A single-arm, phase II trial of neoadjuvant gemcitabine and S1 in patients with resectable and borderline resectable pancreatic adenocarcinoma: PREP-01 ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-09-04

AUTHORS

Fuyuhiko Motoi, Sohei Satoi, Goro Honda, Keita Wada, Hiroyuki Shinchi, Ippei Matsumoto, Masayuki Sho, Akihiko Tsuchida, Michiaki Unno, For the Study Group of Preoperative therapy for Pancreatic cancer (PREP)

ABSTRACT

BackgroundNeoadjuvant chemotherapy (NAC) represents a promising alternative to pancreatic ductal adenocarcinoma (PDAC) planned resection, but the survival impact remains undefined. To assess the feasibility and survival outcomes of NAC with gemcitabine and S1 (GS) for PDAC planned resection by prospective study.MethodsPatients with resectable or borderline resectable PDAC received 2 cycles of NAC-GS and were offered curative resection followed by gemcitabine adjuvant. The primary endpoint was 2-year overall survival (OS). Adverse events during NAC, radiological and tumor marker responses, resection rate, and surgical safety were evaluated as secondary endpoints (UMIN000004148).ResultsWe enrolled 104 patients between 2010 and 2012, with 101 patients treated using NAC-GS as the full analysis set (FAS). Of the 101 patients, 88% received the planned 2 cycles of NAC. Grade 3 neutropenia was common (35%). Radiological partial response and decreased carbohydrate antigen 19-9 concentration (> 50% decrease) were noted in 13% and 41%, respectively. R0/1 resections with M0 were performed in 65 patients without surgical mortality. Of the 65 patients, 44 received planned gemcitabine adjuvant for 6 months as the on-protocol cohort. The primary endpoint for the 2-year OS rate was 55.9% in the FAS (n = 101) and 74.6% in the on-protocol cohort (n = 44).ConclusionsNAC-GS was feasible and actively prolonged survival following PDAC planned resection. Randomized control trials are needed to further clarify the survival benefit of NAC-GS in addition to surgery followed by adjuvant therapy. More... »

PAGES

194-203

Journal

TITLE

Journal of Gastroenterology

ISSUE

2

VOLUME

54

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00535-018-1506-7

DOI

http://dx.doi.org/10.1007/s00535-018-1506-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1106643325

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30182219


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34 schema:description BackgroundNeoadjuvant chemotherapy (NAC) represents a promising alternative to pancreatic ductal adenocarcinoma (PDAC) planned resection, but the survival impact remains undefined. To assess the feasibility and survival outcomes of NAC with gemcitabine and S1 (GS) for PDAC planned resection by prospective study.MethodsPatients with resectable or borderline resectable PDAC received 2 cycles of NAC-GS and were offered curative resection followed by gemcitabine adjuvant. The primary endpoint was 2-year overall survival (OS). Adverse events during NAC, radiological and tumor marker responses, resection rate, and surgical safety were evaluated as secondary endpoints (UMIN000004148).ResultsWe enrolled 104 patients between 2010 and 2012, with 101 patients treated using NAC-GS as the full analysis set (FAS). Of the 101 patients, 88% received the planned 2 cycles of NAC. Grade 3 neutropenia was common (35%). Radiological partial response and decreased carbohydrate antigen 19-9 concentration (> 50% decrease) were noted in 13% and 41%, respectively. R0/1 resections with M0 were performed in 65 patients without surgical mortality. Of the 65 patients, 44 received planned gemcitabine adjuvant for 6 months as the on-protocol cohort. The primary endpoint for the 2-year OS rate was 55.9% in the FAS (n = 101) and 74.6% in the on-protocol cohort (n = 44).ConclusionsNAC-GS was feasible and actively prolonged survival following PDAC planned resection. Randomized control trials are needed to further clarify the survival benefit of NAC-GS in addition to surgery followed by adjuvant therapy.
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41 schema:keywords BackgroundNeoadjuvant chemotherapy
42 ConclusionsNAC-GS
43 FAS
44 II trial
45 M0
46 MethodsPatients
47 NAC
48 NAC-GS
49 OS rates
50 R0/1 resection
51 ResultsWe
52 S1
53 Secondary endpoints
54 addition
55 adenocarcinoma
56 adjuvant
57 adjuvant therapy
58 adverse events
59 alternative
60 analysis
61 antigen 19
62 benefits
63 borderline resectable pancreatic adenocarcinoma
64 borderline resectable pancreatic ductal adenocarcinoma
65 carbohydrate antigen 19
66 chemotherapy
67 cohort
68 concentration
69 control trial
70 curative resection
71 cycle
72 cycles of NAC
73 ductal adenocarcinoma
74 endpoints
75 events
76 feasibility
77 full analysis
78 gemcitabine
79 gemcitabine adjuvant
80 grade 3 neutropenia
81 impact
82 marker response
83 months
84 mortality
85 neoadjuvant gemcitabine
86 neutropenia
87 outcomes
88 overall survival
89 pancreatic adenocarcinoma
90 pancreatic ductal adenocarcinoma
91 partial response
92 patients
93 phase II trial
94 planned gemcitabine
95 primary endpoint
96 promising alternative
97 prospective study
98 protocol cohort
99 radiological partial response
100 randomized control trial
101 rate
102 resectable pancreatic adenocarcinoma
103 resectable pancreatic ductal adenocarcinoma
104 resection
105 resection rate
106 response
107 safety
108 study
109 surgery
110 surgical mortality
111 surgical safety
112 survival
113 survival benefit
114 survival impact
115 survival outcomes
116 therapy
117 trials
118 tumor marker response
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