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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorVan Cutsem, Eric
dc.contributor.authorTempero, Margaret A.
dc.contributor.authorSigal, Darren
dc.contributor.authorOh, Do-Youn
dc.contributor.authorFazio, Nicola
dc.contributor.authorMacarulla Mercadé, Teresa
dc.date.accessioned2021-10-22T11:45:53Z
dc.date.available2021-10-22T11:45:53Z
dc.date.issued2020-09-20
dc.identifier.citationVan Cutsem E, Tempero MA, Sigal D, Oh DY, Fazio N, Macarulla T, et al. Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma. J Clin Oncol. 2020 Sep 20;38(27):3185–94.
dc.identifier.issn1527-7755
dc.identifier.urihttp://hdl.handle.net/11351/6453
dc.descriptionPancreatic Adenocarcinoma; Paclitaxel
dc.description.abstractPURPOSE To evaluate the efficacy and safety of pegvorhyaluronidase alfa (PEGPH20) plus nab-paclitaxel/gemcitabine (AG) in patients with hyaluronan-high metastatic pancreatic ductal adenocarcinoma (PDA). PATIENTS AND METHODS HALO 109-301 was a phase III, randomized, double-blind, placebo-controlled study. Patients ≥ 18 years of age with untreated, metastatic, hyaluronan-high PDA were randomly assigned 2:1 to PEGPH20 plus AG or placebo plus AG. Treatment was administered intravenously in 4-week cycles (3 weeks on, 1 week off) until progression or intolerable adverse events: PEGPH20 3.0 µg/kg twice per week for cycle 1 and once per week thereafter; nab-paclitaxel 125 mg/m2 once per week; and gemcitabine 1,000 mg/m2 once per week. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. Response was independently assessed per RECIST v1.1. RESULTS At data cutoff, 494 patients were randomly assigned, with 492 (327 for PEGPH20 and 165 for placebo) included in intention-to-treat analyses. Baseline characteristics were balanced for PEGPH20 plus AG versus placebo plus AG. There were 330 deaths, with a median OS of 11.2 months for PEGPH20 plus AG versus 11.5 months for placebo plus AG (hazard ratio [HR], 1.00; 95% CI, 0.80 to 1.27; P = .97); median PFS was 7.1 months versus 7.1 months (HR, 0.97 [95% CI, 0.75 to 1.26]); ORR was 47% versus 36% (ORR ratio, 1.29 [95% CI, 1.03 to 1.63]). Grade ≥ 3 adverse events with a ≥ 2% higher rate with PEGPH20 plus AG than with placebo plus AG included fatigue (16.0% v 9.6%), muscle spasms (6.5% v 0.6%), and hyponatremia (8.0% v 3.8%). CONCLUSION The addition of PEGPH20 to AG increased the ORR but did not improve OS or PFS. The safety profile of PEGPH20 plus AG was consistent with that found in previous studies. These results do not support additional development of PEGPH20 in metastatic PDA.
dc.language.isoeng
dc.publisherAmerican Society of Clinical Oncology
dc.relation.ispartofseriesJournal of Clinical Oncology;38(27)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectPàncrees - Càncer - Quimioteràpia
dc.subjectMetàstasi
dc.subject.meshPancreatic Neoplasms
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.titleRandomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1200/JCO.20.00590
dc.subject.decsneoplasias pancreáticas
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.relation.publishversionhttps://doi.org/10.1200/JCO.20.00590
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Van Cutsem E] Digestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium. [Tempero MA] Division of Hematology and Oncology, Department of Medicine, UCSF Medical Center, San Francisco, CA. [Sigal D] Division of Hematology/Oncology, Scripps Clinic and Scripps MD Anderson Cancer Center, La Jolla, CA. [Oh DY] Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea. [Fazio N] Division of Gastrointestinal Medical Oncology & Neuroendocrine Tumors, European Institute of Oncology, IEO, IRCCS, Milan, Italy. [Macarulla T] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
dc.identifier.pmid32706635
dc.identifier.wos000574579100009
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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