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KMID : 1137020190300040082
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Journal of Gynecologic Oncology
2019 Volume.30 No. 4 p.82 ~ p.82
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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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Tangjitgamol Siriwan
Tharavichitkul Ekkasit
Tovanabutra Chokaew
Rongsriyam Kanisa
Asakij Tussawan
Paengchit Kannika
Sukhaboon Jirasak
Penpattanagul Somkit
Kridakara Apiradee
Hanprasertpong Jitti
Chomprasert Kittisak
Wanglikitkoon Sirentra
Atjimakul Thiti
Pariyawateekul Piyawan
Katanyoo Kanyarat
Tanprasert Prapai
Janweerachai Wanwipa
Sangthawan Duangjai
Khunnarong Jakkapan
Chottetanaprasith Taywin
Supawattanabodee Busaba
Lertsanguansinchai Prasert
Srisomboon Jatupol
Isaranuwatchai Wanrudee
Lorvidhaya Vichan
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Abstract
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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.
Trial Registration: ClinicalTrials.gov Identifier: NCT02036164
Thai Clinical Trials Registry Identifier: TCTR 20140106001
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KEYWORD
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Uterine Cervical Neoplasm, Concurrent, Chemoradiotherapy, Adjuvant Chemotherapy
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