Chest
Thoracic Oncology: Original ResearchAprepitant for Cough Suppression in Advanced Lung Cancer: A Randomized Trial
Section snippets
Trial Design
We conducted the trial at Tata Memorial Center (TMC), a tertiary oncology teaching hospital in Mumbai, India. The study was approved by the institutional ethics committee (Institutional Ethics Committee-II of Tata Memorial Center, project 1841) and monitored by the data safety monitoring subcommittee. All patients provided written informed consent. The trial was conducted according to principles laid down by the International Conference on Harmonization Good Clinical Practice guidelines,
Patients
Between June 2017 and June 2018, we randomized 128 patients, 64 to each arm. Details of patient enrollment, allocation, therapy, and analysis are provided in Figure 1. Pertinent demographics and baseline information are included in Table 1.
Therapy for Cough
Patients in both arms received physician’s choice of cough medication; in addition, patients in the aprepitant arm received aprepitant. For any patient whose cough was not controlled, another antitussive could be added. Cough medications used were
Discussion
To the best of our knowledge, ours is the first randomized trial to demonstrate the benefit of a cough medication in patients with advanced lung cancer. Aprepitant improved cough in patients with advanced lung cancer as evidenced by a significant decrease in cough severity and cough impact. This improvement was also seen in the cough domain of the QoL. The decrease in the cough parameters occurred as early as day 3 and continued to decrease at subsequent time points, until day 12, the end of
Conclusions
Aprepitant led to a significant improvement in cough in patients with advanced lung cancer, with no increase in severe side effects. Aprepitant represents a new treatment option for cough in patients with lung cancer.
Acknowledgments
Author contributions: V. N. and K. P. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis, including and especially any adverse effects. V. N., A. B., V. M. P., A. J., N. M., S. S., S. K., S. A. M., K. M., S. I., and K. P. contributed substantially to the study design, data analysis and interpretation, and the writing of the manuscript.
Financial/nonfinancial disclosures: The authors have reported to CHEST the
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Mr Maske is currently at the Marine Medical Services (Mumbai, India); Dr Ishi is currently at the NIMS Hospital (Nashik, India); the Khandesh Cancer Center (Dhule, India), and the Apex Wellness Hospital (Nashik, India).
FUNDING/SUPPORT: This work was supported by an intramural grant from the Tata Memorial Center Research Administrative Council (TRAC), a grant from the Indian Co-operative Oncology Network, and an unrestricted educational grant from Glenmark Pharmaceuticals Ltd.