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

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dc.contributor.authorYalçın, Şuayib
dc.contributor.authorDane, Faysal
dc.contributor.authorÖksüzoǧlu, Berna Çakmak
dc.contributor.authorÖzdemir, Nuriye Yıldırım
dc.contributor.authorIşıkdoğan, Abdurrahman
dc.contributor.authorÖzkan, Metin
dc.contributor.authorDemiragğ, Güzin Gönüllü
dc.contributor.authorÇoşkun, Hasan Şenol
dc.contributor.authorKarabulut, Bülent
dc.contributor.authorEvrensel, Türkkan
dc.contributor.authorUstaoglu, Mehmet Ali
dc.contributor.authorÖzdemir, Feyyaz
dc.date.accessioned2021-07-12T13:16:52Z
dc.date.available2021-07-12T13:16:52Z
dc.date.issued2020en_US
dc.departmentDicle Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıklar Ana Bilim Dalıen_US
dc.descriptionWOS:000524502100004
dc.descriptionPubMed ID32228512
dc.description.abstractBackground: Combination 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. Methods: A total of 125 patients were randomized to combination therapy (1000 mg/m2 gemcitabine + 125 mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000 mg/m2) arms to take treatment weekly for 7 of 8 weeks, and following 3 of 4 weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL. Results: Overall 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 6th month assessments, respectively (p = 0.357). Median overall survivals in combination and single-agent arms were 9.92 months and 5.95 months, 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 3.22 months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p = 0.008). Median time-to-deterioration were 5.36 vs 3.68 months, and objective response rates were 37.1% vs 23.7% (p = 0.009), respectively in combination and single-agent arms. Conclusions: Combination 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 registration: This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered)en_US
dc.identifier.citationYalçın, Ş., Dane, F., Öksüzoǧlu, B. Ç., :Özdemir, N. Y., Işıkdoğan, A., :Özkan, M. ve diğerleri. (2020). Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study. BMC Cancer, 20(1), 259.en_US
dc.identifier.doi10.1186/s12885-020-06758-9
dc.identifier.issn1471-2407
dc.identifier.issue1en_US
dc.identifier.pmid32228512
dc.identifier.scopus2-s2.0-85082792669
dc.identifier.scopusqualityQ2
dc.identifier.startpage259en_US
dc.identifier.urihttps://bmccancer.biomedcentral.com/articles/10.1186/s12885-020-06758-9
dc.identifier.urihttps://hdl.handle.net/11468/7231
dc.identifier.volume20en_US
dc.identifier.wosWOS:000524502100004
dc.identifier.wosqualityQ2
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.institutionauthorIşıkdoğan, Abdurrahman
dc.language.isoenen_US
dc.publisherBioMed Central Ltd.en_US
dc.relation.ispartofBMC Cancer
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectGemcitabineen_US
dc.subjectMetastaticen_US
dc.subjectNab-paclitaxelen_US
dc.subjectPancreatic canceren_US
dc.subjectQuality of lifeen_US
dc.titleQuality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 studyen_US
dc.titleQuality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study
dc.typeArticleen_US

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