Author:
Yalcin Suayib,Dane Faysal,Oksuzoglu Berna,Ozdemir Nuriye Yildirim,Isikdogan Abdurrahman,Ozkan Metin,Demirag Guzin Gonullu,Coskun Hasan Senol,Karabulut Bulent,Evrensel Turkkan,Ustaoglu Mehmet Ali,Ozdemir Feyyaz,Turna Hande,Yavuzsen Tugba,Aykan Faruk,Sevinc Alper,Akbulut Hakan,Yuce Deniz,Hayran Mutlu,Kilickap Saadettin
Abstract
Abstract
Background
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).
Funder
Türk Tıbbi Onkoloji Derneği
Türk Kanser Araştirma ve Savaş Kurumu Derneği
hacettepe onkoloji derneği
Celgene
onkoloji araştırmaları derneği
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
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