Phase I trial of 18F-Fludeoxyglucose based radiation dose painting with concomitant cisplatin in head and neck cancer
| Autor: | Claus Kristensen, Annika Loft, K. Håkansson, Lena Specht, Ivan R. Vogelius, Barbara M. Fischer, Søren M. Bentzen, Marianne C. Aznar, Jeppe Friborg, Jacob H. Rasmussen |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Fluorodeoxyglucose F18 Median follow-up medicine Clinical endpoint Humans Radiology Nuclear Medicine and imaging Aged Cisplatin Squamous Cell Carcinoma of Head and Neck business.industry Head and neck cancer Radiotherapy Dosage Common Terminology Criteria for Adverse Events Chemoradiotherapy Hematology Middle Aged medicine.disease Head and neck squamous-cell carcinoma Oncology Head and Neck Neoplasms Positron-Emission Tomography 030220 oncology & carcinogenesis Concomitant Toxicity Carcinoma Squamous Cell Female Radiopharmaceuticals Nuclear medicine business medicine.drug |
| Zdroj: | Radiotherapy and Oncology. 120:76-80 |
| ISSN: | 0167-8140 |
| Popis: | Purpose The CONTRAST (CONventional vs.Tumor Recurrence Adapted Specification of Target dose) phase I trial tested the safety of FDG PET guided dose redistribution in patients receiving accelerated chemo-radiotherapy for locally advanced head and neck squamous cell carcinoma (HNSCC). Methods and materials CONTRAST was designed with two pre-defined dose-escalation steps to the FDG PET-avid volume (GTV PET ). The primary end point was any early grade 4+ toxicity according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE). The dose to GTV PET was escalated to a uniform prescription of 82Gy EQD2 in the first step. All patients received accelerated radiotherapy (6 fractions a week) delivering 34 fractions of 2.34Gy to the GTV PET as well as concomitant weekly cisplatin. Inclusion criteria were (1) primary SCC of oral cavity, oro- or hypo-pharynx, or laynx, (2) candidates for concomitant chemo-radiotherapy and (3) p16 negative tumors or p16 positive tumors in patients with smoking history of >10 pack years. GTV PET was defined by a specialist in nuclear medicine and a radiologist, while the anatomic GTV was defined in collaboration between an oncologist and a radiologist. Results Median follow up time from the end of treatment was 18months (range 7–21months). All 15 patients completed treatment without interruptions and no incidents of early grade 4+ toxicity were observed. Four patients had ulceration at the evaluation two months after treatment, two have subsequently healed, but two remain, raising concerns regarding late effects. Conclusions With all 15 cases having completed four month follow up and no incidence of early grade 4+ toxicity FDG PET based dose escalation to 82Gy passed the protocol-defined criterion for dose escalation. However, two cases of concern regarding late outcome led us to refrain from further dose escalation and proceed with the current dose level in a larger comparative effectiveness trial. |
| Databáze: | OpenAIRE |
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