Abstract 4217
Background
ieCTs historically excluded HGG patients (pts) due to unavailability of serial bioptic sampling, use of corticosteroids, concerns on activity of immunotherapy in central nervous system, and rapid clinical deterioration.
Methods
Data of all recurrent HGG pts enrolled into ieCTs at the Humanitas Cancer Center Phase I Unit between 2014 and 2019 were retrospectively reviewed. Disease control rate (DCR) according to RANO criteria, six-months progression-free and overall survival (PFS-6; OS-6), and treatment-related adverse events (TRAEs), were evaluated. A control-cohort (CC) of patients treated with standard therapies (temozolomide, fotemustine, lomustine and procarbazine, bevacizumab) matched (1:1) for sex, age, line of treatment, MGMT methylation status, and IDH mutational status, was selected for comparison. A huge series of clinical and laboratory variables with an established prognostic relevance for solid tumors pts treated into ieCTs were studied through univariate analysis.
Results
Only 5 out 23 ieCTs allowed inclusion of HGG pts. The experimental cohort (EC) consisted of 25 pts (M/F: 16/9; median age: 50 years): 22 (88%) glioblastoma, 3 (12%) anaplastic astrocytoma. 17 pts (68%) required steroid therapy, with a median baseline dexamethasone dose of 2 mg (range 1-6). The median number of prior systemic therapies was 1 (range 1-2). 12 pts (48%) received monotherapies (anti PD-1, anti CSFR-1, anti TGF-ß, anti cereblon), 13 (52%) combination regimens (anti PD-L1 + anti CD38, anti PD-1 + anti CSFR-1). DCR was 40% in both EC (1 CR + 2 PR + 7 SD) and CC (1 PR + 9 SD). 4 pts (16%) in EC had grade ≥3 TRAEs (1 neutropenia, 1 pneumonia, 2 hepatitis). With a median follow-up (FU) of 14 months PFS-6 were 35% and 16% (p = 0.075), in EC and CC respectively, while OS-6 was significantly improved in the EC (82% vs 44%, p = 0.004). With limitations due to small sample size, short FU and few events recorded, none of the parameters analyzed resulted prognostic.
Conclusions
Survival of our HGG pts treated into ieCTs compared favorably with a matched CC. Inclusion of HGGs pts into ieCTs should be encouraged. Clinical selection factors predicting which pts may benefit most still lack.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M. Simonelli: Advisory / Consultancy: AbbVie. A. Santoro: Advisory / Consultancy: BRISTOL-MYERS-SQUIBB; Advisory / Consultancy: SERVIER; Advisory / Consultancy: GILEAD; Advisory / Consultancy: EISAI; Advisory / Consultancy: BAYER; Advisory / Consultancy: MERCK SHARP & DOHME; Speaker Bureau / Expert testimony: TAKEDA; Speaker Bureau / Expert testimony: BRISTOL-MYERS-SQUIBB; Speaker Bureau / Expert testimony: ROCHE; Speaker Bureau / Expert testimony: ABBVIE; Speaker Bureau / Expert testimony: AMGEN; Speaker Bureau / Expert testimony: CELGENE; Speaker Bureau / Expert testimony: SERVIER; Speaker Bureau / Expert testimony: GILEAD; Speaker Bureau / Expert testimony: ASTRAZENECA; Speaker Bureau / Expert testimony: PFIZER; Speaker Bureau / Expert testimony: ARQULE; Speaker Bureau / Expert testimony: LILLY; Speaker Bureau / Expert testimony: SANDOZ; Advisory / Consultancy: PFIZER. All other authors have declared no conflicts of interest.
Resources from the same session
860 - Dose differential modulation of the autophagic behavior of estrogen expressing breast carcinoma cells
Presenter: Mariam Fouad
Session: Poster Display session 1
Resources:
Abstract
2304 - Synthetic peptide of tumor–associated antigen L6 formulated with polymer-based adjuvant enhances anti-tumor effects in mice
Presenter: Shih-jen Liu
Session: Poster Display session 1
Resources:
Abstract
4419 - Improving detection level of somatic mosaicism in neurofibromatosis type 1
Presenter: Kristina Karandasheva
Session: Poster Display session 1
Resources:
Abstract
5283 - Preclinical pharmacokinetic/pharmacodynamic (PK/PD) relationship of ABN401, a highly selective Met inhibitor, in gastric and non-small-cell lung cancer models
Presenter: JooSeok Kim
Session: Poster Display session 1
Resources:
Abstract
5488 - Transcription factors of Snail family in the regulation of resistance of breast cancer cells to hypoxic conditions
Presenter: Alvina Khamidullina
Session: Poster Display session 1
Resources:
Abstract
5417 - Metastasis is impaired by endothelial-specific Dll4 loss-of-function through inhibition of epithelial-to-mesenchymal transition and reduction of cancer stem cells and circulating tumour cells
Presenter: Liliana Mendonça
Session: Poster Display session 1
Resources:
Abstract
5494 - Identification of novel and known FGFR gene fusions in Chinese non-small cell lung cancer
Presenter: Weixin Zhao
Session: Poster Display session 1
Resources:
Abstract
3412 - WNT pathway mutations (APC/CTNNB1) and immune checkpoint inhibitors (ICI) response in metastatic non-small cell lung cancer (NSCLC) patients.
Presenter: Francisco Javier Ros Montana
Session: Poster Display session 1
Resources:
Abstract
1815 - Leukocytosis as a negative prognostic factor in patients with lung cancer: Which subpopulation of leukocytes is responsible?
Presenter: Filip Kohutek
Session: Poster Display session 1
Resources:
Abstract
5022 - Identification of MET gene amplifications using next-generation sequencing in non-small cell lung cancer patients
Presenter: Sergi Clavé
Session: Poster Display session 1
Resources:
Abstract