Department of Radiation Oncology, Lianshui County People's Hospital, Huai'an 223300, Jiangsu, People's Republic of China.
J Cancer Res Clin Oncol. 2013 Apr;139(4):703-8. doi: 10.1007/s00432-013-1373-9. Epub 2013 Jan 18.
This study explored whether docetaxel/cisplatin and radiotherapy (TP-R) increases overall survival (OS) and recurrence-free survival (RFS) compared to single-agent cisplatin and radiotherapy (C-R) in patients with high-risk early-stage cervical cancer post surgery.
Patients with clinical stage IB and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or the diameter of the primary tumor ≥4 cm and/or depth of interstitial infiltration ≥1/2 and/or lymphovascular space invasion were eligible for this study. Patients were randomized to receive C-R or TP-R. Radiotherapy in both groups was external radiation (46-54 Gy) followed by high-dose rate brachytherapy (12-24 Gy). Patients were given cisplatin (40 mg/m(2)) every week for five cycles (C-R group) or docetaxel (30 mg/m(2)) and cisplatin (30 mg/m(2)) every week for five cycles (TP-R group).
Between 2003 and 2008, 320 patients were entered onto the study. Final analyses included 285 patients. One hundred and forty patients comprised the C-R group and 145 were in the TP-R group. The 5-year OS were 74.3 % in the C-R group and 82.8 % in the TP-R group. The hazard ratio (HR) for death was 0.65 in the TP-R group (95 % CI: 0.39-1.09, P = 0.098). The RFS were 69.3 % in the C-R group and 79.3 % in the TP-R group, and the HR for recurrence was 0.64 in the TP-R group (95 % CI: 0.40-1.03, P = 0.061). Recurrence rates were similar in both groups (27 in the C-R group and 18 in the TP-R group, P = 0.112). The seriousness of late side effects was similar in the two groups, with a higher rate of reversible hematological effects in the TP-R group.
Compared with single-agent cisplatin and radiotherapy, docetaxel/cisplatin in combination with radiotherapy does not increase OS but has the trend of increasing RFS in patients with high-risk early-stage cervical cancer. However, docetaxel/cisplatin in combination with radiotherapy is associated with a higher incidence of side effects, this effect was reversible, and the incidence of late side effects was similar in the two treatment groups.
本研究旨在探讨与顺铂单药联合放疗（C-R）相比，多西紫杉醇/顺铂联合放疗（TP-R）能否提高高风险早期宫颈癌术后患者的总生存期（OS）和无复发生存期（RFS）。
本研究纳入了临床分期为 IB 期和 IIA 期宫颈癌患者，初始治疗为根治性子宫切除术和盆腔淋巴结切除术，且盆腔淋巴结阳性和/或切缘阳性和/或原发肿瘤直径≥4cm 和/或间质浸润深度≥1/2 和/或脉管间隙浸润，符合本研究条件。患者被随机分配接受 C-R 或 TP-R 治疗。两组均接受外照射（46-54 Gy），随后行高剂量率近距离放疗（12-24 Gy）。C-R 组患者每周给予顺铂（40mg/m²）5 个周期，TP-R 组患者每周给予多西紫杉醇（30mg/m²）和顺铂（30mg/m²）5 个周期。
2003 年至 2008 年间，共纳入 320 例患者。最终分析包括 285 例患者。140 例患者入组 C-R 组，145 例患者入组 TP-R 组。C-R 组 5 年 OS 为 74.3%，TP-R 组为 82.8%。TP-R 组死亡风险比（HR）为 0.65（95%CI：0.39-1.09，P=0.098）。C-R 组的 RFS 为 69.3%，TP-R 组为 79.3%，TP-R 组复发风险比（HR）为 0.64（95%CI：0.40-1.03，P=0.061）。两组复发率相似（C-R 组 27 例，TP-R 组 18 例，P=0.112）。两组晚期不良反应严重程度相似，TP-R 组血液学不良反应可逆性更高。
与顺铂单药联合放疗相比，多西紫杉醇/顺铂联合放疗并未提高高危早期宫颈癌患者的 OS，但有增加 RFS 的趋势。然而，多西紫杉醇/顺铂联合放疗与更高的不良反应发生率相关，这种作用是可逆的，且两组治疗后晚期不良反应发生率相似。
