Abstract

To evaluate the safety and efficacy of combining Endostar antiangiogenic therapy with neoadjuvant chemotherapy for the treatment of stage IIIA (N2) NSCLC, we conducted a randomized, controlled, open-label clinical study of 30 NSCLC patients. Patients were randomly assigned to the test or control groups, which received either two cycles of an NP neoadjuvant chemotherapy regimen combined with Endostar or the NP regimen alone, respectively, at a 2:1 ratio. Efficacy was assessed after 3 weeks, and surgical resection occurred within 4 weeks, in the 26 patients who successfully completed treatment. While total response rates (RR) and clinical benefit rates (CBR) did not differ between the experimental groups, total tumor regression rates (TRR) were higher in the test group than in the control group. Median DFS and OS also did not differ between the test and control groups. Clinical perioperative indicators, including intraoperative blood loss, number of dissected lymph node groups, duration of postoperative indwelling catheter use, and time to postoperative discharge, were comparable in the test and control groups. Finally, hematological and non-hematological toxicities and postoperative pathological indicators, including down-staging ratio, complete resection ratio, and metastatic lymph node ratio, also did not differ between the groups. Overall, combining Endostar with NP neoadjuvant chemotherapy increased therapeutic efficacy without increasing adverse effects in stage IIIA-N2 NSCLC patients. This study is registered with ClinicalTrials.gov (number NCT02497118).

Highlights

  • Lung cancer is a leading cause of death related to malignant tumors

  • We found trends towards increases in total response rates (RR) and clinical benefit rates (CBR) by about 10% and 27.5%, respectively (p>0.05), and tumor regression rates (TRR) increased by about 12% (p

  • Compared to the control group, median diseasefree survival (DFS) (12 months, 95%CI 9.06 to 14.94 vs 9 months, 95%CI 6.23 to 11.77) and median overall survival (OS) (19 months, 95%CI 13.37 to 24.63 vs 16 months, 95%CI 3.07 to 28.94) both tended to increase by approximately 3 months in the test group, these differences were not statistically significant (Figures 1 and 2)

Read more

Summary

Introduction

Mediastinal lymph node-positive stage IIIA non-small cell lung cancer (NSCLC), confirmed either preoperatively or by postoperative pathology, is associated with poor prognosis [1]. Neoadjuvant chemotherapies modestly suppress stage IIIA NSCLC in some patients [24]. Studies have found that, compared to chemotherapy alone, combining Endostar with an NP neoadjuvant chemotherapy regimen markedly improves response rates, clinical benefit rates, and time to progression in advanced NSCLC patients [7,8]. While it is possible that using Endostar concurrently with neoadjuvant therapy could improve response rates, clinical benefit rates, and surgical resection rates, few reports have examined the efficacy and surgical safety of this combined treatment. We conducted a randomized, controlled, open-label clinical study at the Tianjin Medical University Cancer Institute and Hospital between April 2011 and December 2013 to evaluate the perioperative safety and efficacy of NP www.impactjournals.com/oncotarget

Methods
Results
Conclusion
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call