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Proffered paper session 1

1638 - Humanized recombinant endostatin combined with vinorelbine plus cisplatin followed by maintenance therapy with humanized recombinant endostatin in advanced non-small cell lung cancer: a multicentre, double-blind, randomised phase 3 trial (411O)

Date

18 Nov 2017

Session

Proffered paper session 1

Presenters

Yan Wang

Citation

Annals of Oncology (2017) 28 (suppl_10): x124-x143. 10.1093/annonc/mdx671

Authors

Y. Shi1, L. Zhang2, S. Zhang3, M. Shi4, S. Qin5, C. Wu6, Z. Zhuang7, G. Mao8, D. Hua9, X. Zhou10, Y. Qu11, Y. Wang12, X. Shi13, C. Hu14, W. Li15, M. Ouyang16, L. Chen17, Y. Sun18, G. Wu19, Y. Sun1

Author affiliations

  • 1 Department Of Medical Oncology, Beijing Key Laboratory Of Clinical Study On Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 2 Department Of Respiratory Medicin, Peking Union Medical College Hospital, 100032 - Beijing/CN
  • 3 Department Of Medical Oncology, Beigjing Chest Hospital,Capital Medical University, 101149 - Beijing/CN
  • 4 Department Of Medical Oncology, Jiangsu Cancer Hospital, 210000 - Nanjing/CN
  • 5 Department Of Medical Oncology, 81st Hospital of People’s Liberation Army, 21000 - Nanjing/CN
  • 6 Department Of Oncology Center, The first People's Hospital of Changzhou, 213002 - Changzhou/CN
  • 7 Department Of Oncology, The Second Affiliated Hospital of Soochow University, 215004 - Suzhou/CN
  • 8 Department Of Oncology, Affiliated Hospital of Nantong University, 226001 - Nantong/CN
  • 9 Department Of Oncology, Affiliated Hospital, Jiangnan University, 214062 - Wuxi/CN
  • 10 Department Of Respiratory Medicine, Shanghai General Hospital, 200000 - Shanghai/CN
  • 11 Department Of Respiratory Diseases, First Affiliated Hospital of Xiamen University, 361003 - Xiamen/CN
  • 12 Department Of Thoracic Oncology, Cancer Center, West China Hospital ,Sichuan University, 610041 - Chengdu/CN
  • 13 Department Of Oncology, The First Affiliated Hospital of Fujian Medical University, 350005 - Fuzhou/CN
  • 14 Department Of Oncology, The Second Xiangya Hospital of Central South University, 410011 - Changsha/CN
  • 15 Cancer Center, The First Hospital of Jilin University, 130021 - Changchun/CN
  • 16 Department Of Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University, 510000 - Guangzhou/CN
  • 17 Department Of Oncology, The First Affiliated Hospital of Shantou University Medical College, 515041 - Shantou/CN
  • 18 Department Of Oncology, Jinan Central Hospital, 250013 - Jinan/CN
  • 19 The Cancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology, 513400 - Wuhan/CN
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Abstract 1638

Background

Humanized recombinant endostatin (rh-endostatin, Sulijia®) is an inhibitor of tumor angiogenesis. We aimed to assess efficacy and safety of rh-endostatin or placebo with vinorelbine/cisplatin (NP) as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC).

Methods

In this multi-centre, double-blind, placebo-controlled, randomized phase 3 trial, we enrolled treatment-naïve patients with stage IV NSCLC. Patients were randomly allocated (2:1) to receive 4-cycle NP and either rh-endostatin 7.5mg/m2 or matching placebo on day 1-14 of a 21-day cycle, non-progressive patients then received rh-endostatin or placebo until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). This study was registered with NCT03117335 and ChiCTR-TRC-11001539.

Results

Between November 11th, 2011, and September 2nd, 2015, 560 patients were enrolled in this study. The median PFS was 5·4 months (95%CI 4·9-5·8) for patients in rh-endostatin plus NP group and 4·7 months (95%CI 4·4-5·9) for those in placebo plus NP group (Hazard Ratio [HR] 0·692; 95% CI 0·523-0·915; p = 0.0098). Subgroup analysis showed that patients with squamous NSCLC (5·0 [4·3-5·4] vs 3·9 [2·8-4·4] months, HR 0·440 [0·261-0·741], p = 0·0021) and smokers (5·0 [4·5-5·4] vs 4·4 [3·2-4·7] months, HR 0·629 [0·437-0·905], p = 0·0124) had significantly longer PFS in the rh-endostatin plus NP group than those in the placebo plus NP group. Adverse events were 99·7% (364/365) in the rh-endostatin plus NP group and 99·4% (180/181) in the placebo plus NP group. The most common grade 3 or worse adverse events were leukopenia (rh-endostatin vs placebo: 69·6% [254/365] vs 53% [96/181], p = 0·0002), neutropenia (77% [281/365] vs 65·2% [118/181], p = 0·0041), and decreased hemoglobin (19·7% [72/365] vs 12·2% [22/181], p = 0·0301).

Conclusions

Rh-endostatin plus NP improves PFS and is well tolerated as first-line treatment for patients with stage IV NSCLC, especially those with squamous NSCLC and smokers.

Clinical trial identification

ClinicalTrials.gov ID: NCT03117335 Protocol No.:TG1107RHE.

Legal entity responsible for the study

Jiangsu Wuzhong Pharmaceutical Group Operation

Funding

Jiangsu Wuzhong Pharmaceutical Group Operation

Disclosure

All authors have declared no conflicts of interest.

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