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
5437 - Salivary cytokines and oral mucosa cells apoptosis in patients during hematopoietic cell transplantation: possible relationship with oral mucositis
Presenter: Luciana Corrêa
Session: Poster Display session 1
Resources:
Abstract
1483 - A randomized trial of sodium alginate prevention of radiation-induced esophagitis in patients with locally advanced NSCLC receiving concurrent chemoradiotherapy: OLCSG1401
Presenter: Toshihide Yokoyama
Session: Poster Display session 1
Resources:
Abstract
2047 - Taste and smell alterations (TSAs) in patients (pts) with stage II-III colon cancer (CC): a pilot within the PROTECT study
Presenter: Jeroen Derksen
Session: Poster Display session 1
Resources:
Abstract
5984 - Clinical characteristics are associated with acupuncture treatment response for xerostomia in cancer patients
Presenter: Wenli Liu
Session: Poster Display session 1
Resources:
Abstract
2845 - Psychosocial Distress of Adolescent and Young Adults with Cancer at Diagnosis: A Case-Matched Retrospective Cohort of 2045 Patients in British Columbia.
Presenter: Alannah Smrke
Session: Poster Display session 1
Resources:
Abstract
724 - Accuracy of distress thermometer to measure cancer-related mood disorders in Chinese patients with cancer
Presenter: Sudip Thapa
Session: Poster Display session 1
Resources:
Abstract
2357 - Modalities of biosimilar filgrastim use in clinical practice in >1000 patients receiving chemotherapy regimens with a rest period of ≤14 days: the TOPAZE study
Presenter: Jean Marc Phelip
Session: Poster Display session 1
Resources:
Abstract
1426 - The Effect of Increasing Doses of Pegfilgrastim (Peg) on Thrombocytopenia (T) in Breast Cancer (BC) Patients (pts) Receiving Taxotere (Doc), Doxorubicin, Cyclophosphamide (TAC) and Plinabulin (Plin)
Presenter: Douglas Blayney
Session: Poster Display session 1
Resources:
Abstract
712 - The use of intravenous ferric carboxymaltose without erythropoiesis-stimulating agents in the treatment of anemia in cancer patients undergoing chemotherapy with or without radiotherapy
Presenter: Hikmat Abdel-Razeq
Session: Poster Display session 1
Resources:
Abstract
1496 - Randomized, double-blind, cross-over Phase I study comparing pharmacokinetics, pharmacodynamics, safety and immunogenicity of a biosimilar pegfilgrastim with EU and US references
Presenter: Maria Velinova
Session: Poster Display session 1
Resources:
Abstract