Table 10. References for studies on non–cisplatin chemoradiotherapy regimen.
Study | Chemo | RT | OS | DFS | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Author, year | Design | Incl pd | Tx | Arms | Pts (no.) | Median f/u (mo.) | Regimen | Dose to 1’ (Gy) | 3-yr OS | 5-yr OS | Diff in OS | 3-yr DFS | 5-yr DFS | Diff in DFS | ||||
Bonner et al., 2006 (19) | Prosp PIII | 1992–2002 | Def | A. RT alone | 213 | 54 | – | 70–76.8 | 45% | 32% | B>A, P=0.03 | 31% (PFS) | – | B>A, P=0.04 | ||||
B. Cetux-CRT | 211 | 54 | Cetux | 70–76.8 | 55% | 40% | 42% (PFS) | – | ||||||||||
Gillison et al. (RTOG 1016), 2019 (20) | Prosp PIII, HPV-OP | 2011–2014 | Def | A. HDC-CRT | 406 | 54 | HDC | 70 | 90% | 85% | A>B, P=0.016 | 82% | 78% | A>B, P=0.0002 | ||||
B. Cetux-CRT | 399 | 54 | Cetux | 70 | 87% | 78% | 72% | 67% | ||||||||||
Mehanna et al. (DeESCALATE), 2019 (21) | Prosp PIII, HPV-OP | 2012–2016 | Def | A. HDC-CRT | 166 | 25.9 | HDC | 70 | 98% (2-yr) | – | A>B, P=0.0012 | – | – | – | ||||
B. Cetux-CRT | 168 | 25.9 | Cetux | 70 | 89% (2-yr) | – | – | – | – | |||||||||
Shapiro et al., 2014 (22) | Retrosp | 2002–2008 | Def | A. HDC-CRT | 259 | 53.1 | HDC | 70 | – | 87% (4-yr) | A>C, P<0.0001 | – | – | – | ||||
B. Carbo-CRT | 52 | 53.1 | Carbo-5-FU | 70 | – | 70% (4-yr) | B>C, P=0.002 | – | – | – | ||||||||
C. Cetux-CRT | 49 | 53.1 | Cetux | 70 | – | 41% (4-yr) | A vs. B, P=0.35 | – | – | – | ||||||||
Denis et al., 2004 (23) | Prosp PIII, OP | 1994–1997 | Def | A. RT alone | 113 | 66 | – | 70 | – | 16% | B>A, P=0.05 | – | 15% | B>A, P=0.01 | ||||
B. Carbo-CRT | 109 | 66 | Carbo-5FU | 70 | – | 22% | – | 27% | ||||||||||
Tao et al. (REACH), ABSTRACT only (24) | Prosp PIII | Ongoing | Def | A. HDC-CRT | – | – | HDC | 70 | – | – | – | – | – | – | ||||
B. Cetux/Ave–RT | – | – | Cetux-Ave | 70 | – | – | – | – | – | – |
Chemo, chemotherapy; RT, radiotherapy; OS, overall survival; DFS, disease–free survival; PFS, progression–free survival; CIS, cisplatin; CRT, chemoradiation; Incl pd, inclusion period; Tx, treatment; Pts, patients; f/u, follow-up; 1’, primary; Diff, difference; Prosp PIII, prospective phase III; Retrosp, retrospective; Def, definitive; HDC, high-dose cisplatin (80–100 mg/m2 3-weekly, 2–3 cycles); Carbo-5FU: carboplatin-5-Fluorouracil (carboplatin 70 mg/m2 and 5-fluorouracil 600 mg/m2/day continuous infusion for 4 days, 3 cycles on 21-day interval); Cetux: cetuximab (initial dose 400 mg/m2 during the week before radiotherapy followed by maximum of 7 doses of 250 mg/m2 during radiotherapy); Ave: avelumab (10 mg/kg intravenous infusion over 1 hour every 2 weeks during RT and for 12 months following radiotherapy); HPV, human papilloma virus; OP, oropharyngeal cancer.