Evaluation of Safety and Efficacy of Salvage Therapy With Sunitinib, Docetaxel (Tyxan) and Cisplatinum Followed by Maintenance Vinorelbine for Unresectable/Metastatic Nonsmall Cell Lung Cancer: Stage 1 of a Simon 2 Stage Clinical Trial. [Corrected]

Medicine (Baltimore). 2015 Dec;94(52):e2303. doi: 10.1097/MD.0000000000002303.

Abstract

Current chemotherapeutic regimens for nonsmall cell lung cancer (NSCLC) have reached a plateau over the last few years. Targeted therapy makes use of tyrosine kinase inhibitors (TKIs) to suppress a number of signaling pathways including epidermal growth factor receptor and vascular endothelial growth factor which are active in NSCLC biology. In this study, we used sunitinib, a multi-target receptor TKI, combined with chemotherapy for unresectable/metastatic NSCLC.This open label Simon's 2 stage clinical trial enrolled a total of 6 NSCLC patients who received docetaxel (40 mg) and cisplatin (50 mg) on day 1 of each cycle (14 day interval between cycles) and sunitinib (25 mg qd for 10 days between cycles) for a total of 12 cycles (24 weeks), after which patients received maintenance therapy with vinorelbine (30 mg TIW) until disease progression. The sample size was based on a Simon's Optimal Two-Stage Designs for Phase II clinical trials. The expected response rate was set as 35% for P0 and as 60% for P1. The study was designed for a minimum of 6 patients for first stage and 15 patients until second stage with a significance level alpha = 0.10 and power = 70%. Diagnosis of a poor response in the second of 6 patients in Stage I or seventh of the 15 patients in Stage II would lead to early termination of the trial.The overall response rate was 66.7%. Four patients had an overall survival >60 months. The time to PFS ranged from 3 to 42 months. The combination therapy was well-tolerated.Sunitinib combined with chemotherapy shows promise and warrants further investigation.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Carcinoma, Non-Small-Cell Lung* / drug therapy
  • Carcinoma, Non-Small-Cell Lung* / pathology
  • Cisplatin* / administration & dosage
  • Cisplatin* / adverse effects
  • Docetaxel
  • Female
  • Humans
  • Indoles* / administration & dosage
  • Indoles* / adverse effects
  • Lung Neoplasms* / drug therapy
  • Lung Neoplasms* / pathology
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Staging
  • Pyrroles* / administration & dosage
  • Pyrroles* / adverse effects
  • Salvage Therapy / methods
  • Sunitinib
  • Survival Analysis
  • Taxoids* / administration & dosage
  • Taxoids* / adverse effects
  • Treatment Outcome
  • Vinblastine / administration & dosage
  • Vinblastine / adverse effects
  • Vinblastine / analogs & derivatives*
  • Vinorelbine

Substances

  • Antineoplastic Agents
  • Indoles
  • Pyrroles
  • Taxoids
  • Docetaxel
  • Vinblastine
  • Cisplatin
  • Vinorelbine
  • Sunitinib