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Radiation-induced acute toxicities after image-guided intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for patients with spinal metastases (IRON-1 trial) : First results of a randomized controlled trial.
Sprave, T, Verma, V, Förster, R, Schlampp, I, Bruckner, T, Bostel, T, Welte, SE, Tonndorf-Martini, E, El Shafie, R, Nicolay, NH, et al
Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]. 2018;(10):911-920
Abstract
PURPOSE Radiation therapy (RT) provides an important treatment approach in the palliative care of vertebral metastases, but radiation-induced toxicities in patients with advanced disease and low performance status can have substantial implications for quality of life. Herein, we prospectively compared toxicity profiles of intensity-modulated radiotherapy (IMRT) vs. conventional three-dimensional conformal radiotherapy (3DCRT). METHODS This was a prospective randomized monocentric explorative pilot trial to compare radiation-induced toxicity between IMRT and 3DCRT for patients with spinal metastases. A total of 60 patients were randomized between November 2016 and May 2017. In both cohorts, RT was delivered in 10 fractions of 3 Gy each. The primary endpoint was radiation-induced toxicity at 3 months. RESULTS Median follow-up was 4.3 months. Two patients suffered from grade 3 acute toxicities in the IMRT arm, along with 1 patient in the 3DCRT group. At 12 weeks after treatment (t2), 1 patient reported grade 3 toxicity in the IMRT arm vs. 4 patients in the 3DCRT group. No grade 4 or 5 adverse events occurred in either group. In the IMRT arm, the most common side effects by the end of irradiation (t1) were grade 1-2 xerostomia and nausea in 8 patients each (29.6%), and dyspnea in 7 patients (25.9%). In the 3DCRT group, the most frequent adverse events (t1) were similar: grade 1-2 xerostomia (n = 10, 35.7%), esophagitis (n = 10, 35.8%), nausea (n = 10, 35.8%), and dyspnea (n = 5, 17.9%). CONCLUSION This is the first randomized trial to evaluate radiation-induced toxicities after IMRT versus 3DCRT in patients with vertebral metastases. This trial demonstrated an additional improvement for IMRT in terms of acute side effects, although longer follow-up is required to further ascertain other endpoints.
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Adaptive/nonadaptive proton radiation planning and outcomes in a phase II trial for locally advanced non-small cell lung cancer.
Koay, EJ, Lege, D, Mohan, R, Komaki, R, Cox, JD, Chang, JY
International journal of radiation oncology, biology, physics. 2012;(5):1093-100
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Abstract
PURPOSE To analyze dosimetric variables and outcomes after adaptive replanning of radiation therapy during concurrent high-dose protons and chemotherapy for locally advanced non-small cell lung cancer (NSCLC). METHODS AND MATERIALS Nine of 44 patients with stage III NSCLC in a prospective phase II trial of concurrent paclitaxel/carboplatin with proton radiation [74 Gy(RBE) in 37 fractions] had modifications to their original treatment plans after re-evaluation revealed changes that would compromise coverage of the target volume or violate dose constraints; plans for the other 35 patients were not changed. We compared patients with adaptive plans with those with nonadaptive plans in terms of dosimetry and outcomes. RESULTS At a median follow-up of 21.2 months (median overall survival, 29.6 months), no differences were found in local, regional, or distant failure or overall survival between groups. Adaptive planning was used more often for large tumors that shrank to a greater extent (median, 107.1 cm(3) adaptive and 86.4 cm(3) nonadaptive; median changes in volume, 25.3% adaptive and 1.2% nonadaptive; P<.01). The median number of fractions delivered using adaptive planning was 13 (range, 4-22). Adaptive planning generally improved sparing of the esophagus (median absolute decrease in V(70), 1.8%; range, 0%-22.9%) and spinal cord (median absolute change in maximum dose, 3.7 Gy; range, 0-13.8 Gy). Without adaptive replanning, target coverage would have been compromised in 2 cases (57% and 82% coverage without adaptation vs 100% for both with adaptation); neither patient experienced local failure. Radiation-related grade 3 toxicity rates were similar between groups. CONCLUSIONS Adaptive planning can reduce normal tissue doses and prevent target misses, particularly for patients with large tumors that shrink substantially during therapy. Adaptive plans seem to have acceptable toxicity and achieve similar local, regional, and distant control and overall survival, even in patients with larger tumors, vs nonadaptive plans.
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A comparison of the impact of isotope ((125)I vs. (103)Pd) on toxicity and biochemical outcome after interstitial brachytherapy and external beam radiation therapy for clinically localized prostate cancer.
Kollmeier, MA, Pei, X, Algur, E, Yamada, Y, Cox, BW, Cohen, GN, Zaider, M, Zelefsky, MJ
Brachytherapy. 2012;(4):271-6
Abstract
PURPOSE To compare biochemical outcomes and morbidity associated with iodine-125 ((125)I) and palladium-103 ((103)Pd) brachytherapy as part of combined modality therapy for clinically localized prostate cancer. METHODS AND MATERIALS Between October 2002 and December 2008, 259 patients underwent prostate brachytherapy ((125)I prescription dose, 110Gy: n=199; (103)Pd prescription dose, 100Gy: n=60) followed by external beam radiotherapy (median dose, 50.4Gy). Eighty-seven patients also received neoadjuvant androgen deprivation therapy. Toxicities were recorded with CTCAE v 3.0, International Prostate Symptoms Score (IPSS), and International Index of Erectile Function questionnaires. RESULTS Overall, acute Grade ≥2 genitourinary toxicity occurred in 21% and 30% of patients treated with (125)I and (103)Pd, respectively (p=0.16). There were no significant differences in IPSS change or urinary quality-of-life scores between the isotopes at 4, 6, or 12 months (p=0.20, 0.21, and 1.0, respectively). IPSS resolution occurred at a median of 11 and 6 months for (125)I and (103)Pd patients, respectively (p=0.03). On multivariate analysis, only the use of neoadjuvant androgen deprivation therapy was predictive of time to IPSS resolution (p=0.046). Late Grade ≥2 gastrointestinal toxicity occurred in 7% of (125)I patients and 6% of patients treated with (103)Pd. Of 129 potent patients at baseline, there was better erectile function in patients who received (103)Pd (p=0.02); however, the followup was shorter for these patients. The 5-year prostate-specific antigen relapse-free survival for (125)I and (103)Pd patients was 95.2% and 98.2% (p=0.73), respectively. CONCLUSION There were no differences in acute or long-term genitourinary or gastrointestinal toxicity between (125)I and (103)Pd in combined modality therapy for prostate cancer. There may be less erectile toxicity with the use of (103)Pd; however, additional followup of these patients is needed. There was no significant difference in 5-year prostate-specific antigen relapse-free survival between (103)Pd and (125)I.
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New techniques in radiation therapy for head and neck cancer: IMRT, CyberKnife, protons, and carbon ions. Improved effectiveness and safety? Impact on survival?
Thariat, J, Bolle, S, Demizu, Y, Marcy, PY, Hu, Y, Santini, J, Bourhis, J, Pommier, P
Anti-cancer drugs. 2011;(7):596-606
Abstract
The objective of this study was to assess the comparative effectiveness of intensity-modulated radiation therapy (IMRT), conformal and two-dimensional radiation therapy, proton beam, and carbon ion therapy in terms of tumor control and survival on the one hand and adverse events and quality of life on the other in irradiated head and neck cancer patients. A search of the literature was performed. At a given time, innovative techniques in radiation therapy may appear superior to routine irradiation techniques and clinical trials may therefore be considered unethical. IMRT, because of its superiority in terms of dose distributions and potential to preserve the salivary glands, has gradually replaced two-dimensional and conformal irradiation in routine use. The PARSPORT phase III trial is one among the rare trials to randomize two-dimensional and conformal irradiation against IMRT. It showed a 50% reduction in late xerostomia. Similarly, the relevance of clinical trials to prove the superiority of protons compared with photons is highly controversial. Although the expected benefit of particle beam therapy on dose distributions, local control, and quality of life seems sufficient for routine use without phase III trials, it should be noted that new toxicity profiles might be seen as was the case for IMRT (posterior alopecia, anterior mucositis, uncertainties of integral dose, and secondary cancers). Prospective clinical and medico-economic assessment, possibly in phase II trials, is therefore critically needed along with stringent quality assurance programs. Technological advances in radiation therapy clearly provide a benefit for patients despite the lack of level I evidence.
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Comparison of the micronucleus and chromosome aberration techniques for the documentation of cytogenetic damage in radiochemotherapy-treated patients with rectal cancer.
Wolff, HA, Hennies, S, Herrmann, MK, Rave-Fränk, M, Eickelmann, D, Virsik, P, Jung, K, Schirmer, M, Ghadimi, M, Hess, CF, et al
Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]. 2011;(1):52-8
Abstract
PURPOSE The goal of the interdisciplinary Clinical Research Unit KFO179 (Biological Basis of Individual Tumor Response in Patients with Rectal Cancer) is to develop an individual Response and Toxicity Score for patients with locally advanced rectal cancer treated with neoadjuvant radiochemotherapy. The aim of the present study was to find a reliable and sensitive method with easy scoring criteria and high numbers of cell counts in a short period of time in order to analyze DNA damage in peripheral blood lymphocytes. Thus, the cytokinesis-block micronucleus (CBMN) assay and the chromosome aberration technique (CAT) were tested. MATERIALS AND METHODS Peripheral blood lymphocytes obtained from 22 patients with rectal cancer before (0 Gy), during (21.6 Gy), and after (50.4 Gy) radiochemotherapy were stimulated in vitro by phytohemagglutinin (PHA); the cultures were then processed for the CBMN assay and the CAT to compare the two methods. RESULTS A significant increase of chromosomal damage was observed in the course of radiochemotherapy parallel to increasing radiation doses, but independent of the chemotherapy applied. The equivalence of both methods was shown by Westlake's equivalence test. CONCLUSION The results show that the CBMN assay and the CAT are equivalent. For further investigations, we prefer the CBMN assay, because it is simpler through easy scoring criteria, allows high numbers of cell counts in less time, is reliable, sensitive, and has higher statistical power. In the future, we plan to integrate cytogenetic damage during radiochemotherapy into the planned Response and Toxicity Score within our interdisciplinary Clinical Research Unit.
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Influence of 131I diagnostic dose on subsequent ablation in patients with differentiated thyroid carcinoma: discrepancy between the presence of visually apparent stunning and the impairment of successful ablation.
Hu, YH, Wang, PW, Wang, ST, Lee, CH, Chen, HY, Chou, FF, Huang, YE, Huang, HH
Nuclear medicine communications. 2004;(8):793-7
Abstract
BACKGROUND In the management of patients with differentiated thyroid carcinoma, direct comparison of the presence of scintigraphic stunning after a diagnostic dose of 131I with subsequent successful ablation has not been evaluated. METHODS This study included 245 patients who received a dose of 2775-3700 MBq of 131I for thyroid remnant ablation. In all patients, the thyroid-stimulating hormone (TSH) level before ablation was more than 30 microlU x ml. One hundred and twenty-six patients (Group A) were given a 185 MBq diagnostic scan (Dscan) 4-11 days before 131I ablation, and 119 patients (Group B) received 131I ablation directly after thyroidectomy. Scintigraphic stunning was considered to be present on any post-ablation scan that revealed either fewer foci or obviously less prominent uptake compared with the earlier corresponding Dscan. Successful ablation was defined as no visible uptake in the neck region or anywhere else on a follow-up Dscan 6-12 months later. RESULTS Our results revealed that only 13 of the 126 patients (10.3%) in Group A had visually apparent thyroid stunning. Successful ablation was obtained in 56 of 126 cases (44.4%) in Group A, compared with 86 of 119 cases (72.2%) in Group B (P<0.001). In Group A, the success rate of ablation in patients with stunning (5/13) was not statistically different from that in those without (51/113) (odds ratio, 0.76; 95% CI, 0.23-2.47). Multiple logistic regression analysis revealed that the independent determinants of successful ablation were the use of Dscan before ablation (odds ratio, 0.23; 95% CI, 0.10-0.56) and the ablation dose of 131I (odds ratio, 1.05; 95% CI, 1.00-1.10). CONCLUSIONS Visually apparent stunning is infrequent and may not be sufficiently sensitive to detect the influence of a 185 MBq Dscan on subsequent ablation outcome. For patients with differentiated thyroid carcinoma, we recommend that ablation should be performed directly after thyroidectomy.
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A randomised trial of cranberry versus apple juice in the management of urinary symptoms during external beam radiation therapy for prostate cancer.
Campbell, G, Pickles, T, D'yachkova, Y
Clinical oncology (Royal College of Radiologists (Great Britain)). 2003;(6):322-8
Abstract
AIMS: The aim of the study was to assess whether the oral intake of cranberry juice cocktail compared with apple juice was associated with a significant difference in urinary symptoms experienced during radical external beam radiation therapy (EBRT) for prostate carcinoma. MATERIALS AND METHODS One hundred and twelve men with prostate cancer were randomised to either 354 ml cranberry juice or apple juice a day. Stratification was based on a history of a previous transurethral resection of prostate (TURP yes/no) and baseline International Prostate Symptom Score (IPSS < 6 or > or = 6) of urinary symptoms. RESULTS The maximum IPSS (MRT) and the maximum change in IPSS from baseline (DRT) are used to report the results. We analysed the effects of juice allocation on DRT and MRT using analysis of covariates (ANCOVA). We observed no significant difference for DRT (P = 0.39) or MRT (P = 0.76) related to the consumption of cranberry compared with apple juice. However, we found a significant relationship between the history of a previous TURP and both DRT (P = 0.01) and MRT (P = 0.01). The history of a previous TURP was associated with lower values for both end points. Baseline IPSS was significant for DRT (P = 0.004) and MRT (P < or = 0.001). We found a significant relationship between the baseline IPSS < 6 or > or = 6 cut point on MRT (P < or = 0.001) but not on DRT (P = 0.43). The use of neoadjuvant hormones had no significant effect on DRT (P = 0.64) or MRT (P = 0.76). The use of additional symptomatic medication during the study was not significantly different between the two arms. CONCLUSIONS This study shows no significant difference in the urinary symptoms experienced during EBRT related to the consumption of cranberry juice compared with apple juice.
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Microscope-induced retinal phototoxicity in cataract surgery of short duration.
Kleinmann, G, Hoffman, P, Schechtman, E, Pollack, A
Ophthalmology. 2002;(2):334-8
Abstract
OBJECTIVE Microscope-induced retinal phototoxicity has been described after prolonged cataract surgery, usually in operations lasting longer than 100 minutes. The purpose of this study was to compare the features of microscope-induced retinal phototoxicity occurring in patients who underwent cataract surgery of short duration and long duration. DESIGN A retrospective nonrandomized comparative trial. PARTICIPANTS Thirty-four patients, whose medical records documented the development of phototoxic lesions in the retina as a result of cataract surgery, were divided into two groups: group A with 14 patients whose operating time was 30 minutes or less, and group B with 20 patients whose operating time was greater than 30 minutes. INTERVENTION All patients underwent either phacoemulsification or extracapsular cataract extraction (ECCE) with implantation of an intraocular lens. RESULTS The mean operating time was 23.1 minutes (range, 11-30 minutes) in group A, and 60.8 minutes (range, 34-123 minutes) in group B. Phacoemulsification was done more often in group A (P = 0.001) and ECCE in group B (P = 0.0003). A final refraction of +/- 1 D was achieved by 12 eyes (86%) in group A and by 12 eyes (60%) in group B (P = 0.11). The correlation between final refraction and duration of the operation was significant; the closer the final refraction approached to emmetropia, the shorter the duration of surgery (r = 0.53; P = 0.001). Diabetic retinopathy was more common in group A (P = 0.03). CONCLUSIONS Phototoxic lesions of the retina may occur during cataract surgery even when the duration of the operation is short. The most relevant associated factors found in this study were correction approximating emmetropia and diabetic retinopathy.