Le Nha, Vinci Alessio, Schober Marvin, Krug Sebastian, Javed Muhammad A, Kohlmann Thomas, Sund Malin, Neesse Albrecht, Beyer Georg
Second Internal Medicine Department, Gastroenterology Division, Semmelweis University, Budapest, Hungary.
Digestion. 2016;94(4):222-229. doi: 10.1159/000453257. Epub 2016 Dec 29.
Recently, FOLFIRINOX and gemcitabine + nab-paclitaxel have been introduced as a novel intensified chemotherapy regimen for patients with metastasized pancreatic cancer. This study aims to analyze the real-world clinical practice with FOLFIRINOX and gemcitabine + nab-paclitaxel across Europe.
Invitations to participate in an anonymous web-based questionnaire were sent via e-mail to 5,420 doctors in 19 European countries through the network of national gastroenterological, oncological, surgical and pancreatic societies as well as the European Pancreatic Club. The questionnaire consisted of 20 questions, 14 regarding the use of intensified chemotherapy, 4 regarding demographics of the participants, and 1 to verify the active involvement in the management of metastatic pancreatic cancer.
Two hundred and thirteen responses were received and 153 entries were valid for analysis. Of those, 63.4% came from an academic institution, 51% were oncologists, and 52% treated more than 25 cases per year. A majority of responses (71%) were from Italy (40%), Germany (23%), and Spain (8%). As first-line therapy, 11% used gemcitabine +/- erlotinib, 42% used FOLFIRINOX, and 47% used gemcitabine + nab-paclitaxel. Of the intensified regimens, both were applied to equal parts, but the likelihood of protocol deviation was higher when using FOLFIRINOX (p < 0.01). FOLFIRINOX was considered more toxic than gemcitabine + nab-paclitaxel (neutropenia 88 vs. 68%; polyneuropathy 42 vs. 41%; rapid deterioration 42 vs. 31%). FOLFIRINOX was rated to achieve longer survival with an acceptable quality of life (52 vs. 44%). Moreover, 57% of participants thought that gemcitabine + nab-paclitaxel should be the backbone for further clinical trials in pancreatic cancer.
Intensified chemotherapy is widely used in pancreatic cancer patients in Europe following its recent clinical approval. Interestingly, nab-paclitaxel and FOLFIRINOX were used at comparable frequency although the latter had to be de-escalated more often.
最近，FOLFIRINOX方案以及吉西他滨+纳米白蛋白结合型紫杉醇已被引入，作为转移性胰腺癌患者的一种新型强化化疗方案。本研究旨在分析欧洲各地使用FOLFIRINOX方案以及吉西他滨+纳米白蛋白结合型紫杉醇的真实临床实践情况。
通过国家胃肠病学、肿瘤学、外科学和胰腺学会网络以及欧洲胰腺俱乐部，以电子邮件的形式向19个欧洲国家的5420名医生发出参与一项匿名网络调查问卷的邀请。该问卷包含20个问题，其中14个关于强化化疗的使用情况，4个关于参与者的人口统计学信息，1个用于核实是否积极参与转移性胰腺癌的管理工作。
共收到213份回复，其中153份有效问卷用于分析。在这些有效问卷中，63.4%来自学术机构，51%为肿瘤学家，52%每年治疗超过25例患者。大部分回复（71%）来自意大利（40%）、德国（23%）和西班牙（8%）。作为一线治疗方案，11%的医生使用吉西他滨±厄洛替尼，42%使用FOLFIRINOX方案，47%使用吉西他滨+纳米白蛋白结合型紫杉醇。在强化治疗方案中，二者的应用比例相当，但使用FOLFIRINOX方案时方案偏离的可能性更高（p<0.01）。FOLFIRINOX方案被认为比吉西他滨+纳米白蛋白结合型紫杉醇毒性更大（中性粒细胞减少症分别为88%和68%；多发性神经病变分别为42%和41%；病情快速恶化分别为42%和31%）。FOLFIRINOX方案被认为能实现更长的生存期且生活质量可接受（分别为52%和44%）。此外，57%的参与者认为吉西他滨+纳米白蛋白结合型紫杉醇应作为胰腺癌进一步临床试验的基础方案。
强化化疗在近期获得临床批准后已在欧洲的胰腺癌患者中广泛应用。有趣的是，纳米白蛋白结合型紫杉醇和FOLFIRINOX方案的使用频率相当，尽管后者更常需要调整剂量。
