Table 1.
Demographic and clinical characteristics of patients treated with the p53MVA vaccine and gemcitabine chemotherapy.
| p53MVA vaccine in combination with Gemcitabine n=11 | |
|---|---|
|
| |
| Age at study enrollment (median and range) | 59 (range 41-76) |
|
| |
| Race/ethnicity (no. patients): | |
| Asian | 3 (27%) |
| Caucasian | 7 (64%) |
| Hispanic | 1 (9%) |
|
| |
| Performance status (no. patients): | 4 (36%) |
| 0 | |
| 1 | 6 (55%) |
| 2 | 1 (9%) |
|
| |
| Histology (no. patients): | |
| High grade serous carcinoma(Patients 2,3,4,8,9,10) | 6 (54%) |
| Low grade serous carcinoma (Patients 1 and 11) | 2 (36%) |
| Adenocarcinoma, NOS (Patient 6) | 1 (9%) |
| Carcinosarcoma (Patient 5) | 1 (9%) |
| Clear cell (Patient 7) | 1 (9%) |
|
| |
| Stage (no. patients): | |
| III | 4 (36%) |
| IV | 7 (64%) |
|
| |
| Platinum sensitivity (no. patients): | |
| platinum refractory1 | 9 (81%) |
| borderline platinum sensitive | 2 (18%) |
|
| |
| Prior lines of therapy for recurrent disease2 | |
| 0 lines | 2(18%) |
| 1 line | 7(63%) |
| 2 lines | 2(18%) |
|
| |
| Off treatment reason (no. patients) | |
| Disease progression | 6 (55%) |
| Toxicity | 4 (36%) |
| Patient Refusal | 1 (9%) |
|
| |
| Number of study drug courses completed (median and range) | 4 (1, 11) |
|
| |
| Follow up (median months and range) | 17.5 (2.1 – 18.7) |
1
One patient relapsed at 6 months and was considered platinum-resistant.
2
adjuvant or neoadjuvant chemotherapy not included; also non-chemotherapy lines of therapy for recurrent disease not included (PARP inhibition × 1 patient; hormonal therapy × 1 patient).