Randomised clinical trial on 7-days-a-week postoperative radiotherapy vs. concurrent postoperative radio-chemotherapy in locally advanced cancer of the oral cavity/oropharynx.

OBJECTIVE: To compare the efficacy and tolerance of 7-days-a-week accelerated postoperative radiotherapy (p-CAIR) vs postoperative radio-chemotherapy (p-RTCT). METHODS: Between September 2007 and October 2013, 111 patients were enrolled and randomly assigned to receive 63 Gy in 1.8 Gy fractions 7-days-a-week (n = 57, p-CAIR) or 63 Gy in 1.8 Gy fractions 5-days-a-week with concurrent cisplatin 80-100 mg per square meter of body-surface area on days 1, 22 and 43 of the radiotherapy course (p-RTCT). It represents approximately 40% of the intended trial size, that was closed prematurely due to slowing accrual. Only high-risk patients with squamous cell cancer of the oropharynx/oral cavity, considered fit for concurrent treatment were enrolled. RESULTS: The rate of locoregional control (LRC) did not differ significantly between treatment arms (p = 0.18, HR = 0.56), 5 year LRC tended, however, to favour p-RTCT (81%) vs p-CAIR (62%). There was no difference in overall survival between treatment arms (p = 0.90, HR = 1.03).The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms. Haematological toxicity of p-RTCT was, however, considerably increased compared to p-CAIR. CONCLUSION: Concurrent postoperative RTCT tended to improve locoregional control rate as compared to p-CAIR. This, however, did not transferred into improved overall survival. Postoperative RTCT was associated with a substantial increase in haematological toxicity that negatively affected treatment compliance in this arm. ADVANCES IN KNOWLEDGE: To our knowledge, this is the first trial that compares accelerated radiotherapy and radio-chemotherapy in postoperative treatment for oralcavity/oropharyngeal cancer.

Clinical and volumetric predictors of local control after robotic stereotactic radiosurgery for cerebral metastases: active systemic disease may affect local control in the brain.

BACKGROUND: The aim of the study was to assess the association between physical and biological dose normalized to volume of the metastatic tumor as well as clinical factors with local control in patients with brain metastases who underwent robotic stereotactic radiosurgery. PATIENTS AND METHODS: A cohort of 69 patients consecutively treated with robotic radiosurgery between 2011 and 2016 was analyzed. The patients were treated with either single fraction radiosurgery or hypofractionated regimens. Biologically effective dose (BED) was calculated assuming alpha/beta value = 10 and both physical dose and BED were normalized to the tumor volume to allow dose-volume effect evaluation. Moreover, clinical and treatment-related variables were evaluated to asses association with local control. RESULTS: A total of 133 tumors were irradiated and their volumes ranged between 0.001 and 46.99 cm3. Presence of extracranial progression was associated with worse local control whereas higher total dose, BED10 > 59 Gy and single metastasis predicted statistically significantly better local outcome. BED10/cm3 > 36 Gy, and BED2 > 60 Gy negatively affected local control in univariate analysis. In multivariate analysis performed on all these variables, presence of a single metastasis, BED10 > 59 Gy and extracranial progression retained their significance. Excluding a priori the BED2/ cm3 parameter resulted with a Cox model confirming significance of all remaining variables. CONCLUSIONS: Hypofractionated treatment schemes have similar efficiency to single fraction treatment in terms of local control and the effect depends on BED irrespective of fractionation schedule. Effective control of extracranial sites of the disease is associated with higher probability of local control in the brain which in turn is consistently lower in patients with multiple lesions.

Salvage CyberKnife-Based Reirradiation of Patients With Recurrent Prostate Cancer: The Single-Center Experience.

The aim of this study was to evaluate CyberKnife-based radioablation as a salvage treatment for prostate cancer postirradiation relapses based on a group of patients disqualified from available conventional methods of salvage treatment. Thirty-eight patients were treated with a fraction dose varying from 5.5 to 10 Gy (median 7.35) to a total dose of 18 to 36.25 Gy (median 36.25). In all, 55.3% of patients had androgen deprivation therapy during this time. Nine patients had oligometastases in the salvage time. The follow-up varied from 1.6 to 46.4 months (mean 19.7, median 14.4). In all, 92.6% to 97.4% of patients had no gastrointestinal acute adverse effects; no effects higher than G1 were noted. There were particular (up to 4.8%) G2 late gastrointestinal effects. The percentage without genitourinary acute effects varied from 59.1% to 78.9%; 3.7% had G3 toxicity. G3 late genitourinary toxicity appeared 3 times, the maximal percentage being 12.5% (24 months after salvage treatment). The nadir of prostate-specific antigen median was 0.24 ng/mL (9 months after treatment). Twelve (31.6%) patients failed in the timeline of 6 to 42 months after salvage treatment (mean 18.7, median 16.5)-5 due to dissemination. In 2 cases, progression in existing metastases was identified. Five (13.2%) patients had biochemical failure without additional metastases (local relapses); hence, local control was 86.8%. The failure risk is strongly influenced by initial disease stage and presalvage prostate-specific antigen concentration. The obtained results permit us to conclude that such a treatment could be an effective and safe option for prostate cancer postirradiation relapse salvage treatment.

Radiotherapy staffing in the European countries: final results from the ESTRO-HERO survey.

BACKGROUND: The ESTRO Health Economics in Radiation Oncology (HERO) project has the overall aim to develop a knowledge base of the provision of radiotherapy in Europe and build a model for health economic evaluation of radiation treatments at the European level. The first milestone was to assess the availability of radiotherapy resources within Europe. This paper presents the personnel data collected in the ESTRO HERO database. MATERIALS AND METHODS: An 84-item questionnaire was sent out to European countries, through their national scientific and professional radiotherapy societies. The current report includes a detailed analysis of radiotherapy staffing (questionnaire items 47-60), analysed in relation to the annual number of treatment courses and the socio-economic status of the countries. The analysis was conducted between February and July 2014, and is based on validated responses from 24 of the 40 European countries defined by the European Cancer Observatory (ECO). RESULTS: A large variation between countries was found for most parameters studied. Averages and ranges for personnel numbers per million inhabitants are 12.8 (2.5-30.9) for radiation oncologists, 7.6 (0-19.7) for medical physicists, 3.5 (0-12.6) for dosimetrists, 26.6 (1.9-78) for RTTs and 14.8 (0.4-61.0) for radiotherapy nurses. The combined average for physicists and dosimetrists is 9.8 per million inhabitants and 36.9 for RTT and nurses. Radiation oncologists on average treat 208.9 courses per year (range: 99.9-348.8), physicists and dosimetrists conjointly treat 303.3 courses (range: 85-757.7) and RTT and nurses 76.8 (range: 25.7-156.8). In countries with higher GNI per capita, all personnel categories treat fewer courses per annum than in less affluent countries. This relationship is most evident for RTTs and nurses. Different clusters of countries can be distinguished on the basis of available personnel resources and socio-economic status. CONCLUSIONS: The average personnel figures in Europe are now consistent with, or even more favourable than the QUARTS recommendations, probably reflecting a combination of better availability as such, in parallel with the current use of more complex treatments than a decade ago. A considerable variation in available personnel and delivered courses per year however persists among the highest and lowest staffing levels. This not only reflects the variation in cancer incidence and socio-economic determinants, but also the stage in technology adoption along with treatment complexity and the different professional roles and responsibilities within each country. Our data underpin the need for accurate prediction models and long-term education and training programmes.

The effect of tumor volume on radiotherapy outcome and correlation with other prognostic factors in patients with T2 supraglottic cancer.

The retrospective chart review of 110 patients with T2 supraglottic cancer who underwent radiotherapy was performed to correlate tumor volume with other prognostic factors and to analyze its impact on treatment results. Patients with involved nodes, poor histopathological tumor differentiation, or hemoglobin concentration ≤ 14.3 g/dl had significantly larger tumors. Patients with large tumors had significantly lower 5-year local control rate, overall survival rate and presented significantly higher risk of nodal involvement and the ratio of poor histopathological differentiation of the tumor. Tumor volume significantly impacts radiotherapy outcome and should be considered to optimize treatment strategy for patients with T2 supraglottic cancer.

Radiation-free weekend rescued! Continuous accelerated irradiation of 7-days per week is equal to accelerated fractionation with concomitant boost of 7 fractions in 5-days per week: report on phase 3 clinical trial in head-and-neck cancer patients.

PURPOSE: To report long-term results of randomized trial comparing 2 accelerated fractionations of definitive radiation therapy assessing the need to irradiate during weekend in patients with head and neck squamous cell carcinoma. METHODS AND MATERIALS: A total of 345 patients with SCC of the oral cavity, larynx, and oro- or hypo-pharynx, stage T2-4N0-1M0, were randomized to receive continuous accelerated irradiation (CAIR: once per day, 7 days per week) or concomitant accelerated boost (CB: once per day, 3 days per week, and twice per day, 2 days per week). Total dose ranged from 66.6-72 Gy, dose per fraction was 1.8 Gy, number of fractions ranged from 37-40 fractions, and overall treatment time ranged from 37-40 days. RESULTS: No differences for all trial end-points were noted. At 5 and 10 years, the actuarial rates of local-regional control were 63% and 60% for CAIR vs 65% and 60% for CB, and the corresponding overall survival were 40% and 25% vs 44% and 25%, respectively. Confluent mucositis was the main acute toxicity, with an incidence of 89% in CAIR and 86% in CB patients. The 5-year rate of grade 3-4 late radiation morbidity was 6% for both regimens. CONCLUSIONS: Results of this trial indicate that the effects of accelerated fractionation can be achieve by delivering twice-per-day irradiation on weekday(s). This trial has also confirmed that an accelerated, 6-weeks schedule is a reasonable option for patients with intermediate-stage head-and-neck squamous cell carcinoma because of the associated high cure rate and minimal severe late toxicity.

The updated ESTRO core curricula 2011 for clinicians, medical physicists and RTTs in radiotherapy/radiation oncology.

INTRODUCTION: In 2007 ESTRO proposed a revision and harmonisation of the core curricula for radiation oncologists, medical physicists and RTTs to encourage harmonised education programmes for the professional disciplines, to facilitate mobility between EU member states, to reflect the rapid development of the professions and to secure the best evidence-based education across Europe. MATERIAL AND METHODS: Working parties for each core curriculum were established and included a broad representation with geographic spread and different experience with education from the ESTRO Educational Committee, local representatives appointed by the National Societies and support from ESTRO staff. RESULTS: The revised curricula have been presented for the ESTRO community and endorsement is ongoing. All three curricula have been changed to competency based education and training, teaching methodology and assessment and include the recent introduction of the new dose planning and delivery techniques and the integration of drugs and radiation. The curricula can be downloaded at http://www.estro-education.org/europeantraining/Pages/EuropeanCurricula.aspx. CONCLUSION: The main objective of the ESTRO core curricula is to update and harmonise training of the radiation oncologists, medical physicists and RTTs in Europe. It is recommended that the authorities in charge of the respective training programmes throughout Europe harmonise their own curricula according to the common framework.

Intraoperative radiotherapy (IORT) with low-energy photons as a boost in patients with early-stage oral cancer with the indications for postoperative radiotherapy : treatment feasibility and preliminary results.

PURPOSE: To evaluate the feasibility and preliminary results of intraoperative radiotherapy (IORT) with low-energy photons as a boost in patients with early-stage oral cancer with the indications for postoperative radiotherapy. PATIENTS AND METHODS: Between 2003 and 2006, 16 patients with early-stage cancer of mobile tongue (n = 10 [63%]) or floor of the mouth (n = 6 [37%]) treated at Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Poland, were evaluated for IORT boost with the INTRABEAM®System (Carl Zeiss Surgical GmbH; IORT-PRS) because of the high risk of local recurrence due to positive margins on frozen pathologic section. After tumor resection, the applicator was positioned in the tumor bed. The applicator's diameter (range: 1.5-5 cm) was selected to encompass high-risk area of tumor recurrence. The dose (5 Gy, 7 Gy, or 7.5 Gy) was applied according to tumor volume and bone proximity. External-beam radiotherapy (EBRT) was provided to the tumor bed in all patients (50 Gy) and to the nodal area, when needed. Toxicity and local tumor control were assessed. RESULTS: Median follow-up was 36 months. IORT did not increase acute mucosal reaction. Local tumor control was found in all cases. Early mucosal reaction did not exceed 3 according to the RTOG scale and healed in median time of 35 days after completion of EBRT. No late adverse effects were observed. CONCLUSION: This preliminary report has demonstrated the feasibility of IORT-PRS for patients with early oral cancer with the indications for postoperative radiotherapy. This method may be considered an alternative boost technique, although additional studies are needed to establish long-term results in a larger group of patients.

[Comparison of quantitative computerized angiography and intravascular ultrasound in assessment of renal artery stenosis in patients with renovascular hypertension treated with percutaneous transluminal angioplasty with concomitant intravascular brachytherapy]. / Porównanie ilosciowej angiografii i ultrasonografii wewnatrznaczyniowej w ocenie zwezenia resztkowego i restenozy u chorych z nadcisnieniem naczyniowo- nerkowym leczonych metoda przezskórnej angioplastyki tetnicy nerkowej i brachyterapii sródnaczyniowej.

UNLABELLED: Renal Angiography and IntraVascular UltraSonography (IVUS), are valuable diagnosis methods for assessment of renovascular hypertension (RVH). Endovascular techniques employing percutaneous transluminal renal angioplasty (PTRA) are effective for therapy of ischaemic nephropathy in patients with RVH. Success of PTRA is limited by a significant rate of restenosis. THE AIM OF STUDY was to compare the assessment of residual stenosis and restenosis with angiography and IVUS. MATERIAL AND METHODS: Residual stenosis after PTRA (combine with intravascular brachyterapy in 33 patients--group I) were assessed in 62 RVH patients with angiography and IVUS techniques. Both baseline and 9-month follow-up quantitative computerized angiography (QCA) and intravascular ultrasound (IVUS) analysis were performed to assess restenosis. RESULTS: Residual stenosis after PTRA of atherosclerotic lesions was slightly lower with QCA than IVUS (in group I 15.49 +/- 4.69% and 18.81 +/- 4.81% and in group II 15.36 +/- 4.68% and 18.43 +/- 4.69%, respectively). The loss of lumen area in QCA assessment was slightly greater than in IVUS measurement (1.2 +/- 0.7 mm vs. 0.9 +/- 0.8 mm in group I i 1.7 +/- 0.7 mm vs. 1.5 +/- 0.8 mm in group II). The angiographic measurements of late lumen loss, diameter stenosis, and minimal lumen diameter correlated well with IVUS measurements (r = 0.81, r = 0.89 and r = 0.89 respectively). CONCLUSIONS: Angiography and IVUS are equally effective methods for diagnosis and assessment of residual stenosis and restenosis after endovascular renal artery revascularisation.

Comparison of early and late efficacy of percutaneous transluminal renal angioplasty with or without subsequent brachytherapy: the effect on blood pressure in patients with renovascular hypertension.

BACKGROUND: Scarce data exist concerning the long-term effect of percutaneous transluminal renal angioplasty (PTRA) enhanced with intravascular gamma brachytherapy (IVBT) in patients with renovascular hypertension. METHODS: Seventy one patients aged 52 +/- 8 years with refractory renovascular hypertension were randomized to Group I (PTRA + IVBT) or Group II (PTRA). For the IVBT procedure, the PARIS catheter and Microselectron HDR (Nucletron) system was employed. Both baseline and 9-month follow-up quantitative computerized angiography (QCA) and ambulatory blood pressure monitoring analysis was performed to assess luminal parameters of restenosis and the effect of treatment on blood pressure. RESULTS: Thirty three patients from Group I and 29 patients from Group II underwent successful procedure. During nine months of follow-up, three patients died; including two patients in Group I (cardiac causes) and one patient in Group II (stroke). The follow-up lumen diameter stenosis was 30.6 +/- 13.7% and 40.4 +/- 11% in Groups I and II, respectively (p = 0.004). Late lumen loss in quantitative computerized angiography was 1.2 +/- 0.7 mm and 1.7 +/- 0.7 mm in Groups I and II, respectively (p = 0.004). CONCLUSIONS: Intravascular gamma brachytherapy using self-centering source performed after balloon angioplasty is a safe and effective method of prevention of restenosis after PTRA in patients with renovascular hypertension.

Effects of short- and long-term efficacy of percutaneous transluminal renal angioplasty with or without intravascular brachytherapy on regression of left ventricular hypertrophy in patients with renovascular hypertension.

INTRODUCTION: The largest group of patients with secondary hypertension comprises individuals with renovascular hypertension resulting from renal artery stenosis that is a potentially removable condition. It is caused by atherosclerosis in 70-80% of patients. OBJECTIVES: The aim of the study was to evaluate the influence of intravascular brachytherapy (IVBT) procedure performed after percutaneous transluminal renal angioplasty (PTRA) on left ventricular (LV) function, mass regression and type of hypertrophy (LVH) determined on echocardiography during long-term follow-up. PATIENTS AND METHODS: Sixty-two patients with atherosclerotic renal artery stenosis complicated by severe hypertension were treated with PTRA and randomly assigned to group 1 (PTRA alone) or group 2 (PTRA followed by IVBT). Subsequent IVBT was performed with the PARIS catheter and the Microselectron HDR (Nucletron) system for peripheral arteries. Treatment outcomes during follow-up were assessed with quantitative coronary angiography. LV mass and mass index (LVM and LVMI) and functional parameters prior to PTRA and during follow-up were determined by echocardiography with regard to the type of procedure. RESULTS: The degree of renal artery stenosis was significantly different in groups 1 and 2. In both groups elevated LVMI was observed (p = 0.94). There were no significant differences in interventricular septum (IVS) to LV posterior wall (LVPW) ratio, relative LV wall thickness, volumetric parameters and LV ejection fraction between both groups. During follow-up the values of LVMI and IVS to LVPW ratio were significantly lower (p = 0.021 and p = 0.004, respectively) in the PTRA + IVBT group compared to the PTRA group. Analysis of the LV geometry and type of hypertrophy revealed a marked reduction in concentric LVH in the IVBT group during long-term follow-up. CONCLUSIONS: Echocardiographic evaluation comparing several LV parameters in the PTRA alone and PTRA + IVBT groups showed that PTRA with subsequent brachytherapy were associated with better control of blood pressure and greater LVM regression, especially concentric hypertrophy, during long-term follow-up.

Does incidental irradiation with doses below 50 gy effectively reduce isolated nodal failures in non-small-cell lung cancer: dose-response relationship.

PURPOSE: To evaluate the dose-response relationship for a wide range of doses lower than 50 Gy delivered to the hilar and mediastinal lymph node stations from incidental irradiation in 220 patients with non-small-cell lung cancer (NSCLC) treated with three-dimensional conformal radiotherapy. The endpoint was isolated nodal recurrence (INR) in stations that were initially negative. METHODS AND MATERIALS: The individual responses of 2596 nodal stations were analyzed. Different fractionation schedules were used in different patients. Total prescribed tumor doses ranged from 52 Gy to 74 Gy given over 16-56 days. There were 1198 nodal stations (46%) within and 1398 stations beyond the elective nodal irradiation (ENI) volumes. The INR incidence was estimated for six dose levels ranging from 5 +/- 5 Gy to > or = 56 Gy. RESULTS: There were a total of 25 INRs in 17 patients (8%). The incidence of INR within the electively treated volumes was 0.58%, compared with 1.28% in nodal stations beyond the ENI. Almost 80% of the INRs occurred during 10 months of follow-up. A strong dose-response relationship was seen for the lower "incidental" doses, most of which were less than 50 Gy. As the dose increased from 5 +/- 5 Gy to 40 +/- 5 Gy, the rate of freedom from INR increased from 12% to 76% (p = 0.005). CONCLUSIONS: There is evidence of a dose-response relationship between a reduction in the rate of INR and doses lower than 50 Gy. This suggests that incidental irradiation can eradicate at least some subclinical metastases in regional lymph nodes.

Boost in radiotherapy: external beam sunset, brachytherapy sunrise.

Radiobiological limitations for dose escalation in external radiotherapy are presented. Biological and clinical concept of brachytherapy boost to increase treatment efficacy is discussed, and different methods are compared. Oncentra Prostate 3D conformal real-time ultrasound-guided brachytherapy is presented as a solution for boost or sole therapy.

Pattern analysis of acute mucosal reactions in patients with head and neck cancer treated with conventional and accelerated irradiation.

PURPOSE: To evaluate severity of acute mucosal reactions (AMR) caused by conventional (CF) and accelerated fractionation (AF) regimens using a modified Dische system and to analyze differences in incidence and severity of AMR according to frequency and regularity of scoring. METHODS AND MATERIALS: Sixty-six consecutive patients (33 CF, 33 AF) with head and neck cancer irradiated with 5 fractions in 5 days per week (CF) or with 7 fractions in 7 days (AF) to a total dose of 70 Gy. A modified Dische system was used for daily quantitation of AMR during radiotherapy until complete healing. RESULTS: Confluent mucositis (CM) was noted in 79% of patients in the CF group and 85% in the AF group. In 24% of the CF group and 18% of the AF group the CM presented a wave-like pattern. In 55% of CF and 67% of AF a classic triphasic pattern was noted. In 12 patients acute reactions did not transgress the level of spotted mucositis. The present study clearly shows that quantitation of the incidence and severity of acute mucosal effects strongly depends on frequent and regular scoring. A significant difference in the incidence of CM between the CF and AF groups was noted, mainly in weeks 4-6 of irradiation. When once-weekly irregular instead of daily scoring was evaluated, the incidence of CM was underestimated by approximately 20-36%. CONCLUSIONS: Acute mucosal reactions occur as a complex of morphologic and functional disorders with individual intensity, even among patients treated with the same fractionation regimen. In some cases they present a "wave-like" pattern during irradiation. Therefore, precise quantitation of acute effects requires regular and frequent scoring.

Methylation of the MGMT and p16 genes in sporadic colorectal carcinoma and corresponding normal colonic mucosa.

BACKGROUND: Colorectal cancer, one of the most aggressive cancers, occurs with a high incidence in most countries. The usual treatment is surgery and subsequent chemotherapy and radiotherapy. Cancer development and progression is dictated by series of alterations in genes such as tumor suppressor genes, DNA repair genes, oncogenes and others. In colorectal carcinogenesis disturbances different from mutations called an epigenetic regulation are also taken into consideration. Epigenetics is defined as a modifications of the genome, heritable during cell division, which do not involve a change in the DNA sequence. In our study we analyzed methylation of CpG islands in the MGMT and p16 genes in sporadic colorectal cancers and normal corresponding colonic mucosa. MATERIAL/METHODS: Fresh tissue samples were obtained from 68 patients (age of 23 to 81 years) with primary colorectal adenocarcinoma and corresponding normal tissues. We used methylation-specific polymerase chain reaction (MSP) for analysis of the methylation status of MGMT and p16. RESULTS: Methylation of MGMT and p16 was detected in 59% and 53% of tumors, respectively. In corresponding normal colonic mucosa methylation of MGMT was detected in 20% and p16 in 18%. The normal colon mucosa obtained from younger patients (age of <65 years) showed less methylation frequency as compared with the normal mucosa from the older ones (age of >65 years). CONCLUSIONS: The older age and female gender are generally associated with higher methylation levels for most CpG islands in normal colonic mucosa. These results indicate that MGMT and/or p16 aberrant methylation may play an important role in colorectal cancer.

Angiographic and intravascular ultrasound assessment of immediate and 9-month efficacy of percutaneous transluminal renal artery balloon angioplasty with subsequent brachytherapy in patients with renovascular hypertension.

BACKGROUND/AIM: Scarce data exist concerning the long-term effect of renal balloon angioplasty (PTRA) enhanced by intravascular gamma-brachytherapy (IVBT) in patients with renovascular hypertension. The aim of this randomized study was to evaluate long-term outcome after PTRA with IVBT in patients with renal artery stenosis. PATIENTS AND METHODS: 71 patients with renovascular hypertension were randomized into group I (PTRA + IVBT) or group II (PTRA). 9 patients who required stent implantation were excluded. Both baseline and 9-month follow-up quantitative computerized angiography and intravascular ultrasound (IVUS) analysis were performed to assess restenosis. During the 9-month follow-up, 3 patients died - 2 from group I and 1 from group II. RESULTS: The restenosis rate was 16.1% in group I and 32.1% in group II. The 9-month lumen loss in angiography was 1.2 +/- 0.7 and 1.7 +/- 0.7 mm (p = 0.004) and the area loss (IVUS) was 6.5 +/- 4.8 and 10.1 +/- 5.6 mm(2) in groups I and II, respectively (p = 0.01). eGFR increased both in group I (from 75 +/- 22 to 84 +/- 31 ml/min/1.73 m(2); p < 0.001) and in group II (from 74 +/- 23 to 77 +/- 23 ml/min/1.73 m(2); p = 0.04). Only the diastolic blood pressure in group I decreased significantly (65 +/- 17 and 77 +/- 18 mm Hg; p = 0.048). The rate of blood pressure normalization was low in both groups (6.1 and 6.9%). CONCLUSIONS: IVBT after PTRA with a self-centering source is a safe and effective method for prevention of restenosis in patients with renovascular hypertension.

Randomized clinical trial on 7-days-a-week postoperative radiotherapy for high-risk squamous cell head and neck cancer.

PURPOSE: To evaluate the normal tissue reactions and loco-regional control rates (LRC) in patients treated with 7-days-a-week postoperative continuous irradiation (p-CAIR) compared to conventionally fractionated 5-days-a-week postoperative radiotherapy (CF). MATERIALS/METHODS: Between 2001 and 2004, 279 patients with high-risk squamous cell cancer of the larynx (158 pts.) or cancer of the oral cavity/oropharynx (121 pts.) were enrolled. They were stratified according to the primary cancer site (larynx vs. others) and the treating center and randomized to receive 63 Gy in fractions of 1.8 Gy given 5-days-a-week (140 pts: CF) or 7-days-a-week (139 pts: p-CAIR). RESULTS: The acute and late toxicity was considered acceptable, although the proportion of patients with confluent mucositis was higher in p-CAIR compared to CF (60.0 vs. 33.3%). The actuarial 3-year LRC were 64 vs. 70% for CF and p-CAIR, respectively, p=0.32. A statistically significant improvement in 3-year LRC in p-CAIR arm appeared in a subset of the patients with cancer of the oropharynx/oral cavity (74% p-CAIR vs. 53% CF, p=0.02). By contrast, there was no improvement in LRC in a subset of the patients with cancer of the larynx (p=0.46). CONCLUSION: An improvement in LRC attributable to acceleration of postoperative radiotherapy appeared restricted to the patients with cancer of the oropharynx/oral cavity. In patients with cancer of the larynx acceleration of postoperative radiotherapy did not have any beneficial effect.

Continuous accelerated 7-days-a-week radiotherapy for head-and-neck cancer: long-term results of phase III clinical trial.

PURPOSE: To update 5-year results of a previously published study on special 7-days-a-week fractionation continuous accelerated irradiation (CAIR) for head-and-neck cancer patients. METHODS AND MATERIALS: One hundred patients with squamous cell carcinoma of head and neck in Stage T(2-4)N(0-1)M(0) were randomized between two definitive radiation treatments: accelerated fractionation 7 days a week including weekends (CAIR) and conventional 5 days a week (control). Hence the overall treatment time was 2 weeks shorter in CAIR. RESULTS: Five-year local tumor control was 75% in the CAIR group and 33% in the control arm (p < 0.00004). Tumor-cure benefit corresponded with significant improvement in disease-free survival and overall survival rates. Confluent mucositis was the main acute toxicity, with the incidence significantly higher in CAIR patients than in control (respectively, 94% vs. 53%). When 2.0-Gy fractions were used, radiation necrosis developed in 5 patients (22%) in the CAIR group as a consequential late effect (CLE), but when fraction size was reduced to 1.8 Gy no more CLE occurred. Actuarial 5-year morbidity-free survival rate was similar for both treatments. CONCLUSIONS: Selected head-and-neck cancer patients could be treated very effectively with 7-days-a-week radiation schedule with no compromise of total dose and with slight 10% reduction of fraction dose (2 Gy-1.8 Gy), which article gives 1 week reduction of overall treatment time compared with standard 70 Gy in 35 fractions over 47-49 days. Although this report is based on the relatively small group of patients, its results have encouraged us to use CAIR fractionation in a standard radiation treatment for moderately advanced head-and-neck cancer patients.

Randomized clinical trial on continuous 7-days-a-week postoperative radiotherapy for high-risk squamous cell head-and-neck cancer: a report on acute normal tissue reactions.

BACKGROUND AND PURPOSE: To analyse acute mucosal reactions in patients treated with continuous accelerated postoperative irradiation (p-CAIR) compared to conventionally fractionated postoperative radiotherapy (p-CF). PATIENTS AND METHODS: The patients were randomly assigned to receive 63 Gy in 1.8 Gy fractions 7-days-a-week given over a period of 5 weeks (n=88), or 63 Gy in 1.8 Gy fractions given 5-days-a-week over 7 weeks (n=87). It represents 65% of an overall trial size. Acute mucosal reactions were scored using modified Dische system. Polychotomous logistic regression was used to estimate the influence of the selected variables on maximum grade of mucositis, and percent of the body weight loss during radiotherapy. RESULTS: The average maximum Dische score and percent of the patients with confluent mucositis were higher in patients treated with p-CAIR, compared to p-CF (13.3 vs. 10.8 and 54 vs. 27%). Polychotomous logistic regression analysis revealed that fractionation scheme and tumour site have significantly influenced maximum Dische score. Tumour site (laryngeal vs. other) had even stronger influence on maximum Dische score than fractionation scheme. The average residual Dische score 8 weeks after radiotherapy was higher in p-CAIR compared to p-CF (2.1 vs. 1.4), and was, most frequently, related to persistent mucosal erythema (70 vs. 57% of pts.). No severe consequential toxicity of radiotherapy was observed, so far, in the trial. CONCLUSIONS: While the incidence, intensity and duration of mucosal reactions was higher in p-CAIR than in p-CF the accelerated treatment can be considered tolerable with respect to acute toxicity. In both arms of the trial slight or moderate mucosal erythema was the most frequent acute side effect, which did not completely subside within 8 weeks after irradiation.

[Assessment of radiation injuries to the salivary glands after treatment of head and neck cancers]. / Ocena wystepowania póznego odczynu popromiennego w obrebie slinianek po napromienianiu nowotworów glowy i szyi.

PURPOSE: The purpose of this investigation was to evaluate the quality of life, measured in LENT-SOMA and DISCHE scale, of patients with xerostomia as late irradiation injury. MATERIALS AND METHODS: 45 head and neck cancer patients were radically irradiated receiving doses from 48 Gy to 76.8 Gy (mean: 65.1 Gy) on PTV. Patients received doses from 48 to 76 Gy on salivary gland (mean: 63.8 Gy, SD: 8). The irradiation injury of the oral cavity was assessed using DISCHE scale at the end of radiotherapy and late radiation sequels of salivary gland was assessed in 6 and 7 month after radiotherapy using DISCHE and LENT-SOMA scale. The average follow-up for this group of patients was 8 months. RESULTS: All patients with 6 and more points of acute reactions assessed in DISCHE scale at the end of radiotherapy have had xerostomia in follow-up period. Results measured by LENT-SOMA scale was similar to DISCHE scale. CONCLUSIONS: Dose escalation of radiotherapy increases number of xerostomia as late irradiation injury. Both scales (LENT-SOMA and DISCHE) are similar in qualifying and quantifying of salivary gland radiation injury. Minimal therapeutic dosage prescribed on salivary gland after which irradiation injury occurred was 63 Gy.