Fiore Michele, Trodella Lucio, Valeri Sergio, Borzomati Domenico, Floreno Barnaba, Ippolito Edy, Trecca Pasquale, Trodella Luca Eolo, D'Angelillo Rolando Maria, Ramella Sara, Coppola Roberto
Radiotherapy Unit, Campus Bio-Medico University, Via A. del Portillo, 21, 00128, Rome, Italy.
Department of General Surgery, Campus Bio-Medico University, Rome, Italy.
Radiat Oncol. 2015 Dec 15;10:255. doi: 10.1186/s13014-015-0564-8.
Radio-chemotherapy is one of the steps of multidisciplinary management in locally advanced pancreatic cancer. The Epidermal Growth Factor Receptor (EGFR) plays an important role in the disease pathway. The purpose of this prospective study is to evaluate the feasibility and the efficacy of radiotherapy in combination with gemcitabine and EGFR targeting therapy for patients with locally advanced disease.
From November 2008 through January 2012, 34 patients were included in this study. In all cases an accurate pre-treatment staging including CT scan, Endoscopic Ultra-Sonography (EUS), 18F - fluorodeoxyglucose (18F-FDG) PET-CT and laparoscopy with peritoneal washing was performed. External beam radiation was delivered with a total dose of 50.4 Gy (1.8 Gy per fraction). Patients were treated using 3D- conformal radiotherapy, and the clinical target volume was the primary tumor and involved lymph nodes. Gemcitabine 300 mg/m(2) and Cetuximab were given weekly during radiation therapy.
Ten patients (29.4 %) were excluded from the protocol because of the evidence of metastatic disease at the pre-treatment staging. Three patients refused radiochemotherapy. Twenty-one patients completed the therapy protocol. During the combined therapy grade 3-4 toxicities observed were only haematological (leukopenia 47,6 %, trombocytopenia 4.8 %, elevated gamma-GT 23.8 %, elevated alkaline phosphatase 4,8 %). Non-haematological toxicity grade 3-4 was never reported. Post-treatment workup showed partial response in five patients (24 %), stable disease in 11 patients (52 %) and disease progression in 5 patients (24 %). Two-year Local Control was 49 % (median, 18.6 months), 2-year Metastases Free Survival was 24 % (median, 10.8 months). One and two-year Overall Survival were 66 % and 28 % respectively, with a median survival time of 15.3 months.
The combination of cetuximab and gemcitabine with concurrent radiation therapy provides a feasible and well tolerated treatment for locally advanced pancreatic cancer. Patients' selection is crucial in order to treat patients appropriately.
放化疗是局部晚期胰腺癌多学科综合治疗的步骤之一。表皮生长因子受体（EGFR）在该疾病进程中起重要作用。这项前瞻性研究的目的是评估放疗联合吉西他滨及EGFR靶向治疗对局部晚期胰腺癌患者的可行性和疗效。
2008年11月至2012年1月，34例患者纳入本研究。所有病例均进行了精确的治疗前分期，包括CT扫描、内镜超声（EUS）、18F-氟脱氧葡萄糖（18F-FDG）PET-CT以及腹腔镜下腹腔冲洗。外照射总剂量为50.4 Gy（每次分割剂量1.8 Gy）。患者采用三维适形放疗，临床靶区为原发肿瘤及受累淋巴结。放疗期间每周给予吉西他滨300 mg/m²和西妥昔单抗。
10例患者（29.4%）因治疗前分期发现转移病灶被排除在研究方案之外。3例患者拒绝放化疗。21例患者完成了治疗方案。联合治疗期间观察到的3-4级毒性仅为血液学毒性（白细胞减少47.6%，血小板减少4.8%，γ-GT升高23.8%，碱性磷酸酶升高4.8%）。未报告非血液学3-4级毒性。治疗后复查显示5例患者部分缓解（24%），11例患者疾病稳定（52%），5例患者疾病进展（24%）。两年局部控制率为49%（中位值，18.6个月），两年无转移生存率为24%（中位值，10.8个月）。一年和两年总生存率分别为66%和28%，中位生存时间为15.3个月。
西妥昔单抗、吉西他滨与同步放疗联合应用为局部晚期胰腺癌提供了一种可行且耐受性良好的治疗方法。为了对患者进行恰当治疗，患者选择至关重要。
