Weekly docetaxel versus CMF as adjuvant chemotherapy for older women with early breast cancer: Final results of the randomized phase III ELDA trial

Annals of Oncology

Volumn 26, Issue 4, 2015, Pages 675-682

  Perrone, F ^a   Nuzzo, F ^a   Di Rella, F ^a   Gravina, A ^a   Iodice, G ^a   Labonia, V ^a   Landi, G ^a   Pacilio, C ^a   Rossi, E ^a   De Laurentiis, M ^a   D'Aiuto, M ^a   Botti, G ^a   Forestieri, V ^b   Lauria, R ^b   De Placido, S ^b   Tinessa, V ^c   Daniele, B ^c   Gori, S ^d   Colantuoni, G ^e   Barni, S ^f   Riccardi, F ^g   De Maio, E ^a   Montanino, A ^a   Morabito, A ^a   Daniele, G ^a   Di Maio, M ^a   Piccirillo, M C ^a   Signoriello, S ^h   Gallo, C ^h   De Matteis, A ^a   more..

^a NATIONAL CANCER INSTITUTE   (Italy)

^b UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^c G RUMMO HOSPITAL   (Italy)

^d Ospedale Silvestrini   (Italy)

^e S G MOSCATI HOSPITAL   (Italy)

^f TREVIGLIO HOSPITAL   (Italy)

^g CARDARELLI HOSPITAL   (Italy)

^h SECOND UNIVERSITY OF NAPLES   (Italy)

Author keywords

Adjuvant; Breast cancer; CMF; Docetaxel; Elderly; Randomized phase III trial

Indexed keywords

CYCLOPHOSPHAMIDE; DOCETAXEL; FLUOROURACIL; METHOTREXATE; ANTINEOPLASTIC AGENT; TAXOID;

ABDOMINAL PAIN; ADJUVANT THERAPY; AGED; AGING; ALLERGY; ANEMIA; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER MORTALITY; CARDIOTOXICITY; COMORBIDITY; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAIR LOSS; HEMATOLOGIC DISEASE; HUMAN; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SKIN TOXICITY; THROMBOCYTOPENIA; TREATMENT OUTCOME; ADJUVANT CHEMOTHERAPY; BREAST NEOPLASMS; CANCER GRADING; CANCER STAGING; CARCINOMA, DUCTAL, BREAST; CARCINOMA, LOBULAR; CLINICAL TRIAL; COMPARATIVE STUDY; FOLLOW UP; MORTALITY; PATHOLOGY; PROGNOSIS; SURVIVAL RATE; TUMOR RECURRENCE;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CARCINOMA, DUCTAL, BREAST; CARCINOMA, LOBULAR; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; FEMALE; FLUOROURACIL; FOLLOW-UP STUDIES; HUMANS; METHOTREXATE; NEOPLASM GRADING; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROGNOSIS; SURVIVAL RATE; TAXOIDS;

EID: 84926506156     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu564     Document Type: Article

References (29)

1. American Cancer Society. Cancer Facts & Figures 2014. Atlanta: American Cancer Society 2014.
2. Kemeny MM, Peterson BL, Kornblith AB et al. Barriers to clinical trial participation by older women with breast cancer. J Clin Oncol 2003; 21: 2268-2275.
3. Biganzoli L, Goldhirsch A, Straehle C et al. Adjuvant chemotherapy in elderly patients with breast cancer: a survey of the Breast International Group (BIG). Ann Oncol 2004; 15: 207-210.
4. Brunello A, Basso U, Pogliani C et al. Adjuvant chemotherapy for elderly patients (> or =70 years) with early high-risk breast cancer: a retrospective analysis of 260 patients. Ann Oncol 2005; 16: 1276-1282.
5. Crivellari D, Bonetti M, Castiglione-Gertsch M et al. Burdens and benefits of adjuvant cyclophosphamide, methotrexate, and fluorouracil and tamoxifen for elderly patients with breast cancer: the International Breast Cancer Study Group Trial VII. J Clin Oncol 2000; 18: 1412-1422.
6. De Maio E, Gravina A, Pacilio C et al. Compliance and toxicity of adjuvant CMF in elderly breast cancer patients: a single-center experience. BMC Cancer 2005; 5: 30.
7. Early Breast Cancer Trialists' Collaborative Group, Peto R, Davies C et al. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet 2012; 379: 432-444.
8. Valero V, Holmes FA, Walters RS et al. Phase II trial of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracyclineresistant metastatic breast cancer. J Clin Oncol 1995; 13: 2886-2894.
9. Jones SE, Savin MA, Holmes FA et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol 2006; 24: 5381-5387.
10. Martin M, Pienkowski T, Mackey J et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 2005; 352: 2302-2313.
11. Roche H, Fumoleau P, Spielmann M et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol 2006; 24: 5664-5671.
12. Burstein HJ, Manola J, Younger J et al. Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 2000; 18: 1212-1219.
13. Hainsworth JD, Burris HA, III, Yardley DA et al. Weekly docetaxel in the treatment of elderly patients with advanced breast cancer: a Minnie Pearl Cancer Research Network phase II trial. J Clin Oncol 2001; 19: 3500-3505.
14. Goldhirsch A, Glick JH, Gelber RD et al. Meeting highlights: international consensus panel on the treatment of primary breast cancer. Seventh international conference on adjuvant therapy of primary breast cancer. J Clin Oncol 2001; 19: 3817-3827.
15. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987; 40: 373-383.
16. Katz S. Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc 1983; 31: 721-727.
17. Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969; 9: 179-186.
18. Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005; 353:1659-1672.
19. DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med 1994; 13: 1341-1352. discussion 1353-1346.
20. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35: 549-556.
21. Biganzoli L, Wildiers H, Oakman C et al. Management of elderly patients with breast cancer: updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA). Lancet Oncol 2012; 13: e148-e160.
22. Sparano JA, Wang M, Martino S et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 2008; 358: 1663-1671.
23. Del Mastro L, Perrone F, Repetto L et al. Weekly paclitaxel as first-line chemotherapy in elderly advanced breast cancer patients: a phase II study of the Gruppo Italiano di Oncologia Geriatrica (GIOGer). Ann Oncol 2005; 16: 253-258.
24. Crivellari D, Gray KP, Dellapasqua S et al. Adjuvant pegylated liposomal doxorubicin for older women with endocrine nonresponsive breast cancer who are NOT suitable for a "standard chemotherapy regimen": the CASA randomized trial. Breast 2013; 22: 130-137.
25. Leonard R, Ballinger R, Cameron D et al. Adjuvant chemotherapy in older women (ACTION) study-what did we learn from the pilot phase? Br J Cancer 2011; 105:1260-1266.
26. Muss HB, Berry DA, Cirrincione CT et al. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med 2009; 360: 2055-2065.
27. Kornblith AB, Lan L, Archer L et al. Quality of life of older patients with early-stage breast cancer receiving adjuvant chemotherapy: a companion study to cancer and leukemia group B 49907. J Clin Oncol 2011; 29: 1022-1028.
28. Extermann M, Boler I, Reich RR et al. Predicting the risk of chemotherapy toxicity in older patients: the Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score. Cancer 2012; 118: 3377-3386.
29. Hurria A, Togawa K, Mohile SG et al. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol 2011; 29: 3457-3465.