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John L. Dart Library
Closed for Maintenance
Phone: (843) 722-7550
West Ashley Library
9 a.m. - 5 p.m.
Phone: (843) 766-6635
Folly Beach Library
9 a.m. - 2 p.m.
*open the 2nd and 4th Saturday
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Edgar Allan Poe/Sullivan's Island Library
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Phone: (843) 883-3914
Wando Mount Pleasant Library
9 a.m. - 5 p.m.
Phone: (843) 805-6888
Village Library
9 a.m. - 1 p.m.
Phone: (843) 884-9741
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9 a.m. - 5 p.m.
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Patient-reported outcomes in a phase II randomised study of regorafenib compared with lomustine in patients with relapsed glioblastoma (the REGOMA trial).
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- Author(s): Lombardi, Giuseppe1 (AUTHOR); Del Bianco, Paola1,2 (AUTHOR); Brandes, Alba A.3 (AUTHOR); Eoli, Marica4 (AUTHOR); Rudà, Roberta5 (AUTHOR); Ibrahim, Toni6 (AUTHOR); Lolli, Ivan7 (AUTHOR); Rizzato, Simona8 (AUTHOR); Daniele, Bruno9 (AUTHOR); Pace, Andrea10 (AUTHOR); Pasqualetti, Francesco11 (AUTHOR); Caccesse, Mario1 (AUTHOR); Bergo, Eleonora1 (AUTHOR); Magni, Giovanna2 (AUTHOR); De Salvo, Gian Luca1,2 (AUTHOR) ; Zagonel, Vittorina1 (AUTHOR)
- Source:
European Journal of Cancer. Sep2021, Vol. 155, p179-190. 12p.- Subject Terms:
*THERAPEUTIC use of antineoplastic agents; *PYRIDINE; *CANCER patient psychology; *RESEARCH; *DISEASE progression; *DIARRHEA; *PROTEIN kinase inhibitors; *HEALTH outcome assessment; *GLIOMAS; *CANCER relapse; *MEDICAL cooperation; *ANTINEOPLASTIC agents; *RANDOMIZED controlled trials; *COMPARATIVE studies; *QUALITY of life; *QUESTIONNAIRES; *DESCRIPTIVE statistics; *SURVIVAL analysis (Biometry); *STATISTICAL models; *ANOREXIA nervosa; *LONGITUDINAL method; *NEURORADIOLOGY; *EVALUATION - Source:
- Additional Information
- Abstract: The REGOMA trial showed that regorafenib significantly improved overall survival in patients with recurrent glioblastoma compared with lomustine. Patients treated with regorafenib experienced a higher occurrence of grade 3–4 drug-related adverse events than those receiving the standard treatment. Because this safety profile was expected, it was considered of great importance to assess the patient point of view regarding the disease and treatment impact on different aspects of life and patient well-being. We here report the final results of the health-related quality of life (HRQoL) assessment, a secondary end-point of the study. This trial is registered with ClinicalTrials.gov , NCT02926222. Patient-reported outcomes were assessed, within a prospective, randomised, multicentre, open-label phase II trial, by the European Organisation for Research and Treatment of Cancer core questionnaire and brain module at baseline and every 8-weekly neuroradiological assessment till disease progression. Mixed-effect linear models were fitted for each of the HRQoL domain to examine the change over progression-free time within and between arms. Furthermore, differences were also classified as clinically meaningful changes. To correct for multiple comparisons and avoid type I errors, the level of significance was set at P = 0.01 (2-sided). Of 119 enrolled patients, 56/59 (95%) patients and 58/60 (97%) patients treated with regorafenib and lomustime completed questionnaires at baseline, respectively. No significant differences were observed in any generic or cancer-specific domain during treatment in both arms, or between the two arms, except for the appetite loss and diarrhoea scales which were significantly worse in patients treated with regorafenib. The rate of patients with a clinically meaningful worsening for appetite loss, diarrhoea and for any other domain was not statistically different between the two arms. Regorafenib did not negatively affect HRQoL in patients with recurrent glioblastoma. These data combined with the survival benefit shown in the REGOMA trial support the use of regorafenib as a treatment option for these patients. • Regorafenib improved survival of patients with recurrent glioblastoma. • Adverse events associated with regorafenib did not deteriorate health-related quality of life. • No significant differences were observed in any domain between arms. • Regorafenib could represent a treatment option in this setting of disease. [ABSTRACT FROM AUTHOR]
- Abstract: Copyright of European Journal of Cancer is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Abstract:
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