Dataset Information

Ena-DATASET-ErasmusMC-30-07-2021-13:58:26:615-766 - samples

ABSTRACT: Intellance-2: TruSight Tumor 170 panel based RNA-seq

PROVIDER: EGAD00001007944 | EGA |

REPOSITORIES: EGA

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Publications

EGFR mutations are associated with response to depatux-m in combination with temozolomide and result in a receptor that is hypersensitive to ligand.

Hoogstrate Youri Y Vallentgoed Wies W Kros Johan M JM de Heer Iris I de Wit Maurice M Eoli Marica M Sepulveda Juan Manuel JM Walenkamp Annemiek M E AME Frenel Jean-Sebastien JS Franceschi Enrico E Clement Paul M PM Weller Micheal M van Royen Martin E ME Ansell Peter P Looman Jim J Bain Earle E Morfouace Marie M Gorlia Thierry T Golfinopoulos Vassilis V van den Bent Martin M French Pim J PJ

Neuro-oncology advances 20191209 1

<h4>Background</h4>The randomized phase II INTELLANCE-2/EORTC_1410 trial on EGFR-amplified recurrent glioblastomas showed a trend towards improved overall survival when patients were treated with depatux-m plus temozolomide compared with the control arm of alkylating chemotherapy only. We here performed translational research on material derived from this clinical trial to identify patients that benefit from this treatment.<h4>Methods</h4>Targeted DNA-sequencing and whole transcriptome analysis ...[more]

PMID: 32642719

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Project description:To assess feasibility and safety of conventionally fractionated radiotherapy (cfRT) in patients with hepatocellular carcinoma (HCC).Patients with histologically confirmed stage cT1-4, cN0-1 HCC and Child-Pugh Score (CPS) A or B disease were included in a phase I multicenter trial. Metastatic HCC were allowed if ?90% of total tumor volume was located within the liver. Patients were enrolled onto five dose-escalation levels (54-70Gy in 2Gy fractions) based on a modified 3 + 3 design, with cohorts of five patients instead of three patients in dose levels 4 and 5. Primary trial endpoint was dose-limiting toxicity (DLT), as specifically defined for 17 clinical and nine laboratory parameters as grade ?3 or ?4 toxicity (CTCAE vs. 3). The threshold to declare a dose level as maximum tolerated dose (MTD) was defined as a DLT rate of ?16.7% in dose levels 1-3, and ?10% in dose levels 4-5. Best objective response of target liver lesions and adverse events (AE's) were assessed as secondary endpoints.The trial was terminated early in DL 3 due to low accrual. Nineteen patients were recruited. Fifteen patients were evaluable for the primary and 18 for the secondary endpoints. Maximum tolerated dose was not reached. One patient in dose level 1, and one patient in dose level 2 experienced DLT (lipase > 5xULN, and neutrophils <500/?L respectively). However, dose level 3 (62Gy) was completed, with no DLTs in 3 patients. Overall, 56% of patients had a partial response and 28% showed stable disease according to RECIST. No signs of radiation induced liver disease (RILD). Two patients in dose level 3 experienced lymphocytopenia grade 4, with no clinical impact.Conventionally fractionated radiotherapy of 58Gy to even large HCC was safe for patients with CPS A and B. 62Gy was delivered to three patients without any sign of clinically relevant increased toxicity. The maximum tolerated dose could not be determined.ClinicalTrials.gov identifier NCT00777894 , registered October 21st, 2008.

Dataset Information

Ena-DATASET-ErasmusMC-30-07-2021-13:58:26:615-766 - samples

Publications

EGFR mutations are associated with response to depatux-m in combination with temozolomide and result in a receptor that is hypersensitive to ligand.

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