Usage Of Bevacizumab Research Articles

Prognostic factors and long-term survivors in EGFR-mutated lung cancer: A multi-institutional retrospective analysis.

e20594 Background: Evolution of tyrosine kinase inhibitors (TKIs) shapes the treatment paradigm of EGFR-mutated lung cancer, but resistance eventually develops. It is important to dissect the prognostic factors and to know the differences between long-term responders (LTR) and non-responders (NR). Methods: Electronic medical records were retrieved from Chang-Gung Medical Foundation from 2011 to 2020. Kaplan-Meier method was used to estimate survival, such as progression-free survival (PFS), and overall survival (OS). Multivariate Cox proportional hazard models was adopted to estimate adjusted hazard ratios and 95% confidence intervals. P < 0.05 was set to be statistical significance. Results: Totally, there are 3,551 patients receiving frontline TKIs, of which 825 (23.2%) are LTR with OS > 36 months, and 1,036 (29.2%) are NR with OS < 12 months. Besides, there are 1,200 (33.8%) LTRs with PFS > 18 months and 882 (24.8%) NR with PFS < 6 months. LTR tend to be younger, female, non-smoker, clinical stage 3b, no baseline brain metastasis, exon 19 deletions subtype, subsequent T790M development, bevacizumab usage, and osimertinib exposure (p all < 0.05). The median PFS of all enrolled patients is 12.3 months and median OS is 22.3 months. By multivariate analysis, age older than 65 years (Hazard ratio, [HR]:1.25 [1.15-1.36]), male (HR: 1.24 [1.13-1.36]), clinical stage 4 (2.19 [1.78-2.69]), baseline brain metastasis (1.25 [1.12-1.37]) are poor prognostic factors (p < 0.05). Also, T790M is not only predictive to osimertinib but also prognostic factor to OS (p < 0.05), and patients who developed subsequent T790M tend to have better PFS (18.1 v.s. 11.8 months). In patients without detected T790M along their disease course, exposure to osimertinib is related to better OS (33.1 v.s. 18.3 month, log-rank p < 0.05). Conclusions: LTR and NR are of distinctive characteristics, and T790M is prognostic and predictive to osimertinib. Further study is warranted for choosing the optimal treatment by clinical factors and T790M status.

Genetic mutation patterns among glioblastoma patients in the Taiwanese population – insights from a single institution retrospective study

This study utilized Next-Generation Sequencing (NGS) to explore genetic determinants of survival duration in Glioblastoma Multiforme (GBM) patients. We categorized 30 primary GBM patients into two groups based on their survival periods: extended survival (over two years, N = 17) and abbreviated survival (under two years, N = 13). For identifying pathogenic or likely pathogenic variants, we leveraged the ClinVar database. The cohort, aged 23 to 66 (median: 53), included 17 patients in Group A (survival >2 years, 10 males, 7 females), and 13 patients in Group B (survival <2 years, 8 males, 5 females), with a 60% to 40% male-to-female ratio. Identified mutations included CHEK2 (c.1477 G > A, p.E493K), IDH1 (c.395 G > A, p.R132H), and TP53 mutations. Non-coding regions exhibited variants in the TERT promoter (c.-146C > T, c.-124C > T) and TP53 RNA splicing site (c.376-2 A > C, c.376-2 A > G). While Group A had more mutations, statistical significance wasn’t reached, likely due to sample size. Notably, TP53, and ATR displayed a trend toward significance. Surprisingly, TP53 mutations were more prevalent in Group A, contradicting Western findings on poorer GBM prognosis. In Taiwanese GBM patients, bevacizumab usage is linked to improved survival rates, affirming its safety and effectiveness. EGFR mutations are infrequent, suggesting potential distinctions in carcinogenic pathways. Further research on EGFR mutations and amplifications is essential for refining therapeutic approaches. TP53 mutations are associated with enhanced survival, but their functional implications necessitate detailed exploration. This study pioneers genetic analysis in Taiwanese GBM patients using NGS, advancing our understanding of their genetic landscape.

Bevacizumab side effects and adverse clinical complications in colorectal cancer patients: review article.

A literature search was conducted from PUBMED, MEDLINE databases and some valid literatures from another databases that published in the last 10 years, and the design is an observational and randomized controlled trial (RCT). CRC is a malignancy, which happens in the colon or rectum. One of the therapy for CRC is by using bevacizumab, a monoclonal antibody. However, the usage of bevacizumab is still become a controversy because of its clinical complications. Several studies showed that bevacizumab could cause some adverse events in the cardiovascular, gastrointestinal, hematology, and others body systems and affect the CRC patient QoL. However, the clinical complication of this drug is also affected by the combination therapy regimen used. The use of bevacizumab could cause some adverse event in different aspects, including cardiovascular, gastrointestinal, hematology, and others. Some of those are significant, but others are not. Besides that, using bevacizumab as a treatment regiment could also affect the QoL of CRC patients, but it is also affected by the combination therapy regimen used.

Association of bevacizumab and stroke in ovarian cancer: a systematic review and meta-analysis

BackgroundThe prognosis for patients with ovarian cancer is bleak. Clinical trials have shown the efficacy of bevacizumab in ovarian cancer treatment. However, life-threatening strokes may limit the usage of bevacizumab and require specific follow-up strategies. This study aims to systematically evaluate the risk of stroke of bevacizumab treatment in ovarian cancer.MethodsWe retrieved all relevant articles published up to December 4th, 2022, from Embase, PubMed, Web of Science, and the Cochrane Library. The risk of stroke in patients with ovarian cancer treated with bevacizumab combined with chemotherapy was analyzed. Meta-analysis was performed using the Stata 17 software and R 4.2.1 program.ResultsSix randomized controlled trials (RCTs) of bevacizumab combined with chemotherapy or chemotherapy for ovarian cancer and six single-experimental-arm trials were included in this study. The meta-analysis showed a pooled risk ratio (RR) of 2.14 [95% confidence interval (CI): 0.88–7.99] for patients with ovarian cancer treated with bevacizumab combined with chemotherapy. Subgroup analyses showed that the incidence of stroke-related adverse events in the carboplatin + paclitaxel + bevacizumab group was 0.01% (95% CI: 0.00–0.01, p &amp;lt; 0.01). The incidence of stroke-related adverse events was 0.01% (95% CI: 0.00–0.01, p &amp;lt; 0.01) in patients aged ≥60. The incidence of stroke caused by cerebral ischemia and cerebral hemorrhage was 0.01% (95% CI: 0.01–0.02, p = 0.27) and 0.01% (95% CI: 0.00–0.01, p &amp;lt; 0.01), respectively.ConclusionsThis meta-analysis indicates that chemotherapy combined with bevacizumab may not increase the incidence of stroke in patients with ovarian cancer. However, stroke-related adverse events may be higher in older patients. Cerebral hemorrhage might cause the incidence of stroke more than cerebral ischemia.Systematic review registrationPROSPERO (CRD42022381003).

Efficacy of Intrapleural or Intrapericardial Injection of Single Bevacizumab in the Treatment of Lung Cancer-Mediated Malignant Effusion.

The usage of bevacizumab for malignant pleural effusion (MPE) or malignant pericardial effusion (MPCE) has attracted increasing interest from researchers, but the precise ways of bevacizumab administration remain unknown. Patients with histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) with MPE or MPCE were enrolled in the study and treated with a low dose of single bevacizumab (100 mg) intrapleurally or intrapericardially injected after the drainage of the effusions. The Lung Cancer Symptom Scale (LCSS), efficacy, and safety of drug administration were used as evaluation parameters in this study. The results indicated that lung cancer-related symptoms were significantly improved following treatment, compared with symptoms before the treatment (LCSS, score 494 ± 78 vs. score 377 ± 77, mean ± SD) (P < 0.001). Malignant effusions were well controlled, and the median time to progression (TTP) was 91 days and 111 days in MPE and MPCE, respectively. In addition, no severe side effects were observed, except in one patient with mild dizziness. In summary, the low dose of single bevacizumab (100 mg) with intrapleural or intrapericardial injection is effective and safe in the treatment of lung cancer-mediated malignant effusion, rapidly improving the malignant effusion-related symptoms and quality of life in patients with NSCLC.

The Effect of Sample Medication Use on Subsequent Anti-VEGF Agent Selection for Neovascular Age-Related Macular Degeneration

ABSTRACTPurposeMedication samples of anti-VEGF agents can represent a good option for retina specialists to provide timely treatment for newly converted neovascular age-related macular degeneration (nvAMD) while prior-authorizations (PA) are pending. Our study examines the effect of medication sample use (ranibizumab or aflibercept) on future anti-vascular endothelial growth factor (VEGF) agent selection in nvAMD.DesignRetrospective cohort study.ParticipantsnvAMD patients who underwent an initial anti-VEGF injection with a sample medication were compared to nvAMD control patients who never received a medication sample.MethodsCharts from 2017 through 2020 were reviewed for data regarding demographics, anti-VEGF agent selection, and visual acuity outcomes for both groups. The utilization of different anti-VEGF agents in each group was compared at various time points using chi-square tests for independence of proportions.Main Outcome MeasuresAnti-VEGF agent selection for the first four injections and at one year were examined.ResultsAdherence to the initial agent was high between first and subsequent injections (2nd, 3rd, 4th injection, and 1 year) in sample (96.2%, 95.9%, 91.9%, 93.4%, respectively), and control groups (98.1%, 94.2%, 94.9%, 87.8%, respectively). Bevacizumab usage was significantly lower among eyes receiving samples relative to controls at the second (1.9% vs. 38.7%, p < .001), third (3.1% vs. 41.3%, p < .001), fourth injections (4.7% vs. 40.4%, p < .001), and at 1 year (0% vs. 33.8%, p < .001). Aflibercept usage was significantly higher in sample eyes relative to controls at the second (78.3% vs. 43.4%, p < .001), third (76.3% vs. 41.5%, p < .001), and fourth injections (76.7% vs. 43.4%, p < .001), and at 1 year (77.0% vs. 52.7%, p < .001).ConclusionsSample medications in nvAMD may be initiated for many reasons, including awaiting PA approval. Our study found that eyes receiving a sample anti-VEGF agent (ranibizumab or aflibercept) for their initial injection were less likely to receive bevacizumab at future visits relative to eyes that did not receive an anti-VEGF sample, even after one year of treatment. Given the persistent use of more expensive medications at subsequent injections for patients who were initiated on samples, insurance payors may consider waiving PA requirements for bevacizumab to avoid a paradoxical increase in health-care costs.

Bevacizumab increases late toxicity in re-irradiation with image-guided high-dose-rate brachytherapy for gynecologic malignancies.

IntroductionPatients with recurrent gynecologic malignancies having had pelvic irradiation, generally have limited salvage options. This study investigated patients with gynecologic malignancies, who had a history of pelvic irradiation and received salvage re-irradiation using image-guided high-dose-rate brachytherapy (IG-HDR-BT).Material and methodsPatients with gynecologic malignancies, who had a history of previous irradiation and received re-irradiation using IG-HDR-BT for disease recurrences from June 2014 to March 2020 were included in this study.ResultsA total of 37 patients were included in this retrospective analysis. Primary tumor was uterine cervical cancer in 31 patients, endometrial cancer in 5 patients, and vaginal cancer in 1 patient. Median follow-up period of patients who were alive at the time of analysis was 15.4 months (range, 4.1-61.4 months). Two-year overall survival, progression-free survival, and local control were 68.9%, 49.3%, and 67.5%, respectively. Severe late toxicities ≥ grade 3, which were related to re-irradiation, were observed in 9 patients (24.3%). Usage of bevacizumab in the entire course of treatment was associated with development of late ≥ grade 3 fistula formation, bowel perforation, or vaginal ulcer (50% vs. 6.9%, p = 0.013). Tumor size ≥ 2.5 cm was associated with development of late ≥ grade 3 of rectum, bladder, or vaginal toxicities (0% vs. 28%, p = 0.047).ConclusionsIf the recurrent disease was found in small size and there was no history of bevacizumab usage, re-irradiation with IG-HDR-BT could be considered, even in patients with a previous history of pelvic irradiation.

Biosimilars in Ophthalmology: Financial Implications and Beyond

Anti-vascular endothelial growth factors (anti-VEGF) have transformed retinal disease management. However, the benefit of anti-VEGF therapy is still limited by the high cost of treatment, specifically in areas where patients are not well covered with insurance and need to pay out of their pocket. Off-label bevacizumab usage has been associated with the risk of infection due to a lack of compounding pharmacies in such areas. In India, the entry of ranibizumab biosimilars has made a significant change and improved access to anti-VEGF therapy for many patients. Recent ranibizumab biosimilar approvals by the European Medicines Agency and the US Food and Drug Administration have brought this therapy to the forefront and have the potential to save the nation’s healthcare spending on these drugs. However, it is yet to be seen how biosimilar anti-VEGF therapy will fit into the crowded space of anti-VEGF therapy globally.

ACT-6 Clinical manifestations of the patients with relapsed glioblastoma after bevacizumab treatment

Introduction:The outcome of glioblastoma (GBM) is improving recently, but still only temozolomide and bevacizumab (BEV) are recognized as the effective agents that are reimbursed in Japan. On large clinical trials, BEV prolonged progression free survival (PFS) but the remaining survival period from the relapse after BEV is only 3–5 month. On this study, we retrospectively analyzed the data of GBM patients who were treated with BEV to explore the best usage of BEV.Methods:230 patients were diagnosed as GBM and received BEV from July 2013 to March 2021 in our institution. Among them, 104 patient, whose clinical courses were followed, were included in this study. (M:F=59:45, median age was 65.5) Results:The patients were divided into three groups by when they used BEV; upfront group at first line therapy, 1st relapse group at second line, and 2nd+ relapse group at more than third line. There were 42, 35, 27 patients in each group. The median overall survival (OS) was 17.6, 24.7, 46.1 month (p<0.0001), median PFS after BEV treatment (PFSpBEV) was 8.8, 5.1, 5.0 month (p=0.2532), and the median survival after BEV treatment (OSpBEV) was 15.0, 9.9, 9.2 month (p=0.4437), respectively. There were 64 patients (22, 25, 17 in each group) who reached progressive disease (PD) after BEV. The median survival after PD (OSpBEVpPD) was 4.5, 5.8, 4.3 month (p=0.1590), respectively.Discussion:At the first onset, we use BEV only when the patients have low PS. Our results showed that OS was significantly longer when BEV was used in the later stage, but there was no significant difference in OS or PFS after BEV treatment. Especially OSpBEVpPD was 4–6 month regardless of the timing of BEV. To improve the treatment outcome of GBM, breakthrough therapy is needed in addition to optimizing the usage of BEV.

Proportion of and Reason for Bevacizumab Usage in the Treatment of Wet Age-related Macular Degeneration

Purpose: To evaluate the proportion of bevacizumab and the reason for its usage in wet age-related macular degeneration (AMD).Methods: Retrospective analysis of medical records was performed for 1,541 patients who received ranibizumab, aflibercept, or bevacizumab injection to treat wet AMD. The proportion of bevacizumab among the entire set of injections was identified. The reason for selecting bevacizumab was additionally identified.Results: During the study period, a total of 2,929 anti-vascular endothelial growth factor (anti-VEGF) injections were performed; 2,236 (76.3%) were ranibizumab or aflibercept injections and 693 (23.7%) were bevacizumab injections. The most common reason for bevacizumab usage was ‘having a 0.1 or worse best-corrected visual acuity or being unable to assure reimbursement due to the development of extensive scarring or geographic atrophy’ (297 bevacizumab injections, 42.9%). The second most common reason was ‘the inability to assure reimbursement such as extrafoveal choroidal neovascularization (CNV) or early CNV without definite fluid in the foveal region’ (201 bevacizumab injections, 29.0%).Conclusions: Bevacizumab was used in 23.7% of the anti-VEGF injections to treat wet AMD. When analyzing patients’ treatment burden and financial impact, the results of the present study may provide useful information. Further multi-center studies are required to evaluate more precisely the usage of anti-VEGF drugs.

Bevasizumab’a İyi Cevap Veren, Radyoterapi ve Temozolomid Tedavisine Yanıtsız Bir Erişkin Spinal Kord Astrositomu; Olgu Sunumu ve Literatür Derlemesi

The incidence of spinal cord astrocytomas (SCAs) is very low and therefore, management of these tumors are challenging due to this paucity. In this report, a patient with a recurrent SCA was successfully treated with bevacizumab after failing to previous therapies including radiotherapy (RT) and temozolomide (TMZ). Bevacizumab is an angiogenesis inhibitor that is widely used in high grade gliomas and shows promise for SCAs spinal cord astrocytomas but there is limited data about the usage of bevacizumab in SCAs. We herein add an important contribution to the literature by reporting a nearly total response to bevacizumab in a patient with low grade SCA.

Update on Chemotherapeutic Approaches and Management of Bevacizumab Usage for Glioblastoma.

Glioblastoma, the most common primary brain tumor in adults, has one of the most dismal prognoses in cancer. In 2009, bevacizumab was approved for recurrent glioblastoma in the USA. To evaluate the clinical impact of bevacizumab as a first-line drug for glioblastoma, two randomized clinical trials, AVAglio and RTOG 0825, were performed. Bevacizumab was found to improve progression-free survival (PFS) and was reported to be beneficial for maintaining patient performance status as an initial treatment. These outcomes led to bevacizumab approval in Japan in 2013 as an insurance-covered first-line drug for glioblastoma concurrently with its second-line application. However, prolongation of overall survival was not evinced in these clinical trials; hence, the clinical benefit of bevacizumab for newly diagnosed glioblastomas remains controversial. A recent meta-analysis of randomized controlled trials of bevacizumab combined with temozolomide in recurrent glioblastoma also showed an effect only on PFS, and the benefit of bevacizumab even for recurrent glioblastoma is controversial. Here, we discuss the clinical impact of bevacizumab for glioblastoma treatment by reviewing previous clinical trials and real-world evidence by focusing on Japanese experiences. Moreover, the efficacy and safety of bevacizumab are summarized, and we provide suggestions for updating the approaches and management of bevacizumab.

Analysis of survival and prognostic factors in metastatic colorectal cancer patients treated with first line bevacizumab.

e15009 Background: Colorectal cancer is a major cause of mortality worldwide. Survival has been improved by usage of bevacizumab. Our study aimed to analyze survival and prognostic factors in metastatic colorectal cancer patients treated with first-line bevacizumab. Methods: Files of patients were examined retrospectively and 360 patients treated with first-line bevacizumab were included. Data regarding age, gender, family history, location of the primary, histopathology, KRAS status, surgery and chemotherapy were acquired from the files. Overall response rates (ORR) to chemotherapy, progression and exitus dates or dates of last examination were recorded. Median progression-free and overall survival (PFS and OS) were calculated. Survival was analyzed with Kaplan-Meier method. Log-rank test and Cox regression model were used for univariate and multivariate analysis, respectively. Results: 201 (%55,8) of the patients were male and 159 (%44,2) were female. Median age at the time of the diagnosis was 59.5. 260 patients (%72,2) had initially stage IV disease. KRAS was mutant in 125 patients (%34,7). Median PFS was 8.5 months, median OS was 25.3 months and ORR was %51,4. Median PFS was 8.2 and 9.5 months, median OS was 30.4 and 28.1 months, ORR was %62,6 and %58.4 in KRAS wild type and mutant groups, respectively. In patients with left colon cancer median PFS and OS (9.6 and 27.1 months) were superior compared to patients with right colon cancer (7.3 and 19.4 months) (p = 0.005 and 0.016, respectively). Location of the primary, histopathologic grade, primary surgery, metastasectomy and KRAS status affected overall survival significantly (p &lt; 0.05) in univariate analysis. In multivariate analysis, histopathologic grade (p = 0.034) and metastasectomy (p = 0.001) were independent prognostic factors. Conclusions: In our study, response rates and survival of metastatic colorectal cancer patients treated with first-line bevacizumab were similar to previous studies. Left colon cancer patients had superior median PFS and OS compared to right colon cancer patients as shown in recent studies. Histopathologic grade and metastasectomy were independent prognostic factors in correlation with literature.

A study on evaluation of bevacizumab in the management of diabetic retinopathy

Aims: The study stands to evaluate the usage of bevacizumab against diabetic retinal neovascularisation. Materials and Methods: The outcome measures of study include the determination of visual acuity and retinal cum macular thickness after bevacizumab administration. Twenty diabetic retinopathy patients were screened for bevacizumab administration and given either one or two doses of bevacizumab. Patient's visual acuity and optical tomography's results were analyzed to determine the vision, retinal, and macular thickness. Statistical Analysis Used: The numeric results were passed through analysis of variance, employing “Student's t-test” as posttest for statistically determining the numeric outcomes. Results: Within 1 month of bevacizumab administration visual acuity (distant vision, near vision, and pinhole vision) was improved to logarithm of the minimum angle of resolution (MAR) 0.63 ± 0.07 from 0.87 ± 0.12 of distant vision. Pinhole vision was improved to log MAR 0.37 ± 0.06 from 0.478 ± 0.07 and near vision was improve to log MAR 0.477 ± 0.071 from 0.528 ± 0.069, and retinal thickness was decreased to 336 ± 17.35 μm from 429 ± 30.20 μm. Mean macular thickness was improved to 363.75 ± 24.54 μm from 452.37 ± 30.99 μm. Conclusion: Hence, the off-label use of bevacizumab for the said treatment may be proven beneficial.

P3.02c-014 Patients with Recurrence after Resection of Lung Cancer Are Good Candidates for the beyond over Progressive Disease Application of Bevacizumab: Topic: Targeted Therapy

The benefit of the continuation of bevacizumab (BEV) beyond over progressive disease (PD) in patients with non-small cell lung cancer (NSCLC) has not been clarified yet. We present our experience of chemotherapy with BEV continuation beyond over PD in patients with recurrent NSCLC after surgery. They were consisted of 19 patients. There were 10 males and 9 females, and their age at surgery was 69±10 (41-85) years old. Lobectomy was done in 18 patients, and segmentectomy in 1. Pathological stage was IA in 5, IB in 3, IIB in 3, IIIA in 5, IIIB in 1, and IV in 2. Recurrence was observed at 630±460 days after surgery. Sixteen patients among them had been received some chemotherapy protocols before usage of BEV for 507±448 days. Performance status before treatment was grade 0 in 11 patients, 1 in 7, and 3 in 1. Chemotherapy was performed intending to continue BEV beyond over PD in these patients. The average number of protocols with BEV was 3±1 (1-5). BEV was used for 1734±413 days. Side effects (≥ grade 2) due to BEV were hypertension in 6 patients, proteinuria in 4, and hemoptysis in 1. Seven patients were died of cancer, and 1 of COPD worsening. Five-year survival rate after surgery, after recurrence, and after initiation of BEV was 81.2%, 45.0%, and 31.2%, and median survival time was 2384 days, 1661 days, and 1105 days, respectively. The majority of patients with operable NSCLC have good performance status. Moreover, we can detect their recurrence in the early periods at most before the symptoms appear, because of the regular examinations. Therefore, these patients are at an advantage that they can receive more chemotherapy protocols. In these selected patients, their prognosis may be prolonged by the continuation of BEV beyond over PD.

546P - AVAPLUS: Impact of geriatric assessment on first-line treatment duration (TD) and progression free survival (PFS) in mCRC patients ≥ 70 years

Geriatric assessments (GA) allow evaluation of individual global health status and treatment optimisation. This real-life study complements the knowledge on chemotherapy (CT) and bevacizumab usage in elderly with mCRC focussing the impact of geriatric screening and GA on TD, PFS and severe toxicity. This study included 252 Belgian mCRC patients ≥ 70 years receiving CT with or without bevacizumab. Eastern Cooperative Oncology Group (ECOG), geriatric screening with G8 and Flemish Triage Risk Screening Tool (fTRST), as well as GA including activities of daily living (ADL), instrumental activities of daily living (IADL), Mini-Mental State Examination (MMSE), Geriatric Depression Scale (GDS), Mini Nutritional Assessment (MNA), Charlson Comorbidity Index (CCI), and Mobility-Tiredness Test (Mob-T) was performed in all patients at baseline. For correlations with the different screening and GA components, logrank tests (for TD and PFS), Wilcoxon or Student t-tests (for severe toxicity) and multivariate analyses were used. Additionally, a subgroup analysis excluding patients with ECOG ≥ 2 at baseline was performed. Median TD (95% CI) was 5.5m (5.1-6.2) in the total safety population. In univariate analysis, ECOG > 1, which was only 14.6% of patients, and MNA were the only baseline parameters significantly associated with TD (p = 0.0006 and p = 0.0162, respectively), while G8 showed a trend (p = 0.0607). Significant correlations were observed for PFS vs. ECOG (p < 0.0001), MNA (p = 0.0001) and G8 (p = 0.0208) and for severe toxicity vs. ECOG (p < 0.0001) and G8 (p = 0.005). When lowering the G8 cut-off to 12 (i.e. median value), both TD and PFS were significantly associated with G8 (p = 0.0093 and p = 0.0002, respectively). No significant correlation was observed for fTRST. Multivariate analyses show significant correlations for ECOG vs. TD and PFS (p = 0.0047 and p < 0.0001, respectively) and for MNA versus PFS (p = 0.0007). The ECOG was no longer significant when excluding ECOG ≥ 2 patients. In older mCRC patients, ECOG is a strong predictive marker for treatment duration and PFS, mainly driven by patients with ECOG ≥ 2. In the large group of patients with ECOG ≤ 1, MNA is a predictive marker for PFS.

Efficacy of Simultaneous Usage of Bevacizumab and Silicone Oil Injection After Vitrectomy in Diabetic Tractional Retinal Detachment

Abstract Background: Tractional retinal detachment (TRD), a major vision threatening complication, is one of the most common eye emergencies. The most common cause of TRD is proliferative diabetic retinopathy (PDR). The aim of this study was to evaluate the effect of simultaneous usage of bevacizumab and silicone oil injection after vitrectomy for the treatment of diabetic tractional retinal detachment Methods: Twenty five patients (25 eyes) with severe proliferative diabetic retinopathy were recruited into the study. All eyes underwent a single intravitreal injection of bevacizumab 1.25 mg in 0.05 mL along with silicone oil injection after vitrectomy for the management of tractional retinal detachment or vitreous hemorrhage due to severe proliferative diabetic retinopathy. Patients were then scheduled for postoperative clinical examinations at one, three and six months. The main outcome measures were regression of neovascularization, intraocular pressure, visual acuity and retinal reattachment. Results: This study evaluated 25 eyes of 25 patients (12 men, 13 women) with a mean age of 55.686.94 years (range 21 to 49 years). In all eyes visual acuity improved and retinal attachment was accomplished. The mean preoperative visual acuity was 2.01  0.03 Log MAR which significantly improved to 1.10  0.50 Log MAR in 6th month after surgery (P < 0.000). Active neovascularization regressed significantly (P < 0.004) and intraocular pressure was controlled in 88% of patients. Conclusions: The findings of our study may suggest that simultaneous injection of Bevacizumab and silicone oil after vitrectomy improve early results. We have found it to be particularly useful in diabetic eyes with tractional detachments of short duration.

Efficacy of Simultaneous Usage of Bevacizumab and Silicone Oil Injection After Vitrectomy in Diabetic Tractional Retinal Detachment

Efficacy of Simultaneous Usage of Bevacizumab and Silicone Oil Injection After Vitrectomy in Diabetic Tractional Retinal Detachment

ED-38 * AN UPDATED ANALYSIS OF PATIENT REGISTRY DATA ON NOVOTTF-100A ALTERNATING ELECTRIC FIELDS THERAPY FOR RECURRENT GLIOBLASTOMA

The NovoTTF-100A System is an anticancer treatment that emits alternating electric fields, at an intensity of 1 V/cm and a frequency of 200 kHz, which mimic the cytotoxic effect of chemotherapy by disrupting charged cytoplasmic proteins involved in the tightly orchestrated process of mitosis. The pivotal phase III trial demonstrated equivalent efficacy when the device was compared to conventional cytotoxic chemotherapies and bevacizumab, but without their systemic side effects. After the initial approval, patients were prescribed the device at 91 oncology centers in the United States from October 2011 to November 2013 and they provided consent to their protected health information for the patient registry. We then retrospectively analyzed their outcome and treatment-related adverse events. There were 147 women and 310 men (n = 457) and their median age was 55 (range 18-26) years. Over 70% of them had a Karnofsky performance score (KPS) of 70 or higher. Sixty percent were in their first or second recurrence while 27% were in their third or greater recurrence. More than 55% of patients had prior treatment with bevacizumab. The overall Kaplan-Meier median overall survival (OS) was 9.6 (95% confidence interval [CI] 8.0 to 13.7) months and the median treatment duration was 4.1 (95% CI 3.5 to 4.8) months. Favorable prognostic factors include ≥75% treatment compliance (<0.0001), no prior bevacizumab usage (p = 0.0001), KPS of 90-100 (p = 0.0070) and first recurrence (0.0271). The most common device-related adverse events include skin reaction (24.3%), neurological disorders (10.4%), heat sensation (8.9%), electric sensation (7.7%) and headache (5.7%). Treatment with NovoTTF-100A System, as prescribed in the general clinical setting to patients with recurrent glioblastomas, offers favorable outcomes and no new unexpected toxicities. The data also indicate that treatment compliance, no prior bevacizumab usage, high KPS and application of the device at first recurrence are important prognostic factors.

Effect of pretreatment clinical consultation on oncologist prescribing behavior in the initial treatment of NSCLC.

e19130 Background: Oncology Analytics (OA) promotes evidence-based treatments, based upon objective assessments of efficacy and safety. ASCO guidelines and FDA approval recommend bevacizumab only in combination with carboplatin/paclitaxel, based on E4599 which showed improved OS. NCCN guidelines allow bevacizumab with virtually any approved 1st line chemotherapy (2A). Board certified OA oncologists perform real-time clinical consultations if bevacizumab usage in 1st line is not per level 1 evidence. More recently, those conversations include the Phase III Pointbreak Trial’s failure to show OS advantage with carboplatin/pemetrexed/bevacizumab. Methods: All bevacizumab requests with doublet chemotherapy were tabulated, from 2010 through 2012, and the outcome of pre-treatment clinical consultations were retrospectively analyzed. Results: Bevacizumab with a platinum doublet was requested in 91 patients with non-squamous NSCLC. Of these, 53% (48/91) of requests were for carboplatin/paclitaxel/bevacizumab, consistent with level one evidence, FDA approval and ASCO guidelines. All were approved after confirmation of histology and absence of relative contraindications. Approximately half (47%; 43/91) of the requests were not consistent with level 1 evidence, though compliant with non-evidence-based NCCN guidelines. After clinical consultation, 20 of 43 requests (46%) were revised to evidence-based protocols. Conclusions: These data suggest that nearly half of bevacizumab requests in NSCLC are not in accordance with published level 1 evidence. Pre-treatment clinical consultations can promote evidence based care while reducing costs. National guidelines should be evidence based, especially in common cancers where level 1 evidence is available, since practicing physicians may rely on these guidelines when planning treatment. [Table: see text]