NIMG-24. RANO CRITERIA DETECTS EARLY PROGRESSION SOONER THAN MODIFIED RANO CRITERIA IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi133-vi133
Author(s):  
Gilbert Youssef ◽  
Mary Jane Lim-Fat ◽  
Camden Bay ◽  
Omar Arnaout ◽  
Wenya Linda Bi ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Final Analysis ◽  
Response Assessment ◽  
Newly Diagnosed ◽  
Imaging Data ◽  
Treatment Change ◽  
Free Survival ◽  
Rano Criteria ◽  
Newly Diagnosed Glioblastoma ◽  
Post Radiation

Abstract BACKGROUND Accurate response criteria are crucial for determining treatment efficacy. The response assessment in neuro-oncology (RANO) criteria was developed to standardize response assessment in neuro-oncology. Modified RANO (m-RANO) criteria were recently proposed to address some limitations of the initial criteria including the use of a post-radiation baseline and an additional scan to confirm progression. We sought to identify differences in the association of progression-free survival (PFS) and overall survival (OS) using RANO and m-RANO criteria. METHODS We conducted a retrospective review of newly diagnosed glioblastoma (GBM) patients treated at Dana-Farber Cancer Institute from January 2013 until December 2019. Patients with available clinical and imaging data obtained before initiation of treatment, after radiation completion and at intervals of 1 to 3 months were included. MRIs were evaluated by two independent readers, and PD dates determined using RANO and m-RANO criteria. RESULTS 552 patients were included. 97.1% of the tumors were IDH wild-type. MGMT promoter was unmethylated in 51.4%, methylated in 35.1% and undetermined in 8.5%. Median OS among patients was 18.1 months. 72 patients (13%) did not have PD at the end of the study. 83 patients had treatment change while being clinically stable and without a confirmation scan and were excluded from the final analysis. PFS was 8.2 months with RANO and 8.4 months with mRANO. Difference in PD dates between RANO and m-RANO was detected in 76 patients (14%), where PFS was 3.5 months with RANO and 5.1 months with m-RANO. These patients had a worse median OS than those with identical RANO and m-RANO PD dates (15.2 vs. 22.4 months, p< 0.0001). CONCLUSION RANO and m-RANO criteria resulted in identical PFS for most patients. 14% of patients had discordant PD dates and a worse prognosis. These patients progressed early, and their PD was identified sooner with RANO criteria.

Final results of a single-arm phase II study of bevacizumab and temozolomide following radiochemotherapy in newly dignosed adult glioblastoma patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 2076-2076 ◽  
Author(s):  
Martin Kelly Nicholas ◽  
Rimas Vincas Lukas ◽  
Christine Amidei ◽  
Nicholas Vick ◽  
Nina Paleologos ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Treatment ◽  
Treatment Phase ◽  
Progression Free Survival ◽  
Concomitant Administration ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Intention To Treat ◽  
Newly Diagnosed Glioblastoma ◽  
Post Radiation

2076 Background: This study evaluated efficacy and safety of bevacizumab (BEV) added to the post-radiation treatment phase for patients with newly diagnosed glioblastoma (GBM). Methods: Sixty-two participants with newly diagnosed GBM were enrolled between May 2007 and June 2010. Participants received standard radiation therapy (RT) within 6 weeks of surgery, and concomitant administration of temozolomide (TMZ). Four weeks after radiation, treatment with TMZ (Days 1-5 of a 28 day cycle) with BEV, (days 1 and 15 of a 28 day cycle) was started, and continued until disease progressed or adverse effects indicated need to stop treatment. Analyses were completed for all participants by intention to treat (ITT), with progression-free survival (PFS) and overall survival (OS) serving as primary and secondary endpoints respectively. Results: Subbjects completed a mean of 7.7 (range 0-29) cycles of post-RT with BEV and TMZ. Twenty participants (32%) were unable to proceed to the post-RT phase. The forty-two participants who did proceed to the post-RT phase completed a mean of 11.5 cycles of treatment. Thirty-eight participants (61%) stopped the study due to disease progression; 6 participants (14%) voluntarily discontinued treatment after 24 cycles with at least stable disease. At a median follow-up time of 24 months, median progression-free survival (PFS) for all participants was 8.8 months while median overall survival (OS) was 16.5 months for all participants. Ly with These results also compare favorably with recently reported results from the AVAglio study (PFS = 10.6 mo.). The toxicity profile was consistent with that reported in similar studies. MGMT promoter methtion.ylation status is under investiga Conclusions: Participants in this study demonstrated a median 1.9 month PFS benefit as compared to the 6.9 median OS reported by Stupp, et al. (2005) and a median 1.9 month OS benefit as compared to the 14.6 month median OS reported by Stupp, et al. (2005). Results suggest that the addition of bevacizumab to the post-RT phase of treatment improves both PFS and OS for persons with GBM despite the high percentage of participants being unable to progress to post-radiation treatment. Clinical trial information: NCT005906.

scholarly journals Safety and tolerability of asunercept plus standard radiotherapy/temozolomide in Asian patients with newly-diagnosed glioblastoma: a phase I study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kuo-Chen Wei ◽  
Peng-Wei Hsu ◽  
Hong-Chieh Tsai ◽  
Ya-Jui Lin ◽  
Ko-Ting Chen ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Progression Free Survival ◽  
Multicenter Trial ◽  
Newly Diagnosed ◽  
Open Label ◽  
Free Survival ◽  
Asian Patients ◽  
Newly Diagnosed Glioblastoma ◽  
Secondary Endpoints

AbstractAsunercept (company code APG101 [Apogenix AG]; company code CAN008 [CANbridge Pharmaceuticals]) is a novel glycosylated fusion protein that has shown promising effectiveness in glioblastoma. This Phase I study was initiated to evaluate the tolerability and safety of asunercept in combination with standard radiotherapy and temozolomide (RT/TMZ) in Asian patients with newly diagnosed glioblastoma. This was the Phase I portion of a Phase I/II open label, multicenter trial of asunercept plus standard RT/TMZ. Adults with newly-diagnosed glioblastoma received surgical resection followed by standard RT/TMZ plus asunercept 200 mg/week (Cohort 1) or 400 mg/week (Cohort 2) by 30-min IV infusion. The primary endpoint was the safety and tolerability of asunercept during concurrent asunercept and RT/TMZ; dose-limiting toxicities were observed for each dose. Secondary endpoints included pharmacokinetics (PK) and 6-month progression-free survival (PFS6). All patients (Cohort 1, n = 3; Cohort 2, n = 7) completed ≥ 7 weeks of asunercept treatment. No DLTs were experienced. Only one possibly treatment-related treatment emergent adverse event (TEAE), Grade 1 gingival swelling, was observed. No Grade > 3 TEAEs were reported and no TEAE led to treatment discontinuation. Systemic asunercept exposure increased proportionally with dose and showed low inter-patient variability. The PFS6 rate was 33.3% and 57.1% for patients in Cohort 1 and 2, respectively. Patients in Cohort 2 maintained a PFS rate of 57.1% at Month 12. Adding asunercept to standard RT/TMZ was safe and well tolerated in patients with newly-diagnosed glioblastoma and 400 mg/week resulted in encouraging efficacy.Trial registration NCT02853565, August 3, 2016.

scholarly journals Audencel Immunotherapy Based on Dendritic Cells Has No Effect on Overall and Progression-Free Survival in Newly Diagnosed Glioblastoma: A Phase II Randomized Trial

Cancers ◽  
2018 ◽  
Vol 10 (10) ◽  
pp. 372 ◽  
Author(s):  
Johanna Buchroithner ◽  
Friedrich Erhart ◽  
Josef Pichler ◽  
Georg Widhalm ◽  
Matthias Preusser ◽  
...  
Keyword(s):  
Overall Survival ◽  
Dendritic Cells ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Severe Toxicity ◽  
Newly Diagnosed ◽  
Skin Reactions ◽  
Local Skin ◽  
Free Survival ◽  
Newly Diagnosed Glioblastoma

Dendritic cells (DCs) are antigen-presenting cells that are capable of priming anti-tumor immune responses, thus serving as attractive tools to generate tumor vaccines. In this multicentric randomized open-label phase II study, we investigated the efficacy of vaccination with tumor lysate-charged autologous DCs (Audencel) in newly diagnosed glioblastoma multiforme (GBM). Patients aged 18 to 70 years with histologically proven primary GBM and resection of at least 70% were randomized 1:1 to standard of care (SOC) or SOC plus vaccination (weekly intranodal application in weeks seven to 10, followed by monthly intervals). The primary endpoint was progression-free survival at 12 months. Secondary endpoints were overall survival, safety, and toxicity. Seventy-six adult patients were analyzed in this study. Vaccinations were given for seven (3–20) months on average. No severe toxicity was attributable to vaccination. Seven patients showed flu-like symptoms, and six patients developed local skin reactions. Progression-free survival at 12 months did not differ significantly between the control and vaccine groups (28.4% versus 24.5%, p = 0.9975). Median overall survival was similar with 18.3 months (vaccine: 564 days, 95% CI: 436–671 versus control: 568 days, 95% CI: 349–680; p = 0.89, harzard ratio (HR) 0.99). Hence, in this trial, the clinical outcomes of patients with primary GBM could not be improved by the addition of Audencel to SOC.

International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme

2015 ◽  
Vol 33 (35) ◽  
pp. 4145-4150 ◽  
Author(s):  
Wilson Roa ◽  
Lucyna Kepka ◽  
Narendra Kumar ◽  
Valery Sinaika ◽  
Juliana Matiello ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Survival Time ◽  
Progression Free Survival ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Frail Patients ◽  
Short Course ◽  
Newly Diagnosed Glioblastoma ◽  
Short Course Radiotherapy

Purpose The optimal radiotherapy regimen for elderly and/or frail patients with newly diagnosed glioblastoma remains to be established. This study compared two radiotherapy regimens on the outcome of these patients. Patients and Methods Between 2010 and 2013, 98 patients (frail = age ≥ 50 years and Karnofsky performance status [KPS] of 50% to 70%; elderly and frail = age ≥ 65 years and KPS of 50% to 70%; elderly = age ≥ 65 years and KPS of 80% to 100%) were prospectively randomly assigned to two arms in a 1:1 ratio, stratified by age (< and ≥ 65 years old), KPS, and extent of surgical resection. Arm 1 received short-course radiotherapy (25 Gy in five daily fractions over 1 week), and arm 2 received commonly used radiotherapy (40 Gy in 15 daily fractions over 3 weeks). Results The short-course radiotherapy was noninferior to commonly used radiotherapy. The median overall survival time was 7.9 months (95% CI, 6.3 to 9.6 months) in arm 1 and 6.4 months (95% CI, 5.1 to 7.6 months) in arm 2 (P = .988). Median progression-free survival time was 4.2 months (95% CI, 2.5 to 5.9) in arm 1 and 4.2 months (95% CI, 2.6 to 5.7) in arm B (P = .716). With a median follow-up time of 6.3 months, the quality of life between both arms at 4 weeks after treatment and 8 weeks after treatment was not different. Conclusion There were no differences in overall survival time, progression-free survival time, and quality of life between patients receiving the two radiotherapy regimens. In view of the reduced treatment time, the short 1-week radiotherapy regimen may be recommended as a treatment option for elderly and/or frail patients with newly diagnosed glioblastoma.

scholarly journals TMOD-42. PROSPECTIVE VALIDATION OF AN EX VIVO 3D ASSAY FOR PREDICTION OF TEMOZOLOMIDE RESPONSE IN GLIOBLASTOMA

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi272-vi272
Author(s):  
Ashley Smith ◽  
Lillia Holmes ◽  
Stephen Shuford ◽  
Charles Kanos ◽  
Stephen Gardner ◽  
...  
Keyword(s):  
Surgical Resection ◽  
Standard Treatment ◽  
Ex Vivo ◽  
3D Cell Culture ◽  
Progression Free Survival ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Course Of Action ◽  
Newly Diagnosed Glioblastoma ◽  
Cell Culture Assay

Abstract Standard treatment for newly diagnosed glioblastoma (GBM) is surgical resection followed by radiation with concurrent temozolomide (TMZ). For those who do not respond there are few clinical options, survival is low, and there no biomarkers to direct the decision of second-line treatment. We have developed a 3D cell culture assay to predict response to TMZ and 11 other potential therapies for GBM. Our assay uses GBM tissue obtained at surgical resection and the test’s 7-day turnaround maximizes clinical actionability of results. We performed a small, prospective study examining the ability of the assay to predict response to TMZ. Ten newly diagnosed GBM patients were enrolled over 12 months. Two patients were removed due to refusal of treatment, and three failed the assay (3/8, 62.5% success). The remaining five patients received radiation and concurrent TMZ following surgical resection. Using progression-free survival (PFS) measured from the completion of radiation therapy and setting 4 months as the cutoff for response, we were able to determine the ability of our assay to predict TMZ response. The assay correctly predicted all five patients (100%). The average PFS for the two predicted responders was 8 months compared to the three predicted non-responders at 3 months, p = 0.0634. In this limited dataset, MGMT methylation did not appear to play a role as two of three predicted non-responders were methylated along with one of two predicted responders. Average overall survival of the predicted TMZ responders was 13 months compared to 6 months for the predicted non-responders, p = 0.0634. This early data indicates the potential for this assay to inform clinicians of the best course of action for their patients. Further enrollment of patients into the 3D-PREDICT clinical trial will provide a larger dataset for better validation of the predictive value of this new assay.

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