Hurt C N, Falk S, Crosby T, McDonald A, Ray R, Joseph G, Staffurth J, Abrams R A, Griffiths G, Maughan T, Mukherjee S
Centre for Trials Research, Cardiff University, 6th Floor, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK.
Bristol Haematology and Oncology Centre, Bristol BS2 8ED, UK.
Br J Cancer. 2017 May 9;116(10):1264-1270. doi: 10.1038/bjc.2017.95. Epub 2017 Apr 4.
SCALOP, a randomised, phase II trial, tested the activity and safety of gemcitabine (GEM)-based and capecitabine (CAP)-based chemoradiation (CRT) for locally advanced pancreatic cancer (LAPC). Here we present the long-term outcomes.
Eligibility: histologically proven LAPC ⩽7 cm. Following 12 weeks of induction GEMCAP chemotherapy (three cycles: GEM 1000 mg m days 1, 8, 15; CAP 830 mg m days 1-21 q28 days) patients with stable/responding disease, tumour ⩽6 cm, and WHO Performance Status 0-1 were randomised to receive one cycle GEMCAP followed by CAP (830 mg m b.d. on weekdays only) or GEM (300 mg m weekly) with radiation (50.4 Gy per 28 fractions).
One-hundred fourteen patients (28 UK centres) were registered between 24 December 2009 and 25 October 2011, and 74 were randomised (CAP-RT=36; GEM-RT=38). At the time of this analysis, 105 of the 114 patients had died and the surviving 9 patients had been followed up for a median of 10.9 months (IQR: 2.9-18.7). Updated median OS was 17.6 months (95% CI: 14.6-22.7) in the CAP-CRT arm and 14.6 months (95% CI: 11.1-16.0) in the GEM-CRT arm (intention-to-treat adjusted hazard ratio (HR): 0.68 (95% CI: 0.38-1.21, P=0.185)); median progression-free survival (PFS) was 12.0 months (95% CI: 10.0-15.2) in the CAP-CRT arm and 10.4 months (95% CI: 8.8-12.7) in the GEM-CRT arm (intention-to-treat adjusted HR: 0.60 (95% CI: 0.32-1.14, P=0.120)). In baseline multivariable model, age ⩾65 years, better performance status, CA19.9<613 IU l, and shorter tumour diameter predicted improved OS. CAP-CRT, age ⩾65 years, better performance status, CA19.9 <46 IU ml predicted improved OS and PFS in the pre-radiotherapy model. Nine-month PFS was highly predictive of OS.
CAP-CRT remains the superior regimen. SCALOP showed that patients with CA19.9 <46 IU ml after induction chemotherapy are more likely to benefit from CRT.
SCALOP是一项随机II期试验，旨在测试基于吉西他滨（GEM）和基于卡培他滨（CAP）的放化疗（CRT）对局部晚期胰腺癌（LAPC）的活性和安全性。在此我们展示长期结果。
入选标准：组织学证实的LAPC≤7cm。在进行12周的诱导GEMCAP化疗（三个周期：GEM 1000mg/m²，第1、8、15天；CAP 830mg/m²，第1 - 21天，每28天重复）后，疾病稳定/有反应、肿瘤≤6cm且世界卫生组织体能状态为0 - 1的患者被随机分配接受一个周期的GEMCAP，随后接受CAP（仅在工作日每天830mg/m²，分两次服用）或GEM（每周300mg/m²）联合放疗（每28次分割共50.4Gy）。
2009年12月24日至2011年10月25日期间，114例患者（来自英国28个中心）登记入组，74例被随机分组（CAP - RT组 = 36例；GEM - RT组 = 38例）。在本次分析时，114例患者中有105例死亡，存活的9例患者中位随访时间为10.9个月（四分位间距：2.9 - 18.7）。CAP - CRT组更新后的中位总生存期（OS）为17.6个月（95%置信区间：14.6 - 22.7），GEM - CRT组为14.6个月（95%置信区间：11.1 - 16.0）（意向性治疗调整风险比（HR）：0.
