Improvements in data collection through physician use of a computer-based chemotherapy treatment consultant.

1985 ◽  
Vol 3 (10) ◽  
pp. 1409-1417 ◽  
Author(s):  
D L Kent ◽  
E H Shortliffe ◽  
R W Carlson ◽  
M B Bischoff ◽  
C D Jacobs
Keyword(s):  
Data Collection ◽  
Disease Activity ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Clinical Trial Data ◽  
Data Management System ◽  
Before And After ◽  
Computer Based ◽  
Physical Findings ◽  
The Impact

The impact of a computer-based data management system on the completeness of clinical trial data was studied before and after the system's introduction in an oncology clinic. Physicians use the system, termed ONCOCIN, to record data during patient visits and to receive advice about treatment and tests required by experimental cancer protocols. Although ONCOCIN does not force the user to enter all data expected by the protocol, after its introduction there was improvement in the recording frequency of such data. The percentage of expected physical findings recorded increased from 74% to 91% (P less than .05), toxicity history from less than 1% to 45% (P less than .01), general chemistry results from 36% to 82% (P less than .01), x-ray results from 44% to 73% (P less than .01), and physicians' assessments of overall disease activity and Karnofsky performance status from 73% to 91% (P less than .05). Analysis of the steps in data collection and their contribution to loss of data suggests that observations or test ordering which are dependent on the physician are most improved by the system. Furthermore, analysis of post-ONCOCIN visits when the system was unavailable suggests that the recording of physician-dependent data (physical findings and assessments of disease activity and performance status) is likely to revert to pre-ONCOCIN levels if the system is not used routinely. The results show that ONCOCIN can greatly enhance recovery of those data expected for chemotherapy protocol patients. The program's interaction with the physician is central to its effectiveness in data collection, especially for data that arise directly from the patient-physician encounter.

RADT-23. RECURRENT OLIGODENDROGLIOMAS AFTER FIRST CHEMO-RADIATION THERAPY RESPONDED REMARKABLY TO RE-RADIATION

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi46-vi46
Author(s):  
Fumi Higuchi ◽  
Takeo Uzuka ◽  
Keisuke Ueki
Keyword(s):  
Radiation Therapy ◽  
Primary Tumor ◽  
Radiation Treatment ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Lateral Side ◽  
Who Grade ◽  
Recurrent Tumors ◽  
Conventional Radiation ◽  
Before And After

Abstract Oligodendrogliomas with 1p/19q-codeletion are relatively slow progressive tumors that show good response to chemo-radiation therapy after resection. The median survival is about 15 years regardless of WHO grade, although recurrences are mostly inevitable and there is no standard treatment for recurrence. We experienced 5 oligodendroglioma cases who underwent re-radiation for recurrent tumors after chemo-radiation treatment. We retrospectively investigated those for response to re-radiation, the duration from first radiation to second radiation, and Karnofsky Performance Status (KPS) before and after the re-radiation. Patients were all male; the median radiation dose for primary tumor was 60Gy (54-60Gy), the median age at first radiation was 46 years (35-59), the median duration from the first radiation to re-radiation was 65 months (range 18-116 months), and the median follow-up period after re-radiation was 15 months (1-39 months). In all 5 cases, tumors showed good response to re-radiation. In 3 of the 5 cases, tumor recurred in corpus callosum and/or lateral side of cerebral hemisphere or basal ganglia contiguous with primary tumor sites and were radiated by IMRT (50Gy/25fr) . In 2 cases, tumors recurred around the fourth ventricle and posterior fossa and underwent conventional radiation (54Gy/30fr and 30Gy/10fr). In 2 of the 5 cases, the tumors re-recurred 24 months later after re-radiation, but the KPS were maintained until re-recurrence. For oligodendrogliomas, re-radiation therapy appears to be very effective to recurrent tumors after first chemo-radiation. Although evaluation for longer-term side effects is to be examined, re-radiation appears to be a good option for recurrent oligodendrogliomas after first chemo-radiation therapy.

scholarly journals Navigated Intraoperative 2-Dimensional Ultrasound in High-Grade Glioma Surgery: Impact on Extent of Resection and Patient Outcome

2019 ◽  
Author(s):  
Alessandro Moiraghi ◽  
Francesco Prada ◽  
Alberto Delaidelli ◽  
Ramona Guatta ◽  
Adrien May ◽  
...  
Keyword(s):  
Real Time ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Intraoperative Ultrasound ◽  
High Grade Glioma ◽  
Extent Of Resection ◽  
High Grade ◽  
Glioma Surgery ◽  
Supratentorial Gliomas ◽  
The Impact

Abstract BACKGROUND Maximizing extent of resection (EOR) and reducing residual tumor volume (RTV) while preserving neurological functions is the main goal in the surgical treatment of gliomas. Navigated intraoperative ultrasound (N-ioUS) combining the advantages of ultrasound and conventional neuronavigation (NN) allows for overcoming the limitations of the latter. OBJECTIVE To evaluate the impact of real-time NN combining ioUS and preoperative magnetic resonance imaging (MRI) on maximizing EOR in glioma surgery compared to standard NN. METHODS We retrospectively reviewed a series of 60 cases operated on for supratentorial gliomas: 31 operated under the guidance of N-ioUS and 29 resected with standard NN. Age, location of the tumor, pre- and postoperative Karnofsky Performance Status (KPS), EOR, RTV, and, if any, postoperative complications were evaluated. RESULTS The rate of gross total resection (GTR) in NN group was 44.8% vs 61.2% in N-ioUS group. The rate of RTV > 1 cm3 for glioblastomas was significantly lower for the N-ioUS group (P < .01). In 13/31 (42%), RTV was detected at the end of surgery with N-ioUS. In 8 of 13 cases, (25.8% of the cohort) surgeons continued with the operation until complete resection. Specificity was greater in N-ioUS (42% vs 31%) and negative predictive value (73% vs 54%). At discharge, the difference between pre- and postoperative KPS was significantly higher for the N-ioUS (P < .01). CONCLUSION The use of an N-ioUS-based real-time has been beneficial for resection in noneloquent high-grade glioma in terms of both EOR and neurological outcome, compared to standard NN. N-ioUS has proven usefulness in detecting RTV > 1 cm3.

Mature Results of a Prospective Trial of Rituximab in Patients (Pt) with Post Transplant Lymphoproliferative Disorder (PTLD) Unresponsive or Ineligible for Reduced Immunosuppression (RIS).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2755-2755
Author(s):  
Jeff P. Sharman ◽  
Donald E. Tsai ◽  
Clare J. Twist ◽  
Steven M. Horwitz ◽  
Carol D. Jones ◽  
...  
Keyword(s):  
Site Response ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Univariate Analysis ◽  
Prospective Trial ◽  
Large Cell ◽  
Cytotoxic Therapy ◽  
Free Survival ◽  
Co Morbidity ◽  
The Impact

Abstract Background: PTLDs are typically B-cell neoplasms occurring as uncommon but serious complications of reduced T-cell immune surveillance associated with organ transplantation. RIS benefits only a subset of PTLD patients and cytotoxic therapy may be poorly tolerated. Therefore, in October 1998 we initiated a prospective study of rituximab in patients who failed or were unable to receive RIS and now report mature results. Methods: Patients with CD20+ PTLD were eligible if they had failed to completely respond to RIS or RIS was contraindicated and had Karnofsky performance status >60, age 3–70 years (y), measurable disease, and no change in immunosuppression for at least 2 weeks and no cytotoxic therapy within 4 weeks. Rituximab was given as 375 mg/m2 weekly x 4 with disease evaluation at 1, 3, 6, 9, 12 and 18 months. Response data, survival curves, and the impact of clinical and pathological factors were evaluated. Results: 24 of 26 enrolled pt were eligible and evaluable. Median age was 42y with 5 <17 y, 18 were male, and 14 progressed on RIS. Median time to PTLD from transplant was 47 months (m) (8 <24 m). 17/22 were EBV+, 17 were large cell or Burkitt histology, and 10 PTLD occurred in the allograft site. Response rate was 63% (46 %CR, 17% PR) and CRs were durable (1/11 progressed). With median follow-up of 65 m (range 44–82), outcomes at 5 y are: overall survival 48%, freedom from progression 41% and failure-free survival 21%. 7 pt died without progression, yielding 5 y cause-specific survival of 69%. Nine of 13 pt with disease progression were successfully salvaged with second-line therapy. In univariate analysis PTLD characteristics did not significantly correlate with outcome but 2/2 Burkitt pt quickly progressed. Conclusions: Rituximab provided effective, durable treatment for ~40% of pt failing RIS in this series of mainly late PTLD and a majority of pt progressing after rituximab could be treated successfully. However, overall and failure-free survival reflect significant co-morbidity in this population.

Safety and Efficacy of Bortezomib (VELCADE™) in 104 Patients with Relapsed and/or Refractory Multiple Myeloma Who Have Received at Least Two Previous Lines of Therapy: Impact of Cytogenetics on Response from a Canadian Cohort.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5118-5118
Author(s):  
Joseph R. Mikhael ◽  
Donna E. Reece ◽  
Andrew Belch ◽  
Nizar J. Bahlis ◽  
Deepa Sharma
Keyword(s):  
Multiple Myeloma ◽  
Partial Response ◽  
Poor Prognosis ◽  
Progressive Disease ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
M Protein ◽  
Cytogenetic Abnormalities ◽  
Refractory Multiple Myeloma ◽  
The Impact

Abstract Background: Bortezomib (VELCADE™) is a reversible proteasome inhibitor that has been shown to be safe and efficacious in patients (pts) with relapsed and/or refractory multiple myeloma (MM) using a dose of 1.3 mg/m2 on days 1, 4, 8 & 11 of a 21-day cycle. Certain cytogenetic abnormalities are associated with poor prognosis in MM, including deletion 13, t(4;14) and the p53 deletion.(Stewart et al, JCO2005; 23(26):6339–44). Bortezomib has demonstrated the ability to overcome the poor prognosis associated with deletion 13 (Jagannath, JCO2005; 23(16S) 6501). The impact of bortezomib on a broader range of cytogenetic abnormalities, such as t(4;14) has yet to be determined. Methods: In this multicentre, open-label, non-randomized, phase 3b study, pts with MM across 13 centres in Canada, who had received at least 2 previous lines of therapy and who were refractory to or had relapsed after their last therapy were enrolled. Pts received up to eight 3-week cycles of bortezomib on days 1, 4, 8 & 11. Dexamethasone 20 mg PO was administered on each day of and day after bortezomib administration if the pts either experienced progressive disease after receiving at least 2 treatment cycles of bortezomib or had no change in disease status from baseline after receiving at least 4 treatment cycles of bortezomib. Results: 104 pts were enrolled; the mean age in this cohort was 60.7 years, and 65 (62.5%) were male. Approximately 30% of pts had a Karnofsky performance status of 70 or less at baseline. 71 pts (68.3%) had received prior thalidomide therapy, 32 (30.8%) had received a prior autotransplant and 4 (3.8%) had received prior bortezomib treatment. 74 (71.2%) received 3 or more lines of prior MM therapy. During the study, mean number of bortezomib cycles completed was 4.6 (range, 0–11 cycles), and the number of pts that completed 8 cycles of therapy was 36 (34.6%). 15.2% of pts received dexamethasone at cycle 3 and 19.2% at cycle 5. Cytogenetic analysis was performed on approximately half of the pts. Response data for cycle 5 is currently available for 69/99 (69.7%) of evaluable pts (see Table 1). Overall, 76.9% of the pts experienced Grade 3 & 4 adverse events. Safety profile observed is similar to past trial results with bortezomib. Conclusion: In this large Canadian cohort of extensively pre-treated patients with mulitple myeloma, bortezomib demonstrated good response, consistent with previous studies. Analysis correlating cytogenetic profile and response rate is ongoing and will be available at the time of conference. In addition, a detailed safety analysis and impact of prior treatment on response will be analyzed and made available at the time of conference. Table 1. Response to Bortezomib Category of Response* No. of Patients (%) *Modified SWOG: CR 100% M-protein reduction; R 75–99%; PR 50–74%; MR 25–49%; SD<25%, PD increasing M-protein Any Response (CR + VGPR + PR + MR) 47 (68.1) ---Complete Response (CR) + Very Good Partial Response (VGPR) ---22 (31.9) ---Partial Response (PR) + Minimal Response (MR) ---25 (36.2) Stable Disease 10 (14.5) Progressive Disease 12 (17.4)

scholarly journals Melanoma brain metastasis: the impact of stereotactic radiosurgery, BRAF mutational status, and targeted and/or immune-based therapies on treatment outcome

2018 ◽  
Vol 129 (1) ◽  
pp. 50-59 ◽  
Author(s):  
Rupesh Kotecha ◽  
Jacob A. Miller ◽  
Vyshak A. Venur ◽  
Alireza M. Mohammadi ◽  
Samuel T. Chao ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Brain Metastasis ◽  
Stereotactic Radiosurgery ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Braf Inhibitor ◽  
Melanoma Brain Metastasis ◽  
Mutational Status ◽  
Increased Risk ◽  
The Impact

OBJECTIVEThe goal of this study was to investigate the impact of stereotactic radiosurgery (SRS), BRAF status, and targeted and immune-based therapies on the recurrence patterns and factors associated with overall survival (OS) among patients with melanoma brain metastasis (MBM).METHODSA total of 366 patients were treated for 1336 MBMs; a lesion-based analysis was performed on 793 SRS lesions. The BRAF status was available for 78 patients: 35 had BRAFmut and 43 had BRAF wild-type (BRAF-WT) lesions. The Kaplan-Meier method evaluated unadjusted OS; cumulative incidence analysis determined the incidences of local failure (LF), distant failure, and radiation necrosis (RN), with death as a competing risk.RESULTSThe 12-month OS was 24% (95% CI 20%–29%). On multivariate analysis, younger age, lack of extracranial metastases, better Karnofsky Performance Status score, and fewer MBMs, as well as treatment with BRAF inhibitors (BRAFi), anti–PD-1/CTLA-4 therapy, or cytokine therapy were significantly associated with OS. For patients who underwent SRS, the 12-month LF rate was lower among those with BRAFmut lesions (6%, 95% CI 2%–11%) compared with those with BRAF-WT lesions (22%, 95% CI 13%–32%; p < 0.01). The 12-month LF rates among lesions treated with BRAFi and PD-1/CTLA-4 agents were 1% (95% CI 1%–4%) and 7% (95% CI 1%–13%), respectively. On multivariate analysis, BRAF inhibition within 30 days of SRS was protective against LF (HR 0.08, 95% CI 0.01–0.55; p = 0.01). The 12-month rates of RN were low among lesions treated with BRAFi (0%, 95% CI 0%–0%), PD-1/CTLA-4 inhibitors (2%, 95% CI 1%–5%), and cytokine therapies (6%, 95% CI 1%–13%).CONCLUSIONSPrognostic schema should incorporate BRAFi or immunotherapy status and use of targeted therapies. Treatment with a BRAF inhibitor within 4 weeks of SRS improves local control without an increased risk of RN.

scholarly journals Impact of the introduction of the active follow-up care of the third stage of childbirth in the prevention of delivery hemorrhage in the obstetrical gynecology department

2021 ◽  
Vol 11 (2) ◽  
pp. 227-236
Author(s):  
Jeremie Pagnol Bille Bonga ◽  
Michele Corneille Matchim Kamdem ◽  
Leila Sandra Nnanga ◽  
Ghislain François Eyimi Abessolo ◽  
Marcellin Ndoe Guiaro
Keyword(s):  
Data Collection ◽  
Regional Hospital ◽  
Prospective Data ◽  
The Third ◽  
Third Stage ◽  
Follow Up Care ◽  
Before And After ◽  
Study Participants ◽  
The Impact

Background: The majority of pregnancies and births proceed without complications. However, all pregnancies present risks of complications that could endanger the maternal prognosis. One of the most serious of these complications is the bleeding during delivery. It’s often unpredictable nature, when it occurs, involves an urgent obstetric situation which requires early diagnosis and rapid and effective follow-up. The general objective of this study was to assess the impact of the introduction of the active follow-up care of the third phase of childbirth in the prevention of bleeding during delivery with our place of study, the obstetrical gynecology department of Kindia regional hospital (Konacri Guinea), with the aim of optimizing the follow-up care of pregnant women during their childbirth. Methodology: We carried out a case-control study with both retrospective and prospective data collection on the records of participants with cases of hemorrhage during delivery in the gynecology department of the Kindia regional hospital. Retrospective data collection covered a period of 25 months before the active follow-up care of the third stage of childbirth and concerned the control group of study participants, while the one of prospective data covered a period of 19 months after the introduction of the active follow-up care of the third stage of childbirth from the 1st January 2019 to 30th September 2020 and concerned the cases group. The criteria for matching these two groups of study participants were the diagnosis and the follow-up of the delivery hemorrhage. Results: During our study period in the gynecology department of the Kindia regional hospital, we identified 223 cases of delivery hemorrhage out of 2198 deliveries before the period of introduction of the active follow-up care of the third stage. This represents an incidence of 10.14%, compared to 73 cases of delivery hemorrhage out of 2714 deliveries during the period of the active follow-up care of the third stage. For an incidence of 2.68%. We found that the hemorrhages during delivery did not spare any age group and were observed for all parities. There were common reasons for admission before and after the integration of the active follow-up care of the third stage of childbirth namely vulvar hemorrhage and physical asthenia, which were reflected in the clinical picture of all cases bleeding from the issue. In addition, headaches, dizziness, and thirst were found, but in different proportions and significantly less frequent since the introduction of the active follow-up care of the third stage of childbirth. This sign were in this context the consequence of the state of shock with respective frequencies of 46.63% and 28.76% before and after the introduction of the active follow-up care of the third stage of childbirth and anemia was present in all cases of delivery hemorrhage. Conclusion: The introduction of active follow-up care of the third stage of childbirth has reduced the frequency of delivery hemorrhages and may therefore help to reduce maternal morbidity and mortality.

scholarly journals The perception level on the impact of integrated livestock-fish production systems towards the environmental pollution

2021 ◽  
Vol 926 (1) ◽  
pp. 012008
Author(s):  
S Adibrata ◽  
N I Bahtera ◽  
R P Astuti ◽  
F Arkan
Keyword(s):  
Data Collection ◽  
Environmental Pollution ◽  
Production System ◽  
Animal Feed ◽  
Monitoring And Evaluation ◽  
Fish Production ◽  
Wet Season ◽  
Probiotic Treatment ◽  
Before And After ◽  
The Impact

Abstract The integrated farming activities have become more popular in the last decade. It expects to increase productivity by optimizing the land and minimizing environmental pollution. The study aims to understand the perception level of society towards the environmental pollution of the integrated livestock-fish production system on raising catfish and laying duck (Clarias sp and Anas platyrhynchos). The study was conducted in Desa Balunijuk, Bangka. The questionnaire was used for the data collection technique through a face-to-face interview by following the health protocol of Covid-19. Two stages of data collection were applied: before and after treatment of Probio_Fm. Qualitative descriptive was employed to analyze the data. The respondents were the society who lived nearby the location of the study. A mixture of probiotics was employed on the feed and the catfish pond. The study found that the perception was significantly different between before and after treatment of Probio_Fm particularly on the negative environmental effects such as odor pollutants due to unmanaged animal waste. It occurred at the very beginning of the study during the wet season before the probiotic treatment. Interestingly, during the dry season, the probiotic treatment was regularly applied. The odor pollutant impact decreased even not having a bad odor at all. The waste both absorbed in the sand and was streamed through the drain pipeline. However, most of the respondents were not disturbed due to the odor pollutant surrounding the integrated livestock-fish production system. It articulated that the probiotic treatment worked effectively in unraveling the bacteria so that the pollutant level decreased drastically. The study recommended various solutions to the problems: the draining pipeline should be repaired, the animal feed should use probiotics to achieve optimal use of nutrition, consistent and effective feeding should be applied, and the cleanliness of the duck house should be properly maintained. The monitoring and evaluation of the environmental impact towards the integrated livestock-fish production system should involve relevant stakeholders such as a village government, the management, and society as a whole so that the healthy and environment-friendly integrated fisheries activity can be achieved.

scholarly journals Dampak Keberadaan Tambang Pasir Terhadap Kondisi Sosial Ekonomi Masyarakat di Desa Cimpu Utara Kecamatan Suli Kabupaten Luwu

LaGeografia ◽  
2020 ◽  
Vol 18 (2) ◽  
pp. 137
Author(s):  
Sukri Nyompa ◽  
Nur Adha Sari Dewi ◽  
Uca Sideng
Keyword(s):  
Data Collection ◽  
Research Method ◽  
Economic Condition ◽  
Junior High ◽  
Economic Conditions ◽  
Sand Mining ◽  
The People ◽  
Before And After ◽  
The Impact ◽  
Descriptive Qualitative

This study aims to determine: 1) The socio-economic condition of sand miners 2.) The level of income of sand miners before and after the existence of a sand mine in Cimpu Utara Village, Suli District, Luwu Regency. This research method uses descriptive qualitative. The population in this study is the owner and labor of sand miners totaling 36 people. Data collection was carried out using observation techniques, interviews, and documentation. Data were analyzed descriptively qualitatively. The results of this study indicate that: 1) The socio-economic conditions of the people who work as sand mines are aged 40-44 years as much as 30.55%,. graduated from junior high as much as 36.11%. The previous respondents' livelihoods were entrepreneurs, farmers and fishermen. 2) The impact of the existence of a sand mine on the socio-economic conditions of the community that is researchers conclude the impact after the existence of a sand mine is very influential on the level of community income. It can be seen from the income before the sand mine Rp. 375.000-583.000/month while the income after the sand mining is around Rp. 512,000 - 6,250,000 / month.

scholarly journals The Quality of Palliative Sedation in End-Stage Disease: Audit From a Department of Oncology and Haematology

2021 ◽  
Author(s):  
Saviola Alessia ◽  
Schipilliti Francesca Matilde ◽  
Isca Chrystel ◽  
Massimiliano Salati ◽  
Daniele Dini ◽  
...  
Keyword(s):  
Karnofsky Performance Status ◽  
Performance Status ◽  
Critical Role ◽  
Palliative Sedation ◽  
University Hospital ◽  
Refractory Symptoms ◽  
Stage Disease ◽  
End Stage ◽  
The Impact

Abstract PurposePalliative sedation (PS) plays a critical role to give suffering relief from refractory symptoms at the end of life. Our audit aimed to assess and improve quality of PS at the Department of Oncology and Hematology of University Hospital of Modena, to verify the adherence to international guidelines, the cooperation among members of care team, focusing with attention on family’s perception of this delicate situation. MethodsFrom December 2016 to June 2019, data of patients undergoing PS in the Department were collected by an electronic folder tool, “Sedation Tool” (ST), that recorded clinical and PS informations, D-PaP, Rudkin Score and family’s perception. Results245 patients were enrolled. 82% had a Karnofsky Performance Status 10-20%. The most common cancer types were lung and gastro-intestinal carcinomas (27% and 21% respectively). Refractory symptoms observed were confusion and agitation (76%), dyspnea (39%), pain (15%), delirium (10%), psychological distress (5%). Midazolam was the drug of choice for PS. Most of patients had Rudkin score 5 after 24 hours and 33% had terminal event within a period of 24 hours from the beginning of PS. During PS most of Patient’s relatives reported peacefulness (65%), agitation/impatience in 6% of cases, concern for suffering (16%). ConclusionPS is used in case of worsening general conditions at the end-stage disease to relieve refractory symptoms with dignity. The ST can become a simple instrument to evaluate and improve PS quality, providing more attention on the impact of PS on relatives to then possibly develop new supportive procedures for patients and their families.

Bevacizumab and irinotecan in patients (pts) with recurrent glioblastoma multiforme (GBM)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2078-2078 ◽  
Author(s):  
S. Raval ◽  
S. Hwang ◽  
L. Dorsett
Keyword(s):  
Cognitive Function ◽  
Functional Status ◽  
Response Rate ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Recurrent Glioblastoma ◽  
Recurrent Glioblastoma Multiforme ◽  
Pre Treatment ◽  
Grade 3 ◽  
The Impact

2078 Background: Primary GBM exhibits overexpression or amplification of the epidermal growth factor gene. The effectiveness of bevacizumab and irinotecan in pts with relapsed GBM was first reported in 2005 (Stark-Vance, et al, Neuro-Oncol, 2005). In this report, we assess the effects of combination of bevacizumab and irinotecan on overall responses, toxicity, cognitive function and functional status in recurrent GBM pts. Methods: From August 2005 to December 2006, 22 consecutive GBM pts failed > 1 prior chemotherapy with measurable disease on MRI were included. Each patient received bevacizumab 5mg/kg IV and irinotecan 125mg/m2 IV infusion every 2 weeks until disease progression or developed unacceptable toxicity. The response was determined by MRI every 2 cycles. Cognitive function was assessed by Blessed Orientation-Memory-Concentration Test (BOMC) and functional status was assessed by Karnofsky performance status (KPS), Barthel Index (BI) and Instrumental Activities of Daily Living (IADL) prior to each cycle of treatment. Descriptive statistics analysis was used. Results: All pts failed temozolomide and radiation therapy; 1 pt had prior BCNU and 2 pts had prior irinotecan treatment. The median (M) age was 55 years (37-77) with pre treatment M KPS 80 (40–80), BOMC 7 (0–28), BI 85 (10–100) and IADL 6 (0–17); 12 pts exhibited mild (3 pts), moderate (7 pts) to severe (2 pts) cognitive impairment. The M number of cycles received was 8 (2–27); 21 pts are evaluable for MRI responses with 95.2% response rate (2CR’s + 14PR’s + 4 minimal responses). Seven pts have expired; the M length of survival was 4.6 months (range 1.1–15.4+) and the M time to progression was 3 months (0.5–13.8+). There were only two grade 3 thrombocytopenia and one grade 3 neutropenia. Improvement in BOMC score was seen in 15 pts (62%) with M improvement of 7 point. Improvement in functional status was seen in 18 pts (85.7%) with M improvement in KPS by 10 point, BI by 8 points and IADL by 2 point. Conclusions: The combination of bevacizumab and irinotecan is well tolerated and safe. The overall response rate was 95.2% and significant improvements in cognitive functional and functional status were demonstrated. The longer follow up will determine the impact of this most active combination. No significant financial relationships to disclose.

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