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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)
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)
- Source :
- Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 155
- Publication Year :
- 2020
-
Abstract
- Background and purpose 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. Materials and Methods Eligible patients were MRI-staged T3-4NxM0 rectal adenocarcinoma. Treatment consisted of FOLFOX chemotherapy given in weeks 1, 6, and 11 with pelvic radiotherapy (25.2 Gy in 3 weeks in 1.8 Gy/fraction with oxaliplatin and 5-FU continuous infusion) given in weeks 3–5, and weeks 8–10. Surgery was performed 4–6 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. Results 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 50.4 Gy. 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 diarrhoea (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%. Conclusions 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.
- Subjects :
- medicine.medical_specialty
Colorectal cancer
medicine.medical_treatment
Leucovorin
Gastroenterology
030218 nuclear medicine & medical imaging
03 medical and health sciences
Folinic acid
0302 clinical medicine
FOLFOX
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Radiology, Nuclear Medicine and imaging
Prospective Studies
Neoadjuvant therapy
Neoplasm Staging
business.industry
Rectal Neoplasms
Hematology
Middle Aged
medicine.disease
Neoadjuvant Therapy
Oxaliplatin
Regimen
Treatment Outcome
Oncology
Tolerability
030220 oncology & carcinogenesis
Fluorouracil
Neoplasm Recurrence, Local
business
Chemoradiotherapy
medicine.drug
Subjects
Details
- ISSN :
- 18790887
- Volume :
- 155
- Database :
- OpenAIRE
- Journal :
- Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
- Accession number :
- edsair.doi.dedup.....199f4b2fdff396c8164e33da6e5450e7