title: Phase II Study of Gemcitabine and Vinorelbine as Second-Line Chemotherapy in Non-Small Cell Lung Cancer.
abstract: OBJECTIVE
  With the increased use of chemotherapy for non small cell lung cancer (NSCLC), a growing group of patients can now be considered for second-line chemotherapy. However, guidelines for the second line treatment remain to be developed. The objective of this study was to evaluate the efficacy and safety of the gemcitabine and vinorelbine combination therapy in patients with advanced NSCLC, pretreated with taxane and platinum based regimens. Gemcitabine has already demonstrated activity in this patient group, with the combination therapy having been reported to be well tolerated in previous phase I/II studies.
  
  
  METHODS
  Forty two patients with advanced NSCLC (stages III/IV), having received prior taxane and platinum based chemotherapy, with an ECOG performance status (PS) 0~2, and unimpaired hematopoietic and organ function, were treated with vinorelbine, 20 mg/m2, followed by gemcitabine, 1, 000 mg/m2, both administered on days 1, 8 and 15, every 4 weeks.
  
  
  RESULTS
  Out of the 42 patients enrolled, 41 were evaluable for their response, and all 42 for their toxicity. The patient's characteristics were as follows; median age=60 years (42~73), median PS=1 (range 0~2), a gender ratio 31: 11 males/females, with stages IIIA, IIIB and IV in 3, 14 and 25 cases. The objective responses included a partial response (PR) 8/41 (19.5%), a stable disease 15/41 (36.6%) and a progressive disease 18/41 (43.9%). The median time-to progression (TTP) and survival were 4 months, ranging from 2 to 14 months, and 8 months, ranging from 2 to 17+ months, respectively. Grade 3 neutropenia was seen in 19% of the patient, and there was no grade 4 neutropenia or episodes of febrile neutropenia. No grade 4 thrombocytopenia or other grade 3/4 non-hematological toxicities were observed.
  
  
  CONCLUSIONS
  The combination of gemcitabine/vinorelbine is active and well tolerated in patients with advanced NSCLC having failed prior taxane/platinum therapy.
authors.forename: Yoon Jae
authors.initials: YJ
authors.lastname: Kim
authors.forename: Joo Hyuk
authors.initials: JH
authors.lastname: Sohn
authors.forename: Chul
authors.initials: C
authors.lastname: Kim
authors.forename: Yong Tai
authors.initials: YT
authors.lastname: Kim
authors.forename: Hai Jin
authors.initials: HJ
authors.lastname: Kim
authors.forename: Joong Bae
authors.initials: JB
authors.lastname: Ahn
authors.forename: Se Kyu
authors.initials: SK
authors.lastname: Kim
authors.forename: Joon
authors.initials: J
authors.lastname: Chang
authors.forename: Nae Choon
authors.initials: NC
authors.lastname: Yoo
authors.forename: Joo Hang
authors.initials: JH
authors.lastname: Kim
authors.forename: Jae Yong
authors.initials: JY
authors.lastname: Cho
keywords: Gemcitabine; Non-small cell lung cancer; Second line chemotherapy; Vinorelbine