[纳米白蛋白结合型紫杉醇联合盐酸吉西他滨治疗转移性或复发性胰腺癌患者——单中心经验]

[Nab-Paclitaxel plus Gemcitabine Hydrochloride in Patients with Metastatic or Recurrent Pancreatic Cancer - A Single Institution Experience].

作者信息

Takeda Yutaka, Katsura Yoshiteru, Ohmura Yoshiaki, Sakamoto Takuya, Akiyama Yasuki, Kuwahara Ryuichi, Morimoto Yoshihiro, Ishida Tomo, Oneda Yasuo, Murakami Kouhei, Naito Atsushi, Kagawa Yoshinori, Takeno Atsushi, Kato Takeshi, Tamura Shigeyuki

机构信息

Dept. of Surgery, Kansai Rosai Hospital.

出版信息

Gan To Kagaku Ryoho. 2016 Nov;43(12):1674-1677.

PMID:28133095

Abstract

BACKGROUND

Pancreatic adenocarcinoma is one of the leading causes of cancer deaths in Japan.Albumin -bound paclitaxel (nab-paclitaxel)plus gemcitabine hydrochloride(GEM)combination chemotherapy provided significant improvements in the overall and progression-free survival in a phase III trial in Europe and America and a phase II trial in Japan.As a result, this combination therapy was approved for use in Japan.

METHODS

We evaluated the efficacy of nab-paclitaxel plus GEM with metastatic or recurrent pancreatic cancer.Between December 2014 and March 2016, 11 patients received nab-paclitaxel plus GEM as follows: nab-paclitaxel(125mg/m2 of body-surface area)followed by GEM(1,000mg/m2)on days 1, 8, and 15 every 4 weeks.The treatment was continued until disease progression, unacceptable adverse events, discontinuation as decided by the investigators, or patient refusal.

RESULTS

The mean age was 65.6 years(range, 48-75 years), and 8 out of 11 patients were men.Ten patients had an Eastern Cooperative Oncology Group(ECOG)performance status(PS)of 0.Ten patients had metastatic disease.Only 4 patients had no prior therapy.The mean duration of treatment was 10.2 weeks(range, 2-41 weeks).The relative dose intensities of nab-paclitaxel and GEM were 90.6%(66.7-100%)and 87.5%(62.9-100%), respectively.The major Grade 3 or 4 hematological toxicities were leucopenia(54.5%), neutropenia(36.4%), anemia (27.3%), and thrombocytopenia(18.2%).The major grade 2 or 3 non-hematological toxicities were fatigue(45.6%), skin rash(27.3%), peripheral sensory neuropathy(9.1%), anorexia(9.1%), and stomatitis(9.1%).There were no treatmentrelated deaths.Interstitial lung disease was not observed.The 6 month progression-free and overall survival rate were 25.7% and 66.7%, respectively. The disease control rate was 90.9%(complete response, n=0; partial response, n=1; stable disease, n=9; progressive disease, n=1).

CONCLUSIONS

Nab-paclitaxel plus GEM is well tolerated and associated with efficacy and improved survival outcomes.Nab -paclitaxel plus GEM can be the standard treatment for patients with metastatic pancreatic adenocarcinoma.

摘要

背景

胰腺癌是日本癌症死亡的主要原因之一。在欧美进行的一项III期试验以及在日本进行的一项II期试验中，白蛋白结合型紫杉醇（纳米白蛋白紫杉醇）联合盐酸吉西他滨（吉西他滨）化疗在总生存期和无进展生存期方面均有显著改善。因此，这种联合疗法在日本被批准使用。

方法

我们评估了纳米白蛋白紫杉醇联合吉西他滨治疗转移性或复发性胰腺癌的疗效。2014年12月至2016年3月期间，11例患者接受了纳米白蛋白紫杉醇联合吉西他滨治疗，具体如下：纳米白蛋白紫杉醇（125mg/m²体表面积），之后每4周的第1、8和15天给予吉西他滨（1000mg/m²）。治疗持续至疾病进展、出现不可接受的不良事件、研究者决定停药或患者拒绝。

结果

平均年龄为65.6岁（范围48 - 75岁），11例患者中有8例为男性。10例患者东部肿瘤协作组（ECOG）体能状态（PS）为0。10例患者有转移性疾病。只有4例患者未接受过先前治疗。平均治疗持续时间为10.2周（范围2 - 41周）。纳米白蛋白紫杉醇和吉西他滨的相对剂量强度分别为90.6%（66.7 - 100%）和87.5%（62.9 - 100%）。主要的3级或4级血液学毒性为白细胞减少（54.5%）、中性粒细胞减少（36.4%）、贫血（27.3%）和血小板减少（18.2%）。主要的2级或3级非血液学毒性为疲劳（45.6%）、皮疹（27.3%）、周围感觉神经病变（9.1%）、厌食（9.1%）和口腔炎（9.1%）。没有与治疗相关的死亡病例。未观察到间质性肺疾病。6个月的无进展生存率和总生存率分别为25.7%和66.7%。疾病控制率为90.9%（完全缓解，n = 0；部分缓解，n = 1；病情稳定，n = 9；疾病进展，n = 1）。