Table 4.
Randomized clinical trials of molecular targeted therapies combined to radiotherapy in locally advanced HNSCC*
| Treatment arms | Concomitant therapies | Comment | Phase | No. | ORR, % | DFS (or LDC) |
OS |
Reference | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % (at y) | HR | P | % (at y) | HR | P | |||||||
| Cetuximab | RT | III | 211 | 74 | 50 (2y LDC) | 0.7 | .006 | 62 (2y) | 0.74 | .03 | (6) | |
| RT | 213 | 64 | 41 (2y LDC) | 55 (2y) | ||||||||
| Cetuximab | Cisplatin + RT | III | 444 | NA | 59 (3y) | 1.08 | NS | 76 (3y) | 0.95 | NS | (85) | |
| Cisplatin + RT | 447 | NA | 61 (3y) | 73 (3y) | ||||||||
| Cetuximab | RT | HPV+ | III | 168 | NA | 84 (2y) | 3.4 | .0007 | 89 (2y) | 5 | .001 | (86) |
| Cisplatin | RT | and low-risk | 166 | NA | 94 (2y) | 99 (2y) | ||||||
| Cetuximab | RT | HPV+ | III | 399 | NA | 67 (5y) | 1.72 | .0002 | 78 (5y) | 1.45 | NS | (87) |
| Cisplatin | RT | 406 | NA | 78 (5y) | 85 (5y) | |||||||
| Panitumumab | Accelerated RT | III | 159 | NA | 76 (2y) | 0.95 | NS | 88 (2y) | 0.89 | NS | (88) | |
| Cisplatin | Standard RT | 156 | NA | 73 (2y) | 85 (2y) | |||||||
| Panitumumab | Cisplatin + RT | II | 87 | 71 | 61 (2y) | 1.15 | NS | 69 (2y) | 1.63 | NS | (89) | |
| Cisplatin + RT | 63 | 82 | 65 (2y) | 78 (2y) | ||||||||
| Panitumumab | RT | II | 90 | NA | 41 (2y) | 1.73 | .03 | 63 (2y) | 1.59 | NS | (90) | |
| Cisplatin | RT | 61 | NA | 61 (2y) | 71 (2y) | |||||||
| Erlotinib | Cisplatin + RT | II | 99 | 70 | 74 (2y) | 0.9 | NS | NA | NA | — | (91) | |
| Cisplatin + RT | 105 | 63 | 70 (2y) | NA | NA | |||||||
| Gefitinib | Cisplatin + RT | II | 110 | 52 | 33 (2y LDC) | 0.92 | NS | NA | NA | — | (92) | |
| Placebo | Cisplatin + RT | 116 | 60 | 34 (2y LDC) | NA | NA | — | |||||
| Gefitinib | Maintenance post-RT | II | 111 | 59 | 29 (2y LDC) | 0.68 | NS | NA | NA | — | ||
| Placebo | 115 | 54 | 37 (2y LDC) | NA | NA | — | ||||||
| Lapatinib | Cisplatin + RT | Followed by maintenance | II | 34 | 65 | 55 (1.5y) | 0.74 | NS | 68 (1.5y) | 0.9 | NS | (93) |
| Placebo | Cisplatin + RT | 33 | 48 | 41 (1.5y) | 57 (1.5y) | |||||||
| Lapatinib | Cisplatin + RT | Followed by maintenance | III | 346 | NA | 57 (1.5y) | 1.1 | NS | 68 (1.5y) | 0.96 | NS | (94) |
| Placebo | Cisplatin + RT | 342 | NA | 58 (1.5y) | 66 (1.5y) | |||||||
*DFS = disease-free survival; HNSCC = head and neck squamous cell carcinoma; HR = hazard ratio; LDC = local disease control; NA = not available; NS = not statistically significant; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RT = radiotherapy.