An analysis of studies on non-small cell lung cancer registered on clinical trials registry of India

Authors

  • Krisha R. Marolia Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai, Maharashtra, India http://orcid.org/0000-0002-9876-648X
  • Rajan P. Nerurkar Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai, Maharashtra, India
  • Arzan K. Vazifdar Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20223360

Keywords:

Lung carcinoma, Trial registry, EGFR mutation, Pemetrexed, Radiation therapy

Abstract

Background: Lung cancer is the most common cancer in males, of which non-small cell type is more prevalent. It is an active area of research owing to the limited available treatment modalities with several studies registered on CTRI. Objectives of current study was to analyse randomized control trials for non-small cell lung cancer registered on clinical trial registry India.

Methods: Studies registered on CTRI were reviewed in this registry-based audit using the keywords lung cancer and non-small cell lung cancer. Parameters such as type of study, nature of intervention, phase of study, primary and secondary endpoints used, etc, were analysed and summarised using descriptive statistics in Microsoft Excel 365.

Results: Out of 230 trials for lung cancer, 121 studied non-small cell lung cancer, of which 103 studies (85.1%) were interventional studies. Most common intervention under study was drug 97 studies (94.2%) followed by radiation 4 studies (3.3%). Majority of trials were phase 3, 48 trials (39.7%) and only 4 (3.3%) studies were phase 1. Five most common primary and secondary endpoints observed were survival, response rate, safety, pharmacokinetic data & quality of life. Maximum patients were in the advanced stage of cancer(52.1%) and pemetrexed (9.9%) was the most common drug used.

Conclusions: We observed an increasing trend in studies registered on CTRI, with maximum studies in phase 3 with patients in the advanced stage of cancer having overall survival as the endpoint.

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Author Biographies

Krisha R. Marolia, Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai, Maharashtra, India

Junior Resident, Department of Pharmacology

Rajan P. Nerurkar, Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai, Maharashtra, India

Professor and Head, Department of Pharmacology

Arzan K. Vazifdar, Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai, Maharashtra, India

Senior Resident, Department of Pharmacology

References

Sung H, Ferlay J, Siegel R, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Cancer J Clin. 2021;71(3):209-49.

India source: Globacon 2020. Available at: https://gco.iarc.fr/today/data/factsheets/populations/356-india-fact-sheets.pdf. Accessed on 20 November 2021.

Goldstraw P, Ball D, Jett J, Le Chevalier T, Lim E, Nicholson A, et al. Non-small-cell lung cancer. Lancet. 2011;378(9804):1727-40.

Report of National cancer registry programme 2012-2016, projection of cancer cases in India. Available at: https://ncdirindia.org/All_Reports/Report_2020/ resources/Chapter14ProjectionofCancerCasesinIndia.pdf. Accessed on 20 November 2021.

Mohan A, Garg A, Gupta A, Sahu S, Choudhari C, Vashistha V, et al. Clinical profile of lung cancer in North India: A 10-year analysis of 1862 patients from a tertiary care center. Lung India. 2020;37(3):190.

Singh N, Agrawal S, Jiwnani S, Khosla D, Malik P, Mohan A, et al. Lung Cancer in India. J Thorac Oncol. 2021;16(8):1250-66.

Global adult tobacco survey. Available at: https://nhm.gov.in/NTCP/Surveys-Reports-Publications/GATS-2-Highlights-(National-level).pdf. Accessed on 20 November 2021.

Travis W, Brambilla E, Noguchi M, Nicholson A, Geisinger K, Yatabe Y, et al. International association for the study of lung cancer/American Thoracic Society/European respiratory society international multidisciplinary classification of lung adenocarcinoma. J Thorac Oncol. 2011;6(2):244-85.

Shi Y, Au J, Thongprasert S, Srinivasan S, Tsai C, Khoa M, et al. A prospective, molecular epidemiology study of EGFR mutations in asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER). J Thorac Oncol. 2014;9(2):154-62.

Midha A, Dearden S, McCormack R. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity (mutMapII). American J Cancer Res. 2015;5(9):2892-911.

DHR-ICMR advanced molecular oncology diagnostic services. Available at: https://dhr.gov.in/node/1533. Accessed on 20 November 2021.

Yoon S, Shaikh T, Hallman M. Therapeutic management options for stage III non-small cell lung cancer. World J Clin Oncol. 2017;8(1):1.

Report of National cancer registry programme 2012-2016, projection of cancer cases in India. Available at: https://ncdirindia.org/All_Reports/Report_ 2020/resources/Chapter10CancerLung.pdf. Accessed on 20 November 2021.

Reck M, Rabe K. Precision diagnosis and treatment for advanced non-small-cell lung cancer. New Eng J Med. 2017;377(9):849-61.

Cao C, Wang D, Chung C, Tian D, Rimner A, Huang J, et al. A systematic review and meta-analysis of stereotactic body radiation therapy versus surgery for patients with non–small cell lung cancer. J Thorac Cardiovasc Surg. 2019;157(1):362-73.

Clinical trial endpoints. Available at: https://friendsof cancerresearch.org/glossary-term/clinical-trial-endpoints/. Accessed on 20 November 2021.

Delgado A, Guddati A. Clinical endpoints in oncology a primer. Am J Cancer Res. 2021;11(4):1121-31.

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Published

2022-12-26

How to Cite

Marolia, K. R., Nerurkar, R. P., & Vazifdar, A. K. (2022). An analysis of studies on non-small cell lung cancer registered on clinical trials registry of India. International Journal of Basic & Clinical Pharmacology, 12(1), 88–92. https://doi.org/10.18203/2319-2003.ijbcp20223360

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Original Research Articles