title: NAB-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): from clinical trials to clinical practice.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy. ferdinando.devita@unina2.it.
authors: Ferdinando
authors: F
authors: De Vita
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Jole
authors: J
authors: Ventriglia
authors: Division of Medical Oncology, Fatebenefratelli Hospital, Viale Principe di Napoli 14/a, 82100, Benevento, Italy.
authors: Antonio
authors: A
authors: Febbraro
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Maria Maddalena
authors: MM
authors: Laterza
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Alessio
authors: A
authors: Fabozzi
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Beatrice
authors: B
authors: Savastano
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Angelica
authors: A
authors: Petrillo
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Anna
authors: A
authors: Diana
authors: Division of Medical Oncology, Fatebenefratelli Hospital, Viale Principe di Napoli 14/a, 82100, Benevento, Italy.
authors: Guido
authors: G
authors: Giordano
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Teresa
authors: T
authors: Troiani
authors: Divisions of Surgical Oncology, Department of Anesthesiological, Surgical and Emergency Sciences, Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Giovanni
authors: G
authors: Conzo
authors: Divisions of Surgical Oncology, Department of Anesthesiological, Surgical and Emergency Sciences, Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Gennaro
authors: G
authors: Galizia
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Fortunato
authors: F
authors: Ciardiello
authors: Division of Medical Oncology, Department of Internal and Experimental Medicine "F. Magrassi", Second University of Naples - School of Medicine, c/o II Policlinico, Via Pansini, 5, 80131, Naples, Italy.
authors: Michele
authors: M
authors: Orditura
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy*; D057176:Compassionate Use Trials; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine
keywords: Combination chemotherapy; Gemcitabine; Metastatic pancreatic cancer; Nab-paclitaxel