scholarly journals A Systematic Review and Meta-Analysis on the Number of Adjuvant Temozolomide Cycles in Newly Diagnosed Glioblastoma

2021 ◽  
Vol 11 ◽  
Author(s):  
Fahimeh Attarian ◽  
Farzad Taghizadeh-Hesary ◽  
Azar Fanipakdel ◽  
Seyed Alireza Javadinia ◽  
Pejman Porouhan ◽  
...  

BackgroundIn newly diagnosed glioblastoma, radiation with concurrent and adjuvant (six cycles) temozolomide (TMZ) is the established standard of postsurgical care. However, the benefit of extending adjuvant TMZ therapy beyond six cycles has remained unknown.MethodsWe searched PubMed, Web of Science, Scopus, and Embase up to October 1, 2021. The search keywords were “glioblastoma,” “adjuvant chemotherapy,” and their synonyms. The data of randomized clinical trials were extracted and included in this meta-analysis if they had reported patients’ median overall survival (OS) or median progression-free survival (PFS). The standard and extended chemotherapy regimens were considered as adjuvant TMZ up to six cycles and beyond six cycles (up to a total of 12 cycles), respectively. The median OS and median PFS were pooled and compared.ResultsFour studies consisting of 882 patients (461 patients for the standard chemotherapy group and 421 patients for the extended chemotherapy group) were included in this meta-analysis. The extended TMZ regimen was associated with a nonsignificant improvement in PFS [12.0 months (95% CI 9.0 to 15.0) vs. 10.0 months (95% CI 7.0 to 12.0), P = 0.27] without corresponding improvement in OS [23.0 months (95% CI 19.0 to 27.0) and 24.0 months (95% CI 20.0 to 28.0), P = 0.73].ConclusionsIn newly diagnosed glioblastoma, continuing adjuvant TMZ beyond six cycles did not shown an increase neither in PFS nor OS.

2020 ◽  
Vol 16 (10) ◽  
pp. 585-596 ◽  
Author(s):  
Ezzeldin M Ibrahim ◽  
Ahmed A Refae ◽  
Ali M Bayer ◽  
Emad R Sagr

Aim: Poly(ADP-ribose) polymerase inhibitors (PARPIs) improved progression-free survival among patients with recurrent ovarian cancer. This meta-analysis examined the effectiveness of PARPIs as maintenance strategy for newly diagnosed patients with advanced high-grade ovarian cancer with or without mutations. Materials & methods: Using defined selection criteria, a literature search identified four eligible randomized clinical trials involving 2386 patients. Results: Compared with placebo maintenance, PARPIs achieved a 46% reduction in the risk of progression or death as compared with placebo (hazard ratio: 0.54; 95% CI: 0.39–0.73; p < 0.0001). That benefit was shown in all clinical subgroups: among those with BRCA mutation, with negative/unknown BRCA mutation, and in those with homologous recombination deficient tumors. Data about the effect on overall survival are still premature. Conclusion: In patients with newly diagnosed advanced ovarian cancer, PARPIs maintenance after standard therapy achieved a significant improvement in progression-free survival as compared with placebo, overall and in all subgroups.


2021 ◽  
Author(s):  
Yu Wang ◽  
Jianmin Zhang ◽  
Wenbin Li ◽  
Taipeng Jiang ◽  
Songtao Qi ◽  
...  

Aims: To determine how consistently Chinese glioblastoma multiforme (GBM) patients were treated according to the Stupp regimen. Patients and methods: The proportion of treatments conforming to the Stupp regimen and reasons for nonconformity were evaluated in 202 newly diagnosed GBM patients. Results: Only 15.8% of GBM patients received treatments compliant with the Stupp regimen. The main deviations were temozolomide dosages >75 mg/m2 (58/120; 48.3%) and treatment durations <42 days (84/120; 70.0%) in the concomitant phase and temozolomide dosages <150 mg/m2 (89/101; 88.1%) in the maintenance phase. Median overall survival (27.09 vs 18.21 months) and progression-free survival (14.27 vs 12.10 months) were longer in patients who received Stupp regimen-compliant treatments. Conclusion: Increased conformity to the Stupp regimen is needed for GBM patients in China.


CNS Oncology ◽  
2021 ◽  
pp. CNS76
Author(s):  
Srinivas Annavarapu ◽  
Anagha Gogate ◽  
Trang Pham ◽  
Kalatu Davies ◽  
Prianka Singh ◽  
...  

Aim: Investigate real-world outcomes and healthcare utilization of patients with glioblastoma multiforme (GBM) related to O6-methylguanine DNA methyltransferase (MGMT) promoter testing and methylation. Patients & methods: US Oncology Network data were analyzed for patients receiving first-line (1L) treatment for GBM. Results: Most patients received 1L radiation with temozolomide. Unadjusted median overall survival (OS) was higher in tested versus untested (median:18.1 vs 11.8 months) and in methylated versus unmethylated (median: 25.5 vs 12.4 months). Untested status, unmethylated MGMT and older age were associated with reduced OS and longer 1L treatment with increased OS. Similar findings were observed for progression-free survival. Utilization was similar between cohorts. Conclusion: In community oncology practices, MGMT methylation and testing were predictive of better survival in GBM.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kuo-Chen Wei ◽  
Peng-Wei Hsu ◽  
Hong-Chieh Tsai ◽  
Ya-Jui Lin ◽  
Ko-Ting Chen ◽  
...  

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.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 2076-2076 ◽  
Author(s):  
Martin Kelly Nicholas ◽  
Rimas Vincas Lukas ◽  
Christine Amidei ◽  
Nicholas Vick ◽  
Nina Paleologos ◽  
...  

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.


2020 ◽  
Author(s):  
Quanyao Chen ◽  
Wanlong Lin ◽  
Jianhui Yang ◽  
Min Lin ◽  
Xiuxian Lin ◽  
...  

Abstract Background: Although taxane-containing chemotherapy is widely used to treat solid tumors, genetic polymorphisms can influence the chemotherapeutic response. This meta-analysis was conducted to determine the correlation between two polymorphisms in ABCB1 , rs1045642 and rs1128503, and survival of patients administered taxane-containing chemotherapy. Methods: PubMed, Web of Science, Embase, Wanfang database, VIP database, and China National Knowledge Infrastructure database were used to obtain articles published up to August 2019 describing the association between the ABCB1 rs1045642 and rs1128503 polymorphisms and survival. A meta-analysis was conducted using R 3.6.1 software to determine the pooled hazard ratio (HR) and 95% confidence intervals (95% CI). Furthermore, publication bias was assessed, and sensitivity analysis was performed to validate the analysis. Results: Fifteen studies involving 3320 patients were included in the meta-analysis. The summary results showed that the effect of the C1236T polymorphism on progression-free survival remained significant in the heterozygote model (HR 0.81; 95% CI: 0.67–0.98) and homozygote model (HR 0.71; 95% CI: 0.58–0.88). Compared to the C1236 TT phenotype, the CC genotype was associated with a poor overall survival (HR 0.72; 95% CI: 0.53–0.97). Finally, subgroup analysis suggested that different areas, tumor types, and treatment regimens influence patient survival. Conclusions: Patients who are ABCB1 rs1045642 and rs1128503 T gene carriers show a survival benefit with taxane-containing chemotherapy.


2021 ◽  
Author(s):  
Tejpal Gupta ◽  
◽  
Riddhijyoti Talukdar ◽  
Sadhana Kannan ◽  
Archya Dasgupta ◽  
...  

Review question / Objective: To assess the safety and efficacy of extended adjuvant temozolomide compared to standard adjuvant temozolomide after concurrent radiochemotherapy in patients with newly-diagnosed glioblastoma. Condition being studied: Newly-diagnosed glioblastoma. Eligibility criteria: Prospective clinical trials randomly assigning patients to extended (>6-cycles) adjuvant TMZ (experimental arm) or standard (6-cycles) adjuvant TMZ will be included. Randomization in an individual study may have been done upfront before concurrent phase (RT/TMZ), after completion of concurrent RT/TMZ and before starting adjuvant phase, or after completion of standard adjuvant TMZ (6-cycles). Emulated RCTs, quasi-randomized trials, propensity matched analyses, non-randomized comparative studies, or observational studies will not be considered in this review.


Sign in / Sign up

Export Citation Format

Share Document