title: The effect on survival of initial chemotherapy in advanced breast cancer: polychemotherapy versus single drug.
abstract: Since current clinical trials assessing new agents occur in patients with advanced breast cancer having failed one and sometimes many polychemotherapy programs, these new agents may not be given a fair trial. In an effort to assess the possibility of using an alternative study design, we analyzed older clinical trials that used a controlled study design, randomizing between a single new drug and an established polychemotherapy program with a cross-over design upon failure. We were interested in noting that the pooled data did display a slight survival advantage (median 3.7 months) for the group receiving polychemotherapy as initial therapy. The survival distributions were clearly not significant using the log rank test, but did approach significance using the Smirnov. It is apparent that, while some slight advantage does occur for that group of patients receiving initial polychemotherapy, the magnitude of this effect is not great and is short in duration. Serious consideration should be given to the assessment of new agents as first-line therapy, particularly should they have a unique mode of action or lessened morbidities or toxicities.
authors.affiliation: Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905.
authors.forename: D L
authors.initials: DL
authors.lastname: Ahmann
authors.forename: D J
authors.initials: DJ
authors.lastname: Schaid
authors.forename: H F
authors.initials: HF
authors.lastname: Bisel
authors.forename: R G
authors.initials: RG
authors.lastname: Hahn
authors.forename: J H
authors.initials: JH
authors.lastname: Edmonson
authors.forename: J N
authors.initials: JN
authors.lastname: Ingle
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000401:mortality*; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007069:Ifosfamide / Q000627:therapeutic use; D011241:Prednisone / Q000008:administration & dosage; D011897:Random Allocation; D012673:Semustine / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D012673:Semustine; D004317:Doxorubicin; D003520:Cyclophosphamide; D005472:Fluorouracil; D007069:Ifosfamide; D011241:Prednisone