title: N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group (NCCTG) Trial.
abstract: BACKGROUND
  Because of the single-agent activity of irinotecan hydrochloride, combination of irinotecan and docetaxel treatment against metastatic breast cancer (MBC) should be evaluated.
  
  
  METHODS
  Single-stage phase 2 study of irinotecan and docetaxel to evaluate tumor response, toxicity, time to progression, and overall survival was carried out. Regimen of docetaxel (25 mg/m(2)) and irinotecan (70 mg/m(2)) was administered on days 1 and 8 of each 3-week cycle. Patients had histologically confirmed breast adenocarcinoma and metastatic cancer measurable with RECIST.
  
  
  RESULTS
  Of 70 patients enrolled, 64 were assessable. Prior treatment with an anthracycline and a taxane was required. Eighteen (28%) patients [95% confidence interval (CI) 15% to 31%] had tumor response, plus four patients had stable disease (less than 30% decrease in sum of longest diameter and less than 20% increase) for >6 months. The clinical benefit rate was 34% overall. Median duration of tumor response was 6.7 months (95% CI 4.2-37.7 months); median follow-up was 18.6 months (range 8.5-37.7 months). The most common severe adverse events included fatigue [n = 16 (25%)] and neutropenia [n = 13 (20%)].
  
  
  CONCLUSIONS
  Weekly dosing of combination of irinotecan and docetaxel is active against MBC. However, the response rate to our regimen was not significantly better than single-agent docetaxel. Other schedules of irinotecan plus docetaxel should be considered for future studies.
authors.affiliation: Division of Hematology and Oncology, Mayo Clinic, Jacksonville, FL. Electronic address: tan.winston@mayo.edu.
authors.forename: W W
authors.initials: WW
authors.lastname: Tan
authors.affiliation: Division of Biostatistics, Mayo Clinic, Rochester, MN, USA.
authors.forename: D W
authors.initials: DW
authors.lastname: Hillman
authors.affiliation: Division of Hematology and Oncology, Allan Blair Cancer Center, Regina, Saskatchewan, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Salim
authors.affiliation: Division of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ.
authors.forename: D W
authors.initials: DW
authors.lastname: Northfelt
authors.affiliation: Division of Hematology and Oncology, Abbott Northwestern Hospital, Minneapolis, MN.
authors.forename: D M
authors.initials: DM
authors.lastname: Anderson
authors.affiliation: Department of Hematology and Oncology, Michigan Cancer Research Consortium, Ann Arbor, MI.
authors.forename: P J
authors.initials: PJ
authors.lastname: Stella
authors.affiliation: Department of Hematology and Oncology, Duluth CCOP, Duluth, MN.
authors.forename: R
authors.initials: R
authors.lastname: Niedringhaus
authors.affiliation: Department of Hematology and Oncology, Geisinger Clinic and Medical Center, Danville, PA.
authors.forename: A M
authors.initials: AM
authors.lastname: Bernath
authors.affiliation: Department of Hematology and Oncology, Missouri Valley Cancer Consortium, Omaha, NE, USA.
authors.forename: S S
authors.initials: SS
authors.lastname: Gamini
authors.affiliation: Division of Hematology and Oncology, Mayo Clinic, Jacksonville, FL.
authors.forename: F
authors.initials: F
authors.lastname: Palmieri
authors.affiliation: Division of Hematology and Oncology, Mayo Clinic, Jacksonville, FL.
authors.forename: E A
authors.initials: EA
authors.lastname: Perez
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D016879:Salvage Therapy; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin