title: Results of a Phase II study of carboplatin plus gemcitabine in patients with untreated extensive small cell lung cancer.
abstract: OBJECTIVE
  To determine the response rate (RR) and survival produced by carboplatin + gemcitabine therapy in patients with untreated extensive small cell lung cancer (ESCLC).
  
  
  METHODS
  Treatment consisted of carboplatin (AUC = 5) on day 1 and gemcitabine (1100 mg/m(2)) on days 1 and 8 of each 21-day cycle for 4 planned cycles (additional cycles allowed as per treating physician). ECOG performance status 0/1/2 was 29, 58, and 13%. Median age was 66.5 years (range: 41.3-83.1), 94% were white, and 50.7% were female.
  
  
  RESULTS
  Between August 2000 and February 2002, 69 patients with ESCLC were enrolled. All 69 patients were included in the safety analysis, and 66 patients were evaluable for response. There were 2 CR (3.0%), 26 PR (39.5%), 23 SD (34.8%), and 15 PD (22.7%) resulting in a RR of 42.5%. The median survival was 9.2 months (range: <1-22.6), and the estimated 1-year survival was 33%. The median TTP was 3.9 months (range: <1-12.8), and the estimated 6-month progression free survival was 24%. The median duration of response was 3.8 months (range: 1.0-9.9). Out of 69 patients, 29, 3, and 16 received 4, 5, and 6 cycles of therapy, respectively. The major Grade 3, 4 toxicities included neutropenia (39.1%), thrombocytopenia (31.9%), anemia (13.0%), and fatigue (4.3%).
  
  
  CONCLUSIONS
  This regimen resulted in survival data that was similar to other regimens for ESCLC and treatment appeared to be well tolerated. Gemcitabine in combination with carboplatin or other active drugs in ESCLC may be worth further investigation.
authors.affiliation: US Oncology Research, Inc., Kansas City Cancer Center, 12200 West 110th Street, Overland Park, KS 66210, USA. marcus.neubauer@usoncology.com
authors.forename: Marcus
authors.initials: M
authors.lastname: Neubauer
authors.forename: Ralph
authors.initials: R
authors.lastname: Heaven
authors.forename: Jairo
authors.initials: J
authors.lastname: Olivares
authors.forename: Alvin
authors.initials: A
authors.lastname: Otsuka
authors.forename: Eugene
authors.initials: E
authors.lastname: Paschold
authors.forename: Christopher
authors.initials: C
authors.lastname: Sirridge
authors.forename: Des
authors.initials: D
authors.lastname: Ilegbodu
authors.forename: Troy
authors.initials: T
authors.lastname: Tuttle
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine