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Phase I dose escalation trial using stereotactic body radiation therapy (SBRT) for partial breast irradiation (PBI).

医学 肿块切除术 美容 队列 乳腺癌 耐受性 放射治疗 核医学 外科 乳房切除术 放射科 癌症 内科学 不利影响
作者
Asal Rahimi,Ann Spangler,Dan Garwood,A. Marilyn Leitch,Roshni Rao,Stephen J. Seiler,Rachel Wooldridge,Aeisha Rivers,Stella Stevenson,Sally Goudreau,Barbara Haley,Ying Dong,David Euhus,Kevin Albuquerque,M.R. Folkert,J.H. Heinzerling,Chuxiong Ding,Chul Ahn,Hak Choy,Robert Timmerman
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:33 (15_suppl): 1057-1057 被引量:2
标识
DOI:10.1200/jco.2015.33.15_suppl.1057
摘要

1057 Background: To evaluate tolerability of escalating doses of 5 fraction SBRT PBI in treating early stage breast cancer after partial mastectomy on a phase I dose escalation trial. The primary objective was to escalate the PBI dose utilizing a robotic stereotactic radiation system treating the lumpectomy cavity without exceeding the maximum tolerated dose (MTD). Methods: Eligible patients included DCIS or invasive ductal histologies, AJCC stage 0-II with tumor size < 3cm, and margins ≥ 2mm. Prior to simulation 3-4 four gold fiducials were placed around the lumpectomy cavity for real-time respiratory tracking. Dose limiting toxicity (DLT) equaled grade ≥ 3 toxicity by CTCAE deemed definitely related to treatment for: skin, bone (fracture), pulmonary, neurological (intercostal or brachial plexus nerves) or any grade 4/ 5 toxicity definitely attributed to therapy. Both patients and physicians completed baseline and subsequent cosmesis questionnaires using a four point scale – excellent, good, fair, poor. Starting dose was 30 Gy in 5 fractions. Dose was escalated by 2.5 Gy total, provided 4 or fewer of 15 patients experienced a DLT within 90 days of treatment within each dose group. If more patients had DLT in a given dose cohort, the MTD would be exceeded. Results: 68 patients (15 per dose cohort (cohort 5 -8 patients)) enrolled with median age 62 years. Median follow-up for cohorts 1,2,3,4, and 5 were - 36.3, 26.4, 16, 8.8, and 2.3 months. The first 3 dose cohorts completed 90 day follow-up without DLTs. There was 1 focal grade 3 dermatitis DLT at 37.5 Gy. DLT follow-up is still ongoing in cohort 5. There were 72 grade 1 toxicity events, 2 grade 2 toxicities (rib fracture and breast pain), and 2 grade 3 radiation dermatitis toxicities. Physicians scored cosmesis as excellent or good in 94.9%, 100%, 97.7%, and 100% respectively (p = 0.28), at baseline, 6, 12, and 24 months post SBRT, while patients scored the same periods 82.7%, 96.2%, 95.4%, and 92.8% (p = 0.04). Conclusions: Dose is escalated to 37.5 Gy in 5 fractions without MTD thus far. Soon we are completing dose escalation for 40Gy in 5 fractions PBI, hoping to increase the likelihood of long term tumor control while evaluating toxicity and cosmesis of this innovative therapy. Clinical trial information: NCT01162200.
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