title: Phase II study of epirubicin in combination with weekly docetaxel for patients with advanced NSCLC who have failed or relapsed after the frontline platinum-based chemotherapy.
abstract: BACKGROUND
  We conducted a phase II study to evaluate the efficacy and toxicity of weekly docetaxel combined with epirubicin on D15 as second-line chemotherapy in Taiwanese patients with advanced non small cell lung cancer (NSCLC) who failed or relapsed after the frontline platinum-based chemotherapy.
  
  
  METHODS
  Patients with histologically confirmed advanced NSCLC (Stage IIIB-IV) were entered into this Phase II trial. Eastern Cooperative Oncology Group performance status was 0 to 2 and adequate organ function was required. Docetaxel, 30 mg/m, was given intravenously on days 1, 8, and 15 for 30 minutes and epirubicin, 60 mg/m, was given intravenously on day 15, then following one week of rest. Treatment was repeated every 4 weeks for a maximal total of 6 cycles.
  
  
  RESULTS
  Of the 43 eligible patients, 39 patients were evaluated for response, and all were evaluated for toxicity. The overall response rate was 11.6% [95% confidence interval (CI), 1.6-21.6%]. The median time to disease progression for all patients was 2.8 months (95% CI 1.3-4.3%). The median survival time for all patients was 7.7 months (95% CI 5.5-9.9%). The 1-year survival was 32.6% (95% CI 25.4%-39.7%). The major hematologic toxicities were neutropenia, 8/43 (19%) with grade 3-4 neutropenia, as well as anemia, 6/43 (14%) with grade 3-4 anemia. Nonhematological toxicities were modest. Fatigue was common, 77.8% in all, but only 3 (7%) patients with grade 3-4 toxicities. Diarrhea was also common but not severe, 7/43 (16%) with grade 1-2 episodes, and 1/43 (2%) with grade 3-4 episodes. Nail changes, peripheral edema, lacrimation, and alopecia were mild. Hepatic and renal impairment was also only mild.
  
  
  CONCLUSIONS
  Combining weekly doses of docetaxel 30 mg/m with epirubicin 60 mg/m on D15 was not shown to improve both efficacy and tolerability for advanced NSCLC patients who have relapsed disease after frontline platinum-based chemotherapy.
authors.affiliation: Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan.
authors.forename: Chih-Ming
authors.initials: CM
authors.lastname: Lin
authors.forename: Chih-Hung
authors.initials: CH
authors.lastname: Chen
authors.forename: John W C
authors.initials: JW
authors.lastname: Chang
authors.forename: Thomas C Y
authors.initials: TC
authors.lastname: Tsao
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis; D009367:Neoplasm Staging; D011379:Prognosis; D016879:Salvage Therapy; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D017211:Treatment Failure
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin