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

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.

Miltirone‑induced apoptosis in cisplatin‑resistant lung cancer cells through upregulation of p53 signaling pathways

“…Cell viability assay. HCC827 and A549 cells were seeded in duplicate in 96-well plates at a density of 5x10 3…”

“…Even though chemotherapy has improved the survival rate of patients with lung cancer, the 5-year survival rate in the last 25 years has remained at 15% (2). Multidrug resistance is the primary reason for the low survival rates (3). Cisplatin is widely used as first-line therapy for the treatment of lung cancer; however, drug resistance presents a major concern (2).…”

Evaluation of Safety and Efficacy of Salvage Therapy With Sunitinib, Docetaxel (Tyxane) and Cisplatinum Followed by Maintenance Vinorelbine for Unresectable/Metastatic Nonsmall Cell Lung Cancer

“…In the article “Evaluation of Safety and Efficacy of Salvage Therapy With Sunitinib, Docetaxel (Tyxane) and Cisplatinum Followed by Maintenance Vinorelbine for Unresectable/Metastatic Nonsmall Cell Lung Cancer Stage 1 of a Simon 2 Stage Clinical Trial”, 1 which appeared in Volume 94, Issue 52 of Medicine , the word tyxan was spelled incorrectly as tyxane. The article has since been corrected online.…”

Associations between abnormal vitamin D metabolism pathway function and non‑small cell lung cancer

“…At this advanced stage of disease, surgical procedures are of no benefit to patients and therefore lung cancer is the principal cause of cancer-associated mortality worldwide (3,4). Due to the changes of lifestyle and environmental pollution aggravation, lung cancer presents an increasing rate of mortality, and younger trend (5,6). As the occurrence and development of lung cancer is multi-factorial, polygenic and multi-level process, there is still a requirement for an accurate diagnosis method in the early stages.…”