Table 2.
Author | Therapy | Patients | n | Outcome and survival | Complications |
Chang et al[77] | Cytoimplant (mixed lymphocyte culture) | Unresectable PDAC | 8 | Median survival: 13.2 mo. 2 partial responders and 1 minor response | 7/8 developed low-grade fever 3/8 required biliary stent placement |
Hecht et al[78] | ONYX-015 (55-kDa gene-deleted adenovirus) + IV gemcitabine | Unresectable PDAC | 21 | No patient showed tumour regression at day 35. After commencement of gemcitabine, 2/15 had a partial response | Sepsis: 2/15 Duodenal perforation: 2/15 |
Hecht et al[79] Chang et al[80,81] | TNFerade (replication-deficient adenovector containing human tumour necrosis factor (TNF)-α gene) | Locally advanced PDAC | 50 | Response: One complete response, 3 partial responses. Seven patients eventually went to surgery, 6 had clear margins and 3 survived > 24 mo | Dose-limiting toxicities of pancreatitis and cholangitis were observed in 3/50 |
Herman et al[82] | Phase III study of standard care plus TNFerade (SOC + TNFerade) vs standard care alone (SOC) | Locally advanced PDAC | 304 (187 SOC + TNFerade) | Median survival: 10.0 mo for patients in both the SOC + TNFerade and SOC arms [hazard ratio (HR), 0.90, 95%CI: 0.66-1.22, P = 0.26] | No major complications. Patients in the SOC + TNFerade arm experienced more grade 1 to 2 fever than those in the SOC alone arm (P < 0.001) |
Sun et al[83] | EUS-guided implantation of radioactive seeds (iodine-125) | Unresectable PDAC | 15 | Tumour response: "partial" in 27% and "minimal" in 20%. Pain relief: 30% | Local complications (pancreatitis and pseudocyst formation) 3/15. Grade III hematologic toxicity in 3/15 |
Jin et al[84] | EUS-guided implantation of radioactive seeds (iodine-125) | Unresectable PDAC | 22 | Tumour response: “partial” in 3/22 (13.6%) | No complications |
PDAC: Pancreatic ductal adenocarcinoma; EUS: Endoscopic ultrasound.