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NAB-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): from clinical trials to clinical practice.
- Source :
-
BMC Cancer . 9/2/2016, Vol. 16, p1-8. 8p. 5 Charts, 5 Graphs. - Publication Year :
- 2016
-
Abstract
- <bold>Background: </bold>Pancreatic adenocarcinoma is an aggressive disease with poor prognosis. In a randomized phase III trial, combination of Nab-paclitaxel (Nab-P) plus gemcitabine showed superior activity and efficacy in first-line treatment compared with gemcitabine alone.<bold>Methods: </bold>Nab-P is not dispensed in Italy; however, we obtained this drug from our Ethics Committee for compassionate use. The aim of this study was to evaluate the efficacy and safety profile of this Nab-P and gemcitabine combination in a cohort of patients treated outside clinical trials. From January 2012 to May 2014, we included 41 patients with advanced pancreatic adenocarcinoma receiving combination of 125 mg/m(2) Nab-P and 1 g/m(2) gemcitabine on days 1, 8 and 15 of a 28-day cycle, as first-line treatment. Median age of patients was 67 (range 41-77) years, and 11 patients were aged ≥70 years.<bold>Results: </bold>Eastern Co-operative Oncology Group performance status was 0 or 1 in 32 patients (78 %) and 2 in nine patients (22 %). Primary tumor was located in the pancreatic head or body/tail in 24 (58.5 %) and 17 (41.5 %) patients, respectively, and nine patients had received biliary stent implantation before starting chemotherapy. Median carbohydrate antigen 19-9 level was 469 U/l (range 17.4-61546 U/l) and 29 patients (70.7 %) had referred pain at the time of diagnosis. Patients received a median six cycles (range 1-14) of treatment. Overall response rate was 36.6 %; median progression-free survival was 6.7 months [(95 % confidence interval (CI) 5.966-8.034), and median overall survival was 10 months (95 % CI 7.864-12.136). Treatment was well tolerated. No grade 4 toxicity was reported. Grade 3 toxicity included neutropenia in 10 patients (24.3 %), thrombocytopenia in five (12 %), anemia in three (7.3 %), diarrhea in four (9.7 %), nausea and vomiting in two (4.9 %), and fatigue in six (14.6 %). Finally, pain control was achieved in 24 of 29 patients (82.3 %) with a performance status improvement of 10 % according to the Karnofsky scale.<bold>Conclusions: </bold>Our results confirm that combination of gemcitabine plus Nab-P is effective both in terms of overall response rate, progression-free survival and overall survival, with a good safety profile. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PANCREATIC cancer treatment
*PANCREATIC cancer
*PACLITAXEL
*COMBINATION drug therapy
*DRUG efficacy
*CLINICAL trials
*PROGNOSIS
*ANTINEOPLASTIC agents
*DRUG administration
*EXPERIMENTAL design
*METASTASIS
*PANCREATIC tumors
*SURVIVAL analysis (Biometry)
*TREATMENT effectiveness
*ALBUMINS
*RETROSPECTIVE studies
*DUCTAL carcinoma
*DEOXYCYTIDINE
*THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 14712407
- Volume :
- 16
- Database :
- Academic Search Index
- Journal :
- BMC Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 117902039
- Full Text :
- https://doi.org/10.1186/s12885-016-2671-9