2 research outputs found
STELLAR: Final results of a phase II trial of TTFields with chemotherapy for first-line treatment of pleural mesothelioma
STELLAR: Final updated results of a phase II trial of TTFields with chemotherapy for unresectable malignant pleural mesothelioma
Background: Tumor Treating Fields (TTFields), an anti-mitotic, regional treatment
approved for glioblastoma utilizes low intensity, alternating electric fields delivered
non-invasively to the tumor using a portable medical device. In-vitro, human mesothelioma cells were highly susceptible to TTFields.
Methods: The trial accrued 80 patients with unresectable, previously untreated mesothelioma. Patients were treated with continuous 150 kHz TTFields (>18h/day) in combination with pemetrexed and cisplatin or carboplatin. Inclusion criteria included
ECOG PS of 0-1 and pathologically proven mesothelioma. The primary endpoint was
overall survival (OS). A visual analog scale was used to assess EOCG performance status
and cancer-related pain assessed until disease progression. The sample size provided
80% power with two-sided alpha of 0.05 to detect an increase in median OS of 5.5
months compared to historical controls (Vogelzang, JCO 2003).
Results: All 80 patients had a minimum follow up of 12 months. Median age was 67
(range 27-78), 84% were male and 44% (35 patients) had an ECOG PS of 1. 66% (53
patients) had epithelioid histology, similar to the Vogelzang study. Median OS was 18.2
months (95% CI 12.1-25.8) versus 12.1 months in the historical control. Median OS
for epithelioid patients was 21.2 months (95% CI 13.2-25.8). ECOG score was stable
during the first year of follow up. Median time to deterioration in performance status
was 13.1 months. Average score of pain was lower compared to baseline during the first
7 months of the treatment and was higher later on the study, with a median time to a
clinical significant 33% increase in pain of 8.4 months. No device-related serious
adverse events (AEs) were reported. Expected TTFields-related dermatitis was reported
in 46% (37 patients). Four patients (5%) had grade 3 dermatitis.
Conclusions: The study met primary endpoint of significant extension of overall survival in previously untreated mesothelioma patients. TTFields was not associated with
a decrease in performance status or an increase in pain for the duration of TTFields use.
TTFields in combinati