Patient safety program and incident review of high-dose-rate brachytherapy at an academic center in Thailand.

Purpose: An incident review of errors related to using high-dose-rate brachytherapy (HDR-BT) and associated patient safety program were presented. This study was based on 9 years' experience using VariSource afterloader system. Material and methods: Analysis was made on radiotherapy (RT) incidents (including near-misses) that were routinely recorded using manual and electronic incident reporting systems between July 2012 and December 2021. Each incident's origin was categorized as 'apparatus', 'system functionality', 'treatment procedure', and 'other causes'. Results: From 8,100 fractions and 2,216 patients, there were 164 RT incidents. The most frequent cases included non-dosimetric errors arising from system malfunction (49/151), difficulties caused by insufficient instruments (47/151), problems with treatment delivery (55/151), and planning procedure errors (13/142). Eleven incidents were near-misses, another 11 were not harmful, and zero were harmful. The frequency rate of dosimetric errors was 0.14 per 100 BT insertions, and 0.5 per 100 patients. The review also discovered 45 of the 164 incidents related to tube sensor failures and source blockages. These delivery errors were associated with 0.56 incidents per 100 insertions and 2.03 incidents per 100 patients, inconveniencing patients in treatment delays. Conclusions: The effectiveness of our HDR-BT safety program was evidenced by low-rate of dosimetric errors. Based on the analysis of 9 years of incidents, the error sources included uncommon or complex procedures, human factors, and work environment (equipment availability and maintenance).

Vaginal 11-point and volumetric dose related to late vaginal complications in patients with cervical cancer treated with external beam radiotherapy and image-guided adaptive brachytherapy.

OBJECTIVE: To investigate the vaginal 11-point and volumetric dose-toxicity relationships in definitive cervical cancer radiotherapy. METHODS: A retrospective cohort study of patients with cervical cancer with a complete response of at least 12 months was performed. Additional per vaginal examinations and patient-scoring questionnaires on the date of patient enrolment were assessed for vaginal strictures. Retrospective dosimetric analysis of vaginal 11-point and volumetric doses was performed with descriptive and probit analyses to investigate dose-toxicity relationships. RESULTS: Ninety-seven patients were included in the study, with a 20-month median follow-up. The incidence rate of grade 3 vaginal strictures was 22.7%. A comparison between patients with grade 1-3 vaginal strictures revealed significant differences in age, stage, initial tumour size, and vaginal involvement. PIBS + 2, PIBS, PIBS-2, D + 5, and D2cc were all significantly different among grade 1-3 vaginal strictures and showed significant probit coefficients. The lateral dose points were significantly higher in grade 2 strictures, but negative probit coefficients failed to establish causal inferences. Post-estimation analyses yielded effective doses (ED) for 15% and 20% probability of grade 3 vaginal strictures (ED15 and ED20) for PIBS + 2 at 57.4 and 111 Gy3, respectively. PIBS-2 yielded an ED20 of 7 Gy3. D + 5 yielded positive ED10, ED15, and ED20 values of 52.2, 66.6, and 78 Gy3, respectively. CONCLUSIONS: This study showed a significant relationship between age, tumour size, and lower-third vaginal involvement with the incidence of vaginal toxicity. The goal of a cumulative radiotherapy dose of ≤ 55 Gy3 to PIBS + 2, ≤5 Gy3 to PIBS-2, and ≤ 65 Gy3 to D + 5 points may reduce the risk of grade 3 vaginal stenosis to less than 15-20%.

Preliminary survey of 3D image-guided brachytherapy for cervical cancer at representative hospitals in Asian countries.

3D image-guided brachytherapy (3D-IGBT) has become a standard therapy for cervical cancer. However, the use of 3D-IGBT is limited in East and Southeast Asia. This study aimed to clarify the current usage patterns of 3D-IGBT for cervical cancer in East and Southeast Asia. A questionnaire-based survey was performed in 11 countries within the framework of the Forum for Nuclear Cooperation in Asia. The questionnaire collected the treatment information of patients with cervical cancer who underwent 3D-IGBT. The cumulative external beam radiotherapy and 3D-IGBT doses were summarized and normalized to a biological equivalent dose of 2 Gy per fraction (EQD2) using a linear-quadratic model. Of the 11 institutions representing the participating countries, six (55%) responded to the questionnaire. Overall, data of 36 patients were collected from the six institutions. Twenty-one patients underwent whole-pelvic irradiation and 15 underwent whole-pelvic irradiation with central shielding. Patients received a median of four treatment sessions of 3D-IGBT (range, 2-6). All 3D-IGBT sessions were computed tomography (CT)-based and not magnetic resonance image-based. The median doses to the high-risk clinical target volume D90, bladder D2cc, rectum D2cc and sigmoid colon D2cc were 80.9 Gy EQD2 (range, 58.9-105.9), 77.7 Gy EQD2 (range, 56.9-99.1), 68.0 Gy EQD2 (range, 48.6-90.7) and 62.0 Gy EQD2 (range, 39.6-83.7), respectively. This study elucidated the current patterns of 3D-IGBT for the treatment of cervical cancer in East and Southeast Asia. The results indicate the feasibility of observational studies of CT-based 3D-IGBT for cervical cancer in these countries.

Multi-institutional Observational Study of Prophylactic Extended-Field Concurrent Chemoradiation Therapy Using Weekly Cisplatin for Patients With Pelvic Node-Positive Cervical Cancer in East and Southeast Asia.

PURPOSE: This multi-institutional observational study conducted among 11 countries in East and Southeast Asia aimed to assess the clinical outcomes of prophylactic extended-field concurrent chemoradiation therapy using weekly cisplatin for patients with locally advanced cervical cancer. METHODS AND MATERIALS: Between October 2007 and May 2016, 106 patients with untreated squamous cell carcinoma of the cervix were enrolled in the present study. Radiation therapy consisted of pelvic irradiation (total dose, 50 Gy in 25 fractions including central shielding), prophylactic paraortic regional irradiation (36-40 Gy in 20 fractions), and either high- or low-dose-rate intracavitary brachytherapy (ICBT) according to institutional practice. The planned point A dose was 21 to 28 Gy in 3 to 4 fractions for high-dose-rate ICBT and 40 to 41 Gy in 1 to 2 fractions for low-dose-rate ICBT. Five cycles of weekly cisplatin (40 mg/m2) were administered during the radiation therapy course. RESULTS: A total of 106 patients were enrolled. Of these, 9 had major protocol violations and 2 did not receive treatment because of worsened general condition. Thus, 95 patients were evaluable. The median follow-up was 56 months. Of the 95 patients, 76 (80%) received 4 or 5 cycles of chemotherapy. Acute grade 3 leukopenia was observed in 20 of the patients (21%), and late grade 3 gastrointestinal toxicity was observed in 3%. The 2-year local control, progression-free survival, and overall survival rate for all patients were 96%, 78%, and 90%, respectively. CONCLUSIONS: The results indicated that prophylactic extended-field concurrent chemoradiation therapy using weekly cisplatin is feasible and effective for patients with locally advanced cervical cancer in East and Southeast Asia.

Dosimetric analysis and preliminary clinical result of image-guided brachytherapy with or without hybrid technique for cervical cancer using VariSource titanium ring applicator with "Siriraj Ring Cap".

PURPOSE: Titanium ring cap applicator (VariSource) was applied in treating cervical cancer patients by using image-guided brachytherapy (IGBT). However, its sizes appeared to be relatively large for most of our patients. Thus, we have developed a specific applicator "Siriraj Ring Cap," which is slightly smaller and more suitable for our patients. This study was to evaluate effectiveness of this equipment. METHODS AND MATERIALS: Locally advanced cervical cancer patients were treated with external beam radiation therapy with or without concomitant chemotherapy. Siriraj Ring Cap was applied in all of the patients for at least one fraction. Dosimetric analysis was performed in each fraction of IGBT. Clinical outcomes of these patients were evaluated. RESULTS: Twenty-nine patients with 117 dosimetric planning were evaluated between January and December of 2014. Siriraj Ring Cap was fit to all patients in this study. By using this applicator, radiation doses to the targets (D90 high-risk clinical target volume and D90 intermediate-risk clinical target volume) were higher in each fraction. There were no statistically differences of radiation doses to the bladder, rectum, sigmoid colon, and small bowel. Within 2-year followup, 3 patients (10.3%) developed locoregional recurrence. Two-year disease-free survival and overall survival were 75.9% and 89.7%, respectively. According to RTOG/EORTC complication criteria, Grade 1, 2, and 3 gastrointestinal complications were developed in 2 (6.9%), 4 (13.8%), and 1 (3.4%) patients, respectively. For genitourinary complications, 3 patients (10.3%) and 1 patient (3.4%) had Grades 1 and 2, respectively. CONCLUSIONS: Siriraj Ring Cap is feasible for IGBT in cervical cancer patients with narrow vagina. Dosimetry and clinical outcomes were satisfactory by using our specific applicator.

Multicentre dose audit for clinical trials of radiation therapy in Asia.

A dose audit of 16 facilities in 11 countries has been performed within the framework of the Forum for Nuclear Cooperation in Asia (FNCA) quality assurance program. The quality of radiation dosimetry varies because of the large variation in radiation therapy among the participating countries. One of the most important aspects of international multicentre clinical trials is uniformity of absolute dose between centres. The National Institute of Radiological Sciences (NIRS) in Japan has conducted a dose audit of participating countries since 2006 by using radiophotoluminescent glass dosimeters (RGDs). RGDs have been successfully applied to a domestic postal dose audit in Japan. The authors used the same audit system to perform a dose audit of the FNCA countries. The average and standard deviation of the relative deviation between the measured and intended dose among 46 beams was 0.4% and 1.5% (k = 1), respectively. This is an excellent level of uniformity for the multicountry data. However, of the 46 beams measured, a single beam exceeded the permitted tolerance level of ±5%. We investigated the cause for this and solved the problem. This event highlights the importance of external audits in radiation therapy.

Concurrent chemoradiotherapy for T3-4 and N0-1 nasopharyngeal cancer: Asian multicenter trial of the Forum for Nuclear Cooperation in Asia.

The aim of this study was to evaluate the toxicity and efficacy of radiotherapy concurrent with weekly cisplatin for T3-4 and N0-1 nasopharyngeal cancer. Between 2005 and 2010, 70 patients with nasopharyngeal cancer (T3-4 N0-1 M0, World Health Organization Type 2-3) from Vietnam, Indonesia, Malaysia and Thailand were registered. Patients were treated with 2D radiotherapy concurrent with weekly cisplatin (30 mg/m(2)). Neither adjuvant nor induction chemotherapy was given. Ninety-three percent of the patients completed at least four cycles of weekly cisplatin during radiotherapy. The median total doses for the primary tumor and positive lymph nodes were 70 and 66 Gy, respectively. The median overall treatment time of concurrent chemoradiotherapy was 52 days. No treatment-related deaths occurred. Grade 3-4 acute toxicities of mucositis, nausea/vomiting and leukopenia were observed in 34%, 4% and 4% of patients, respectively. With a median follow-up time of 52 months for the 40 surviving patients, the 3-year local control, locoregional tumor control, distant metastasis-free survival and overall survival rates were 80%, 75%, 74% and 80%, respectively. In conclusion, the current results illustrate that our concurrent chemoradiotherapy regimen was feasible, but disease control remained insufficient. Further research is encouraged in order to improve clinical outcomes.

Posterior cervical lymph node metastasis as the valuable prognostic factor for stage IVA/IVB nasopharyngeal carcinoma treated with induction chemotherapy followed by concurrent chemo-radiotherapy.

INTRODUCTION/AIM: To evaluate the prognostic properties of retropharyngeal lymph node (RP), posterior cervical lymph node (PCN), and supraclavicular lymph node (SPC), in stage IVA/IVB nasopharyngeal carcinoma (NPC) patients in setting of induction chemotherapy. METHODS: We performed a retrospective study including 43 patients with stage IVA/IVB NPC (7th AJCC) treated with induction chemotherapy followed by concurrent chemo-radiotherapy. We analyzed prognosis with the multivariate Cox regression model and p-value from the Wald's test, using the backward elimination method (by likelihood ratio test and percent change of coefficient factors). RESULT: Overall, 24 patients (55.8%) were in stage IVA and 19 (44.2%) in stage IVB. After a median follow-up time of 30 months, the 2-year overall survival (OS) was 79.1%, while the 2-year progression free survival (PFS) and distant metastasis free survival (DMFS) were 59.8% and 69.1%, respectively. In multivariate analysis for predicting DMFS, SPC involvement was not statistically significant (HR 3.39; 95% CI 0.76-15.07; p=0.1), whereas RP involvement was statistically significant (HR 5.81; 95% CI 1.08-31.16; p=0.04). Moreover, and more importantly, PCN involvement was the only nodal factor to predict all of DMFS, PFS, and OS (respectively HR 5.57, 95% CI 1.12-27.71, p=0.036; HR 16.05, 95% CI 1.93-133.65, p=0.01; and HR 28.02, 95% CI 2.74-286.22, p=0.005). DISCUSSION: PCN involvement is the only independent prognostic factor of stage IVA/IVB NPC patients treated by induction chemotherapy that predicts DMFS and turns this effect to PFS and OS. PCN involvement is a highly accurate predictor for failure of conventional chemo-radiotherapy. Therefore, patients with PCN involvement should be defined at high-risk, as to be investigated for a new staging system.

Brachytherapy boost in loco-regionally advanced nasopharyngeal carcinoma: a prospective randomized trial of the International Atomic Energy Agency.

BACKGROUND: The purpose was to determine whether a brachytherapy boost improves outcomes in patients with advanced nasopharyngeal carcinoma treated with standard chemo-radiotherapy. METHODS: Patients with nasopharyngeal carcinoma WHO grades I-III and TNM stages III or non-metastatic stage IV were eligible for this phase III study. Patients were randomized to either arm (A) induction chemotherapy, followed by external beam radiotherapy (EBRT) with concomitant cisplatin (n = 139) or arm (B), the same schedule plus a brachytherapy boost to the nasopharynx (n = 135). The EBRT doses given were 70 Gy to the primary tumour and positive lymph nodes and 46 Gy to the negative neck. The additional brachytherapy boost in arm (B) was given by either low dose-rate (LDR - 11 Gy) or high dose-rate (HDR - 3 fractions of 3.0 Gy) brachytherapy. The primary endpoint was 3-year overall survival (OS) and secondary endpoints were: local control, regional control, distant metastasis and grade 3-4 adverse events. RESULTS: 274 patients were randomized between September 2004 and December 2008. The two arms were comparable with regard to age, gender, stage and grade. 273 patients completed treatment. Median follow-up was 29 months (0.2-67 months). The effect of treatment arm, country, age, gender, WHO pathology, stage (T3-4, N2-3 versus other) and chemotherapy on overall survival (OS), disease-free survival (DFS) and local recurrence-free survival (LRFS) was studied. Stage significantly affected OS (p = 0.024) and DFS (p = 0.018) while age significantly affected OS (p = 0.014). None of the other factors studied were significant. The 3-year LRFS was 60.5% and 54.4% in arms A and B respectively (p = 0.647). The 3-year regional control rate in the neck was 59.7% and 54.3% respectively (p = 0.7). Distant metastasis developed in 59.7% of patients in arm A and 55.4% in arm B (p = 0.377). Patients with T1/T2 N + had a 3 year LRFS of 51.8% in Arm A (62 patients) versus 57.9% in Arm B (67 patients) (p = 0.343). The grade 3-4 toxicity rate was 21.6% (30/139) and 24.4% (33/135) respectively (p = 0.687). CONCLUSIONS: The addition of a brachytherapy boost to external beam radiotherapy and chemotherapy did not improve outcome in loco-regionally advanced nasopharyngeal carcinoma.

Long-term follow-up results of a multi-institutional phase 2 study of concurrent chemoradiation therapy for locally advanced cervical cancer in east and southeast Asia.

PURPOSE: To report the long-term survival and toxicity of a multi-institutional phase 2 study of concurrent chemoradiation therapy (CCRT) for locally advanced cervical cancer in east and southeast Asia. METHODS AND MATERIALS: Ten institutions from 8 Asian countries participated in the study. Between April 2003 and March 2006, 120 patients (60 with bulky stage IIB and 60 with stage IIIB) were treated with CCRT. Radiation therapy consisted of pelvic external beam radiation therapy and either high-dose-rate or low-dose-rate intracavitary brachytherapy. Five cycles of weekly cisplatin (40 mg/m(2)) were administered during the course of radiation therapy. Treatment results were evaluated by the rates of local control, overall survival, and late toxicities. RESULTS: Median follow-up was 63.7 months, and the follow-up rate at 5 years was 98%. The 5-year local control and overall survival rates for all patients were 76.8% and 55.1%, respectively. The 5-year rates of major late toxicities of the rectum and bladder were 7.9% and 0%, respectively. CONCLUSIONS: The long-term results have suggested that CCRT is safe and effective for patients with locally advanced cervical cancer in east and southeast Asia. However, further efforts are needed to improve overall survival.

High dose rate endobronchial brachytherapy (HDR-EB) in recurrent benign complex tracheobronchial stenosis: experience in two cases.

UNLABELLED: Benign complex tracheobronchial stenosis (BCTS) is a tracheobronchial stenosis that is longer than 1 cm or has more than one site of stenotic area. The most common etiology of the stenosis is endobronchial tuberculosis. BCTS causes challenge in diagnosis and management because of nonspecific presentation and usually precluded surgical treatment. Available interventional bronchoscopic techniques fail to manage BCTS because of high rate of restenosis. Experience in using HDR brachytherapy to prevent restenosis in two cases of BCTS is reported. CASES REPORT: There were two cases of BCTS who received HDR brachytherapy in order to prevent restenosis. First case was a 39 year-old female who had 5 cms tracheal and 2 cms left main bronchial stenosis from previous endobronchial tuberculosis. After 36 procedures of tracheobronchial dilatation by rigid bronchoscopy and two tracheal stents placement, her trachea became restenosis in an average time of 1 month. She also developed anaphylactic reaction with lidocaine. She received HDR brachytherapy with the dose of 10 Gy and no restenosis was found after 5 months follow-up. The second case was a 18 year-old male who had 4 cms tracheal stenosis result from post intubation. He was done dilatation and stenting of the trachea by regid bronchoscopy because he refused surgery. After 1 year the tracheal stent was removed and rapid restenosis of the trachea resulted in respiratory failure occurred in 7 days. The tracheal stent was reimplanted and 1 year later 7.0 Gy HDR brachytherapy was done after stent removal. He was doing well 4 months after with 50% tracheal stenosis and occasional stridor. CONCLUSION: Failure of intervention bronchoscopic techniques in management of BCTS was significantly shown by the restenosis even after endobronchial stent placement. HDR brachytherapy had a beneficial role in preventing granulation tissue formation and delay or prevent restenosis after bronchoscopic dilatation in selected case of BCTS patients. The case selection and long term outcome were needed before introduced HDR brachytherapy to be the standard care of BCTS patients.

Radiotherapy concurrently with weekly cisplatin, followed by adjuvant chemotherapy, for N2-3 nasopharyngeal cancer: a multicenter trial of the Forum for Nuclear Cooperation in Asia.

The purpose of this study was to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly cisplatin, followed by adjuvant chemotherapy, for the treatment of N2-3 nasopharyngeal cancer (NPC) in Asian countries, especially regions of South and Southeast Asian countries where NPC is endemic. Between 2005 and 2009, 121 patients with NPC (T1-4 N2-3 M0) were registered from Vietnam, Malaysia, Indonesia, Thailand, The Philippines, China and Bangladesh. Patients were treated with 2D radiotherapy concurrently with weekly cisplatin (30 mg/m (2)), followed by adjuvant chemotherapy, consisting of cisplatin (80 mg/m(2) on Day 1) and fluorouracil (800 mg/m(2) on Days 1-5) for 3 cycles. Of the 121 patients, 56 patients (46%) required interruption of RT. The reasons for interruption of RT were acute non-hematological toxicities such as mucositis, pain and dermatitis in 35 patients, hematological toxicities in 11 patients, machine break-down in 3 patients, poor general condition in 2 patients, and others in 8 patients. Of the patients, 93% completed at least 4 cycles of weekly cisplatin during radiotherapy, and 82% completed at least 2 cycles of adjuvant chemotherapy. With a median follow-up time of 46 months for the surviving 77 patients, the 3-year locoregional control, distant metastasis-free survival and overall survival rates were 89%, 74% and 66%, respectively. No treatment-related deaths occurred. Grade 3-4 toxicities of mucositis, nausea/vomiting and leukopenia were observed in 34%, 4% and 4% of the patients, respectively. In conclusion, further improvement in survival and locoregional control is necessary, although our regimen showed acceptable toxicities.

Advanced imaging applications for locally advanced cervical cancer.

Advanced imaging approaches (computed tomography, CT; magnetic resonance imaging, MRI; 18F-fluorodeoxyglucose positron emission tomography, FDG PET) have increased roles in cervical cancer staging and management. The recent FIGO (International Federation of Gynecology and Obstetrics) recommendations encouraged applications to assess the clinical extension of tumors rather than relying on clinical examinations and traditional non-cross sectional investigations. MRI appears to be better than CT for primary tumors and adjacent soft tissue involvement in the pelvis. FDG-PET/CT has increased in usage with a particular benefit for whole body evaluation of tumor metabolic activity. The potential benefits of advanced imaging are assisting selection of treatment based upon actual disease extent, to adequately treat a tumor with minimal normal tissue complications, and to predict the treatment outcomes. Furthermore, sophisticated external radiation treatment and brachytherapy absolutely require advanced imaging for target localization and radiation dose calculation.

Sensorineural hearing loss after concurrent chemoradiotherapy in nasopharyngeal cancer patients.

BACKGROUND: Sensorineural hearing loss (SNHL) is one of the major long term side effects from radiation therapy (RT) in nasopharyngeal cancer (NPC) patients. This study aims to review the incidences of SNHL when treating with different radiation techniques. The additional objective is to determine the relationship of the SNHL with the radiation doses delivered to the inner ear. METHODS: A retrospective cohort study of 134 individual ears from 68 NPC patients, treated with conventional RT and IMRT in combination with chemotherapy from 2004-2008 was performed. Dosimetric data of the cochlea were analyzed. Significant SNHL was defined as >15 dB increase in bone conduction threshold at 4 kHz and PTA (pure tone average of 0.5, 1, 2 kHz). Relative risk (RR) was used to determine the associated factors with the hearing threshold changes at 4 kHz and PTA. RESULTS: Median audiological follow up time was 14 months. The incidence of high frequency (4 kHz) SNHL was 44% for the whole group (48.75% in the conventional RT, 37% with IMRT). Internal auditory canal mean dose of >50 Gy had shown a trend to increase the risk of high frequency SNHL (RR 2.02 with 95% CI 1.01-4.03, p=0.047). CONCLUSION: IMRT and radiation dose limitation to the inner ear appeared to decrease SNHL.

Multi-institutional phase II clinical study of concurrent chemoradiotherapy for locally advanced cervical cancer in East and Southeast Asia.

PURPOSE: To evaluate the toxicity and efficacy of concurrent chemoradiotherapy using weekly cisplatin for patients with locally advanced cervical cancer in East and Southeast Asia, a multi-institutional Phase II clinical study was conducted among eight Asian countries. METHODS AND MATERIALS: Between April 2003 and March 2006, 120 patients (60 with bulky Stage IIB and 60 with Stage IIIB) with previously untreated squamous cell carcinoma of the cervix were enrolled in the present study. Radiotherapy consisted of pelvic external beam radiotherapy (total dose, 50 Gy) and either high-dose-rate or low-dose-rate intracavitary brachytherapy according to institutional practice. The planned Point A dose was 24-28 Gy in four fractions for high-dose-rate-intracavitary brachytherapy and 40-45 Gy in one to two fractions for low-dose-rate-intracavitary brachytherapy. Five cycles of weekly cisplatin (40 mg/m(2)) were administered during the radiotherapy course. RESULTS: All patients were eligible for the study. The median follow-up was 27.3 months. Of the 120 patients, 100 (83%) received four or five cycles of chemotherapy. Acute Grade 3 leukopenia was observed in 21% of the patients, and Grade 3 gastrointestinal toxicity was observed in 6%. No patient failed to complete the radiotherapy course because of toxicity. The 2-year local control and overall survival rate for all patients was 87.1% and 79.6%, respectively. The 2-year major late rectal and bladder complication rate was 2.5% and 0%, respectively. CONCLUSION: The results have suggested that concurrent chemoradiotherapy using weekly cisplatin is feasible and effective for patients with locally advanced cervical cancer in East and Southeast Asia.

Accelerated hyperfractionated radiotherapy for cervical cancer: multi-institutional prospective study of forum for nuclear cooperation in Asia among eight Asian countries.

PURPOSE: To evaluate the toxicity and efficacy of accelerated hyperfractionated radiotherapy (RT) for locally advanced cervical cancer. METHODS AND MATERIALS: A multi-institutional prospective single-arm study was conducted among eight Asian countries. Between 1999 and 2002, 120 patients (64 with Stage IIB and 56 with Stage IIIB) with squamous cell carcinoma of the cervix were treated with accelerated hyperfractionated RT. External beam RT consisted of 30 Gy to the whole pelvis, 1.5 Gy/fraction twice daily, followed by 20 Gy of pelvic RT with central shielding at a dose of 2-Gy fractions daily. A small bowel displacement device was used with the patient in the prone position. In addition to central shielding RT, intracavitary brachytherapy was started. Acute and late morbidities were graded according to the Radiation Therapy Oncology Group and Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer criteria. RESULTS: The median overall treatment time was 35 days. The median follow-up time for surviving patients was 4.7 years. The 5-year pelvic control and overall survival rate for all patients was 84% and 70%, respectively. The 5-year pelvic control and overall survival rate was 78% and 69% for tumors > or = 6 cm in diameter, respectively. No treatment-related death occurred. Grade 3-4 late toxicities of the small intestine, large intestine, and bladder were observed in 1, 1, and 2 patients, respectively. The 5-year actuarial rate of Grade 3-4 late toxicity at any site was 5%. CONCLUSION: The results of our study have shown that accelerated hyperfractionated RT achieved sufficient pelvic control and survival without increasing severe toxicity. This treatment could be feasible in those Asian countries where chemoradiotherapy is not available.

A regional cooperative clinical study of radiotherapy for cervical cancer in east and south-east Asian countries.

PURPOSE: Radiotherapy differed widely in east and south-east Asia because of technical, cultural, and socio-economic differences. With the purpose of standardizing radiotherapy for cervical cancer in the region, an international clinical study was conducted. MATERIALS AND METHODS: Eleven institutions in eight Asian countries participated in the study. Between 1996 and 1998, 210 patients with stage IIIB cervical cancer were enrolled. Patients were treated with a combination of external beam radiotherapy (total dose, 50Gy) and either high-dose-rate (HDR) or low-dose-rate (LDR) intracavitary brachytherapy (ICBT) according to the institutional practice. The planned point A dose was 20-28Gy/4 fractions for HDR-ICBT and 30-40Gy/1-2 fractions for LDR-ICBT. RESULTS: Hundred patients were treated with HDR-ICBT and 110 were treated with LDR-ICBT. The ICBT doses actually delivered to point A ranged widely: 12-32Gy in the HDR group and 26-52.7Gy in the LDR group. The 5-year follow-up rate among the countries differed greatly, from 29% to 100%. The 5-year major complication rates were 6% in the HDR group and 10% in the LDR group. The 5-year overall survival rates were 51.1% in the HDR group and 57.5% in the LDR group. CONCLUSIONS: Although there were several problems with treatment compliance and patients' follow-up, the study suggests that the protocols provided favorable outcomes with acceptable rates of late complications in the treatment of advanced cervical cancer in east and south-east Asia.

Hyperthermia in combination with radiation therapy for treatment of advanced inoperable breast cancer.

Twelve breast cancer patients with locally advanced inoperable lesions were studied. Six cases had received chemotherapy, 6 had not. Most of the tumors were ulcerative lesions with an average size of 11.5 cm. The patients were treated with 43 degrees C hyperthermia once or twice a week together with radiation at a dose of 20-70 Gy. Six of them were also treated with concurrent chemotherapy. Two cases responded completely (17%) and 10 cases responded partially (83%). The result indicates that the combination of hyperthermia and radiation, with or without chemotherapy, might be a good treatment option for locally advanced inoperable breast cancer, especially for patients who have had failure or contraindication to chemotherapy. It is an effective treatment for palliation of local symptoms, showing a tendency to achieve local control of large, ulcerative advanced breast lesions especially when such treatment is followed by salvage surgery.