Liposomal Irinotecan+5-FU/LV in Metastatic Pancreatic Cancer Subgroup Analyses of Patient, Tumor, and Previous Treatment Characteristics in the Pivotal NAPOLI-1 Trial

被引:20
作者
Macarulla Mercade, Teresa [1 ,2 ]
Chen, Li-Tzong [3 ,4 ]
Li, Chung-Pin [5 ,6 ]
Siveke, Jens T. [7 ,8 ,9 ]
Cunningham, David [10 ]
Bodoky, Gyorgy [11 ]
Blanc, Jean-Frederic [12 ]
Lee, Kyung-Hun [13 ,14 ]
Dean, Andrew [15 ]
Belanger, Bruce [16 ]
Wang-Gillam, Andrea [17 ]
机构
[1] Vall dHebron Univ Hosp HUVH, Barcelona, Spain
[2] VHIO, Barcelona, Spain
[3] Natl Cheng Kung Univ, Natl Inst Canc Res, Natl Hlth Res Inst, Tainan, Taiwan
[4] Natl Cheng Kung Univ, Natl Cheng Kung Univ Hosp, Dept Internal Med, Tainan, Taiwan
[5] Taipei Vet Gen Hosp, Dept Med, Div Gastroenterol & Hepatol, Taipei, Taiwan
[6] Natl Yang Ming Univ, Sch Med, Taipei, Taiwan
[7] Univ Hosp Essen, West German Canc Ctr, Div Solid Tumor Translat Oncol, Heidelberg, Germany
[8] Gennan Canc Consortium DKTK, Partner Site Essen, Heidelberg, Germany
[9] German Canc Res Ctr, DKFZ, Heidelberg, Germany
[10] Royal Marsden NHS Fdn Trust London & Surrey, London, England
[11] Szent Laszlo Hosp, Dept Oncol, Budapest, Hungary
[12] CHU Bordeaux, Pole ADEN, Hop Haut Leveque, Bordeaux, France
[13] Seoul Natl Univ, Coll Med, Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea
[14] Seoul Natl Univ, Coll Med, Seoul Natl Univ Hosp, Canc Res Inst, Seoul, South Korea
[15] St John God Hosp, Subiaco, WA, Australia
[16] Ipsen Biosci Inc, Cambridge, MA USA
[17] Washington Univ, St Louis, MO 63110 USA
关键词
irinotecan liposomal injection; mPAC; pancreatic cancer; phase 3 clinical trial; subanalysis; post hoc; QUALITY-OF-LIFE; GEMCITABINE; SURVIVAL;
D O I
10.1097/MPA.0000000000001455
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Objectives The NAnoliPOsomaL Irinotecan (NAPOLI-1) study (NCT01494506) was the largest global phase 3 study in a post-gemcitabine metastatic pancreatic adenocarcinoma (mPAC) population (N = 417). The subanalyses reported here investigated the prognostic effect of tumor characteristics and disease stage, prior treatment characteristics, baseline patient characteristics on survival outcomes in NAPOLI-1, and whether liposomal irinotecan (nal-IRI) + 5-fluorouracil/leucovorin (5-FU/LV) benefited patients with mPAC across subgroups. Methods Post hoc analyses were performed in the NAPOLI-1 population (4 across tumor characteristics and disease stage, 6 across prior treatment characteristics, and 4 across patient baseline characteristics). Survival outcomes were estimated by Kaplan-Meier analysis and patient safety data were evaluated. Results Mortality and morbidity risk was lower on nal-IRI+5-FU/LV treatment across subgroups. Exceptions were patients who had received prior nonliposomal irinotecan and those who had undergone prior Whipple procedure (overall survival hazard ratio = 1.25 and 1.23, respectively). Decreased appetite, liver metastases, and number of measurable metastatic lesions seemed to be prognostic of survival in this population. Subgroup safety data were generally comparable with those in the overall NAPOLI-1 safety population. Conclusions A diverse population of patients with mPAC that progressed on gemcitabine-based therapy benefited from nal-IRI+5-FU/LV versus 5-FU/LV, potentially helping guide treatment decisions for challenging cases.
引用
收藏
页码:62 / 75
页数:14
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