Table 2.
Subject | Age at Dx | Gender | Race | Date of initial Dx | Primary site | Histology | Initial Stage | ARa | HER2 statusb | Initial Tx | Completed Initial Tx | First recurrence | Prior Systemic Tx | Started tipifarnib | Starting dosec | Time on therapy (months)d | BOR | % Tumor changee |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 48 | M | W | 06/15/13 | PAR | AcCC | IVA | − | 0 | S+R | 04/15/14 | 09/23/14 | ICI | 10/25/18 | 600 mg | 14.0+ | PR | −31.4 |
2 | 75 | M | W | 05/12/17 | PAR | CexPA | IVA | + | 0 | S+R | 09/26/17 | 01/16/18 | ADT | 03/08/19 | 600 mg | 1.0 | PD | +15.6 |
3 | 61 | M | W | 05/21/15 | PAR | SDC | IVC | + | 1+ | C | -- | -- | ADT | 09/09/16 | 900 mg | 1.0 | PD | +6.7 |
4 | 69 | M | W | 12/03/10 | PAR | MyoEpC | IV | − | 0 | S+R | 02/28/11 | 11/22/13 | Phase I | 09/30/15 | 900 mg | 13.0 | SD | −27.5 |
5 | 34 | M | A | 08/23/11 | PAR | MyoEpC | IV | S | 10/11/11 | 01/14/14 | CT | 05/13/15 | 300 mg | 1.0 | PD | +20.6 | ||
6 | 58 | M | B | 09/26/14 | PAR | Adeno | IV | + | 0 | S+CRT | 01/16/15 | -- | Cisplatin | 01/14/16 | 900 mg | 3.0 | SD | −14.1 |
7 | 65 | M | W | 03/07/14 | PAR | SDC | IV | S+CRT | 06/30/14 | 03/07/15 | Cisplatin | 10/15/15 | 900 mg | 7.0 | SD | +6.9 | ||
8 | 53 | F | W | 12/09/11 | PAR | OncCA | IV | S+CRT | 03/26/12 | 09/04/15 | Cisplatin | 01/21/16 | 900 mg | 8.0 | SD | +3.1 | ||
9 | 73 | M | W | 08/16/17 | PNS | SGC | IV | C | -- | -- | CD | 02/20/18 | 900 mg | 10.0 | SD | −16.9 | ||
10 | 38 | M | A | 06/03/10 | PAR | SDC | IVA | + | 2+ | S+CRT | 09/09/10 | 02/15/12 | Alpelisib | 06/18/19 | 600 mg | 6.0+ | UE | -- |
11 | 56 | F | W | 08/25/11 | PAR | MyoEpC | I | + | 1+ | S+R | 11/16/11 | 10/25/16 | CT | 05/08/18 | 900 mg | 5.0 | SD | −14.2 |
12 | 59 | M | W | 06/15/08 | PAR | MyoEpC | II | S+R | 08/15/08 | 05/15/15 | ICI | 02/14/19 | 600 mg | 10.0+ | SD | −10.3 | ||
13 | 50 | M | W | 05/27/16 | PAR | MEC | IVA | + | 2+ | S+R | 08/15/16 | 11/28/17 | ADT | 05/20/19 | 600 mg | 2.0 | PD | +21.1 |
reported ‘+’ if greater than or equal to 1% expression by immunohistochemistry (IHC) was observed, blank spaces were not available for testing;
HER-2/neu status was defined by IHC using standard immune expression intensity scoring from 0 to 1–3+ (none had amplification), if available;
reported milligram (mg) doses were dosed by mouth twice daily;
a ‘+’ indicates that the patient remains on therapy at the date of analysis (1/6/20);
as determined by RECIST v1.1 with central review; Dx = diagnosis, AR = androgen receptor, Tx = treatment, BOR = best overall response per RECIST v1.1, PAR = parotid, PNS = paranasal sinuses, AcCC = acinic cell carcinoma, CexPA = carcinoma ex pleomorphic adenoma, SDC = salivary duct carcinoma, MyoEpC = myoepithelial-epithelial carcinoma, Adeno = adenocarcinoma, OncCA = oncocytic carcinoma, SGC = salivary gland cancer not otherwise specified, MEC = mucoepidermoid carcinoma, S = surgery, R = radiation, CRT = concurrent chemoradiation, ICI = immune checkpoint inhibitor, ADT = androgen deprivation therapy, CT = carboplatin/paclitaxel, CD = carboplatin/docetaxel, SD = stable disease, PD = progression of disease, UE = unevaluable.