Table 3.
Patient characteristics (phase II cohort, n = 18).
| No. (%) | |
|---|---|
| Age (years) | |
| Median (range) | 67 (56-84) |
| <70 | 10 (55.6) |
| ≥70 | 8 (44.4) |
| Sex | |
| Male | 15 (83.3) |
| Female | 3 (16.7) |
| ECOG PS | |
| 0 | 7 (38.9) |
| 1 | 11 (61.1) |
| Disease status | |
| Initially metastatic | 12 (66.7) |
| Recurrent | 6 (33.3) |
| Time to PD on first-line therapy | |
| <6 months | 4 (22.2) |
| ≥6 months | 14 (77.8) |
| Tumor grade | |
| Well differentiated | 1 (5.6) |
| Moderately differentiated | 9 (50.0) |
| Poorly differentiated | 8 (44.4) |
| Histologic subtype | |
| Intestinal | 6 (33.3) |
| Diffuse | 2 (11.1) |
| Unknown or not available | 10 (55.6) |
| Previous surgery for gastric cancer | |
| No | 10 (55.6) |
| Yes | 8 (44.4) |
| Total gastrectomy | 4 (22.2) |
| Partial gastrectomy | 3 (16.7) |
| Palliative gastro-jejunostomy | 1 (5.6) |
| Adjuvant chemotherapy | |
| No | 15 (83.3) |
| Yes | 3 (16.7) |
| TS-1 | 2 (11.1) |
| XP + Pembrolizumab (or Placebo) | 1 (5.6) |
| Site of metastasis | |
| Lymph node | 10 (55.6) |
| Liver | 9 (50.0) |
| Peritoneal seeding | 9 (50.0) |
| Pleural seeding | 1 (5.6) |
| Lung | 1 (5.6) |
| Number of metastatic organs | |
| 1 | 9 (50.0) |
| 2 | 7 (38.9) |
| 3 | 1 (5.6) |
| 4 | 1 (5.6) |
| Prior therapy for metastatic disease | |
| Oxaliplatin based chemotherapy | 14 (77.8) |
| Cisplatin based chemotherapy | 3 (16.7) |
| XP + Trastuzumab | 1 (5.6) |
| Time from the start of first-line therapy to thestart of AZD8186 trial (median, range) | 10.5 (2.4-47.3) |
| PTEN IHC | |
| Positive | 0 |
| Negative | 18 (100.0) |
| PIK3CB gene abnormality | |
| Positive | 1 (5.6) |
| Negative | 11 (61.1) |
| Unknown or not available | 6 (33.3) |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; IHC, immunohistochemistry; PD, progressive disease; PIK3CB, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit beta; PTEN, phosphatase and tensin homolog; XP, capecitabine + cisplatin