In-hospital mortality and complications following surgical resection of glioblastoma Chevalier P1, Van Gils C1, Lamotte M1 1QuintilesIMS, RWES, Zaventem, Belgium; Introduction Glioblastoma multiform (GBM) is a very aggressive form of brain tumour, accounting for about 15% of all brain tumours. Tumour resection, with or without administration of adjuvant chemotherapy, is the first-line treatment for patients diagnosed with glioblastoma. However, there is a paucity of real-life data regarding the complications/ mortality associated with this type of surgery in Belgium. This study aimed at describing the in-hospital mortality/ complications associated with the surgical resection of glioblastoma in Belgian patients, using retrospective data. Methods Study design: Retrospective database analysis Data source: IMS RWD Hospital Data - Belgium– covering about 25% of all hospital beds in Belgium (located in North and Brussels) Information available in database: • Demographic variables: age, gender • Diagnoses and procedures: ICD-9-CM codes, APRDRG and severity level • Characteristics of hospitalization: LOS (total and per service), admission via an emergency room (ER) and in-hospital mortality • Resource use: details on all procedures performed and all drugs invoiced during the hospitalization • Information on medications includes ATC category, molecule name, brand name, dosage, number of units dispensed, administration start-date and end-date. However, limited information is available on drugs dispensed from the hospital pharmacy but not during a hospitalization Time frame of study: full 2013-2014 period Table 1: ICD-9 codes used for patient selection Indication Brain tumors (ICD-9 diagnosis codes) excluding Code 191.0–191.9 Glioblastoma (ICD-0 codes) Brain biopsies (ICD-9 procedure codes) Pressure relief surgery (ICD-9 procedure codes) Resection of brain tissue (ICD9 procedure codes) Complications (ICD-9 diagnosis/ procedure codes) Label 191.6 191.7 M9440/3 M9441/3 Malignant neoplasm of cerebellum Malignant neoplasm of brain stem Glioblastoma, not specified Giant cell glioblastoma 01.13 Percutaneous biopsy of brain 01.14 Open biopsy of brain 01.24 Other craniotomy (including cranial decompression) 01.52 Hemispherectomy 01.53 Lobectomy of brain 01.59 Other excision or destruction of lesion of tissue of brain (including transtemporal excision of brain tumour) 997.02 Cerebrovascular haemorrhage – post operative stroke 998.12 331.3-331.4 02.2 (Proc) 451.1,451.2 & 453.4 Hematoma complicating a procedure Hydrocephalus Ventriculostomy Pulmonary embolism Figure 1: Invasive procedures Selection of eligible population: • Hospitalizations were selected based on the presence of an ICD-9-CM diagnosis code for primary brain tumour combined with a ICD-0 code for glioblastoma (see Table 1) Exclusion criteria:Patients with a concomitant diagnosis for another tumor (ICD-9 codes 140-209) Follow-up period: from first diagnosis of GBM until death/ end of study period Identification of chemotherapy treatments: • Chemotherapy sessions were identified based on a diagnosis code for chemotherapy or documented administration of a chemotherapeutical agent (ATC category L01) • When no agent was documented, the regimen was labeled as “Unknown” • Complex administration schedules were captured based on exact dates of administration Study endpoints: • % of invasive procedures • % of post-surgery complications • Kaplan Meier estimates: time to post-surgery chemotherapy Figure 2: Post-surgery complications Post-surgery mortality Any of the selected complications Pulmonary embolism Ventriculostomy Results A total of 709 GBM patients were retrieved in the data (average age: 62.9 years; 60.6% male). Invasive procedures were documented in 53.9% (n=382). • 23.1% of the patients (n=164) had a biopsy • 1.4% (n=10) underwent pressure relief surgery • Resection surgery (lobectomy/ mastoid excision) was documented in 36.1% (n=256). However, it was most likely under-documented due to the fact that not all hospital in the database have capacity to perform such surgery (so surgery was performed in another hospital). Among those patients, • 4.7% (n=12) died during hospitalization • 12.5% (n=32) experienced post-surgery complications (including haemorrhage: 8.2% [n=21]; hematoma: 2.0% [n=5]; hydrocephalus: 2.0% [n=5]; ventriculostomy: 1.2% [n=3]; pulmonary embolism: 0.8% [n=2]). The average length of stay (LOS) for resection surgery was 20.0 days, with a significantly higher LOS in patients with complications (42.1 days vs. 16.2 days without complication; p<0.001). For 26.6% (n=68) of the patients having undergone surgery, a chemotherapy was documented post-surgery, mostly with temozolomide [n=48]. In the majority of cases, chemotherapy was initiated within the first month following surgery (Figure 3). 12.5% (n=32) 0.8% (n=2) 1.2% (n=3) Hydrocephalus 2.0% (n=5) Hematoma 2.0% (n=5) Post-operative stroke 0.0% 8.2% (n=21) 2.0% 4.0% 6.0% Figure 3: Time to post-surgery chemotherapy Conclusions The surgical resection of glioblastoma may be associated with severe and potentially lethal complications, significantly impacting length of stay. FOR FURTHER INFORMATION: Please contact - Pierre Chevalier: [email protected] ISPOR 19th Annual European Congress, Vienna, Austria; 29 October – 02 November 2016 (PCN45) Copyright © 2016 QuintilesIMS. All rights reserved. 4.7% (n=12) 8.0% 10.0% 12.0% 14.0%
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