J Gynecol Oncol.  2019 Jul;30(4):e82. 10.3802/jgo.2019.30.e82.

A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial

• Tangjitgamol S
• Tharavichitkul E
• Tovanabutra C
• Rongsriyam K
• Asakij T
• Paengchit
• Sukhaboon
• Penpattanagul S
• Kridakara
• Hanprasertpong J
• Chomprasert K
• Wanglikitkoon S
• Atjimakul
• Pariyawateekul P
• Katanyoo K
• Tanprasert P
• Janweerachai W
• Sangthawan D
• Khunnarong J
• Chottetanaprasith T
• Supawattanabodee B
• Lertsanguansinchai P
• Srisomboon J
• Isaranuwatchai W
• Lorvidhaya V

• KMID: 2450246
• DOI: http://doi.org/10.3802/jgo.2019.30.e82

Abstract

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

Keyword

Uterine Cervical Neoplasm; Concurrent; Chemoradiotherapy; Adjuvant Chemotherapy

MeSH Terms

Arm
Asian Continental Ancestry Group
Carboplatin
Chemoradiotherapy
Chemotherapy, Adjuvant*
Cisplatin
Disease-Free Survival
Follow-Up Studies
Gynecology
Humans
Lymph Nodes
Obstetrics
Paclitaxel
Recurrence
Statistics as Topic
Uterine Cervical Neoplasms*
Carboplatin
Cisplatin
Paclitaxel