Yalçın, ŞuayibDane, FaysalÖksüzoǧlu, Berna ÇakmakÖzdemir, Nuriye YıldırımIşıkdoğan, AbdurrahmanÖzkan, MetinDemiragğ, Güzin GönüllüÇoşkun, Hasan ŞenolKarabulut, BülentEvrensel, TürkkanUstaoglu, Mehmet AliÖzdemir, Feyyaz2021-07-122021-07-122020Yalçın, 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), 259.1471-2407https://bmccancer.biomedcentral.com/articles/10.1186/s12885-020-06758-9https://hdl.handle.net/11468/7231WOS:000524502100004PubMed ID32228512Background: 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)eninfo:eu-repo/semantics/openAccessGemcitabineMetastaticNab-paclitaxelPancreatic cancerQuality of lifeArticle201259WOS:0005245021000042-s2.0-850827926693222851210.1186/s12885-020-06758-9Q2Q2