title: Α multicenter phase II study of pegylated liposomal doxorubicin in combination with irinotecan as second-line treatment of patients with refractory small-cell lung cancer.
abstract: OBJECTIVE
  To evaluate efficacy and toxicity of a combination of pegylated liposomal doxorubicin and irinotecan in patients with refractory small-cell lung cancer.
  
  
  METHODS
  Thirty-one patients with early relapse after first-line therapy with cisplatin/etoposide were treated with pegylated liposomal doxorubicin 15 mg/m(2) and irinotecan 125 mg/m(2) on days 1 and 15. Treatment was repeated every 28 days.
  
  
  RESULTS
  A total of 144 chemotherapy courses were administered. All patients were evaluable for toxicity and twenty-six (84%) for response. Grade 3 neutropenia occurred in two (6.5%) patients and grade 1 thrombocytopenia in one (3.2%). Fatigue was the most frequent grade 3 non-hematologic toxicity and was observed in seven patients (23%). Four (12.9; 95% CI: 1.1-24.7%) patients achieved a partial response, and disease stabilization was observed in additional two (6.5%) patients (Tumor Growth Control: 19.4; 95% CI: 5.5-33.3%). The median TTP was 2.03 months, and the median survival time was 3.16 months.
  
  
  CONCLUSIONS
  The combination of pegylated doxorubicin and irinotecan is very well tolerated but with modest activity in patients with refractory SCLC.
authors.affiliation: Department of Medical Oncology, University General Hospital of Alexandroupolis, Alexandroupolis, Greece.
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Xenidis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Vardakis
authors.forename: Ioannis
authors.initials: I
authors.lastname: Varthalitis
authors.forename: Stylianos
authors.initials: S
authors.lastname: Giassas
authors.forename: Emmanouel
authors.initials: E
authors.lastname: Kontopodis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Ziras
authors.forename: Ioannis
authors.initials: I
authors.lastname: Gioulbasanis
authors.forename: George
authors.initials: G
authors.lastname: Samonis
authors.forename: Kostas
authors.initials: K
authors.lastname: Kalbakis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D000077146:Irinotecan; D004317:Doxorubicin; D002166:Camptothecin