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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.
- Source :
-
BMC Cancer . 3/30/2020, Vol. 20 Issue 1, p1-7. 7p. 3 Charts, 1 Graph. - Publication Year :
- 2020
-
Abstract
- <bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.<bold>Trial Registration: </bold>This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered). [ABSTRACT FROM AUTHOR]
- Subjects :
- *PROGRESSION-free survival
*QUALITY of life
*PANCREATIC cancer
*ADENOCARCINOMA
*ANAPLASTIC thyroid cancer
*ALBUMINS
*PANCREATIC tumors
*RESEARCH
*COMBINATION drug therapy
*CLINICAL trials
*RESEARCH methodology
*DEOXYCYTIDINE
*METASTASIS
*EVALUATION research
*MEDICAL cooperation
*TUMOR classification
*COMPARATIVE studies
*RANDOMIZED controlled trials
*SURVIVAL analysis (Biometry)
*PACLITAXEL
Subjects
Details
- Language :
- English
- ISSN :
- 14712407
- Volume :
- 20
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- BMC Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 142471305
- Full Text :
- https://doi.org/10.1186/s12885-020-06758-9