BACKGROUND Vaccine therapy in combination with radiation therapy may improve distant and/or local control in prostate cancer. We present long-term follow-up data on the secondary and exploratory endpoints of safety and biochemical failure, respectively, from patients with clinically localized prostate cancer treated definitively with a poxviral vector-based therapeutic vaccine combined with external beam radiation therapy (EBRT). METHODS Thirty-six prostate cancer patients received definitive EBRT plus vaccine. A total of 18 patients were treated with adjuvant standard-dose interleukin-2 (S-IL-2) (4 MIU m(-2)) and 18 were treated with very low-dose IL-2 (M-IL-2) (0.6 MIU m(-2)). Seven patients were treated with EBRT alone. Twenty-six patients treated with EBRT plus vaccine returned for follow-up, and we reviewed the most recent labs and clinical notes of the remaining patients. RESULTS Median follow-up for the S-IL-2, M-IL-2 and EBRT-alone groups was 98, 76 and 79 months, respectively. Actuarial 5-year PSA failure-free probability was 78%, 82% and 86% (P=0.58 overall), respectively. There were no significant differences between the actuarial overall survival and the prostate cancer-specific survival between the two vaccine arms. Of the 26 patients who returned for follow-up, Radiation Therapy Oncology Group grade ≥2 genitourinary (GU) and gastrointestinal (GI) toxicity was seen in 19% and 8%, respectively, with no difference between the arms (P=1.00 and P=0.48 for grade ≥2 GU and GI toxicity, respectively). In all, 12 patients were evaluated for PSA-specific immune responses, and 1 demonstrated a response 66 months post-enrollment. CONCLUSIONS We demonstrate that vaccine combined with EBRT does not appear to have significant differences with regard to PSA control or late-term toxicity compared with standard treatment. We also found limited evidence of long-term immune response following vaccine therapy.

中文翻译：

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接受疫苗和根治性放射治疗的前列腺癌患者的长期随访。

背景疫苗疗法与放射疗法组合可以改善前列腺癌的远处和/或局部控制。我们分别提供了关于安全性和生化失败的次要和探索性终点的长期随访数据，这些患者来自临床局限性前列腺癌患者，这些患者接受了基于痘病毒载体的治疗性疫苗联合外照射放射治疗 (EBRT) 的最终治疗。方法 36 名前列腺癌患者接受了明确的 EBRT 加疫苗。共有 18 名患者接受了辅助标准剂量的白细胞介素 2 (S-IL-2) (4 MIU m(-2)) 和 18 名患者接受了极低剂量的 IL-2 (M-IL-2) (0.6 MIU m(-2))。7 名患者仅接受 EBRT 治疗。26 名接受 EBRT 加疫苗治疗的患者返回随访，我们审查了其余患者的最新实验室和临床记录。结果 S-IL-2、M-IL-2 和 EBRT 单独组的中位随访时间分别为 98、76 和 79 个月。精算的 5 年 PSA 无故障概率分别为 78%、82% 和 86%（总体 P=0.58）。两个疫苗组之间的精算总生存率和前列腺癌特异性生存率之间没有显着差异。在返回进行随访的 26 名患者中，放射治疗肿瘤学组≥2 级的泌尿生殖系统 (GU) 和胃肠道 (GI) 毒性分别占 19% 和 8%，两组之间没有差异（P=1.00 和对于≥2级的GU和GI毒性，分别为P=0.48）。总共有 12 名患者接受了 PSA 特异性免疫反应的评估，1 名患者在入组后 66 个月表现出反应。结论 我们证明，与标准治疗相比，疫苗联合 EBRT 在 PSA 控制或晚期毒性方面似乎没有显着差异。我们还发现了疫苗治疗后长期免疫反应的有限证据。