Intermediate-term results of trans-abdominal ultrasound (TAUS)-guided brachytherapy in cervical cancer.

OBJECTIVES: To report the intermediate-term results of trans-abdominal ultrasound (TAUS)-guided brachytherapy in cervical cancer. MATERIALS AND METHODS: Ninety-two patients with cervical cancer (stage IB-IVA, according to FIGO staging), were treated by curative radiotherapy from February 2012 to June 2015. All patients were treated with whole pelvic radiotherapy to 50 Gy in 25 fractions and central shielding after 44 Gy, in combination with TAUS-guided brachytherapy, in order to escalate the total dose (EQD2) to the minimal dose at cervical points (in EQD2 concepts) defined by TAUS, while maintaining low doses to ICRU bladder and rectal points. The treatment results and toxicity profiles were reported. RESULTS: At median follow-up time of 41.2 months (range 8 to 61 months) the pelvic control, disease-free survival, and overall survival rates were 84.8%, 75%, and 88%, respectively. The mean applied doses to cervix, bladder, and rectal points were 83.5, 72.3, and 76.5 Gy, respectively. Eight patients developed grade 2 Gastrointestinal toxicity. CONCLUSION: The 3-year results demonstrated that TAUS-guided brachytherapy is feasible and associated with excellent tumor control/toxicity rates in cervical cancer.

Preliminary results of adjuvant image-guided vaginal brachytherapy alone for early stage endometrial carcinoma.

Objective: This retrospective study evaluated the preliminary outcomes of image-guided vaginal brachytherapy (IG-VBT) in the adjuvant treatment of high intermediate risk endometrial cancer. Materials and Methods: Data were collected from 48 patients who underwent adjuvant IG-VBT between 2019 and 2022 at the Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University. The vaginal cuff clinical target volume (CTV-VC) is composed of a 4-mm-thick band around vaginal cylinder at the upper 3 cm of the vaginal cuff. A total dose of 21 Gy in three fractions was delivered to the CTV-VC, and the dose to the bladder and rectum were evaluated. Treatment details, patient characteristics, and outcomes were analyzed. Descriptive statistics were used for analysis, and Kaplan-Meier method was employed for survival analysis. Results: The mean age was 62 years, with mainly endometrioid carcinoma pathology (96 %). All patients were at stage I, with 87.5 % receiving complete surgical staging. Mean total treatment time was 10 days with mean D90 of CTV-VC was 29.7 Gy, and D2cc of bladder, rectum, and sigmoid were 24.6 Gy, 21.0 Gy, and 7.7 Gy, respectively. At a median follow-up of 37 months, 3-year local control, disease-free survival, and overall survival rates were 100 %, 100 %, and 97.9 %. respectively. Two patients (4.2 %) experienced grade 1-2 gastrointestinal toxicity, while no genitourinary toxicity or serious adverse events were observed. Conclusions: The preliminary results of IG-VBT in endometrial cancer demonstrated favorable outcomes in terms of vaginal control and toxicity. Further studies with larger cohorts and longer follow-up durations are warranted.

Intermediate-term results of image-guided brachytherapy and high-technology external beam radiotherapy in cervical cancer: Chiang Mai University experience.

OBJECTIVE: To evaluate the outcomes of image-guided brachytherapy combined with 3D conformal or intensity modulated external beam radiotherapy (3D CRT/IMRT) in cervical cancer at Chiang Mai University. METHODS: From 2008 to 2011, forty-seven patients with locally advanced cervical cancer were enrolled in this study. All patients received high-technology (3D CRT/IMRT) whole pelvic radiotherapy with a total dose of 45-46 Gy plus image-guided High-Dose-Rate intracavitary brachytherapy 6.5-7 Gy × 4 fractions to a High-Risk Clinical Target Volume (HR-CTV) according to GEC-ESTRO recommendations. The dose parameters of the HR-CTV for bladder, rectum and sigmoid colon were recorded, as well as toxicity profiles. In addition, the endpoints for local control, disease-free, metastasis-free survival and overall survival were calculated. RESULTS: At the median follow-up time of 26 months, the local control, disease-free survival, and overall survival rates were 97.9%, 85.1%, and 93.6%, respectively. The mean dose of HR-CTV, bladder, rectum and sigmoid were 93.1, 88.2, 69.6, and 72 Gy, respectively. In terms of late toxicity, the incidence of grade 3-4 bladder and rectum morbidity was 2.1% and 2.1%, respectively. CONCLUSIONS: A combination of image-guided brachytherapy and IMRT/3D CRT showed very promising results of local control, disease-free survival, metastasis-free survival and overall survival rates. It also caused a low incidence of grade 3-4 toxicity in treated study patients.

The association of vagina equivalent dose in 2Gy fraction (EQD2) to late vagina toxicity in patients of cervical cancer treated with WPRT plus IGABT.

AIM: To evaluate the associations of vaginal dose parameters and incidence of vaginal stenosis in patients with cervical cancer treated with image-guided brachytherapy (IGBT). MATERIALS AND METHODS: Fifty-four patients with cervical cancer treated with IGBT were included. The vagina contouring was done on previously treated CT images and the vaginal dose points were marked. The cumulative dose in EQD2 from EBRT and IGBT was calculated for both aspects and the vaginal toxicity was evaluated. RESULTS: At median follow-up time of 18.5 months, grade 2 or higher vaginal stenosis was observed in 24% of patients. On univariate analysis, parameters that were associated with ≥ grade 2 vaginal stenosis were age, mean dose of lateral 5 mm vagina, dose at PIBS-2 cm, mid vaginal D0 .03cc, mid vagina D1cc, lower vagina D0.03cc, lower vagina D0.1cc, lower vagina D1cc and lower vagina D2cc. On multivariate analysis, the significant parameters were age > 68.5 years old (P = 0.038), mean dose of lateral 5-mm (P = 0.034), and dose at PIBS-2 cm (P = 0.042). CONCLUSIONS: Age > 68.5 years old, mean dose of lateral 5 mm vagina and dose at PIBS-2 cm were associated with grade 2 or higher vaginal stenosis.

Comparison of clinical outcomes achieved with image-guided adaptive brachytherapy for cervix cancer using CT or transabdominal ultrasound.

PURPOSE: This study aimed to evaluate retrospectively the treatment results when using various image-guided adaptive brachytherapy treatments for cervical cancer treated by radical radiotherapy. METHODS AND MATERIALS: From 2014 to 2017, 188 patients with cervical carcinoma were treated by whole pelvic radiotherapy plus four fractions of image-guided brachytherapy. Eight patients were excluded because of missing data. Consequently, 180 patients were analyzed. Of 180 patients, 92 were treated by CT-based brachytherapy (CT-BT), and transabdominal ultrasound-based brachytherapy (TAUS-BT) was used to treat another group. The treatment results and toxicity outcomes were evaluated by comparing the image-guidance techniques. RESULTS: The mean follow-up time was 32 months (interquartile range 29.5-42 months). The mean age was 57 years (interquartile range from 50 to 65 years). In the CT-BT group, the mean cumulative doses to high-risk clinical target volume, bladder, rectum, and sigmoid were 87.2 Gy, 84.0 Gy, 68.8 Gy, and 69.8 Gy, respectively. In the TAUS-BT group, the mean cumulative doses to the cervix reference, bladder, and rectum points were 84.0 Gy, 65.5 Gy, and 74.0 Gy, respectively. There were no differences in the 2-year local control rate (p = 0.88) and disease-free survival rate (p = 0.34) in both groups. No difference in gastrointestinal and genitourinary toxicity was observed in both groups, but there was higher vaginal toxicity in the TAUS-BT group compared with the CT-BT group (p = 0.03). CONCLUSIONS: No difference in treatment results was observed between CT-based and TAUS-based approaches. However, TAUS-BT had higher vaginal toxicity in our retrospective analysis.

Long-term outcome after static intensity-modulated total body radiotherapy using compensators stratified by pediatric and adult cohorts.

PURPOSE: To report the long-term outcome after total body irradiation with intensity-modulating compensators and allogeneic/autologous transplantation, especially in terms of therapy-related toxicity in pediatric and adult cohorts. METHODS AND MATERIALS: A total of 257 consecutive patients (40 children and 217 adults) have been treated since 1983 with TBI using static intensity-modulated radiotherapy for hematologic malignancies. The total dose of 12 Gy was applied in six fractions within 3 days before allogeneic (n = 174) or autologous (n = 83) transplantation. The median follow-up was 9.2 years. RESULTS: The 5-year overall survival rate was 47.9% (49.8% for the adults and 37.5% for the children, p = 0.171). The 5-year tumor-related mortality rate was 23%, and the 5-year treatment-related mortality rate 29.2% (29.5% in the adults and 27.5% in the pediatric patients). Interstitial pneumonitis developed in 28 (10.9%) of 257 patients and in 12.5% of the pediatric cohort. The interstitial pneumonitis rate was 25% in pediatric patients treated with a 12-Gy lung dose compared with 4.2% for those treated to an 11-Gy lung dose. The overall survival rate stratified by lung dose was 26.7% for 12 Gy and 52.4% for 11 Gy (p = 0.001). The incidence of veno-occlusive disease and cataract was 5.8% and 6.6% in all patients and 12.5% and 15% in the pediatric patients, respectively (p < 0.05). Secondary malignancies were found in 4.3% of all patients, all in the adult cohort at transplantation. CONCLUSION: Static intensity-modulated total body irradiation with a total dose of 12 Gy before allogeneic/autologous transplantation is a successful treatment with good long-term outcome and acceptable therapy-related toxicities. Constraining the lung dose to 11 Gy substantially lowered the actuarial treatment-related mortality. This effect was especially striking in the pediatric patients.

Two-year results of transabdominal ultrasound-guided brachytherapy for cervical cancer.

PURPOSE: To report the preliminary results of transabdominal ultrasound (TAUS)-guided brachytherapy (BT) in cervical cancer. METHODS AND MATERIALS: Twenty-nine patients with cervical cancer Stage IB-IVA according to The International Federation of Gynecology and Obstetrics staging were treated by radical radiotherapy from February 2012 to December 2012. Treatment was composed of WPRT to 50 Gy in 25 fractions and central shielding after 44 Gy in combination with TAUS-guided BT to optimize the total dose (equivalent dose of 2 Gy [EQD2]) to the minimal dose at cervical points (in EQD2 concepts) defined by TAUS ≥80 Gy while maintaining low doses to the ICRU report no. 38 bladder and rectal points. The treatment results and toxicity profiles were reported. RESULTS: At median followup time of 19 months (range, 17-27), the local control and disease-free survival rates were 93.1% and 86.2%, respectively. One episode of Grade 3 vaginal toxicity was observed in this followup period. The mean applied doses to cervix, bladder, and rectal points were 82.6, 72.5, and 75 Gy, respectively. TAUS-guided planning reduced bladder (defined as >80 Gy in EQD2) and rectal overdose (defined as >75 Gy in EQD2) in 44.9% and 34.5% of patients, respectively. CONCLUSION: The 2-year results demonstrate that TAUS-guided BT is feasible and associated with excellent tumor control/toxicity rates in cervical cancer.

The using of megavoltage computed tomography in image-guided brachytherapy for cervical cancer: a case report.

We present a case of cervical cancer treated by concurrent chemoradiation. In radiation therapy part, the combination of the whole pelvic helical tomotherapy plus image-guided brachytherapy with megavoltage computed tomography of helical tomotherapy was performed. We propose this therapeutic approach could be considered in a curative setting in some problematic situation as our institution.

Long-term outcome by risk factors using conformal high-dose-rate brachytherapy (HDR-BT) boost with or without neoadjuvant androgen suppression for localized prostate cancer.

PURPOSE: The aim of this study is to analyze, during the prostate-specific antigen (PSA) era, the long-term outcome of patients treated with conformal high-dose-rate (HDR) brachytherapy boost to the prostate with or without androgen deprivation therapy (ADT) when patients are stratified by risk factors for failure. METHODS AND MATERIALS: Between 1986 and 2000, 611 patients were treated for clinically localized prostate cancer in three prospective trials of external beam radiation therapy (EBRT) and dose-escalating HDR brachytherapy (BT) boost. There were 104 patients treated at Seattle, 198 at Kiel University, and 309 at William Beaumont Hospital. Of the 611 patients, 177 received a short course of neoadjuvant/concurrent ADT. The patients were divided into three risk groups. Group I, comprised of 46 patients, had stage < or =T2a, Gleason score (GS) < or = 6, and initial PSA (iPSA) < or = 10 ng/mL. Group II comprised 188 patients with stage > or =T2b, GS > or = 7, and iPSA > or = 10, with any one factor higher. Group III included 359 patients with any two risk factors higher. The American Society for Therapeutic Radiology and Oncology definition for biochemical failure was used. RESULTS: The mean follow-up was 5 years (range, 0.2-15.3). For the 611 patients, the 5-year and 10-year biochemical control (BC) rates were 77% and 73%, disease-free survival (DFS) was 67% and 49%, and cause-specific survival (CSS) was 96% and 92%, respectively. BC at 5 years for Group I patients was 96%, for Group II 88%, and for Group III patients 69%. CSS at 5 years was 100% in Group I, 99% in Group II, and 95% in Group III patients. In univariate and multiple regression analyses for BC, risk group, stage, iPSA, and GS were significant in predicting failure. However, age, follow-up interval, and ADT did not. CONCLUSIONS: EBRT with HDR-BT produced excellent long-term outcomes in terms of BC, DFS, and CSS in patients with prostate cancer even for those at highest risk. Conformal HDR-BT is both a precise dose delivery system and an effective treatment for both favorable and unfavorable prostate cancer. The addition of a short course of neoadjuvant/concurrent ADT failed to improve outcome. The results were similar at all three institutions, giving credence to the reproducibility of the brachytherapy treatment.

Long-term outcome after elective irradiation of the pelvic lymphatics and local dose escalation using high-dose-rate brachytherapy for locally advanced prostate cancer.

PURPOSE: To report the 8-year outcome of local dose escalation using high-dose-rate conformal brachytherapy combined with elective irradiation of the pelvic lymphatics for localized prostate cancer. METHODS AND MATERIALS: One hundred forty-four consecutively treated men (1986-1992) were recorded prospectively. Twenty-nine (20.14%) patients had T1b-2a tumors, and 115 (79.86%) patients had T2b-3 tumors according to, respectively, American Joint Committee on Cancer/Union Internationale Contre le Cancer 1992. All patients had a negative nodal status, proven by CT or MRI. The mean initial PSA value was 25.61 ng/mL (Initial value for 41.66% of patients was <10 ng/mL, for 21.52% was 10-20 ng/mL, and for 32.63% was >20 ng/mL). The total dose applied by external beam radiotherapy was 50 Gy in the pelvis and 40 Gy in the prostate. The high-dose-rate brachytherapy was delivered in two fractions, which were incorporated into the external beam treatment (after 20-Gy and 40-Gy external beam radiotherapy dose). The dose per fraction was 15 Gy for the PTV1 (peripheral prostate zone) and 9 Gy for the PTV2 (entire prostatic gland). Any patient free of clinical or biochemical evidence of disease was termed bNED. Actuarial rates of outcome were calculated by Kaplan-Meier and compared using the log-rank. Cox regression models were used to establish prognostic factors of the various measures of outcome. RESULTS: The median follow-up was 8 years (range 60-171 months). The overall survival rate was 71.5%, and the disease-free survival rate was 82.6%. The bNED survival rate was 72.9%. Freedom from local recurrence for T3 stage was 91.3%, whereas for G3 lesions it was 88.23%. Freedom from distant recurrence for T3 stage was 82.6% and for G3 lesions 70.59%. Univariate survival analyses revealed that low stage (T1-2), low grade (G1-2), no hormonal therapy, initial PSA value less than 40 ng/mL, and PSA normalization <1.0 ng/mL after irradiation were associated with long survival. In multivariate analyses, initial PSA value, PSA kinetics after radiation therapy, and no adjuvant hormonal treatment were independent prognostic factors. Grade 3 late radiation toxicity (according to RTOG/EORTC scoring scheme) was 2.3% for the genitourinary system in terms of cystitis and 4.10% for the gastrointestinal system in terms of proctitis. Grades 4 and 5 genitourinary/gastrointestinal morbidity was not observed. A history of transurethral resection of the prostate with a median interval of less than 6 months from radiotherapy was associated with a high risk of genitourinary toxicity. CONCLUSION: The 8-year results confirm the feasibility and effectiveness of combined elective irradiation of the pelvic lymphatics and local dose escalation using high-dose-rate brachytherapy for cure of localized and especially high-risk prostate cancer.

Computed tomography after breast conserving carcinoma treatment: recognition of surgically induced lesions prior to radiation therapy.

To introduce computed tomography for the detection of post-surgical intramammarian lesions, exposing risk factors for subsequent radiation therapy. 104 patients with breast cancer were treated. They previously underwent breast conserving carcinoma treatment and were subsequently irradiated. The techniques were planned individually based on a CTdata set. All the acquired slices were evaluated with regard to seromas, larger tissue defects or organized hematomas. Seromas and tissue defects are raising the rate of byeffects during radiation therapy and deteriorating the cosmetic results. Pretherapeutical CT allows the puncture of hidden seromas and the individual adaptation of the irradiation technique in order to avoid overdosage due to tissue defects. Therefore CT is valuable for all patients prior to radiation therapy.

The 15-year outcomes of high-dose-rate brachytherapy for radical dose escalation in patients with prostate cancer - a benchmark for high-tech external beam radiotherapy alone?

PURPOSE: Dose escalation using high-dose-rate brachytherapy (HDR-BT) is an established treatment method for prostate cancer. First, long-term results were previously published (specific Kiel method). This study aims to evaluate 10-/15-year outcomes of Kiel Protocol 1 (1986-1992). METHODS AND MATERIALS: Conformal external beam radiotherapy (EBRT) was delivered to the pelvis (50 Gy per conventional fractionation) along with an HDR boost to the prostate amounting to a combined biologic equivalent dose in 2 Gy per fraction of 117.25 Gy (α/ß = 3). The HDR-BT was performed in two fractions of 15 Gy to the peripheral zone of McNeal. The EBRT-clinical target volume covered the full pelvis. The analyzed cohort totaled 122 patients. The reported end points were overall/cancer-specific survival, local recurrence/distant metastasis rates, and biochemical (BC) control rates according to American Society for Therapeutic Radiology and Oncology/Phoenix definitions. All end points were calculated using the Kaplan-Meier method and the log-rank test in univariate analyses. RESULTS: The mean follow-up time was 116.8 months. The 5-, 10-, and 15-year survival rates were 81%, 62.1%, and 45% for overall survival; 92.1%, 83.1%, and 75.3% for cancer-specific survival; 92.5%, 91.4%, and 83.9% for local recurrence-free survival; and 83.8%, 81.2%, and 69.8% for distant metastasis-free survival, respectively. American Society for Therapeutic Radiology and Oncology-defined BC tumor control rates at 5, 10, and 15 years were 81.1%, 74%, and 67.8%, respectively. According to Phoenix, the BC control rates at 5, 10, and 15 years were 77.8%, 69%, and 63.6%, respectively. CONCLUSIONS: The long-term results for the combination of HDR-BT and EBRT continue to show excellent results, providing high equivalent dose in 2 Gy per fraction and high disease control rates. These outcomes were reproducible for the extended follow-up period ranging up to 21.9 years.

Is standard breast-conserving therapy (BCT) in elderly breast cancer patients justified? A prospective measurement of acute toxicity according CTC-classification.

BACKGROUND: Breast conserving therapy (BCT) is an accepted treatment for early-stage breast cancer. This study aimed to measure prospectively acute radiation-related toxicity and to create a comprehensive data base for long-term temporal analyses of 3D conformal adjuvant radiotherapy. The specific aspect of age has been neglected by traditional research. Therefore, the impact of age on acute BCT toxicity should be also specifically addressed. METHODS: Toxicity was measured in 109 patients at initiation (t1), during radiotherapy (t2-t7), and 6 weeks after treatment completion (t8) using a new topographic module. Organ systems were recorded in 15 scales and scored according to symptom intensity (grade 0-5) based on CTC (Common Toxicity Criteria) -classification. Radiotherapy was virtually CT-based planned and applied with 6-MeV-photons. Mean total dose was 60.1 Gy. Patients were stratified by age in 3 Groups: <50, 50-60, and >60 years. RESULTS: Registered toxicity was generally low. Mean overall-grade climbed from 0.29-0.40 (t1-t7), and dropped to 0.23 (t8). Univariate analyses revealed slightly higher toxicity in older (> 60 years) versus young patients (< 50 years) in 2 scales only: breast-symmetry (p = 0.033), and arm function (p = 0.007). However, in the scale "appetite" toxicity was higher in younger (< 50 years) versus older (> 60 years) patients (p = 0.039). Toxicity differences in all other scales were not significant. Between older (> 60 years) and midaged patients (50-60 years) no significant differences in toxicity were found. This was also true for the comparison between young (< 50 years) versus midaged patient groups (50-60 years). CONCLUSION: The treatment concept of BCT for breast cancer is generally well tolerated. The toxicity-measurement with the new topographic module is feasible. Not modified standard treatment for BC should be performed in elderly women.

Hypofractionated conformal HDR brachytherapy in hormone naïve men with localized prostate cancer. Is escalation to very high biologically equivalent dose beneficial in all prognostic risk groups?

PURPOSE: To analyze the long-term effect of local dose escalation using conformal hypofractionated high-dose-rate brachytherapy (HDR-BT) boost and pelvic external-beam radiation therapy (EBRT) in hormone-naïve men with localized prostate cancer. PATIENTS AND METHODS: A total of 579 men were consecutively treated with pelvic EBRT and dose escalating HDR-BT since 1986 in two prospective trials: 378 patients at William Beaumont Hospital (1991-2002), and 201 patients at Kiel University (1986-1999). BT optimization was done modulating both, the dwell times and spatial source positions. A short course of neoadjuvant/concurrent androgen deprivation therapy was given to 222 patients. Hormone-naïve patients only (n = 324) with a follow-up > or = 18 months were analyzed. All patients had at least one poor prognostic factor (stage > or = T2b, Gleason Score > or = 7, pretreatment prostate-specific antigen [PSA] > or = 10 ng/ml): any one factor 122 patients, any two factors 122 patients, and three factors 80 patients. This cohort was stratified by equivalent dose (ED): dose level 1, < or = 94 Gy, n = 58, and dose level 2, > 94 Gy, n = 266, assuming an alpha/beta ratio of 1.2. The ASTRO definition for biochemical failure was used. RESULTS: Mean follow-up was 5.3 years (1.5-13.9 years). For all 324 patients, the 5-year biochemical control (BC) rate was 79%. Cancer-specific survival was 98%, and overall survival 90%. Similar analysis by institution demonstrated no difference in outcomes. For the entire cohort of hormone-naïve men, dose escalation to > 94 Gy resulted in a better 5-year BC of 59% versus 85% (p < 0.001). Discriminating by risk group a striking dose escalation effect was seen in the groups with two or three poor prognostic factors (p = 0.022 and < 0.001, respectively). In the group with only one poor prognostic factor, no statistical difference could be detected questioning the need for ED > 94 Gy. CONCLUSION: The results demonstrate that conformal HDR-BT is a successful method for delivering very high radiation dose to the prostate. The ability to escalate dose to ED > 94 Gy was reflected in improved long-term outcomes in terms of BC, significantly for those patients with two or three poor prognostic factors reaching BC rates of 85%.

Significant negative impact of adjuvant chemotherapy on health-related quality of life (HR-QoL) in women with breast cancer treated by conserving surgery and postoperative 3-D radiotherapy. A prospective measurement.

PURPOSE: To prospectively assess health-related quality of life (HR-QoL) in women after conserving surgery for breast cancer during/after postoperative 3-D radiotherapy. PATIENTS AND METHODS: 109 consecutively treated patients were analyzed. HR-QoL was assessed at initiation (t1), end (t2), and 6 weeks after radiotherapy (t3) using the EORTC modules QLQ-C30/BR23. Patients were divided into three therapy groups. Group I comprised 41 patients (radiotherapy and adjuvant chemotherapy), group II 45 patients (radiotherapy and adjuvant hormonal therapy), and group III 23 patients (radiotherapy alone). Reliability was tested. Scale means were calculated. Univariate (ANOVA) and multivariate (MANCOVA) analyses were performed. RESULTS: Reliability testing revealed mean Cronbach's alpha> 0.70 at all measurement points. ANOVA/MANCOVA statistics revealed significantly better HR-QoL for patients in group II versus I. Patients receiving radiotherapy alone (group III) showed the best results in HR-QoL. However, scale mean differences between groups II and III were not significant. CONCLUSION: HR-QoL measurement using EORTC instruments during/after radiotherapy is reliable. Adjuvant chemotherapy significantly lowered HR-QoL versus hormones or radiotherapy alone. Chemotherapy patients did not recover longitudinally (from t1 to t3).

Health-related quality of life measurement in long-term survivors and outcome following radical radiotherapy for localized prostate cancer.

PURPOSE: To report long-term outcomes in terms of health-related quality of life (HRQoL) and survival of a dose-escalating radiotherapy protocol and to validate a new disease-specific HRQoL instrument. PATIENTS AND METHODS: 189 consecutive men with prostate cancer were analyzed; 127 patients had T1-2 (1% T1, 66% T2) and 62 patients (33%) T3 tumors. The pelvic lymphatics were treated to a dose of 50 Gy by external-beam irradiation. The prostate dose was limited to 40 Gy using compensators. The prostate was treated to the total nominal dose of 70 Gy using high-dose-rate (HDR) brachytherapy. The fraction dose was 15 Gy in the McNeal zone (planning target volume [PTV] 1), while 8-9 Gy were applied in the entire prostate (PTV 2). The HRQoL of the 145 long-term survivors was assessed using the EORTC QLQ-C30 and a new prostate-specific instrument (PSM-G 1.0). The reliability of the instruments used and HRQoL scale scores were calculated. Uni-/multivariate analyses of variance were performed. RESULTS: At a mean follow-up of 6.5 years 86.3% of the patients were disease-free, and 78% were biochemically controlled. The mean Cronbach's alpha-values were 0.81 for the QLQ-C30, and 0.74 for the prostate-specific module. Univariate analyses of variance by T-stage, grading, prostata-specific antigen (PSA) status after therapy and adjuvant androgen suppression (AS) revealed that PSA elevation after irradiation and AS were associated with significantly diminished HRQoL. In multivariate analyses AS significantly lowered the HRQoL without survival benefit. CONCLUSION: The described radiotherapy regimen represents a curative and well-tolerated treatment for localized prostate cancer. The HRQoL assessment with both instruments used was reliable. Adjuvant AS and PSA elevation were associated with diminished HRQoL.