PMID- 27034791
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160401
LR  - 20220408
IS  - 2078-6891 (Print)
IS  - 2219-679X (Electronic)
IS  - 2078-6891 (Linking)
VI  - 7
IP  - 2
DP  - 2016 Apr
TI  - Phase II trial of capecitabine plus nab-paclitaxel in patients with metastatic 
      pancreatic adenocarcinoma.
PG  - 234-8
LID - 10.3978/j.issn.2078-6891.2015.107 [doi]
AB  - BACKGROUND: Combination chemotherapy regimens including fluoropyrimidines as well 
      as albumin-bound paclitaxel have shown promising results in patients with 
      metastatic pancreatic adenocarcinoma (mPC). Based on the recently described 
      excellent therapeutic index of capecitabine plus nab-paclitaxel in metastatic 
      breast cancer, the present phase II trial was initiated. METHODS: Patients with 
      previously untreated mPC were treated with capecitabine (825 mg/m(2) orally bid 
      on days 1-15) and nab-paclitaxel (125 mg/m(2) intravenously on days 1 and 8) 
      every 3 weeks. In patients without clinically relevant adverse reactions after 
      the 1st treatment course (</= grade 2 toxicities according to NCI-CTC vs. 4.0, 
      exuding alopecia and fatigue of any degree) and adequate bone marrow function, 
      the nab-paclitaxel dose was escalated to 100 mg/m(2) on days 1, 8 and 15 of each 
      cycle; this intra-individual dose escalation was maintained during subsequent 
      treatment courses if tolerated. The primary endpoint was objective response rate 
      (ORR) according to RECIST criteria, assessed by an independent radiological 
      review committee with evaluation performed every 2 months. RESULTS: Between 
      12/2013 and 01/2015, 30 patients were entered in this monocentric academic phase 
      II trial. All patients had an ECOG performance status of 0-1, 80% had liver 
      metastases and 23% had biliary stents in place at time of study initiation. 
      Median CA19-9 was 1,004 U/mL (0.9-100.000 U/mL). In all patients except 2, a dose 
      escalation of nab-paclitaxel after the 1st treatment course could be 
      accomplished. The most common grade 3 adverse events (AEs) included transient 
      sensory neuropathy (23%), (afebrile) neutropenia (17%), hand-foot-syndrome (13%) 
      and phototoxic skin reaction (10%). Among 29 RECIST-response assessable patients, 
      the ORR was 41.4% and stable disease (SD) was noted in 34.5%, resulting in a 
      disease control rate (DCR) of 76%. After a median follow-up duration of 10.3 
      months (range, 1.9-19.0 months), 13/30 patients (43.3%) are presently being 
      alive. CONCLUSIONS: The combination of capecitabine + nab-paclitaxel at these 
      doses and scheduling was well tolerated and showed substantial antitumor 
      efficacy.
FAU - Scheithauer, Werner
AU  - Scheithauer W
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Kornek, Gabriela
AU  - Kornek G
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Prager, Gerald
AU  - Prager G
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Stranzl, Nadja
AU  - Stranzl N
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Laengle, Friedrich
AU  - Laengle F
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Schindl, Martin
AU  - Schindl M
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Friedl, Josef
AU  - Friedl J
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Klech, Julia
AU  - Klech J
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Roethlin, Sabine
AU  - Roethlin S
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
FAU - Zielinski, Christoph
AU  - Zielinski C
AD  - 1 Department of Internal Medicine I, Medical University Vienna, Vienna, Austria ; 
      2 Department of Surgery, Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria 
      ; 3 Department of Surgery, Medical University Vienna, Vienna, Austria.
LA  - eng
PT  - Journal Article
PL  - China
TA  - J Gastrointest Oncol
JT  - Journal of gastrointestinal oncology
JID - 101557751
PMC - PMC4783742
OTO - NOTNLM
OT  - Pancreatic cancer
OT  - capecitabine
OT  - nab-paclitaxel
COIS- Conflicts of Interest: W Scheithauer-Consultant & advisory role, honoraria and 
      research funding, Celgene Corporation; G Kornek and G Prager-honoraria as invited 
      speakers, Celgene Corporation; S Schindl-advisory role, Celgene Corporation.
EDAT- 2016/04/02 06:00
MHDA- 2016/04/02 06:01
PMCR- 2016/04/01
CRDT- 2016/04/02 06:00
PHST- 2016/04/02 06:00 [entrez]
PHST- 2016/04/02 06:00 [pubmed]
PHST- 2016/04/02 06:01 [medline]
PHST- 2016/04/01 00:00 [pmc-release]
AID - jgo-07-02-234 [pii]
AID - 10.3978/j.issn.2078-6891.2015.107 [doi]
PST - ppublish
SO  - J Gastrointest Oncol. 2016 Apr;7(2):234-8. doi: 
      10.3978/j.issn.2078-6891.2015.107.