Specific adverse events predict survival benefit in patients treated with tamoxifen or aromatase inhibitors: An international tamoxifen exemestane adjuvant multinational trial analysis

Journal of Clinical Oncology

Volumn 31, Issue 18, 2013, Pages 2257-2264

  Fontein, Duveken B Y ^a   Seynaeve, Caroline ^b   Hadji, Peyman ^c   Hille, Elysée T M ^a   Van De Water, Willemien ^a   Putter, Hein ^a   Kranenbarg, Elma Meershoek Klein ^a   Hasenburg, Annette ^d   Paridaens, Robert J ^e   Vannetzel, Jean Michel ^f   Markopoulos, Christos ^g   Hozumi, Yasuo ^h   Bartlett, John M S ⁱ   Jones, Stephen E ^k   Rea, Daniel William ^j   Nortier, Johan W R ^a   Van De Velde, Cornelis J H ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c PHILIPPS UNIVERSITY MARBURG   (Germany)

^d UNIVERSITY OF FREIBURG   (Germany)

^e UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^f Institut du Sein Henri Hartmann (ISHH)   (France)

^g UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^h JICHI MEDICAL UNIVERSITY   (Japan)

ⁱ UNIVERSITY OF EDINBURGH   (United Kingdom)

^j UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^k US Oncology Research   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

EXEMESTANE; TAMOXIFEN; ANDROSTANE DERIVATIVE; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; AROMATASE INHIBITOR;

ADJUVANT THERAPY; ADULT; ARTHRALGIA; ARTHRITIS; ARTICLE; BONE PAIN; BREAST CANCER; CANCER SURVIVAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DISTANT METASTASIS; DRUG EFFICACY; DRUG WITHDRAWAL; DYSPAREUNIA; ENDOMETRIAL DISEASE; FEMALE; HOT FLUSH; HUMAN; LIBIDO DISORDER; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; MYALGIA; NIGHT SWEAT; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VAGINA DISCHARGE; VAGINAL DRYNESS; VAGINAL PRURITUS; VASOMOTOR DISORDER; VULVOVAGINAL DISEASE; ADJUVANT CHEMOTHERAPY; ADRENERGIC SYSTEM; AGED; BREAST TUMOR; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; FOLLOW UP; GYNECOLOGIC DISEASE; INTERNATIONAL COOPERATION; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY (TOPIC); PATHOLOGY; PHASE 3 CLINICAL TRIAL (TOPIC); PROGNOSIS; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICS; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANDROSTADIENES; ANTINEOPLASTIC AGENTS, HORMONAL; AROMATASE INHIBITORS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS, PHASE III AS TOPIC; DISEASE-FREE SURVIVAL; FEMALE; FOLLOW-UP STUDIES; GENITAL DISEASES, FEMALE; HUMANS; INTERNATIONAL COOPERATION; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; MUSCULOSKELETAL DISEASES; OUTCOME ASSESSMENT (HEALTH CARE); PROGNOSIS; PROPORTIONAL HAZARDS MODELS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TAMOXIFEN; VASOMOTOR SYSTEM;

EID: 84883047727     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.45.3068     Document Type: Article

References (33)

1. Fisher B, Redmond C, Brown A, et al: Treatment of primary breast cancer with chemotherapy and tamoxifen. N Engl J Med 305:1-6, 1981
2. Fisher B, Costantino J, Redmond C, et al: A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med 320:479-484, 1989
3. Howell A, Cuzick J, Baum M, et al: Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet 365: 60-62, 2005
4. Breast International Group (BIG) 1-98 Collaborative Group, Thürlimann B, Keshaviah A, et al: A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med 353:2747-2757, 2005
5. Regan MM, Neven P, Giobbie-Hurder A, et al: Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: The BIG 1-98 randomised clinical trial at 8.1 years median follow-up. Lancet Oncol 12:1101-1108, 2011
6. van de Velde CJ, Rea D, Seynaeve C, et al: Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): A randomised phase 3 trial. Lancet 377:321-331, 2011
7. Coombes RC, Kilburn LS, Snowdon CF, et al: Survival and safety of exemestane versus tamoxifen after 2-3 years’ tamoxifen treatment (Intergroup Exemestane Study): A randomised controlled trial. Lancet 369:559-570, 2007
8. Burstein HJ: Aromatase inhibitor-associated arthralgia syndrome. Breast 16:223-234, 2007
9. Felson DT, Cummings SR: Aromatase inhibitors and the syndrome of arthralgias with estrogen deprivation. Arthritis Rheum 52:2594-2598, 2005
10. Hadji P, Kauka A, Bauer T, et al: Effects of exemestane and tamoxifen on hormone levels within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) Trial: Results of a German substudy. Climacteric 15:460-466, 2012
11. Stearns V, Ullmer L, López JF, et al: Hot flushes. Lancet 360:1851-1861, 2002
12. Hadji P: Menopausal symptoms and adjuvant therapy-associated adverse events. Endocr Relat Cancer 15:73-90, 2008
13. Shifren JL, Schiff I: The aging ovary. J Womens Health Gend Based Med 9:S3-S7, 2000 (suppl 1)
14. Kokolus KM, Hong CC, Repasky EA: Feeling too hot or cold after breast cancer: Is it just a nuisance or a potentially important prognostic factor? Int J Hyperthermia 26:662-680, 2010
15. Charkoudian N: Skin blood flow in adult human thermoregulation: How it works, when it does not, and why. Mayo Clin Proc 78:603-612, 2003
16. Coleman RE, Bolten WW, Lansdown M, et al: Aromatase inhibitor-induced arthralgia: Clinical experience and treatment recommendations. Cancer Treat Rev 34:275-282, 2008
17. Bertelli G, Hall E, Ireland E, et al: Long-term endometrial effects in postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES): A randomised controlled trial of exemestane versus continued tamoxifen after 2-3 years tamoxifen. Ann Oncol 21:498-505, 2010
18. Morales L, Timmerman D, Neven P, et al: Third generation aromatase inhibitors may prevent endometrial growth and reverse tamoxifen-induced uterine changes in postmenopausal breast cancer patients. Ann Oncol 16:70-74, 2005
19. Mortimer JE, Boucher L, Baty J, et al: Effect of tamoxifen on sexual functioning in patients with breast cancer. J Clin Oncol 17:1488-1492, 1999
20. Stearns V, Gelmann EP: Does tamoxifen cause cancer in humans? J Clin Oncol 16:779-792, 1998
21. Barron TI, Connolly R, Bennett K, et al: Early discontinuation of tamoxifen: A lesson for oncologists. Cancer 109:832-839, 2007
22. Chlebowski RT, Geller ML: Adherence to endocrine therapy for breast cancer. Oncology 71:1-9, 2006
23. Fontein DB, Nortier JW, Liefers GJ, et al: High non-compliance in the use of letrozole after 2.5 years of extended adjuvant endocrine therapy: Results from the IDEAL randomized trial. Eur J Surg Oncol 38:110-117, 2012
24. Hadji P: Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. Crit Rev Oncol Hematol 73:156-166, 2010
25. Partridge AH, LaFountain A, Mayer E, et al: Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol 26:556-562, 2008
26. Hershman DL, Shao T, Kushi LH, et al: Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat 126:529-537, 2011
27. Cuzick J, Sestak I, Cella D, et al: Treatment-emergent endocrine symptoms and the risk of breast cancer recurrence: A retrospective analysis of the ATAC trial. Lancet Oncol 9:1143-1148, 2008
28. Mortimer JE, Flatt SW, Parker BA, et al: Tamoxifen, hot flashes and recurrence in breast cancer. Breast Cancer Res Treat 108:421-426, 2008
29. Fontein DB, Houtsma D, Hille ET, et al: Relationship between specific adverse events and efficacy of exemestane therapy in early postmenopausal breast cancer patients. Ann Oncol 23:3091-3097, 2012
30. Huober JB, Cole BF, Wu J, et al: Symptoms of endocrine treatment and outcome: A retrospective analysis of the monotherapy arms of the BIG 1-98 trial. J Clin Oncol 29:50s, 2011 (abstr 522)
31. Stearns V, Chapman JW, Ma CX, et al: Relationship of treatment-emergent symptoms and recurrence-free survival in the NCIC CTG MA.27 adjuvant aromatase inhibitor trial. J Clin Oncol 29: 51s, 2011 (suppl; abstr 525)
32. Savard MH, Savard J, Quesnel C, et al: The influence of breast cancer treatment on the occurrence of hot flashes. J Pain Symptom Manage 37:687-697, 2009
33. Pritchard KI: Endocrine symptoms to predict risk of recurrence? Lancet Oncol 9:1117-1119, 2008