PMID- 28413785
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220310
IS  - 2278-330X (Print)
IS  - 2278-4306 (Electronic)
IS  - 2278-330X (Linking)
VI  - 6
IP  - 1
DP  - 2017 Jan-Mar
TI  - Efficacy of erlotinib as first-line maintenance therapy in patients with locally 
      advanced or metastatic nonsmall cell lung cancer who have not experienced disease 
      progression or unacceptable toxicity during chemotherapy.
PG  - 1-5
LID - 10.4103/2278-330X.202573 [doi]
AB  - BACKGROUND: First-line maintenance with erlotinib in nonsmall cell lung cancer 
      (NSCLC) patients without progression after four cycles of chemotherapy was well 
      tolerated and significantly prolonged progression-free survival (PFS) compared 
      with placebo. AIM AND DESIGN: This open-label, single arm, Phase IV, 
      interventional study was designed to evaluate erlotinib as first-line maintenance 
      after chemotherapy in Indian NSCLC patients. Primary efficacy objective was to 
      evaluate PFS rate (PFSR) at week 52 and secondary objectives were determination 
      of PFS, overall survival (OS), overall response rate (ORR), disease control rate, 
      and safety. SUBJECTS AND METHODS: Patients were treated with erlotinib until 
      disease progression/death/unacceptable toxicity or end of study. Patients with 
      disease progression underwent scheduled clinical assessments every 12 weeks 
      thereafter. Kaplan-Meier estimates were used to evaluate PFSR, PFS, and OS. The 
      ORR was summarized using number and percentage along with two-sided 95% 
      Clopper-Pearson confidence interval. The incidence of adverse events (AEs) and 
      serious AEs (SAEs) was tabulated according to severity, outcome, and relationship 
      to erlotinib. RESULTS: Of the 51 enrolled patients, 47 patients completed the 
      study (2: Continuing treatment, 41: Disease progression, and 4: Death) and four 
      patients discontinued treatment (3: Lost to follow-up; 1: Withdrew consent). PFSR 
      was 22.5% at 12 months, median PFS 99 days (14.14 weeks), and median OS was 671 
      days (22 months). The probability of OS was 74.5% at 14 months. The ORR was 
      25.5%, and disease control rate was 55.3%. AEs were reported in 62.7% and SAE in 
      7.8% of patients. Common AEs were diarrhea and rash. CONCLUSIONS: Erlotinib was 
      well tolerated by Indian patients in first-line maintenance setting and resulted 
      in median PFS of 14 weeks and median OS of 22 months better than previously 
      reported and with no new safety concerns in this population.
FAU - Rajappa, Senthil
AU  - Rajappa S
AD  - Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and 
      Research Institute, Hyderabad, Telangana, India.
FAU - Doval, Dinesh Chandra
AU  - Doval DC
AD  - Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research 
      Centre, Rohini, New Delhi, India.
FAU - Biswas, Jaydip
AU  - Biswas J
AD  - Department of Medical Oncology, Chittaranjan National Cancer Institute, Kolkata, 
      West Bengal, India.
FAU - Patil, Shekar
AU  - Patil S
AD  - Department of Medical Oncology, HCG Bangalore Institute of Oncology, Bengaluru, 
      Karnataka, India.
FAU - Somani, Naresh
AU  - Somani N
AD  - Department of Medical Oncology, Bhagwan Mahaveer Cancer Hospital and Research 
      Centre, Jaipur, Rajasthan, India.
FAU - Srinivasan, Sankar
AU  - Srinivasan S
AD  - Department of Medical Oncology, Apollo Speciality Hospital, Chennai, Tamil Nadu, 
      India.
FAU - Bondarde, Shailesh
AU  - Bondarde S
AD  - Department of Medical Oncology, Shatabdi Super Speciality Hospital, Suyojit City 
      Centre, Nashik, Maharashtra, India.
FAU - Palwe, Nitin S
AU  - Palwe NS
AD  - Department of Medical, Roche Products (India) Pvt. Ltd, Mumbai, Maharashtra, 
      India.
FAU - Swarup, Binay
AU  - Swarup B
AD  - Department of Medical, Roche Products (India) Pvt. Ltd, Mumbai, Maharashtra, 
      India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - South Asian J Cancer
JT  - South Asian journal of cancer
JID - 101618774
PMC - PMC5379883
OTO - NOTNLM
OT  - Epidermal growth factor receptor-tyrosine kinase inhibitor
OT  - first-line maintenance therapy
OT  - nonsmall cell lung cancer
OT  - progression-free survival rate
OT  - targeted therapy
COIS- There are no conflicts of interest.
EDAT- 2017/04/18 06:00
MHDA- 2017/04/18 06:01
PMCR- 2017/01/01
CRDT- 2017/04/18 06:00
PHST- 2017/04/18 06:00 [entrez]
PHST- 2017/04/18 06:00 [pubmed]
PHST- 2017/04/18 06:01 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - SAJC-6-1 [pii]
AID - 10.4103/2278-330X.202573 [doi]
PST - ppublish
SO  - South Asian J Cancer. 2017 Jan-Mar;6(1):1-5. doi: 10.4103/2278-330X.202573.