PMID- 31695838
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191108
IS  - 1949-2553 (Electronic)
IS  - 1949-2553 (Linking)
VI  - 10
IP  - 59
DP  - 2019 Oct 29
TI  - 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.
PG  - 6297-6307
LID - 10.18632/oncotarget.27214 [doi]
AB  - 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.
CI  - Copyright: (c) 2019 Patil et al.
FAU - Patil, Vijay
AU  - Patil V
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Joshi, Amit
AU  - Joshi A
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Noronha, Vanita
AU  - Noronha V
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Agarwala, Vivek
AU  - Agarwala V
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Chougule, Anuradha
AU  - Chougule A
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Kanan, Sadhana
AU  - Kanan S
AD  - Department of Biostatistics, Advanced Center for Treatment, Research, and 
      Education in Cancer, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Bhattacharjee, Atanu
AU  - Bhattacharjee A
AD  - Section of Biostatistics, Centre for Cancer Epidemiology, Tata Memorial Hospital, 
      Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Chandrasekharan, Arun
AU  - Chandrasekharan A
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Pande, Nikhil
AU  - Pande N
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Simha, Vijai
AU  - Simha V
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Goud, Supriya
AU  - Goud S
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - More, Sucheta
AU  - More S
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Kumar, Rajiv
AU  - Kumar R
AD  - Department of Pathology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Mahajan, Abhishek
AU  - Mahajan A
AD  - Department of Radiology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Janu, Amit
AU  - Janu A
AD  - Department of Radiology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Purandare, Nilendu
AU  - Purandare N
AD  - Department of Nuclear Medicine, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
FAU - Prabhash, Kumar
AU  - Prabhash K
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
AD  - Homi Bhabha National Institute, Mumbai, India.
LA  - eng
PT  - Journal Article
DEP - 20191029
PL  - United States
TA  - Oncotarget
JT  - Oncotarget
JID - 101532965
PMC - PMC6824869
OTO - NOTNLM
OT  - NSCLC
OT  - erlotinib
OT  - maintenance
OT  - pemetrexed
COIS- CONFLICTS OF INTEREST The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests: Dr. Noronha reports grants from Dr. Reddy's LaboratoriesEthnc, grants 
      from Amgen, grants from Sanofi Aventis, outside the submitted work. Dr. Prabhash 
      reports grants from Biocon Ltd, grants from Dr. Reddy's Laboratories Inc, grants 
      from Fresenius Kabi India Pvt Ltd, grants from Alkem Laboratories, grants from 
      Natco Pharma Ltd, grants from BDR Pharmaceutics Intl Pvt Ltd, grants from Roche 
      Holding AG, outside the submitted work. None of the other authors have anything 
      to declare that maybe considered as potential competing interests.
EDAT- 2019/11/07 06:00
MHDA- 2019/11/07 06:01
PMCR- 2019/10/29
CRDT- 2019/11/08 06:00
PHST- 2019/02/04 00:00 [received]
PHST- 2019/08/29 00:00 [accepted]
PHST- 2019/11/08 06:00 [entrez]
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2019/11/07 06:01 [medline]
PHST- 2019/10/29 00:00 [pmc-release]
AID - 27214 [pii]
AID - 10.18632/oncotarget.27214 [doi]
PST - epublish
SO  - Oncotarget. 2019 Oct 29;10(59):6297-6307. doi: 10.18632/oncotarget.27214. 
      eCollection 2019 Oct 29.