Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine plus nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study

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dc.contributor.authorYalcin, Suayib
dc.contributor.authorDane, Faysal
dc.contributor.authorOksuzoglu, Berna
dc.contributor.authorOzdemir, Nuriye Yildirim
dc.contributor.authorIsikdogan, Abdurrahman
dc.contributor.authorOzkan, Metin
dc.contributor.authorKilickap, Saadettin
dc.date.accessioned2020-12-01T12:01:56Z
dc.date.available2020-12-01T12:01:56Z
dc.date.issued2020
dc.departmentEge Üniversitesien_US
dc.description.abstractBackgroundCombination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown.MethodsA total of 125 patients were randomized to combination therapy (1000mg/m2 gemcitabine +125mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000mg/m2) arms to take treatment weekly for 7 of 8weeks, and following 3 of 4weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL.ResultsOverall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p=0.018). These proportions were 27.3 and 36.6% in 6(th) month assessments, respectively (p=0.357). Median overall survivals in combination and single-agent arms were 9.92months and 5.95months, respectively (HR: 0.64, 95% CI: 0.42-0.86, p=0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p=0.008). Median time-to-deterioration were 5.36 vs 3.68months, and objective response rates were 37.1% vs 23.7% (p=0.009), respectively in combination and single-agent arms.ConclusionsCombination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer.Trial registrationThis study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).en_US
dc.description.sponsorshipCelgene [aaaa] Funding Source: Medline; onkoloji arastirmalari dernegi [aaa] Funding Source: Medline; hacettepe onkoloji dernegi [wwww] Funding Source: Medline; Turk Kanser Arastirma ve Savas Kurumu Dernegi [awe] Funding Source: Medline; Turk Tibbi Onkoloji Dernegi (TR) [wwww] Funding Source: Medlineen_US
dc.identifier.doi10.1186/s12885-020-06758-9en_US
dc.identifier.issn1471-2407
dc.identifier.issue1en_US
dc.identifier.pmid32228512en_US
dc.identifier.scopus2-s2.0-85082792669en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://doi.org/10.1186/s12885-020-06758-9
dc.identifier.urihttps://hdl.handle.net/11454/62557
dc.identifier.volume20en_US
dc.identifier.wosWOS:000524502100004en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherBmcen_US
dc.relation.ispartofBmc Canceren_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectNab-paclitaxelen_US
dc.subjectGemcitabineen_US
dc.subjectPancreatic canceren_US
dc.subjectMetastaticen_US
dc.subjectQuality of lifeen_US
dc.titleQuality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine plus nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 studyen_US
dc.typeArticleen_US

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