Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis

被引:7
|
作者
Pelzer, Uwe [1 ]
Wislocka, Lilianna [1 ]
Juehling, Anja [1 ]
Striefler, Jana [1 ]
Klein, Fritz [2 ]
Roemmler-Zehrer, Josefine [4 ]
Sinn, Marianne [1 ]
Denecke, Tim [3 ]
Bahra, Marcus [2 ]
Riess, Hanno [1 ]
机构
[1] Charite Univ Med Berlin, Freie Univ Berlin, Humboldt Univ, Div Hematol Oncol & Tumor Immunol,Univ Berlin,Be, Berlin, Germany
[2] Charite Univ Med Berlin, Med Dept Charite, Div Surg, Berlin, Germany
[3] Charite Univ Med Berlin, Med Dept Charite, Div Radiol, Berlin, Germany
[4] Celgene GmbH, Munich, Germany
关键词
Advanced pancreatic carcinoma; Cholestasis; Hyperbilirubinaemia; Chemotherapy; Nab-paclitaxel; Gemcitabine; CLINICAL-PRACTICE; SURVIVAL;
D O I
10.1016/j.ejca.2018.06.001
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Introduction: Treatment of patients with advanced pancreatic carcinoma (APC) and hyperbilirubinaemia is problematic because these patients were regularly excluded from clinical studies. Nanoparticle albumin-bound paclitaxel and gemcitabine (nab-P/G) is an evidence-based treatment for patients with APC. This retrospective study investigated the safety and efficacy of nab-P/G in patients with APC and cholestatic hyperbilirubinaemia. Methods: We screened our prospective database for patients with APC treated with nab-P/G at total bilirubin levels of >= 1.2 mg/dl. Patients were assigned into three groups according to their bilirubin level (A: 1.2-3 mg/di, B: >3-5 mg/di, C: >5 mg/dl). Analyses with regard to safety and survival were performed. Results: Twenty-nine of 168 patients screened between Dec 2013 and Dec 2015 fulfilled the inclusion criteria. Most patients (83%) were male; median age was 63 [41-79] years. Nab-P/G administrations in patients with an elevated bilirubin level (median, range) did not result in unexpected toxicities assessed by predefined (non-)haematological parameters. Median overall survival (mOS) for the whole group was 11.7 (95% confidence interval [CI]: 6.8-14.0) months; for A: 11.8 (95% CI: 6.5-16.5), B: 9.2 (95% CI: 1.1 - NA) months and C 11.8 (95% CI: 5.9-20.0] months (p = 0.843). Again, mOS from the first application of nab-PIG did not differ between the groups (p = 0.13). Conclusion: Nab-P/G administrations in our pts with cholestatic hyperbilirubinaemia suffering from APC were feasible and safe with respect to individualised dose administrations. A multicenter phase 1 trial in pts with hyperbilirubinaemia is started (AIO-PAK-0117) to confirm these findings in a prospective setting. (C) 2018 Elsevier Ltd. All rights reserved.
引用
收藏
页码:85 / 93
页数:9
相关论文
共 50 条
  • [11] Predictors of vulnerability to nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer
    Iede, Kiyotsugu
    Yamada, Terumasa
    Tominaga, Shusei
    ANNALS OF ONCOLOGY, 2023, 34 : S1453 - S1453
  • [13] The Efficacy and Safety of PD-1 Inhibitors Combined with Nab-Paclitaxel Plus Gemcitabine versus Nab-Paclitaxel Plus Gemcitabine in the First-Line Treatment of Advanced Pancreatic Cancer: A Retrospective Monocentric Study
    Zhang, Feng
    Wang, Yuyang
    Yang, Fangfang
    Zhang, Yuming
    Jiang, Man
    Zhang, Xiaochun
    CANCER MANAGEMENT AND RESEARCH, 2022, 14 : 535 - 546
  • [14] FOLFIRINOX for Advanced Pancreatic Cancer Patients After Nab-Paclitaxel Plus Gemcitabine Failure
    Matsumoto, Toshihiko
    Kurioka, Yusuke
    Okazaki, Ukyo
    Matsuo, Yu
    Kimura, Shogo
    Miura, Kou
    Tsuduki, Takao
    Takagi, Shinjiro
    Takatani, Masahiro
    Morishita, Hirofumi
    PANCREAS, 2020, 49 (04) : 574 - 578
  • [15] Gemcitabine plus nab-paclitaxel vs. FOLFIRINOX for patients with advanced pancreatic cancer
    Junko Tahara
    Kyoko Shimizu
    Nao Otsuka
    Junichi Akao
    Yukiko Takayama
    Katsutoshi Tokushige
    Cancer Chemotherapy and Pharmacology, 2018, 82 : 245 - 250
  • [16] Gemcitabine plus nab-paclitaxel vs. FOLFIRINOX for patients with advanced pancreatic cancer
    Tahara, Junko
    Shimizu, Kyoko
    Otsuka, Nao
    Akao, Junichi
    Takayama, Yukiko
    Tokushige, Katsutoshi
    CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2018, 82 (02) : 245 - 250
  • [17] EFFICACY AND SAFETY OF NAB-PACLITAXEL IN COMBINATION WITH GEMCITABINE FOR METASTATIC PANCREATIC CANCER
    You, Min Su
    Ryu, Ji Kon
    Kang, Jinwoo
    Choi, Jin Ho
    Choi, Young Hoon
    Huh, Gunn
    Paik, Woo Hyun
    Lee, Sang Hyub
    Kim, Yong-Tae
    GASTROENTEROLOGY, 2018, 154 (06) : S285 - S285
  • [18] Maintenance treatment with gemcitabine after gemcitabine plus Nab-paclitaxel in advanced pancreatic cancer
    Kodama, Tomoko
    Nakazawa, Junichi
    Kawahira, Masahiro
    Ymasuji, Akihiro
    Iwashita, Yuji
    Hori, Takeshi
    Kawahira, Machiko
    Arima, Shiho
    Tubouchi, Hirohito
    Ido, Akio
    ANNALS OF ONCOLOGY, 2022, 33 : S484 - S484
  • [19] Association between the use of antibiotics and efficacy of gemcitabine plus nab-paclitaxel in advanced pancreatic cancer
    Nakano, Shintaro
    Komatsu, Yoshito
    Kawamoto, Yasuyuki
    Saito, Rika
    Ito, Ken
    Nakatsumi, Hiroshi
    Yuki, Satoshi
    Sakamoto, Naoya
    MEDICINE, 2020, 99 (39) : E22250
  • [20] A retrospective analysis of S-1 in patients with Gemcitabine plus nab-Paclitaxel refractory pancreatic cancer
    Tsumura, Hidetaka
    Sakai, Hideki
    Tokuyama, Nagahiro
    Kushida, Saeko
    Sakai, Aya
    Mimura, Takuya
    Sakamoto, Takeshi
    Yamamoto, Yoshinobu
    Miki, Ikuya
    Tsuda, Masahiro
    ANNALS OF ONCOLOGY, 2017, 28