Parimi Sunil, Bondy Suraya, Tsang Erica, McKenzie Michael Ross, Bachand Francois, Aparicio Maria, Duncan Graeme, Sunderland Katherine, Olson Robert Anton, Pai Howard Huaihan, Alexander Abraham Skaria, LaPointe Vincent, Chi Kim N, Tyldesley Scott
Medical Oncology, British Columbia Cancer Agency, BC, Canada.
Genitourinary Cancer Outcomes Unit, British Columbia Cancer Agency, BC, Canada.
Can Urol Assoc J. 2019 Oct;13(10):E311-E316. doi: 10.5489/cuaj.5685.
Clinical trials have shown that radium-223 (Ra223) can prolong survival and improve quality of life in patients with metastatic castration-resistant prostate cancer (mCRPC). The objectives of this study were to evaluate pain responses with Ra223 at a population-based level and to determine if there is an association between pain response and alkaline phosphatase (ALP) response.
All patients from the Vancouver and Kelowna Cancer Centers (CC) in British Columbia who were treated with Ra223 between June 2015 and December 2016 were identified. Patients completed the Brief Pain Inventory (BPI) just prior to each Ra223 injection. Pain response was defined as a two or more point improvement in worst pain relative to baseline, without an increase in pain medication level. ALP was determined at each visit, with a response threshold defined as a 30% decrease from baseline, consistent with the definition of response used in the ALSYMPCA trial.
A total of 65 patients in Vancouver and Kelowna CC received Ra223 during the study period and 56 patients had at least one BPI record, of which 44 (79%) patients were assessable for change in worst pain. Of the assessable patients, 23 (52%, 95% confidence interval [CI] 38-67) had a pain response, although the use of concurrent external beam radiotherapy was a confounder in four cases. Of the 44 patients assessable for change in worst pain, 59% had ALP responses greater than 30%. An ALP response was seen in 56% of pain-responders vs. 43% of non-pain-responders. There was no association between pain response and ALP response (Phi =-0.05; p=0.77).
Ra223 administration was associated with a meaningful pain response rate in this cohort. There was no correlation between pain response and ALP response.
临床试验表明，镭-223（Ra223）可延长转移性去势抵抗性前列腺癌（mCRPC）患者的生存期并改善其生活质量。本研究的目的是在人群水平上评估Ra223的疼痛反应，并确定疼痛反应与碱性磷酸酶（ALP）反应之间是否存在关联。
确定了2015年6月至2016年12月期间在不列颠哥伦比亚省温哥华和基洛纳癌症中心（CC）接受Ra223治疗的所有患者。患者在每次注射Ra223之前完成简明疼痛量表（BPI）。疼痛反应定义为相对于基线，最严重疼痛改善两点或更多点，且止痛药物水平未增加。每次就诊时测定ALP，反应阈值定义为较基线降低30%，这与ALSYMPCA试验中使用的反应定义一致。
在研究期间，温哥华和基洛纳癌症中心共有65例患者接受了Ra223治疗，56例患者至少有一次BPI记录，其中44例（79%）患者的最严重疼痛变化可评估。在可评估的患者中，23例（52%，95%置信区间[CI] 38-67）有疼痛反应，不过在4例中同时使用外照射放疗是一个混杂因素。在44例可评估最严重疼痛变化的患者中，59%的患者ALP反应大于30%。疼痛反应者中有56%出现ALP反应，而非疼痛反应者中为43%。疼痛反应与ALP反应之间无关联（Phi=-0.05；p=0.77）。
在该队列中，给予Ra223与有意义的疼痛反应率相关。疼痛反应与ALP反应之间无相关性。
