (Australia)

^r International Breast Cancer Study Group   (Switzerland)

^s Clinical Trials Group   (Canada)

^t NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

EXEMESTANE; TAMOXIFEN; TRIPTORELIN; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS;

ADULT; ANTIANDROGEN THERAPY; ARTHRALGIA; ARTICLE; BONE PAIN; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER HORMONE THERAPY; CANCER RADIOTHERAPY; CONTROLLED STUDY; EARLY CANCER; FEMALE; HOT FLUSH; HUMAN; LIBIDO DISORDER; MAJOR CLINICAL STUDY; OVARIECTOMY; PHASE 3 CLINICAL TRIAL; PREMENOPAUSE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SEXUAL AROUSAL DISORDER; SWEATING; TREATMENT OUTCOME; VAGINAL DRYNESS; ADJUVANT CHEMOTHERAPY; BREAST NEOPLASMS; CANCER STAGING; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECTS; EARLY DIAGNOSIS; FOLLOW UP; MIDDLE AGED; MORTALITY; ORAL DRUG ADMINISTRATION; OVARY; PATHOLOGY; PHYSIOLOGY; RISK ASSESSMENT; SURVIVAL; TUMOR INVASION;

ADMINISTRATION, ORAL; ADULT; ANTINEOPLASTIC AGENTS, HORMONAL; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; EARLY DETECTION OF CANCER; FEMALE; FOLLOW-UP STUDIES; HUMANS; MIDDLE AGED; NEOPLASM INVASIVENESS; NEOPLASM STAGING; OVARY; PREMENOPAUSE; QUALITY OF LIFE; RISK ASSESSMENT; SELF REPORT; SURVIVAL ANALYSIS; TAMOXIFEN; TREATMENT OUTCOME;

EID: 84937513028     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)00049-2     Document Type: Article

References (29)

1. Pagani O, Regan MM, Walley BA, et al. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med 2014, 371:107-118.
2. Regan MM, Pagani O, Fleming GF, et al. Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast 2013, 22:1094-1100.
3. Fallowfield L, Cella D, Cuzick J, Francis S, Locker G, Howell A Quality of life of postmenopausal women in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial. J Clin Oncol 2004, 22:4261-4271.
4. Cella D, Fallowfield L, Barker P, et al. Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast Cancer Res Treat 2006, 100:273-284.
5. Fallowfield LJ, Bliss JM, Porter LS, et al. Quality of life in the Intergroup Exemestane Study: a randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer. J Clin Oncol 2006, 24:910-917.
6. Day R, Ganz PA, Costantino JP, Cronin WM, Wickerham DL, Fisher B Health-related quality of life and tamoxifen in breast cancer prevention: a report from the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Clin Oncol 1999, 17:2659-2669.
7. Fallowfield L, Fleissig A, Edwards R, et al. Tamoxifen for the prevention of breast cancer: psychosocial impact on women participating in two randomized controlled trials. J Clin Oncol 2001, 19:1885-1892.
8. Goss PE, Ingle JN, Ales-Martinez JE, et al. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med 2011, 364:2381-2391.
9. Maunsell E, Goss PE, Chlebowski RT, et al. Quality of life in MAP.3 (Mammary Prevention 3): a randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. J Clin Oncol 2014, 32:1427-1436.
10. Nystedt M, Berglund G, Bolund C, Fornander T, Rutqvist LE Side effects of adjuvant endocrine treatment in premenopausal breast cancer patients: a prospective randomized study. J Clin Oncol 2003, 21:1836-1844.
11. Bernhard J, Hurny C, Coates AS, et al. Quality of life assessment in patients receiving adjuvant therapy for breast cancer: the IBCSG approach. The International Breast Cancer Study Group. Ann Oncol 1997, 8:825-835.
12. Butow P, Coates A, Dunn S, Bernhard J, Hurny C On the receiving end. IV: Validation of quality of life indicators. Ann Oncol 1991, 2:597-603.
13. Hurny C, Bernhard J, Coates A, et al. Responsiveness of a single-item indicator versus a multi-item scale: assessment of emotional well-being in an international adjuvant breast cancer trial. Med Care 1996, 34:234-248.
14. Hurny C, Bernhard J, Bacchi M, et al. The Perceived Adjustment to Chronic Illness Scale (PACIS): a global indicator of coping for operable breast cancer patients in clinical trials. Swiss Group for Clinical Cancer Research (SAKK) and the International Breast Cancer Study Group (IBCSG). Support Care Cancer 1993, 1:200-208.
15. Hurny C, van Wegberg B, Bacchi M, et al. Subjective health estimations (SHE) in patients with advanced breast cancer: an adapted utility concept for clinical trials. Br J Cancer 1998, 77:985-991.
16. Bernhard J, Sullivan M, Hurny C, Coates AS, Rudenstam CM Clinical relevance of single item quality of life indicators in cancer clinical trials. Br J Cancer 2001, 84:1156-1165.
17. Bernhard J, Maibach R, Thurlimann B, Sessa C, Aapro MS Patients' estimation of overall treatment burden: why not ask the obvious?. J Clin Oncol 2002, 20:65-72. Swiss Group for Clinical Cancer Research.
18. Ganz PA, Day R, Ware JE, Redmond C, Fisher B Base-line quality-of-life assessment in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial. J Natl Cancer Inst 1995, 87:1372-1382.
19. Greendale GA, Reboussin BA, Hogan P, et al. Symptom relief and side effects of postmenopausal hormones: results from the Postmenopausal Estrogen/Progestin Interventions Trial. Obstet Gynecol 1998, 92:982-988.
20. Alfano CM, McGregor BA, Kuniyuki A, et al. Psychometric properties of a tool for measuring hormone-related symptoms in breast cancer survivors. Psychooncology 2006, 15:985-1000.
21. Radloff LS The CES-D Scale: a self-reported depression scale for research in the general population. Appl Psychol Meas 1977, 1:385-401.
22. Sherbourne CD Social functioning: sexual problems measures. Measuring functioning and well-being: the Medical Outcomes Study approach 1992, 194-204. Duke University Press, Durham NC. A.L. Stewart, J.E. Ware (Eds.).
23. Sloan JA, Dueck A Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials. J Biopharm Stat 2004, 14:73-96.
24. Duric VM, Fallowfield LJ, Saunders C, Houghton J, Coates AS, Stockler MR Patients' preferences for adjuvant endocrine therapy in early breast cancer: what makes it worthwhile?. Br J Cancer 2005, 93:1319-1323.
25. Thewes B, Meiser B, Duric VM, et al. What survival benefits do premenopausal patients with early breast cancer need to make endocrine therapy worthwhile?. Lancet Oncol 2005, 6:581-588.
26. Hickey M, Saunders CM, Stuckey BGA Management of menopausal symptoms in patients with breast cancer: an evidence-based approach. Lancet Oncol 2005, 6:687-695.
27. Drewe J, Bucher KA, Zahner C A systematic review of non-hormonal treatments of vasomotor symptoms in climacteric and cancer patients. Springerplus 2015, 4:65.
28. de Haes H, Olschewski M, Kaufmann M, et al. Quality of life in goserelin-treated versus cyclophosphamide + methotrexate + fluorouracil-treated premenopausal and perimenopausal patients with node-positive, early breast cancer: the Zoladex Early Breast Cancer Research Association Trialists Group. J Clin Oncol 2003, 21:4510-4516.
29. Bernhard J, Zahrieh D, Castiglione-Gertsch M, et al. Adjuvant chemotherapy followed by goserelin compared with either modality alone: the impact on amenorrhea, hot flashes, and quality of life in premenopausal patients-the International Breast Cancer Study Group Trial VIII. J Clin Oncol 2007, 25:263-270.