A Phase 1/2 Radiation Dose Escalation Trial Using Sib-Imrt Technique With Concurrent Chemotherapy In Unresectable Esophageal Carcinoma
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS(2017)
摘要
To investigate the safety and tolerability of SIB-IMRT technique with concurrent chemotherapy for patients with unresectable esophageal carcinoma. In phase I, the prophylactic PTVs received a dose of 50.40Gy /2.14Gy /28 fractions, while the therapeutic PGTVs were planned to be prescribed with three consecutive dose levels: 60.76Gy /2.17Gy /28f (dose level 1), 61.88Gy /2.21Gy /28f (dose level 2) and 64.12Gy /2.29Gy /28f (dose level 3). Concurrent chemotherapy consisted of paclitaxel, 50 mg/m2, and nedaplatin, 25 mg/m2, given weekly. Starting from dose level 1, the escalation process was practiced on a group containing three patients. If none of them developed dose liming toxicities (DLTs, defined as Grade 3 or higher non-hematological toxicities and/or Grade 4 or higher hematological toxicities, according to the Common Terminology Criteria for Adverse Events, version 3.0), the dose escalation process continued. In case one of them developed a DLT, another three patients would be enrolled at the same dose level. Once another DLT happened, the escalation process ceased and the previous dose level was determined as the Maximum Tolerated Dose (MTD). In phase II, patients were treated with the determined MTD, and we counted acute toxicities and the completion rate of treatment, based on which the safety and tolerability of SIB-IMRT technique were analyzed in details. From December 2014 to December 2016, forty-nine patients were enrolled. In phase I part, one patient developed a Grade 4 thrombopenia at dose level 1. Another three patients were enrolled and one experienced a Grade 4 weight loss, so we suspended the escalation process and added a lower dose level of 59.92Gy /2.14Gy /28f. Three patients were treated in this dose and none of them reached a DLT. Considering the DLTs developed in previous level 1, we determined the newly added level to be the MTD. In phase II, forty patients were treated with the dose of 59.92Gy /2.14Gy /28f, twenty-eight of them (70.0%) completed radiotherapy and at least five cycles of chemotherapy. The most common Grade 3 or 4 toxicities in phase II included leukopenia (27.5%), esophagitis (12.5%), pulmonitis (2.5%) and thrombopenia (2.5%). The most common Grade 1 or 2 toxicities were dermatitis (87.5%), esophagitis (87.5%), leukopenia (60.0%), tracheitis (30.0%), thrombopenia (27.5%) and anemia (22.5%). No treatment-related deaths were observed. The SIB-IMRT technique was found to be feasible and safe at the recommended doses of 59.92Gy to PGTV and 50.40Gy to PTV concurrent with chemotherapy for patients with unresectable esophageal carcinoma.
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关键词
radiation dose escalation trial,unresectable esophageal carcinoma,radiation dose,concurrent chemotherapy,sib-imrt
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