直肠癌术前容积调强弧形放疗同步整合加量化疗：一项II期研究

Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer: A Phase II Study.

作者信息

Picardi Vincenzo, Macchia Gabriella, Guido Alessandra, Giaccherini Lucia, Deodato Francesco, Farioli Andrea, Cilla Savino, Compagnone Gaetano, Ardizzoni Andrea, Cuicchi Dajana, Gambacorta Maria Antonietta, Cellini Francesco, Frezza Giovanni, Poggioli Gilberto, Valentini Vincenzo, Fuccio Lorenzo, Morganti Alessio Giuseppe

机构信息

Radiotherapy Unit, Fondazione di Ricerca e Cura "Giovanni Paolo II", Catholic University of Sacred Heart, Campobasso, Italy.

Radiation Oncology Center, Department of Experimental, Diagnostic, and Specialty Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.

出版信息

Clin Colorectal Cancer. 2017 Mar;16(1):16-22. doi: 10.1016/j.clcc.2016.06.004. Epub 2016 Jun 23.

DOI:10.1016/j.clcc.2016.06.004

PMID:27435759

Abstract

PURPOSE

The aim of this study was to investigate the efficacy and toxicity of volumetric modulated arc therapy (VMAT)-simultaneous integrated boost (SIB) in preoperative combined treatment of locally advanced rectal cancer.

METHODS

Radiation therapy was performed using the VMAT-SIB technique. The dose to mesorectum and pelvic lymph nodes was 45 Gy (1.8 Gy/fraction). A concomitant boost was delivered on GTV + 2-cm margin with a total dose of 57.5 Gy (2.3 Gy/fraction). The following concomitant chemotherapy was administered: capecitabine (825 mg/m twice daily, 5 days per week) and oxaliplatin (130 mg/m on days 1, 17, and 35). Efficacy was evaluated in terms of complete pathological response (pCR). Acute toxicities were evaluated according to Common Terminology Criteria for Adverse Events version 3.0 criteria.

RESULTS

A total of 18 patients (7 women; median age 62 years; clinical stage: 4 local recurrences, 6 cT4, 5 cT3, 3 cT2, 2 cN0, 7 cN1, 9 cN2) were enrolled. Sixteen patients underwent surgical resection (9 low anterior resection, 6 abdominal perineal amputations; 1 transanal excision) and 2 patients did not undergo surgery for early metastatic progression or death from acute pulmonary edema. R0 resection was achieved in all patients who underwent surgery. Overall, 4 patients had a pCR and 7 patients only a microscopic residual of disease (pT0-Tmic: 11/18 = 61.1%; 95% CI, 36.2-86.1). Acute grade ≥ 3 toxicity was as follows: 1 case of leukopenia, 1 skin toxicity, 1 genitourinary toxicity, and 5 gastrointestinal toxicities, with an overall incidence of 8 (44.4%) of 18 patients. One-, 3-, and 5-year cumulative local control was 100%, 68.6%, and 68.6%, respectively. One-, 3-, and 5-year cumulative disease-free survival was 88.9%, 66.7%, and 66.7%, respectively. One-, 3-, and 5-year cumulative overall survival was 85%, 63.8%, and 63.8%, respectively.

CONCLUSION

The regimen used in this study showed excellent results in terms of pathologic responses. However, despite the use of the VMAT technique, more than one-third of patients had severe acute toxicity.

摘要

目的

本研究旨在探讨容积调强弧形放疗（VMAT）同步整合加量（SIB）在局部晚期直肠癌术前综合治疗中的疗效和毒性。

方法

采用VMAT-SIB技术进行放射治疗。直肠系膜和盆腔淋巴结的剂量为45 Gy（1.8 Gy/分次）。在大体肿瘤体积（GTV）+ 2 cm边缘给予同步加量，总剂量为57.5 Gy（2.3 Gy/分次）。给予以下同步化疗：卡培他滨（825 mg/m²，每日2次，每周5天）和奥沙利铂（130 mg/m²，在第1、17和35天）。根据完全病理缓解（pCR）评估疗效。根据不良事件通用术语标准3.0版标准评估急性毒性。

结果

共纳入18例患者（7例女性；中位年龄62岁；临床分期：4例局部复发，6例cT4，5例cT3，3例cT2，2例cN0，7例cN1，9例cN2）。16例患者接受了手术切除（9例低位前切除术，6例腹会阴联合切除术；1例经肛门切除术），2例患者因早期转移进展或急性肺水肿死亡未接受手术。所有接受手术的患者均实现了R0切除。总体而言，4例患者达到pCR，7例患者仅存在微小疾病残留（pT0-Tmic：11/18 = 61.1%；95% CI，36.2 - 86.1）。急性3级及以上毒性如下：1例白细胞减少，1例皮肤毒性，1例泌尿生殖系统毒性，5例胃肠道毒性，18例患者中总体发生率为8例（44.4%）。1年、3年和5年的累积局部控制率分别为100%、68.6%和68.6%。1年、3年和5年的累积无病生存率分别为88.9%、66.7%和66.7%。1年、3年和5年的累积总生存率分别为85%、63.8%和63.8%。