背景:胰腺癌(PC)一线治疗通常包括多化疗方案,但是在疾病进展后选择二线治疗,尤其是在一线FOLFIRINOX之后,仍然是一个临床挑战。这项研究提出了一个大的结果,多中心,回顾性分析接受Nab-紫杉醇/吉西他滨(AG)作为二线或后期治疗的意大利转移性PC(mPC)患者.该研究的主要目的是确定可以为治疗决策提供信息的预后因素。
方法:该研究包括在17个意大利机构接受AG治疗的160名mPC患者。AG根据标签剂量给药,直到疾病进展,不可接受的毒性或患者拒绝。时间表的变化,剂量修改,支持性措施,和反应评估由个别临床医生实践确定。
结果:AG具有良好的耐受性并表现出良好的临床活性。总有效率(ORR)和疾病控制率(DCR)分别为22.5%和45.6%,分别。中位无进展生存期(PFS)和总生存期(OS)分别为3.9和6.8个月,分别。在接受AG作为二线治疗的患者中(n=111,66.9%),中位PFS和OS分别为4.2和7.4个月,分别。值得注意的是,在一线FOLFIRINOX后接受AG的76例患者(68%)中,观察到19.7%的ORR和46.0%的DCR,导致中位PFS为3.5个月,中位OS为5.7个月。该研究确定了特定的临床或实验室参数(LDH,NLR,空腹血糖,肝转移,ECOGPS,和一线PFS)作为多变量水平的独立预后因素。这些因素被用来创建一个预后列线图,将患者分为三个风险等级,帮助预测二线OS和PFS。
结论:这项研究代表了接受AG作为第二或更晚治疗的mPC患者的最大现实世界人群。它支持该方案在一线FOLFIRINOX之后的可行性,特别是在具有特定临床和实验室特征并从一线治疗中获得长期益处的患者中。
BACKGROUND: Pancreatic cancer (PC) first-line therapy often consists of polychemotherapy regimens, but choosing a second-line therapy after disease progression, especially following first-line FOLFIRINOX, remains a clinical challenge. This study presents results from a large, multicenter, retrospective analysis of Italian patients with metastatic PC (mPC) treated with Nab-paclitaxel/Gemcitabine (AG) as second or later line of treatment. Main objective of the study is to identify prognostic factors that could inform treatment decisions.
METHODS: The study included 160 mPC patients treated with AG in 17 Italian institutions. AG was administered according to labelling dose, until disease progression, unacceptable toxicity or patient refusal. Variations in schedules, dose modifications, supportive measures, and response evaluation were determined by individual clinicians\' practice.
RESULTS: AG was well-tolerated and exhibited promising clinical activity. The overall response rate (ORR) and the disease control rate (DCR) were 22.5% and 45.6%, respectively. Median progression-free survival (PFS) and overall survival (OS) were 3.9 and 6.8 months, respectively. Among the patients who received AG as a second-line therapy (n = 111, 66.9%), median PFS and OS were 4.2 and 7.4 months, respectively. Notably, in the 76 patients (68%) receiving AG after first-line FOLFIRINOX, an ORR of 19.7% and a DCR of 46.0% were observed, resulting in a median PFS of 3.5 and median OS of 5.7 months. The study identified specific clinical or laboratory parameters (LDH, NLR, fasting serum glucose, liver metastases, ECOG PS, and first-line PFS) as independent prognostic factors at multivariate level. These factors were used to create a prognostic nomogram that divided patients into three risk classes, helping to predict second-line OS and PFS.
CONCLUSIONS: This study represents the largest real-world population of mPC patients treated with AG as a second or later line of therapy. It supports the feasibility of this regimen following first-line FOLFIRINOX, particularly in patients with specific clinical and laboratory characteristics who derived prolonged benefit from first-line therapy.