title: Gemcitabine and vinorelbine in the second-line treatment of nonsmall cell lung carcinoma patients: a minnie pearl cancer research network phase II trial.
abstract: BACKGROUND
  Second-line chemotherapy for patients with nonsmall cell lung carcinoma has been ineffective due to the lack of activity of older agents following platinum-based therapy. This Phase II trial evaluated the feasibility, toxicity, and efficacy of two active new agents, gemcitabine and vinorelbine, used in combination as second-line therapy for patients with nonsmall cell lung carcinoma.
  
  
  METHODS
  Patients with advanced nonsmall cell lung carcinoma who had progressive disease after previous chemotherapy or combined-modality therapy were eligible for this trial. All patients received vinorelbine 20 mg/m(2) followed by gemcitabine 1000 mg/m(2) on Days 1, 8, and 15 of each 28-day cycle. Patients were reevaluated for a response after two treatment courses: responding patients and those with stable disease received a maximum of six courses. Fifty-five patients were treated between January 1998 and November 1998; 47 patients (85%) had previously received both a taxane and a platinum agent.
  
  
  RESULTS
  Objective responses were seen in 9 of 50 evaluable patients (18%), including 8 partial responses and 1 complete response. Twenty-four additional patients (48%) had either minor response or stable disease. The median time to progression for patients with objective response or stable disease was 5 months. The median survival was 6.5 months with an actuarial 1-year survival of 20%. The treatment was well tolerated with uncommon nonhematologic toxicity and no alopecia. Grade 3 neutropenia and thrombocytopenia occurred in 27% and 22% of patients, respectively, but Grade 4 neutropenia was uncommon (occurring in 9% of patients) and only 4 patients required hospitalization for treatment of neutropenia and fever.
  
  
  CONCLUSIONS
  The combination of vinorelbine and gemcitabine is active and well tolerated as second-line therapy for patients with advanced nonsmall cell lung carcinoma. This regimen merits further evaluation as a first-line therapy for patients with this disease.
authors.affiliation: Sarah Cannon Cancer Center, Nashville, Tennessee 37203, USA.
authors.forename: J D
authors.initials: JD
authors.lastname: Hainsworth
authors.forename: H A
authors.initials: HA
authors.lastname: Burris
authors.forename: S
authors.initials: S
authors.lastname: Litchy
authors.forename: J B
authors.initials: JB
authors.lastname: Erland
authors.forename: J K
authors.initials: JK
authors.lastname: Hon
authors.forename: J E
authors.initials: JE
authors.lastname: Brierre
authors.forename: F A
authors.initials: FA
authors.lastname: Greco
mesh_terms: D000206:Actuarial Analysis; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017671:Platinum Compounds / Q000008:administration & dosage; D012074:Remission Induction; D015996:Survival Rate; D043823:Taxoids; D013921:Thrombocytopenia / Q000139:chemically induced; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D001952:Bridged-Ring Compounds; D017671:Platinum Compounds; D043823:Taxoids; D003841:Deoxycytidine; C080625:taxane; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine