Table 2.
Clinical trials | Recruitment period | Phase | Study arms | Chemotherapy regime | No. of patients | Overall survival | p-value | Progression-free survival | P-value |
Hui 2009 | 2002–2004 | II | IC + CCRT | IC: cisplatin 75 mg/m2 d1 +docetaxel 75 mg/m2 d1, Q3W for two cycles CC: cisplatin 40 mg/m2 d1, QW for eight cycles |
34 | 94.1% | 0.012 | 88.2% | 0.12 |
CCRT | 31 | 67.7% | 59.5% | ||||||
Fountzilas 2012 | 2003–2008 | II | IC + CCRT | IC: epirubicin 75 mg/m2 d1 +paclitaxel 175 mg/m2 d1 +cisplatin 75 mg/m2 d2, Q3W for three cycles CC: cisplatin 40 mg/m2 d1, QW for eight cycles |
72 | 70% | 0.89 | 65% | 0.38 |
CCRT | 69 | 59% | 64% | ||||||
Tan 2015 | 2004–2012 | II/III | IC + CCRT | IC: carboplatin AUC = 2.5 d1 +gemcitabine 1000 mg/m2 d1, d8 +paclitaxel 70 mg/m2 d1, d8, Q3W for three cycles CC: cisplatin 40 mg/m2 d1, QW for eight cycles |
86 | 94.3% | 0.494 | 74.9% | 0.362 |
CCRT | 86 | 92.3% | 67.4% | ||||||
Sun 2016 | 2011–2013 | III | IC +CCRT | IC: cisplatin 60 mg/m2 d1 +docetaxel 60 mg/m2 d1 +fluorouracil 600 mg/m2/day d1-5, Q3W for three cycles CC: cisplatin 100 mg/m2 d1, Q3W for three cycles |
241 | 92% | 0.029 | 80% | 0·034 |
CCRT | 239 | 86% | 72% | ||||||
Cao 2017 | 2008–2015 | III | IC +CCRT | IC: cisplatin 80 mg/m2 d1 +fluorouracil 800 mg/m2/day d1-5, Q3W for two cycles CC: cisplatin 80 mg/m2 d1, Q3W for three cycles |
238 | 88.2% | 0.815 | 82.0% | 0.028 |
CCRT | 238 | 88.5% | 74.1% | ||||||
Frikha 2018 | 2009–2012 | III | IC +CCRT | IC: docetaxel 75 mg/m2 d1 +cisplatin 75 mg/m2 d1 +fluorouracil 750 mg/m2/day d1-5, Q3W for three cycles CC: cisplatin 40 mg/m2 d1, QW for seven cycles |
42 | 86.3% | 0.059 | 73.9% | 0.042 |
CCRT | 41 | 68.9% | 57.2% | ||||||
Hong 2018 | 2003–2009 | III | IC +CCRT | IC: mitomycin 8 mg/m2 d1 +epirubicin 60 mg/m2 d1 +cisplatin 60 mg/m2 d1 +fluorouracil 450 mg/m2 d8 +leucovorin 30 mg/m2 d8, Q3W CC: cisplatin 30 mg/m2 d1, QW |
239 | 72% | 0.62 | 61% | 0.026 |
CCRT | 240 | 68% | 50% |
IC, induction chemotherapy; CCRT, concurrent chemoradiotherapy; CC, concurrent chemotherapy;QW, every week; Q3W, every 3 weeks.
3-year survival results are presented, except that the 5 year results are presented for the trial Hong 2018.