title: A Phase II NCCTG study of irinotecan and docetaxel in previously treated patients with non-small cell lung cancer.
abstract: OBJECTIVE
  This Phase II study was undertaken to define the efficacy and toxicity of the combination of docetaxel and irinotecan for the second-line treatment of non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Forty-six patients with measurable NSCLC who had relapsed after an initial response to chemotherapy or who had failed to respond to initial chemotherapy, received 130 mg/m2 of irinotecan IV over 90 minutes and 50 mg/m2 docetaxel IV over 60 minutes on Day 1 q3 weeks for 6 cycles. Dexamethasone and diphenhydramine pretreatment were given. Response to treatment was evaluated by response evaluation criteria in solid tumors RECIST criteria, and toxicity was graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0.
  
  
  RESULTS
  The most common severe (NCI CTC Grade 3+) adverse events were neutropenia (67 percent), diarrhea (28 percent), fatigue (20 percent), nausea (17 percent), infection (15 percent), vomiting (13 percent), leucopenia (13 percent), abdominal pain (11 percent), and dyspnea (11 percent). Grade 5 toxic events were seen in 2 patients. One of these 2 cases was a possibly-treatment related event (intestinal fistula). The median number of treatment cycles received was 3. Twelve patients (26 percent) received all 6 cycles of treatment. Five patients (11 percent) had a confirmed response (complete response (CR), partial response (PR), or regression). Median follow-up for the five surviving patients is 26.5 months (range: 25.1-28.4). Forty-two patients have reported progressive disease and 41 patients have died. Median time-to-progression (TTP) and survival are 2.6 months and 7.5 months, respectively.
  
  
  CONCLUSIONS
  This second-line treatment regimen of irinotecan and docetaxel in NSCLC patients has shown activity, but can not be recommended over single-agent regimens because of significant toxicity.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
authors.forename: Julian R
authors.initials: JR
authors.lastname: Molina
authors.forename: Daniel
authors.initials: D
authors.lastname: Nikcevich
authors.forename: Shauna
authors.initials: S
authors.lastname: Hillman
authors.forename: Susan
authors.initials: S
authors.lastname: Geyer
authors.forename: Timothy
authors.initials: T
authors.lastname: Drevyanko
authors.forename: James
authors.initials: J
authors.lastname: Jett
authors.forename: Joseph
authors.initials: J
authors.lastname: Verdirame
authors.forename: Henry
authors.initials: H
authors.lastname: Tazelaar
authors.forename: Kendrith
authors.initials: K
authors.lastname: Rowland
authors.forename: Edward
authors.initials: E
authors.lastname: Wos
authors.forename: Leila
authors.initials: L
authors.lastname: Kutteh
authors.forename: Suresh
authors.initials: S
authors.lastname: Nair
authors.forename: Tom
authors.initials: T
authors.lastname: Fitch
authors.forename: Patrick
authors.initials: P
authors.lastname: Flynn
authors.forename: Philip
authors.initials: P
authors.lastname: Stella
authors.forename: Alex A
authors.initials: AA
authors.lastname: Adjei
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D000077143:Docetaxel; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin