Table 3.
Trials of Small Molecule Tyrosine Kinase Inhibitors and RT.
| Trials | Study years | Study arms | Chemo therapy |
TKI dose |
Median follow UP (years) | Primary endpoint | Result | Comment |
|---|---|---|---|---|---|---|---|---|
| GREGOIRE a,b | 2006–2009 | CT + RT + GEF CT + RT + PL |
3 weekly Cisplatin |
250 mg/day 500 mg/day |
2 | LCR | 32.7% v/s 33.6% (p = NS) |
No benefit |
| MARTINS a | 2006–2011 | CT + RT + ER CT + RT |
3 weekly Cisplatin |
150 mg/day | 2 | CRR | 52% v/s 40% (p-NS) |
No benefit |
| HARRINGTON b,c | 2006–2013 | CT + RT + LAP CT + RT + PL |
3 weekly Cisplatin |
1500 mg/day |
3 | DFS | 56.9% v/s 57.7% (p-NS) |
No benefit More toxicity |
GEF – Gefitinib, PL – Placebo, ER – Erlotinib, LAP – Lapatinib, LCR – Local Control Rate, CRR – Complete Response Rate, DFS – Disease Free Survival.
a – phase 2 study; b – used maintenance therapy also; c - post op adjuvant high risk patients receiving CCRT.