ASCO Overview:
Central Nervous System:

Written by: Suely Maymone de Melo - Neuro-Oncology - H Cor
Marcos Maldaun - Neurosurgery - Hospital Sirio Libanes e Centro Oncológico Antônio Erminio de Moraes

OA 2009: David A Reardon
ReACT( Phase II study - Rindopepimut + Bevacizumab) – 73 patients with recurring GBM were evaluated – it is a specific vaccine for the GBM EGFRvIII (+) . The data, previously presented during the 2014 SNO meeting, was updated. The primal objective (PFS 6 m – considered an alpha = 0,2) was reached (28 X 16% p = 0,1163). In relation to the secondary objectives of this study, an increase in the reduction of the tumor was observed (ORR 30% X 18%), with the greater lasting of the radiographic response for the arm undergoing the procedure with the vaccine, as well as an increase in survival (11,6 X 9,3). The treatment was well tolerated (local temporary reaction G I-II). The patients who responded to treatment presented a high level of antibody against the vaccine, suggesting that it can be used as a marker for the treatment response. However the population treated at their first recurring episode was greater in the Rindopepimut arm (92 X 76%), and also the greater resected volume in the treated group. According to the author, the comparison after the stratification of patients in relation to these variables did not show impact of these differences in the result. The results of the Phase III study in the recently diagnosed GBM should be presented in a few months’ time.

OA 2010: David S Baskin
Immuntherapy cytotoxic, using Adenovirus in patients recently diagnosed with malignant gliomas (phase II multicentre not randomized study) – this is a local injection, after tumor ressection, of non-replicant adenovirus, expressing the timidina-quinase gene, promotes phosporilation of valaciclovir, which afterward is tri-phosporilated by the tumoral cell, making it cytotoxic for the cell. As a consequence, there is the release of antigens and pro-inflamatory cytokines in the microenvironment. The treatment was well tolerated, with few cases on G 3-4 toxicity and it stimulated the immune response. There was an increase in survival (17,1 X 13,5 months p = 0,0417) and in the progression free survival (PFS) ( 8,1 X 6,4 months p= 0,010). After the stratification by total Gross resection versus subtotal, the benefit was only significant in the first group (GBM + AA + OA = 25 X 16,9 p = 0,0492 / onlyGBM = 25,1 X 16,3 p = 0,0120). These encouraging results need a randomized study with greater power for its confirmation.

OA2011; Orin Bloch
Prophage– Vaccine composed by dendriticas cells exposed to the peptide “heat shock” (HSP) in the treatment of recently diagnosed GBM (phase II study only branch)HSP extracted from the tumor cells, linked to peptides are incorporated by the dendritic cells and the antigens presented in the MHC-I and MHC-II form. HSP also stimulates pro-inflammatory cytokines in the dendritic cells. In order to include the patient in the study, a tumor resection should be superior to 90%. The primary endpoint was survival. 46 patients were selected and the authors observed an increase in the frequency of MGMT+ in relation to the general population. The vaccine was well tolerated. The median survival was 23,8 months ( MGMT+ = 44,7 months / MGMTwt = 18 months) and the PFS was of 18 months. It is worth noticing that the comparison was made with historic controls and that were selected by resection superior to 90% (Patients with the best prognosis). The authors evaluated, in 32 patients, the PD-L1 expression in the circulating monocites and verified that those that expressed high title showed less survival when compared to those with low title (18 X 44,7 months p = 0,007- univariated analysis).

In general, for the cancer treatment, the imunosupression blocking ( anti-PD1, anti-CTLA4) was the highlight of the congress. In relation to patients with GBM, no results of studies with these very promising drugs were presented yet.

Oral Presentations’ Abstracts:
OA 2000: Roger Stupp.
NewTTF: Phase III study – Randomization after radiotherapy, comparing TTF + TMZ versus TMZ. Final analysis with 695 patients.
Results previously presented during SNO in november 2014 were updated during this presentation (back then there were 315 patients in the analysis). The only observed side effect was skin reaction at the locations of the electrodes (G 2). The PFS was of 7.1months for the TTF/TMZ combination vs 4.2 months for isolated TMZ p = 0.0010; The median survival observed, as from the randomization, was of 19.4 vs 16.6 months, p =0.0222. The survival in 2 years was of 43% (CI 36-50%) vs. 29% (CI 21-38%). The quality of life in both arms was similar.

OA 2001: Wolfgang Wick
NOA-04: Long term analysis of phase III study in anaplasticglioma(GIII) - sequential radio chemotherapy - comparison between PCV and Temozolamida. Arm A (RT), Arm B (PCV), Arm C ( TMZ). After progression, arm B and C were submitted to RT and the Arm A patients were divided into 2 groups: PCV or TMZ. Primary objective: Time until second progression( TTF). There weren't differences in any of the 3 arms. PFS and OS ( secondary objectives) also weren’t different in the 3 arms. In relation to the comparison between AA and AOA, the study showed greater PFS in the AOA group and no difference, within each group, between RT versus QT. In 207 patients, the IDH mutation was evaluated: 3 groups were observed, where the IDHmut-Codel group was the best TTF/PFS/OS, the IDHmut-non Codelgroup with intermediary TTF/PFS/OS and theIDHwt group with lower TTF/PFS/OS. In the IDHwt group, MGMT had predictive value, given that MGMT+ patients presented TTF/PFS/OS superior to those in MGMT- when treated with chemotherapy (TMZ ou PCV), while there wasn't any difference in TTF/PFS/OS between the MGMT+ patients versus MGMT- after radiotherapy.

OS 2002: Susan Chang
NRG oncology/RTOG 9813: Phase III study radiotherapy + Temozolamide versus Radiotherapy + Nitrosourea (NU) - took place in 198 patients diagnosed with anaplastic astrocitoma. Main objective: Survival. There wasn’t any difference between the 2 groups (3,9 versus 3,8 years)
The radiotherapy was completed in approximately 96% of the patients in both arms. However, 64% of patients in the TMZ group and only 21,4% of patients in the NU group completed the QT cycles. The discontinuity occurred due to progression/death in 28,1% of patients in the TMZ group and in 38,8% of the NU group and for toxicity in 0% in the TMZ and 27,6% in the NU group. IDH was taken by 111 patients, and mutation was observed in approximately 50% of the group. The survival was of 7,9 years in IDHmut patients versus 2,8 in theIDHwt. ( p = 006). The ATRX mutation was tested in 64 patients, where the following results were observed: survival of 9,4 years for ATRX+ versus 3,9 years for ATRX - (p=0,008).
The mentioned limitations are related to the impossibility of reaching the planned number of patients and the absence of the isolated RT arm.

OS - 2003: Elizabeth Hovey
CABARET –Phase II in patients diagnosed with recurrent GBM –Continue or stop with Bevacizumabafter disease progression.
The results were negative for the Bev continuation, sending us the important message that the continuation of treatment with Bev after disease progression does not result in increased survival, reduction in the use of decadron or improvement in life quality.This study also suggest a higher number of complication in patients that continued the treatment.

OA - 2006:Brigitta Baumert.
EORTC/NCIC-CTG/TROG/MRC-CTU (EORTC 22033-26033) –Phase III –Subgroup analysis of molecular markers in 407 patients with GII high grade (age> 40 years, astrocitoma, neurologic deficit, tumor diameter> 6 cm or crossing median line):
The relation between the 1p19q,IDH and MGMT markers was evaluated in 318 patients: IDHmut/Codel =104 (33%), IDHmut /1p19qwt = 165 (52%), IDHwt = 49 (15%). 3 prognostic groups were made: IDHmut/Codel with better prognosis, IDHmut /1p19qwt with intermediary prognosis and IDH with worse prognosis. In IDHmut/Codel patients and IDHwt there weren’t any differences in response in relation to the 2 types of treatment (RT versus TMZ- p not significant), while in IDHmut /1p19qwtpatients the response to RT was superior to TMZ ( p = 0,004).

Michael Weller (OA 2007 ) and Hiromichi Suzuki (OA 2008) – evaluated the molecular markers of the difuse gliomas, grouping them into three bigger groups, based on IDHmutand 1p19qCodel , IDHmut 1p19qCodel tumors having the best prognosis, an intermediary prognosis the IDHmut 1p19qwt tumors and the IDHwt 1p19qwt tumors behave as GBM. The evaluation of the temporal hierarchy of events, (2nd abstract) showed the initially observed event was the IDH mutation (troncular mutation), and during the mutation evolution, new mutations appeared, different and in different regions of the same (shared and private mutations), demonstrating the intra-tumoral heterogeneity.

Brain metastasis
poster : 2020 : Masaaki Yamamoto.
5 - 10 brain metastasis—> The initial treatment with radio surgery showed itself equivalent, in the lesions’ control, in the adverse effects of radiosurgery and in the cognitive function (evaluated by MMSE) when compared to the 2-4 metastases treatment. The patients submitted to total cerebral radiotherapy had a greater decrease in the cognitive function to those submitted to isolated radiosurgery. This test limitations were: not be randomized (prospective observational), loss of patients in metastases group 5-10, non volumetric measurement of the metastases with RM and quality of life evaluation by MMSE (wasn’t done to evaluate QOL) A prospective comparative study is necessary to evaluate the data.
Talk : Dr Frank Winkler –The BHE represents a smaller role in the penetration of many target drugs in micro-metastases cases, only being relevant in the macro-metastases due to the heterogeneous break of this barrier. In relation to the target therapy, even though there isn’t level I evidence in this area, phase II studies, retrospective analysis of phase III studies and case studies suggest some activity in renal cells carcinomas, breast cancer, lung and melanoma. The response of the melanoma brain metastases to the BRAF and CTLA-4 inhibitors is similar to the response out of this site.
RANO criteria for brain metastases proposed by RANO Working Group:
- RM >> CT
- SNC—>evaluation–independent of the extra-cranial
- Measurable disease - minimum size considered: 10 mm ( 1dimension)
- T2 :not considered




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