Impact of Early Prophylactic Cranial Irradiation With Hippocampal Avoidance on Neurocognitive Function in Patients With Limited Disease Small Cell Lung Cancer. A Multicenter Phase 2 Trial (SAKK 15/12)
| Autor: | Michael Mark, Francesca Caparrotti, Christine Biaggi Rudolf, Daniel R. Zwahlen, F. Martucci, Eric I. Eboulet, A. Xyrafas, Paul Martin Putora, Tobias Finazzi, Urs R. Meier, Daniel M. Aebersold, Abdelkarim S. Allal, Olgun Elicin, Andrea Corinne Fuhrer, Karin Ribi, H. Vees |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Organs at Risk Cancer Research medicine.medical_specialty Lung Neoplasms Time Factors Anemia Population Phases of clinical research Hippocampus 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Internal medicine Clinical endpoint Medicine Humans Radiology Nuclear Medicine and imaging education Adverse effect Aged education.field_of_study Radiation business.industry Middle Aged medicine.disease Mental Status and Dementia Tests Small Cell Lung Carcinoma Oncology 030220 oncology & carcinogenesis Concomitant Quality of Life Female Prophylactic cranial irradiation Cranial Irradiation business Febrile neutropenia Stress Psychological |
| Zdroj: | International journal of radiation oncology, biology, physics. 107(2) |
| ISSN: | 1879-355X |
| Popis: | Purpose Our purpose was to evaluate neurocognitive function (NCF) and clinical outcomes after early hippocampal avoidance (HA) prophylactic cranial irradiation (PCI) in limited disease (LD) small cell lung cancer (SCLC). Methods and Materials In a phase 2 trial, patients with LD SCLC received HA-PCI concomitant with the second cycle of chemotherapy and thoracic radiation therapy. All patients underwent objective NCF testing at baseline, 6 weeks, and 6 and 12 months after HA-PCI. NCF tests included Hopkins Verbal Learning Test Revised, Controlled Oral Word Association, and Trail Making Tests A and B. The primary endpoint was NCF decline at 6 months after HA-PCI. We assumed ≤30% of patients with no NCF decline to be unpromising. Secondary endpoints included brain metastases-free survival (BMFS), overall survival (OS), and safety of the concomitant treatment. Results Among the 44 patients enrolled in the trial, 38 had evaluable NCF assessment at 6 months after HA-PCI. The proportion of evaluable patients showing no NCF decline at 6 and 12 months was 34.2% (90% confidence interval [CI], 21.6-48.8) and 48.5% (95% CI, 30.8-66.5), respectively. Median follow-up was 13.2 months (95% CI, 12.6-14.1). At 12 months, BMFS was 84.2% and OS was 87.7% (95% CI, 73.0-94.7). Four patients died of SCLC, 1 of respiratory failure, 1 of hemorrhage, and 1 for unknown reason. The most frequently reported grade ≥3 acute adverse events were anemia (21.4%), febrile neutropenia (19.1%), and fatigue (14.3%). Conclusions The proportion of patients showing no NCF decline 6 and 12 months after early HA-PCI does not appear to be better than, but rather similar to, that observed in patients receiving sequential PCI without HA. Early HA-PCI in LD SCLC is feasible, with observation of promising BMFS and OS in this selected population. |
| Databáze: | OpenAIRE |
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