Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

BACKGROUND: PRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system. METHODS: Participants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0-4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed. RESULTS: 103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55-0.90); tablet vs paper: 0.81 (0.62-0.96); IVRS vs paper: 0.78 (0.60-0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = -0.04 [-0.16-0.22]; tablet vs paper = -0.02 [-0.11-0.14]; IVRS vs paper = 0.02 [-0.07-0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/-0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported "no problems" responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper. CONCLUSIONS: Mode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration. TRIAL REGISTRATION: NCT Clinicaltrials.gov identifier: NCT02158637.

HISTORY OF SUNLIGHT EXPOSURE IS A RISK FACTOR FOR AGE-RELATED MACULAR DEGENERATION.

PURPOSE: To evaluate effects of current and past sunlight exposure and iris color on early and late age-related macular degeneration (AMD). METHODS: Of 3,701 individuals from the EUGENDA database, 752 (20.3%) showed early AMD, 1,179 (31.9%) late AMD, and 1,770 (47.8%) were controls. Information about current and past sunlight exposure, former occupation type, subdivided in indoor working and outdoor working, and iris color were obtained by standardized interviewer-assisted questionnaires. Associations between environmental factors adjusted for age, gender, and smoking and early and late AMD were performed by multivariate regression analysis. RESULTS: Current sunlight exposure showed no association with early AMD or late AMD, but past sunlight exposure (≥8 hours outside daily) was significantly associated with early AMD (odds ratio: 5.54, 95% confidence interval 1.25-24.58, P = 0.02) and late AMD (odds ratio: 2.77, 95% confidence interval 1.25-6.16, P = 0.01). Outside working was found to be associated with late AMD (odds ratio: 2.57, 95% confidence interval 1.89-3.48, P = 1.58 × 10). No association was observed between iris color and early or late AMD. CONCLUSION: Sunlight exposure during working life is an important risk factor for AMD, whereas sunlight exposure after retirement seems to have less influence on the disease development. Therefore, preventive measures, for example, wearing sunglasses to minimize sunlight exposure, should start early to prevent development of AMD later in life.

[The morbidity and mortality of residents of Kazakhstan exposed to radiation impact and their posterity].

The most part of population exposed to radiation and their offspring residing in territories bordering upon the Semipalatinsk nuclear testing area represent objects of studying aged 40 years and older because the age is the factor decreasing health indices at the expense of natural gerontological processes. In these conditions, additional radiation exposition, besides radiological biological effects, plays the role ofpotentiation of common biological and environmental risk factors. From the archives of research institute of radiation medicine and ecology the primary medical documents were retrieved containing information about established diagnoses of individuals included into elaboration of epidemiological statistical analysis of dynamics of morbidity of persons in 2008-2012. Within the same period, the acts-certificates of causes of death of specific persons included into study groups were retrieved. It is established that in 8 classes of diseases in the main group and in 5 classes of diseases in comparison group significant exceeding of average annual indices of prevalence of diseases as compared with control group was established. The common prevalence of diseases in the main group comprised 3147.5 cases, in the comparison group - 2615.6 cases and in control group - 2203.8 cases per 1000 of population (RR=1.42;1.19; p<0.05;0.05). The indices of total mortality in the main group comprised 1887.3 cases, in the comparison group - 1531.2 cases and in control group - 1155.1 cases per 100 000 of population (RR=1.58;1.36; p<0.05;0.05). Among persons in the main group in 7 classes of diseases and in the comparison group in 5 classes of diseases significant exceeding of indices of mortality was registered over same indices in control group was registered as causes of death.

NONINVASIVE GRADING OF RADIATION RETINOPATHY: The Use of Optical Coherence Tomography Angiography.

PURPOSE: Previous studies have shown that spectral domain optical coherence tomography can diagnose radiation retinopathy (RR) before ophthalmoscopic findings. Recently, optical coherence tomography angiography (OCT-A) has been helpful in seeing vascular findings undetected by spectral domain optical coherence tomography. The authors wish to demonstrate the OCT-A grading at varying levels of RR. METHODS: The OCT-A, spectral domain optical coherence tomography, and ophthalmoscopic findings on 7 patients from December 2014 to March 2015 with varying levels of RR are demonstrated. RESULTS: Findings on OCT-A could be demonstrated before spectral domain optical coherence tomography findings. Patients can be graded on a scale of increasing severity from 0 to 5, based on positive or negative clinical findings of RR between OCT-A. Optical coherence tomography increased central macular thickness, optical coherence tomography evident cysts, and ophthalmoscopy (Grade 0: -,-,-,-; Grade 1: +,-,-,-; Grade 2: +,+,-,-; Grade 3: +,+,+,-; Grade 4: ++,+,+,+; Grade 5: unreadable,++,++,+). CONCLUSION: The use of OCT-A allows for earlier detection of RR; thus, existing grading systems should be modified to include OCT-A.

Late complications after radiotherapy for prostate cancer.

BACKGROUND: The aim of the present study was to analyze in detail the time course of the incidence of radiation-induced late effects. For this purpose, unpublished data of patients treated by radiation therapy in Hamburg in the late 1980s were analyzed. Relatively large volumes were exposed to comparatively high doses, thus leading to a high rate of treatment-related side effects. PATIENTS AND METHODS: A total of 180 consecutive patients received radiotherapy for prostate cancer. The median age was 66 years (range 41-88 years). The median of the maximum dose was 77.5 Gy (range 56.3-95 Gy) and overall treatment time was 51 days (range 28-128 days). Endpoints analyzed were late complications of grade 3 or higher, overall and disease-free survival, local tumor control, and distant metastases. Data analysis was actuarial and the log-rank test was used to compare the various subgroups. RESULTS: After 2 years, 80.5 ± 3.2% of the patients were without any complications of grade 3 or higher, and after 5 years a constant level of 70.3 ± 4.0% was approached. When multiple lesions occurred per patient, the later events were disregarded. A total of 66 complications occurred in 42 patients. The percentage of patients being free from late complications, plotted as a function of time after start of radiation therapy, was adequately described by an exponential function and a constant fraction. Complications approached a constant level of 70.3% at a rate of 5.3% per month. This means that patients who will develop a complication do so at exponential kinetics and at a relatively high rate, whereas about 70% of the patients will never experience a late effect even over long observation periods. After subdividing the maximum dose into three equal dose groups of 55 patients each (< 73.3 Gy, 73.3-80 Gy, > 80 Gy), the constant fraction decreased from 85.7 to 72.8% and 52.2%, whereas the incidence rate was 4.3%, 7.7%, and 5.6% per month and, thus, almost independent of radiation dose. CONCLUSION: For a given group of patients, the rate of the incidence of late complications appears to be independent of radiation dose and (from analyzing data in the literature) independent of the grade of lesions, whereas the fraction of patients without late effects depends on both parameters.

Radiation-induced morphological changes in the vagina.

BACKGROUND AND PURPOSE: Treatment-induced chronic vaginal changes after definitive radio(chemo)therapy for locally advanced cervical cancer patients are reported as one of the most distressing consequences of treatment, with major impact on quality of life. Although these vaginal changes are regularly documented during gynecological follow-up examinations, the classic radiation morbidity grading scales are not concise in their reporting. The aim of the study was therefore to identify and qualitatively describe, on the basis of vaginoscopies, morphological changes in the vagina after definitive radio(chemo)therapy and to establish a classification system for their detailed and reproducible documentation. PATIENTS AND METHODS: Vaginoscopy with photodocumentation was performed prospectively in 22 patients with locally advanced cervical cancer after definitive radio(chemo)therapy at 3-24 months after end of treatment. All patients were in complete remission and without severe grade 3/4 morbidity outside the vagina. RESULTS: Five morphological parameters, which occurred consistently after treatment, were identified: mucosal pallor, telangiectasia, fragility of the vaginal wall, ulceration, and adhesions/occlusion. The symptoms in general were observed at different time points in individual patients; their quality was independent of the time of assessment. Based on the morphological findings, a comprehensive descriptive and semiquantitative scoring system was developed, which allows for classification of vaginal changes. A photographic atlas to illustrate the morphology of the alterations is presented. CONCLUSION: Vaginoscopy is an easily applicable, informative, and well-tolerated procedure for the objective assessment of morphological vaginal changes after radio(chemo)therapy and provides comprehensive and detailed information. This allows for precise classification of the severity of individual changes.

Radiation necrosis: relevance with respect to treatment of primary and secondary brain tumors.

Radiation injury to the central nervous system (CNS) manifests in multiple forms and is divided into three categories termed acute, early-delayed, and late-delayed injury patterns. Late-delayed radiation injury, primarily manifesting as leukoencephalopathy or radiation necrosis, is often progressive and may have a negative impact on quality of life. Radiation injury is believed to be a consequence of cell membrane and DNA injury with a pathological expression as vascular injury, depletion of oligodendroglial progenitor cells, and failure of cell-cell interactions that constitute the cellular network of the CNS. In addition, radiation injury results in activation of the inflammatory cascade with perturbation of cytokines, production of reactive oxygen species and vascular endothelial growth factor. Medical treatment of CNS radiation injury and in particular radiation necrosis remains problematic as there is a paucity of clinical trial data to inform treatment decisions, and aside from surgery and corticosteroids only bevacizumab appears to have a compelling therapeutic role.

[Radiological protection: its concept and principles].

Main concepts and principles of radiation protection system are reviewed. Especially, the concept of LNT model and its background are discussed. Also, the major principles, i.e., (i) justification, (ii) optimization, and (iii) the application of dose limits, are reviewed with emphasis on the existing situation, which is mostly related to the current situation in Fukushima.

The Dutch-Belgian Registry of Stereotactic Body Radiation Therapy for Liver Metastases: Clinical Outcomes of 515 Patients and 668 Metastases.

PURPOSE: Although various studies have reported that stereotactic body radiation therapy (SBRT) for liver metastases has high local control rates and relatively low toxicity, most series included a small number of patients. We aimed to validate these outcomes in a large multi-institution patient cohort treated in accordance with a common protocol. METHODS AND MATERIALS: A shared web-based registry of patients with liver metastases treated with SBRT was developed by 13 centers (12 in the Netherlands and 1 in Belgium). All the centers had previously agreed on the items to be collected, the fractionation schemes, and the organs-at-risk constraints to be applied. Follow-up was performed at the discretion of the centers. Patient, tumor, and treatment characteristics were entered in the registry. Only liver metastases treated individually as independent targets and with at least 1 radiologic follow-up examination were considered for local control analysis. Toxicity of grade 3 or greater was scored according to the Common Terminology Criteria of Adverse Events (v4.03). RESULTS: Between January 1, 2013, and July 31, 2019, a total of 515 patients were entered in the web-based registry. The median age was 71 years. In total, 668 liver metastases were registered, and 447 were included for local control analysis. The most common primary tumor origin was colorectal cancer (80.3%), followed by lung cancer (8.9%) and breast cancer (4%). The most-used fractionation scheme was 3x18-20 Gy (36.0%), followed by 8x7.5 Gy (31.8%), 5x11-12 Gy (25.5%), and 12x5 Gy (6.7%). The median follow-up time was 1.1 years for local control and 2.3 years for survival. Actuarial 1-year local control was 87%; 1-year overall survival was 84%. Toxicity of grade 3 or greater was found in 3.9% of the patients. CONCLUSIONS: This multi-institutional study confirms the high rates of local control and limited toxicity in a large patient cohort. Stereotactic body radiation therapy should be considered a valuable part of the multidisciplinary approach to treating liver metastases.

Classification and treatment of radiation maculopathy.

PURPOSE OF REVIEW: Radiation maculopathy is a sight-limiting consequence of radiotherapy in the management of uveal melanoma and other intraocular tumors. In this review, we consider clinical, fluorescein angiographic and optical coherence tomographic findings, propose a classification for radiation maculopathy and discuss the management of this condition. RECENT FINDINGS: Radiation macular edema (RME) can be classified by optical coherence tomography into noncystoid or cystoid edema, with foveolar or extrafoveolar involvement. Optical coherence tomographic grading of RME has been found to correlate with visual acuity. Focal argon laser might have some limited benefit in the treatment of RME. Intravitreal triamcinolone and intravitreal antivascular endothelial growth factor agents can be of short-term benefit in the treatment of RME. In a randomized controlled trial, periocular triamcinolone significantly reduced rates of RME and vision loss up to 18 months following plaque radiotherapy for uveal melanoma. SUMMARY: Currently, there is no proven treatment for established RME, though periocular triamcinolone has been shown to have a preventive benefit. An accepted classification system for radiation maculopathy would be of benefit in planning and comparing future treatment trials.

I-125 brachytherapy for choroidal melanoma photographic and angiographic abnormalities: the Collaborative Ocular Melanoma Study: COMS Report No. 30.

OBJECTIVES: (1) To summarize the protocol used for grading features of postradiation abnormalities from fundus photographs and fluorescein angiograms of patients enrolled in the Collaborative Ocular Melanoma Study (COMS); (2) to document the prevalence of features of interest in the posterior pole of these eyes during 8 years of follow-up; and (3) to investigate baseline patient, tumor, and treatment characteristics associated with posterior pole features. DESIGN: Observational case series within a randomized, multicenter clinical trial. PARTICIPANTS: We evaluated 650 patients who were assigned to and received iodine-125 brachytherapy in the COMS for medium-sized tumors. METHODS: Color fundus photographs and fluorescein angiograms were taken at baseline and 2, 5, and 8 years; 30 features were graded according to a standard protocol. MAIN OUTCOME MEASURES: Prevalence at selected time intervals of fundus photographic features associated with retinopathy and optic neuropathy. RESULTS: The percentage of patients with >/=1 feature of interest was 49.2% at baseline, 84.4% at 2 years, 91.2% at 5 years, and 90.7% at 8 years. The most frequent findings across all follow-up examinations were macular microaneurysms (75.6% of examinations), macular angiographic leakage (75.1%), and optic disc hyperfluorescence (62.8%). The median number of features present increased significantly with each follow-up to a maximum of 7 features at 8 years. The prevalence of neovascularization of the disc at 5 years was 5.2%. The prevalence of optic neuropathy at 5 years was 27.4%. Prognostic factors for more prevalent and severe posterior pole abnormalities were diabetes, tumor location close to both optic nerve and foveal avascular zone, and greater dose of radiation to the foveola and optic nerve head. CONCLUSIONS: The amount and severity of retinopathy and optic neuropathy after iodine-125 brachytherapy increased through 8 years of follow-up. Assessment of photographs and angiograms taken in accord with a standard protocol provided reliable estimates of rates of development of features of retinopathy and optic neuropathy in eyes treated using the COMS brachytherapy protocol. Our findings support earlier reports that tumor factors in addition to radiation treatment may contribute to posterior pole abnormalities. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.

Treatment Toxicity: Radiation.

Intentional and unintentional radiation exposures have a powerful impact on normal tissue function and can induce short-term and long-term injury to all cell systems. Radiation effects can lead to lifetime-defining health issues for a patient and can produce complications to all organ systems. Providers need to understand acute and late effects of radiation treatment and how the fingerprints of therapy can have an impact on health care in later life. This article reviews current knowledge concerning normal tissue tolerance with therapy.

The Lens Opacities Classification System III Grading in Irradiated Uveal Melanomas to Characterize Proton Therapy-Induced Cataracts.

PURPOSE: To evaluate the use of the Lens Opacities Classification System III grading (LOCS III) for the characterization of radiation-induced cataract, and to correlate the proton beam projection onto the lens with cataract location and grade as defined by the LOCS III. DESIGN: Prospective, interventional case series. METHODS: Fifty-two consecutive patients with cataract following proton therapy were included. All cataracts were graded using LOCS III. Relationships between proton beam and cataract subtypes, as well as between dose, proportion of lens irradiated, and extent of cataracts, were assessed. RESULTS: Tumor diameter, volume, stage, and equatorial tumor location were associated with extent of posterior subcapsular cataracts (PSC) that were diagnosed at a median (interquartile range) 36 months (22;83) after treatment. In multivariate analysis, the tumor volume (P < .01) and an equatorial tumor location (P = .01) were risk factors for extensive PSC. Lens irradiation was avoided in 10 patients. In the remaining 42 patients (81%), the extent of PSC significantly correlated with the dose to the lens receiving 10, 26, and 47 Gy (P = .03, P = .03, and P = .04, respectively), the dose to the lens periphery receiving 10 and 26 Gy (P = .02 and P = .02, respectively), and the dose to the ciliary body receiving 10 and 26 Gy (P = .03 and P = .02, respectively). Nuclear color significantly correlated with the dose to the ciliary body receiving 10 Gy (P = .03) and 26 Gy (P = .02). After adjustment of the results on tumor volume and tumor location, the volume of lens receiving 10 Gy (P = .04) and 26 Gy (P = .03) remained significantly associated with the extent of PSC. CONCLUSIONS: Proton dose correlated with the occurrence of PSC and nuclear color cataracts as defined by LOCS III grading. Better characterization of cataracts with the LOCS III after irradiation may help to further fill gaps in the current understanding of the mechanisms of radiation-induced cataracts.

High-dose-rate brachytherapy for large prostate volumes (> or =50cc)-Uncompromised dosimetric coverage and acceptable toxicity.

PURPOSE: The purpose of this study was to review our single-institution experience using high-dose-rate (HDR) brachytherapy in patients with large-volume prostate glands (> or =50cc). METHODS AND MATERIALS: Fifty-four patients treated with HDR brachytherapy for prostate cancer at the Penrose Cancer Center between 2001 and 2006 were identified as having an ultrasound volume of at least 50cc at the time of implant (range, 50-97.3cc; mean, 61.5cc; median, 57cc; upper quartile, 83.3-97.3cc). Neoadjuvant hormones (17 patients) were not routinely recommended unless the initial ultrasound volume suggested pubic arch interference or the patient's Gleason score or prostate specific antigen prompted use. All patients received HDR brachytherapy as a boost before or after conformal external beam radiation therapy to 4500cGy. Boost brachytherapy doses ranged from 1600 to 1900cGy, given in two to three fractions. RESULTS: The median D(90) (minimal dose to 90% of the prostate) was 109% of prescription dose (range, 95-115%) and the median V(100) (volume receiving 100% of the dose) was 96% (range, 90-99%). V(150) ranged from 10% to 35%, with a median value of 18.3%. Six patients (11%) required temporary placement of a urinary catheter for acute obstructive symptoms after brachytherapy. With a median followup of 1.8 years, there has been a single case of Grade 2 gastrointestinal toxicity and 1 patient has developed a bulbo-urethral stricture requiring dilation. There have been no cases of rectal bleeding. CONCLUSIONS: Large prostate volume is not a contraindication to HDR brachytherapy. Excellent dosimetric coverage can be attained with acceptable acute toxicity.

Combined brachytherapy with external beam radiotherapy for localized prostate cancer: reduced morbidity with an intraoperative brachytherapy planning technique and supplemental intensity-modulated radiation therapy.

PURPOSE: To report the acute and late treatment-related toxicities of combined permanent interstitial (125)I implantation delivered via real-time intraoperative planning and supplemental intensity-modulated radiotherapy (IMRT) for patients with clinically localized prostate cancer. METHODS AND MATERIALS: One hundred twenty-seven patients were treated with a combined modality (CM) regimen consisting of (125)I implantation (110Gy) using a transrectal ultrasound-guided approach followed 2 months later by 50.4Gy of IMRT directed to the prostate and seminal vesicles. Late toxicity was scored according to the NCI Common Terminology Criteria for Adverse Events toxicity scale. The acute and late toxicities were compared to a contemporaneously treated cohort of 216 patients treated with (125)I alone to a prescribed dose of 144Gy. RESULTS: The incidence of Grade 2 acute rectal and urinary side effects was 1% and 10%, respectively, and 2 patients developed Grade 3 acute urinary toxicities. The 4-year incidence of late Grade 2 gastrointestinal toxicity was 9%, and no Grade 3 or 4 complications have been observed. The 4-year incidence of late Grade 2 gastrourinary toxicities was 15% and 1 patient developed a Grade 3 urethral stricture, which was corrected with urethral dilatation. The percentage of patients who experienced resolution of late rectal and urinary symptoms was 92% and 65%, respectively. Multivariate analysis revealed that in addition to higher baseline International Prostate Symptom Score, those patients treated with implant alone compared to CM were more likely to experience Grade 2 acute urinary symptoms. Increased Grade 2 late rectal toxicities were noted for CM patients (9% vs. 1%; p=0.001) as well as a significant increase for late Grade 2 urinary toxicities (15% vs. 9%; p=0.004). CONCLUSIONS: Adherence to dose constraints with combination real-time brachytherapy using real-time intraoperative planning and IMRT is associated with a low incidence of acute and late toxicities. Acute urinary side effects were significantly less common for CM patients compared to those treated with implantation alone. Late Grade 2 rectal and urinary toxicities were more common for patients treated with CM compared to implant alone.

Chemoradiotherapy for locally advanced pancreatic cancer: a radiotherapy dose escalation and organ motion study.

AIMS: To determine the efficacy of radiation dose escalation and to examine organ motion during conformal radiotherapy for locally advanced pancreatic cancer. MATERIALS AND METHODS: Thirty-nine patients who were consecutively treated with chemoradiotherapy were studied. Fifteen patients, treated from 1993 to 1997, received 50 Gy in 20 fractions (group I). Twenty-four patients, treated from 1997 to 2003, received an escalated dose of 55 Gy in 25 fractions (group II). Intra-fraction pancreatic tumour motion was assessed in three patients using megavoltage movies during radiation delivery to track implanted radio-opaque markers. RESULTS: Improved survival rates were seen in latterly treated group II patients (P=0.083), who received escalated radiotherapy to smaller treatment volumes due to advances in verification. Worse toxicity effects (World Health Organization grade 3-4) were reported by some patients (<10%), but treatment compliance was similar in both groups, indicating equivalent tolerance. Substantial intra-fraction tumour displacement due to respiratory motion was observed: this was greatest in the superior/inferior (mean=6.6 mm) and anterior/posterior (mean=4.75 mm) directions. Lateral displacements were small (<2 mm). CONCLUSIONS: Dose escalation is feasible in pancreatic cancer, particularly when combined with a reduction in irradiated volume, and enhanced efficacy is indicated. Large, globally applied margins to compensate for pancreatic tumour motion during radiotherapy may be inappropriate. Strategies to reduce respiratory motion, and/or the application of image-guided techniques that incorporate individual patients' respiratory motion into radiotherapy planning and delivery, will probably improve pancreatic radiotherapy.

Evaluation of acute and late radiation morbidity in patients with gynaecologic malignancy using the RTOG criteria and Franco-Italian glossary.

PURPOSE: The purpose of this study was to evaluate acute and late radiation morbidity in patients with gynaecologic malignancy using the RTOG criteria and Franco-Italian glossary, and to compare the usefulness and disadvantages of each system. MATERIALS AND METHODS: Between February 2001 and February 2003, 107 patients with gynaecologic malignancy who received either radical or djuvant external radiotherapy +/- intracavitary brachytherapy or radiochemotherapy were enrolled in this study. The patients were evaluated before radiotherapy and weekly during radiotherapy for acute morbidity using the RTOG grading system and Franco-Italian glossary. Postradiotherapy evaluation was done one month after radiotherapy and at 3-month intervals thereafter. Median follow-up duration was 17 months. Morbidity was graded and recorded according to each scoring system. RESULTS: Median age was 46 years (range 37-82). Sixty-four patients (59.8%) had endometrial cancer. Radical radiotherapy was applied to 26 patients because of inoperability and 81 patients received postoperative radiotherapy. Biologically effective doses for the bladder, rectum and vagina were 98.39, 103.54 and 121.81, respectively, for late morbidity (BED3); 70.88, 72.84 and 80.92, respectively, for acute morbidity (BED10). According to the RTOG grading system acute morbidity rate for the genitourinary and gastrointestinal systems, and skin were 52.3%, 83.2% and 63.5%, respectively. Late morbidity rate for the bladder, colon-rectum, skin and vagina were 16.8%, 20.6%, 47.7% and 51.4%, respectively. The morbidity rate for the bladder, nonspecific abdominal, hematopoietic system, uterus-vulva-vagina, skin and rectum were 35.4%, 29.9%, 5.6%, 60.8%, 40.1% and 32.7%, respectively using the Franco-Italian glossary. In patients with carcinoma of the vulva--whose treatment fields were wider--acute morbidity rate according to RTOG criteria was higher (p = 0.057); photon energy (6 Mv rather than 1.25 MV) (p = 0.01) and treatment interruption of more than eight days (p = 0.019) were correlated with decreased long-term morbidity. According to the Franco-Italian glossary morbidity rates were higher in patients who received chemotherapy (p = 0.047), both external radiotherapy and brachytherapy (p = 0.022) and treatment interruption of less than eight days (p = 0.019). CONCLUSION: There is no common language between the RTOG grading system and Franco-Italian glossary for defining and scoring radiation morbidity. Up to date no standard and well-defined system has been developed for recording and reporting acute and late radiation morbidity in gynaecologic malignancy, but rather it depends on the subjective evaluation and experience of a radiation oncologist and subjective complaints of the patient, and sometimes on clinical findings. A standard and well-defined user friendly objective scoring system is needed to define and predict the morbidity rate more properly.

Predictability of acute radiation injury severity.

Results of dose-response analyses for different clinical symptoms of acute radiation syndrome (ARS) are reported here. The analyses were performed on dosimetric and clinical data from a group of ARS patients (59 cases) exposed to gamma and neutron or gamma radiation alone due to nuclear accidents at Mayak Production Association (Mayak PA). Findings suggested the possibility of prediction of injury severity within the first hours or days after acute exposure based on clinical symptoms and signs such as the onset of vomiting, neutrophil count abnormalities in the peripheral blood within the first 2-3 hours after acute exposure, and lymphocyte count abnormalities in the peripheral blood within the first 24-48 h after acute exposure.