Attenuated FOLFIRINOX in the salvage treatment of gemcitabine-refractory advanced pancreatic cancer: a phase II study
- 주제(키워드) Attenuated FOLFIRINOX , Second-line , Pancreatic cancer , Gemcitabine
- 주제(기타) Oncology
- 설명문(일반) [Kim, Jung Hoon; Kang, Jung Hun] Gyeongsang Natl Univ, Inst Hlth Sci, Dept Internal Med, 15 Jinju Daero 816Beon Gil, Jinju 52727, South Korea; [Lee, Sang-Cheol; Lee, Kyu Taek; Bae, Sang-Byung; Kim, Han Jo] Soonchunhyang Univ Hosp Cheonan, Dept Internal Med, Div Hematol & Oncol, Cheonan 31151, South Korea; [Oh, Sung Yong] Dong A Univ Hosp, Dept Internal Med, Busan 49201, South Korea; [Song, Seo-Young] Kangwon Natl Univ, Sch Med, Dept Internal Med, Chunchon 24289, South Korea; [Lee, Namsu] Soonchunhyang Univ Hosp Seoul, Dept Internal Med, Div Hematol & Oncol, Seoul 04401, South Korea; [Nam, Eun Mi] Ewha Womans Univ, Coll Med, Dept Internal Med, Seoul 07985, South Korea; [Lee, Soonil; Lim, Do Hyoung] Dankook Univ Hosp, Dept Internal Med, Cheonan 31116, South Korea; [Hwang, In Gyu; Jang, Joung Soon] Chung Ang Univ, Coll Med, Dept Internal Med, Seoul 06973, South Korea; [Lee, Hyo Rak] Korea Canc Hosp, Dept Internal Med, Div Hematol & Med Oncol, Seoul 01812, South Korea; [Lee, Hyun Woo; Kang, Seok Yun] Ajou Univ Hosp, Dept Hematol Oncol, Suwon 16499, South Korea
- 등재 SCIE
- 발행기관 BIOMED CENTRAL LTD
- 발행년도 2018
- URI http://www.dcollection.net/handler/ewha/000000151623
- 본문언어 영어
- Published As http://dx.doi.org/10.1186/s40880-018-0304-1
초록/요약
Background: 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. Methods: 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/m(2), irinotecan 135 mg/m(2), and leucovorin 400 mg/m(2) injected intravenously on day 1 and 5-fluorouracil 2000 mg/m(2) 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. Results: 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. Conclusion: Attenuated FOLFIRINOX may be promising as a second-line therapy for gemcitabine-refractory pancreatic cancer.
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