Regorafenib in patients with refractory metastatic pancreatic cancer: a Phase II study (RESOUND)

被引：9
作者：
Bozzarelli, Silvia [1 ]
Rimassa, Lorenza [1 ,2 ]
Giordano, Laura [3 ]
Sala, Simona [1 ]
Tronconi, Maria Chiara [1 ]
Pressiani, Tiziana [1 ]
Smiroldo, Valeria [1 ]
Prete, Maria G. [1 ]
Spaggiari, Paola [4 ]
Personeni, Nicola [2 ]
Santoro, Armando [1 ,2 ]
机构：
[1] IRCCS, Humanitas Clin & Res Ctr, Humanitas Canc Ctr, Med Oncol & Hematol Unit, I-20089 Milan, Italy
[2] Humanitas Univ, Dept Biomed Sci, I-20090 Milan, Italy
[3] IRCCS, Humanitas Clin & Res Ctr, Humanitas Canc Ctr, Biostat Unit, I-20089 Milan, Italy
[4] IRCCS, Humanitas Clin & Res Ctr, Anat Pathol Unit, I-20089 Milan, Italy
来源：
FUTURE ONCOLOGY | 2019年 / 15卷 / 35期
关键词：
advanced; angiogenesis; metastatic; pancreatic cancer; regorafenib; ENDOTHELIAL GROWTH-FACTOR; GEMCITABINE PLUS PLACEBO; DOUBLE-BLIND; IN-VITRO; TRIAL; COMBINATION; BEVACIZUMAB; EXPRESSION; CARCINOMA; SURVIVAL;
D O I：
10.2217/fon-2019-0480
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
Aim: Regorafenib may be active in different cancer types. This Phase II trial included patients with various refractory cancer types treated with regorafenib. Here, we report the results of the pancreatic adenocarcinoma cohort. Methods: The primary end point was progression-free survival (PFS) rate at 8 weeks; further investigation of regorafenib would be warranted with a PFS rate >= 50%. Results: A total of 20 patients were enrolled. The best response was stable disease in four patients (20%). The 8-week PFS rate was 25% with a median PFS of 1.7 months (95% CI: 1.5-2.0). A total of 13 patients (65%) experienced grade 3-4 treatment-related adverse events. Conclusion: The study did not meet its primary end point. Further investigation of regorafenib monotherapy in this setting is not recommended.
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收藏
页码：4009 / 4017
页数：9
相关论文
共 40 条
  • [1] Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer
    Abou-Alfa, Ghassan K.
    Letourneau, Richard
    Harker, Graydon
    Modiano, Manuel
    Hurwitz, Herbert
    Tchekmedyian, Nerses Simon
    Feit, Kevie
    Ackerman, Judie
    De Jager, Robert L.
    Eckhardt, S. Gail
    O'Reilly, Eileen M.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (27) : 4441 - 4447
  • [2] [Anonymous], 2019, J CLIN ONCOL S
  • [3] A prospective randomised phase-II trial with gemcitabine versus gemcitabine plus sunitinib in advanced pancreatic cancer
    Bergmann, L.
    Maute, L.
    Heil, G.
    Ruessel, J.
    Weidmann, E.
    Koeberle, D.
    Fuxius, S.
    Weigang-Koehler, K.
    Aulitzky, W. E.
    Woermann, B.
    Hartung, G.
    Moritz, B.
    Edler, L.
    Burkholder, I.
    Scheulen, M. E.
    Richly, H.
    [J]. EUROPEAN JOURNAL OF CANCER, 2015, 51 (01) : 27 - 36
  • [4] Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297
    Berlin, JD
    Catalano, P
    Thomas, JP
    Kugler, JW
    Haller, DG
    Benson, AB
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2002, 20 (15) : 3270 - 3275
  • [5] Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial
    Bruix, Jordi
    Qin, Shukui
    Merle, Philippe
    Granito, Alessandro
    Huang, Yi-Hsiang
    Bodoky, Gyrogy
    Pracht, Marc
    Yokosuka, Osamu
    Rosmorduc, Olivier
    Breder, Valeriy
    Gerolami, Rene
    Masi, Gianluca
    Ross, Paul J.
    Song, Tianqiang
    Bronowicki, Jean-Pierre
    Ollivier-Hourmand, Isabelle
    Kudo, Masatoshi
    Cheng, Ann-Lii
    Llovet, Josep M.
    Finn, Richard S.
    LeBerre, Marie-Aude
    Baumhauer, Annette
    Meinhardt, Gerold
    Han, Guohong
    [J]. LANCET, 2017, 389 (10064) : 56 - 66
  • [6] Pancreatic cancer growth is inhibited by blockade of VEGF-RII
    Büchler, P
    Reber, HA
    Urich, A
    Shiroiki, M
    Roth, M
    Büchler, MW
    Lavey, RS
    Friess, H
    Hines, OJ
    [J]. SURGERY, 2003, 134 (05) : 772 - 782
  • [7] Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial
    Burris, HA
    Moore, MJ
    Andersen, J
    Green, MR
    Rothenberg, ML
    Madiano, MR
    Cripps, MC
    Portenoy, RK
    Storniolo, AM
    Tarassoff, P
    Nelson, R
    Dorr, FA
    Stephens, CD
    VanHoff, DD
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (06) : 2403 - 2413
  • [8] In Vitro Elucidation of Drug Combination Synergy in Treatment of Pancreatic Ductal Adenocarcinoma
    Bush, Kevin T.
    Boichard, Amelie
    Tsigelny, Igor F.
    [J]. ANTICANCER RESEARCH, 2018, 38 (04) : 1967 - 1977
  • [9] Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer: A GISCAD randomized phase II study
    Cascinu, Stefano
    Berardi, Rossana
    Sobrero, Alberto
    Bidoli, Paolo
    Labianca, Roberto
    Siena, Salvatore
    Ferrari, Daris
    Barni, Sandro
    Aitini, Enrico
    Zagonel, Vittorina
    Caprioni, Francesco
    Villa, Federica
    Mosconi, Stefania
    Faloppi, Luca
    Tonini, Giuseppe
    Boni, Corrado
    Conte, Pierfranco
    Di Costanzo, Francesco
    Cinquini, Michela
    [J]. DIGESTIVE AND LIVER DISEASE, 2014, 46 (02) : 182 - 186
  • [10] FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer
    Conroy, Thierry
    Desseigne, Francoise
    Ychou, Marc
    Bouche, Olivier
    Guimbaud, Rosine
    Becouarn, Yves
    Adenis, Antoine
    Raoul, Jean-Luc
    Gourgou-Bourgade, Sophie
    de la Fouchardiere, Christelle
    Bennouna, Jaafar
    Bachet, Jean-Baptiste
    Khemissa-Akouz, Faiza
    Pere-Verge, Denis
    Delbaldo, Catherine
    Assenat, Eric
    Chauffert, Bruno
    Michel, Pierre
    Montoto-Grillot, Christine
    Ducreux, Michel
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (19) : 1817 - 1825
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