Feasibility of the EORTC/NCIC Trial Protocol in a Neurosurgical Outpatient Unit: The Case for Neurosurgical Neuro-Oncology.
OBJECTIVE
With the publication of the European Organization for Research and Treatment of Cancer/National Cancer Information Center (EORTC/NCIC) trial, concomitant radiochemotherapy followed by intermittent chemotherapy became the new treatment standard for patients with primary glioblastoma. Eight years after widespread introduction of this protocol, it is of interest to investigate whether this new standard has been established in daily neuro-oncologic practice. We were particularly interested in its practicality within a neurosurgical neuro-oncologic setting.


METHODS
We analyzed primary glioblastoma patients diagnosed between 2005 and 2013 treated at our center according to the EORTC/NCIC trial. Parameters associated with treatment performance (interruption of radiotherapy, concomitant chemotherapy and intermittent chemotherapy, total number of cycles, and side effects) were retrospectively analyzed and compared with the available data from the EORTC/NCIC trial.


RESULTS
In this single-center retrospective study, we identified 189 patients (116 men, 73 women; median age: 62 years) who were treated according to the EORTC/NCIC trial protocol. A total of 176 patients received cytoreductive surgery; 13 patients had stereotactic biopsy only (EORTC/NCIC trial: 239 patients and 48 patients, respectively). Radiotherapy had to be interrupted in 9 patients (5%) (EORTC/NCIC trial: 15 patients [5%]) and concomitant chemotherapy in 26 patients (14%) (EORTC/NCIC trial: 37 patients [13%]). In 156 patients (83%), adjuvant TMZ chemotherapy was initiated (6 median temozolomide [TMZ] cycles; range: 1-30). In the EORTC/NCIC trial, 223 patients (47%) received the intermittent chemotherapy protocol (median: 3 cycles; range: 1-7). Overall, 97 patients (62%) completed 6 TMZ cycles (EORTC/NCIC-trial: 105 patients [47%]); dose escalation to 200 mg/qm at the second cycle was performed in 91 patients (58%) (versus 149 patients [67%]). Intermittent TMZ therapy was discontinued in 59 patients (38%) (versus 118 patients [53%]). Median overall survival in our patient cohort was 19 months (versus 14.6 months); median time to progression was 9 months (versus 6.9 months).


CONCLUSIONS
Comparison between the feasibility of the treatment protocol established by the EORTC/NCIC trial (performed within the setting of a prospective randomized trial) and the daily routine in a dedicated neurosurgical neuro-oncologic department demonstrates that the protocol is suitable for daily practice within a neurosurgical unit.
Department of Neurosurgery, Heinrich Heine Medical Centre, Düsseldorf, Germany.
Marion
M
Rapp
Department of Neurosurgery, Heinrich Heine Medical Centre, Düsseldorf, Germany.
Hosai
H
Sadat
Department of Neurosurgery, Heinrich Heine Medical Centre, Düsseldorf, Germany.
Philipp Joerg
PJ
Slotty
Neurochirurgische Klinik, Universitätsklinik Düsseldorf, Düsseldorf, Germany.
Hans Jakob
HJ
Steiger
Department of Radiation Oncology, Heinrich Heine Medical Centre, Düsseldorf, Germany.
Wilfried
W
Budach
Department of Neurosurgery, Heinrich Heine Medical Centre, Düsseldorf, Germany.
Michael
M
Sabel
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000601:surgery / Q000628:therapy; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D002985:Clinical Protocols; D015331:Cohort Studies; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D005240:Feasibility Studies; D005260:Female; D005909:Glioblastoma / Q000601:surgery / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009423:Nervous System Neoplasms / Q000601:surgery* / Q000628:therapy*; D009493:Neurosurgery / Q000458:organization & administration*; D011446:Prospective Studies; D012189:Retrospective Studies; D016019:Survival Analysis; D000077204:Temozolomide; D055815:Young Adult
D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide