title: Clinical feasibility of (neo)adjuvant taxane-based chemotherapy in older patients: analysis of >4,500 patients from four German randomized breast cancer trials.
abstract: BACKGROUND
  Despite the fact that people older than 65 years of age have the highest incidence of developing breast cancer, these patients are excluded from clinical trials in most cases. Furthermore, most physicians tend towards therapy regimens without the use of dose-dense, highly active taxane-based treatments because of a lack of data regarding toxicities of these compounds in older patients.
  
  
  METHODS
  Pooled side-effect data were analyzed from four prospective, randomized clinical trials in which patients of different age groups (< 60 years, between 60 and 64 years, and > 64 years) with primary breast cancer received taxane-based chemotherapy.
  
  
  RESULTS
  Dose delays, dose reductions, hospitalization, and therapy discontinuation increased with age. Hematologic toxicities and some nonhematologic toxicities were generally more common in older patients. Leucopenia increased from 55.3% in patients aged < 60 years to 65.5% in patients aged > 64 years (P < 0.001), and neutropenia increased from 46.9% to 57.4% (P < 0.001). There was no difference, however, in clinically more relevant febrile neutropenia between the different age groups. Thrombopenia shows a similar age-dependent increase, whereas there is no difference between the age groups concerning anemia. Hot flushes and elevated liver enzymes decreased with increasing age.
  
  
  CONCLUSIONS
  The present pooled analysis of a substantial cohort of older primary breast cancer patients demonstrates that taxane-containing (neo)adjuvant chemotherapy is feasible in older patients and that toxicity can be reduced by sequential therapy regimens.
authors.affiliation: Department of Obstetrics and Gynecology, German Breast Group, Neu-Isenburg, Germany. Sibylle.loibl@germanbreastgroup.de
authors.forename: Sibylle
authors.initials: S
authors.lastname: Loibl
authors.forename: Gunter
authors.initials: G
authors.lastname: von Minckwitz
authors.forename: Nadia
authors.initials: N
authors.lastname: Harbeck
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Janni
authors.forename: Dirk
authors.initials: D
authors.lastname: Elling
authors.forename: Manfred
authors.initials: M
authors.lastname: Kaufmann
authors.forename: Holm
authors.initials: H
authors.lastname: Eggemann
authors.forename: Valentina
authors.initials: V
authors.lastname: Nekljudova
authors.forename: Harald
authors.initials: H
authors.lastname: Sommer
authors.forename: Marion
authors.initials: M
authors.lastname: Kiechle
authors.forename: Sherko
authors.initials: S
authors.lastname: Kümmel
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005221:Fatigue / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D005858:Germany; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D014747:Vinblastine; D000069287:Capecitabine; D003520:Cyclophosphamide; D017239:Paclitaxel; D000077235:Vinorelbine; D005472:Fluorouracil
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