The effect of length of follow-up on substantial clinical benefit thresholds in patients undergoing surgery for cervical degenerative myelopathy

2019 ◽  
Vol 62 ◽  
pp. 88-93
Author(s):  
Morgan P. Spurgas ◽  
Syed F. Abbas ◽  
Benjamin S. Szewczyk ◽  
Benjamin Yim ◽  
Ashar Ata ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Substantial Clinical Benefit ◽  
Degenerative Myelopathy

scholarly journals A tiered system using substantial clinical benefit and patient acceptable symptomatic state scores to evaluate 2-year outcomes of hip arthroscopy with the Hip Outcome Score

2020 ◽  
Vol 7 (1) ◽  
pp. 62-69
Author(s):  
RobRoy L Martin ◽  
Benjamin R Kivlan ◽  
John J Christoforetti ◽  
Andrew B Wolff ◽  
Shane J Nho ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Hip Arthroscopy ◽  
Self Report ◽  
Initial Assessment ◽  
Characteristic Analysis ◽  
Level Of Evidence ◽  
Outcome Score ◽  
Substantial Clinical Benefit ◽  
Tiered System

Abstract There is no information to define variations in hip arthroscopy outcomes at 2-year follow-up using the Hip Outcome Score (HOS). To offer a tiered system using HOS absolute substantial clinical benefit (SCB) and patient acceptable symptomatic state (PASS) scores for 2-year hip arthroscopy outcome assessment. This was a retrospective review of patients having hip arthroscopy for femoroacetabular impingement and/or chondrolabral pathology. On initial assessment and 2 years (±2 months) post-operatively, subjects completed the HOS activity of daily living (ADL) and Sports subscales, categorical self-rating of function and visual analog scale for satisfaction with surgery. Receiver operator characteristic analysis identified absolute SCB and PASS HOS ADL and Sports subscale scores. Subjects consisted of 462 (70%) females and 196 (30%) males with a mean age of 35.3 years [standard deviation (SD) 13] and mean follow-up of 722 days (SD 29). SCB and PASS scores for the HOS ADL and Sports subscales were accurate in identifying those at a ‘nearly normal’ and ‘normal’ self- report of function and at least 75% and 100% levels of satisfaction (area under the curve >0.70). This study provides tiered SCB and PASS HOS scores to define variations in 2-year (±2 months) outcome after hip arthroscopy. HOS ADL subscale scores of 84 and 94 and Sports subscale scores of 61 and 87 were associated with a ‘nearly normal’ and ‘normal’ self-report of function, respectively. HOS ADL subscale scores of 86 and 94 and Sports subscale score of 74 and 87 were associated with being at least 75% and 100% satisfied with surgery, respectively. Level of evidence: III, retrospective comparative study.

scholarly journals The likelihood of reaching minimum clinically important difference and substantial clinical benefit at 2 years following a 3-column osteotomy: analysis of 140 patients

2015 ◽  
Vol 23 (3) ◽  
pp. 340-348 ◽  
Author(s):  
Shayan Fakurnejad ◽  
Justin K. Scheer ◽  
Virginie Lafage ◽  
Justin S. Smith ◽  
Vedat Deviren ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Minimum Clinically Important Difference ◽  
Thoracic Region ◽  
Self Image ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit ◽  
Thoracolumbar Region ◽  
Upper Thoracic ◽  
The Impact

OBJECT Three-column osteotomies (3COs) are technically challenging techniques for correcting severe rigid spinal deformities. The impact of these interventions on outcomes reaching minimum clinically important difference (MCID) or substantial clinical benefit (SCB) is unclear. The objective of this study was to determine the rates of MCID and SCB in standard health-related quality of life (HRQOL) measures after 3COs in patients with adult spinal deformity (ASD). The impacts of location of the uppermost instrumented vertebra (UIV) on clinical outcomes and of maintenance on sagittal correction at 2 years postoperatively were also examined. METHODS The authors conducted a retrospective multicenter analysis of the records from adult patients who underwent 3CO with complete 2-year radiographic and clinical follow-ups. Cases were categorized according to established radiographic thresholds for pelvic tilt (> 22°), sagittal vertical axis (> 4.7 cm), and the mismatch between pelvic incidence and lumbar lordosis (> 11°). The cases were also analyzed on the basis of a UIV in the upper thoracic (T1–6) or thoracolumbar (T9–L1) region. Patient-reported outcome measures evaluated preoperatively and 2 years postoperatively included Oswestry Disability Index (ODI) scores, the Physical Component Summary and Mental Component Summary (MCS) scores of the 36-Item Short Form Health Survey, and Scoliosis Research Society-22 questionnaire (SRS-22) scores. The percentages of patients whose outcomes for these measures met MCID and SCB were compared among the groups. RESULTS Data from 140 patients (101 women and 39 men) were included in the analysis; the average patient age was 57.3 ± 12.4 years (range 20–82 years). Of these patients, 94 had undergone only pedicle subtraction osteotomy (PSO) and 42 only vertebral column resection (VCR); 113 patients had a UIV in the upper thoracic (n = 63) orthoracolumbar region (n = 50). On average, 2 years postoperatively the patients had significantly improved in all HRQOL measures except the MCS score. For the entire patient cohort, the improvements ranged from 57.6% for the SRS-22 pain score MCID to 24.4% for the ODI score SCB. For patients undergoing PSO or VCR, the likelihood of their outcomes reaching MCID or SCB ranged from 24.3% to 62.3% and from 16.2% to 47.8%, respectively. The SRS-22 self-image score of patients who had a UIV in the upper thoracic region reached MCID significantly more than that of patients who had a UIV in the thoracolumbar region (70.6% vs 41.9%, p = 0.0281). All other outcomes were similar for UIVs of upper thoracic and thoracolumbar regions. Comparison of patients whose spines were above or below the radiographic thresholds associated with disability indicated similar rates of meeting MCID and SCB for HRQOL at the 2-year follow-up. CONCLUSIONS Outcomes for patients having UIVs in the upper thoracic region were no more likely to meet MCID or SCB than for those having UIVs in the thoracolumbar region, except for the MCID in the SRS-22 self-image measure. The HRQOL outcomes in patients who had optimal sagittal correction according to radiographic thresholds determined preoperatively were not significantly more likely to reach MCID or SCB at the 2-year follow-up. Future work needs to determine whether the Schwab preoperative radiographic thresholds for severe disability apply in postoperative settings.

scholarly journals Associations With Definitive Outcomes and Clinical Benefit of Cancer Drugs at the Time of Marketing Approval and in the Postmarketing Period

2021 ◽  
pp. 1-9
Author(s):  
Aida Bujosa ◽  
Consolación Moltó ◽  
Thomas J. Hwang ◽  
José Carlos Tapia ◽  
Kerstin N. Vokinger ◽  
...  
Keyword(s):  
Anticancer Drugs ◽  
Clinical Benefit ◽  
Checkpoint Inhibitors ◽  
Marketing Approval ◽  
Substantial Benefit ◽  
Level Data ◽  
Substantial Clinical Benefit ◽  
Surrogate Measures

Background: Most anticancer drugs are approved by regulatory agencies based on surrogate measures. This article explores the variables associated with overall survival (OS), quality of life (QoL), and substantial clinical benefit among anticancer drugs at the time of approval and in the postmarketing period. Methods: Anticancer drugs approved by the FDA between January 2006 and December 2015 and with postmarketing follow-up until April 2019 were identified. We evaluated trial-level data supporting approval and any updated OS and/or QoL data. We applied the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) and the ASCO Value Framework (ASCO-VF) to initial and follow-up studies. Results: We found that 58 drugs were approved for 96 indications based on 96 trials. At registration, approval was based on improved OS in 39 trials (41%) and improved QoL in 16 of 45 indications (36%). Postmarketing data showed an improvement in OS for 28 of 59 trials (47%) and in QoL for 22 of 48 indications (46%). At the time of approval, 25 of 94 (27%) and 26 of 80 scorable trials (33%) met substantial benefit thresholds using the ESMO-MCBS and ASCO-VF, respectively. In the postmarketing period, 37 of 69 (54%) and 35 of 65 (54%) trials met the substantial benefit thresholds. Drugs with companion diagnostics and immune checkpoint inhibitors were associated significantly with substantial clinical benefit. Conclusions: Compared with the time of approval, more anticancer drugs showed improved OS and QoL and met the ESMO-MCBS or ASCO-VF thresholds for substantial benefit over the course of postmarketing time. However, only approximately half of the trials met the threshold for substantial benefit. Companion diagnostic drugs and immunotherapy seemed to be associated with greater clinical benefit.

Rechallenge with ifosfamide-containing regimen as salvage option for patients with metastatic soft tissue sarcomas progressing after multiple pretreatments.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10046-10046
Author(s):  
Mathias Hoiczyk ◽  
Petra Kuschel ◽  
Florian Grabellus ◽  
Mareike Geffken ◽  
Marit Ahrens ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Median Time ◽  
Clinical Benefit ◽  
Locally Advanced ◽  
Soft Tissue Sarcomas ◽  
Dose Intensity ◽  
Line Treatment ◽  
Substantial Clinical Benefit ◽  
Disease Stabilization

10046 Background: Ifosfamide (I) is commonly used in first or second-line treatment of locally advanced or metastatic soft tissue sarcomas (STS). The clinical efficacy of a rechallenge with ifosfamide (IR) or I-containing regimen (ICR) is unclear. We conducted a retrospective analysis of our institutional database (n=1354) of pts who received IR or ICR. Methods: 66 STS pts were identified, who had received more than one I-based regimen. Ifosfamide retreatment was given in neoadjuvant (n=26), adjuvant (n=18) or metastatic settings (n=22) and most patient were pretreated with doxorubicin (D; 94%). PFS was determined from first administration of IR until disease progression, OS from R until last follow-up or death. ORR (RECIST) was assessed to determine the clinical benefit rate (CBR) defined as CR, PR plus SD. Covariates were age, gender, histology, pretreatment, dose intensity, response and toxicity. Results: Median age at time of first I was 45y (range: 17-74, 44% f 56% m). Median time from diagnosis until first ICR treatment was 4mo. Median time from first I until IR, which was given as median 3rd-line treatment (2-9 lines), was 17 mo. Histologies were 12 leiomyo-, 11 lipo- 13 pleomorphic,14 synovial, 4 rhabdomyosarcomas and 12 other subtypes. Pts received a median of I 9.6 g/m²/cycle and a median of 4 cycles. I was given as monotherapy (38%) or in combination (D: 45%, other 17%). Overall median PFS was 5mo with PFS-rates of 63% at 12 and 25% at 24 wks. Median PFS was 6 mo for ICR and 2 mo for IR. The median OS was 36 mo from time of first diagnosis of metastases or locally advanced disease. ORR was 29% for I/D combination (CBR 70%) and 12 % for I monotherapy (CBR: 52%). 22 pts received a second IR with a median of 2 cycles (27% PR; CBR:77%; 69% combinations). Most common toxicities for IR/ICR were neutropenia (42%), encephalopathy (21%) and neutropenic fever (18%). Dose reductions were necessary in 18% of pts and treatment was stopped in 8% due to toxicity. No significant cardiotoxicity was observed. Conclusions: Patients with soft tissue sarcomas who had at least disease stabilization after initial ifosfamide-based therapy may derive substantial clinical benefit from a rechallenge.

Factors associated with change in the magnitude of clinical benefit of anti-cancer drugs in the post-marketing period.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7052-7052
Author(s):  
Aida Bujosa Rodríguez ◽  
Consolacion Molto ◽  
Thomas J Hwang ◽  
Kerstin Noëlle Vokinger ◽  
Jose Carlos Tapia ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Multivariable Analysis ◽  
Drug Approval ◽  
Cancer Drug ◽  
Marketing Approval ◽  
Cancer Drugs ◽  
Companion Diagnostics ◽  
Substantial Clinical Benefit ◽  
Post Marketing

7052 Background: Initial drug approval is often based on surrogate endpoints. Definitive outcomes like Overall Survival (OS) or Quality of life (QoL) may not be available. Here, we evaluate changes in the magnitude of clinical benefit using the American Society of Clinical Oncology Value Framework (ASCO-VF) and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) comparing the time of approval to the most recent available data for cancer drugs approved by the US Food and Drug Administration (FDA) between 2006 and 2015. Methods: We examined data on trials supporting FDA accelerated (AA) and regular (RA) cancer drug approvals between January 2006 and December 2015. We performed a systematic search of Pubmed and ClinicalTrials.gov to identify updated OS and/or QoL data, with follow up through April 2019. For AA drugs we analysed initial and confirmatory trials as follow-up. ASCO-VF and ESMO-MCBS grades were applied for trials at approval and after marketing. We explored variables associated with improved clinical benefit scores using multivariable logistic regression. Results: We identified 102 trials supporting the approval of 59 drugs for 96 solid tumour indications. Of these indications, 22 (23%) were granted AA and 21 (95%) were converted to RA. At time of approval, 38% of trials showed improved OS and 17% improved QoL. Substantial clinical benefit was observed in 26% of initial approval trials using ESMO-MCSB and in 34% using ASCO-VF. After a median post-marketing period of 3.3 years, updated results changed substantial clinical benefit in 20 trials with ESMO-MCBS (19 upgrades, 1 downgrade) and in 23 trials using ASCO-VF (19 upgrades, 4 downgrades). For 25% of trials no updated information was found. In the palliative setting, multivariable analysis showed association between improved ASCO-VF scores and initial approvals based on single-arm trials (OR 9.21, 95%CI 1.36-62.29, P=0.023), drugs with companion diagnostics (OR 4.95, 95%CI 1.01-24.22, P=0.049) and second or later lines (OR 7.80, 95%CI 1.35-45.02, P=0.022) while for ESMO-MCBS, drugs with companion diagnostics (OR 6.86, 95%CI 1.82-25.86, P=0.004) and immunotherapy drugs (OR 6.42, 95%CI 1.27-32.59, P=0.025) were associated with greater clinical benefit. Conclusions: Drugs with companion diagnostic tests, immunotherapy as well as approved based on single-arm trials were associated with increased clinical benefit after marketing approval. For a quarter of trials there were no updated data in the post-marketing period.

scholarly journals Endoscopic Repair of Partial Thickness Under-Surface Tears of The Abductor Tendon (pusta): Clinical Outcomes with Minimum Two-year Follow-up

2018 ◽  
Vol 6 (7_suppl4) ◽  
pp. 2325967118S0011
Author(s):  
David Edward Hartigan ◽  
Itay Perets ◽  
Sherwin S.W. Ho ◽  
John P. Walsh ◽  
Leslie Yuen ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Clinical Benefit ◽  
Gluteus Medius ◽  
Partial Thickness ◽  
Patient Satisfaction Scores ◽  
Substantial Clinical Benefit ◽  
Patient Reported ◽  
Average Patient ◽  
Minimally Clinical Important Difference

Objectives: To report the minimum two-year outcomes of trans-tendinous repairs of Partial Thickness Undersurface Tears of the Abductor (PUSTA) tendon using patient reported outcomes (PROs), visual analog scale (VAS), and patient satisfaction scores. Methods: All patients who underwent endoscopic trans-tendinous gluteus medius repair between October 2009 and May 2013 at one institution were prospectively evaluated. Exclusion criteria consisted of less than two-year follow-up, previous hip surgery, inflammatory arthritis, open surgery, full thickness abductor tear, and worker’s compensation patients. All patients had a documented pre-operative physical exam with strength testing (0-5) and observation of their gait. Patient satisfaction and PRO scores were recorded preoperatively, at 3 months postoperatively, and annually thereafter. The PRO scores collected were mHHS, HOS-ADL, HOS-SSS, NAHS, and VAS. Preoperative strength and gait were compared to latest follow-up. Results: There were 25 patients that fit our criteria. Significant improvement in PRO scores were demonstrated for mHHS, HOS-ADL, HOS-SSS, NAHS, and VAS from 54.9-76.2, 50.2-80.6, 30.1-67.3, 51.9-82.4, and 7.1-2.7 respectively (p<0.001). There were 11 patients with objective weakness prior to surgery; seven of these patients moved up at least one strength grade by final follow-up. There were 14 patients who had a Trendelenbrug gait pre-operatively, 12 of them had a normal gait at latest follow-up (p-<0.001). Average patient satisfaction was 7.5. There were no revision surgeries, and no complications noted. Conclusion: PUSTA lesions can be treated successfully with endoscopic trans-tendinous repair preserving the intact attachment of superficial fibers of the gluteus medius. We recommend this treatment for partial undersurface tears recalcitrant to non-operative treatment, as patients demonstrated clinical benefit at greater than 2 years follow up that exceeds substantial clinical benefit and minimally clinical important difference.

Time Required to Achieve Minimal Clinically Important Difference and Substantial Clinical Benefit After Arthroscopic Treatment of Femoroacetabular Impingement

2018 ◽  
Vol 46 (11) ◽  
pp. 2601-2606 ◽  
Author(s):  
Benedict U. Nwachukwu ◽  
Brenda Chang ◽  
Joshua Adjei ◽  
William W. Schairer ◽  
Anil S. Ranawat ◽  
...  
Keyword(s):  
Femoroacetabular Impingement ◽  
Clinical Benefit ◽  
Hip Arthroscopy ◽  
Minimal Clinically Important Difference ◽  
Arthroscopic Treatment ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit ◽  
Outcome Improvement ◽  
Clinically Significant

Background: Minimal clinically important difference (MCID) defines the minimum degree of quantifiable outcome improvement that a patient perceives as the result of an intervention or in the process of healing. Substantial clinical benefit (SCB) defines the amount of quantifiable outcome improvement that is needed for a patient to feel substantially better. Little is known about when clinically significant outcome improvement is achieved. Purpose: To investigate the time-dependent nature of MCID and SCB after hip arthroscopy for femoroacetabular impingement (FAI). Study Design: Cohort study; Level of evidence, 2. Methods: An institutional hip preservation registry was queried. The modified Harris Hip Score, Hip Outcome Score, and 33-item International Hip Outcome Tool (iHOT-33) were administered to patients undergoing hip arthroscopy for FAI. Follow-up times for outcome measures were classified into 3 periods: 5 to 11 months (6 months), 12 to 23 months (1 year), and 24 to 35 months (2 years). Cumulative probabilities for achieving MCID and SCB were calculated with Kaplan-Meier survival curve analysis and interval censoring. A Weibull parametric regression analysis evaluated the odds of achieving earlier MCID. Results: A total of 719 patients undergoing primary hip arthroscopy were included. The mean ± SD age was 32.5 ± 10.5 years, and the majority were female (n = 380, 52.9%). Across all 4 outcome instruments, patients had the highest probability for achieving MCID and SCB by the 6-month postoperative period. The iHOT-33 demonstrated the highest probability for capturing MCID and SCB improvement at each of the 3 periods, with 76.0%, 84.8%, and 93.6% achieving MCID by 6 months, 1 year, and 2 years, respectively. Similarly, the probabilities of achieving SCB on the iHOT-33 were as follows: 57.1%, 68.0%, and 71.7%. A similar trend was demonstrated across other outcome tools. Older male patients and those with Outerbridge classification 1 to 4 (vs grade 0) had a significantly increased risk for taking a longer time to achieve MCID and SCB. Additionally, patients with higher preoperative outcome scores took a longer time to achieve MCID and SCB. Conclusion: At least half of patients treated with hip arthroscopy for FAI achieve MCID and SCB within the first 6 months after the procedure. However, clinically significant outcome improvement continues to be attained until 2 years postoperatively. Female patients, younger individuals, and those without chondral defects achieve faster clinical outcome improvement. These findings can be helpful for establishing shared decision-making aids and follow-up guidelines for arthroscopic treatment of FAI.

scholarly journals Establishing the Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptomatic State following Primary Medial Patellofemoral Ligament Reconstruction

2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0046
Author(s):  
Hailey Huddleston ◽  
Neal Naveen ◽  
Taylor Southworth ◽  
Benedict Nwachukwu ◽  
Brian Cole ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Surgical Procedure ◽  
Predictive Power ◽  
Medial Patellofemoral Ligament ◽  
Minimal Clinically Important Difference ◽  
Mpfl Reconstruction ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit ◽  
Patient Reported

Objectives: Medial patellofemoral ligament (MPFL) reconstruction is an effective surgical procedure for patients with recurrent lateral dislocations. Outcome measurements can identify the success of a surgical procedure but are shifting away from absolute values or deltas of patient-reported outcomes (PROs) towards the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS), representing the smallest clinical improvement that patients perceive as important, the threshold at which patients notice a considerable improvement, and patient satisfaction with their outcome, respectively. To our knowledge no prior study has defined these thresholds in MPFL reconstruction patients. Methods: An institutional database was reviewed for patients who underwent primary MPFL reconstruction between August 2015 to February 2018 with a minimum 6-month follow-up. IKDC, Kujala and KOOS were administered to all patients pre-operatively and at 6-months and 1-year post-operatively. An anchor-based approach with a receiver-operator curve/area under the curve analysis using the Youden index was performed to calculate the MCID, SCB and PASS. The predictive power was determined to be acceptable with AUC≥70% and excellent with AUC≥80%. Results: From 2015 to 2018, 93 of 162 patients (mean age 23.7±10.1 years; 25 males, 68 females) completed for 6-month follow-up. At 6-months follow-up, SCB and PASS were defined with acceptable predictive power for all scores listed, while MCID achieved this for KOOS pain and sports subscores only (Table 1). At 1-year follow-up, SCB and PASS were each defined with acceptable predictive power for all scores listed, while MCID achieved this mark for KOOS pain and quality of life subscores as well as both Kujala scales. Conclusion: This study establishes MCID, SCB and PASS for IKDC, Kujala, and KOOS subscores at 6-months and 1-year postoperatively with excellent predictive power for 19/23 PROMs investigated at 1-year. These findings represent important benchmarks in patients undergoing primary MPFL reconstruction.

scholarly journals NCOG-19. BEVACIZUMAB IN REAL LIFE PATIENTS WITH RECURRENT GLIOBLASTOMA: BENEFIT OR FUTILITY?

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii133-ii133
Author(s):  
Cristina Smolenschi ◽  
Emeline Colomba ◽  
Elie Rassy ◽  
Naima Lezghed ◽  
Mohamed Kettab ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Therapeutic Option ◽  
Performance Status ◽  
Objective Response ◽  
Real Life ◽  
Complete Response ◽  
Recurrent Glioblastoma ◽  
Arterial Bleeding ◽  
Substantial Clinical Benefit ◽  
Radiological Response

Abstract Angiogenesis represents a hallmark of glioblastoma but most trials disappointed and failed to change the poor outcome of this disease. However, Bevacizumab (Bev) is widely used in clinical practice by expert oncologists due to experience or efficacy in real life.We retrospectively reviewed the use of Bev and its benefit in terms of Time to treatment failure (TTF), Overall Survival(OS), Objective Response Rate (ORR) and clinical benefit. METHODS: We analyzed two hundred and two patients treated at Gustave Roussy Cancer Campus with Bev until definitive failure for recurrent glioblastoma between 2006 and 2016. Patients were treated with Bev alone or in association with radiotherapy, temozolomide, lomustine or irinotecan. RESULTS: The median duration of Bev treatment until definitive failure was 6 months. The median TTF was 7.27 months(95%CI 6.30-8.24) and the median OS from diagnosis was 22.43 months(95%CI 19.68-25.18). Two patients were still alive without active treatment at the end of study. A hundred and fourteen (56%) patients experienced symptom amelioration and seventy-five (37%) improved their Performance Status. Fifty percent of patients exhibited Partial and Complete Response on MRI, as best radiological response, within 1.6 months. No patient had anaphylactic reaction. Grade 1-2 hypertension(HT)(17%) and grade 1(10%) proteinuria were most common. Six patients presented lethal toxicity: 4 with GI perforation, 1 p with cerebral hemorrhage and 1 p with arterial bleeding. HT was correlated with treatment response in 67% of patients. A neutrophil count superior to 6000/mm³ was associated with longer TTF(mTTF 8.23m(95%CI 6.64-9.82). CONCLUSION: This retrospective study reports a substantial clinical benefit of Bev in patients with recurrent glioblastoma with an acceptable toxicity profile. As the panel of therapeutic option is still very limited in these tumors, this work supports the maintained use of Bev as a therapeutic option.

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