NAB-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): from clinical trials to clinical practice

被引:49
作者
De Vita, Ferdinando [1 ]
Ventriglia, Jole [1 ]
Febbraro, Antonio [2 ]
Laterza, Maria Maddalena [1 ]
Fabozzi, Alessio [1 ]
Savastano, Beatrice [1 ]
Petrillo, Angelica [1 ]
Diana, Anna [1 ]
Giordano, Guido [2 ]
Troiani, Teresa [1 ]
Conzo, Giovanni [3 ]
Galizia, Gennaro [3 ]
Ciardiello, Fortunato [1 ]
Orditura, Michele [1 ]
机构
[1] Univ Naples 2, Sch Med, Policlin 2, Dept Internal & Expt Med F Magrassi,Div Med Oncol, Via Pansini 5, I-80131 Naples, Italy
[2] Fatebenefratelli Hosp, Div Med Oncol, Viale Principe Napoli 14-A, I-82100 Benevento, Italy
[3] Univ Naples 2, Sch Med, Policlin 2, Dept Anesthesiol Surg & Emergency Sci,Div Surg On, Via Pansini 5, I-80131 Naples, Italy
关键词
Metastatic pancreatic cancer; Combination chemotherapy; Nab-paclitaxel; Gemcitabine; PHASE-III TRIAL; CANCER; SURVIVAL; FLUOROURACIL; OXALIPLATIN; COMBINATION;
D O I
10.1186/s12885-016-2671-9
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
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