PMID- 30396819
OWN - NLM
STAT- MEDLINE
DCOM- 20190422
LR  - 20240102
IS  - 1424-3911 (Electronic)
IS  - 1424-3903 (Linking)
VI  - 19
IP  - 1
DP  - 2019 Jan
TI  - Tumor treating fields in combination with gemcitabine or gemcitabine plus 
      nab-paclitaxel in pancreatic cancer: Results of the PANOVA phase 2 study.
PG  - 64-72
LID - S1424-3903(18)30698-7 [pii]
LID - 10.1016/j.pan.2018.10.004 [doi]
AB  - BACKGROUND: Tumor Treating Fields (TTFields), low intensity alternating electric 
      fields with antimitotic activity, have demonstrated survival benefit in patients 
      with glioblastoma. This phase 2 PANOVA study was conducted to examine the 
      combination of TTFields plus chemotherapy in patients with pancreatic ductal 
      adenocarcinoma (PDAC). METHODS: Forty patients with newly-diagnosed, locally 
      advanced or metastatic PDAC received continuous TTFields (150 KHz for >/=18 h/day) 
      plus gemcitabine (1000 mg/m(2)), or gemcitabine plus nab-paclitaxel 
      (125 mg/m(2)). The primary endpoint was safety and secondary endpoints included 
      compliance to TTFields, progression-free survival (PFS), and overall survival 
      (OS). RESULTS: Seventeen patients (85%) in each cohort reported Grade >/=3 adverse 
      events (AEs). No increase in serious AEs (SAEs) was observed compared to that 
      anticipated with systemic chemotherapy alone. Twenty-one patients reported 
      TTFields-related skin toxicity, of which 7 were Grade 3; all resolved following 
      temporary reduction of daily TTFields usage. No TTFields-related SAEs were 
      reported. Compliance to TTFields was 68-78% of the recommended average daily use 
      in both cohorts. Median PFS was 8.3 months (95% CI 4.3, 10.3) and median OS was 
      14.9 months (95% CI 6.2, NA) in the TTFields + gemcitabine cohort. In the 
      TTFields + gemcitabine + nab-paclitaxel cohort, the median PFS was 12.7 months 
      (95% CI 5.4, NA); median OS has not been reached. CONCLUSION: The PANOVA trial 
      demonstrated that the combination of TTFields and systemic chemotherapy is safe 
      and tolerable in patients with advanced PDAC. Based on the safety and preliminary 
      efficacy results of this phase 2 study, a randomized phase 3 study (PANOVA-3) is 
      underway.
CI  - Copyright (c) 2018 IAP and EPC. Published by Elsevier B.V. All rights reserved.
FAU - Rivera, Fernando
AU  - Rivera F
AD  - Hospital Universitario Marques de Valdecilla, Santander, Spain. Electronic 
      address: fernando.rivera@scsalud.es.
FAU - Benavides, Manuel
AU  - Benavides M
AD  - Hospital Universitario Regional y Virgen de la Victoria, Andalucia, Spain. 
      Electronic address: manuel.benavides.sspa@juntadeandalucia.es.
FAU - Gallego, Javier
AU  - Gallego J
AD  - Plazas Hospital General Universitario de Elche, Elche, Spain. Electronic address: 
      gallego.jav@gva.es.
FAU - Guillen-Ponce, Carmen
AU  - Guillen-Ponce C
AD  - Ramon y Cajal, Madrid, Spain. Electronic address: 
      carmen.guillen@salud.madrid.org.
FAU - Lopez-Martin, Jose
AU  - Lopez-Martin J
AD  - Hospital 12 de Octubre, Madrid, Spain. Electronic address: 
      jalopez.hdoc@salud.madrid.org.
FAU - Kung, Marc
AU  - Kung M
AD  - Hopital Fribourgeois, Fribourg, Switzerland. Electronic address: 
      marc.kueng@h-fr.ch.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20181017
PL  - Switzerland
TA  - Pancreatology
JT  - Pancreatology : official journal of the International Association of 
      Pancreatology (IAP) ... [et al.]
JID - 100966936
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 0 (Albumins)
RN  - 0 (Antineoplastic Agents)
RN  - 0W860991D6 (Deoxycytidine)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Albumins/administration & dosage/*therapeutic use
MH  - Antineoplastic Agents/administration & dosage/therapeutic use
MH  - *Combined Modality Therapy
MH  - Deoxycytidine/administration & dosage/*analogs & derivatives/therapeutic use
MH  - *Electric Stimulation Therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Paclitaxel/administration & dosage/*therapeutic use
MH  - Pancreatic Neoplasms/*therapy
MH  - Gemcitabine
OTO - NOTNLM
OT  - Gemcitabine
OT  - Nab-paclitaxel
OT  - PANOVA
OT  - Pancreatic cancer
OT  - Tumor treating fields
EDAT- 2018/11/07 06:00
MHDA- 2019/04/23 06:00
CRDT- 2018/11/07 06:00
PHST- 2018/06/03 00:00 [received]
PHST- 2018/09/18 00:00 [revised]
PHST- 2018/10/16 00:00 [accepted]
PHST- 2018/11/07 06:00 [pubmed]
PHST- 2019/04/23 06:00 [medline]
PHST- 2018/11/07 06:00 [entrez]
AID - S1424-3903(18)30698-7 [pii]
AID - 10.1016/j.pan.2018.10.004 [doi]
PST - ppublish
SO  - Pancreatology. 2019 Jan;19(1):64-72. doi: 10.1016/j.pan.2018.10.004. Epub 2018 
      Oct 17.