Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/25154
Title: Results of Phase II Trial of Intensified Neoadjuvant Treatment with Interdigitating Radiotherapy and Chemotherapy with Oxaliplatin, 5-Fluorouracil and Folinic Acid in Patients with Locally Advanced Rectal Cancer (PROARCT trial).
Austin Authors: Ng, Sweet Ping ;Chu, Julie;Chander, Sarat;Bressel, Mathias;McKendrick, Joseph;Wong, Rachel;Steel, Malcolm;Murray, William K;Leong, Trevor;Heriot, Alexander;Michael, Michael;Ngan, Samuel Y
Affiliation: Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia
Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia
Department of Medical Oncology, Eastern Health, Box Hill Hospital, Victoria Australia
Monash University, Eastern Health Clinical School, Box Hill, Victoria Australia
Department of Surgical Oncology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia
The Sir Peter MacCallum Department of Oncology, University of Melbourne..
Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne Victoria Australia
Radiation Oncology
Department of Pathology, Peter MacCallum Cancer Centre, Melbourne Victoria Australia
Department of Colorectal Surgery, Box Hill Hospital, Melbourne Victoria Australia
Department of Medical Oncology, Eastern Health, Box Hill Hospital, Victoria Australia
Olivia Newton-John Cancer Wellness and Research Centre
Issue Date: Feb-2021
metadata.dc.date: 2020-10-13
Publication information: Radiotherapy and Oncology 2021; 155: 27-32
Abstract: The chemotherapy exposure during chemoradiotherapy for rectal cancer is adequate for radiosensitization but suboptimal for treatment of distant micrometastasis. This study aimed to determine tolerability, dose intensity, response, and toxicity of a novel intensified neoadjuvant treatment approach. Eligible patients were MRI-staged T3-4NxM0 rectal adenocarcinoma. Treatment consisted of FOLFOX chemotherapy given in weeks 1, 6, and 11 with pelvic radiotherapy (25.2Gy in 3 weeks in 1.8Gy/ fraction with oxaliplatin and 5-FU continuous infusion) given in weeks 3-5, and weeks 8-10. Surgery was performed 4 to 6 weeks later. The primary endpoint was tolerability defined as the percentage of patients who were able to complete the planned treatment course. Survival rates were estimated using the Kaplan-Meier method. Median age of the 40 patients was 61.5 years. Rectal MRI-stage was T3 in 88%. Overall, 95% completed the regimen. All patients received 50.4Gy. Relative dose intensity (≥75%) was 92% and 98% for oxaliplatin and 5-FU, respectively. High grade toxicities included neutropenia (25% grade 3; 7.5% grade 4) and diarrhea (10%). Pathologic CR rate was 20%. Median follow-up was 54 months. The 5-year overall survival, freedom from relapse, locoregional control, and freedom from distant metastasis of the cohort was 82%, 72%, 97% and 72%. Delivery of intensified neoadjuvant treatment with interdigitating chemotherapy and radiotherapy is feasible with no increase in acute perioperative complications. A larger prospective study is required to further evaluate the potential survival benefit of this design.
URI: https://ahro.austin.org.au/austinjspui/handle/1/25154
DOI: 10.1016/j.radonc.2020.10.012
PubMed URL: 33065186
Type: Journal Article
Subjects: neoadjuvant
preoperative
radiotherapy
rectal
Appears in Collections:Journal articles

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