Assessment of Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line chemotherapy in patients with advanced HER-2 negative gastric ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-03-29

AUTHORS

Maria Di Bartolomeo, Monica Niger, Federica Morano, Salvatore Corallo, Maria Antista, Stefano Tamberi, Sara Lonardi, Samantha Di Donato, Rossana Berardi, Mario Scartozzi, Giovanni Gerardo Cardellino, Francesco Di Costanzo, Lorenza Rimassa, Alberto Gianluigi Luporini, Raffaella Longarini, Alberto Zaniboni, Alessandro Bertolini, Gianluca Tomasello, Graziella Pinotti, Giorgio Scagliotti, Giampaolo Tortora, Andrea Bonetti, Andrea Spallanzani, Giovanni Luca Frassineti, Davide Tassinari, Francesco Giuliani, Saverio Cinieri, Evaristo Maiello, Claudio Verusio, Sergio Bracarda, Vincenzo Catalano, Michele Basso, Libero Ciuffreda, Ferdinando De Vita, Hector Soto Parra, Lorenzo Fornaro, Marta Caporale, Filippo de Braud, Filippo Pietrantonio

ABSTRACT

BACKGROUND: Platinum/fluoropyrimidine regimens are the backbone of first-line chemotherapy for advanced gastric cancer (AGC). However response rates to first line chemotherapy range from 30 to 50% and disease progression occurs after 4-6 cycles. The optimal duration of first-line therapy is still unknown and its continuation until disease progression represents the standard. However this strategy is often associated with cumulative toxicity and rapid development of drug resistance. Moreover, only about 40% of AGC pts. are eligible for second-line treatment. METHODS: This is a randomized, open-label, multicenter phase III trial. It aims at assessing whether switch maintenance to ramucirumab plus paclitaxel will extend the progression-free survival (PFS) of subjects with HER-2 negative AGC who have not progressed after 3 months of a first-line with a platinum/fluoropyrimidine regimen (either FOLFOX4, mFOLFOX6 or XELOX). The primary endpoint is to compare Progression-Free Survival (PFS) of patients in ARM A (switch maintenance to ramucirumab and placlitaxel) versus ARM B (continuation of the same first-line therapy with oxaliplatin/fluoropyrimidine). Secondary endpoints are: overall survival, time-to-treatment failure, overall response rate, duration of response, percentage of patients that will receive a second line therapy according to arm treatment, safety, quality of life. Exploratory studies including Next-Generation Sequencing (NGS) in archival tumor tissues are planned in order to identify potential biomarkers of primary resistance and prognosis. DISCUSSION: The ARMANI study estimates if patients treated with early swich with ramucirumab plus paclitaxel received benefit when compared to those treated with continuation of first line therapy. The hypothesis is that the early administration of an active, non-cross resistant second-line regimen such as ramucirumab plus paclitaxel may prolong the time in which patients are progression-free, and consequently have a better quality of life. Moreover, this strategy may rescue all those subjects that become ineligible for second-line therapy due to the rapid deterioration of health status after the first disease progression. TRIAL REGISTRATION: ARMANI is registered at ClinicalTrials.gov ( NCT02934464 , October 17, 2016) and EudraCT(2016-001783-12, April 202,016). More... »

PAGES

283

Journal

TITLE

BMC Cancer

ISSUE

1

VOLUME

19

Author Affiliations

  • Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, via G. Venezian, 1, 20133 Milan, Italy
  • Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Ravenna Viale Randi, 5, 48121 Ravenna, Italy
  • Department of Medical Oncology, IOV Istituto Oncologico Veneto, Via Gattamelata, 64, 35128 Padova, PD Italy
  • Sandro Pitigliani Medical Oncology Department, Nuovo Ospedale di Prato, Via Suor Niccolina Infermiera, 20, 59100 Prato, Italy
  • Department of Medical Oncology, AOU Ospedali Riuniti Di Ancona, via Corridoni, 11, 60123 Ancona, Italy
  • Department of Medical Oncology, AOU Cagliari, Via Ospedale, 54, 09124 Cagliari, Italy
  • Department of Medical Oncology, Azienda Sanitaria Universitaria Integrata di Udine, Via Pozzuolo, 330 – 33100, piazzale Santa Maria della misericordia 15, 33100 Udine, Udine Italy
  • Department of Medical Oncology, AOU Careggi di Firenze, Largo Brambilla, 3, 50134 Florence, Italy
  • Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, Via Alessandro Manzoni, 56, 20089 Rozzano, Milan Italy
  • Department of Medical Oncology, IRCCS Policlinico San Donato, Piazza Edmondo Malan, 2, 20097 San Donato Milanese, MI Italy
  • Department of Medical Oncology, Ospedale San Gerardo, Via G. B. Pergolesi, 33, 20900 Monza, Italy
  • Department of Medical Oncology, Fondazione Poliambulanza, Via Leonida Bissolati, 57, 25124 Brescia, Italy
  • Department of Medical Oncology, ASST della Valtellina e dell’Alto Lario, Via Stelvio, 25, 23100 Sondrio, Italy
  • Department of Medical Oncology, Ospedale di Cremona, Viale Concordia, 1, 26100 Cremona, Italy
  • Department of Medical Oncology, Ospedale di Circolo e Fondazione Macchi, Viale Luigi Borri, 57, 21100 Varese, Italy
  • Department of Medical Oncology, AOU San Luigi Gonzaga, Regione Gonzole, 10, 10043 Orbassano, Torino Italy
  • Department of Medical Oncology, AOUI Verona Ospedale Policlinico ‘Giambattista Rossi’ di Borgo Roma, Piazzale L.A. Scuro, 10, 37134 Verona, VR Italy
  • Department of Medical Oncology, Ospedale Mater Salutis, Via Carlo Gianella, 1, 37045 Legnago, Verona, Italy
  • Department of Medical Oncology, AOU di Modena, Via Emilia Est, 583-585, 41122 Modena, MO Italy
  • Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, via P. Maroncelli, 40, 47014 Meldola, Italy
  • Department of Medical Oncology, Ospedale degli infermi di Rimini, Viale L. Settembrini, 2, 47923 Rimini, Italy
  • Department of Medical Oncology, I.R.C.C.S. Istituto Tumori Bari, Viale Orazio Flacco, 65, 70124 Bari, Italy
  • Department of Medical Oncology, Ospedale A. Perrino di Brindisi, Strada Statale 7 per Mesagne, 72100 Brindisi, Italy
  • Department of Medical Oncology, Casa Sollievo della Sofferenza, Viale Cappuccini, 1, 71013 San Giovanni Rotondo, FG Italy
  • Department of Medical Oncology, ASST Valle Olona, PO Saronno Piazzale Borella 1, 21047 Saronno, Varese Italy
  • Department of Medical Oncology, Ospedale San Donato, Azienda USL Toscana Sudest Via Pietro Nenni, 20/22, 52100 Arezzo, Italy
  • Department of Medical Oncology, Azienda Ospedaliera “Ospedali Riuniti Marche Nord”, Piazzale Cinelli, 4, 61121 Pesaro, Italy
  • Department of Medical Oncology, Fondazione Policlinico Universitario “A. Gemelli” - IRCCS, Università Cattolica del Sacro Cuore, Largo Agostino Gemelli, 8, 00168 Rome, Italy
  • Department of Medical Oncology, A.O.U. Citta della Salute e della Scienza di Torino, H Molinette, corso Bramante, 88, 10126 Torino, Italy
  • Division of Medical Oncology, Department of Precision Medicine, University of Campania ‘Luigi Vanvitelli’ - School of Medicine, Via S.Pansini, 5, 80131 Naples, Italy
  • Department of Medical Oncology, P.O. G. Rodolico, Via Plebiscito, 628 Catania, Italy
  • Department of Medical Oncology, AOU Pisana, Polo Oncologico - Osp. S. Chiara, via Roma 67, 56100 Pisa, Italy
  • Department of Hematology-Oncology, University Milan, Milan, Italy
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s12885-019-5498-3

    DOI

    http://dx.doi.org/10.1186/s12885-019-5498-3

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1113059578

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30922323


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    25 schema:description BACKGROUND: Platinum/fluoropyrimidine regimens are the backbone of first-line chemotherapy for advanced gastric cancer (AGC). However response rates to first line chemotherapy range from 30 to 50% and disease progression occurs after 4-6 cycles. The optimal duration of first-line therapy is still unknown and its continuation until disease progression represents the standard. However this strategy is often associated with cumulative toxicity and rapid development of drug resistance. Moreover, only about 40% of AGC pts. are eligible for second-line treatment. METHODS: This is a randomized, open-label, multicenter phase III trial. It aims at assessing whether switch maintenance to ramucirumab plus paclitaxel will extend the progression-free survival (PFS) of subjects with HER-2 negative AGC who have not progressed after 3 months of a first-line with a platinum/fluoropyrimidine regimen (either FOLFOX4, mFOLFOX6 or XELOX). The primary endpoint is to compare Progression-Free Survival (PFS) of patients in ARM A (switch maintenance to ramucirumab and placlitaxel) versus ARM B (continuation of the same first-line therapy with oxaliplatin/fluoropyrimidine). Secondary endpoints are: overall survival, time-to-treatment failure, overall response rate, duration of response, percentage of patients that will receive a second line therapy according to arm treatment, safety, quality of life. Exploratory studies including Next-Generation Sequencing (NGS) in archival tumor tissues are planned in order to identify potential biomarkers of primary resistance and prognosis. DISCUSSION: The ARMANI study estimates if patients treated with early swich with ramucirumab plus paclitaxel received benefit when compared to those treated with continuation of first line therapy. The hypothesis is that the early administration of an active, non-cross resistant second-line regimen such as ramucirumab plus paclitaxel may prolong the time in which patients are progression-free, and consequently have a better quality of life. Moreover, this strategy may rescue all those subjects that become ineligible for second-line therapy due to the rapid deterioration of health status after the first disease progression. TRIAL REGISTRATION: ARMANI is registered at ClinicalTrials.gov ( NCT02934464 , October 17, 2016) and EudraCT(2016-001783-12, April 202,016).
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