title: VATS lobectomy facilitates the delivery of adjuvant docetaxel-carboplatin chemotherapy in patients with non-small cell lung cancer.
abstract: BACKGROUND
  To evaluate the safety and tolerability of docetaxel/carboplatin regimen in the post-operative setting of patients with non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Enrolment of 133 patients with stage Ib - IIIa NSCLC was undertaken in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.
  
  
  RESULTS
  Patient accrual was completed at 1 center in the US and 10 centers in China in <6 months. Febrile neutropenia complicated treatment in 12 patients (9.0%), below the predetermined safety threshold of 14 patients. Four VATS and 8 open thoracotomy patients experienced febrile neutropenia (P=0.26). Completion of the three-cycle adjuvant regimen was achieved in 86% (95% CI, 77-95%) of patients. Sixty-two of 66 VATS patients compared to 53 of 67 open thoracotomy patients received all three doses according to protocol (P<0.01). Thirteen serious adverse events (9.8%) and no deaths were attributed to the study regimen.
  
  
  CONCLUSIONS
  In this rapidly accrued study, docetaxel and carboplatin were well-tolerated in the adjuvant treatment of NSCLC. Adjuvant treatment compliance was higher among patients undergoing a minimally invasive surgical approach. (ClinicalTrials.gov number NCT00883675).
authors.affiliation: Beijing Lung Cancer Center, Capital Medical University, Beijing, China;
authors.forename: Xiuyi
authors.initials: X
authors.lastname: Zhi
authors.forename: Wen
authors.initials: W
authors.lastname: Gao
authors.forename: Baohui
authors.initials: B
authors.lastname: Han
authors.forename: Yue
authors.initials: Y
authors.lastname: Yang
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.forename: Deruo
authors.initials: D
authors.lastname: Liu
authors.forename: Changli
authors.initials: C
authors.lastname: Wang
authors.forename: Gong
authors.initials: G
authors.lastname: Min
authors.forename: Hao
authors.initials: H
authors.lastname: Long
authors.forename: James R
authors.initials: JR
authors.lastname: Rigas
authors.forename: Mark
authors.initials: M
authors.lastname: Carey
authors.forename: Thierry
authors.initials: T
authors.lastname: Jahan
authors.forename: Amanda
authors.initials: A
authors.lastname: Sammann
authors.forename: Joseph
authors.initials: J
authors.lastname: Reza
authors.forename: Daoyuan
authors.initials: D
authors.lastname: Wang
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mann
authors.forename: David M
authors.initials: DM
authors.lastname: Jablons
authors.forename: Jianxing
authors.initials: J
authors.lastname: He
keywords: Non-small cell lung cancer; adjuvant chemotherapy; carboplatin; docetaxel