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Randomized phase 3 open label study of quality of life of patients on Pemetrexed versus Erlotinib as maintenance therapy for advanced non squamous non EGFR mutated non small cell lung cancer

Vijay Patil, Amit Joshi, Vanita Noronha, Vivek Agarwala, Anuradha Chougule, Sadhana Kanan, Atanu Bhattacharjee, Arun Chandrasekharan, Nikhil Pande, Vijai Simha, Supriya Goud, Sucheta More, Rajiv Kumar, Abhishek Mahajan, Amit Janu, Nilendu Purandare and Kumar Prabhash _

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Oncotarget. 2019; 10:6297-6307. https://doi.org/10.18632/oncotarget.27214

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Abstract

Vijay Patil1,7,*, Amit Joshi1,7,*, Vanita Noronha1,7, Vivek Agarwala1,7, Anuradha Chougule1,7, Sadhana Kanan2,7, Atanu Bhattacharjee3,7, Arun Chandrasekharan1,7, Nikhil Pande1,7, Vijai Simha1,7, Supriya Goud1,7, Sucheta More1,7, Rajiv Kumar4,7, Abhishek Mahajan5,7, Amit Janu5,7, Nilendu Purandare6,7 and Kumar Prabhash1,7

1 Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India

2 Department of Biostatistics, Advanced Center for Treatment, Research, and Education in Cancer, Mumbai, India

3 Section of Biostatistics, Centre for Cancer Epidemiology, Tata Memorial Hospital, Mumbai, India

4 Department of Pathology, Tata Memorial Hospital, Mumbai, India

5 Department of Radiology, Tata Memorial Hospital, Mumbai, India

6 Department of Nuclear Medicine, Tata Memorial Hospital, Mumbai, India

7 Homi Bhabha National Institute, Mumbai, India

* These authors contributed equally to this work

Correspondence to:

Kumar Prabhash,email: kumarprabhashtmh@gmail.com

Keywords: maintenance; pemetrexed; erlotinib; NSCLC

Received: February 04, 2019     Accepted: August 29, 2019     Published: October 29, 2019

ABSTRACT

Background: We planned to compare pemetrexed maintenance with erlotinib maintenance in non squamous non Epidermal Growth Factor Receptor (EGFR) mutated non small cell lung cancer (NSCLC). The null hypothesis for this study was that there would be no difference in quality of life (QOL) between pemetrexed and erlotinib maintenance.

Results: The QL2 scores at 3 months were 63.35 (SD 24.99) in pemetrexed arm and 63.01(SD 23.04) in erlotinib arm (p-0.793). Except in 1 domain, the scores were statistically similar between the 2 arms. In the domain of diarrhea, the score was higher as expected in the erlotinib arm (p-0.048). The median progression free survival was 4.5 months (95%CI 4.1–4.9 months) in pemetrexed arm versus 4.5 months (95%CI 3.8–5.2 months) in erlotinib arm (p-0.94). The median overall survival was 16.6 months (15.2–17.9 months) in pemetrexed arm versus 18.3 months (95% CI 13.75–22.91 months) in erlotinib arm (p-0.49).

Methods: The study was an open label, single centre, parallel, phase 3 randomized study with 1:1 randomization between maintenance pemetrexed arm and erlotinib arm. Adult patients (age > or = 18 years), with non squamous EGFR mutation, treated with first line palliative therapy, with non progressive disease post 4–6 cycles of pemetrexed-carboplatin were randomized. Primary outcome was change in the score of QOL (Global health status {QL2}) at 3 months. We estimated that with 200 patients, the study had 80% power to detect a significant difference between the two groups in the change in the global health status score at 3 months with an alpha error of 5%, with an effect size of 0.3 SD.

Conclusions: Maintenance pemetrexed post pemetrexed-platinum chemotherapy fails to improve QOL or time to event outcomes over maintenance erlotinib in EGFR mutation negative NSCLC.


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