Petrioli Roberto, Torre Pamela, Pesola Guido, Paganini Giovanni, Paolelli Loretta, Miano Salvatora Tindara, Martellucci Ignazio, Francini Guido, Francini Edoardo
Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Italy.
Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Italy.
J Geriatr Oncol. 2020 May;11(4):647-651. doi: 10.1016/j.jgo.2019.08.008. Epub 2019 Aug 27.
The aim of this study was to evaluate the efficacy and safety of the combination Gemcitabine (Gem) plus nab-Paclitaxel (NabP) (Gem/NabP), followed by maintenance Gem in older adults with locally advanced or metastatic pancreatic cancer (PC).
In this prospective observational study, the induction chemotherapy consisted of NabP 125 mg/m followed by Gem 1000 mg/m on days 1, 8, and 15 of a 4-week cycle. After a maximum of 3 cycles, patients without evidence of progressive disease (PD) were administered Gem 1000 mg/m2 weekly for 3 of 4 weeks as maintenance therapy until documentation of PD or unacceptable toxicity. The primary endpoint was six-month disease-control rate (DCR).
Overall, 36 patients >70 years with metastatic or locally advanced PC were enrolled at participating Institutions. After completion of Gem/NabP, 18 (50%) patients achieved partial response, 13 (36%) had stable disease, and 5 (14%) had PD. Thirty-one patients (86%) received Gem monotherapy as maintenance treatment for a median of 3 cycles (range, 2-9 cycles). Six-month DCR was 61% (95% CI, 45-77), median PFS was 6.4 months (95% CI, 5.4-8.3), and median OS was 13.4 months (95% CI, 11.1-16.7). During Gem/NabP regimen, the most common grade 3 toxicity included neutropenia (22%), anemia (19%) and thrombocytopenia (8%). Grade 3 neuropathy was not observed. During Gem maintenance therapy, grade 3 hematological toxicity was described in 6 patients (19%).
Gem/NabP followed by maintenance Gem appears to be safe and effective for older patients with locally advanced or metastatic PC.
本研究旨在评估吉西他滨（Gem）联合纳米白蛋白结合型紫杉醇（NabP）（Gem/NabP），随后使用吉西他滨维持治疗在老年局部晚期或转移性胰腺癌（PC）患者中的疗效和安全性。
在这项前瞻性观察研究中，诱导化疗包括在4周周期的第1、8和15天给予纳米白蛋白结合型紫杉醇125mg/m²，随后给予吉西他滨1000mg/m²。最多3个周期后，无疾病进展（PD）证据的患者接受吉西他滨1000mg/m²每周1次，共4周中的3周作为维持治疗，直至记录到疾病进展或出现不可接受的毒性。主要终点是六个月疾病控制率（DCR）。
总体而言，36例年龄>70岁的转移性或局部晚期胰腺癌患者在参与机构入组。吉西他滨/纳米白蛋白结合型紫杉醇治疗完成后，18例（50%）患者达到部分缓解，13例（36%）疾病稳定，5例（14%）疾病进展。31例（86%）患者接受吉西他滨单药维持治疗，中位周期数为3个周期（范围2 - 9个周期）。六个月疾病控制率为61%（95%CI，45 - 77），中位无进展生存期为6.4个月（95%CI，5.4 - 8.3），中位总生存期为13.4个月（95%CI，11.1 - 16.7）。在吉西他滨/纳米白蛋白结合型紫杉醇治疗方案期间，最常见的3级毒性包括中性粒细胞减少（22%）、贫血（19%）和血小板减少（8%）。未观察到3级神经病变。在吉西他滨维持治疗期间，6例患者（19%）出现3级血液学毒性。
吉西他滨/纳米白蛋白结合型紫杉醇序贯吉西他滨维持治疗对于老年局部晚期或转移性胰腺癌患者似乎是安全有效的。
