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

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

Impact of time interval between radical hysterectomy with pelvic node dissection and initial adjuvant therapy on oncological outcomes of early stage cervical cancer / 부인종양

OBJECTIVE: To determine the impact of time interval (TI) from radical hysterectomy with pelvic node dissection (RHND) to adjuvant therapy on oncological outcomes in cervical cancer. METHODS: The study included 110 stage IA2–IB1 cervical cancer patients who underwent RHND and adjuvant therapy. The patients were divided into 2 groups based on the cut-off points of TI of 4 and 6 weeks, respectively. The associations of TI and clinicopathologic factors with oncological outcomes were evaluated using Cox proportional-hazards regression. RESULTS: The median TI was 4.5 weeks. There were no statistical differences in 5-year recurrence-free survival (RFS) (89.2% vs. 81.0%, and 83.2% vs. 100.0%) or 5-year overall survival (OS) rates (90.9% vs. 97.2%, and 93.2% vs. 100.0%) between patients according to TI (≤4 vs. >4, and ≤6 vs. >6 weeks, respectively). Deep stromal invasion (p=0.037), and parametrial involvement (PI) (p=0.002) were identified as independent prognostic factors for RFS, together with the interaction between TI and squamous cell carcinoma histology (p<0.001). In patients with squamous cell carcinoma, a TI longer than 4 weeks was significantly associated with a worse RFS (hazard ratio [HR]=15.8; 95% confidence interval [CI]=1.4–173.9; p=0.024). Univariate analysis showed that only tumor size (p=0.023), and PI (p=0.003) were significantly associated with OS. CONCLUSION: Delay in administering adjuvant therapy more than 4 weeks after RHND in early stage squamous cell cervical cancer results in poorer RFS.

Fear of cancer recurrence and its predictors among cervical cancer survivors / 부인종양

OBJECTIVE: To identify the characteristics of fear of cancer recurrence (FCR) in cervical cancer survivors (CCSs) and investigate the relationship of FCR with demographic and medical characteristics, level of quality of life (QOL), and psychological distress. We also aimed to determine the predictors of FCR. METHODS: The short version of the Fear of Progression Questionnaire (FoP-Q-SF), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-Cervical (FACT-Cx) questionnaire were administered to 699 CCSs who had complete treatment at Songklanagarind Hospital between 2006 and 2016. Analysis was performed to determine potential predictors associated with FCR. RESULTS: Among the 12 items of the FoP-Q-SF, the 3 greatest fears were 1) worrying about what would happen to their family; 2) being afraid of pain; and 3) fear of disease progression. The prevalences of anxiety and depression disorder were 20.46% and 9.44%, respectively. CCSs who had FCR at the 5th quintile were more likely to have medical co-morbidities, low FACT-Cx scores in all domains and a high HADS scores (anxiety and depression disorder). Multivariate analysis showed that only anxiety disorder (odds ratio [OR]=4.99; p<0.001) and low FACT-Cx score (total) (OR=6.14; p<0.001) were identified as independent predictors for FCR at the 5th quintile. CONCLUSION: FCR is an important problem in cervical cancer which should be addressed during post-treatment care. Only anxiety disorder and low QOL were independently associated with high FCR.

Impact of diabetes mellitus on oncological outcomes after radical hysterectomy for early stage cervical cancer / 부인종양

OBJECTIVE: To evaluate the relationship between type 2 diabetes mellitus (DM) and oncological outcomes in early stage cervical cancer patients who underwent radical surgical resection. METHODS: Patients with early stage cervical cancer diagnosed between 2001 and 2014 were retrospectively enrolled. We assessed the outcomes of 402 non-DM and 42 DM patients with cervical cancer. We tested the prognostic value of DM via Cox proportional hazard modeling. RESULTS: Patients with DM were more likely to be older and overweight. In the DM group, 20 and 22 patients were and were not taking metformin, respectively. The 5-year recurrence-free survival (RFS) and 5-year overall survival (OS) rate for the whole study population were 88.49% and 96.34%, respectively. In the DM group, there was no evidence that metformin affected the RFS (p=0.553) or the OS (p=0.429). In multivariate analysis, age (p=0.007), histology (p=0.006), and deep stromal invasion (p=0.007) were independent adverse prognostic factors for RFS. There was a borderline significant association of increased RFS with DM (p=0.051). However, a time-varying-effect Cox model revealed that the DM was associated with a worse RFS (hazard ratio, 11.15; 95% CI, 2.00 to 62.08, p=0.022) after 5 years. DM (p=0.008), age (p=0.009), and node status (p=0.001) were the only 3 independent prognostic factors for OS. CONCLUSION: Early stage cervical cancer patients with type 2 DM have a poorer oncological outcome than patients without DM.

Longer waiting times for early stage cervical cancer patients undergoing radical hysterectomy are associated with diminished long-term overall survival / 부인종양

OBJECTIVE: The aim of this study was to evaluate the impact of surgical waiting time on clinical outcome in early stage cervical cancer. METHODS: The cohort consisted of 441 patients diagnosed with stages IA2-IB1cervical cancer who underwent radical hysterectomy and pelvic node dissection. The patients were divided into two groups based on surgical waiting time. The associations between waiting time and other potential prognostic factors with clinical outcome were evaluated. RESULTS: The median surgical waiting time was 43 days. Deep stromal invasion (hazard ratio [HR], 2.5; 95% confidence interval [CI], 1.4 to 4.6; p=0.003) and lymph node metastasis (HR, 2.9; 95% CI, 1.3 to 6.7; p=0.026) were identified as independent prognostic factors for recurrence-free survival while no prognostic significance of surgical waiting time was found (p=0.677). On multivariate analysis of overall survival (OS), only deep stromal invasion (HR, 2.6; 95% CI, 1.3 to 5.0; p=0.009) and lymph node metastasis (HR, 3.6; 95% CI, 1.5 to 8.6; p=0.009) were identified as independent prognostic factors for OS. Although OS showed no significant difference between short (8 weeks) waiting times, multivariate analysis of OS with time-varying effects revealed that a waiting time longer than 8 weeks was associated with poorer long-term survival (after 5 years; HR, 3.4; 95% CI, 1.3 to 9.2; p=0.021). CONCLUSION: A longer surgical waiting time was associated with diminished long-term OS of early stage cervical cancer patients.