title: A phase II trial of Cremorphor EL-free paclitaxel (Genexol-PM) and gemcitabine in patients with advanced non-small cell lung cancer.
abstract: OBJECTIVE
  Genexol-PM is a Cremorphor EL (CrEL)-free polymeric micelle formulation of paclitaxel that allows higher-dose administration with less hypersensitivity. This study was designed to evaluate the efficacy and safety of Genexol-PM and gemcitabine combination in advanced non-small cell lung cancer patients as a first-line treatment.
  
  
  METHODS
  This is a prospective, single-arm, single-center phase II study. Patients with advanced NSCLC received Genexol-PM at 230 mg/m(2) on day 1 and gemcitabine 1,000 mg/m(2) on day 1 and day 8 of a 3-week cycle. Six cycles of chemotherapy were planned unless there was disease progression. The primary endpoint was overall response rate.
  
  
  RESULTS
  Forty-three patients received the study drugs with a median of 4 cycles per patient (range 1-6). The overall response rate was 46.5%. The median progression-free survival was 4.0 months (95% CI 2.0-6.0 months), and median overall survival was 14.8 months (95% CI 9.1-20.5 months). The most common toxicities were anemia (n = 29, 67%), asthenia (n = 17, 40%), myalgia (n = 16, 37%), peripheral neuropathy (n = 15, 35 %), and diarrhea (n = 12, 30%). The most common grade 3/4 adverse events were neutropenia (n = 7, 16%) and pneumonia (n = 5, 12%). Two patients died of pneumonia and dyspnea.
  
  
  CONCLUSIONS
  CrEL-free paclitaxel in combination with gemcitabine demonstrated favorable antitumor activity with little emetogenicities in non-small cell lung cancer patients. However, frequent grade 3/4 toxicities were observed, and safety should be evaluated thoroughly in future studies.
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 1198 Guwol-dong, Namdong-gu, Incheon, 405-760, Republic of Korea.
authors.forename: Hee Kyung
authors.initials: HK
authors.lastname: Ahn
authors.forename: Minkyu
authors.initials: M
authors.lastname: Jung
authors.forename: Sun Jin
authors.initials: SJ
authors.lastname: Sym
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Shin Myung
authors.initials: SM
authors.lastname: Kang
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Kyung
authors.forename: Jeong-Woong
authors.initials: JW
authors.lastname: Park
authors.forename: Sung Hwan
authors.initials: SH
authors.lastname: Jeong
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008081:Liposomes; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D053758:Nanoparticles / Q000737:chemistry; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D008081:Liposomes; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine