A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial
A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial
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DOI：
10.3802/jgo.2019.30.e82
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发表时间：
2019-07-01
影响因子：
3.9
通讯作者：
Lorvidhaya, Vichan
中科院分区：
文献类型：
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作者：
Tangjitgamol, Siriwan;Tharavichitkul, Ekkasit;Lorvidhaya, Vichan
目的：比较局部晚期宫颈癌患者接受标准同步放化疗（CCRT）和CCRT后接受辅助化疗（ACT）的缓解率和生存率。方法：年龄为18 - 70岁的国际妇产科联合会IIB-IVA期且无主动脉旁淋巴结肿大的患者，东部肿瘤协作组评分为0 - 2，和非侵袭性组织病理学的患者随机接受CCRT和每周顺铂，随后观察（A组）或ACT和紫杉醇加卡铂，每4周1次，共3个周期（B组）。对259例患者的数据分析显示，A组（n = 129）和B组（n = 130）治疗后4个月的完全缓解无显著差异：分别为94.1%和87.0%（p = 0.154）。中位随访时间为27.4个月，A组15.5%的患者和B组10.8%的患者复发（p = 0.123）。总体或局部区域失败无显著差异。然而，B组的全身复发率显著低于A组：5.4% vs. 10.1%（p = 0.029）。两组患者的3年无进展生存期（PFS）和3年总生存期（OS）无显著差异。与A组相比，B组PFS和OS的风险比分别为1.26（95%CI = 0.82 - 1.96; p = 0.293）和1.42（95%CI = 0.81 - 2.49; p = 0.221）。仅观察到ACT的全身复发率显著降低，但未观察到整体或局部区域失败。
Objective: To compare response rate and survivals of locally advanced stage cervical cancer patients who had standard concurrent chemoradiation therapy (CCRT) alone to those who had adjuvant chemotherapy (ACT) after CCRT.Methods: Patients aged 18-70 years who had International Federation of Gynecology and Obstetrics stage IIB-IVA without para-aortic lymph node enlargement, Eastern Cooperative Oncology Group scores 0-2, and non-aggressive histopathology were randomized to have CCRT with weekly cisplatin followed by observation (arm A) or by ACT with paclitaxel plus carboplatin every 4 weeks for 3 cycles (arm B).Results: Data analysis of 259 patients showed no significant difference in complete responses at 4 months after treatment between arm A (n= 129) and arm B (n= 130): 94.1% vs. 87.0% (p= 0.154) respectively. With the median follow-up of 27.4 months, 15.5% of patients in arm A and 10.8% in arm B experienced recurrences (p= 0.123). There were no significant differences of overall or loco-regional failure. However, systemic recurrences were significantly lower in arm B than arm A: 5.4% vs. 10.1% (p= 0.029). The 3-year progression-free survival (PFS) and 3-year overall survival (OS) of the patients in both arms were not significantly different. The hazard ratio of PFS and OS of arm B compared to arm A were 1.26 (95% CI= 0.82-1.96; p= 0.293) and 1.42 (95% CI= 0.81-2.49; p= 0.221) respectively.Conclusions: ACT with paclitaxel plus carboplatin after CCRT did not improve response rate and survival compared to CCRT alone. Only significant decrease of systemic recurrences with ACT was observed, but not overall or loco-regional failure.