PDF(Pubmed)
Abstract：
UNASSIGNED: Pancreatic Stereotactic Body Radiotherapy (SBRT) allows for the administration of a higher biologically effective doses (BED), that would be essential to achieve durable tumor control. Escalating treatment doses need a very accurate tumor positioning and motion control during radiotherapy.The aim of this study to assess the feasibility and safety of a Simultaneous Integrated Boost (SIB) dose-escalated protocol at 45 Gy, 50 Gy and 55 Gy in 5 consecutive daily fractions, in Border Line Resectable Pancreatic Cancer (BRCP) /Locally Advanced Pancreatic Cancer (LAPC) by means of a standard LINAC platform.
UNASSIGNED: Patients diagnosed of BRPC/LAPC, candidates for neoadjuvant chemotherapy and SBRT, in four university hospitals of the province of Las Palmas (Canary Islands, Spain) were included in this prospective study. Radiotherapy was administered using standard technology (LINACS) with advanced positioning (Lipiodol® and metallic stent used as fiducial markers) and tumor motion control (4D, DBH, Calypso®). There were 3 planned dose-escalated SIB groups, 45 Gy/5f (9 patients) 50 Gy/5f (9 + 9 patients) and 55 Gy/5f (9 patients). The defined primary end points of the study were the safety and feasibility of the proposed treatment protocol. Secondary endpoints included radiological tumor response after SBRT, local control and survival.
UNASSIGNED: From June 2017 to December 2022, sixty-two patients were initially assessed for eligibility in the study in the four participating centers, and 49 were candidates for chemotherapy (CHT). Forty-one were referred to radiotherapy after CHT and 33 finally were treated by escalated-dose SIB, 45 Gy (9 patients) 50 Gy (16 patients), 55 Gy(8 patients). All patients completed the scheduled treatment and no acute or late severe (≥grade3) gastrointestinal toxicity was observed.Local response was analyzed by CT/MRI two months after the end of SBRT. Ten patients (31,25 %) achieved objective response (2/9:45 Gy, 5/15:50 Gy, 3/8:55 Gy). Follow-up was closed as July 2023. Freedom from local progression at 1-2y were 89,3% (95 %CI:83,4-95,2%) and 66 % (95 %CI:54,6-77,4%) respectively. The 1-2y survival rates were 95,7% (95 %CI:91,4-100 % and 48,6% (95 %CI:37,7-59,5%) respectively.
UNASSIGNED: These promising results should be confirmed by further studies with larger sample size and extended follow-up period.
UNASSIGNED: Patients diagnosed of BRPC/LAPC, candidates for neoadjuvant chemotherapy and SBRT, in four university hospitals of the province of Las Palmas (Canary Islands, Spain) were included in this prospective study. Radiotherapy was administered using standard technology (LINACS) with advanced positioning (Lipiodol® and metallic stent used as fiducial markers) and tumor motion control (4D, DBH, Calypso®). There were 3 planned dose-escalated SIB groups, 45 Gy/5f (9 patients) 50 Gy/5f (9 + 9 patients) and 55 Gy/5f (9 patients). The defined primary end points of the study were the safety and feasibility of the proposed treatment protocol. Secondary endpoints included radiological tumor response after SBRT, local control and survival.
UNASSIGNED: From June 2017 to December 2022, sixty-two patients were initially assessed for eligibility in the study in the four participating centers, and 49 were candidates for chemotherapy (CHT). Forty-one were referred to radiotherapy after CHT and 33 finally were treated by escalated-dose SIB, 45 Gy (9 patients) 50 Gy (16 patients), 55 Gy(8 patients). All patients completed the scheduled treatment and no acute or late severe (≥grade3) gastrointestinal toxicity was observed.Local response was analyzed by CT/MRI two months after the end of SBRT. Ten patients (31,25 %) achieved objective response (2/9:45 Gy, 5/15:50 Gy, 3/8:55 Gy). Follow-up was closed as July 2023. Freedom from local progression at 1-2y were 89,3% (95 %CI:83,4-95,2%) and 66 % (95 %CI:54,6-77,4%) respectively. The 1-2y survival rates were 95,7% (95 %CI:91,4-100 % and 48,6% (95 %CI:37,7-59,5%) respectively.
UNASSIGNED: These promising results should be confirmed by further studies with larger sample size and extended follow-up period.
摘要：
■胰腺立体定向身体放射治疗（SBRT）允许给予更高的生物有效剂量（BED），这对于实现持久的肿瘤控制至关重要。在放射治疗过程中，逐步增加治疗剂量需要非常准确的肿瘤定位和运动控制。这项研究的目的是评估在45Gy的同时集成增强（SIB）剂量递增方案的可行性和安全性，50Gy和55Gy在5个连续的每日分数，通过标准LINAC平台在边界线可切除胰腺癌（BRCP）/局部晚期胰腺癌（LAPC）中。
■被诊断为BRPC/LAPC的患者，新辅助化疗和SBRT的候选人，在拉斯帕尔马斯省（加那利群岛，西班牙)被纳入这项前瞻性研究。放射治疗是使用标准技术（LINACS）进行的，具有高级定位（Lipiodol®和金属支架用作基准标记）和肿瘤运动控制（4D，DBH,Calypso®)。有3个计划剂量递增的SIB组，45Gy/5f(9例)50Gy/5f(9+9例)和55Gy/5f(9例)。本研究确定的主要终点是拟议治疗方案的安全性和可行性。次要终点包括SBRT后放射学肿瘤反应，本地控制和生存。
■从2017年6月到2022年12月，在四个参与中心对62名患者的研究资格进行了初步评估。49人是化疗（CHT）的候选人。41人在CHT后接受放疗，33人最终接受递增剂量SIB治疗，45Gy（9例）50Gy（16例），55Gy(8例)。所有患者均完成预定治疗，未观察到急性或晚期严重（≥3级）胃肠道毒性。SBRT结束后两个月通过CT/MRI分析局部反应。10例患者（31,25％）达到客观反应（2/9：45Gy，5/15:50Gy,3/8：55Gy）。后续行动于2023年7月结束。1-2y的局部进展自由分别为89,3％（95CI：83,4-95,2％）和66％（95CI：54,6-77,4％）。1-2年生存率分别为95,7％（95CI：91,4-100％和48,6％（95CI：37,7-59,5％）。
■这些有希望的结果应通过更大样本量和延长随访期的进一步研究得到证实。
■被诊断为BRPC/LAPC的患者，新辅助化疗和SBRT的候选人，在拉斯帕尔马斯省（加那利群岛，西班牙)被纳入这项前瞻性研究。放射治疗是使用标准技术（LINACS）进行的，具有高级定位（Lipiodol®和金属支架用作基准标记）和肿瘤运动控制（4D，DBH,Calypso®)。有3个计划剂量递增的SIB组，45Gy/5f(9例)50Gy/5f(9+9例)和55Gy/5f(9例)。本研究确定的主要终点是拟议治疗方案的安全性和可行性。次要终点包括SBRT后放射学肿瘤反应，本地控制和生存。
■从2017年6月到2022年12月，在四个参与中心对62名患者的研究资格进行了初步评估。49人是化疗（CHT）的候选人。41人在CHT后接受放疗，33人最终接受递增剂量SIB治疗，45Gy（9例）50Gy（16例），55Gy(8例)。所有患者均完成预定治疗，未观察到急性或晚期严重（≥3级）胃肠道毒性。SBRT结束后两个月通过CT/MRI分析局部反应。10例患者（31,25％）达到客观反应（2/9：45Gy，5/15:50Gy,3/8：55Gy）。后续行动于2023年7月结束。1-2y的局部进展自由分别为89,3％（95CI：83,4-95,2％）和66％（95CI：54,6-77,4％）。1-2年生存率分别为95,7％（95CI：91,4-100％和48,6％（95CI：37,7-59,5％）。
■这些有希望的结果应通过更大样本量和延长随访期的进一步研究得到证实。
