Table 1: The characteristics of the included RCTs.

StudyRegionType of studyAgeNo. of patientsGender (male/female)TreatmentFollow-up timeduration of treatment Outcomes

Stewart, 2009Multi-centrePhase III RCTNR486396/90T1: Gefitinib (250 mg/d)
T2: Gefitinib (500 mg/d)
C: Methotrexate
2 yearsuntil disease progressionOS, ORR, ADR
Gregoire, 2011Multi-centrePhase II RCTNR226198/28T:RT+Cisplatin+Gefitinib
C:RT+Cisplatin+ placebo
2 yearsa maximum of 2 years after randomization or until disease progression, unacceptable toxicity, patient withdrawal, study closure, or deathOS, ORR, PFS, ADR
Argiris, 2013AmericaPhase III RCT60.8
61.4
270190/49T:Gefitinib+Docetaxel
C: Docetaxel+placebo
35 monthsuntil progressionOS, ORR, ADR
Singh, 2013IndiaRCT55
53
6048/12T:RT+gefitinib
C: RT
20 months90 days;
7 weeks
ORR, ADR
Bhattacharya, 2014IndiaRCTNR6154/7T:RT+Cisplatin+Gefitinib
C: RT+Cisplatin
1 year7 weeksORR, ADR
Kushwaha, 2015IndiaRCT47
46.9
46.95
117111/6T: Gefitinib
C1: Methotrexate
C2:Methotrexate+ fluorouracil
27 months8.89 months;
6.42 months;
6.5 months
ORR, ADR
Saini, 2016IndiaRCT50
54
6764/3T:RT+Cisplatin+Gefitinib
C: RT+Cisplatin
42 months;
45 months
9 weeks;
7 weeks
OS, PFS, ORR, ADR

RCTs: randomized controlled trials; NR: no report; T: treatment group; C: control group; OS: overall survival; ORR: overall response rate; PFS: progression free survival; ADR: adverse drug reaction.