Cost-utility analysis of adjuvant chemotherapy after concurrent chemoradiation in patients with locally advanced cervical cancer.

INTRODUCTION: This study aimed to compare the cost utility of concurrent chemoradiation (CCRT) to CCRT followed by adjuvant chemotherapy (CCRT/ACT) in locally advanced cervical cancer (LACC) using provider and societal viewpoints. METHODS: Data from our trial which was a multi-centre study evaluating the efficacy of ACT compared to CCRT/ACT were entered into a decision tree model. The data included clinical probability, direct medical and non-medical costs, and utility obtained from the patients. The total cost, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICER) were estimated for a time horizon of 3 years. All costs and outcomes were discounted at 3% annually. RESULTS: The cost of CCRT and CCRT/ACT was approximately 3,058 and 6,896 USD and 4,309 and 7,480 USD from provider and from societal viewpoints, respectively. The QALYs for CCRT and CCRT/ACT were 2.31480 and 2.32045, respectively. The ICER was 569,575 USD per QALY. For stage III-IVA LACC, the ICER was 28,050 USD per QALY. In the sensitivity analysis, the cost of ACT was the most significant influential parameter on the ICER. The ICER would be 0.26-fold lower if the cost of ACT was reduced by 25%. At the current ceiling threshold of 5,000 USD/QALY, CCRT had a 100% probability of being the best option. CONCLUSIONS: In the Thai context, CCRT is more cost effective than CCRT/ACT for stage IIB-IVA LACC. CCRT/ACT may be considered only for stage III-IVA LACC because it has a lower ICER than other types of LACC.

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

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.

Randomized comparison of fluorouracil plus cisplatin vs. cisplatin as an adjunct to radiation therapy in stage IIB-IVA squamous cell carcinoma of the cervix: pilot study.

OBJECTIVE: To compare the efficacy and toxicity of pelvic radiotherapy with concomitant cisplatin plus fluorouracil versus cisplatin alone in patients with locally advanced squamous cell cervical cancer. MATERIAL AND METHOD: Twenty women with squamous cell cervical cancer were randomly assigned to receive ether standard whole pelvic radiotherapy with concurrent cisplatin and fluorouracil infusion every 4 weeks or the same radiotherapy with concurrent cisplatin every 1 week. The primary endpoint was the response rate. RESULTS: All patients in cisplatin plus fluorouracil regimen and in cisplatin regimen had complete response. In cisplatin group there was higher frequencies of adverse hematologic effects. Grade 3 or 4 neutropenia occurred in 10% of the cisplatin plus fluorouracil group and in 40% of the cisplatin group (p = 0.049). CONCLUSION: No difference was found in the response rate, but higher frequencies of hemotological adverse effects in the cisplatin group.

Reduced incidence and severity of acute radiation mucositis by WF10 (IMMUNOKINE) as adjunct to standard of cure in the management of head & neck cancer patients.

OBJECTIVE: To evaluate the role of WF10-immunotherapy in reducing oro-pharyngeal complications in head and neck cancer chemoradiotherapy. MATERIAL AND METHOD: Thirteen patients were enrolled and assigned either to WF10- (n = 6) or control group (n = 7). After completion of their initial (neoadjuvant) chemotherapy, patients received WF10 intravenous infusions at 0.5 mL/kg body weight/day for five consecutive days and repeated every 3 weeks, concomitantly to standard radiotherapy (6,600-7,500 cGy, 200 cGy/day). Control patients received radiotherapy alone. RESULTS: Patients in the WF10-group had a lower incidence of oro-pharyngeal complications grade > 2, including oral mucositis (1 vs. 5), dysphagia (2 vs. 7), oral pain (3 vs. 5), taste alteration (4 vs. 6) and weight loss (2 vs. 4). The statistical significances were achieved for the parameters of oral mucositis (p = 0. 048) and dysphagia (p = 0.009). CONCLUSION: WF10 appears to reduce severity of oro-pharyngeal complications associated with standard chemoradiotherapy for head and neck cancer.