High-dose Intensity-modulated proton therapy versus Standard-dose Intensity-modulated RadIation therapy for esophageal squamous cell carcinoma (HI-SIRI): study protocol for a randomized controlled clinical trial.

BACKGROUND: Chemoradiotherapy is the standard of care for esophageal cancer as a neoadjuvant treatment before surgery, or as a definitive treatment for unresectable disease. Intensity-modulated radiotherapy (IMRT) has been considered the standard radiation technique. However, patients suffer from treatment-related toxicities, and most die from disease progression or recurrence. With emerging technological advancement, proton therapy has theoretical advantages over IMRT because it offers apparent dosimetric benefits to allow dose escalation to the target while better sparing surrounding tissues such as the lungs, heart, liver, and spinal cord. The purpose of this study protocol is to investigate the survival benefit of proton therapy using modern intensity-modulated proton therapy (IMPT) compared to standard IMRT for esophageal cancer. METHODS: This is a two-arm open phase II/III multi-institution randomized controlled trial. Eligible patients will have histologically confirmed squamous cell carcinoma of the thoracic esophagus with no evidence of tracheoesophageal/esophagobronchial fistula or distant metastasis. After stratification according to resectability status (resectable vs. borderline resectable/unresectable), a total of 232 patients will be randomized to receive IMPT or IMRT using a 1:1 allocation ratio. In resectable cases, surgical resection following concurrent chemoradiation will be attempted for the patients who are medically fit at the time of surgery. In those with initially borderline resectable/unresectable disease, definitive concurrent chemoradiation will be performed. The phase II study will assess safety (toxicity and postoperative complications) and feasibility (recruitment rate and chemoradiation dose modification) in 40 patients into each arm. The study will then continue into phase III, further recruit 76 patients into each arm, and compare progression-free survival between IMPT vs IMRT groups. The secondary endpoints will be overall survival, local and distant control, toxicities, health-related quality of life, and cost-utility. This protocol describes a detailed radiotherapy and chemotherapy. DISCUSSION: This randomized clinical trial will demonstrate the clinical benefit of IMPT in esophageal cancer treatment in terms of survival and toxicity outcomes which will further establish high-level evidence for radiation modality in squamous cell carcinoma of the thoracic esophagus. TRIAL REGISTRATION: TCTR20200310006 . Registered 10 March 2020.

A comparison of six approaches for measuring utility values among patients with locally advanced cervical cancer.

BACKGROUND: Several instruments are available to measure health utility values. However, limited studies have not yet comprehensively assessed the agreement among these instruments. This study therefore aimed to investigate the performance and agreement of six instruments for utility measures: EQ-5D-3L, EQ-5D-5L (cTTO model), EQ-5D-5L (DCE model), EQ-5D-5L (Hybrid model), TTO, and VAS, among locally advanced cervical cancer (LACC) patients in Thailand. METHODS: We compared utility scores derived from six approaches using Friedman's test. We also assessed the agreement of utility scores between each pairwise comparison by intraclass correlation coefficient (ICC) and Bland-Altman plot. RESULTS: The mean (SD) utility values derived from six approaches were as follows: 0.755 ± 0.248 (EQ-5D-3L), 0.801 ± 280 (TTO), 0.806 ± 0.156 (VAS), 0.871 ± 0.184 (cTTO model), 0.875 ± 0.168 (Hybrid model), and 0.900 ± 0.142 (DCE model). Significant differences across six approaches were found in Friedman's test. The ICC showed high agreement between EQ-5D-5L and EQ-5D-3L, and very high agreement between all three models of EQ-5D-5L. The Bland-Altman plots showed wide limit of agreement, except the pairwise comparison, between each model of the EQ-5D-5L. CONCLUSION: TTO, VAS, EQ-5D-3L and EQ-5D-5L could not be used interchangeably in LACC patients. The impact of using different instruments on economic evaluation findings warrants further investigation.

Cost-Effectiveness Analysis of Diagnostic Tests for Para-Aortic Lymph Node Detection in Locally Advanced Cervical Cancer.

PURPOSE: We aimed to determine the cost-effectiveness of diagnostic tests, ie, computed tomography (CT), magnetic resonance imaging (MRI), and fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) for para-aortic lymph node detection (PALND), in locally advanced cervical cancer (LACC) patients (stages IB3-IVA) with or without laparoscopic lymphadenectomy (LL) compared with no investigation (NoIx) based on provider and societal perspectives during 5 years. PATIENTS AND METHODS: Hybrid decision tree and Markov models were conducted to compare the cost and utility of six interventions including: 1) CT without LL, 2) CT with LL, 3) MRI without LL, 4) MRI with LL, 5) PET/CT without LL, and 6) PET/CT with LL compared with NoIx. All clinical parameters were obtained from published studies. Costs were presented in year 2019 values. Direct medical costs were retrieved from hospital database, while direct non-medical costs and utility were collected from interviewing 194 LACC patients during June to December 2019. One-way and probabilistic sensitivity analysis were used to investigate parameter uncertainties. RESULTS: Total costs of NoIx were $8026 and $11,444 from provider and societal perspectives, respectively, and quality-adjusted life year (QALY) was 3.70. NoIx was more effective and less costly. When six strategies were compared with NoIx, more additional costs were shown with $1835, $1735, $2022, $1987, $4002, and $4176 for CT without LL, CT with LL, MRI without LL, MRI with LL, PET/CT without LL, and PET/CT with LL, whereas QALYs were decreased with 0.07, 0.08, 0.07, 0.08, 0.05, and 0.07, respectively. Sensitivity analyses strengthened the benefit of NoIx. The most significant parameter was treatment outcomes of patients with PALN metastasis. CONCLUSION: NoIx or receiving basic clinical staging was a dominant option when compared with CT, MRI, and PET/CT for PALND before providing the treatment for LACC patients.

The Cost of Locally Advanced Cervical Cancer in Thailand: an Empirical Study for Economic Analysis.

OBJECTIVE: To evaluate cost of illness of locally advanced cervical cancer patients from societal perspective in three scenarios including completely cured without severe late side effects (S1), completely cured with late grade 3-4 gastrointestinal side effects (S2.1) or genitourinary side effects (S2.2), and disease recurrence and death (S3). METHODS:  The incidence-based approach was conducted. The cost was calculated for 5-year time horizon starting for the treatment initiation. Direct medical costs were extracted from hospital database. Cost of using two-dimensional technique and three-dimensional conformal radiation therapy were calculated separately. Direct non-medical costs and indirect costs in terms of productivity loss were based on actual expenses from the interview of 194 locally advanced cervical cancer patients from two tertiary hospitals in Bangkok, during June to December 2019. All costs were converted to US dollar in 2019 values. RESULTS: For 5 years, cost of illness per patient for using two-dimensional technique and three-dimensional conformal radiation therapy were US $8,391 and US $10,418 for S1, US $18,018 and US $20,045 for S2.1, US $17,908 and US $19,936 for S2.2, and US $61,076 and US $63,103 for S3, respectively. The economic burden for newly diagnosed locally advanced cervical cancer patients in Thailand in 2018 was approximately US $129 million and US $131 million for using two-dimensional technique and three-dimensional conformal radiation therapy, respectively. Cost from S3 accounted for 70% of all total cost. Premature death was the most important cost driver of cost of illness accounted for 64 % of the total cost estimates. CONCLUSIONS: Cost of illness of locally advanced cervical cancer patients produced significant economic burden from societal perspective. Disease recurrence and early death from cancer was the most influential cause of this burden.

Clinical Impact of Pelvic Lymph Node Status in Locally Advanced Cervical Cancer Patients Treated by Concurrent Chemoradiation Therapy.

OBJECTIVE: To explore the treatment outcomes of locally advanced cervical cancer (LACC) patients with pelvic lymph node enlargement (PLNE) or stage IIIC1 when compared with no PLNE and unknown PLN status (UNK). MATERIALS AND METHODS: Retrospective cohort study was designed by matching with the ratio of 1:4:4 for patients with PLNE, no PLNE and UNK between 2003 and 2017. The main factor which was used to match was clinical staging. RESULTS: All 360 LACC patients who treated as concurrent chemoradiation therapy (CCRT) were composed of 40 with PLNE, 160 with no PLNE and 160 with UNK. The majority of tumor histology (78.9%) was squamous cell carcinoma and 51.1% were diagnosed in stage IIB. Five-year progression free survival rates of patients with PLNE, no PLNE and UNK were 42.7%, 64.5% and 59.0%, respectively (P = 0.191), and corresponding with 5-year overall survival rates of 57.0%, 66.0% and 61.9% (P = 0.608). Patients with PLNE had local recurrence (LR) at 22.5%, compared with no PLNE at 11.3% and UNK at 11.9%. The most common site of LR for patients with PLNE was PLN with odds ratio of 19.7 when using no PLNE as reference (P < 0.001). There was no statistically significant difference between distant metastasis rates in PLN statuses of patients with PLNE, no PLNE and UNK at 20.6%, 30.0% and 26.3%, respectively.  Conclusions: LACC patients with PLNE had a trend of poorer survival rates than patients with no PLNE, while treatment outcomes of patients with UNK were not inferior to no PLNE.
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Comparison of Treatment Outcome between Hypofractionated Radiotherapy and Conventional Radiotherapy in Postmastectomy Breast Cancer.

OBJECTIVE: The aim of this study was to compare Conventional fractionated radiotherapy (CFRT) and Hypofractionated radiotherapy (HFRT) in terms of treatment outcomes, such as in 5-year loco-regional recurrence free survival, disease free survival, overall survival, and distant metastatic free survival rates as well as toxicity. MATERIALS AND METHODS: We retrospectively analyzed the data obtained from 462 breast cancer patients who received complete adjuvant radiotherapy treatment between January 2012 and December 2014. One hundred twenty eight patients received CFRT 2 Gy daily fractions at a total dose of 48-60 Gy (group 1), while 334 patients received HFRT 2.65-2.67 Gy daily for 15-19 fractions at a total dose of 39.7-47.8 Gy 9 (grup 2). Treatment outcome such as 5-year loco-regional recurrence free survival, disease free survival, overall survival, and distant metastatic free survival rates as well as toxicity were measured and compared between two groups. RESULTS: Median follow-up was 65.7 months (ranging from 45.1 to 95.2 months). Five-year loco-regional recurrence free survival rate was 96.1% in both CFRT and HFRT groups (p=0.993). Five-year disease-free survival rate of CFRT group was higher (68.8%), but this difference was not significant (HFRT =63.5%) (p=0.396). These were complied with 5-year overall survival rate (71.9% and 64.7%, p=0.385). Five-year distant metastatic free survival rate was 85.9% in CFRT group and 79.6% in HFRT group (p=0.169). No difference was observed between two groups in terms of toxicities, including changes in chest wall appearance, skin fibrosis, brachial plexopathy, arm edema, pulmonary fibrosis, and cardiovascular events. CONCLUSION: The treatment outcomes of hypofractionated radiotherapy in the postmastectomy breast cancer patients is comparable to the outcomes of conventional treatment at the Chonburi Cancer Hospital as previously reported from other studies, and HFRT can be implemented in resource-limited settings.

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.

Cost-utility analysis of 5-fluorouracil and capecitabine for adjuvant treatment in locally advanced rectal cancer.

BACKGROUND: Adjuvant chemotherapy at concurrent time with radiation therapy (RT) or at adjuvant time alone in locally advanced rectal cancer (LARC) is used with several regimens. The cost-utility analysis was conducted to compare administration of two 5-FU regimens and capecitabine in the aspect of provider and societal viewpoint. METHODS: Stage II or III rectal cancer patients who received pre-operative or post-operative concurrent chemoradiotherapy and adjuvant chemotherapy were compared by using decision tree model between (I) 5-FU plus leucovorin (LV) for 5 days per cycle (Mayo Clinic regimen); (II) 5-FU continuous infusion (CI) for 120-h per cycle (CAO/ARO/AIO-94 protocol); (III) standard regimen of capecitabine. All probability data were extracted from landmark study. Direct medical costs were the cost from database of Drug Medical Supply Information Center, while direct non-medical cost and utility were interviewed from stage II and III rectal cancer patients. The time horizon of this study was 5 years. Incremental cost-effectiveness ratio (ICER) was the final result in this study, which determined as the numerator of the difference of costs among three drug regimens, and the difference of quality-adjusted life years (QALYs) from each drug was the denominator. RESULTS: 5-FU plus LV was the cheapest and least efficacy for adjuvant treatment of LARC in both provider and societal viewpoint. In provider viewpoint, the ICERs of 5-FU CI and capecitabine were 334,550 THB/QALY (US $9,840/QALY) and 189,935 THB/QALY (US $5,586/QALY), respectively, with the corresponding societal viewpoint of 264,447 THB/QALY (US $7,778/QALY) and 119,120 THB/QALY (US $3,504/QALY) when 5-FU plus LV was used as comparator. The most influential parameter for value of treatment was acquisition cost of capecitabine. At the willingness to pay for one QALY gained in Thailand (160,000 THB or US $4,706), 5-FU plus LV, 5-FU CI and capecitabine had probabilities of cost-effectiveness of 63%, 2% and 35%, respectively. CONCLUSIONS: Capecitabine was the most expensive regimen but produced the higher effectiveness than 5-FU plus LV and 5-FU CI. The most influential parameter in the model was acquisition cost of capecitabine.

Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis.

PURPOSE: The purpose of the study is to compare the efficacy of benzydamine HCl with sodium bicarbonate in the prevention of concurrent chemoradiation-induced oral mucositis in head and neck cancer patients. METHODS: Sixty locally advanced head and neck cancer patients treated with high-dose radiotherapy concurrently with platinum-based chemotherapy were randomly assigned to receive either benzydamine HCl or sodium bicarbonate from the first day of treatment to 2 weeks after the completion of treatment. The total score for mucositis, based on the Oral Mucositis Assessment Scale (OMAS), was used for the assessment, conducted weekly during the treatment period and at the fourth week of the follow-up. Pain score, all prescribed medications, and tube feeding needs were also recorded and compared. RESULTS: The median of total OMAS score was statistically significant lower in patients who received benzydamine HCl during concurrent chemo-radiotherapy (CCRT) than in those who received sodium bicarbonate, (p value < 0.001). There was no difference in median pain score, (p value = 0.52). Nineteen percent of patients in sodium bicarbonate arm needed oral antifungal agents whereas none in the benzydamine HCl arm required such medications, (p value = 0.06). Tube feeding needs and the compliance of CCRT were not different between the two study arms. CONCLUSIONS: For patients undergoing high-dose radiotherapy concurrently with platinum-based chemotherapy, using benzydamine HCl mouthwash as a preventive approach was superior to basic oral care using sodium bicarbonate mouthwash in terms of reducing the severity of oral mucositis and encouraging trend for the less need of oral antifungal drugs.

Comparing treatment outcomes of stage IIIB cervical cancer patients between those with and without lower third of vaginal invasion.

OBJECTIVE: To evaluate treatment outcomes between stage IIIB cervical cancer with and without lower third of vaginal invasion (LTI) in terms of response to treatment and overall survival (OS). METHODS: Matching one patient with LTI for 2 patients without LTI who had completed treatment between 1995 and 2012 were conducted by using treatment modalities (radiation therapy [RT] alone vs. concurrent chemoradiation therapy [CCRT]) and tumor histology (squamous cell carcinoma [SCC] vs. adenocarcinoma [ADC]). Treatment outcomes including complete response (CR) rate of RT/CCRT, patterns of treatment failure and survival outcomes were analyzed. RESULTS: Of 216 stage IIIB cervical cancer patients, 114 of them had no LTI and 72 had LTI. Most of the patients (83.8%) had tumor histology as SCC. The CR rates between stage IIIB without LTI and with LTI were 93.8% and 81.9% (p=0.009), and corresponding with disease progression at pelvis accounted for 18.2% and 34.4% (p=0.017), respectively. Distant metastasis was comparable between 2 groups of patients, 28.9% in patients without LTI and 29.5% in patients with LTI (p=0.988). The 2-year and 5-year OS of stage IIIB without LTI were 66.5% and 46.8% compared to stage IIIB with LTI which were 43.1% and 28.9% (p=0.004), respectively. For multivariable analysis, stage IIIB with LTI was only the influential factor on OS with hazard ratio (HR) of 1.63 (p=0.012). CONCLUSION: Stage IIIB cervical cancer patients with LTI have poorer treatment outcomes including response to treatment and survival outcomes than patients in the same stage without LTI.

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.

Adjuvant chemotherapy after concurrent chemoradiation for locally advanced cervical cancer.

BACKGROUND: Current standard treatment for patients with cervical cancer who have locally advanced stage disease (International Federation of Gynecology and Obstetrics (FIGO) stage IIB to IVA) is concurrent chemoradiation therapy (CCRT). However, less than two-thirds of patients in this group survive for longer than five years post treatment. Adjuvant chemotherapy (ACT) can be given in an attempt to improve survival by eradicating residual disease in the pelvis and treating occult disease outside the pelvic radiation field. However, inconsistency in trial design, inclusion criteria for participants, interventions and survival benefit has been noted among trials of ACT after CCRT for locally advanced cervical cancer (LACC). OBJECTIVES: To evaluate the effect of adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) on survival of women with locally advanced cervical cancer compared with CCRT alone. SEARCH METHODS: We searched the Cochrane Gynaecological Review Group Trial Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and conference proceedings to March 2014. We handsearched citation lists of relevant studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing CCRT alone versus CCRT plus ACT were included. Patients were diagnosed with cervical cancer FIGO stage IIB to IVA with a histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma. DATA COLLECTION AND ANALYSIS: Two review authors (ST, KK) selected relevant trials, extracted data, assessed risk of bias independently, compared results and resolved disagreements by discussion. MAIN RESULTS: We identified two RCTs involving 978 women with cervical cancer stage IIB to IVA. As the trials were significantly different clinically, we did not perform meta-analyses. One industry-funded trial involving 515 women compared CCRT (cisplatin) versus CCRT (cisplatin and gemcitabine) plus ACT (two additional cycles). This trial reported significant improvement in progression-free survival (PFS) and overall survival (OS) in women who were given CCRT plus ACT compared with those treated with CCRT alone: Three-year PFS was 74.4% versus 65.0% (hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.49 to 0.95, P value 0.027), and three-year OS was 80% versus 69% (HR 0.68, 95% CI 0.49 to 0.95, P value 0.022). However, as the CCRT chemotherapy differed between the two arms, we considered the findings to be at high risk of bias.The second trial was a four-arm study from which we extracted data on 463 women in two study arms receiving CCRT (intravenous mitomycin C and oral 5-fluorouracil (5-FU)) or CCRT plus ACT (oral 5-FU for three cycles). The HR for OS in women who received ACT after CCRT compared with the HR for OS in those who were given CCRT alone was 1.309 (95% CI 0.795 to 2.157), and the HR for disease-free survival (DFS) was 1.125 (95% CI 0.799 to 1.586).Haematological adverse events were more common in the ACT arms of both trials. Quality of life (QoL) was not reported in either trial. AUTHORS' CONCLUSIONS: With limited data from only two trials, we found insufficient evidence to support the use of ACT after CCRT. Future large trials are required to demonstrate efficacy, toxicities and QoL.

Cost-utility analysis of treatments for stage IB cervical cancer.

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.

Comparison of treatment outcomes between squamous cell carcinoma and adenocarcinoma in locally advanced cervical cancer.

OBJECTIVE: To compare the treatment outcomes between squamous cell carcinoma (SCC) and adenocarcinoma (ACA) in locally advanced cervical cancer patients. METHODS: All medical records of stages IIB-IVA of cervical cancer patients who had completed treatment between 1995 and 2008 were reviewed. ACA 1 case was matched for SCC 2 cases with clinical stage, tumor size, treatment modalities (radiation therapy (RT) vs concurrent chemoradiation (CCRT)). Treatment outcomes including response to RT/CCRT, time to complete response (CR), patterns of treatment failure and survival outcomes were analyzed. RESULTS: A total of 423 patients with stages IIB-IVA (141 ACA: 282 SCC) were included. Most of the patients (about 60%) had stage IIB. The overall complete responses (CR) between ACA and SCC were 86.5% and 94.7%, respectively (p=0.004). Median time to clinical CR from RT/CCRT of ACA were 2 months (0-5 months) compared with 1 month (0-4 months) for SCC (p=0.001). Pelvic recurrence and distant failure were found in 2.1% and 14.9% in ACA, and corresponding with 3.9% and 15.6% in SCC. The 5-year overall survival rates of ACA compared to SCC were 59.9% and 61.7% (p=0.191), respectively. When all prognostic factors are adjusted, clinical staging was the only factor that influenced overall survival. CONCLUSION: ACA in locally advanced cervical cancer had poorer response rate from treatment and also used longer time to achieve CR than SCC. However, these effects were not determinants of survival outcomes.

Treatment outcomes of concurrent weekly carboplatin with radiation therapy in locally advanced cervical cancer patients.

OBJECTIVE: To evaluate treatment outcomes of locally advanced cervical cancer patients who received concurrent weekly carboplatin with radiation therapy. METHODS: Patients with locally advanced cervical cancer who had primary radiation treatment in concurrent with weekly carboplatin (100mg/m(2) or AUC 2) from 1997 to 2008 were identified. Demographic data, chemotherapy cycles, total treatment time, toxicities, and treatment outcomes were recorded. RESULTS: One hundred and forty-eight patients with stage IIB (50.7%), IIIB (48.0%) and IVA (1.3%) cervical cancer patients were included in the study. Median total treatment time was 53.5 days (range, 45-100 days). Carboplatin was given for a median number of 6 cycles (range, 3-6 cycles). Complete response was achieved in 142 patients (95.9%) while six (4.1%) had persistent diseases. Among the 142 responders, 36 experienced recurrences: pelvic recurrences in seven (4.7%), distant failure in 25 (16.9%), and both pelvic and distant in four (2.7%). The 2-year and 5-year progression-free survival rates were 75.1% and 63.0%, respectively with the corresponding 2-year and 5-year overall survival rates of 81.9% and 63.5%. No grade 3 or 4 hematologic and non-hematologic toxicities were observed during treatment in any patients. Late grade 3-4 gastrointestinal or genitourinary toxicities were 10.1% and 0.7%, respectively. CONCLUSION: Concurrent weekly carboplatin with radiation therapy yields high response rate with modest progression-free and overall survivals in locally advanced cervical cancer. The regimen is feasible with minimal toxicities.

Pretreatment levels of serum vascular endothelial growth factor do not correlate with outcome in patients with locally advanced cervical cancer.

OBJECTIVE: To evaluate pretreatment levels of serum VEGF in locally advanced cervical cancer patients, and assess any association with clinocopathological parameters and response to radiotherapy. METHODS: Patients with histologically proven and diagnosed locally advanced cervical cancer or stages IIB-IVA were included in this study. Blood serum was obtained by peripheral venous puncture about 24 hours before the beginning of radiotherapy. All patients were followed up at one and three month intervals from the last day of the complete treatment for evaluating the responses to radiotherapy. RESULTS: Mean age of the 40 patients was 52.8 ± 11.1 years. Sixty percent were in stage IIB and 90% had squamous cell carcinoma. The median pretreatment level of serum VEGF was 611.3 pg/ml (0.00-4,067 pg/ml). The pretreatment levels of serum VEGF did not correlate with stage (p=0.75), tumor histology (p=0.91), tumor size (p=0.46) or tumor characteristics (p=0.49). Almost all patients received concurrent chemoradiation as a curative treatment, with a complete response found in 94.9%. Values for patients who were completed response was rather lower than in patients with persistent disease, but without statistical significance (581.4 pg/ml vs 759.6 pg/ml, p=0.37). CONCLUSION: Pretreatment levels of serum VEGF do not correlate with clinicopathological factors or response to radiation therapy.

Treatment outcomes and prognostic factors of patients with breast cancer: a retrospective review.

OBJECTIVE: To determine overall survival (OS), disease-free survival (DFS), and prognostic factors for survival in patients with invasive breast cancer treated with combined-modality therapy at BMA Medical College and Vajira Hospital. MATERIAL AND METHOD: The authors retrospectively analyzed the patient-tumor characteristic and treatment outcomes of 615 patients with invasive breast cancer who were treated in our radiation oncology division between 1997 and 2006. The authors used the Kaplan-Meier method to describe OS and DFS. The authors analyzed associations of patients and tumor characteristics with OS using the log-rank test and Cox proportional hazards models. RESULTS: The median follow-up time of 60 months, there were 46 loco-regional relapses, 108 distant relapses, and 129 deaths. The 5-year OS and DFS were 77.5% and 73.8%, respectively. The median times to local recurrence (LR) and to distant recurrence (DR) were 23 months (range, 10-67 months) and 24 months (range, 5-91 months). Characteristic statistically significant associated with decreased OS included lymphocascular invasion (LVI), estrogen receptor (ER) and progesterone receptor (PR) status, tumor stage, nodal stage, lymph node involvement > or =20%, and stage of disease. CONCLUSION: Overall, the prognosis of patients with breast cancer was good However the subgroup of patients who presented with LVI, ER, and PR negative, T3-4 stage, N3-nodal stage, lymph node involvement > OR =20%, and higher stage of disease had a poor long-term outcome.

Evaluation of safety and efficacy of transdermal therapeutic system-fentanyl in adult patients with gynecological cancer-related pain.

OBJECTIVES: To assess the analgesic safety and efficacy of Transdermal Therapeutic System (TTS)-fentanyl in the treatment of chronic gynecological cancer-related pain. BACKGROUND: TTS-fentanyl is a Transdermal Therapeutic System, which contains a rate-limiting membrane that provides constant release of fentanyl. TTS-fentanyl can be properly used to control pain. Therefore, this trial was designed to establish the analgesic efficacy and safety of TTS-fentanyl in the treatment of chronic gynecological cancer-related pain. MATERIAL AND METHOD: Thirty patients were recruited into the study. This open study was comprised of two phases. Phase 1: an oral morphine stabilization phase where eligible patients, who took other opioids and/or analgesic drugs, were entered into the stabilization phase and should be converted to oral morphine according to the conversion chart. The patients were then titrated to a stable oral morphine dose. Phase 2: an open TTS-fentanyl treatment phase where the daily dose of oral morphine was switched to TTS-fentanyl according to the conversion chart. The efficacy parameters of pain score were assessed by visual analogue scale (VAS) and global assessments. The safety was evaluated by monitoring the patient's clinical conditions and adverse events. RESULTS: TTS-fentanyl was generally well tolerated. Only one patient was dropped out from the study due to lacking enrollment in the stabilization phase. The most frequent adverse events were mild nausea or vomiting (46%) and constipation (33%). The median pain VAS during TTS-fentanyl treatment was decreased from 8 to 3 and global assessments at the end of the treatment were better than at the start of the treatment. CONCLUSION: The results suggest that TTS-fentanyl is safe and effective in managing chronic gynecological cancer-related pain.