title: Nab-Paclitaxel and Gemcitabine in Advanced Pancreatic Cancer: The One-year Experience of the National Cancer Institute of Naples.
abstract: Pancreas adenocarcinoma is the sixth cause of cancer-related death worldwide with an increasing mortality in the Western countries. Recently, the association between nab-paclitaxel (nab-P) and gemcitabine (GEM) has significantly improved progression-free and overall survival.
  
  
  
  Patients affected by metastatic pancreas adenocarcinoma were treated at the Department of Abdominal Oncology of the National Cancer Institute of Naples from July 2015 to July 2016 with nab-P at 125 mg per square meter of body-surface area followed by GEM at 1,000 mg per square meter on days 1, 8 and 15 every 4 weeks. Computed tomography (CT) was performed every three months of therapy. Toxicity was graded with National Cancer Institute-Common Toxicity Criteria (NCI-CTC) v4.0. Objective responses were evaluated with Response Evaluation Criteria in Solid Tumors (RECIST). Analysis of time-to-progression is only descriptive. Pain was evaluated with a visual analogue scale (VAS).
  
  
  
  Twenty-three patients were treated. Median age was 67 years (range=45-81); 8 patients were ≥70 years old. Performance status (PS) Eastern Cooperative Oncology Group (ECOG) was 2 in 8 patients, 1 in 10 and 0 in 5. Twelve patients presented with diffuse hepatic metastases, 4 with carcinosis, 7 with more than one organ involvement. Nab-P was reduced at 100 mg per square meter in all patients. The most common G3/G4 adverse events were neutropenia (13.0% G4, 8.6% G3; none was febrile), neuropathy (30.4% G3) and asthenia (G3 17.3%). The disease control rate was 43.4% (partial response+stable disease (PR+SD) 10/23). The median time-to-progression was 7.9 months (95% confidence interval (CI)=5.8-11.2). After three months of therapy the PS improved in 14 patients, as well as pain in 18 patients.
  
  
  
  We present an experience with nab-P and GEM association in a series with poor PS and highly metastatic disease relatively to a previous randomized study. The schedule is feasible, with nab-P at 100 mg per square meter achieving a good disease control rate, as well as a clinical benefit.
authors.affiliation: Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy ale.otto@libero.it.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Ottaiano
authors.affiliation: Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.|ENETS Center of Excellence, Multidisciplinary Group for Neuroendocrine Tumors in Naples, Naples, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Capozzi
authors.affiliation: Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.|ENETS Center of Excellence, Multidisciplinary Group for Neuroendocrine Tumors in Naples, Naples, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: DE Divitiis
authors.affiliation: Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: VON Arx
authors.affiliation: Units of Endoscopy, Istituto Nazionale Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: DI Girolamo
authors.affiliation: Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Nasti
authors.affiliation: Laboratory Unit, Istituto Nazionale Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.
authors.forename: Ernesta
authors.initials: E
authors.lastname: Cavalcanti
authors.affiliation: Pathology Unit of the Department of Diagnostic Pathology and Laboratory, Istituto Nazionale Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.
authors.forename: Fabiana
authors.initials: F
authors.lastname: Tatangelo
authors.affiliation: Department of Abdominal Surgery, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Romano
authors.affiliation: Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Avallone
authors.affiliation: Department of Abdominal Oncology, Istituto Nazionale, Tumori di Napoli "G. Pascale" IRCCS, National Cancer Institute, Naples, Italy.|ENETS Center of Excellence, Multidisciplinary Group for Neuroendocrine Tumors in Naples, Naples, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Tafuto
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007558:Italy; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D011379:Prognosis; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine
keywords: Nab-Paclitaxel; chemotherapy; clinical study; gemcitabine; pancreatic cancer