Centre Hospitalier Régional Universitaire, Besançon, France.
Cancer Medicine, Institut Gustave Roussy, University of Paris Saclay, Villejuif, France.
Oncologist. 2021 Jul;26(7):e1179-e1188. doi: 10.1002/onco.13803. Epub 2021 May 21.
The phase III PROSELICA (NCT01308580) and FIRSTANA (NCT01308567) trials investigated taxane chemotherapy among men with postdocetaxel metastatic, castration-resistant prostate cancer (mCRPC) or chemotherapy-naïve mCRPC, respectively. We present a post hoc analysis of patient-reported health-related quality of life (HRQL) among patients with or without a clinical (pain, tumor, or prostate-specific antigen [PSA]) response.
PROSELICA and FIRSTANA HRQL and pain data were collected and analyzed using protocol-defined Functional Assessment of Cancer Therapy-Prostate (FACT-P) and McGill-Melzack (Present Pain Intensity scale) questionnaires. Outcomes included definitive FACT-P Total Score (TS) improvements and longitudinal assessment of FACT-P TS.
In PROSELICA and FIRSTANA, the proportion of patients receiving taxane chemotherapy with a definitive FACT-P TS improvement was significantly higher among patients with versus without a pain or PSA response (pain: PROSELICA: 67% vs. 33.5%; p < .001; FIRSTANA: 75.2% vs. 45.8%; p < .001; PSA: PROSELICA: 50.3% vs. 34.2%; p < .001; FIRSTANA: 49.8% vs. 38.9%; p = .001). In PROSELICA, the proportion of patients receiving taxane chemotherapy with a definitive FACT-P TS improvement was significantly higher among patients with versus without a tumor response; the proportion was numerically higher in FIRSTANA (PROSELICA: 54.4% vs. 36.7%; p = .001; FIRSTANA: 50.6% vs. 45.3%). FACT-P TS was significantly improved or maintained for the majority of treatment cycles analyzed.
In PROSELICA and FIRSTANA, HRQL improvements were significantly higher among patients with a pain, tumor, or PSA response versus those without, with the exception of patients with a tumor response in FIRSTANA.
Using data from the FIRSTANA and PROSELICA phase III clinical trials, this study demonstrated that patients with metastatic, castration-resistant prostate cancer (mCRPC) receiving docetaxel or cabazitaxel who exhibited a response (pain, tumor, prostate-specific antigen), often experienced significantly greater improvements in health-related quality of life (HRQL) compared with patients without a response. For patients with a pain response, significant HRQL improvements occurred early and were maintained. This study provides further insight into the impact of taxane chemotherapy on the HRQL of patients with mCRPC and allows for a better understanding of the relationship between treatment, response, and HRQL, supporting therapeutic decision making.
III 期 PROSELICA（NCT01308580）和 FIRSTANA（NCT01308567）试验分别研究了接受多西紫杉醇化疗的转移性去势抵抗性前列腺癌（mCRPC）或化疗初治 mCRPC 男性中的紫杉醇化疗。我们报告了对有或无临床（疼痛、肿瘤或前列腺特异性抗原[PSA]）应答的患者的患者报告的健康相关生活质量（HRQL）的事后分析。
使用协议定义的癌症治疗前列腺功能评估（FACT-P）和麦吉尔-梅兹拉克（当前疼痛强度量表）问卷收集和分析 PROSELICA 和 FIRSTANA 的 HRQL 和疼痛数据。结局包括明确的 FACT-P 总评分（TS）改善和 FACT-P TS 的纵向评估。
在 PROSELICA 和 FIRSTANA 中，与无疼痛或 PSA 应答的患者相比，接受紫杉醇化疗且明确 FACT-P TS 改善的患者比例在有疼痛或 PSA 应答的患者中显著更高（疼痛：PROSELICA：67%比 33.5%；p<0.001；FIRSTANA：75.2%比 45.8%；p<0.001；PSA：PROSELICA：50.3%比 34.2%；p<0.001；FIRSTANA：49.8%比 38.9%；p=0.001）。在 PROSELICA 中，与无肿瘤应答的患者相比，接受紫杉醇化疗且明确 FACT-P TS 改善的患者比例显著更高；在 FIRSTANA 中，这一比例数值更高（PROSELICA：54.4%比 36.7%；p=0.001；FIRSTANA：50.6%比 45.3%）。在分析的大多数治疗周期中，FACT-P TS 均显著改善或维持。
在 PROSELICA 和 FIRSTANA 中，与无应答者相比，有疼痛、肿瘤或 PSA 应答的患者的 HRQL 改善显著更高，除了 FIRSTANA 中的肿瘤应答患者。
本研究使用来自 FIRSTANA 和 PROSELICA 三期临床试验的数据，表明接受多西紫杉醇或卡巴他赛治疗的转移性去势抵抗性前列腺癌（mCRPC）患者，如果有应答（疼痛、肿瘤、前列腺特异性抗原），则经常经历健康相关生活质量（HRQL）的显著改善，与无应答者相比。对于有疼痛应答的患者，早期即出现显著的 HRQL 改善，并得以维持。本研究进一步深入了解了紫杉醇化疗对 mCRPC 患者 HRQL 的影响，并更好地理解了治疗、应答和 HRQL 之间的关系，支持治疗决策。
