title: Phase II study of irinotecan and etoposide in patients with metastatic non-small-cell lung cancer.
abstract: OBJECTIVE
  To determine the effects of irinotecan (CPT-11) given in combination with etoposide (VP-16) in metastatic non-small-cell lung cancer (NSCLC), to evaluate response and survival rates, and to determine the qualitative and quantitative toxicities of the combination chemotherapy.
  
  
  METHODS
  Sixty-one metastatic NSCLC patients received concurrent administration of CPT-11 and VP-16 for 3 days with recombinant human granulocyte colony-stimulating factor (rhG-CSF) support.
  
  
  RESULTS
  Fifty-nine patients were assessable for response and all 61 patients were assessable for toxicity and survival. Fifty-six patients were treated with two or more courses of chemotherapy. Thirteen patients achieved a partial response (PR), 36 showed no change (NC), and 10 showed progressive disease (PD). The overall response rate was 21.3% (95% confidence interval, 12.9% to 33.1%). The median duration of PRs was 141 days (range, 62 to 299). Of the hematologic toxicities, 14 (23%) and 24 (39%) patients experienced grade 3 or 4 leukopenia and neutropenia, respectively. The toxicities were feasible. Treatment-related death occurred in one patient who suffered hypovolemic shock induced by hematemesis. The median survival time was 10.0 months and the 1-year survival rate was 36.1%.
  
  
  CONCLUSIONS
  Combination chemotherapy with concurrent administration of CPT-11 and VP-16 with rhG-CSF support was only modestly effective against metastatic NSCLC, with feasible toxicities of moderate diarrhea and pulmonary toxicity. The results were equivalent to those expected with either cisplatin-based chemotherapy or with CPT-11 alone.
authors.affiliation: Eastern Japanese Lung Cancer Chemotherapy Group, National Cancer Center, Tokyo, Japan.
authors.forename: F
authors.initials: F
authors.lastname: Oshita
authors.forename: K
authors.initials: K
authors.lastname: Noda
authors.forename: Y
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: A
authors.initials: A
authors.lastname: Fujita
authors.forename: Y
authors.initials: Y
authors.lastname: Kurita
authors.forename: T
authors.initials: T
authors.lastname: Nakabayashi
authors.forename: K
authors.initials: K
authors.lastname: Tobise
authors.forename: S
authors.initials: S
authors.lastname: Abe
authors.forename: S
authors.initials: S
authors.lastname: Suzuki
authors.forename: I
authors.initials: I
authors.lastname: Hayashi
authors.forename: Y
authors.initials: Y
authors.lastname: Kawakami
authors.forename: T
authors.initials: T
authors.lastname: Matsuda
authors.forename: S
authors.initials: S
authors.lastname: Tsuchiya
authors.forename: S
authors.initials: S
authors.lastname: Takahashi
authors.forename: T
authors.initials: T
authors.lastname: Tamura
authors.forename: N
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018287:Carcinoma, Large Cell / Q000188:drug therapy; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D000077146:Irinotecan; D002166:Camptothecin