Tumor treating fields in combination with gemcitabine or gemcitabine plus nab-paclitaxel in pancreatic cancer: Results of the PANOVA phase 2 study

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...

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Published in:Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] Vol. 19; no. 1; pp. 64 - 72
Main Authors: Rivera, Fernando, Benavides, Manuel, Gallego, Javier, Guillen-Ponce, Carmen, Lopez-Martin, José, Küng, Marc
Format: Journal Article
Language:English
Published: Switzerland Elsevier B.V 01.01.2019
Elsevier Limited
Subjects:
Adenocarcinoma
Aged
Aged, 80 and over
Albumins - administration & dosage
Albumins - therapeutic use
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - therapeutic use
Cancer therapies
Cell adhesion & migration
Chemotherapy
Combined Modality Therapy
Deoxycytidine - administration & dosage
Deoxycytidine - analogs & derivatives
Deoxycytidine - therapeutic use
Electric fields
Electric Stimulation Therapy
Female
Gemcitabine
Glioblastoma
Humans
Male
Medical equipment
Metastases
Metastasis
Middle Aged
Nab-paclitaxel
Neutropenia
Paclitaxel
Paclitaxel - administration & dosage
Paclitaxel - therapeutic use
Pancreatic cancer
Pancreatic Neoplasms
Pancreatic Neoplasms - therapy
PANOVA
Patients
Skin
Survival
Toxicity
Tumor treating fields
Israel
PANOVA
Tumor treating fields
Gemcitabine
Pancreatic cancer
Nab-paclitaxel
ISSN:1424-3903, 1424-3911, 1424-3911
Online Access:Get full text
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Summary: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). Forty patients with newly-diagnosed, locally advanced or metastatic PDAC received continuous TTFields (150 KHz for ≥18 h/day) plus gemcitabine (1000 mg/m2), or gemcitabine plus nab-paclitaxel (125 mg/m2). The primary endpoint was safety and secondary endpoints included compliance to TTFields, progression-free survival (PFS), and overall survival (OS). 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. 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.
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ISSN:1424-3903
1424-3911
1424-3911
DOI:10.1016/j.pan.2018.10.004