Rochet Nathalie, Lindel Katja, Katayama Sonja, Schubert Kai, Herfarth Klaus, Schneeweiss Andreas, Sohn Christoph, Harms Wolfgang, Debus Juergen
Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany.
Strahlenther Onkol. 2015 Jul;191(7):582-9. doi: 10.1007/s00066-015-0830-6. Epub 2015 Mar 19.
A prospective study to assess toxicity and survival outcomes after intensity-modulated whole-abdominal irradiation (IM-WAI) following surgery and adjuvant intravenous carboplatin/taxane chemotherapy in advanced FIGO stage III ovarian cancer.
Between 2006 and 2009, 16 patients with optimally resected FIGO stage III ovarian cancer, who had received six cycles of adjuvant carboplatin/taxane chemotherapy were treated with consolidation IM-WAI. Radiotherapy was delivered to a total dose of 30 Gy in 1.5-Gy fractions, using step-and-shoot (n = 3) or helical tomotherapy (n = 13). The first 10 patients were treated within a phase I trial; the following patients received the same treatment modality. The target volume included the entire peritoneal cavity, the diaphragm, the liver capsule, and the pelvic and para-aortic node regions. Organs at risk were kidneys, liver, heart, and bone marrow.
Median follow-up was 44 months (range 19.2-67.2 months). No grade 4 toxicities occurred during IM-WAI. Common Toxicity Criteria for Adverse Events (CTCAE) grade 3 toxicities were: diarrhea (25 %), leucopenia (19 %), nausea/vomiting (6 %), and thrombocytopenia (6 %). No toxicity-related treatment break was necessary. Small bowel obstruction occurred in a total of 6 patients: in 3 cases (19 %) due to postsurgical adhesions and in 3 cases due to local tumor recurrence (19 %). Median recurrence-free survival (RFS) was 27.6 months (95 % confidence interval, CI = 24-44 months) and median overall survival (OS) was 42.1 months (95 %CI = 17-68 months). The peritoneal cavity was the most frequent site of initial failure.
Consolidation IM-WAI following surgery and adjuvant chemotherapy is feasible and can be performed with manageable acute and late toxicity. The favorable RFS outcome is promising and justifies further clinical trials.
一项前瞻性研究，旨在评估在晚期国际妇产科联盟（FIGO）III期卵巢癌手术及辅助静脉注射卡铂/紫杉烷化疗后，调强全腹照射（IM-WAI）的毒性和生存结果。
2006年至2009年期间，16例FIGO III期卵巢癌患者接受了六个周期的辅助卡铂/紫杉烷化疗，术后接受巩固性IM-WAI治疗。放疗总剂量为30 Gy，每次1.5 Gy，采用步进式（n = 3）或螺旋断层放疗（n = 13）。前10例患者在I期试验中接受治疗；后续患者接受相同的治疗方式。靶区包括整个腹膜腔、膈肌、肝包膜以及盆腔和腹主动脉旁淋巴结区域。危及器官包括肾脏、肝脏、心脏和骨髓。
中位随访时间为44个月（范围19.2 - 67.2个月）。IM-WAI期间未发生4级毒性反应。不良事件通用毒性标准（CTCAE）3级毒性反应包括：腹泻（25%）、白细胞减少（19%）、恶心/呕吐（6%）和血小板减少（6%）。无需因毒性反应中断治疗。共有6例患者发生小肠梗阻：3例（19%）因术后粘连，3例因局部肿瘤复发（19%）。中位无复发生存期（RFS）为27.6个月（95%置信区间，CI = 24 - 44个月），中位总生存期（OS）为42.1个月（95%CI = 17 - 68个月）。腹膜腔是最常见的初始复发部位。
手术及辅助化疗后进行巩固性IM-WAI是可行的，且急性和晚期毒性可控。良好的RFS结果很有前景，值得进一步开展临床试验。
