1.A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial
Siriwan TANGJITGAMOL ; Ekkasit THARAVICHITKUL ; Chokaew TOVANABUTRA ; Kanisa RONGSRIYAM ; Tussawan ASAKIJ ; Kannika PAENGCHIT ; Jirasak SUKHABOON ; Somkit PENPATTANAGUL ; Apiradee KRIDAKARA ; Jitti HANPRASERTPONG ; Kittisak CHOMPRASERT ; Sirentra WANGLIKITKOON ; Thiti ATJIMAKUL ; Piyawan PARIYAWATEEKUL ; Kanyarat KATANYOO ; Prapai TANPRASERT ; Wanwipa JANWEERACHAI ; Duangjai SANGTHAWAN ; Jakkapan KHUNNARONG ; Taywin CHOTTETANAPRASITH ; Busaba SUPAWATTANABODEE ; Prasert LERTSANGUANSINCHAI ; Jatupol SRISOMBOON ; Wanrudee ISARANUWATCHAI ; Vichan LORVIDHAYA
Journal of Gynecologic Oncology 2019;30(4):e82-
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
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
Result Analysis
Print
Save
E-mail