Ottaiano Alessandro, Capozzi Monica, DE Divitiis Chiara, VON Arx Claudia, DI Girolamo Elena, Nasti Guglielmo, Cavalcanti Ernesta, Tatangelo Fabiana, Romano Giovanni, Avallone Antonio, Tafuto Salvatore
Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy
Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.
Anticancer Res. 2017 Apr;37(4):1975-1978. doi: 10.21873/anticanres.11539.
Pancreas adenocarcinoma is the sixth cause of cancer-related death worldwide with an increasing mortality in the Western countries. Recently, the association between nab-paclitaxel (nab-P) and gemcitabine (GEM) has significantly improved progression-free and overall survival.
Patients affected by metastatic pancreas adenocarcinoma were treated at the Department of Abdominal Oncology of the National Cancer Institute of Naples from July 2015 to July 2016 with nab-P at 125 mg per square meter of body-surface area followed by GEM at 1,000 mg per square meter on days 1, 8 and 15 every 4 weeks. Computed tomography (CT) was performed every three months of therapy. Toxicity was graded with National Cancer Institute-Common Toxicity Criteria (NCI-CTC) v4.0. Objective responses were evaluated with Response Evaluation Criteria in Solid Tumors (RECIST). Analysis of time-to-progression is only descriptive. Pain was evaluated with a visual analogue scale (VAS).
Twenty-three patients were treated. Median age was 67 years (range=45-81); 8 patients were ≥70 years old. Performance status (PS) Eastern Cooperative Oncology Group (ECOG) was 2 in 8 patients, 1 in 10 and 0 in 5. Twelve patients presented with diffuse hepatic metastases, 4 with carcinosis, 7 with more than one organ involvement. Nab-P was reduced at 100 mg per square meter in all patients. The most common G3/G4 adverse events were neutropenia (13.0% G4, 8.6% G3; none was febrile), neuropathy (30.4% G3) and asthenia (G3 17.3%). The disease control rate was 43.4% (partial response+stable disease (PR+SD) 10/23). The median time-to-progression was 7.9 months (95% confidence interval (CI)=5.8-11.2). After three months of therapy the PS improved in 14 patients, as well as pain in 18 patients.
We present an experience with nab-P and GEM association in a series with poor PS and highly metastatic disease relatively to a previous randomized study. The schedule is feasible, with nab-P at 100 mg per square meter achieving a good disease control rate, as well as a clinical benefit.
胰腺腺癌是全球癌症相关死亡的第六大原因，在西方国家死亡率呈上升趋势。最近，纳米白蛋白结合型紫杉醇（nab-P）与吉西他滨（GEM）联合使用显著改善了无进展生存期和总生存期。
2015年7月至2016年7月期间，那不勒斯国家癌症研究所腹部肿瘤科对转移性胰腺腺癌患者进行治疗，每4周的第1、8和15天给予nab-P，剂量为每平方米体表面积125毫克，随后给予GEM，剂量为每平方米1000毫克。治疗期间每三个月进行一次计算机断层扫描（CT）。毒性按照美国国立癌症研究所通用毒性标准（NCI-CTC）v4.0分级。客观缓解情况根据实体瘤疗效评价标准（RECIST）进行评估。对无进展生存期的分析仅为描述性分析。疼痛采用视觉模拟量表（VAS）进行评估。
共治疗23例患者。中位年龄为67岁（范围=45 - 81岁）；8例患者年龄≥70岁。东部肿瘤协作组（ECOG）体能状态（PS）评分为2分的患者有8例，1分的有10例，0分的有5例。12例患者出现弥漫性肝转移，4例有癌性腹膜炎，7例有一个以上器官受累。所有患者的nab-P剂量减至每平方米100毫克。最常见的G3/G4级不良事件为中性粒细胞减少（G4级为13.0%，G3级为8.6%；均无发热）、神经病变（G3级为30.4%）和乏力（G3级为17.3%）。疾病控制率为43.4%（部分缓解+病情稳定（PR+SD）为10/23）。中位无进展生存期为7.9个月（95%置信区间（CI）=5.8 - 11.2）。治疗三个月后，14例患者的PS有所改善，18例患者的疼痛有所缓解。
相对于之前的一项随机研究，我们展示了nab-P与GEM联合治疗PS较差且具有高度转移性疾病患者的经验。该方案可行，nab-P剂量为每平方米100毫克时可实现良好的疾病控制率以及临床获益。
