Attenuated FOLFIRINOX in the salvage treatment of gemcitabine-refractory advanced pancreatic cancer: a phase II study

Cancer Communications

Hyun Woo Lee¹  Seok Yun Kang¹  In Gyu Hwang²  Joung Soon Jang²  Do Hyoung Lim³  Soonil Lee³  Sung Yong Oh⁴  Eun Mi Nam⁵  Jung Hoon Kim⁶  Jung Hun Kang⁶  Seo-Young Song⁷  Hyo Rak Lee⁸  Han Jo Kim⁹  Sang-Cheol Lee⁹  Kyu Taek Lee⁹  Sang-Byung Bae⁹  Namsu Lee^1,10 

[1]Department of Hematology-Oncology, Ajou University Hospital, Suwon, Republic of Korea

[2]Department of Internal Medicine, Chung-Ang University, College of Medicine, Seoul, Republic of Korea

[3]Department of Internal Medicine, Dankook University Hospital, Cheonan, Republic of Korea

[4]Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea

[5]Department of Internal Medicine, Ewha Womans University, College of Medicine, Seoul, Republic of Korea

[6]Department of Internal Medicine, Institute of Health Sciences, Gyeongsang National University, Jinju, Republic of Korea

[7]Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Republic of Korea

[8]Division of Hematology and Medical Oncology, Department of Internal Medicine, Korea Cancer Hospital, Seoul, Republic of Korea

[9]Divsion of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Hospital Cheonan, Cheonan, Republic of Korea

[10]Divsion of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Hospital Seoul, Seoul, Republic of Korea

关键词: Attenuated FOLFIRINOX;    Second-line;    Pancreatic cancer;    Gemcitabine;   

DOI  :  10.1186/s40880-018-0304-1

学科分类：肿瘤学

来源: Springer

【 摘 要 】

Combination therapy with oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) chemotherapy drastically improves survival of advanced pancreatic cancer patients. However, the efficacy of FOLFIRINOX as a second-line treatment after gemcitabine failure has not been tested prospectively. We investigated the feasibility and safety of attenuated FOLFIRINOX in patients with gemcitabine-refractory advanced pancreatic cancer. A multicenter phase II prospective open-label, single-arm study was conducted at 14 hospitals. Patients with histologically proven invasive ductal pancreatic adenocarcinoma, a measurable or evaluable lesion, Eastern Cooperative Oncology Group performance status 0 or 1, adequate organ function, and aged 19 years or older were eligible. Attenuated FOLFIRINOX consisted of oxaliplatin 65 mg/m2, irinotecan 135 mg/m2, and leucovorin 400 mg/m2 injected intravenously on day 1 and 5-fluorouracil 2000 mg/m2 continuously infused intravenously over 46 h on days 1–2, repeated every 2 weeks. The primary endpoint was progression-free survival from the initiation of FOLFIRINOX. Secondary endpoints were the objective response rate, disease control rate, overall survival, safety, and tolerability. We estimated overall survival and progression-free survival using the Kaplan–Meier methods. We enrolled 39 patients from 14 institutions. The objective response rate was 10.3%, while the disease control rate was 64.1%. The 6-month and 1-year overall survival rates were 59.0% and 15.4%, respectively. Median progression-free survival and overall survival were 3.8 months (95% confidence interval [CI] 1.5–6.0 months) and 8.5 months (95% CI 5.6–11.4 months), respectively. Grade 3 or 4 adverse events were neutropenia (41.0%), nausea (10.3%), anorexia (10.3%), anemia (7.7%), mucositis (7.7%), pneumonia/pleural effusion (5.1%), and fatigue (5.1%). One treatment-related death attributable to septic shock occurred. Attenuated FOLFIRINOX may be promising as a second-line therapy for gemcitabine-refractory pancreatic cancer.

【 授权许可】

CC BY