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

Cost-utility analysis of treatments for stage IB cervical cancer / 부인종양

OBJECTIVE: To analyze the cost-utility of two common clinical practices for stage IB cervical cancer patients from provider and societal viewpoints. METHODS: A decision tree model was conducted to examine value for expenditure between the following: (1) radical hysterectomy with pelvic lymph node dissection (RHPLND) with or without postoperative adjuvant therapy according to the risk of recurrence and (2) concurrent chemoradiotherapy (CCRT). The relevant studies were identified to extract the probability data, and meta-analysis was performed. Direct medical costs were estimated from hospital database and medical records review. Direct non-medical costs and utility parameters were obtained through interviews with patients to estimate quality-adjusted life years (QALYs) outcome. The time horizon was according to the life expectancy of Thai women. RESULTS: From provider viewpoint, RHPLND and CCRT resulted in approximate costs of US $5,281 and US $5,218, respectively. The corresponding costs from societal viewpoint were US $6,533 and US $6,335, respectively. QALYs were 16.40 years for RHPLND and 15.94 years for CCRT. The estimated incremental cost effectiveness ratio of RHPLND in comparison to CCRT from provider and societal viewpoints were US $100/QALY and US $430/QALY, respectively. RHPLND had more cost-effectiveness than CCRT if patients did not need adjuvant therapy. The most effective parameter in model was a direct medical cost of CCRT. At the current ceiling ratio in Thailand, RHPLND provides better value for money than CCRT, with a probability of 75%. CONCLUSION: RHPLND is an efficient treatment for stage IB cervical cancer. This advantage is only for patients who require no adjuvant treatment.

Evaluating the Quality of Drug Users' Information from Health Treatment Centers and

Abstract Evaluating the Quality of Drug Users' Information from Health Treatment Centers and Police Stations Sources in Bangkok under Capture-recapture Method Busaba    Supawattanabodee    BNS,MSc (Biostatistics) Clinical Epidemiology Unit, BMA Medical College and Vajira Hospital Objective: To evaluate the quality of data from health treatment centers and police stations sources. Study design: Survey research. Subjects: Drug dependencies from 61 health treatment centers and narcotics cases from 88 police stations in Bangkok. Methods: The data were taken from 61 health treatment centers and 88 police stations    in Bangkok during the period of 3 months from October 1 to December 31,              2001. Main outcome measures: Quality of data were evaluated by the following three criteria;   the first criterion was the accuracy of drug users' information which remained on the list after duplicate records were removed, the second was completeness of key variables such as name, surname, sex, age, type of drugs/cases, place of residence/place of occurrence, and the last criterion was investigation from percentage of under-reporting number of drug users form two sources comparison with the number of drug users estimated by capture-method. Results: In health treatment centers source, 26,703 cases were recorded in the list, 11,222 cases remained on the list after duplicate record were removed or the accurate record rate was 42% For the second criterion, all key variables were recorded for all persons (100%). In police station sources, 12,389 cases were recorded in the list, 12,012 cases remained on the list after duplicate record were removed or the accurate record rate was 97%. For the second criterion, some key variables such as place of recorded only 5 % As for the last criterion, the values of percentage          under-reporting from two sources were over 97%.   Conclusion: In health centers source, the accuracy of drug users' information was only   42%. However, the completeness of key variables such as name, surname, sex, age, type of drug, and place of residence were recorded in all cases. As for the police stations source, the accuracy of narcotics cases' information was 97%. However, only some key variables such as name, surname and sex were recorded in all cases. As for the percentage of under-reporting from two sources were over 97% because the estimate of drug users in match type A+B+C+D was 427,933 which deviated far from the number of drug users reported from two sources. Key words: Drug users, capture-recapture, dual records, data quality.Vajira Med J 2004 ; 48 : 135 - 143

Relationship between Enzyme Alanine Aminotransferase Level and Liver Histology in Chronic Hepatitis B

Abstract Relationship between Enzyme Alanine Aminotransferase Level and Liver Histology in Chronic Hepatitis B Supatsri      Sethasine                         MD* Somnuek    Jesdapatarakul              MD** Busaba       Supawattanabodee       MSc (biostatistics)*** * Department of medicine, BMA Medical College and Vajira Hospital ** Department of pathology, BMA Medical College and Vajira Hospital ***Clinical Epidemiology Unit, BMA Medical College and Vajira Hospital Objective: To study the relationship between enzyme alanine aminotransferase (ALT) level and liver histology in chronic hepatitis B patient (CHB). Study design: Cross-sectional study. Subjects: A total of 38 adult patients underwent percutaneous liver biopsy during January to December 2006 at liver clinic, BMA Medical College and Vajira Hospital were enrolled. Methods: Clinical and histological data were assessed from medical record and pathological report. Main outcome measures: Histological activity index score, portal inflammatory score, fibrotic score and level of enzyme ALT. Results: From 38 patients, 21 patients (55.3%) had ALT level of 3-5 times above the upper normal limit (ULN) and 5 patients (13.2%) had ALT level more than 5 time of the upper normal limit. 60% of patients had portal inflammation score ≥ 3 and 21% of patients had fibrosis score ≥ 3. Portal inflammatory score was increased according to increase level of ALT significantly (p-value \< 0.05). The study revealed that portal inflammatory score in CHB with fibrosis score ≥ 3 was significantly higher than non-fibrotic CHB (2.75 vs 1.64, p-value \< 0.05). ALT level and HBV DNA level between CHB with fibrosis score ≥ 3 and non-fibrotic CHB were not different (127 U/L vs 112 U/L), (1.1 x 106 cp/ml vs 1.2 x 106 cp/ml) (p-value \> 0.05). Conclusion: The level of alanine aminotransferase enzyme related well with the degree of portal necro-inflammatory score but did not relate with the degree of fibrosis. Vajira Med J 2007 ; 51 : 9- 17