Simultaneous Integrated Boost Volumetric Modulated Arc Therapy in the Postoperative Treatment of High-Risk to Intermediate-Risk Endometrial Cancer: Results of ADA II Phase 1-2 Trial

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• 作者：Gabriella Macchia ; MD^&lowast ; ; ^{gmacchia@rm.unicatt.it" class="auth_mail" title="E-mail the corresponding author} ; Savino Cilla ; PhD^&dagger ; ; Francesco Deodato ; MD^&lowast ; ; Anna Ianiro ; PhD^&dagger ; ; Francesco Legge ; MD^&Dagger ; ; Martina Marucci ; RTT^&lowast ; ; Silvia Cammelli ; MD^§ ; ; Anna Myriam Perrone ; MD^‖ ; Pierandrea De Iaco ; MD^‖ ; Maria Antonietta Gambacorta ; MD^¶ ; ; Rosa Autorino ; MD^¶ ; ; Vincenzo Valentini ; MD^&lowast ; ; ^¶ ; ; Alessio G. Morganti ; MD^§ ; ; Gabriella Ferrandina ; MD^#
• 刊名：International Journal of Radiation Oncology*Biology*Physics
• 出版年：2016
• 出版时间：1 November 2016
• 年：2016
• 卷：96
• 期：3
• 页码：606-613
• 全文大小：248 K

文摘

A prospective phase 1-2 clinical trial aimed at determining the recommended postoperative dose of simultaneous integrated boost volumetric modulated arc therapy (SIB-VMAT) in a large series of patients with high-risk and intermediate-risk endometrial cancer (HIR-EC) is presented. The study also evaluated the association between rate and severity of toxicity and comorbidities and the clinical outcomes.

Methods and Materials

Two SIB-VMAT dose levels were investigated for boost to the vaginal vault, whereas the pelvic lymph nodes were always treated with 45 Gy. The first cohort received a SIB-VMAT dose of 55 Gy in 25 consecutive 2.2-Gy fractions, and the subsequent cohort received higher doses (60 Gy in 2.4-Gy fractions).

Results

Seventy consecutive HIR-EC patients, roughly half of whom were obese (47.1%) or overweight (37.1%), with Charlson Age-Comorbidity Index >2 (48.5%), were enrolled. Thirty-one patients (44.3%) were administered adjuvant chemotherapy before starting radiation therapy. All patients (n=35 per dose level) completed irradiation without any dose-limiting toxicity. Proctitis (any grade) was associated with radiation therapy dose (P=.001); not so enterocolitis. Grade ≥2 gastrointestinal (GI) and genitourinary (GU) toxicity were recorded in 17 (24.3%) and 14 patients (20.0%), respectively, and were not associated with radiation dose. As for late toxicity, none of patients experienced late grade ≥3 GI or grade ≥2 GU toxicity. The 3-year late grade ≥2 GI and GU toxicity–free survival were 92.8% and 100%, respectively, with no difference between the 2 dose levels. With a median follow-up period of 25 months (range, 4-60 months), relapse/progression of disease was observed in 10 of 70 patients (14.2%). The 3-year cumulative incidence of recurrence was 1.5% (95% confidence interval (CI): 0.2-10.7), whereas the 3-year disease-free survival was 81.3% (95% CI: 65.0-90.0).

Conclusions

This clinical study showed the feasibility of this technique and its good profile in terms of acute and late toxicity at the recommended doses even in aged and frail patients.