Cyclophosphamide rescue therapy for relapsed low-grade alimentary lymphoma after chlorambucil treatment in cats

2021 ◽  
pp. 1098612X2199649
Author(s):  
Changseok Kim ◽  
Raelene M Wouda ◽  
Juan Borrego ◽  
Esther Chon
Keyword(s):  
Medical Records ◽  
Rescue Therapy ◽  
Therapeutic Option ◽  
Progression Free Survival ◽  
Low Grade ◽  
Complete Clinical Response ◽  
First Line ◽  
Clinical Factor ◽  
Free Survival ◽  
Cyclophosphamide Treatment

Objectives The aims of this study were to evaluate the response, outcome and prognostic factors in cats with clinically presumed relapsed low-grade alimentary lymphoma (LGAL) receiving cyclophosphamide as a first-line rescue therapy after failing chlorambucil treatment. Methods The medical records of 20 cats (from three institutions, between 2002 and 2017) treated with cyclophosphamide for relapsed LGAL after initial treatment with chlorambucil were retrospectively reviewed. Progression-free survival (PFS), overall survival time (OST) and the association of select variables with measures of outcome were assessed. Adverse events (AEs) were also described. Results Eighteen cats (90%) achieved a complete clinical response (CR) for a median duration of 239 days. The median PFS was 215 days. The median OST was 1065 days. The only clinical factor associated with a longer PFS was achievement of a CR with cyclophosphamide treatment. Cyclophosphamide was associated with few and reversible constitutional, gastrointestinal and hematologic AEs. Conclusions and relevance Cyclophosphamide appears to be a safe and effective first-rescue therapeutic option for cats with relapsed LGAL.

Clinical implications of the T790M mutation in disease characteristics and treatment response in patients with EGFR-mutated NSCLC.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9031-9031
Author(s):  
Daria Gaut ◽  
Myung Shin Sim ◽  
Brian R. Wolf ◽  
Phillip A. Abarca ◽  
James M. Carroll ◽  
...  
Keyword(s):  
Medical Records ◽  
Response Rate ◽  
Kinase Inhibitor ◽  
Resistance Mutation ◽  
Progression Free Survival ◽  
First Line ◽  
T790m Mutation ◽  
Free Survival ◽  
Egfr Mutant ◽  
Nsclc Patients

9031 Background: The secondary T790M mutation accounts for more than 50% of acquired tyrosine kinase inhibitor (TKI) resistance in epidermal growth factor receptor (EGFR)-mutant NSCLC patients. Recent reports suggest this resistance mutation may be more common among patients with longer progression-free survival (PFS) on first-line TKI therapy, but much is still unknown about this resistance mechanism’s association with response to other therapies. Methods: Our group collected medical records from patients who underwent a biopsy for T790M mutation testing in the process of screening for clinical trials involving third generation EGFR inhibitors. Medical records were retrospectively analyzed for demographic data, PFS, best response (BR) to previous therapies, and presence or absence of an acquired T790M mutation. Progression-free survival was estimated using the Kaplan-Meier method and compared across two groups using the log-ranked test followed by univariate and multivariate cox proportional hazard regression analysis. Response rates were compared using Fisher’s exact test. Results: Out of 102 patients who obtained a diagnostic biopsy, 73 patients had a T790M mutation. Patients who later developed a T790M mutation had a longer PFS on first-line TKI therapy (12.0 months in T790M+ vs. 8.0 months in T790M-, p = 0.038, HR 1.66, 95% CI 1.03-2.67), though there was no difference in response rate (75.5% in T790M+ vs 77.3% in T790M-, p = 1.00). T790M+ patients also had a longer PFS on initial chemotherapy treatment (5.0 months in T790M+ vs. 4.0 months in T790M-, p = 0.020, HR 1.97, 95% CI 1.11-3.49) and a higher response rate to chemotherapy (22.7% in T790M+ vs 0% in T790M-, p = 0.033). Median PFS was short (3.0 months) for patients treated with immunotherapy with no difference based on T790M mutation status (p = 0.33). Conclusions: Our study confirms that tumors expressing T790M have a more indolent progression of disease compared to their T790M negative counterparts when treated with both first-line TKI and cytotoxic chemotherapy. This data provides context for therapeutic decision making in EGFR-mutant NSCLC patients.

scholarly journals Effectiveness of Afatinib and Gefitinib in Non-Small Cell Lung Cancer (NSCLC) Epidermal Growth Factor Receptor (EGFR) Mutations in Indonesia: Observational Studies with Retrospectives

2019 ◽  
Vol 10 (4) ◽  
pp. 3516-3522
Author(s):  
Seftika Sari ◽  
Tri Murti Andayani ◽  
Dwi Endarti ◽  
Kartika Widayati
Keyword(s):  
Overall Survival ◽  
Clinical Practice ◽  
Medical Records ◽  
Progression Free Survival ◽  
Egfr Mutations ◽  
First Line ◽  
Free Survival ◽  
First Line Therapy ◽  
Line Therapy ◽  
Nsclc Patients

Effectiveness data can describe the results or performance of an intervention (treatment) in daily clinical practice and also provide recommendations to policymakers regarding the need or not of health technology to be implemented into the health care system. Research related to the effectiveness of afatinib and gefitinib is still minimal, especially in Indonesia. This study aims to provide an overview of the effectiveness of afatinib and gefitinib in daily clinical practice (the real world) as first-line therapy. This research is an observational study with a retrospective approach that observes the medical records of NSCLC patients who have EGFR mutations in Dr. Sardjito General Hospital Yogyakarta and Dr. Kariadi General Hospital Semarang, Java Island, Indonesia in the period January 2016 - March 2019. The effectiveness seen is the Progress Free Survival and Overall Survival based on the patient's medical records and analyzed using the Kaplan Meier test to see survival. There were 113 patients identified, 27 patients using afatinib and 86 patients using gefitinib. Afatinib had significantly superior progression-free survival (448 days or 14.7 months; 95% CI = 12-17.4 months; p = 0.002) compared to gefitinib (344 days or 11.3 months; 95% CI = 8, 4-14.3 months), however, overall survival of afatinib is no better than gefitinib (472 days or 15.5 months; 95% CI = 13.8-17.2 months vs 653 days or 21.4 months; 95% CI = 18-24.8 months) with a value of p = 0.302. Afatinib has superior progression-free survival compared to gefitinib, but not overall survival as first-line therapy in NSCLC patients with EGFR mutations.

Second-Line Chemotherapy With Irinotecan Plus Carmustine in Glioblastoma Recurrent or Progressive After First-Line Temozolomide Chemotherapy: A Phase II Study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)

2004 ◽  
Vol 22 (23) ◽  
pp. 4779-4786 ◽  
Author(s):  
Alba A. Brandes ◽  
Alicia Tosoni ◽  
Umberto Basso ◽  
Michele Reni ◽  
Francesco Valduga ◽  
...  
Keyword(s):  
Phase Ii ◽  
Karnofsky Performance Status ◽  
Therapeutic Option ◽  
Performance Status ◽  
Progression Free Survival ◽  
Second Line ◽  
First Line ◽  
Free Survival ◽  
Irinotecan Dose ◽  
Line Chemotherapy

Purpose Glioblastoma multiforme (GBM), the most frequent brain tumor in adults, is not considered chemosensitive. Nevertheless, there is widespread use of first-line chemotherapy, often with temozolomide, as a therapeutic option in patients with progressive disease after surgery and radiotherapy. However, at the time of second recurrence and/or progression, active and noncross-resistant chemotherapy regimens are required. The aim of the present multicenter phase II trial, therefore, was to ascertain the efficacy of second-line carmustine (BCNU) and irinotecan chemotherapy. Patients and Methods Patients with histologically confirmed GBM, recurring or progressing after surgery, standard radiotherapy and a first-line temozolomide-based chemotherapy, were considered eligible. The primary end-point was progression-free survival at 6 months (PFS-6), and secondary end-points included response rate, toxicity, and survival. All patients were on enzyme-inducing antiepileptic prophylaxis. Chemotherapy consisted of BCNU (100 mg/m2 on day 1) plus irinotecan (175 mg/m2/weekly for 4 weeks), every 6 weeks, for a maximum of eight cycles. In the absence of grade 2 toxicity, the irinotecan dose was increased to 200 mg/m2. Results A total of 42 patients (median age, 53.4 years; median Karnofsky performance status, 80; range, 60 to 90) were included in the study. PFS-6 was 30.3% (95% CI, 18.5% to 49.7%). Median time to progression was 17 weeks (95% CI, 11.9 to 23.9). Nine partial responses (21.4%; 95% CI, 9% to 34%) were obtained. Toxicity was manageable. Conclusion The BCNU plus irinotecan regimen seems active and non–cross-resistant in patients with GBM with recurrence after temozolomide-based chemotherapy.

scholarly journals Alemtuzumab therapy in T-cell prolymphocytic leukemia: comparing efficacy in a series treated intravenously and a study piloting the subcutaneous route

Blood ◽  
2011 ◽  
Vol 118 (22) ◽  
pp. 5799-5802 ◽  
Author(s):  
Claire E. Dearden ◽  
Amit Khot ◽  
Monica Else ◽  
Mike Hamblin ◽  
Effie Grand ◽  
...  
Keyword(s):  
T Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Rescue Therapy ◽  
Progression Free Survival ◽  
Lymphocytic Leukemia ◽  
First Line ◽  
Prolymphocytic Leukemia ◽  
Free Survival ◽  
Median Progression Free Survival

Abstract Intravenous alemtuzumab is an effective and well-tolerated treatment for T-cell prolymphocytic leukemia (T-PLL). Alemtuzumab given intravenously as first-line treatment in 32 patients resulted in an overall response rate of 91% with 81% complete responses. Studies in B-cell chronic lymphocytic leukemia have shown subcutaneous alemtuzumab to be equally as effective as intravenous alemtuzumab. The UKCLL05 pilot study examined the efficacy and toxicity of this more convenient method of administration in 9 previously untreated patients with T-PLL. Only 3 of 9 patients (33%) responded to treatment. Furthermore, 2 of 9 patients (22%) died while on treatment. Recruitment was terminated because of these poor results. After rescue therapy with intravenous alemtuzumab and/or pentostatin, median progression-free survival and overall survival were similar to the intravenous group. Alemtuzumab delivered intravenously, but not subcutaneously, remains the treatment of choice for previously untreated T-PLL. This study is registered at www.eudract.ema.europa.eu as #2004-004636-31.

Therapy with Ibritumomab Tiuxetan (Zevalin®) in Patients with Previously Untreated and Relapsed Low Grade Follicular Lymphoma: The Mayo Clinic Florida Experience, 2000-2016

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5324-5324
Author(s):  
Aixa Elena Soyano ◽  
Ryan D Frank ◽  
Han W Tun ◽  
Jennifer Peterson
Keyword(s):  
Overall Survival ◽  
Follicular Lymphoma ◽  
Mayo Clinic ◽  
Response Rate ◽  
Progression Free Survival ◽  
Low Grade ◽  
First Line ◽  
Ibritumomab Tiuxetan ◽  
Free Survival ◽  
Line Therapy

Abstract Introduction: Ibritumomab tiuxetan (Zevalin¨) is a radioimmunoconjugate agent that targets CD20-expressing B cell lymphomas. Currently, it is the only radioimmunoconjugate agent available on the market and is FDA approved for relapsed/refractory follicular lymphoma (FL). A retrospective study of patients with low grade FL (WHO grade 1 and 2) treated with ibritumomab tiuxetan at Mayo Clinic Florida from 2000 to 2016 was performed. Methods: The patient population consisted of previously untreated as well as relapsed low grade FL. We evaluated patient characteristics, response rate, duration of response, progression free survival, overall survival and time to next treatment. Previously untreated patients were treated with ibritumomab tiuxetan due to ineligibility for standard chemotherapy and prolonged immunotherapy, or their preference. Comparison between previously untreated FL patients treated with ibritumomab tiuxetan as the first line of treatment versus patients with relapsed FL treated with ibritumomab tiuxetan as second, third or fourth line therapy was made. Results: Low grade FL patients (n=41) that received ibritumomab tiuxetan were identified; 13 patients (32%) with previously untreated FL and 28 patients (68%) with relapsed FL. The data on response to treatment is presented in Table 1. Ibritumomab tiuxetan use in previously untreated FL was associated with more complete responses than in the relapse setting (92% vs 50% at 6 months, p=0.036). Previously untreated FL patients that received ibritumomab tiuxetan as first line therapy had better progression free survival (80% vs 35% at 3 years). Ibritumomab tiuxetan use in relapsed FL was associated with significant shorter time to relapse compared to previously untreated FL (median 1.3 years vs 4.8 years, p=0.017, figure 1) and shorter time to next treatment (65% at 4 years compared to 0% in previously untreated, p=0.007). 15% of newly diagnosed FL treated with ibritumomab tiuxetan relapsed compared to 64% of relapsed FL patient. There was no significant difference in overall survival between the two groups. The incidence of grades 3-4 neutropenia (Absolute Neutrophil Count <1000 x109/L), Anemia (Hb <8 g/dL) and Thrombocytopenia (Platelets <25 x109/L) were 47%, 7.7% and 48.7% respectively. Only 6/41 patients (15%) had cytopenias that required transfusion of blood products. More significant cytopenias were seen in relapsed group compared to previously untreated group. Conclusions: Ibritumomab tiuxetan as first line treatment in previously untreated FL patients at our institution was associated with improved response rate, better progression free survival and shorter time to next treatment when compared to its use in relapsed FL. Ibritumomab tiuxetan has significant therapeutic efficacy for both previously untreated as well as relapsed low grade FL. It was well tolerated without significant treatment-related morbidity or mortality. Moreover, treatment schedule was very convenient for the patients. Our results suggest that treatment with ibritumomab tiuxetan is an effective option for those previously untreated low grade FL patients who cannot take standard chemoimmunotherapy. Disclosures No relevant conflicts of interest to declare.

Phase II Study of Weekly Vinblastine in Recurrent or Refractory Pediatric Low-Grade Glioma

2012 ◽  
Vol 30 (12) ◽  
pp. 1358-1363 ◽  
Author(s):  
Eric Bouffet ◽  
Regina Jakacki ◽  
Stewart Goldman ◽  
Darren Hargrave ◽  
Cynthia Hawkins ◽  
...  
Keyword(s):  
Phase Ii ◽  
Pediatric Patients ◽  
Phase Ii Study ◽  
Single Agent ◽  
Progression Free Survival ◽  
Low Grade Glioma ◽  
Low Grade ◽  
First Line ◽  
Free Survival ◽  
Line Chemotherapy

Purpose To evaluate the efficacy of single-agent vinblastine in pediatric patients with recurrent or refractory low-grade glioma. Patients and Methods Patients were eligible if they had experienced previous treatment failure (chemotherapy and/or radiation) for incompletely resected or unresectable low-grade glioma (LGG). Vinblastine (6 mg/m2) was administered weekly for 1 year unless unacceptable toxicity or progression (confirmed on two consecutive imaging studies) occurred. Results Fifty-one patients (age range, 1.4 to 18.2 years; median age, 7.2 years) were prospectively enrolled onto this phase II study. Fifty patients had previously received at least one prior regimen of chemotherapy, and 10 patients had previously received radiation treatment. Fifty patients were evaluable for response; 18 patients (36%) had a complete, partial, or minor response, and 31 patients completed 1 year of treatment. At a median follow-up of 67 months, 23 patients had not experienced progression; three patients have died. Five-year overall survival was 93.2% ± 3.8%, and 5-year progression-free survival was 42.3% ± 7.2%. Toxicity was manageable and mostly hematologic, although a few patients needed transfusions. Conclusion Weekly vinblastine seems to be a reasonable alternative to radiation for pediatric patients with LGG who have experienced treatment failure with first-line chemotherapy. The 5-year progression-free survival observed in this phase II trial is comparable to results observed with first-line chemotherapy in chemotherapy-naive patients. The role of single-agent vinblastine and other vinca alkaloid in the management of pediatric LGGs deserves further investigation.

Immediate and long-term results of the first line chemotherapy in patients with metastatic triple negative breast cancer. Final analysis of randomized study

2020 ◽  
pp. 75-80
Author(s):  
S.A. Lyalkin ◽  
◽  
L.A. Syvak ◽  
N.O. Verevkina ◽  
◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Randomized Study ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Group 2 ◽  
Line Chemotherapy ◽  
Group 1

The objective: was to evaluate the efficacy of the first line chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Materials and methods. Open randomized study was performed including 122 patients with metastatic TNBC. The efficacy and safety of the first line chemotherapy of regimens АТ (n=59) – group 1, patients received doxorubicine 60 мг/м2 and paclitaxel 175 мг/м2 and ТР (n=63) – group 2, patients received paclitaxel 175 мг/м2 and carboplatin AUC 5 were evaluated. Results. The median duration of response was 9.5 months (4.5–13.25 months) in patients received AT regimen and 8.5 months (4.7–12.25 months), in TP regimen; no statistically significant differences were observed, р=0.836. The median progression free survival was 7 months (95% CI 5–26 months) in group 1 and 7.5 months (95% CI 6–35 months) in group 2, p=0.85. Both chemotherapy regimens (AT and TP) had mild or moderate toxicity profiles (grade 1 or 2 in most patients). No significant difference in gastrointestinal toxicity was observed. The incidence of grade 3–4 neutropenia was higher in patients of group 2 (TP regimen): 42.8% versus 27% (р<0.05). Conclusions. Both regimens of chemotherapy (AT and TP) are appropriate to use in the first line setting in patients with metastatic TNBC. Key words: metastatic triple negative breast cancer, chemotherapy, progression free survival, chemotherapy toxicity.

An Italian, multicenter, real-world, retrospective study of first-line pazopanib in unselected metastatic renal-cell carcinoma patients: the ‘Pamerit’ study

2020 ◽  
Author(s):  
Alessandra Mosca ◽  
Ugo De Giorgi ◽  
Giuseppe Procopio ◽  
Umberto Basso ◽  
Giacomo Cartenì ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Renal Cell Cancer ◽  
Real World ◽  
Renal Cell ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Metastatic Renal Cell Cancer ◽  
Metastatic Rcc

Abstract Objective Despite the current immunotherapy era, VEGFR inhibitors maintain effectiveness in metastatic renal cell cancer. Real-world data concerning pazopanib are limited. The aim of this study is to add information about efficacy and safety of pazopanib as first-line treatment in metastatic renal cell cancer patients not enrolled into clinical trials. Methods Retrospective analysis (the PAMERIT study) of first-line pazopanib in real-world metastatic renal cell cancer patients among 39 Centers in Italy. Outcomes were progression-free survival, overall survival, objective response rate and treatment-related adverse events. Kaplan–Meier curves, log-rank test and multivariable Cox’s models were used and adjusted for age, histology, previous renal surgery, International Metastatic RCC Database Consortium score and pazopanib initial dose. Results Among 474 patients, 87.3% had clear cell metastatic renal cell cancer histology. Most of them (84.6%) had upfront renal surgery. Median progression-free survival and overall survival were 15.8 and 34.4 months, respectively, significantly correlating with International Metastatic RCC Database Consortium’s good prognosis (P &lt; 0.001), ECOG PS 0 (P &lt; 0.001), age (&lt;75 years, P = 0.005), surgery (P &lt; 0.001) and response to pazopanib (P &lt; 0.001). After 3 months of pazopanib, overall disease control rate have been observed in 76.6% patients. Among International Metastatic RCC Database Consortium’s favorable group patients, 57/121 (47%) showed complete/partial response. No unexpected AEs emerged. Conclusions In this real-world study, metastatic renal cell cancer patients treated with first-line pazopanib reached greater progression-free survival and overall survival than in pivotal studies and had high response rates when belonging to International Metastatic RCC Database Consortium’s favorable group, without new toxicities. Pazopanib has been confirmed a valid first-line option for International Metastatic RCC Database Consortium’s good prognosis metastatic renal cell cancer patients who cannot be submitted to immunotherapy.

scholarly journals A survival analysis of surgically treated incidental low-grade glioma patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lingcheng Zeng ◽  
Qi Mei ◽  
Hua Li ◽  
Changshu Ke ◽  
Jiasheng Yu ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Low Grade Glioma ◽  
Low Grade ◽  
Total Resection ◽  
Surgical Timing ◽  
Asymptomatic Group ◽  
Free Survival ◽  
Symptomatic Group ◽  
Significant Difference ◽  
Asymptomatic Phase

AbstractTo evaluate the surgical effect on survival in patients with incidental low-grade glioma (LGG) through comparison between asymptomatic and symptomatic patients. The medical records of surgically treated adult cerebral incidental LGG (iLGG) patients in our department between January 2008 and December 2015 were retrospectively reviewed. The survival of patients was calculated starting from the initial imaging diagnosis. Factors related to progression-free survival (PFS), overall survival (OS) and malignant progression-free survival (MPFS) were statistically analyzed. Seventy-five iLGG patients underwent surgery: 49 in the asymptomatic group, who underwent surgery in the asymptomatic period, and 26 in the symptomatic group, who underwent surgery after the tumor had grown and the patients had developed tumor-related symptoms. Significantly more tumors were initially located adjacent to the functional area in the symptomatic group than in the asymptomatic group (P < 0.05), but there was no significant difference in the total resection rate between the two groups. The incidence of postoperative complications (15.4%) and postoperative epilepsy (23.1%) was higher in the symptomatic group than in the asymptomatic group (4.1% and 10.2%, respectively). Multivariate analysis showed that surgical timing, namely, surgery performed before or after symptom occurrence, had no significant effect on PFS, OS or MPFS, while total resection significantly prolonged PFS, OS and MPFS, and the pathology of oligodendroglioma was positively correlated with PFS and OS (P < 0.05). Surgical timing for iLGGs should facilitate total resection. If total resection can be achieved, even after symptom occurrence, patients can achieve comparable survival benefits to those treated with surgery in the asymptomatic phase.

scholarly journals RTID-05. INDIGO: A GLOBAL, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF VORASIDENIB (AG-881) VS PLACEBO IN PATIENTS WITH RESIDUAL/RECURRENT GRADE II GLIOMA WITH AN ISOCITRATE DEHYDROGENASE 1/2 (IDH1/2) MUTATION

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii194-ii194
Author(s):  
Ingo Mellinghoff ◽  
Martin van den Bent ◽  
Jennifer Clarke ◽  
Elizabeth Maher ◽  
Katherine Peters ◽  
...  
Keyword(s):  
High Risk ◽  
Dose Escalation ◽  
Objective Response ◽  
Data Monitoring Committee ◽  
Progression Free Survival ◽  
High Risk Population ◽  
Low Grade ◽  
Who Grade ◽  
Free Survival ◽  
Grade Ii

Abstract BACKGROUND Low-grade gliomas (LGGs; WHO grade II) are incurable and ultimately progress to high-grade gliomas. The current treatment options are surgery followed by observation (“watch and wait”) for patients with lower risk for disease progression or postoperative chemoradiotherapy (high-risk population). There are no approved targeted therapies. IDH1 and IDH2 mutations (mIDH1/2) occur in approximately 80% and 4% of LGGs, respectively, and promote tumorigenesis via neomorphic production of D-2-hydroxyglutarate. Vorasidenib, an oral, potent, reversible, brain-penetrant pan-inhibitor of mIDH1/2, was evaluated in 76 patients with glioma in two phase 1 studies (dose escalation and perioperative) and was associated with a favorable safety profile at daily doses below 100 mg. Preliminary clinical activity was observed in non-enhancing glioma patients in both studies, with an objective response rate (ORR) of 18.2% and median progression-free survival of 31.4 months in the dose escalation study. METHODS Approximately 366 patients will be randomized 1:1 to vorasidenib (50 mg QD) or matched placebo and stratified by 1p19q status (intact vs co-deleted). Key eligibility criteria: age ≥ 12 years; grade II oligodendroglioma or astrocytoma (per WHO 2016 criteria) not in need of immediate treatment and without high-risk features; centrally confirmed mIDH1/2 status; ≥ 1 surgery for glioma with most recent ≥ 1 year but ≤ 5 years before randomization, and no other anticancer therapy; Karnofsky performance status ≥ 80%; and centrally confirmed measurable, non-enhancing disease evaluable by magnetic resonance imaging. Crossover from placebo to the vorasidenib arm is permitted upon centrally confirmed radiographic progression per RANO-LGG criteria. Primary endpoint: progression-free survival assessed by independent review. Secondary endpoints: safety and tolerability, tumor growth rate assessed by volume, ORR, overall survival, and quality of life. Clinical data will be reviewed regularly by an independent data monitoring committee. The study is currently enrolling patients in the US, with additional countries planned (NCT04164901).

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