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SP-0207 INCIDENTS IN MEDICAL ONCOLOGY: MANAGEMENT AND CLINICAL IMPACT
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Results:To reach these security requirements, the French thoracic surgery society, following publication in newspapers of hospitals prize lists, took a very original initiative: the creation of the 'Epithor system'. This is a dynamic database, allowing any participant to benefit from the national practice. Conclusions: To understand the interest of such project, we will explain all stages of its implementation, how to obtain a quality collection, to examine the impact on safety and quality of care and improve the training of young surgeons. SP-0207 INCIDENTS IN MEDICAL ONCOLOGY: MANAGEMENT AND CLINICAL IMPACT P. Aftimos1, A. Awada1 1 Institut J. Bordet, Medical Oncology Clinic, Brussels, Belgium While patient seek optimal care and cure at hospital centers, safety issues can arise and complicate medical procedures and treatments. Cytotoxics remain the mainstay of treatment in medical oncology, with a very thin line between patient benefit and side effects. They are most frequently administered in inpatient services as well as in day-hospital by specialized and well-trained staff. Precautions are usually taken and specific procedures have been written to standardize administration in order to avoid mishaps. Incidents that occur are mainly extravasations of “corrosive” agents, errors in dosage calculation and hypersensitivity reactions. This last adverse event is mainly encountered with the advent of targeted agents, especially chimeric monoclonal antibodies. Progress in biotechnology has resulted in humanized and fully human monoclonal antibodies, however hypersensitivity reactions remain a significant cause of morbidity, rarely mortality, and very often treatment delays or interruptions. Shift in paradigm towards molecularly targeted drugs has also been accompanied by a new kind of side effects that weren’t expected at the beginning. These toxicities differ from chemotherapy side effects because they are mostly class dependant and dose independent. Frequent examples are skin toxicity of anti-EGFR agents, left ventricular dysfunction of anti-HER-2 agents, wound healing and hemorrhage with anti-VEGF therapy. Biotechnology has also designed devices that allow administration of chemotherapy at home, along with its share of potential complications such as infections and incidents with infusion pumps. Oral formulations of chemotherapy agents and targeted agents carry the risk of dosing errors by patients, drug interactions, food interactions and non-compliance. Many procedures are being developed to avoid intra-hospital errors in drug administration. Those include computerized checklists that need to be validated and updated regularly. Electronic prescription systems are being adopted in order to render uniform the preparation and administration of anti-tumoral agents. With the end of patents approaching for many cytotoxic drugs as well as some targeted agents, more effort should be put in controlling the quality of generics and biosimilars.
POSTER DISCUSSION: 5: MISCELLANEOUS PD-0208 REIRRADIATION WITH/WITHOUT TEMOZOLOMIDE RESULTS IN A MEDIAN SURVIVAL OF 11 MONTHS IN PATIENTS WITH RECURRENT GLIOMA I. Compter1, R.M.A. Houben1, J.J. Jager1, S. de Kunder1, G. Bosmans1, M.H.M.E. Anten2, B.G. Baumert1 1 MAASTRO clinic, Radiotherapy, Maastricht, The Netherlands 2 Maastricht University Medical Centre +, Neurology, Maastricht, The Netherlands Purpose/Objective: The objective of this study is to determine the overall survival and progression free survival after re-irradiation for recurrent glioma with a specific view to clinical outcome and toxicity. Materials and Methods: Sixty-six patients received re-irradiation (reRT) for a recurrent glioma between January 2003 and September 2011. 74.2% of patients presented with a glioblastoma (GBM) at recurrence (primary n = 35, secondary n = 14). Patients were treated with either conformal radiotherapy (CRT) (n = 17), fractionated stereotactic radiotherapy (SRT) (n = 15), intensity modulated radiotherapy (IMRT) (n = 33) or stereotactic radiosurgery (SRS) (n = 1). Re-RT was preceded by a resection in 25 patients. 33.3% (n = 22) of patients received concurrent temozolomide at re-RT, of which 15 patients had a primary GBM. The median total dose was 54 Gy (range 8 - 60). Since 2009 a uniform protocol with 30x1.8Gy to a total dose of
ESTRO 31
54 Gy and concurrent and adjuvant temozolomide (if possible) is used for non - stereotactic RT. Response to treatment was assessed clinically and radiologically with MRI. Data were analyzed using the Kaplan-Meier Method Results: At a median follow-up of 8.5 months, 67% of patients had died due to tumor progression. The median overall survival (OS) was 11.2 months with a median 6-month-OS of 71.5%. The median OS for all patients with a primary GBM was 6.9 months with a 6-month OS of 55.8%. The median progression-free survival (PFS) for patients with a primary GBM was 3.6 months, compared to 7.1 months for patients with a secondary GBM. Clinical response (stable and/or improvement) to re-RT was 66.6%, compared to 91.8 % after initial RT. Corticosteroids of 8.3% of patients could be tapered back to zero after re-RT. Acute toxicity within 3 months was mild to moderate (8 patients). One patient developed radiation necrosis 4 months after SRS (CTC grade 2). Of 7 significant prognostic factors in univariate analysis only 2 prognostic factors remained significant in multivariate analysis: patients with an extended interval between initial RT and reRT had a significantly longer OS and PFS (p = 0.02 and p = 0.03 respectively) and patients with corticosteroid dependency 3 months post-RT had a significantly worse OS and PFS (p = 0.001 and p = 0.003). For primary GBM alone an extended interval between initial RT and re-RT was a significant factor for both a longer OS and PFS (p = 0.005 and 0.001 respectively). Conclusions: The interval between initial irradiation and reirradiation is the main prognostic factor for survival after treatment. However, the prognosis of these patients remains infaust and quality of life after re-irradiation should in addition prospectively be investigated. PD-0209 PEDIATRIC INTRAMEDULLARY SPINAL CORD ASTROCYTOMA MANAGEMENT: A TERTIARY CARE CENTER'S EXPERIENCE 1 2 3 3 Z.D. Guss , S. Moningi , S. Batra , G.I. Jallo , K.J. Cohen4, M. Wharam2, S.A. Terezakis2 1 Johns Hopkins University and University of Oxford, Department of Radiation Oncology and Molecular Radiation Sciences and Gray Institute for Radiation Oncology and Biology, Oxford, United Kingdom 2 Johns Hopkins University, Department of Radiation Oncology and Molecular Radiation Sciences, Baltimore, USA 3 Johns Hopkins University, Department of Neurosurgery, Baltimore, USA 4 Johns Hopkins University, Department of Pediatric Oncology, Baltimore, USA Purpose/Objective: Pediatric intramedullary spinal cord tumors (IMSCT) are exceedingly rare, and most of these lesions are astrocytomas. The purpose of this study is to report the outcomes of pediatric patients with spinal cord astrocytomas treated at a tertiary care center. Materials and Methods: An IRB-approved retrospective singleinstitution study was performed for pediatric patients with spinal cord astrocytomas treated at a tertiary care center from 1990-2010. Inclusion criteria included age <25 years of age at diagnosis, intramedullary spinal cord tumor, and a tissue diagnosis of astrocytoma. Patients were evaluated on the extent of resection, progression free survival (PFS), and development of radiation-related toxicities. For the extent of resection, gross total resection (GTR) was defined as greater than 90% resection or no visible tumor remaining, subtotal resection (STR) was defined as 50-90% resection, and partial resection (PR) was defined as <50% resection. Kaplan-Meier curves and multivariate regression model methods were used for analysis. Results: 29 patients were included in the study, 24 (83%) with grade I or II (low-grade) tumors and 5 (17%) with grade III or IV (high-grade) tumors. Median follow-up was 55 months (range 1-215 months) for patients with low-grade tumors and 17 months (range 10-52 months) for high-grade tumors. Median time to death for high-grade tumors was 16.5 months (range 10-52 months). 13 (45%) patients in the cohort received chemotherapy. All patients underwent at least one surgical resection. For patients with low grade tumors, GTR was achieved in 11 (46%) cases, and STR or PR was achieved in 13 patients (54%). For patients with high grade lesions, GTR was achieved in 4 (80%) cases and STR was achieved in 1 (20%) patient. 12 (41%) patients received radiation therapy to a median radiation dose of 48.6 Gy (range 28.654.0 Gy). 37.5% of patients received 3D conformal treatment, 25% received craniospinal irradiation, 25% received conventional treatment, and 12.5% received intensity-modulated radiation therapy (IMRT). 15 (71%) patients with low grade tumors and 1 (20%) patient
Results:To reach these security requirements, the French thoracic surgery society, following publication in newspapers of hospitals prize lists, took a very original initiative: the creation of the 'Epithor system'. This is a dynamic database, allowing any participant to benefit from the national practice. Conclusions: To understand the interest of such project, we will explain all stages of its implementation, how to obtain a quality collection, to examine the impact on safety and quality of care and improve the training of young surgeons. SP-0207 INCIDENTS IN MEDICAL ONCOLOGY: MANAGEMENT AND CLINICAL IMPACT P. Aftimos1, A. Awada1 1 Institut J. Bordet, Medical Oncology Clinic, Brussels, Belgium While patient seek optimal care and cure at hospital centers, safety issues can arise and complicate medical procedures and treatments. Cytotoxics remain the mainstay of treatment in medical oncology, with a very thin line between patient benefit and side effects. They are most frequently administered in inpatient services as well as in day-hospital by specialized and well-trained staff. Precautions are usually taken and specific procedures have been written to standardize administration in order to avoid mishaps. Incidents that occur are mainly extravasations of “corrosive” agents, errors in dosage calculation and hypersensitivity reactions. This last adverse event is mainly encountered with the advent of targeted agents, especially chimeric monoclonal antibodies. Progress in biotechnology has resulted in humanized and fully human monoclonal antibodies, however hypersensitivity reactions remain a significant cause of morbidity, rarely mortality, and very often treatment delays or interruptions. Shift in paradigm towards molecularly targeted drugs has also been accompanied by a new kind of side effects that weren’t expected at the beginning. These toxicities differ from chemotherapy side effects because they are mostly class dependant and dose independent. Frequent examples are skin toxicity of anti-EGFR agents, left ventricular dysfunction of anti-HER-2 agents, wound healing and hemorrhage with anti-VEGF therapy. Biotechnology has also designed devices that allow administration of chemotherapy at home, along with its share of potential complications such as infections and incidents with infusion pumps. Oral formulations of chemotherapy agents and targeted agents carry the risk of dosing errors by patients, drug interactions, food interactions and non-compliance. Many procedures are being developed to avoid intra-hospital errors in drug administration. Those include computerized checklists that need to be validated and updated regularly. Electronic prescription systems are being adopted in order to render uniform the preparation and administration of anti-tumoral agents. With the end of patents approaching for many cytotoxic drugs as well as some targeted agents, more effort should be put in controlling the quality of generics and biosimilars.
POSTER DISCUSSION: 5: MISCELLANEOUS PD-0208 REIRRADIATION WITH/WITHOUT TEMOZOLOMIDE RESULTS IN A MEDIAN SURVIVAL OF 11 MONTHS IN PATIENTS WITH RECURRENT GLIOMA I. Compter1, R.M.A. Houben1, J.J. Jager1, S. de Kunder1, G. Bosmans1, M.H.M.E. Anten2, B.G. Baumert1 1 MAASTRO clinic, Radiotherapy, Maastricht, The Netherlands 2 Maastricht University Medical Centre +, Neurology, Maastricht, The Netherlands Purpose/Objective: The objective of this study is to determine the overall survival and progression free survival after re-irradiation for recurrent glioma with a specific view to clinical outcome and toxicity. Materials and Methods: Sixty-six patients received re-irradiation (reRT) for a recurrent glioma between January 2003 and September 2011. 74.2% of patients presented with a glioblastoma (GBM) at recurrence (primary n = 35, secondary n = 14). Patients were treated with either conformal radiotherapy (CRT) (n = 17), fractionated stereotactic radiotherapy (SRT) (n = 15), intensity modulated radiotherapy (IMRT) (n = 33) or stereotactic radiosurgery (SRS) (n = 1). Re-RT was preceded by a resection in 25 patients. 33.3% (n = 22) of patients received concurrent temozolomide at re-RT, of which 15 patients had a primary GBM. The median total dose was 54 Gy (range 8 - 60). Since 2009 a uniform protocol with 30x1.8Gy to a total dose of
ESTRO 31
54 Gy and concurrent and adjuvant temozolomide (if possible) is used for non - stereotactic RT. Response to treatment was assessed clinically and radiologically with MRI. Data were analyzed using the Kaplan-Meier Method Results: At a median follow-up of 8.5 months, 67% of patients had died due to tumor progression. The median overall survival (OS) was 11.2 months with a median 6-month-OS of 71.5%. The median OS for all patients with a primary GBM was 6.9 months with a 6-month OS of 55.8%. The median progression-free survival (PFS) for patients with a primary GBM was 3.6 months, compared to 7.1 months for patients with a secondary GBM. Clinical response (stable and/or improvement) to re-RT was 66.6%, compared to 91.8 % after initial RT. Corticosteroids of 8.3% of patients could be tapered back to zero after re-RT. Acute toxicity within 3 months was mild to moderate (8 patients). One patient developed radiation necrosis 4 months after SRS (CTC grade 2). Of 7 significant prognostic factors in univariate analysis only 2 prognostic factors remained significant in multivariate analysis: patients with an extended interval between initial RT and reRT had a significantly longer OS and PFS (p = 0.02 and p = 0.03 respectively) and patients with corticosteroid dependency 3 months post-RT had a significantly worse OS and PFS (p = 0.001 and p = 0.003). For primary GBM alone an extended interval between initial RT and re-RT was a significant factor for both a longer OS and PFS (p = 0.005 and 0.001 respectively). Conclusions: The interval between initial irradiation and reirradiation is the main prognostic factor for survival after treatment. However, the prognosis of these patients remains infaust and quality of life after re-irradiation should in addition prospectively be investigated. PD-0209 PEDIATRIC INTRAMEDULLARY SPINAL CORD ASTROCYTOMA MANAGEMENT: A TERTIARY CARE CENTER'S EXPERIENCE 1 2 3 3 Z.D. Guss , S. Moningi , S. Batra , G.I. Jallo , K.J. Cohen4, M. Wharam2, S.A. Terezakis2 1 Johns Hopkins University and University of Oxford, Department of Radiation Oncology and Molecular Radiation Sciences and Gray Institute for Radiation Oncology and Biology, Oxford, United Kingdom 2 Johns Hopkins University, Department of Radiation Oncology and Molecular Radiation Sciences, Baltimore, USA 3 Johns Hopkins University, Department of Neurosurgery, Baltimore, USA 4 Johns Hopkins University, Department of Pediatric Oncology, Baltimore, USA Purpose/Objective: Pediatric intramedullary spinal cord tumors (IMSCT) are exceedingly rare, and most of these lesions are astrocytomas. The purpose of this study is to report the outcomes of pediatric patients with spinal cord astrocytomas treated at a tertiary care center. Materials and Methods: An IRB-approved retrospective singleinstitution study was performed for pediatric patients with spinal cord astrocytomas treated at a tertiary care center from 1990-2010. Inclusion criteria included age <25 years of age at diagnosis, intramedullary spinal cord tumor, and a tissue diagnosis of astrocytoma. Patients were evaluated on the extent of resection, progression free survival (PFS), and development of radiation-related toxicities. For the extent of resection, gross total resection (GTR) was defined as greater than 90% resection or no visible tumor remaining, subtotal resection (STR) was defined as 50-90% resection, and partial resection (PR) was defined as <50% resection. Kaplan-Meier curves and multivariate regression model methods were used for analysis. Results: 29 patients were included in the study, 24 (83%) with grade I or II (low-grade) tumors and 5 (17%) with grade III or IV (high-grade) tumors. Median follow-up was 55 months (range 1-215 months) for patients with low-grade tumors and 17 months (range 10-52 months) for high-grade tumors. Median time to death for high-grade tumors was 16.5 months (range 10-52 months). 13 (45%) patients in the cohort received chemotherapy. All patients underwent at least one surgical resection. For patients with low grade tumors, GTR was achieved in 11 (46%) cases, and STR or PR was achieved in 13 patients (54%). For patients with high grade lesions, GTR was achieved in 4 (80%) cases and STR was achieved in 1 (20%) patient. 12 (41%) patients received radiation therapy to a median radiation dose of 48.6 Gy (range 28.654.0 Gy). 37.5% of patients received 3D conformal treatment, 25% received craniospinal irradiation, 25% received conventional treatment, and 12.5% received intensity-modulated radiation therapy (IMRT). 15 (71%) patients with low grade tumors and 1 (20%) patient