Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial
| Autor: | Boer, S.M. de, Powell, M.E., Mileshkin, L., Katsaros, D., Bessette, P., Haie-Meder, C., Ottevanger, P.B., Ledermann, J.A., Khaw, P., Colombo, A., Fyles, A., Baron, M.H., Kitchener, H.C., Nijman, H.W., Kruitwagen, R.F., Nout, R.A., Verhoeven-Adema, K.W., Smit, V.T., Putter, H., Creutzberg, C.L., PORTEC Study Grp |
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| Přispěvatelé: | Obstetrie & Gynaecologie, RS: GROW - R2 - Basic and Translational Cancer Biology, MUMC+: MA Arts Assistenten Obstetrie Gynaecologie (9), MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Targeted Gynaecologic Oncology (TARGON), Translational Immunology Groningen (TRIGR) |
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Gastrointestinal Diseases INTERMEDIATE-RISK medicine.medical_treatment EUROPEAN-ORGANIZATION GYNECOLOGIC-ONCOLOGY-GROUP Carboplatin law.invention CARCINOMA PATIENTS 0302 clinical medicine Randomized controlled trial law Antineoplastic Combined Chemotherapy Protocols Medicine Common Terminology Criteria for Adverse Events Middle Aged CHEMOTHERAPY Prognosis 3. Good health Women's cancers Radboud Institute for Health Sciences [Radboudumc 17] Survival Rate STAGE-I Oncology Lymphatic Metastasis 030220 oncology & carcinogenesis Female PELVIC RADIATION-THERAPY medicine.medical_specialty Paclitaxel OVARIAN-CANCER 03 medical and health sciences Internal medicine Humans Neoplasm Invasiveness External beam radiotherapy Survival rate Aged Neoplasm Staging III TRIAL business.industry Endometrial cancer Chemoradiotherapy Adjuvant medicine.disease Hematologic Diseases Cystadenocarcinoma Serous Endometrial Neoplasms Surgery Clinical trial 030104 developmental biology EXTERNAL-BEAM RADIOTHERAPY Case-Control Studies Quality of Life Radiotherapy Adjuvant Lymphadenectomy Cisplatin Neoplasm Grading Nervous System Diseases business Chemoradiotherapy Adenocarcinoma Clear Cell Follow-Up Studies |
| Zdroj: | Lancet oncology, 17(8), 1114-1126. Elsevier Science The Lancet. Oncology Lancet Oncology, 17, 8, pp. 1114-26 Lancet Oncology, 17(8), 1114-1126. ELSEVIER SCIENCE INC The Lancet Oncology, 17(8), 1114-1126 Lancet Oncology, 17, 1114-26 |
| ISSN: | 1470-2045 |
| DOI: | 10.1016/s1470-2045(16)30120-6 |
| Popis: | Contains fulltext : 171831.pdf (Publisher’s version ) (Open Access) BACKGROUND: About 15% of patients with endometrial cancer have high-risk features and are at increased risk of distant metastases and endometrial cancer-related death. We designed the PORTEC-3 trial to investigate the benefit of adjuvant chemoradiotherapy compared with radiotherapy alone for women with high-risk endometrial cancer. METHODS: PORTEC-3 was a multicentre, open-label, randomised, international trial. Women with high-risk endometrial cancer were randomly allocated (1:1) to radiotherapy alone (48.6 Gy) in 1.8 Gy fractions five times a week or chemoradiotherapy (two cycles concurrent cisplatin 50 mg/m(2) and four adjuvant cycles of carboplatin area under the curve [AUC] 5 and paclitaxel 175 mg/m(2)) using a biased coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage of cancer, and histological type. The primary endpoints of the PORTEC-3 trial were overall survival and failure-free survival analysed in the intention-to-treat population. This analysis focuses on 2-year toxicity and health-related quality of life as secondary endpoints; analysis was done according to treatment received. Health-related quality of life was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) the cervix cancer module and chemotherapy and neuropathy subscales of the ovarian cancer module at baseline, after radiotherapy and at 6, 12, 24, 36, and 60 months after randomisation. Adverse events were graded with Common Terminology Criteria for Adverse Events version 3.0. The study was closed on Dec 20, 2013, after achieving complete accrual, and follow-up remains ongoing for the primary outcomes analysis. This trial is registered with ISRCTN.com, number ISRCTN14387080, and with ClinicalTrials.gov, number NCT00411138. FINDINGS: Between Sept 15, 2006, and Dec 20, 2013, 686 women were randomly allocated in the PORTEC-3 trial. Of these, 660 met eligibility criteria, and 570 (86%) were evaluable for health-related quality of life. Median follow-up was 42.3 months (IQR 25.8-55.1). At completion of radiotherapy and at 6 months, EORTC QLQ-C30 functioning scales were significantly lower (worse functioning) and health-related quality of life symptom scores higher (worse symptoms) for the chemoradiotherapy group compared with radiotherapy alone, improving with time. At 12 and 24 months, global health or quality of life was similar between groups, whereas physical functioning scores remained slightly lower in patients who received chemoradiotherapy compared with patients who received radiotherapy alone. At 24 months, 48 (25%) of 194 patients in the chemoradiotherapy group reported severe tingling or numbness compared with 11 (6%) of 170 patients in the radiotherapy alone group (p |
| Databáze: | OpenAIRE |
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