Abstract：
OBJECTIVE: Initial treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma (R/M NPC) often involves Gemcitabine plus cisplatin with or without PD-1 inhibitors. However, PD-1 inhibitors\' effectiveness varies, prompting for better treatments. This study explores effect and safety of combining PD-1 inhibitors with chemoradiotherapy for oligometastatic NPC patients.
METHODS: Oligometastatic NPC patients underwent radical treatment with PD-1 inhibitors and chemotherapy, followed by concurrent PD-1 inhibitors and chemoradiotherapy, and then maintenance PD-1 inhibitors. Objective response rate (ORR) and disease control rate (DCR) were calculated by irRECIST-1.1, and CTCAE-4.0 was used to evaluate the toxicity.
RESULTS: The study enrolled 47 patients with a median age of 46. The median follow-up lasted 16.5 months, with metastatic lesions receiving a median radiation dose of 45 Gy. The median courses of PD-1 inhibitors and chemotherapy were 9.5 and 5 respectively. The metastasis sites included lung (40.8 %), liver (21.1 %), mediastinal lymph node (7.9 %), abdominal lymph nodes (3.9 %), bone (21.1 %), adrenal gland (3.9 %), and brain (1.3 %). ORR and DCR were 85.1 % and 100 % at 3 months after radiotherapy. The median survival was not reached yet, and 1 and 2-year OS rates were 93.1 % and 78.4 %. The median PFS was 18 months, with 1 and 2-year PFS rates of 70.2 % and 47.7 % respectively. PD-L1 expression showed a positive correlation for PFS. Twenty-five patients experienced grade 3 or 4 adverse events (AE) that were possibly related to chemotherapy. No grade 5 AE was observed.
CONCLUSIONS: The synergy of concurrent PD-1 inhibitors and chemoradiotherapy shows promising efficacy and an acceptable toxicity for oligometastasis NPC patients.
METHODS: Oligometastatic NPC patients underwent radical treatment with PD-1 inhibitors and chemotherapy, followed by concurrent PD-1 inhibitors and chemoradiotherapy, and then maintenance PD-1 inhibitors. Objective response rate (ORR) and disease control rate (DCR) were calculated by irRECIST-1.1, and CTCAE-4.0 was used to evaluate the toxicity.
RESULTS: The study enrolled 47 patients with a median age of 46. The median follow-up lasted 16.5 months, with metastatic lesions receiving a median radiation dose of 45 Gy. The median courses of PD-1 inhibitors and chemotherapy were 9.5 and 5 respectively. The metastasis sites included lung (40.8 %), liver (21.1 %), mediastinal lymph node (7.9 %), abdominal lymph nodes (3.9 %), bone (21.1 %), adrenal gland (3.9 %), and brain (1.3 %). ORR and DCR were 85.1 % and 100 % at 3 months after radiotherapy. The median survival was not reached yet, and 1 and 2-year OS rates were 93.1 % and 78.4 %. The median PFS was 18 months, with 1 and 2-year PFS rates of 70.2 % and 47.7 % respectively. PD-L1 expression showed a positive correlation for PFS. Twenty-five patients experienced grade 3 or 4 adverse events (AE) that were possibly related to chemotherapy. No grade 5 AE was observed.
CONCLUSIONS: The synergy of concurrent PD-1 inhibitors and chemoradiotherapy shows promising efficacy and an acceptable toxicity for oligometastasis NPC patients.
摘要：
目的：复发性/转移性鼻咽癌（R/MNPC）的初始治疗通常涉及吉西他滨加顺铂，有或没有PD-1抑制剂。然而,PD-1抑制剂的有效性各不相同，促使更好的治疗。本研究探讨PD-1抑制剂联合放化疗治疗寡转移鼻咽癌患者的疗效和安全性。
方法：低转移性鼻咽癌患者接受PD-1抑制剂和化疗的根治性治疗，然后是PD-1抑制剂和放化疗，然后维持PD-1抑制剂。通过irRECIST-1.1计算客观缓解率（ORR）和疾病控制率（DCR），并使用CTCAE-4.0评估毒性。
结果：该研究纳入了47名患者，中位年龄为46岁。中位随访时间为16.5个月,转移性病变接受45Gy的中位放射剂量。PD-1抑制剂和化疗的中位疗程分别为9.5和5。转移部位包括肺（40.8%），肝脏（21.1%），纵隔淋巴结（7.9%），腹部淋巴结(3.9%)，骨（21.1%），肾上腺（3.9%），和大脑(1.3%)。放疗后3个月ORR和DCR分别为85.1%和100%。中位生存期尚未达到，1年和2年OS率分别为93.1％和78.4％。中位PFS为18个月，1年和2年PFS率分别为70.2%和47.7%。PD-L1表达与PFS呈正相关。25例患者出现3级或4级不良事件（AE），可能与化疗有关。没有观察到5级AE。
结论：PD-1抑制剂和放化疗的协同作用对寡转移NPC患者具有良好的疗效和可接受的毒性。
方法：低转移性鼻咽癌患者接受PD-1抑制剂和化疗的根治性治疗，然后是PD-1抑制剂和放化疗，然后维持PD-1抑制剂。通过irRECIST-1.1计算客观缓解率（ORR）和疾病控制率（DCR），并使用CTCAE-4.0评估毒性。
结果：该研究纳入了47名患者，中位年龄为46岁。中位随访时间为16.5个月,转移性病变接受45Gy的中位放射剂量。PD-1抑制剂和化疗的中位疗程分别为9.5和5。转移部位包括肺（40.8%），肝脏（21.1%），纵隔淋巴结（7.9%），腹部淋巴结(3.9%)，骨（21.1%），肾上腺（3.9%），和大脑(1.3%)。放疗后3个月ORR和DCR分别为85.1%和100%。中位生存期尚未达到，1年和2年OS率分别为93.1％和78.4％。中位PFS为18个月，1年和2年PFS率分别为70.2%和47.7%。PD-L1表达与PFS呈正相关。25例患者出现3级或4级不良事件（AE），可能与化疗有关。没有观察到5级AE。
结论：PD-1抑制剂和放化疗的协同作用对寡转移NPC患者具有良好的疗效和可接受的毒性。
