A randomized phase III adjuvant study in high-risk cervical cancer: simultaneous radiochemotherapy with cisplatin (S-RC) versus systemic paclitaxel and carboplatin followed by percutaneous radiation (PC-R): a NOGGO-AGO Intergroup Study

作者：Sehouli J^*; Runnebaum I B; Fotopoulou C; Blohmer U; Belau A; Leber H; Hanker L C; Hartmann W; Richter R; Keyver Paik M D; Oberhoff C; Heinrich G; du Bois A; Olbrich C; Simon E; Friese K; Kimmig R; Boehmer D; Lichtenegger W; Kuemmel S

来源：Annals of Oncology, 2012, 23(9): 2259-2264.

DOI：10.1093/annonc/mdr628

• cervical cancer
• morbidity
• percutaneous radiation
• radiochemotherapy
• sequential treatment
• survival

Simultaneous adjuvant platinum-based radiochemotherapy in high-risk cervical cancer (CC) is an established treatment strategy. Sequential paclitaxel (Taxol) and platinum followed by radiotherapy may offer further advantages regarding toxicity. %26lt;br%26gt;An open-labeled randomized phase III trial was conducted to compare paclitaxel (175 mg/m(2)) plus carboplatin (AUC5) followed by radiation (50.4 Gy) (experimental arm-A) versus simultaneous radiochemotherapy with cisplatin (40 mg/m(2)/week) (arm-B) in patients with stage IB-IIB CC after surgery. Primary objective was progression-free survival (PFS). %26lt;br%26gt;Overall, 271 patients were randomized and 263 were eligible for evaluation; 132 in arm-A and 131 in arm-B appropriately balanced. The estimated 2-year PFS was 81.8% [95% confidence interval (CI) 74.4-89.1] in arm-B versus 87.2% (95% CI 81.2-93.3) in arm-A (P = 0.235) and the corresponding 5-year survival rates were 85.8% in arm-A and 78.9% in arm-B (P = 0.25). Hematological grade 3/4 toxicity was higher in arm-B. Alopecia (87.9% versus 4.1%; P %26lt; 0.001) and neurotoxicity (65.9% versus 15.6%; P %26lt; 0.001) were significantly higher in arm-A. Early treatment termination was significantly more frequent in arm-B than in arm-A (32.1% versus 12.9%; P = 0.001). %26lt;br%26gt;Sequential chemotherapy and radiation in high-risk CC could not show any significant survival benefit; however, a different toxicity profile appeared. This sequential regime may constitute an alternative option when contraindications for immediate postoperative radiation are present.

• 出版日期2012-9