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2914 Neuro-oncology information system: A comprehensive tool to improve quality of care
Abstracts treatment involving maximal safe resection, Carmustine implants and concurrent chemo-radiation. Methods and Materials: Retrospective analysis of patients recurring after triple modality therapy in our centre between 2009–2014 with a minimum of 12 months follow-up. We evaluated the local recurrence rate, time for recurrence, survival from day of surgery. Imaging from relapse was then fused with the radiotherapy treatment volumes analysing the relapse patterns within the 95% Iso-dose volume. Results: We identified 23 patients as having had maximal dubulking surgery and insertion of Carmustine implants followed by concurrent chemo-radiation to a dose of 60Gy in 30 daily fractions using 3D-conformal radiotherapy technique synchronously with oral Temozolamide (75mg/m2 ) followed by adjuvant Temozolamide chemotherapy. The mean age of patient was 57 years (range 42−69 months), male: female ratio being 1:1.3. Out of the 23 patients, 18 patients have died, 1 patient is alive with local relapse, 4 patients are alive without relapse. 15 patients (65%) had relapsed locally. The median time to local relapse was 8 months. The median overall survival was 12 months in those who died (n = 18) and 26 months in those who did not relapse and alive post treatment (n = 4). The pattern of local relapse was with in 2cm of the original radiotherapy planning target volume. Conclusion: Local recurrence rate was predominantly a pattern of failure in all these patients treated with triple modality treatment and first relapse was within the 95% Iso-dose volume of radiotherapy. No conflict of interest.
S589 Table 1. Patient characteristics Characteristic Gender Male Female Age Median (range) Comorbidity Yes No Clinical signs/symptoms at diagnosis Epilepsy Higher mental functions Motor Visual Language Sensitive Others Location Lobar Deep structures Corpus callosum Medullary Cerebellum Multicentric Previous low-grade glioma Yes No
Number
%
46 21 62 (30−82)
64 36
42 30
58 42
10 27 25 7 14 6 19
14 37.5 35 10 19 8 26
68 12 17 1 1 12
96 18 25.8 1.8 1.8 20.7
4 68
5 95
2914 POSTER Neuro-oncology information system: A comprehensive tool to improve quality of care 1 ´ 3, ˜ Gomez ´ , J. Ripoll2 , G. Barbosa2 , D. Hervas C. Salvador1 , O. Nino L. Bataller4 , Y. Bernisz5 , J. Ferrer6 , A. Lucas7 , R. Prat8 , G. Reynes ´ 1. 1 University Hospital La Fe, Medical Oncology, Valencia, Spain; 2 University Hospital La Fe, Computing Department, Valencia, Spain; 3 University Hospital La Fe, Biostatistics, Valencia, Spain; 4 University Hospital La Fe, Neurology, Valencia, Spain; 5 University Hospital La Fe, Radiotherapy, Valencia, Spain; 6 University Hospital La Fe, Pathology, Valencia, Spain; 7 University Hospital La Fe, Radiology, Valencia, Spain; 8 University Hospital La Fe, Neurosurgery, Valencia, Spain
Background: Multidisciplinary Clinical Boards and evidence-based protocols are an optimal approach for care of patients with brain tumors. Nevertheless, the degree of compliance with protocols and their actual impact on the quality of care and outcomes need to be evaluated. The aim of this project was to develop a software application to prospectively register clinical data of patients, including protocol-based quality indicators, as well as decisions taken by the Neuro-Oncology Clinical Board, in order to evaluate the quality of care and clinical outcomes. Material and Methods: The development of the database structure was carried out in four steps: 1) Update of multidisciplinary clinical protocols by members of the Neuro-Oncology Clinical Board. 2) Structuring of the database including relevant variables related to protocols; basic outcome variables, as dates of tumor progression and death were also included. 3) Selection of quality indicators based on updated protocols and literature. 4) Development of a software application in collaboration with the Informatics Unit of the Research Institute La Fe. For the selection of indicators, aspects related to effectiveness, efficiency and safety were taken into account. Data have been entered and maintained prospectively. We present the results of a series of patients with glioblastoma. Results: Table 1 shows the characteristics of 72 patients with glioblastoma diagnosed at our center between January 2013 and May 2014. 16 patients underwent biopsy only and 2 patients did not undergo any type of intervention. Resective surgery was performed in 47 patients (gross resection 25 (38.5%) and complete surgery 22 (33.8%). 6 patients had surgical complications and 2 (2.7%) of them died. Most patients had early postoperative imaging assessment (56 patients, 77.8% including patients with biopsy). The median time from surgery to Pathology results was 9 days (macroscopic report in 59 patients (82%); microscopic report in 55 patients (76%). The median time from surgery to start of radiotherapy was 39 days. 61 patients (84.7%) received also concomitant and adjuvant chemotherapy. These patients had a better performance status than patients not receiving chemotherapy. The most common toxicity grade 3−4 was hematological (thrombocytopenia in 11 patients (15.3%) and neutropenia in 3 patients (4.2%). There were no toxic deaths. Conclusions: This prospective database is a useful tool for assessing clinical outcomes and quality of care. No conflict of interest.
2915 POSTER Synergic effect of high-dose irradiation and temozolomide on local control of MGMT unmethylated glioblastomas T. Iuchi1 , R. Hara2 , K. Hatano3 , S. Yokoi4 , M. Itami5 , S. Hirono1 , Y. Hasegawa1 , T. Sakaida1 . 1 Chiba Cancer Center, Neurological Surgery, Chiba, Japan; 2 Chiba Cancer Center, Radiation Oncology, Chiba, Japan; 3 Tokyo Bay Advanced Imaging & Radiation Oncology Clinic, Makuhari, Radiation Oncology, Chiba, Japan; 4 Chiba Cancer Center, Cancer Genomics, Chiba, Japan; 5 Chiba Cancer Center, Surgical Pathology, Chiba, Japan Background: Temozolomide (TMZ) had improved the survival of patients with glioblastoma (GBM). However, how to treat patients with MGMT unmethylated GBM is a remaining problem, because TMZ shows only a limited efficacy on this subset of tumors. High dose irradiation (HdI) is one of the candidates to improve local control of these tumors, but synergic effect of HdI with TMZ has not been evaluated. In this study, we evaluated the differences in effects of TMZ on local control of MGMT unmethylated GBMs owing to the different irradiated doses to the target, to clarify the synergic effect of HdI and TMZ on the control of this chemo-resistant subset of GBMs. Materials and Methods: Methylation status of MGMT gene promoter was evaluated by methylation specific PCR. 127 GBMs with unmethylated MGMT gene promoter were enrolled in this study. All patients were classified owing to the treatment protocols; conventional radiation therapy (cRT; 60Gy/30F) alone (Group C, n = 22), cRT with concurrent TMZ (Group T, n = 29), HdI (hypofractionated high-dose IMRT; 68Gy/8F) alone (Group H, n = 17), and HdI with concurrent TMZ (Group HT, n = 59). Adjuvant TMZ was administrated for a total of 12 cycles or until tumor progression in Group T and HT. The differences in local progression-free survivals (PFSs) among these four groups were evaluated. Results: This retrospective study could not standardize the distribution of patients among the groups. Gross total removal (>95%) was less frequently achieved in Group C (4.8%) than Group T (46.4%), H(47.1%) and HT(65.0%). However, other clinical backgrounds (patient’ age and gender, KPS at diagnosis, and tumor volume) were not significantly different. The median PFSs of Groups C, T, H, and HT were 5.8m, 7.4m, 8.2m, and “not reached”, respectively. TMZ did not improve tumor control, when it administrated with cRT (Relative risk (RR): 1.5, P = 0.279). HdI alone also could not show effect on local control of tumors in compared with cRT (RR: 1.4, P = 0.355). However, TMZ showed excellent effect, when it administered with HdI (RR: 4.6, P = 0.0001). PFS of Group HT was also significantly longer than that of Group T (RR: 3.2, P = 0.0009) and H (RR: 3.1, P = 0.005). Among the clinical variables, “gross total removal” was also significantly correlated with prolonged PFS (RR: 2.2, P = 0.003). However, HdI concurrent with TMZ still kept independent significance on prolonged PFS with multivariate analysis (RR: 3.1, P = 0.0001).
S589 Table 1. Patient characteristics Characteristic Gender Male Female Age Median (range) Comorbidity Yes No Clinical signs/symptoms at diagnosis Epilepsy Higher mental functions Motor Visual Language Sensitive Others Location Lobar Deep structures Corpus callosum Medullary Cerebellum Multicentric Previous low-grade glioma Yes No
Number
%
46 21 62 (30−82)
64 36
42 30
58 42
10 27 25 7 14 6 19
14 37.5 35 10 19 8 26
68 12 17 1 1 12
96 18 25.8 1.8 1.8 20.7
4 68
5 95
2914 POSTER Neuro-oncology information system: A comprehensive tool to improve quality of care 1 ´ 3, ˜ Gomez ´ , J. Ripoll2 , G. Barbosa2 , D. Hervas C. Salvador1 , O. Nino L. Bataller4 , Y. Bernisz5 , J. Ferrer6 , A. Lucas7 , R. Prat8 , G. Reynes ´ 1. 1 University Hospital La Fe, Medical Oncology, Valencia, Spain; 2 University Hospital La Fe, Computing Department, Valencia, Spain; 3 University Hospital La Fe, Biostatistics, Valencia, Spain; 4 University Hospital La Fe, Neurology, Valencia, Spain; 5 University Hospital La Fe, Radiotherapy, Valencia, Spain; 6 University Hospital La Fe, Pathology, Valencia, Spain; 7 University Hospital La Fe, Radiology, Valencia, Spain; 8 University Hospital La Fe, Neurosurgery, Valencia, Spain
Background: Multidisciplinary Clinical Boards and evidence-based protocols are an optimal approach for care of patients with brain tumors. Nevertheless, the degree of compliance with protocols and their actual impact on the quality of care and outcomes need to be evaluated. The aim of this project was to develop a software application to prospectively register clinical data of patients, including protocol-based quality indicators, as well as decisions taken by the Neuro-Oncology Clinical Board, in order to evaluate the quality of care and clinical outcomes. Material and Methods: The development of the database structure was carried out in four steps: 1) Update of multidisciplinary clinical protocols by members of the Neuro-Oncology Clinical Board. 2) Structuring of the database including relevant variables related to protocols; basic outcome variables, as dates of tumor progression and death were also included. 3) Selection of quality indicators based on updated protocols and literature. 4) Development of a software application in collaboration with the Informatics Unit of the Research Institute La Fe. For the selection of indicators, aspects related to effectiveness, efficiency and safety were taken into account. Data have been entered and maintained prospectively. We present the results of a series of patients with glioblastoma. Results: Table 1 shows the characteristics of 72 patients with glioblastoma diagnosed at our center between January 2013 and May 2014. 16 patients underwent biopsy only and 2 patients did not undergo any type of intervention. Resective surgery was performed in 47 patients (gross resection 25 (38.5%) and complete surgery 22 (33.8%). 6 patients had surgical complications and 2 (2.7%) of them died. Most patients had early postoperative imaging assessment (56 patients, 77.8% including patients with biopsy). The median time from surgery to Pathology results was 9 days (macroscopic report in 59 patients (82%); microscopic report in 55 patients (76%). The median time from surgery to start of radiotherapy was 39 days. 61 patients (84.7%) received also concomitant and adjuvant chemotherapy. These patients had a better performance status than patients not receiving chemotherapy. The most common toxicity grade 3−4 was hematological (thrombocytopenia in 11 patients (15.3%) and neutropenia in 3 patients (4.2%). There were no toxic deaths. Conclusions: This prospective database is a useful tool for assessing clinical outcomes and quality of care. No conflict of interest.
2915 POSTER Synergic effect of high-dose irradiation and temozolomide on local control of MGMT unmethylated glioblastomas T. Iuchi1 , R. Hara2 , K. Hatano3 , S. Yokoi4 , M. Itami5 , S. Hirono1 , Y. Hasegawa1 , T. Sakaida1 . 1 Chiba Cancer Center, Neurological Surgery, Chiba, Japan; 2 Chiba Cancer Center, Radiation Oncology, Chiba, Japan; 3 Tokyo Bay Advanced Imaging & Radiation Oncology Clinic, Makuhari, Radiation Oncology, Chiba, Japan; 4 Chiba Cancer Center, Cancer Genomics, Chiba, Japan; 5 Chiba Cancer Center, Surgical Pathology, Chiba, Japan Background: Temozolomide (TMZ) had improved the survival of patients with glioblastoma (GBM). However, how to treat patients with MGMT unmethylated GBM is a remaining problem, because TMZ shows only a limited efficacy on this subset of tumors. High dose irradiation (HdI) is one of the candidates to improve local control of these tumors, but synergic effect of HdI with TMZ has not been evaluated. In this study, we evaluated the differences in effects of TMZ on local control of MGMT unmethylated GBMs owing to the different irradiated doses to the target, to clarify the synergic effect of HdI and TMZ on the control of this chemo-resistant subset of GBMs. Materials and Methods: Methylation status of MGMT gene promoter was evaluated by methylation specific PCR. 127 GBMs with unmethylated MGMT gene promoter were enrolled in this study. All patients were classified owing to the treatment protocols; conventional radiation therapy (cRT; 60Gy/30F) alone (Group C, n = 22), cRT with concurrent TMZ (Group T, n = 29), HdI (hypofractionated high-dose IMRT; 68Gy/8F) alone (Group H, n = 17), and HdI with concurrent TMZ (Group HT, n = 59). Adjuvant TMZ was administrated for a total of 12 cycles or until tumor progression in Group T and HT. The differences in local progression-free survivals (PFSs) among these four groups were evaluated. Results: This retrospective study could not standardize the distribution of patients among the groups. Gross total removal (>95%) was less frequently achieved in Group C (4.8%) than Group T (46.4%), H(47.1%) and HT(65.0%). However, other clinical backgrounds (patient’ age and gender, KPS at diagnosis, and tumor volume) were not significantly different. The median PFSs of Groups C, T, H, and HT were 5.8m, 7.4m, 8.2m, and “not reached”, respectively. TMZ did not improve tumor control, when it administrated with cRT (Relative risk (RR): 1.5, P = 0.279). HdI alone also could not show effect on local control of tumors in compared with cRT (RR: 1.4, P = 0.355). However, TMZ showed excellent effect, when it administered with HdI (RR: 4.6, P = 0.0001). PFS of Group HT was also significantly longer than that of Group T (RR: 3.2, P = 0.0009) and H (RR: 3.1, P = 0.005). Among the clinical variables, “gross total removal” was also significantly correlated with prolonged PFS (RR: 2.2, P = 0.003). However, HdI concurrent with TMZ still kept independent significance on prolonged PFS with multivariate analysis (RR: 3.1, P = 0.0001).