title: Phase II clinical trial with gemcitabine and paclitaxel sequential monotherapy as first-line treatment for advanced non-small-cell lung cancer (SLCG 01-04).
abstract: BACKGROUND
  In advanced-stage (IIIB or IV) non-small-cell lung cancer (NSCLC), combination chemotherapy has demonstrated response rates of 20% and a 1-year survival rate of 30%. We conducted a multicentre, open-label, nonrandomised phase II trial to determine the efficacy and tolerability of sequential monotherapy with gemcitabine followed by paclitaxel in chemotherapy-naïve patients with advanced NSCLC.
  
  
  METHODS
  Between December 2002 and July 2004, the Spanish Lung Cancer Group (SLCG) conducted a study in which 34 patients with advanced (stage IIIB or IV) NSCLC received 1200 mg/m(2) of i.v. gemcitabine on days 1, 8 and 15 of each 28-day cycle for a total of 3 cycles followed by 100 mg/m(2) of weekly i.v. paclitaxel for a maximum of 8 weeks. If objective response or stable disease was achieved, 70 mg/m(2) of weekly i.v. paclitaxel was maintained until disease progression was evident or toxic effects were intolerable. Lung Cancer Symptom Scale (LCSS) analysis was performed. Baseline levels of serum VEGF, EGFR, telomerase reverse transcriptase (hTERT) and K-ras mutations were analysed. The primary endpoint was the objective response rate.
  
  
  RESULTS
  The median age of the 34 patients who were enrolled was 67 years (range 46-77), but later 8 patients were excluded; 78.8% were men, 81.8% had performance status 1 and also 81.8% had metastatic disease at diagnosis. The objective response rate was 28% (95% CI, 14.2-47.8); the median overall survival was 7.2 months (95% CI, 2.1-12.3) and the median time to progression (TTP) was 3.1 months (95% CI, 2.5-5.3). Grade 3 or 4 drug-related haematological toxicities were observed in 6 patients. Patients with lower baseline serum VEGF levels had significantly longer survival.
  
  
  CONCLUSIONS
  Sequential therapy with gemcitabine followed by paclitaxel was well tolerated with a low proportion of grade 3 or 4 adverse events, the absence of unexpected toxicity and with an improvement in quality of life. Unfortunately, the response rate did not meet the minimally required rate of 20% and the study was prematurely closed. VEGF was identified as a poor prognostic factor for TTP and survival.
authors.affiliation: Medical Oncology Department, Hospital General Universitario de Valencia, Valencia, Spain.
authors.forename: Vega
authors.initials: V
authors.lastname: Iranzo
authors.forename: Rafael
authors.initials: R
authors.lastname: Sirera
authors.forename: Alfredo
authors.initials: A
authors.lastname: Carrato
authors.forename: Andrea
authors.initials: A
authors.lastname: Cabrera
authors.forename: Eloísa
authors.initials: E
authors.lastname: Jantus
authors.forename: Ricardo
authors.initials: R
authors.lastname: Guijarro
authors.forename: Elena
authors.initials: E
authors.lastname: Sanmartín
authors.forename: Ana
authors.initials: A
authors.lastname: Blasco
authors.forename: Mireia
authors.initials: M
authors.lastname: Gil
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Gómez-Aldaraví
authors.forename: José Luis
authors.initials: JL
authors.lastname: González-Larriba
authors.forename: Bertomeu
authors.initials: B
authors.lastname: Massuti
authors.forename: Amalia
authors.initials: A
authors.lastname: Velasco
authors.forename: Mariano
authors.initials: M
authors.lastname: Provencio
authors.forename: Rafael
authors.initials: R
authors.lastname: Rossell
authors.forename: Carlos
authors.initials: C
authors.lastname: Camps
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy* / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine