Weekly docetaxel versus CMF as adjuvant chemotherapy for elderly breast cancer patients: Safety data from the multicentre phase 3 randomised ELDA trial

Critical Reviews in Oncology/Hematology

Volumn 66, Issue 2, 2008, Pages 171-180

  Nuzzo, Francesco ^a   Morabito, Alessandro ^a   De Maio, Ermelinda ^a   Di Rella, Francesca ^a   Gravina, Adriano ^a   Labonia, Vincenzo ^a   Landi, Gabriella ^a   Pacilio, Carmen ^a   Piccirillo, Maria Carmela ^a   Rossi, Emanuela ^a   D'Aiuto, Giuseppe ^a   Thomas, Renato ^a   Gori, Stefania ^b   Colozza, Mariantonietta ^b   De Placido, Sabino ^c   Lauria, Rossella ^c   Signoriello, Giuseppe ^d   Gallo, Ciro ^d   Perrone, Francesco ^a   de Matteis, Andrea ^a  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b SANTA MARIA DELLA MISERICORDIA HOSPITAL   (Italy)

^c UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^d SECOND UNIVERSITY OF NAPLES   (Italy)

Author keywords

Adjuvant; Breast cancer; CMF; Docetaxel; Elderly; Phase 3

Indexed keywords

AROMATASE INHIBITOR; CREATININE; CYCLOPHOSPHAMIDE; DOCETAXEL; FLUOROURACIL; GRANULOCYTE COLONY STIMULATING FACTOR; METHOTREXATE; RECOMBINANT ERYTHROPOIETIN; TAMOXIFEN;

ABDOMINAL PAIN; AGED; ANEMIA; ANOREXIA; BREAST CANCER; BREAST SURGERY; CANCER ADJUVANT THERAPY; CANCER RADIOTHERAPY; CARDIOTOXICITY; CLINICAL TRIAL; COMORBIDITY; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DIARRHEA; DRUG DOSE REDUCTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; DYSURIA; ELDERLY CARE; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HAIR LOSS; HEART ARRHYTHMIA; HUMAN; INFECTION; LEUKOPENIA; LIVER TOXICITY; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALE; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NAUSEA; NEPHROTOXICITY; NEUROPATHY; NEUTROPENIA; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; SENSORY NEUROPATHY; SKIN TOXICITY; THROMBOCYTOPENIA; TREATMENT PLANNING; VOMITING;

AGE FACTORS; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HEMATOLOGIC DISEASES; HUMANS; ITALY; METHOTREXATE; PATIENT COMPLIANCE; TAXOIDS; TREATMENT OUTCOME;

EID: 41249088803     PISSN: 10408428     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.critrevonc.2007.10.006     Document Type: Review

References (26)

1. Chu C., Tarone R.E., and Kessler L.G. Recent trends in US breast cancer incidence, survival and mortality rates. J Natl Cancer Inst 88 (1996) 1571-1579
2. Early Breast Cancer Trialist' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Lancet 365 (2005) 1687-1717
3. Trimble E.L., Carter C.L., Cain D., Freidlin B., Ungerleider R.S., and Friedman M.A. Representation of older patients in cancer treatment trials. Cancer 74 (1994) 2208-2214
4. Kemeny M.M., Peterson B.L., Kornblith A.B., et al. Barriers to clinical trial participation by older women with breast cancer. J Clin Oncol 21 (2003) 2268-2275
5. Crivellari D., Aapro M., Leonard R., et al. Breast cancer in the elderly. J Clin Oncol 25 (2007) 1882-1890
6. 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 15 (2004) 207-210
7. Crivellari D., Bonetti M., Castiglione-Gertsch M., et al. Burdens and benefit of adjuvant cyclophoshamide, methotrexate, and fluorouracil and tamoxifen for elderly patients with breast cancer: the International Breast Cancer Study Group Trial VII. J Clin Oncol 18 (2000) 1412-1422
8. 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 5 (2005) 30-40
9. Valero V., Holmes F.A., Walters R.S., et al. Phase II trial of docetaxel. A new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer. J Clin Oncol 13 (1995) 2886-2894
10. Martin M., Pienkowski T., Mackey J., et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 352 (2005) 2302-2313
11. Jones S.E., Savin M.A., Holmes F.A., et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol 24 (2006) 5381-5387
12. Roché 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 24 (2006) 5664-5671
13. Wildiers H., and Paridaens R. Taxanes in elderly breast cancer patients. Cancer Treat Rev 30 (2004) 333-342
14. Hainsworth J.D., Burris III H.A., Erland J.B., Thomas M., and Greco F.A. Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer. J Clin Oncol 16 (1998) 2164-2168
15. Burstein H.J., Manola J., Younger J., et al. Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 18 (2000) 1212-1219
16. Hainsworth J.D., Burris III H.A., Yardley D.A., 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 19 (2001) 3500-3505
17. Gelman R.S., and Taylor S.G. Cyclophosphamide, methotrexate, and 5-fluorouracil chemotherapy in women more than 65 years old with advanced breast cancer: the elimination of age trends in toxicity by using doses based on creatinine clearance. J Clin Oncol 2 (1984) 1404-1413
18. Goldhirsch A., Glick G.H., Gelber R.D., Coates A.S., and Senn H.J. Meeting highlights: consensus panel on the treatment of primary breast cancer. J Clin Oncol 19 (2001) 3817-3827
19. Katz S. Assessing self maintenance: activities of daily living, mobility and instrumental activities of daily living. J Am Geriatr Soc 31 (1983) 721-727
20. Lawton M.P., and Brody E.M. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 9 (1969) 179-186
21. Colleoni M., Litman H.J., Castiglione-Gertsch M., et al. Duration of adjuvant chemotherapy for breast cancer: a joint analysis of two randomised trials investigating three versus six courses of CMF. Br J Cancer 86 (2002) 1705-1714
22. Brunello A., Basso U., Pogliani C., et al. Adjuvant chemotherapy for elderly patients (>70 years) with early high-risk breast cancer: a retrospective analysis of 260 patients. Ann Oncol 16 (2005) 1276-1282
23. Hurria A., Brogan K., Panageas K.S., et al. Patterns of toxicity in older patients with breast cancer receiving adjuvant chemotherapy. Breast Cancer Research and Treatment 92 (2005) 151-156
24. Ibrahim N.K., Sahin A.A., Dubrow R.A., et al. Colitis associated with docetaxel-based chemotherapy in patients with metastatic breast cancer. Lancet 355 (2000) 281-283
25. de Matteis A., Nuzzo F., Rossi E., Landi G., and Perrone F. Intestinal side-effects of docetaxel/vinorelbine combination. Lancet 355 (2000) 1098-1099
26. Fargeot P., Bonneterre J., Roché H., et al. Disease-free survival advantage of weekly epirubicin plus tamoxifen versus tamoxifen alone as adjuvant treatment of operable, node-positive, elderly breast cancer patients: 6-year follow-up results of the French adjuvant study group 08 trial. J Clin Oncol 22 (2004) 4622-4630