Salvage Treatment and Outcomes of Locally Advanced Cervical Cancer after Failed Concurrent Chemoradiation with or without Adjuvant Chemotherapy: Post Hoc Data Analysis from the ACTLACC Trial.

OBJECTIVES: To evaluate the type of salvage treatment and outcomes of patients with locally advanced cervical cancer who failed treatment with concurrent chemoradiation with or without adjuvant chemotherapy. METHODS: This was post hoc analyses of data from the randomized trial which included 259 patients who had FIGO stage IIB-IVA and had either pelvic radiation therapy concurrent with cisplatin followed by observation or paclitaxel plus carboplatin. Data of the patients who failed primary treatment were collected: type of salvage treatments, time to progress after salvage therapy, progression-free (PFS) and overall survivals (OS). RESULTS: After primary treatment, 85 patients had either persistence (36.5%), progression (18.8%), or recurrences (44.7%). The sites of failure were loco/regional in 52.9%, systemic failure in 30.6%, and loco-regional and systemic in 16.5%. Chemotherapy was given in 51.8%, being the sole therapy in 34.1%. Majority were combination agents (31.8%), with paclitaxel/carboplatin as the most common regimen. Radiation to the metastatic sites along with chemotherapy was used in 14.1% whereas palliative radiation therapy or supportive care was used in approximately 10% of each. The median time from the start of salvage treatment to progression was 9.2 months (range 0.2-64.0 months) with median PFS of 11.2 months (95% CI, 7.2-15.3 months). Median overall survival 27.3 months (95% CI, 4.4-69.6 months). CONCLUSIONS: Chemotherapy, either alone or with radiation therapy, was the most common salvage treatment in LACC after failure from primary treatment. The time to progress and PFS were less than 1 year with OS of approximately 2 years.

Long-Term Outcomes and Sites of Failure in Locally Advanced, Cervical Cancer Patients Treated by Concurrent Chemoradiation with or without Adjuvant Chemotherapy: ACTLACC Trial.

OBJECTIVES: To evaluate sites of failure and long-term survival outcomes of locally advanced stage cervical cancer patients who had standard concurrent chemo-radiation (CCRT) versus those along with adjuvant chemotherapy (ACT) after CCRT. METHODS: Patients aged 18-70 years who had FIGO stage IIB-IVA without para-aortic lymph node enlargement (excluding by International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IIIC2r), The Eastern Cooperative Oncology Group (ECOG) scores 0-2, and non-aggressive histopathology were randomized to have CCRT with weekly cisplatin followed by observation (arm A) or ACT with paclitaxel plus carboplatin every 4 weeks for 3 cycles (arm B). RESULTS: From 2015-2017, 259 patients were evaluated. The majority of patients were in stage II and had squamous cell carcinoma with a median tumor size of 5 cm. After the median follow-up of 40.87 months, 17.1% of the patients in arm A and 12.3% of the patients in arm B experienced recurrences (p=0.280). Adding all events of failure (persistence/progression/recurrence), treatment failures tended to be lower in arm A than in arm B: 13.2 versus 21.5 % for loco-regional failure (p = 0.076) and 3.9 versus 6.9% for loco-regional failure and systemic failure (p = 0.278). On the other hand, systemic failure tended to be higher in arm A than in arm B: 13.2% versus 6.9% (p =0.094). The 5-year progression-free survival and 5-year overall survival of patients in both arms were not significantly different. CONCLUSIONS: ACT with paclitaxel plus carboplatin after CCRT did not improve response or survival of patients compared to CCRT alone. Although systemic failure tended to be lower in patients who had ACT after CCRT than those who had only CCRT, loco-regional failure with or without systemic failure tended to be higher. However, all of these differences were not statistically significant.

Treatment Outcomes of Patients With Cervical Intraepithelial Neoplasia or Invasive Carcinoma Who Underwent Loop Electrosurgical Excision Procedure.

BACKGROUND: This study aimed to evaluate the treatment outcomes of cervical intraepithelial neoplasia (CIN) or cancer patients who underwent loop electrosurgical excision procedure (LEEP) in terms of primary outcome and factors associated with persistence/recurrence. METHODS: Patients with CIN or cancer who underwent LEEP from January 2007 to December 2015 were reviewed. Data collected were age, parity, menopausal status, human immunodeficiency virus (HIV) infection, smoking, cervical cytology, histopathology from cervical biopsy and LEEP including margin status, final histopathology, and follow-up data. RESULTS: The mean age of 385 patients was 41.9 ± 10.8 years (range 18 - 79 years). Majority were multiparous (81.6%) and premenopausal (78.2%). There were 15.3% of patients with HIV infection. The most common cervical cytology was high-grade squamous cell intraepithelial lesion (HSIL, 44.1%), followed by atypical squamous cells of undetermined significance (ACS-US, 21%). Minor complications of bleeding or infection from LEEP were encountered in 7.3%. Among 153 patients (39.7%) who had positive margin(s), 43 underwent second LEEP, whereas 76 had hysterectomy. From all patients, 47 had failure after treatment (12.2%), being either persistence (30 patients; 7.8%) or recurrence (17 patients; 4.4%). Factors associated with persistence or recurrence by multivariate analysis were age ≥ 55 years old, HIV infection, final diagnosis of invasive cancer, and positive endocervical margin or both ecto- and endo- cervical margins. CONCLUSIONS: LEEP had low rate of persistence/recurrence. Age ≥ 55 years old, HIV infection, final diagnosis of cancer, and positive endocervical or both endo- and ecto- surgical margin(s) were significantly associated with persistent or recurrent diseases.

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.

Prevalence and Associated Factors of Abnormal Cervical Cytology and HighRisk HPV DNA among Bangkok Metropolitan Women.

BACKGROUND: Many strategies are required for cervical cancer reduction e.g. provision of education cautious sexual behavior, HPV vaccination, and early detection of preinvasive cervical lesions and invasive cancer. Basic health data for cervical cytology/ HPV DNA and associated factors are important to make an appropriate policy to fight against cervical cancer. AIMS: To assess the prevalence of abnormal cervical cytology and/or HPV DNA and associated factors, including sexual behavior, among Bangkok Metropolitan women. MATERIALS AND METHODS: Thai women, aged 25to65 years old, had lived in Bangkok for ≥5 years were invited into the study. Liquidbased cervical cytology and HPV DNA tests were performed. Personal data were collected. MAIN OUTCOMES MEASURES: Rates of abnormal cytology and/ or highrisk HPV (HRHPV) and factors associated with abnormal test(s) were studied. RESULTS: Abnormal cytology and positive HRHPV were found in 6.3% (279/4442 women) and 6.7% (295/4428), respectively. The most common abnormal cytology was ASCUS (3.5%) while the most common HRHPV genotype was HPV 16 (1.4%) followed by HPV 52 (1.0%), HPV 58 (0.9%), and HPV 18 and HPV 51 at equal frequency (0.7%). Both tests were abnormal in 1.6% (71/4428 women). Rates of HRHPV detection were directly associated with severity of abnormal cytology: 5.4% among normal cytology and 13.0%, 30.8%, 40.0%, 39.5%, 56.3% and 100.0% among ASCUS, ASCH, AGCNOS, LSIL, HSIL, and SCC, respectively. Some 5% of women who had no HRHPV had abnormal cytology, in which 0.3% had ≥ HSIL. Factors associated with abnormal cytology or HRHPV were: age ≤40 years, education lower than (for cytology) or higher than bachelor for HRHPV), history of sexual intercourse, and sexual partners ≥2. CONCLUSIONS: Rates for abnormal cytology and HRHPV detection were 6.3% and 6.7% HRHPV detection was directly associated with severity of abnormal cytology. Significant associated factors were age ≤40 years, lower education, history of sexual intercourse, and sexual partners ≥2.

Expression of the p16 and Ki67 in Cervical Squamous Intraepithelial Lesions and Cancer.

PURPOSE: To evaluate the expression of p16 and Ki67 in cervical intraepithelial neoplasia (CIN) and cancer. MATERIALS AND METHODS: We performed a immunohistochemical study of p16 and Ki67 in 243 cervical tissues 53 nondysplastic lesions, 106 CIN1, 61 CIN2/3 and 23 squamous cell carcinomas. The expression of p16 and Ki67 was interpreted independently by 2 researchers and the sensitivity and specificity to detect clinically significant lesions (≥ CIN2) were determined. RESULTS: The overall agreement results of positive or negative immunostaining of intrainter observer variability were 0.659 for p16 and 0.808 for Ki67. p16 expression was demonstrated in 91.3% of invasive carcinomas, 78.7% of CIN2/3, 10.4% of CIN1 and 9.4% of nondysplasic lesions. The corresponding Ki67 expression was: 100% of all invasive carcinomas, 75.4% of CIN2/3, 22.6% of CIN1, and 11.3% with nondysplasia. The expression was significantly different between CIN2/3 vs CIN1 for both p16 and Ki67 (pvalues <0.001 both), and cancer vs CIN2/3 for Ki67 (pvalue 0.008). The differences were not significant between CIN1 vs nondysplasia (pvalues 1.000 for p16 and 0.130 of Ki67), and cancer vs CIN2/3 for p16 (p value 0.219). The sensitivity and specificity to detect > CIN2 were 84.5% and 90.5% by p16 and 82.1% and 88.6% by Ki67. CONCLUSIONS: The rates for 16 and Ki67 expression were directly associated with the severity of cervical lesions. Significant differences in these markers expression may be useful in cases with equivocal histologic features among cervical intraepithelial lesions, but not between CIN1 and nondysplastic lesions. The two markers had high sensitivity and specificity in determining >CIN2.

Knowledge and Attitudes of Bangkok Metropolitan Women towards HPV and Self-Sampled HPV Testing.

BACKGROUND: To evaluate knowledge of Bangkok women regarding HPV and self-sampled HPV testing, and their attitudes towards testing. MATERIALS AND METHODS: Thai women who had lived in Bangkok for more than 5 years, aged 25-to-65 years old, were invited to join the study. Participating women were asked to a complete self-questionnaire (Thai language), with literate assistance as needed. The questionnaire was divided into 3 parts: (I) demographic data, (II) knowledge and (III) attitudes towards self-sampled HPV testing. Before proceeding to Part III of the questionnaire, a 15-minute educational video of self-sampled HPV testing was presented to all participants. RESULTS: Among 2,810 women who answered the questionnaires, 33.7% reported that they did not know about HPV. The characteristic features of these women were older age (>50 years), lower income (<600 USD/month), unemployed status, and non-attendees at cervical cancer screening. Only small numbers of women (4.6%) responded that they had heard about self-sampled HPV testing. After having information, 59.6% would not use the self-sampled HPV testing as a method of cervical cancer screening (non-acceptance). Factors significantly associated with the non-acceptance were older age, lower income, having no knowledge about HPV or self-collected HPV testing, a perception that the testing was unreliable and a concern that they might not be able to perform it correctly. CONCLUSIONS: Nearly half and almost all Bangkok women did not know about HPV and self-sampled HPV testing, respectively. Approximately 60% of Bangkok women refused to do the self-sampled HPV testing. Significant negative attitudes were concerns that the testing would be unreliable and a lack of confidence to perform the procedure correctly. Education about HPV and self-sampled HPV testing, ease of the procedure, or the testing models may increase rate of acceptability or positive attitudes.

Uterine Sarcoma: Clinical Presentation, Treatment and Survival Outcomes in Thailand.

BACKGROUND: Uterine sarcoma is a group of rare gynecologic tumors with various natures, and different lines of treatment. Most have a poor treatment outcome. This study targeted clinical characteristics, treatment, overall survival (OS), progression-free survival (PFS), and prognostic factors in uterine sarcoma patients in one tertiary center for cancer care. MATERIALS AND METHODS: Uterine sarcoma patients who were treated at the Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital between January 1994 and December 2014 were identified. Clinico-pathological data were analyzed. Prognostic outcomes were examined by Kaplan-Meier curves and Cox regression analysis. RESULTS: We identified 46 uterine sarcoma patients: 25 carcinosarcoma (CS) (54.3%), 15 leiomyosarcoma (LMS) (32.6%), and 6 undifferentiated uterine sarcoma (UUS) (13.1%) cases. Mean age was 54.0±11.9 years (range 25-82 years). Abnormal uterine bleeding was the most common presenting symptom (63.0%). Among 33 patients (71.7%) who had pre-operative tissue collected, diagnosis of malignancy was correct in 29 (87.9%). All patients received primary surgery and retroperitoneal lymph nodes were resected in 34 (73.9%). After surgery, 5 (10.9%) had gross residual tumors. Stage I disease was most commonly found (56.5%). Adjuvant treatment was given to 27 (58.7%), most commonly chemotherapy. After a median follow-up of 16.0 months (range 0.8-187.4 months), recurrence was encountered in 22 patients (47.8%). Median time to recurrence was 5.8 months (range1.0-105.5 months). Distant metastasis was more common than local or loco- regional failure. The 2-year PFS was 45.2% (95% confidence interval [CI], 30.6%-59.7%) and the 2-year OS was 48.3% (95% CI, 33.3%-60.7%). Multivariable analyses found residual disease after surgery as a significant factor only for PFS. CONCLUSIONS: Uterine sarcoma is a rare tumor entity. Even with multimodalities of treatment, the prognosis is still poor. Successful cytoreductive surgery is a key factor for a good survival outcome.

Knowledge, Attitudes and Behavior of Bangkok Metropolitan Women Regarding Cervical Cancer Screening.

PURPOSE: To assess knowledge, attitudes and cervical cancer screening behavior of Bangkok Metropolitan women. MATERIALS AND METHODS: Thai women, aged 25-to-65 years old, having lived in Bangkok for 5 years or more were invited to participate in the study. After signing informed consent, all women were asked to complete a self-questionnaire (Thai language) with literate assistance if needed. The questionnaire was divided into 3 parts: (I) demographic data; (II) knowledge about cervical cancer screening; and (III) behavior and attitudes, towards cervical cancer screening. Adequate screening was defined as women who had ≥two cervical cancer screening tests except women aged 25-30 years who may have only one screening, and the last screen was within 5 year or had had regular screening. RESULTS: Of 4,339 women, there were 1,857 (42.8%) with adequate screening and 2,482 (57.2%) with inadequate screening. Significant factors associated with inadequate screening included age < 45 years, pre-menopausal status, family monthly income <625 USD, no reported sexual intercourse, nulliparous, no knowledge, lack of awareness and poor attitudes. Three major reasons provided by women for inadequate screening were no symptoms (54.4%), fear of pain (33.2%), and embarrassment (34.6%). CONCLUSIONS: Personal features, knowledge, and attitudes influence screening behavior of Bangkok Metropolitan women. The three most common reasons of women for not undergoinging screening are no symptoms, fear of pain, and embarrassment. These factors should be the focus of attention to improve coverage of cervical cancer screening in Bangkok.

Other Gynecologic Pathology in Endometrial Cancer Patients.

BACKGROUND: To evaluate the prevalence and features of other gynecologic or surgical lesions in endometrial cancer (EMC) patients. MATERIALS AND METHODS: Clinico-pathological data of EMC patients who were treated in the institution from 1995 to 2012 were collected. Data collected were age, stage of disease according to the FIGO 2009 criteria (FIGO), histopathology, tumor grade, adjuvant therapy, other gynecologic or surgical lesions, follow-up period, and living status. RESULTS: The mean age of 396 patients was 56.7 ± 10.64 years. Abnormal uterine bleeding was the most common presenting symptom (90.1%). Bleeding was accompanied with pelvic mass in 7.7% and 5.4% had only a pelvic mass. Abnormal cervical cytology was found in 3.8%. Approximately 75% had early stage diseases and 86% had endometrioid histology. We found 55.8% of EMC patients had other gynecologic lesions: 89.6% benign and 9.5% malignant. Some 4.5% had pre-invasive cervical/vulva/vagina lesions. The two most common gynecologic lesions were myoma uteri and ovarian tumors. Focusing on the latter, approximately 14% were benign while 8% were malignant. Among 364 patients with available data, surgical lesions were found in 11.8%, 5.7% benign and 9.2% malignant. The most common benign surgical condition was chronic appendicitis while breast and colon cancers were the two most common malignant lesions found. CONCLUSIONS: More than half of EMC patients had other gynecologic lesions including benign and malignant tumors. Surgical lesions were also found in more than one-tenth of patients. Careful pre-operative evaluation and intra-operative inspection are advised for proper management and better prognosis.

Synchronous and metachronous malignancy in endometrial cancer patients treated in a tertiary care center of Thailand.

OBJECTIVE: To evaluate the prevalence and features of non-endometrial cancers in Thai endometrial cancer (EC) patients. METHODS: EC patients treated in our institution were identified and the following data were collected: age, EC stage, histopathology, adjuvant therapy, other cancers, living status, and cause of death. RESULTS: The mean age of the 344 patients was 56.8 ± 10.8 years. Fifty (14.5%) had other synchronous and metachronous cancers. Mean ages of the patients with or without other cancers were not significantly different, 55.7 ± 10.04 years versus 57.1 ± 11.0 years, respectively (p=0.358). History of any cancer in the family and tumor in the lower uterine segment were more frequent among the patients with other cancers (6.0% vs. 1.7%, p=0.095; 12.0% vs. 1.0%, p<0.001; respectively). Six patients had ≥ 2 other cancers. Ovarian, breast, and colon were the three most common other cancers. After a median follow-up of 57.1 months, 18.3% of patients had died: 30.0% of patients with other cancers and 16.3% of those without other cancers. The corresponding EC deaths were 14.0% and 11.2%. The 5-year overall survival was significantly lower in patients who had other cancers: 79.3% (95% confidence interval [CI], 68.3 to 90.3) vs. 86.0% (95% CI, 81.7 to 90.3) than in those without (p=0.023). However, the corresponding disease-specific survival was not significantly different: 85.1% (95% CI, 75.5 to 94.7) compared with 89.0% (95% CI, 85.1 to 92.9), respectively (p=0.514). CONCLUSION: Thai EC patients had a high incidence of other cancers. Overall survival of EC patients who had other cancers was worse than those without, while disease-specific survival was not significantly different.

Patterns of adjuvant therapy for endometrial cancer: single institutional experience in Thailand.

AIM: The aim of this study was to evaluate the use of adjuvant therapy and treatment outcomes in patients with endometrial cancer (EMC). METHODS: Patients with EMC treated in the institution were identified. Data collected were age, stage of disease, histopathology, and adjuvant therapy. Progression-free survival (PFS) and overall survival (OS) were studied. RESULTS: The median age of 383 patients was 57 years (30-86 years). Majority had early-stage diseases (76.5%), endometrioid histopathology (87.2%), and high-grade tumors (74.9%). Less than half (44.4%) had adjuvant therapy. Pelvic radiation was the most common type of adjuvant treatment. We found that 25.7% of stages III to IV patients did not have adjuvant therapy (mainly from old age or poor performance status). On the other hand, 21.5% of patients with stage IA had adjuvant treatment (owing to risk factors or other synchronous cancers). The 5-year PFS and 5-year OS (95% confidence interval) were 84.3% (80.5%-88.1%) and 81.2% (77.1%-85.4%), respectively. Significant prognostic factors for survival by univariable analyses were stage, tumor grade, and histopathology. By multivariable analyses, significant prognostic factors were stage, tumor grade (only for OS), histopathology, and adjuvant therapy. Focusing on stage and adjuvant therapy, we found that the PFS and OS of early-stage patients who had or did not have adjuvant therapy were not significantly different, whereas the PFS and OS of advanced-stage patients who had adjuvant treatment were significantly higher than the PFS and OS of those who did not have adjuvant treatment. CONCLUSIONS: The use of adjuvant therapy for patients with EMC was not according to the standard recommendation in all patients for many reasons. The benefit of adjuvant therapy was demonstrated in advanced- but not in early-stage cancer.

Medical morbidities in endometrial cancer patients.

OBJECTIVES: The aim of this study was to evaluate the prevalence and types of medical morbidities in Thai endometrial cancer (EMC) patients and their impact on treatment outcomes. METHODS: The EMC patients treated in the institution from 1995 to 2012 and with available medical history were identified. Data collected were age; medical morbidities; tumor stage, histopathology, and grade; adjuvant therapy; living status; and cause of death. RESULTS: Of the 335 EMC patients included in the study, 77.3% had early-stage diseases, and 46.6% received adjuvant therapy. A total of 220 patients (65.7%) had medical morbidities. Median age of patients with medical morbidities was significantly higher than those without: 59 years (range, 30-84 years) versus 52 years (range, 30-86 years) (P < 0.001). One or more components of metabolic syndrome were the most common: 10.9% had all 4 components, 30.0% had three, and 31.4% had two. Thyroid dysfunction, as the second most common, was found in 8.2%. From a median follow-up of 56.5 months (0.07-234.04 months), 18.5% were dead: 11.6% from EMC, 4.8% from medical conditions, and 2.1% from other causes. Survival of the patients who had or had no medical morbidities was not significantly different: 5-year overall survival and 5-year cancer-specific survival were 84.7% (95% confidence interval [CI], 79.6%-89.8%) versus 84.0% (95% CI, 76.9%-91.0%) (P = 0.918) and 87.3% (95% CI, 82.6%-92.0%) versus 89.3% (95% CI, 83.2%-95.3%) (P = 0.986), respectively. CONCLUSION: This was the first large analysis in South-East Asia showing common incidence of medical morbidities in EMC patients. One or more components of metabolic syndrome were the most common. Some medical illnesses were the causes of death. Comprehensive and continual medical care for EMC patients is important.

Treatment outcomes of gemcitabine in refractory or recurrent epithelial ovarian cancer patients.

BACKGROUND: To study the response rate (RR), progression-free survival (PFS) and toxicity profiles of recurrent epithelial ovarian cancer (EOC) patients treated with gemcitabine. MATERIALS AND METHODS: Recurrent EOC patients who were treated with gemcitabine between January 2000 and December 2013 at the Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital were identified and medical records were reviewed. Clinico-pathological features including data of gemcitabine treatment, response and toxicity were collected. RESULTS: We identified 43 EOC patients who had gemcitabine treatment. All except one patient who did not receive any adjuvant treatment, had received platinum-based chemotherapy. Among these 42 patients, 31.0% had refractory cancer to first-line chemotherapy while 69.0% had recurrence with 48.8% being platinum- sensitive. The total cycles of gemcitabine used were 203 (median 4, range 2-9 cycles). Overall RR was 11.6%: 19% in platinum-sensitive vs 4.5% in platinum-resistant groups (p=0.158) and 42.9% in the patients having gemcitabine together with platinum vs 5.6% using gemcitabine alone (P=0.024). Median PFS was 3.6 months (95% confidence interval [CI], 2.73-4.49 months): 8.1 months (95% CI, 2.73-4.49 months) in combination regimen vs 3.2 months (95% CI, 2.01-4.42 months) in single regimen (p=0.077) and 8.1 months (95% CI, 4.73-11.48 months) with the gemcitabine combination vs 2.7 months (95% CI, 1.98-3.38 months) by single gemcitabine in platinum sensitive patients (P=0.007). Common toxicities were hematologic which were well tolerated and manageable. CONCLUSIONS: Gemcitabine has modest activity in pre-treated EOC. A combination regimen had higher activity than single agent in platinum sensitive patients with a significant improvement in RR and PFS.

Treatment outcomes of paclitaxel for refractory or recurrent epithelial ovarian cancer patients in Thailand.

BACKGROUND: To study the response rate, toxicity profiles, and survival of refractory or recurrent epithelial ovarian cancer (EOC) patients treated with paclitaxel. MATERIALS AND METHODS: Patients with refractory or recurrent EOC who were treated with paclitaxel between January 2002 and December 2011 at the Department of Obstetrics and Gynecology, Faculty of Medicine, Vajira Hospital were identified. Clinicopathological features of the patients including detailed data of paclitaxel treatment were collected. RESULTS: During the study period, a total of 44 patients were identified, with a mean age of 52.9±8.2 years. Some 13.6% (six patients) had refractory cancer to first-line chemotherapy while 86.4% (38 patients) had recurrent cancer. Among these, 35 (79.6%) and 9 (20.4%) patients were considered as platinum-sensitive and platinum-resistant, respectively. Three patients (6.8%) received fewer than 2 cycles of paclitaxel due to loss to follow-up, leaving 41 patients evaluable for response. The overall response rate observed in all 41 patients was 41.5% (17 patients; 12 complete and five partial responses): 12.5% or 1/8 patients with refractory or platinum-resistant cancer and 48.5% or 16/33 patients with platinum-sensitive disease. Stable disease was demonstrated in 17.0% (seven patients) while progressive disease was apparent in 41.5% (17 patients). Median time to progress was 4.5 months (range, 0.67- 58.6 months). Median progression-free survival was not reached while median overall survival was 16.3 months (95% confidence interval, 11.0 months -21.6 months). Common toxicities were neutropenia, neuropathy, and alopecia. CONCLUSIONS: Paclitaxel is an active agent for refractory or recurrent EOC. Neutropenia, neuropathy and alopecia are common side effects.

Endometrial carcinoma: clinical characteristic and survival rates by the new compared to the prior FIGO staging systems.

OBJECTIVE: To compare clinical characteristic features and survival rates of endometrial cancer (EMC) patients according to the new 2009 and prior 1988 FIGO staging systems. MATERIAL AND METHOD: Clinico-pathological data of EMC patients who had primary surgical treatment between 1992 and 2008 were collected. The new FIGO staging was compared to the prior assigned staging. Survivals of patients according to prior and new staging were compared RESULTS: Data from 259 patients was reviewed. Mean age was 55.4 +/- 9.9 years. Radiation was the most common adjuvant therapy after surgery, 95/106 patients (89.6%). Progression and recurrences occurred in 34 patients (16 with progression and 18 with recurrence) while 47 died (18.1%). Comparing the prior and current staging, early stage I-II was commonly found in both systems. Stages were the same in 81 patients (31.3%), lower in 177 (68.3%), and higher in one (0.4%). After a median follow-up of 57.5 months, 5-year progression-free, cancer-specific and overall survivals according to the prior and new systems were similar in stage III-IV. Survivals of new stage IA (from 16-prior stage IA, 124-IB, 12-IIA, and 1-IIIA) and stage IB (from 32-IC and 8-IIA) were worse than those of prior stage IA or IB. Survivals of the new stage II patients (11-IIB) were the same as prior stage IIB. CONCLUSION: The "new" FIGO staging system for endometrial cancer patients resulted in lower stage in a large number of patients. Survival trends were worse in the new stage I and remained similar in the other stages.

Expression of ER, PR, and Her-2/neu in endometrial cancer: a clinicopathological study.

OBJECTIVE: To determine any association between expression of estrogen receptor (ER), progesterone receptor (PR), and Her-2/neu and clinicopathological features, including survival, of endometrial carcinoma (EMC) patients. METHODS: Samples of formalin-fixed, paraffin-embedded tissue of 108 patients with EMC treated at our institution between January 1994 and December 2007 were immunohistochemically studied. RESULTS: ER, PR, and Her-2/neu expression were positive in 59.3%, 65.7% and 2.8% of cases, respectively. Positive ER expression was significantly associated with grade I-II tumor while PR expression was linked with endometrioid histology, grade I-II tumor, less myometrial invasion (MI) and negative lymph node involvement. Her-2/neu expression was significantly associated with deep MI, while positive ER and negative Her-2/neu expression in combination was significantly associated with longer disease-free and overall survival. CONCLUSION: ER expression is a good prognostic factor while Her-2/neu expression appears to be a poor indicator for both disease-free and overall survival, while PR tended to show favorable influence for only disease-free survival of Thai EMCs.

Clinicopathological features including hormonal receptor expression and survival in young endometrial cancer patients: a case control study.

OBJECTIVE: To compare clinicopathological features, including hormonal receptor expression and survival, in young Thai endometrial carcinoma (EMC) patients with older patients. METHODS: Young EMC patients aged ≤45 years, treated in the institution from 1992 to 2008, were identified as cases. Controls included EMC patients aged >45 years who had an operation on the nearest dates to the cases. Clinicopathological data and survival of the cases and controls were compared. RESULTS: Mean ages of 41 cases and 123 controls were 40.4 ± 3.7 years and 58.4 ± 8.3 years, respectively. Cases were significantly different from controls in terms of having more nulliparity (58% vs 25%), less medical illness (57% vs 79%), more low-grade tumors (49% vs 14%), more positive estrogen (78% vs 56%) and progesterone (97% vs 61%) receptors expression, and fewer nodal metastases (3% vs 21%). Adjuvant therapy was administered in 29% of the cases and 46% of the controls. From a median follow up of 51 months, cases had significantly fewer progression events and recurrence (5% vs 19%), cancer-related deaths (2% vs 16%), and all deaths (5% vs 23%), with significantly longer 5-year disease-free (97.2% vs 79.6%, p=0.023), cancer-specific (97.1% vs 83.2%, p=0.020), and overall survival (93.1% vs 78.8% p=0.005) than controls as determined by univariate analysis. Survival of cases and controls were not significantly different after adjusting for other prognostic factors. CONCLUSION: Young Thai EMC patients had more favorable clinicopathological features with significantly longer survival than older patients as determined by univariate analysis.

Endometrial cancer in Thai women: clinico-pathological presentation and survival.

OBJECTIVE: To assess the characteristic features, treatment, survival, and prognostic factors of Thai endometrial cancer (EMC) patients. METHODS: Clinico-pathological data of EMC patients who were treated in the institution from 1992 to 2008 were collected. Survival rates and prognostic factors were studied. RESULTS: The mean age of the 261 patients was 55.4 ± 9.92 years. The most common complaint was abnormal uterine bleeding (87.3%). More than half (75.4%) had other medical illnesses or other cancers (10.7%). The majority (78%) had early stage disease. Post-operative adjuvant therapy was given in 41.4%; the most common was radiation therapy (37.2%). From a median follow-up of 57.5 months (range 0.03-212.3 months), progressive disease was encountered in 16 patients. Eighteen experienced recurrence (three local, 13 distant metastases and two local and distant). Overall, 30 patients died of cancer, while 18 died of other medical illnesses. The 5-year progression-free, cancer specific, and overall survivals (95% confidence intervals) were 86.5% (82.1-90.8%), 88.0% (83.9-92.2%), and 83.6% (78.7-88.4%), respectively. Significant prognostic factors for survival were: histology, grade, depth of myometrial invasion, cervical involvement, lymphovascular invasion, lymph node status, and Her-2/ neu expression. CONCLUSION: Most endometrial cancer patients in Thailand present at early stages and experience good survival outcomes.