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Cancer Commun (Lond). 2018 Jun 4;38(1):32. doi: 10.1186/s40880-018-0304-1.

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

Author information

1
Department of Internal Medicine, Institute of Health Sciences, Gyeongsang National University, 15 Jinju-daero 816beon-gil, Jinju, 52727, Republic of Korea.
2
Divsion of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Hospital Cheonan, Cheonan, 31151, Republic of Korea.
3
Department of Internal Medicine, Dong-A University Hospital, Busan, 49201, Republic of Korea.
4
Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, 24289, Republic of Korea.
5
Divsion of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Hospital Seoul, Seoul, 04401, Republic of Korea.
6
Department of Internal Medicine, Ewha Womans University, College of Medicine, Seoul, 07985, Republic of Korea.
7
Department of Internal Medicine, Dankook University Hospital, Cheonan, 31116, Republic of Korea.
8
Department of Internal Medicine, Chung-Ang University, College of Medicine, Seoul, 06973, Republic of Korea.
9
Division of Hematology and Medical Oncology, Department of Internal Medicine, Korea Cancer Hospital, Seoul, 01812, Republic of Korea.
10
Department of Hematology-Oncology, Ajou University Hospital, Suwon, 16499, Republic of Korea.
11
Department of Internal Medicine, Institute of Health Sciences, Gyeongsang National University, 15 Jinju-daero 816beon-gil, Jinju, 52727, Republic of Korea. newatp@naver.com.

Abstract

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/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.

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.

KEYWORDS:

Attenuated FOLFIRINOX; Gemcitabine; Pancreatic cancer; Second-line

PMID:
29866170
PMCID:
PMC5993129
DOI:
10.1186/s40880-018-0304-1
[Indexed for MEDLINE]
Free PMC Article

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