Clinical responses in patients. (A) Esophageal cancer patient E-1: large neck (top) and para-tracheal (bottom) lymph node metastases (yellow arrow) observed in CT images at 6 months after initiating treatment with the vaccine and a hemorrhagic protrusion in the esophagus (yellow arrow) observed by endoscopy at 3 months disappeared at 13 and 6 months, respectively. Only a scar was observed in the esophagus. Tumor recurrence was noted at 21 months and the patient died of disease progression at 23 months. Abbreviations: T, trachea; E, esophagus; V, vertebra. Esophageal cancer patient E-2: para-tracheal (top) and para-esophageal (middle) lymph node metastases (yellow arrow) observed at baseline in CT images disappeared by 3.5 months after initiating vaccine treatment. However, a metastatic tumor in the liver (bottom) (red arrow) grew rapidly and a new lesion was observed in a vertebra (bottom) (red arrow). Abbreviation: SGT, substituted gastric tube emplaced by surgical treatment. Esophageal cancer patient E-3: recurrence was observed after surgical treatment, radiation and chemotherapy. However, the tumor remained unusually stable for 7 months without any other treatment during vaccination. Esophageal cancer patient E-4: liver and multiple thoracic lymph node metastases were noted 4 months after esophagectomy. He was treated by chemotherapy, but showed no response. The patient was then treated with the vaccine, but no clinical response was observed. Abbreviations: ChT, chemotherapy; RT, radiation therapy; ST, surgical treatment. (B) PSA values were plotted over time for patients P-1, P-2, P-3 and P-4 who had recurrent hormone-refractory prostate cancer. Recurrence was defined as a continuous increase of PSA values at 3 consecutive time points at least 2 weeks apart. The PSA values of patients P-3 and P-4 showed no significant increase over a period of time during vaccination. The PSA values of patient P-2 also showed limited increase during vaccination. In malignant melanoma patient M-1, tumor infiltrates in the skin became surrounded by reddish areas associated with blistering at 10 days after the 2nd vaccination. Pictures at top left and right show the skin before and after blisters appeared, respectively. The blisters ruptured (bottom left) and recovered tumor cells were apoptotic as shown by HE staining (200x magnification) and annexin V staining (not shown). The patient died of rapid growth of metastatic tumors in the lung.