Veronica Dell'Acqua1, Alessia Surgo2, Simona Arculeo1,3, Maria Alessia Zerella4,5, Vincenzo Bagnardi6, Samuele Frassoni6, Maria Giulia Zampino7, Paola Simona Ravenda7, Maria Saveria Rotundo7, Fatjona Kraja8, Jarek Kobiela9, Piotr Spychalski9, Cristiana Fodor1, Marianna Alessandra Gerardi1, Federica Cattani10, Alessia Bazani10, Wanda Petz11, Robert Glynne-Jones12, Roberto Orecchia13, Maria Cristina Leonardi1, Barbara Alicja Jereczek-Fossa1,3. 1. Division of Radiotherapy, IEO European Institute of Oncology, IRCCS, Via Ripamonti 435, 20141, Milan, Italy. 2. Radiation Oncology Department, General Regional Hospital "F. Miulli", Acquaviva delle Fonti, Italy. 3. Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy. 4. Division of Radiotherapy, IEO European Institute of Oncology, IRCCS, Via Ripamonti 435, 20141, Milan, Italy. mariaalessia.zerella@ieo.it. 5. Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy. mariaalessia.zerella@ieo.it. 6. Department of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy. 7. Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IRCCS, Milan, Italy. 8. Division of Oncology, University Hospital Centre "Mother Theresa", Rruga e Dibrës 372, 1000, Tirana, AL, Albania. 9. Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk, Marii Skłodowskiej-Curie 3a, 80-210, Gdańsk, Poland. 10. Unit of Medical Physics, European Institute of Oncology, IRCCS, Via Ripamonti 435, 20141, Milan, Italy. 11. Division of Gastrointestinal Surgery, European Institute of Oncology, IRCCS, Via Ripamonti 435, 20141, Milan, Italy. 12. Mount Vernon Centre for Cancer Treatment, Northwood, Middlesex, HA6 2RN, UK. 13. Scientific Directorate, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Abstract
PURPOSE: To retrospectively review our experience on 84 patients with squamous cell anal canal cancer (SCAC) within 12 months after combined treatment with intensity-modulated RT (IMRT), in terms of acute and early-late toxicity, overall treatment time and interruptions, colostomy-free survival (CFS), and tumor response. METHODS: Acute gastrointestinal (GI), genitourinary (GU), and cutaneous (CU) toxicities were assessed according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Early-late toxicity was scored using the Radiation Therapy Oncology Group (RTOG) late radiation morbidity scoring system. Tumor response was evaluated with response evaluation criteria in solid tumors (RECIST) v1.1. RESULTS: Acute toxicity for 84 subjects (100%): severe (≥ G3) GI and skin toxicity was observed in 4 (5%) and 19 patients (23%), respectively. Early-late toxicity for 73 subjects (87%): severe (≥ G3) GI and vulvo-vaginal toxicity was observed in 2 (3%) and 2 (3%) patients, respectively. No acute or early-late severe GU toxicity was reported. A treatment interruption occurred in 65 patients (77%). CFS was 96% (95% CI 89-99) at 6 months and 92% (95% CI 83-96) at 12 months. At 6 months complete response (CR), partial response (PR) and progressive disease (PD) was observed in 70 (83%), 3 (4%), and 7 patients (8%), respectively. At 12 months, CR was observed in 60 patients (81%); eleven patients (15%) experienced PD. CONCLUSION: Our study showed an excellent clinical result and very low acute toxicity rates, confirming the IMRT as standard of care for curative treatment of anal cancer patients. The current trial was registered with the number IEO N87/11.
PURPOSE: To retrospectively review our experience on 84 patients with squamous cell anal canal cancer (SCAC) within 12 months after combined treatment with intensity-modulated RT (IMRT), in terms of acute and early-late toxicity, overall treatment time and interruptions, colostomy-free survival (CFS), and tumor response. METHODS: Acute gastrointestinal (GI), genitourinary (GU), and cutaneous (CU) toxicities were assessed according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Early-late toxicity was scored using the Radiation Therapy Oncology Group (RTOG) late radiation morbidity scoring system. Tumor response was evaluated with response evaluation criteria in solid tumors (RECIST) v1.1. RESULTS: Acute toxicity for 84 subjects (100%): severe (≥ G3) GI and skin toxicity was observed in 4 (5%) and 19 patients (23%), respectively. Early-late toxicity for 73 subjects (87%): severe (≥ G3) GI and vulvo-vaginal toxicity was observed in 2 (3%) and 2 (3%) patients, respectively. No acute or early-late severe GU toxicity was reported. A treatment interruption occurred in 65 patients (77%). CFS was 96% (95% CI 89-99) at 6 months and 92% (95% CI 83-96) at 12 months. At 6 months complete response (CR), partial response (PR) and progressive disease (PD) was observed in 70 (83%), 3 (4%), and 7 patients (8%), respectively. At 12 months, CR was observed in 60 patients (81%); eleven patients (15%) experienced PD. CONCLUSION: Our study showed an excellent clinical result and very low acute toxicity rates, confirming the IMRT as standard of care for curative treatment of anal cancerpatients. The current trial was registered with the number IEO N87/11.
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