title: A Phase II study of weekly irinotecan and capecitabine in patients with previously treated non-small cell lung cancer.
abstract: OBJECTIVE
  Irinotecan and capecitabine have synergistic antitumor activity with distinct mechanisms of action but without overlapping major toxicity. We conducted a Phase II study to evaluate the efficacy of weekly irinotecan plus capecitabine in patients with previously treated non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Eligible patients had received at least one prior chemotherapy regimen. The treatment consisted of irinotecan (90-100 mg/m2 i.v.) on days 1 and 8 plus capecitabine (1000 mg/m2 p.o. b.i.d.) on days 1-14 of a 21-day cycle. Treatment was given until disease progression or unacceptable toxicity.
  
  
  RESULTS
  Thirty-seven patients with median age of 59 years were enrolled. Eighteen (49%) patients had received one prior regimen, and 19 (51%) patients had received two or more prior regimens. The Initial 5 patients received 100 mg/m2 irinotecan with grade 3 diarrhea seen in 3 of 5 patients, and subsequent 32 patients received 90 mg/m2 irinotecan. Four (11.4%) of 35 evaluable patients had partial response and 12 (34.3%) had stable disease. There was no complete response. All responses were noted in patients who had received one prior regimen (4 of 18, 22%), but there was no response among the patients who had received two or more regimens. Median duration of response was 5.6 months (range, 5-8.7 months). At a median follow-up of 6 months, median survival was 7.4 months (95% confidence interval, 3.6-9.0). Grade 3 or 4 toxicities were neutropenia (12%), anemia (13%), and diarrhea (12%) at the dose level of 90 mg/m2.
  
  
  CONCLUSIONS
  Weekly irinotecan plus capecitabine had favorable antitumor activity and toxicity profile as a second-line treatment for recurrent NSCLC. This regimen may provide an additional treatment option for patients with advanced NSCLC.
authors.affiliation: Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, Korea.
authors.forename: Ji-Youn
authors.initials: JY
authors.lastname: Han
authors.forename: Dae Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Hyae Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Eun-A
authors.initials: EA
authors.lastname: Kim
authors.forename: Jae Jin
authors.initials: JJ
authors.lastname: Lee
authors.forename: So Young
authors.initials: SY
authors.lastname: Ju
authors.forename: Eun Hee
authors.initials: EH
authors.lastname: Shin
authors.forename: Jin Soo
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000069287:Capecitabine; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin