Kurzzeitstrahlentherapie mit 5 × 5 Gy gefolgt von präoperativer Chemotherapie und Resektion bei Patienten mit lokal fortgeschrittenen Rektumkarzinomen führt zu einer Verbesserung des krankheitsfreien Überlebens
| العنوان: | Kurzzeitstrahlentherapie mit 5 × 5 Gy gefolgt von präoperativer Chemotherapie und Resektion bei Patienten mit lokal fortgeschrittenen Rektumkarzinomen führt zu einer Verbesserung des krankheitsfreien Überlebens |
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| المؤلفون: | Simon Kirste, Emmanouil Fokas, Claus Rödel |
| المصدر: | Strahlentherapie Und Onkologie |
| بيانات النشر: | Springer Science and Business Media LLC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Male, medicine.medical_specialty, Disease free survival, Time Factors, medicine.medical_treatment, Adenocarcinoma, Antineoplastic Combined Chemotherapy Protocols, Rectal carcinoma, Carcinoma, medicine, Humans, Preoperative chemotherapy, Radiology, Nuclear Medicine and imaging, In patient, Treatment Failure, Progression-free survival, Oncology, Radiotherapy, Digestive System Surgical Procedures, Neoadjuvant therapy, Aged, Neoplasm Staging, Rectal Neoplasms, business.industry, Chemoradiotherapy, Adjuvant, Middle Aged, medicine.disease, Neoadjuvant Therapy, United States, Europe, Radiation therapy, Disease Progression, Female, Dose Fractionation, Radiation, Radiology, Neoplasm Recurrence, Local, business, Literatur Kommentiert |
| الوصف: | Systemic relapses remain a major problem in locally advanced rectal cancer. Using short-course radiotherapy followed by chemotherapy and delayed surgery, the Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation (RAPIDO) trial aimed to reduce distant metastases without compromising locoregional control.In this multicentre, open-label, randomised, controlled, phase 3 trial, participants were recruited from 54 centres in the Netherlands, Sweden, Spain, Slovenia, Denmark, Norway, and the USA. Patients were eligible if they were aged 18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, had a biopsy-proven, newly diagnosed, primary, locally advanced rectal adenocarcinoma, which was classified as high risk on pelvic MRI (with at least one of the following criteria: clinical tumour [cT] stage cT4a or cT4b, extramural vascular invasion, clinical nodal [cN] stage cN2, involved mesorectal fascia, or enlarged lateral lymph nodes), were mentally and physically fit for chemotherapy, and could be assessed for staging within 5 weeks before randomisation. Eligible participants were randomly assigned (1:1), using a management system with a randomly varying block design (each block size randomly chosen to contain two to four allocations), stratified by centre, ECOG performance status, cT stage, and cN stage, to either the experimental or standard of care group. All investigators remained masked for the primary endpoint until a prespecified number of events was reached. Patients allocated to the experimental treatment group received short-course radiotherapy (5 × 5 Gy over a maximum of 8 days) followed by six cycles of CAPOX chemotherapy (capecitabine 1000 mg/mBetween June 21, 2011, and June 2, 2016, 920 patients were enrolled and randomly assigned to a treatment, of whom 912 were eligible (462 in the experimental group; 450 in the standard of care group). Median follow-up was 4·6 years (IQR 3·5-5·5). At 3 years after randomisation, the cumulative probability of disease-related treatment failure was 23·7% (95% CI 19·8-27·6) in the experimental group versus 30·4% (26·1-34·6) in the standard of care group (hazard ratio 0·75, 95% CI 0·60-0·95; p=0·019). The most common grade 3 or higher adverse event during preoperative therapy in both groups was diarrhoea (81 [18%] of 460 patients in the experimental group and 41 [9%] of 441 in the standard of care group) and neurological toxicity during adjuvant chemotherapy in the standard of care group (16 [9%] of 187 patients). Serious adverse events occurred in 177 (38%) of 460 participants in the experimental group and, in the standard of care group, in 87 (34%) of 254 patients without adjuvant chemotherapy and in 64 (34%) of 187 with adjuvant chemotherapy. Treatment-related deaths occurred in four participants in the experimental group (one cardiac arrest, one pulmonary embolism, two infectious complications) and in four participants in the standard of care group (one pulmonary embolism, one neutropenic sepsis, one aspiration, one suicide due to severe depression).The observed decreased probability of disease-related treatment failure in the experimental group is probably indicative of the increased efficacy of preoperative chemotherapy as opposed to adjuvant chemotherapy in this setting. Therefore, the experimental treatment can be considered as a new standard of care in high-risk locally advanced rectal cancer.Dutch Cancer Foundation, Swedish Cancer Society, Spanish Ministry of Economy and Competitiveness, and Spanish Clinical Research Network. |
| تدمد: | 1439-099X 0179-7158 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a31d521c04fafb8b9b82766281b27d3fTest https://doi.org/10.1007/s00066-021-01763-8Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....a31d521c04fafb8b9b82766281b27d3f |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1439099X 01797158 |
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