Mytomicin-C、节拍卡培他滨和贝伐单抗在阑尾源性腹膜假性粘液瘤不可切除或复发患者中的应用。

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2023-12-01 DOI:10.1016/j.clcc.2023.08.005

Filippo Ghelardi , Alessandra Raimondi , Federica Morano , Giovanni Randon , Alessandra Pannone , Marcello Guaglio , Giacomo Mazzoli , Vincenzo Nasca , Massimo Milione , Giuseppe Leoncini , Giovanna Sabella , Gabriella Francesca Greco , Bianca Rosa Lampis , Margherita Galassi , Sara Delfanti , Margherita Nannini , Rossana Intini , Dario Baratti , Maria Di Bartolomeo , Marcello Deraco , Filippo Pietrantonio

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引用次数: 0

摘要

腹膜假性黏液瘤(PMP)是一种罕见的、生长缓慢的肿瘤，传统上认为是耐药的。唯一的治疗方法是细胞减少手术(CRS)，然后是高温腹腔化疗(HIPEC)。在疾病复发时，或在诊断时无法手术的患者中，没有确定标准治疗方法，尽管非随机系列显示以氟嘧啶为基础的方案有希望的结果。患者和方法:我们对复发或不可切除的PMP患者进行了一项前瞻性研究，并在基线时确认疾病进展。患者接受MMC(每6周7 mg/m2，最多4个周期)加节拍卡培他滨(625 mg/m2 /day b.i.d)和贝伐单抗(7.5 mg/kg每3周)，直到疾病进展、不可接受的毒性或同意退出。主要终点为无进展生存期(PFS);次要终点是总生存期(OS)，根据RECIST v1.1标准的总有效率，血清标志物反应和安全性。结果:纳入15例患者。中位随访26.1个月(IQR, 17.7-49.6)，中位PFS为17.9个月(95% CI, 11.0-NE)， 1年PFS和OS率分别为73%和87%。安全性是可控的，只有13%的G3/G4治疗相关不良事件。结论:节拍卡培他滨、贝伐单抗和MMC是晚期和进展性PMP的积极方案，与历史系列相比具有优势。

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Mytomicin-C, Metronomic Capecitabine, and Bevacizumab in Patients With Unresectable or Relapsed Pseudomyxoma Peritonei of Appendiceal Origin

Introduction

Pseudomyxoma peritonei (PMP) is a rare, slow growing tumor, traditionally considered chemoresistant. The only curative approach is cytoreductive surgery (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC). At disease relapse, or in patients with inoperable disease at diagnosis, no standard treatment has been defined, though nonrandomized series showed promising results with fluoropyrimidine-based regimens.

Patients and Methods

We conducted a prospective study in patients with relapsed or unresectable PMP and confirmed disease progression at baseline. Patients received MMC (7 mg/m² every 6 weeks, up to a maximum of 4 cycles) plus metronomic capecitabine (625 mg/sqm/day b.i.d.) and bevacizumab (7.5 mg/kg every 3 weeks) until disease progression, unacceptable toxicity, or consent withdrawal. Primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), overall response rate according to RECIST v1.1 criteria, serum markers response and safety.

Results

Fifteen patients were included. At a median follow-up of 26.1 months (IQR, 17.7-49.6), median PFS was 17.9 months (95% CI, 11.0-NE), with 1-year PFS and OS rates of 73% and 87%. Safety profile was manageable, with only 13% G3/G4 treatment-related adverse events.