Multicenter retrospective analysis for efficacy and safety of liposomal irinotecan (nal-IRI) plus 5-FU/leucovorin (5-FU/LV) after progression on gemcitabine-based therapy in Korean patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC): A study by Korean cancer study group (KCSG).

Authors

null

Changhoon Yoo

Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South)

Changhoon Yoo , Hyeon-Su Im , Kyu-Pyo Kim , Do-Youn Oh , Kyung-Hun Lee , Hong Jae Chon , Joo Hoon Kim , Myoung Joo Kang , Il-Hwan Kim , Guk Jin Lee , Sung Yong Oh , Younak Choi , Hye Jin Choi , Seung Tae Kim , Joon Oh Park , Baek-Yeol Ryoo

Organizations

Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South), Department of Oncology, Asan Medical Center, Seoul, Korea, Republic of (South), Seoul National University Hospital, Seoul, Korea, Republic of (South), Department of Medical Oncology, CHA Bundang Medical Center, CHA University, Seongnam, Korea, Republic of (South), Department of Medical Oncology, CHA Bundang Medical Center, CHA University,, Seongnam, Korea, Republic of (South), Department of Oncology, Inje University Haeundae Paik Hospital, Busan, Korea, Republic of (South), Department of internal medicine, Inje University, Haeundae Paik Hospital, Busan, Republic of Korea, Catholic University of Korea, Bucheon, Korea, Republic of (South), Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea, Republic of (South), Division of Hemato-Oncology, Department of Internal Medicine, Dongguk University, Gyeongju Hospital, Gyeongju, Korea, Republic of (South), Yonsei Cancer Center, Seoul, Korea, Republic of (South), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of (South), Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of (South), Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South)

Research Funding

Other

Background: Nal-IRI plus 5-FU/LV has demonstrated efficacy in mPDAC pts who previously received gemcitabine-based therapy in the pivotal NAPOLI-1 trial. Real-world data are helpful to measure the clinical outcomes and safety profile of this regimen in daily practice setting. Methods: Between January 2017 and April 2018, a Named Patient Program (NPP) was activated to provide controlled, pre-approval access of nal-IRI in Korea. This analysis is multicenter retrospective study for patients who received nal-IRI plus 5-FU/LV under the NPP. Results: A total of 86 patients entered into this NPP among 10 Korean institutions. Median age was 61 years (range, 37-79) and 52 pts (60%) were male. Liver (n=49, 57%), peritoneum (30, 35%), and lung (27, n=31%) were the most common metastatic sites. All patients had ECOG performance status 0-1 and previously received gemcitabine-based therapy. Prior to nal-IRI plus 5-FU/LV, 35 (41%) and 51 (59%) patients received <2 and ≥ 2 lines of chemotherapy for unresectable/metastatic disease, respectively. Best response was complete response (n=2, 2%), partial response (7, 8%), stable disease (38, 44%), and progressive disease (32, 37%), indicating overall response rates of 10% and disease control rate of 55%. With median follow-up duration of 6.4 months, median progression-free survival (PFS) was 3.5 months (95% CI, 1.3-5.7) and median overall survival (OS) was not yet reached. The 6-month PFS and OS rates were 37.5% and 65.1%, respectively. Most common grade 3-4 toxicities were neutropenia (n=32, 37%), nausea (9, 10%), vomiting (8, 9%), anemia (7, 8%), and diarrhea (4, 5%). Febrile neutropenia occurred in 7 patients (8%). Conclusions: Nal-IRI plus 5-FU/LV was well tolerated and effective for mPDAC patients who progressed on gemcitabine-based therapy. Despite heavily pretreated patients were included, efficacy and safety outcomes in our cohort were consistent with the results of previous NAPOLI-1 trial.

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Abstract Details

Meeting

2019 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Citation

J Clin Oncol 37, 2019 (suppl 4; abstr 344)

DOI

10.1200/JCO.2019.37.4_suppl.344

Abstract #

344

Poster Bd #

J2

Abstract Disclosures