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1.
Background
No selection criteria for helical tomotherapy (HT) based stereotactic ablative radiotherapy (SABR) to treat early stage non-small cell lung cancer (NSCLC) or solitary lung metastases has been established. In this study, we investigate the dosimetric selection criteria for HT based SABR delivering 70 Gy in 10 fractions to avoid severe toxicity in the treatment of centrally located lesions when adequate target dose coverage is desired.Materials and Methods
78 HT-SABR plans for solitary lung lesions were created to prescribe 70 Gy in 10 fractions to the planning target volume (PTV). The PTV was set to have ≥95% PTV receiving 70 Gy in each case. The cases for which dose constraints for ≥1 OAR could not be met without compromising the target dose coverage were compared with cases for which all target and OAR dose constraints were met.Results
There were 23 central lesions for which OAR dose constraints could not be met without compromising PTV dose coverage. Comparing to cases for which optimal HT-based SABR plans were generated, they were associated with larger tumor size (5.72±1.96 cm vs. 3.74±1.49 cm, p<0.0001), higher lung dose, increased number of immediately adjacent OARs ( 3.45±1.34 vs. 1.66±0.81, p<0.0001), and shorter distance to the closest OARs (GTV: 0.26±0.22 cm vs. 0.88±0.54 cm, p<0.0001; PTV 0.19±0.18 cm vs. 0.48±0.36 cm, p = 0.0001).Conclusion
Delivery of 70 Gy in 10 fractions with HT to meet all the given OAR and PTV dose constraints are most likely when the following parameters are met: lung lesions ≤3.78 cm (11.98 cc), ≤2 immediately adjacent OARs which are ≥0.45 cm from the gross lesion and ≥0.21 cm from the PTV. 相似文献2.
Krzysztof ?losarek Wojciech Osewski Aleksandra Grz?dziel Micha? Radwan ?ukasz Dolla Marta Szlag Ma?gorzata St?pór-Fudzińska 《Reports of Practical Oncology and Radiotherapy》2015,20(2):99-103
Aim
Comparisons of integral dose delivered to the treatment planning volume and to the whole patient body during stereotactic, helical and intensity modulated radiotherapy of prostate.Background
Multifield techniques produce large volumes of low dose inside the patient body. Delivered dose could be the result of the cytotoxic injuries of the cells even away from the treatment field. We calculated the total dose absorbed in the patient body for four radiotherapy techniques to investigate whether some methods have a potential to reduce the exposure to the patient.Materials and methods
We analyzed CyberKnife plans for 10 patients with localized prostate cancer. Five alternative plans for each patient were calculated with the VMAT, IMRT and TomoTherapy techniques. Alternative dose distributions were calculated to achieve the same coverage for PTV. Integral Dose formula was used to calculate the total dose delivered to the PTV and whole patient body.Results
Analysis showed that the same amount of dose was deposited to the treated volume despite different methods of treatment delivery. The mean values of total dose delivered to the whole patient body differed significantly for each treatment technique. The highest integral dose in the patient''s body was at the TomoTherapy and CyberKnife treatment session. VMAT was characterized by the lowest integral dose deposited in the patient body.Conclusions
The highest total dose absorbed in normal tissue was observed with the use of a robotic radiosurgery system and TomoTherapy. These results demonstrate that the exposure of healthy tissue is a dosimetric factor which differentiates the dose delivery methods. 相似文献3.
Alejandro Floriano Icíar Santa-Olalla Alberto Sanchez-Reyes 《Reports of Practical Oncology and Radiotherapy》2013,18(3):173-178
Aim
To analyze intrafraction movement in patients undergoing frameless robotic radiosurgery and evaluate the influence of image acquisition frequency on global accuracy.Background
Stereotactic radiosurgery requires high spatial accuracy in dose delivery. In conventional radiosurgery, a rigid frame is used to guarantee a correct target alignment and no subsequent movement. Frameless radiosurgery with thermoplastic mask for immobilization cannot completely eliminate intrafraction patient movement. In such cases, it is necessary to evaluate its influence on global treatment accuracy.Materials and methods
We analyzed the intrafraction motion of the first 15 patients undergoing intracranial radiosurgery (39 fractions) with the CyberKnife VSI system at our institution. Patient position was measured at a 15–90-s interval and was used to estimate intrafraction patient movement.Results
With our acquisition image protocol and immobilization device, the 99% displacement error was lower than 0.85 mm. The systematic movement components were lower than 0.05 mm and the random component was lower than 0.3 mm in the 3 translational axes. Clear linear time dependence was found in the random component.Conclusions
Selection of the X-ray image acquisition time is necessary to meet the accuracy required for radiosurgery procedures with the CyberKnife VSI system. We verified that our image acquisition protocol met the 1-mm criterion. 相似文献4.
5.
Lijian Zhang Jinfeng Chen Yang Ke Robert E Mansel Wen G Jiang 《World journal of surgical oncology》2005,3(1):1-12
Background
Placenta growth factor (PlGF) is a member of the vascular endothelial growth factor (VEGF) family. Over-expression of PlGF is known to be associated with pathological angiogenesis. This study examined PlGF expression at protein and message levels in non-small cell lung cancer (NSCLC), in which no reports on the significance of PlGF expression is available to date.Patients and methods
We used immunohistochemistry to assess the PlGF protein and correlated PlGF with microvessel density (MVD), as well as clinical outcome in patients with NSCLC tumours (n = 91). In addition, we applied a real time quantitative PCR assay using SYBR Green chemistry to measure PlGF mRNA in normal lung tissues and NSCLC tumours.Results
PlGF was positively stained mainly in cytoplasm of lung cancer cells. High level staining of PlGF was found in 38.5% NSCLC patients. A high level of MVD in NSCLC was found in 42.9% of cases. Tumours with high level and low level PlGF staining had a significantly different MVD (26.69 vs. 20.79, respectively, p = 0.003). Using both univariate and multivariate analyses, PlGF was found to be an independent prognostic factor. Real time PCR analysis revealed that PlGF mRNA was higher in the cancer tissue than normal tissue (0.95 ± 0.19 vs. 0.57 ± 0.24; p < 0.005) and that PlGF mRNA was significant higher in III-IV stage patients than in I-II stage patients (1.03 ± 0.20 vs. 0.80 ± 0.17; p = 0.011).Conclusion
PlGF expression is significantly more in NSCLC tumour tissues than in matched normal tissues. It has a significant positive association with MVD and is an independent factor for NSCLC patients. PlGF may have a pivotal role in NSCLC development and disease progression. 相似文献6.
David A. Smith Paul Conkling Donald A. Richards John J. Nemunaitis Thomas E. Boyd Alain C. Mita Guillaume de La Bourdonnaye David Wages Alice S. Bexon 《Cancer immunology, immunotherapy : CII》2014,63(8):787-796
Background
IMO-2055 is a Toll-like receptor 9 (TLR9) agonist that potentially enhances the efficacy of antitumor agents through immune stimulation. The objective of this phase Ib dose-escalation trial (3 + 3 design) was to determine the recommended phase II dose (RP2D) of IMO-2055 when combined with erlotinib and bevacizumab in patients with advanced non-small cell lung cancer (NSCLC).Methods
Patients with stage 3/4 NSCLC and progressive disease (PD) following chemotherapy received IMO-2055 0.08, 0.16, 0.32, or 0.48 mg/kg once weekly plus erlotinib 150 mg daily and bevacizumab 15 mg/kg every 3 weeks. Patients could receive treatment until PD or unacceptable toxicity.Results
Thirty-six patients were enrolled; 35 received at least one treatment dose. Two dose-limiting toxicities were observed across the dose range (Grade 3 dehydration and fatigue) with neither suggestive of a consistent toxicity pattern. IMO-2055 0.32 mg/kg was adopted as RP2D based on clinical and pharmacodynamic data. The most common treatment-emergent adverse events (TEAEs) were diarrhea (74 %), nausea (51 %), fatigue (51 %), rash (51 %), and injection-site reactions (49 %). Four patients experienced serious TEAEs considered to be study drug related. Five patients died, all due to PD. High-grade neutropenia and electrolyte disturbances previously reported with TLR9 agonists combined with platinum-based therapy were not observed in this study. Five of 33 patients evaluable for response (15 %) achieved partial response; another 20 (61 %) had stable disease, including 13 with stable disease ≥4 months.Conclusions
IMO-2055 demonstrated good tolerability and possible antitumor activity in combination with erlotinib and bevacizumab in heavily pretreated patients with advanced NSCLC. 相似文献7.
Introduction
The purpose of the present study was to systematically review the effect of cyclophosphamide treatment on pulmonary function in patients with systemic sclerosis and interstitial lung disease.Methods
The primary outcomes were the mean change in forced vital capacity and in diffusing capacity for carbon monoxide after 12 months of therapy in patients treated with cyclophosphamide.Results
Three randomized clinical trials and six prospective observational studies were included for analysis. In the pooled analysis, the forced vital capacity and the diffusing capacity for carbon monoxide predicted values after 12 months of therapy were essentially unchanged, with mean changes of 2.83% (95% confidence interval = 0.35 to 5.31) and 4.56% (95% confidence interval = -0.21 to 9.33), respectively.Conclusions
Cyclophosphamide treatment in patients with systemic sclerosis-related interstitial lung disease does not result in clinically significant improvement of pulmonary function. 相似文献8.
Ying-Yi Chen Tsai-Wang Huang Wen-Chiuan Tsai Li-Fan Lin Jian-Bo Cheng Hung Chang Shih-Chun Lee 《World journal of surgical oncology》2014,12(1):1-8
Background
Despite advances in radiation therapy, chemotherapy, and newly developed molecular targeting therapies, long-term survival after resection for patients with NSCLC remains less than 50%. We investigated factors predicting postoperative locoregional recurrences and distant metastases in patients with clinical stage I non-small-cell lung cancer (NSCLC) after surgical resection.Methods
All patients with clinical stage I NSCLC, who underwent surgical resection between January 2002 and June 2006, were reviewed retrospectively. Multiple logistic regression analyses were used to identify independent risk factors for patients with locoregional recurrences and distant metastases.Results
A total of 261 patients were eligible. Overall survival was significant related to locoregional recurrences (P?=?0.03) and distant metastases (P <0.001). There were significant differences of locoregional recurrence in tumor differentiation (P?=?0.032) and advanced pathological stage (P?=?0.002). In the group of distant metastases, there were significant differences in tumor differentiation (P?=?0.035), lymphovascular space invasion (P?=?0.031). Among the relationship between pattern of distant metastasis and clinicopathologic variables in patients with clinical stage I NSCLC, SUVmax (P?=?0.02) and tumor size (P?=?0.001) had significant differences. According to multiple logistic regression analysis, tumor differentiation is the only risk factor of postoperative outcome for locoregional recurrence and serum CEA (>3.5 ng/mL) is the predictor of distant metastasis.Conclusions
Tumor differentiation and serum CEA were predictors of postoperative relapse for clinical stage I NSCLC after surgical resection. Risk factors of postoperative recurrence in patients with clinical stage I NSCLC may enable us to optimize the patient selection for postoperative adjuvant therapies or neoadjuvant treatment before surgery. 相似文献9.
Chun-Wei Wang Yin-Chun Lin Ham-Min Tseng Furen Xiao Chang-Mu Chen Wei-Li Cheng Szu-Huai Lu Keng-Hsueh Lan Wan-Yu Chen Hsiang-Kuang Liang Sung-Hsin Kuo 《PloS one》2015,10(4)
Introduction
The accuracy of radiation delivery is increasingly important as radiotherapy technology continues to develop. The goal of this study was to evaluate intrafractional motion during intracranial radiosurgery and the relationship between motion change and treatment time.Methods and Materials
A total of 50 treatment records with 5988 images, all acquired during treatments with the CyberKnife Radiosurgery System, were retrospectively analyzed in this study. We measured translation and rotation motion including superior-inferior (SI), right-left (RL), anterior-posterior (AP), roll, tilt and yaw. All of the data was obtained during the first 45 minutes of treatment. The records were divided into 3 groups based on 15-min time intervals following the beginning of treatment: group A (0-15 min), group B (16-30 min) and group C (31-45 min). The mean deviations, systematic errors, random errors and margin for planning target volume (PTV) were calculated for each group.Results
The mean deviations were less than 0.1 mm in all three translation directions in the first 15 minutes. Greater motion occurred with longer treatment times, especially in the SI direction. For the 3D vector, a time-dependent change was observed, from 0.34 mm to 0.77 mm (p=0.01). There was no significant correlation between the treatment time and deviations in the AP, LR and rotation axes. Longer treatment times were associated with increases in systematic error, but not in random error. The estimated PTV margin for groups A, B and C were 0.86 / 1.14 / 1.31 mm, 0.75 / 1.12 / 1.20 mm, and 0.43 / 0.54 / 0.81 mm in the SI, RL, and AP directions, respectively.Conclusions
During intracranial radiosurgery, a consistent increase in the positioning deviation over time was observed, especially in the SI direction. If treatment time is greater than 15 minutes, we recommend increasing the PTV margins to ensure treatment precision. 相似文献10.
Cristina Firanescu Paul NM Lohle Jolanda de Vries Caroline A Klazen Job R Juttmann William Clark Willem Jan van Rooij 《Trials》2011,12(1):1-5
Background
Combination of erlotinib and bevacizumab is a promising regimen in advanced non-squamous non-small-cell lung cancer (NSCLC). We are conducting a single arm phase II trial which aims to evaluate the efficacy and safety of this regime as a second- or third-line chemotherapy.Methods
Key eligibility criteria were histologically or cytologically confirmed non-squamous NSCLC, stage III/IV or recurrent NSCLC not indicated radical chemoradiation, prior one or two regimen of chemotherapy, age 20 years or more, and performance status of two or less. The primary endpoint is objective response rate. The secondary endpoints include overall survival, progression-free survival, disease control rate and incidence of adverse events. This trial plans to accrue 80 patients based on a two-stage design employing a binomial distribution with an alternative hypothesis response rate of 35% and a null hypothesis threshold response rate of 20%. A subset analysis according to EGFR mutation status is planned.Discussion
We have presented the design of a single arm phase II trial to evaluate the efficacy and safety of combination of bevacizumab and erlotinib in advanced non-squamous NSCLC patients. In particular we are interested in determining the merit of further development of this regimen and whether prospective patient selection using EGFR gene is necessary in future trials.Trial registration
This trial was registered at the UMIN Clinical Trials Registry as UMIN000004255 (http://www.umin.ac.jp/ctr/index.htm). 相似文献11.
Radovan Vojtí?ek Jan Mu?ík Pavel ?lampa Marie Budíková Jaroslav Hejsek Petr Smolák Ji?í Ferda Jind?ich Fínek 《Reports of Practical Oncology and Radiotherapy》2014,19(3):182-190
Aim
To compare radiotherapy plans made according to CT and PET/CT and to investigate the impact of changes in target volumes on tumour control probability (TCP), normal tissue complication probability (NTCP) and the impact of PET/CT on the staging and treatment strategy.Background
Contemporary studies have proven that PET/CT attains higher sensitivity and specificity in the diagnosis of lung cancer and also leads to higher accuracy than CT alone in the process of target volume delineation in NSCLC.Materials and methods
Between October 2009 and March 2012, 31 patients with locally advanced NSCLC, who had been referred to radical radiotherapy were involved in our study. They all underwent planning PET/CT examination. Then we carried out two separate delineations of target volumes and two radiotherapy plans and we compared the following parameters of those plans: staging, treatment purpose, the size of GTV and PTV and the exposure of organs at risk (OAR). TCP and NTCP were also compared.Results
PET/CT information led to a significant decrease in the sizes of target volumes, which had the impact on the radiation exposure of OARs. The reduction of target volume sizes was not reflected in the significant increase of the TCP value. We found that there is a very strong direct linear relationship between all evaluated dosimetric parameters and NTCP values of all evaluated OARs.Conclusions
Our study found that the use of planning PET/CT in the radiotherapy planning of NSCLC has a crucial impact on the precise determination of target volumes, more precise staging of the disease and thus also on possible changes of treatment strategy. 相似文献12.
Oliver Tafel Philipp Latzin Karl Paul Tobias Winter Markus Woischnik Matthias Griese 《BMC pulmonary medicine》2008,8(1):1-8
Background
The reported diagnostic yield from bronchoscopies in patients with lung cancer varies greatly. The optimal combination of sampling techniques has not been finally established. The objectives of this study were to find the predictors of diagnostic yield in bronchoscopy and to evaluate different combinations of sampling techniques.Methods
All bronchoscopies performed on suspicion of lung malignancy in 2003 and 2004 were reviewed, and 363 patients with proven malignant lung disease were included in the study. Sampling techniques performed were biopsy, transbronchial needle aspiration (TBNA), brushing, small volume lavage (SVL), and aspiration of fluid from the entire procedure. Logistic regression analyses were adjusted for sex, age, endobronchial visibility, localization (lobe), distance from carina, and tumor size.Results
The adjusted odds ratios (OR) with 95% confidence intervals (CI) for a positive diagnostic yield through all procedures were 17.0 (8.5–34.0) for endobronchial lesions, and 2.6 (1.3–5.2) for constriction/compression, compared to non-visible lesions; 3.8 (1.3–10.7) for lesions > 4 cm, 6.7 (2.1–21.8) for lesions 3–4 cm, and 2.5 (0.8–7.9) for lesions 2–3 cm compared with lesions <= 2 cm. The combined diagnostic yield of biopsy and TBNA was 83.7% for endobronchial lesions and 54.2% for the combined group without visible lesions. This was superior to either technique alone, whereas additional brushing, SVL, and aspiration did not significantly increase the diagnostic yield.Conclusion
In patients with malignant lung disease, visible lesions and larger tumor size were significant predictors of higher diagnostic yield, after adjustment for sex, age, distance from carina, side and lobe. The combined diagnostic yield of biopsy and TBNA was significant higher than with either technique alone. 相似文献13.
Magnus Anderberg Johan Larsson Christina C Kockum Einar Arnbjörnsson 《Annals of surgical innovation and research》2010,4(1):1-6
Background
Randomized trials comparing VATS lobectomy to open lobectomy are of small size. We analyzed a case-control series using propensity score-weighting to adjust for important covariates in order to compare the clinical outcomes of the two techniques.Methods
We compared patients undergoing lobectomy for clinical stage I lung cancer (NSCLC) by either VATS or open (THOR) methods. Inverse probability of treatment weighted estimators, with weights derived from propensity scores, were used to adjust cohorts for determinants of perioperative morbidity and mortality including age, gender, preop FEV1, ASA class, and Charlson Comorbidity Index (CCI). Bootstrap methods provided standard errors. Endpoints were postoperative stay (LOS), chest tube duration, complications, and lymph node retrieval.Results
We analyzed 136 consecutive lobectomy patients. Operative mortality was 1/62 (1.6%) for THOR and 1/74 (1.4%) for VATS, P = 1.00. 5/74 (6.7%) VATS were converted to open procedures. Adjusted median LOS was 7 days (THOR) versus 4 days (VATS), P < 0.0001, HR = 0.33. Adjusted median chest tube duration (days) was 5 (THOR) versus 3 (VATS), P < 0.0001, HR = 0.42. Complication rates were 39% (THOR) versus 34% (VATS), P = 0.61. Adjusted mean number of lymph nodes dissected per patient was 18.1 (THOR) versus 14.8 (VATS), p = 0.17.Conclusions
After balancing covariates that affect morbidity, mortality and LOS in this case-control series using propensity-weighting, the results confirm that VATS lobectomy is associated with a statistically significant shorter LOS, similar mortality and complication rates and similar rates of lymph node removal in patients with clinical stage I NSCLC. 相似文献14.
Shuhei Sekii Yoshinori Ito Ken Harada Mayuka Kitaguchi Kana Takahashi Koji Inaba Naoya Murakami Hiroshi Igaki Ryohei Sasaki Jun Itami 《Reports of Practical Oncology and Radiotherapy》2018,23(5):398-401
Aim
To investigate the intrafraction movement of the esophagus using fiducial markers.Background
Studies on intrafraction esophageal motion using the fiducial markers are scarce.Materials and methods
We retrospectively analyzed patients with clinical T1N0 esophageal cancer who had received fiducial markers at our hospital between July 2007 and December 2013. Real-Time Position Management System to track the patient's respiration was used, and each patient underwent three-dimensional computed tomography of the resting expiratory and inspiratory level. We used the center of the marker to calculate the distance between the expiratory and inspiratory breath-holds, which were measured with the radiotherapy treatment planning system in three directions: left–right (LR), superior–inferior (SI), and anterior–posterior (AP). The movements at each site were compared with the Kruskal–Wallis analysis and Wilcoxon rank sum test with a Bonferroni correction.Results
A total of 101 patients with 201 fiducial markers were included. The upper, middle and lower thoracic positions had 40, 77, and 84 markers, respectively. The mean absolute magnitudes of the shifts (standard deviation) were 0.18 (0.19)?cm, 0.68 (0.46)?cm, and 0.24 (0.24)?cm in the LR, SI, and AP directions, respectively. From the cumulative frequency distribution, we assumed that 0.35?cm LR, 0.8?cm SI, and 0.3?cm AP in the upper; 0.5?cm LR, 1.55?cm SI, and 0.55?cm AP in the middle; and 0.75?cm LR, 1.9?cm SI, and 0.95?cm AP in the lower thoracic esophagus covered 95% of the cases.Conclusions
The internal margin based on the site of esophagus was estimated. 相似文献15.
Halvor Naess Jan C Brogger Jr Titto Idicula Ulrike Waje-Andreassen Gunnar Moen Lars Thomassen 《BMC neurology》2009,9(1):44-5
Background
No large study has compared the yield of diffusion-weighted imaging (DWI) with clinical examination in order to differentiate lacunar stroke from other stroke subtypes. This differentiation is important for guiding further investigations and treatment.Methods
Consecutive patients admitted with cerebral infarction were classified according to the Oxfordshire Community Stroke Project scale. Based on DWI and CT stroke was classified as lacunar (LI) and non-lacunar (NLI). Acute ischemic lesion <1.5 cm and located in subcortex or in brainstem were classified as LI. All other infarctions were classified as NLI.Results
DWI was performed in 419 (69%) patients. Among patients with lacunar syndrome (LACS) 45 (40.5%) had NLI on DWI. All patients with total anterior syndrome (TACS) and 144 (88.3%) with partial anterior syndrome (PACS) had NLI on DWI.Conclusion
DWI is important among patients presenting with clinical symptoms suggestive of lacunar syndrome to differentiate between LI and NLI. On the other hand, there is good correspondence between TACS or PACS and NLI on DWI. 相似文献16.
17.
Aziza Nassar Nicole Sookhan Marta Santisteban Sandra C Bryant Judy C Boughey Tamar Giorgadze Amy Degnim 《Diagnostic pathology》2010,5(1):1-10
Aims
As one of the five Lactate dehydrogenase (LDH) isoenzymes, LDH5 has the highest efficiency to catalyze pyruvate transformation to lactate. LDH5 overexpression in cancer cells induces an upregulated glycolytic metabolism and reduced dependence on the presence of oxygen. Here we analyzed LDH5 protein expression in a well characterized large cohort of primary lung cancers in correlation to clinico-pathological data and its possible impact on patient survival.Methods
Primary lung cancers (n = 269) and non neoplastic lung tissue (n = 35) were tested for LDH5 expression by immunohistochemistry using a polyclonal LDH5 antibody (ab53010). The results of LDH5 expression were correlated to clinico-pathological data as well as to patient's survival. In addition, the results of the previously tested Transketolase like 1 protein (TKTL1) expression were correlated to LDH5 expression.Results
89.5% (n = 238) of NSCLC revealed LDH5 expression whereas LDH5 expression was not detected in non neoplastic lung tissues (n = 34) (p < 0.0001). LDH5 overexpression was associated with histological type (adenocarcinoma = 57%, squamous cell carcinoma = 45%, large cell carcinoma = 46%, p = 0.006). No significant correlation could be detected with regard to TNM-stage, grading or survival. A two sided correlation between the expression of TKTL1 and LDH5 could be shown (p = 0.002) within the overall cohort as well as for each grading and pN group. A significant correlation between LDH5 and TKTL1 within each histologic tumortype could not be revealed.Conclusions
LDH5 is overexpressed in NSCLC and could hence serve as an additional marker for malignancy. Furthermore, LDH5 correlates positively with the prognostic marker TKTL1. Our results confirm a close link between the two metabolic enzymes and indicate an alteration in the glucose metabolism in the process of malignant transformation. 相似文献18.
Jon G Quatromoni Lilah F Morris Timothy R Donahue Yue Wang William McBride Talal Chatila James S Economou 《Journal of hematology & oncology》2011,4(1):1-9
Background
The CyberKnife is an appealing delivery system for hypofractionated stereotactic body radiation therapy (SBRT) because of its ability to deliver highly conformal radiation therapy to moving targets. This conformity is achieved via 100s of non-coplanar radiation beams, which could potentially increase transitory testicular irradiation and result in post-therapy hypogonadism. We report on our early experience with CyberKnife SBRT for low- to intermediate-risk prostate cancer patients and assess the rate of inducing biochemical and clinical hypogonadism.Methods
Twenty-six patients were treated with hypofractionated SBRT to a dose of 36.25 Gy in 5 fractions. All patients had histologically confirmed low- to intermediate-risk prostate adenocarcinoma (clinical stage ≤ T2b, Gleason score ≤ 7, PSA ≤ 20 ng/ml). PSA and total testosterone levels were obtained pre-treatment, 1 month post-treatment and every 3 months thereafter, for 1 year. Biochemical hypogonadism was defined as a total serum testosterone level below 8 nmol/L. Urinary and gastrointestinal toxicity was assessed using Common Toxicity Criteria v3; quality of life was assessed using the American Urological Association Symptom Score, Sexual Health Inventory for Men and Expanded Prostate Cancer Index Composite questionnaires.Results
All 26 patients completed the treatment with a median 15 months (range, 13-19 months) follow-up. Median pre-treatment PSA was 5.75 ng/ml (range, 2.3-10.3 ng/ml), and a decrease to a median of 0.7 ng/ml (range, 0.2-1.8 ng/ml) was observed by one year post-treatment. The median pre-treatment total serum testosterone level was 13.81 nmol/L (range, 5.55 - 39.87 nmol/L). Post-treatment testosterone levels slowly decreased with the median value at one year follow-up of 10.53 nmol/L, significantly lower than the pre-treatment value (p < 0.013). The median absolute fall was 3.28 nmol/L and the median percent fall was 23.75%. There was no increase in biochemical hypogonadism at one year post-treatment. Average EPIC sexual and hormonal scores were not significantly changed by one year post-treatment.Conclusions
Hypofractionated SBRT offers the radiobiological benefit of a large fraction size and is well-tolerated by men with low- to intermediate-risk prostate cancer. Early results are encouraging with an excellent biochemical response. The rate of new biochemical and clinical hypogonadism was low one year after treatment. 相似文献19.
Vera Hirsh John Glaspy Paul Mainwaring Christian Manegold Rodryg Ramlau Joseph E Eid 《Trials》2007,8(1):1-15
Background
C.E.R.A. (Continuous Erythropoietin Receptor Activator) is an innovative agent with unique erythropoietin receptor activity and prolonged half-life. This study evaluated C.E.R.A. once weekly (QW) or once every 3 weeks (Q3W) in patients with anemia and advanced non-small cell lung cancer (NSCLC) receiving chemotherapy.Methods
In this Phase II, randomized, open-label, multicenter, dose-finding study, patients (n = 218) with Stage IIIB or IV NSCLC and hemoglobin (Hb) ≤ 11 g/dL were randomized to one of six treatment groups of C.E.R.A. administered subcutaneously for 12 weeks: 0.7, 1.4, or 2.1 μg/kg QW or 2.1, 4.2, or 6.3 μg/kg Q3W. Primary endpoint was average Hb level between baseline and end of initial treatment (defined as last Hb measurement before dose reduction or transfusion, or the value at week 13). Hematopoietic response (Hb increase ≥ 2 g/dL or achievement of Hb ≥ 12 g/dL with no blood transfusion in the previous 28 days determined in two consecutive measurements within a 10-day interval) was also measured.Results
Dose-dependent Hb increases were observed, although the magnitude of increase was moderate. Hematopoietic response rate was also dose dependent, achieved by 51% and 62% of patients in the 4.2 and 6.3 μg/kg Q3W groups, and 63% of the 2.1 μg/kg QW group. In the Q3W group, the proportion of early responders (defined as ≥ 1 g/dL increase in Hb from baseline during the first 22 days) increased with increasing C.E.R.A. dose, reaching 41% with the highest dose. In the 6.3 μg/kg Q3W group, 15% of patients received blood transfusion. There was an inclination for higher mean Hb increases and lower transfusion use in the Q3W groups than in the QW groups. C.E.R.A. was generally well tolerated.Conclusion
C.E.R.A. administered QW or Q3W showed clinical activity and safety in patients with NSCLC. There were dose-dependent increases in Hb responses. C.E.R.A. appeared to be more effective when the same dose over time was given Q3W than QW, with a suggestion that C.E.R.A. 6.3 μg/kg Q3W provided best efficacy in this study. However, further dose-finding studies using higher doses are required to determine the optimal C.E.R.A. dose regimen in cancer patients receiving chemotherapy. 相似文献20.