Abstract 4255
Background
Tumor Treating Fields (TTFields) are an anti-mitotic, regional treatment modality, utilizing low intensity alternating electric fields delivered non-invasively to the tumor. TTFields have significantly extended survival of patients with glioblastoma. In vitro, human MPM cells are highly susceptible to TTFields. In the phase 2 STELLAR study [NCT02397928], patients with unresectable MPM treated with first line chemotherapy in combination with TTFields had a significantly higher median overall survival compared with historical controls (18.2 Vs. 12.1 months). We report on radiological data from STELLAR patients whose tumors responded while receiving the combined therapy.
Methods
The STELLAR trial accrued 80 patients with unresectable, previously untreated MPM. Patients received continuous 150 kHz TTFields (>18h/day) combined with pemetrexed and cisplatin or carboplatin (standard dosing). Inclusion criteria: ECOG PS of 0-1, pathologically proven MPM and > measurable lesion per modified RECIST. Patients were followed q3w (CT scan q6w) until disease progression. Radiological assessments were done 6-weekly at study sites.
Results
Partial responses (PRs) were seen in 40.3% (29/72) of evaluable patients and clinical benefit (PR+SD) was seen in 97.2% (70/72) patients. The median time between treatment start and PR was 1.9 months (range: 1.4-4.4 months). All patients presenting with PR during the STELLAR study had continuous reduction in the total sum of lesion diameters, suggesting no initial/pseudo-progression. 83% of the patients who responded to the combined therapy finally had disease progression with a median response duration of 5.7 months (range: 1.4-13 months). One patient did not progress for more than 27 months. 28 responders (97%) reported at least 1 adverse event, and 7 patients (24%) had TTFields-related skin toxicities.
Conclusions
The STELLAR study significantly extended survival in previously untreated MPM patients. Response rates were similar to those reported for the current MPM standard of care treatment, but were of longer duration with the addition of TTFields. The only TTFields-related adverse event was skin irritation beneath the arrays.
Clinical trial identification
NCT02397928.
Editorial acknowledgement
Legal entity responsible for the study
Novocure.
Funding
Novocure.
Disclosure
F. Grosso: Travel / Accommodation / Expenses: Novocure. G.L. Ceresoli: Travel / Accommodation / Expenses: Novocure.
Resources from the same session
4883 - A New Population Model Validated Pharmacokinetic Similarity of HLX01 and Rituximab in B-Cell Lymphoma
Presenter: Yuankai Shi
Session: Poster Display session 1
Resources:
Abstract
4908 - Efficacy of salvage therapy in the treatment of Helicobacter pylori-positive gastric low-grade mucosa-associated lymphoid tissue lymphoma
Presenter: Sung-Nam Lim
Session: Poster Display session 1
Resources:
Abstract
2360 - Mutational analysis of extranodal marginal zone lymphoma using next generation sequencing
Presenter: Seok Jae Huh
Session: Poster Display session 1
Resources:
Abstract
2430 - Clinical features, treatment and outcomes of colon and rectum mucosa-associated lymphoid tissue (MALT) lymphoma: Literature reviews published in English between 1993 and 2017
Presenter: Jeong Yeon Kim
Session: Poster Display session 1
Resources:
Abstract
4654 - Splenic marginal zone lymphoma: clinical characteristics and prognostic factors in a series of 52 patients
Presenter: Guldane Cengiz Seval
Session: Poster Display session 1
Resources:
Abstract
1732 - Safety and efficacy of Bendamustine and Rituximab (BR) regimen in Indian Chronic Lymphocytic Leukemia patients
Presenter: Ajay Gogia
Session: Poster Display session 1
Resources:
Abstract
5784 - N-terminal B-type natriuretic peptide (NT-proBNP) as an independed prognostic marker for patients with newly diagnosed multiple myeloma complicated by dialysis-dependent renal failure
Presenter: Sergey Semochkin
Session: Poster Display session 1
Resources:
Abstract
836 - The first-line effect of Bortezomib-based Therapy on Clinical Outcomes for Taiwanese Patients with multiple myeloma
Presenter: Ching-Liang Ho
Session: Poster Display session 1
Resources:
Abstract
2085 - Impact of Donor Lymphocyte Infusion in Relapsing Myeloid Neoplasms Post Allogeneic Hematopoietic Stem Cell Transplantation
Presenter: Hanafy Hafez
Session: Poster Display session 1
Resources:
Abstract
6079 - Invasive fungal diseases in patients with Hodgkin’s lymphoma before and after allogeneic hematopoietic stem cell transplantation
Presenter: Marina Popova
Session: Poster Display session 1
Resources:
Abstract