Ippolito Edy, Toppi Lucrezia, Carrafiello Sofia, Greco Carlo, Fiore Michele, Alaimo Rita, Minuti Salvatore, Pantano Francesco, Casale Giuseppe, D'Angelillo Rolando Maria, Turriziani Adriana, De Marinis Maria Grazia, Ramella Sara
Research Unit of Radiation Oncology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Rome, Italy.
Operative Research Unit of Radiation Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Rome, Italy.
J Clin Med. 2025 Jul 1;14(13):4662. doi: 10.3390/jcm14134662.
: CDK4/6 inhibitor plus ET is a standard treatment for advanced HR+ BC. This study evaluates the efficacy and safety of CDK4/6 inhibitors with concurrent RT (SBRT and non-SBRT) in terms of pain, analgesic therapy changes, toxicities, and net clinical benefit (NCB). : BC patients with bone metastases treated with RT and CDK4/6 inhibitor in the prospective observational COMBART study were analyzed. Pain was measured with the NRS. The NCB was defined by pain reduction (NRS), toxicity, and treatment changes. Adverse events (AEs) were graded per CTCAE v5.0. Statistical tests included chi-square and -test. : Forty patients were treated with CDK4/6 inhibitor (palbociclib 30.8%, ribociclib 51.3%, abemaciclib 17.9%) and RT (131 lesions; 100 SBRT, 31 non-SBRT). The mean NRS score dropped from 3.52 (pre-treatment) to 1.31 (post-treatment) ( < 0.001), with better outcomes for patients treated with moderate hypofractionation (58.6% vs. 39.9% pain relief, = 0.016). Pain relief was independent of the type of CDK4/6 inhibitor used ( = NS). Analgesic reduction was most common with palbociclib (35.4%, = 0.001). Eight toxicities (grade 1-2) were reported. The NCB was 0.6 overall, higher with non-SBRT (0.74 vs. 0.52). : RT plus CDK4/6 inhibitor, especially with moderate hypofractionation, significantly reduced pain with manageable toxicity. Analgesic therapy can often continue without stopping CDK4/6 inhibitor.
CDK4/6抑制剂联合内分泌治疗（ET）是晚期激素受体阳性（HR+）乳腺癌的标准治疗方法。本研究评估了CDK4/6抑制剂联合立体定向放疗（SBRT）和非SBRT在疼痛、镇痛治疗变化、毒性和净临床获益（NCB）方面的疗效和安全性。对前瞻性观察性COMBART研究中接受放疗和CDK4/6抑制剂治疗的骨转移乳腺癌患者进行分析。采用数字评分量表（NRS）测量疼痛。NCB由疼痛减轻（NRS）、毒性和治疗变化来定义。不良事件（AE）根据美国国立综合癌症网络（NCCN）肿瘤学临床实践指南（第5版）（CTCAE v5.0）进行分级。统计检验包括卡方检验和t检验。40例患者接受了CDK4/6抑制剂（哌柏西利占30.8%，瑞博西尼占51.3%，阿贝西利占17.9%）和放疗（131个病灶；100个SBRT，31个非SBRT）。NRS平均评分从治疗前的3.52降至治疗后的1.31（P<0.001），中等分割放疗患者的疗效更好（疼痛缓解率为58.6% vs. 39.9%，P = 0.016）。疼痛缓解与所用CDK4/6抑制剂的类型无关（P = 无统计学意义）。哌柏西利导致的镇痛药物减少最为常见（35.4%，P = 0.001）。报告了8例1 - 2级毒性反应。总体NCB为0.6，非SBRT的NCB更高（0.74 vs. 0.52）。放疗联合CDK4/6抑制剂，尤其是中等分割放疗，可显著减轻疼痛且毒性可控。镇痛治疗通常可以在不停用CDK4/6抑制剂的情况下继续进行。
