Table 1.
Trial | Tumor type | Treatment (s) | n | Frequency of Toxicity [n = (%)] | Median PFS (months) | ||||
---|---|---|---|---|---|---|---|---|---|
HT ≥ grade 2 | HFSR ≥ grade 2 | HT < grade 2 vs. ≥ grade 2 | Log-Rank P = | HFSR < grade 2 vs. ≥ grade 2 | Log-Rank P = | ||||
APC-CRPC | mCRPC | Bevacizuamb + Thalidomide + Docetaxel | 60 | 15 (25.0) | 4 (6.7) | 14.9 vs. 31.5 | 0.0009 | N/A* | ND* |
BAY-BEV | ST | Sorafenib + Bevacizumab | 27 | 15 (55.6) | 13 (48.1) | 3.7 vs. 11.9 | 0.052 | 3.7 vs. 12.6 | 0.094 |
BAY-CRPC† | mCRPC | Sorafenib | 46 | 9 (19.6) | 7 (15.2) | 3.7 vs. 1.8 | 0.067 | 2.0 vs. 3.1 | 0.29 |
BAY-NSCLC | NSCLC | Sorafenib | 22 | 9 (40.9) | 10 (45.5) | 1.9 vs. 4.6 | 0.19 | 2.9 vs. 3.7 | 0.38 |
BAY-CRC | CRC | Sorafenib + Cetuximab | 18 | 1 (5.6) | 2 (11.1) | N/A* | ND* | 4.7 vs. 8.7 | 0.0065 |
BAY-KS‡ | KS | Sorafenib +/- Protease inhibitor | 8 | 3 (37.5) | 2 (25.0) | N/A* | ND* | N/A* | ND* |
*Not done (ND). Patients were not evaluated in this analysis due to low frequency of toxicity (i.e. APC-CRPC vs. HFSR and BAY-CRC vs. HT) or due to limited PFS data (KS).
†3 Patients participating on this trial were also treated on APC-CRPC.
‡Two patients on BAY-KS trial received only sorafenib.
C: Caucasian, AA: African-American, Others: Hispanic or Asians, mCRPC: metastatic castrate resistant prostate cancer, NSCLC: non-small cell lung cancer, CRC: colorectal cancer, KS: Kaposi's sarcoma, ST: solid tumors, HFSR: hand-foot skin reaction syndrome, NA: not applicable