Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of a Phase III randomized trial to compare the benefit of gefitinib versus pemetrexed/carboplatin for epidermal growth factor receptor-mutated non-small cell lung cancer
| Autor: | Atanu Bhattacharjee, Anant Ramaswamy, Vijay Patil, Nandini Menon, Nikhil Pande, Ashay Karpe, Arun Chandrasekharan, Anuradha Chougule, Abhishek Mahajan, Vanita Noronha, Amit Joshi, Vikas Talreja, Alok Goel, Kumar Prabhash, Amit Janu, Nilendu Purandare |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Oncology
medicine.medical_specialty Randomization gefitinib lcsh:RC254-282 law.invention chemistry.chemical_compound Gefitinib Randomized controlled trial epidermal growth factor receptor mutation law Internal medicine medicine Epidermal growth factor receptor Lung cancer pemetrexed non-small cell lung cancer biology business.industry General Medicine quality-adjusted time without symptoms or toxicity medicine.disease lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens Carboplatin Pemetrexed chemistry Toxicity carboplatin biology.protein business epidermal growth factor receptor medicine.drug |
| Zdroj: | Cancer Research, Statistics, and Treatment, Vol 2, Iss 1, Pp 21-27 (2019) |
| ISSN: | 2590-3225 2590-3233 |
| Popis: | Background:> In an open-label, Phase III randomized study, gefitinib was found to be superior to pemetrexed-platinum in terms of progression-free survival in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer. In this analysis, we have assessed the efficacy of gefitinib over pemetrexed-platinum using quality-adjusted time without symptoms or toxicity (Q-TWiST) of treatment analysis method. Methods: The overall survival in each arm was partitioned into the following three health states: time spent in Grade 2 or above toxicity after randomization and before progression (TOX state), time spent after randomization and before progression without Grade 2 or above toxicity (TWiST state), and time spent after progression (REL state). The mean Q-TWiST was calculated for each arm using utility coefficients of 0.65 for TOX, 0.71 for TWiST, and 0.67 for REL states. The difference in Q-TWiST and the 95% confidence interval (CI) of the difference were calculated using a nonparametric bootstrap.P= 0.05 was considered statistically significant. Results: The mean TOX duration (37.6 vs. 16.2 days,P < 0.001) and TWiST duration (211.7 vs. 162.2 days, P = 0.002) were higher in the gefitinib arm. The mean REL state duration was higher in the pemetrexed-carboplatin arm (164.4 vs. 74.3 days,P < 0.001). The mean Q-TWiST was 224.6 days in the gefitinib arm versus 235.9 days in the pemetrexed-carboplatin arm. The difference was 11.3 days; 95% CI, 6.920–29.564,P= 0.224. Conclusion: The mean Q-TWiST of patients in the gefitinib arm was similar to that of patients in the pemetrexed-carboplatin arm. These results challenge the superiority of sequencing gefitinib followed by chemotherapy over pemetrexed-carboplatin followed by gefitinib in terms of Q-TWiST. |
| Databáze: | OpenAIRE |
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