title: Compliance and toxicity of adjuvant CMF in elderly breast cancer patients: a single-center experience.
abstract: BACKGROUND
  Few data are available on compliance and safety of adjuvant chemotherapy when indicated in elderly breast cancer patients; CMF (cyclophosphamide, methotrexate, fluorouracil) can be reasonably considered the most widely accepted standard of treatment.
  
  
  METHODS
  We retrospectively reviewed compliance and safety of adjuvant CMF in patients older than 60. The treatment was indicated if patients had no severe comorbidity, a high-risk of recurrence, and were younger than 75. Toxicity was coded by NCI-CTC. Toxicity and compliance were compared between two age subgroups (< 65, > or = 65) by Fisher exact test and exact Wilcoxon rank-sum test.
  
  
  RESULTS
  From March 1991 to March 2002, 180 patients were identified, 100 older than 60 and younger than 65, and 80 aged 65 or older. Febrile neutropenia was more frequent among older patients (p = 0.05). Leukopenia, neutropenia, nausea, cardiac toxicity and thrombophlebitis tended to be more frequent or severe among elderlies, while mucositis tended to be more evident among younger patients, all not significantly. Almost one half (47%) of the older patients receiving concomitant radiotherapy experienced grade 3-4 haematological toxicity. Compliance was similar in the two groups, with 6 cycles administered in 86% and 79%, day-8 chemotherapy omitted at least once in 36% and 39%, dose reduction in 27% and 38%, prolonged treatment duration (> or = 29 weeks) in 10% and 11% and need of G-CSF in 9% and 18%, among younger and older patients, respectively.
  
  
  CONCLUSIONS
  Our data show that, in a highly selected population of patients 65 or more years old, CMF is as feasible as in patients older than 60 and younger than 65, but with a relevant burden of toxicity. We suggest that prospective trials in elderly patients testing less toxic treatment schemes are mandatory before indicating adjuvant chemotherapy to all elderly patients with significant risk of breast cancer recurrence.
authors.affiliation: Clinical Trials Unit, National Cancer Institute, Naples, Italy. e.demaio@unina.it
authors.forename: Ermelinda
authors.initials: E
authors.lastname: De Maio
authors.forename: Adriano
authors.initials: A
authors.lastname: Gravina
authors.forename: Carmen
authors.initials: C
authors.lastname: Pacilio
authors.forename: Gerardo
authors.initials: G
authors.lastname: Amabile
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Labonia
authors.forename: Gabriella
authors.initials: G
authors.lastname: Landi
authors.forename: Francesco
authors.initials: F
authors.lastname: Nuzzo
authors.forename: Emanuela
authors.initials: E
authors.lastname: Rossi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Aiuto
authors.forename: Immacolata
authors.initials: I
authors.lastname: Capasso
authors.forename: Massimo
authors.initials: M
authors.lastname: Rinaldo
authors.forename: Brunello
authors.initials: B
authors.lastname: Morrica
authors.forename: Massimo
authors.initials: M
authors.lastname: Elmo
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Maio
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Andrea
authors.initials: A
authors.lastname: de Matteis
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D010349:Patient Compliance; D018714:Radiotherapy, Adjuvant; D012189:Retrospective Studies
chemical_list: D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate