共查询到20条相似文献,搜索用时 31 毫秒
1.
F. Thangarajah J. Heilmann W. Malter S. Kunze S. Marnitz P. Mallmann F. Wenz E. Sperk 《Breast cancer research and treatment》2018,168(3):739-744
Purpose
Mastectomy is the standard procedure in patients with in-breast tumor recurrence (IBTR) or breast cancer after irradiation of the chest due to Hodgkin’s disease. In certain cases a second breast conserving surgery (BCS) in combination with intraoperative radiotherapy (IORT) is possible. To date, data concerning BCS in combination with IORT in pre-irradiated patients are limited. This is the first pooled analysis of this special indication with a mature follow-up of 5 years.Methods
Patients with IBTR after external beam radiotherapy (EBRT; treated in two centers) for breast cancer were included. Patients with previous EBRT including the breast tissue due to other diseases were also included. IORT was performed with the Intrabeam?-device using low kV X-rays. Clinical data including outcome for all patients and toxicity for a representative cohort (LENT-SOMA scales) were obtained. Statistical analyses were done including Kaplan–Meier estimates for local recurrence, distant metastasis and overall survival.Results
A total of 41 patients were identified (39 patients with IBTR, 2 with Hodgkin`s disease in previous medical history). Median follow-up was 58 months (range 4–170). No grade 3/4 acute toxicity occurred within 9 weeks. Local recurrence-free survival rate was 89.9% and overall survival was 82.7% at 5 years. Seven patients developed metastasis within the whole follow-up.Conclusions
BCS in combination with IORT in IBTR in pre-irradiated patients is a feasible method to avoid mastectomy with a low risk of side effects and an excellent local control and good overall survival.2.
C. V. Sole F. A. Calvo M. Cambeiro A. Polo A. Montero R. Hernanz C. Gonzalez M. Cuervo D. Perez M. S. Julian R. Martinez-Monge 《Clinical & translational oncology》2014,16(9):834-842
Purpose
A joint analysis of data from centers within the intraoperative radiotherapy (IORT)-Spanish cooperative initiative was performed to investigate the main contributions of IORT to the multidisciplinary treatment of trunk-wall soft-tissue sarcoma (TW-STS).Materials and methods
Patients with a histologic diagnosis of TW-STS (primary tumor 53 %; locally recurrent 47 %) with absence of distant metastases, undergoing surgery with radical intent and IORT (median dose 12.5 Gy) were considered eligible for participation in this study. In addition, all primary tumors received external-beam radiotherapy (median dose 50 Gy).Results
From 1986 to 2012, a total of 68 patients were analyzed in the study from three Spanish institutions. With a median follow-up time of 53 months (range 4–316), 5-year local control (LC) was 58 %. Five-year IORT in-field control, disease-free survival (DFS) and overall survival were 70, 45 and 51 %, respectively. On multivariate analysis, only microscopically involved margin (R1) resection status retained significance in relation to LC (HR 3.97, p < 0.001). In regard to IORT in field control, incomplete resection (HR 3.23, p = 0.008) and recurrent disease status (HR 2.52, p = 0.04) retained a significant association in multivariate analysis.Conclusion
From this joint analysis emerges the fact that margin and disease status influences local and central control, but DFS remains modest, given the high risk of distant metastases. Intensified local treatment needs to be tested in the context of more efficient concurrent, neo-, and adjuvant systemic therapy. 相似文献3.
Sawaki M Sato S Noda S Idota A Uchida H Tsunoda N Kikumori T Aoyama Y Ishihara S Itoh Y Imai T 《Breast cancer (Tokyo, Japan)》2012,19(4):353-359
Background
Intraoperative radiotherapy (IORT) is under evaluation in breast-conserving surgery. We have begun our study with the first step being a phase I?CII study. This study was designed to identify the recommended dose and to test the feasibility of and tolerance to IORT in Japanese patients (UMIN000000918).Methods
A phase I study was designed using a scheme of dose escalation from 19 to 20 to 21?Gy. We designed the phase II study to use the recommended dose. The primary endpoint was early toxicity. Secondary endpoints were efficacy for a long period and late toxicity. Inclusion criteria included the following: (1) T?2.5?cm, (2) age?>50?years, (3) surgical margin?>1?cm, (4) intraoperative pathologically free margins, and (5) sentinel node negative. Partial resection was performed with at least a 1?cm margin around the tumor. Radiation was delivered directly to the mammary gland with the use of a Mobetron?. The toxicity was evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.Results
Nine patients were enrolled for the phase I study. All patients tolerated and we therefore recommend 21?Gy. The following 23 patients were enrolled in a phase II study and received 21?Gy. After a median follow-up of 26.0?months, their toxicities within 3?months included deep connective tissue fibrosis (G1 23/26, G2 2/26), hematoma (G1 9/26), infection in the musculoskeletal soft tissue (G1 4/26), and soft tissue necrosis (G2 3/26). There have been no local recurrences.Conclusions
The first group of Japanese female patients treated with IORT showed very good tolerability in the phase I/II study. 相似文献4.
H. Elkaoui A. Bounaim S. M. Bouchentouf H. Baba K. Sair A. Zentar 《Journal africain du cancer / African Journal of Cancer》2012,4(1):18-22
Aim
Treatment of locally recurrent rectal cancer remains a difficult and controversial issue. The aim of this study was to retrospectively assess the efficiency of various treatment methods and to define the most accurate management of those recurrences.Patients and methods
From January 2000 to December 2009, 113 patients were treated for rectal cancer, out of which 14 (8 men and 6 women) presented local recurrences. Five patients received preoperative radiotherapy.Result
More than 50% of local recurrences occur in the first postoperative year, and symptoms were present in 86% of cases. Operability was 71%, and resectability was 60%. Six patients underwent a curative resection, and four patients underwent palliative treatment: laparotomy with biopsy in two cases and colostomy in other two cases. The resection was R0 in three cases (30%); it consisted of an anterior resection extended to small bowel with colorectal anastomosis, a posterior exenteration and an abdominoperineal resection. The resection was palliative in three cases: R1 in two cases and R2 in one case. Operative mortality was zero, and morbidity was 50%. The global survival was 12 months.Conclusion
The results of this study suggest that management of resection of local recurrences remains a challenge. Long-term results may possibly be improved by using adjuvant treatment. 相似文献5.
Background
External beam radiotherapy (EBRT) is a curative therapeutic option in prostate cancer.Percutaneous radiotherapy with curative intent
Patients with low risk can be cured with EBRT. For patients at intermediate risk, EBRT may be combined with androgen deprivation therapy (ADT) for 4 months. For patients at high risk, ADT should be administered for 2–3 years and the EBRT dose should be escalated. Hypofractionation is currently under intensive clinical investigation, but is currently not a clinical standard.Recurrence
A recurrence after EBRT is defined as two prostate-specific antigen (PSA) values higher than nadir +2 ng/ml.Adjuvant radiotherapy
Adjuvant EBRT is recommended after pT3 and/or R1 resection. In patients with lower stages or with more comorbidities, a PSA follow-up can be recommended with initiation of salvage EBRT only after increase of PSA (but preferably < 0.5 ng/ml).6.
Murakami Y Nagata Y Nishibuchi I Kimura T Kenjo M Kaneyasu Y Okabe T Hashimoto Y Akagi Y 《International journal of clinical oncology / Japan Society of Clinical Oncology》2012,17(3):263-271
Background
The aim of this study was to assess the long-term outcomes of combining high-dose-rate intraluminal brachytherapy (IBT) with external beam radiotherapy (EBRT) for superficial esophageal cancer (SEC).Methods
From 1992 to 2002, 87 patients with T1N0M0 thoracic esophageal cancer received IBT in combination with EBRT. Of these, 44 had mucosal cancer and 43 had submucosal cancer. For patients with tumor invasion within the lamina propria mucosa, IBT alone was performed (n?=?27). IBT boost following EBRT was performed for patients with tumor invasion in the muscularis mucosa or deeper (n?=?60). No patient received chemotherapy.Results
The median follow-up time was 94?months. For mucosal cancer, the 5-year locoregional control (LRC), cause-specific survival (CSS) and overall survival (OS) rates were 75, 97 and 84%, respectively, and 49, 55 and 31%, respectively, for submucosal cancer. Tumor depth was a significant factor associated with LRC (p?=?0.02), CSS (p?<?0.001) and OS (p?<?0.001) by univariate analysis. Multivariate analysis revealed that tumor depth was the only significant predictor for OS (p?=?0.003). Late toxicities of grade 3 or higher in esophagus, pneumonitis, pleural effusion and pericardial effusion were observed in 5, 0, 0 and 1 patients, respectively. Grade ??3 events of cardiac ischemia and heart failure after radiotherapy were observed in 9 patients, and history of heart disease before radiotherapy was the only significant factor (p?=?0.002).Conclusion
There was a clear difference in outcomes of IBT combined with EBRT between mucosal and submucosal esophageal cancers. More intensive treatment should be considered for submucosal cancer. 相似文献7.
B. Elsberger A. Romsauerova S. Vinnicombe P. Whelehan D.C. Brown J.A. Dewar A.M. Thompson A. Evans 《European journal of surgical oncology》2014
Background
The TARGIT (TARGeted Intraoperative Radiotherapy) trial was designed to compare local recurrence and complication rates in breast cancer patients, prospectively randomised to either EBRT (external beam whole breast radiotherapy) or a single dose of IORT (intraoperative radiotherapy). The aim of our study was to compare follow-up mammographic findings, ultrasound and biopsy rates in each group.Methods
Follow-up imaging and breast biopsies of women from one centre participating in the TARGIT-A trial were independently reviewed by two radiologists blinded to the radiotherapy treatment received.Results
The cohort consisted of 141 patients (EBRT n = 80/IORT n = 61). There was no significant difference in the patient or disease characteristics of the two groups. The number of follow-up mammograms and length of follow-up was similar (EBRT/IORT n = 2.0/2.4; 4.3yr/5.1yr; p = 0.386 χ2 test). There were no significant differences in mammographic scar or calcification appearances of the post-operative site. Generalised increase in breast density and skin thickening were more common in the EBRT compared to the IORT group (p = 0.002; p = 0.030, χ2 test respectively). A trend towards additional ultrasound at follow-up was observed in the IORT group (15 of 61 [24.6%] versus 11 of 80 [13.8%]), however this was not statistically significant (p = 0.100 χ2 test). No disease recurrence was demonstrated on any of the breast biopsies taken. Only one biopsy was reported as fat necrosis in the IORT group.Conclusions
Mammographic changes were more common following EBRT, although more additional follow-up ultrasounds were performed in the IORT group. IORT is not detrimental to subsequent radiological follow up. 相似文献8.
M. Faruolo A. Fiorentino G. Gallucci L. Lapadula V. Fusco 《Clinical & translational oncology》2013,15(10):861-864
Objectives
To investigate the effect of external beam radiotherapy (EBRT) for head and neck cancer (HNC) the intimal–medial thickness (IMT) and the lumen of the carotid artery.Methods
Patients with HNC and an indication for EBRT were enrolled. A carotid artery color Doppler examination was performed before and 6 and 12 months after EBRT.Results
From 2008 to 2011, 50 patients were enrolled. The mean carotid IMT was 0.9 vs. 1.02 mm before and 6 months after EBRT, respectively (p = 0.0001). The common carotid artery lumen was narrowed without statistical significance, 6 months after EBRT (p = 0.3). 1 year from EBRT, the IMT increase and the lumen reduction were statistically significant (p = 0.001, p = 0.01, respectively). Neurological events (stroke or TIA) were not observed.Conclusions
Our data showed a significant IMT increase 6 months from EBRT without a corresponding narrowing of the common carotid lumen while a significant increase 12 months after EBRT. 相似文献9.
目的 :分析不能手术切除的晚期胰腺癌术中放射 (IORT)和体外放射 (EBRT)治疗的疗效。方法 :回顾我院 1987- 1999年 75例不能手术切除的晚期胰腺癌患者进行单纯IORT、单纯EBRT和IORT加EBRT治疗的临床资料。结果 :单纯IORT、单纯EBRT和IORT加EBRT治疗的 1年生存率分别为15 2 %、14 3%和 31 8% ,IORT加EBRT治疗的结果优于前两者 ,P <0 0 5。结论 :IORT加EBRT治疗可以延长晚期胰腺癌患者的生存期 相似文献
10.
Naresh K. Panda K. Saravanan R. K. Verma Vankalakunti Mahesha 《Indian journal of otolaryngology and head and neck surgery》2007,59(4):369-373
Objectives
The ideal management of bilateral, recurrent inverted papillomas is intriguing and often controversial. We describe the ideal management of such tumors.Design
Retrospective, case seriesMethods
The three patients in this series inspite of several surgical procedures in the past had recurrences and behaved in an aggressive fashion. The patients underwent surgical excision by either bilateral lateral rhinotomy, midfacial degloving or craniofacial approaches.Results
One patient who underwent excision by midfacial degloving approach had recurrence. This was removed by lateral rhinotomy approach. Two patients were subjected to radiotherapy due to the presence of mitotic figures on histopathology. All the patients are asymptomatic at 6 months follow-up.Conclusion
Aggressive inverted papillomas may have varied presentation. They could have multiple recurrences, bilateral presentation or intracranial extension. They can be effectively managed with bilateral lateral rhinotomy or cranio-facial resection. Adjuvant radiotherapy has a role in controlling recurrences. 相似文献11.
J Y Bobin T Al-Lawati L E Granero M Adham P Romestaing O Chapet S Issac J P Gerard 《European journal of surgical oncology》2003,29(8):676-681
AIMS: To report outcomes of adults with retroperitoneal sarcoma (RS) treated by surgery, external beam radiotherapy (EBRT) and intraoperative electron beam radiotherapy (IORT). METHODS: From July 1988 to February 2001; 24 patients with primary and recurrent RS were diagnosed and treated. The median dose and energy of IORT delivered was 15 Gy/9meV. EBRT dose varies between 45-50 Gy. RESULTS: There were five primary and 19 recurrent tumours. One primary and five recurrent tumours underwent R0 resection. There were 12 liposarcomas and 19 grade I tumours; 13 patients developed local recurrence and three developed distant metastases.Twenty-two patients received IORT associated with EBRT: 11 developed recurrences. Six patients developed Neurotoxicity (4 grade II and 2 grade III). Disease free survival and overall survival at 5 years was 28 and 56% respectively. CONCLUSIONS: EBRT with IORT treatment is a promising technique for local control. Lower recurrence rates are associated with radical (R0) surgical procedures. 相似文献
12.
Andrea Farioli Francesco Saverio Violante Stefano Mattioli Stefania Curti David Kriebel 《Cancer causes & control : CCC》2013,24(8):1535-1545
Purpose
To investigate the association between external beam radiotherapy (EBRT) for prostate cancer and mesothelioma using data from the US Surveillance, Epidemiology, and End Results (SEER) cancer registries.Methods
We analyzed data from the SEER database (1973–2009). We compared EBRT versus no radiotherapy. Incidence rate ratios (IRR) and 95 % confidence intervals (95 % CI) of mesothelioma among prostate cancer patients were estimated with multilevel Poisson models adjusted by race, age, and calendar year. Confounding by asbestos was investigated using relative risk of mesothelioma in each case’s county of residence as a proxy for asbestos exposure.Results
Four hundred and seventy-one mesothelioma cases (93.6 % pleural) occurred in 3,985,991 person-years. The IRR of mesothelioma was increased for subjects exposed to EBRT (1.28; 95 % CI 1.05, 1.55) compared to non-irradiated patients, and a population attributable fraction of 0.49 % (95 % CI 0.11, 0.81) was estimated. The IRR increased with latency period: 0–4 years, IRR 1.08 (95 % CI 0.81, 1.44); 5–9 years, IRR 1.31 (95 % CI 0.93, 1.85); ≥10 years, IRR 1.59 (95 % CI 1.05, 2.42). Despite the fairly strong evidence of association with EBRT, the population attributable rate of mesothelioma was modest—3.3 cases per 100,000 person-years. The cumulative incidence of mesothelioma attributable to EBRT was 4.0/100,000 over 5 years, 24.5/100,000 over 10 years, and 65.0/100,000 over 15 years.Conclusions
Our study provides evidence that EBRT for prostate cancer is a small but detectable risk factor for mesothelioma. Patients should be advised of risk of radiation-induced second malignancies. 相似文献13.
Purpose
To correlate comorbidity and acute radiation toxicity in elderly patients treated with adjuvant external beam radiotherapy (EBRT) plus brachytherapy-high dose rate (HDR-BRT) for endometrial cancer (EC).Methods
Endometrial cancer patients over 65 were treated and evaluated for comorbidity assessment with ACE-27 and Charlson comorbidity index (CCI). EBRT total dose was 45–50.4 Gy (1.8 Gy/day). The vault vagina boost of dose was performed by HDR-BRT with 2/3 fractions with a total dose of 10–15 Gy.Results
From 2008 to 2011, 35 patients were analyzed. Eighteen patients (51.43 %) had not ACE-27 comorbidity; while 27 patients (77.14 %) had CCI lower than three. During treatment, acute toxicity was mild and not influenced by the comorbidity score. Two-year Progression Free and Overall Survival were 69 and 80 %. ACE-27 and CCI did not affect progression-free survival (p = 0.51, p = 0.3) and OS (p = 0.26, p = 0.5).Conclusion
External beam radiotherapy plus BRT-HDR are well tolerated in EC elderly with good performance status and low comorbidity profile. 相似文献14.
Amit Javed Sujoy Pal Nihar Ranjan Dash Vineet Ahuja Bidhu Kalyan Mohanti Sreenivas Vishnubhatla Peush Sahni Tushar Kanti Chattopadhyay 《Journal of gastrointestinal cancer》2012,43(1):63-69
Background
A majority of patients with esophageal cancer present with inoperable disease and require rapid and long-lasting palliation of dysphagia.Study aim
To compare the duration of relief of dysphagia in patients with inoperable esophageal cancer treated with esophageal stenting alone or a combination of esophageal stenting and external beam radiotherapy (EBRT), and to assess overall survival, treatment-related complications, and quality of life (QOL) in the two groups.Patients and methods
Patients with inoperable esophageal cancer and with high grade dysphagia were randomized to receive esophageal stenting with self-expandable metal stent (Ultraflex) alone (Group I), versus a combination of stenting followed by EBRT (30 gray in ten divided fractions over 2?weeks) (Group II). Dysphagia relief, overall survival, QOL (using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, version 3), and treatment-related complications were assessed in the two groups.Results
From April 2007 to March 2009, 84 patients were randomized to receive esophageal stent alone (42 patients) or a combination of stent and EBRT (42 patients). The two groups were comparable in demographics, tumor characteristics, indications for palliative treatment, and pretreatment dysphagia score. Dysphagia scores improved significantly in both groups following stent insertion. However, dysphagia relief was more sustained in Group II than in Group I (7 vs. 3?months, p?=?0.002). Overall median survival was significantly higher in Group II than in Group I (180 vs. 120?days, p?=?0.009). Addition of radiotherapy following stenting prolonged the mean dysphagia-free survival (118.6?±?55.8 vs. 96.8?±?43.0?days, p?=?0.054). There was significant improvement in all QOL parameters at 1?week after stenting. The QOL, however, significantly declined immediately after radiotherapy. There was no treatment-related mortality, and the incidence of complications was similar in the two groups.Conclusion
Post-stenting EBRT effectively prolongs duration of dysphagia relief and improves overall survival in inoperable esophageal cancer. 相似文献15.
F. A. Calvo C. V. Sole R. Obregón M. Gómez-Espí C. González- San Segundo L. González- Bayón E. Alvarez J. L. García-Sabrido 《Clinical & translational oncology》2013,15(6):443-449
Introduction
To report feasibility, tolerance, anatomical sites of upper abdominal locoregional recurrence and long-term outcome of gastric cancer patients treated with surgery and a component of intraoperative electron beam radiotherapy (IORT).Materials and methods
From January 1995 to December 2010, 32 patients with primary gastric adenocarcinoma treated with curative resection (R0) [total gastrectomy (n = 9; 28 %), subtotal (n = 23; 72 %) and D2 lymphadenectomy in all patients] and apparent disease confined to locoregional area [Stage: II (n = 15; 47 %), III (n = 17; 53 %)] were treated with a component of IORT (IORT applicator size 5–9 cm in diameter, dose 10–15 Gy, beam energy 6–5 MeV) over the celiac axis and peripancreatic nodal areas. Sixteen (50 %) patients also received adjuvant treatment (external beam radiotherapy n = 6, chemoradiation n = 9, chemotherapy alone n = 1).Results
With a median follow-up time of 40 months (range, 2–60), locoregional recurrence was observed in five (16 %) patients (4 nodal in hepatic hilum and 1 anastomotic). Only pN1 patients developed locoregional relapse. No recurrence was observed in the IORT-treated target volume (celiac trunk and peripancreatic nodes). Overall survival at 5 years was 54.6 % (95 % CI: 48.57–60.58). Postoperative mortality was 6 % (n = 2) and postoperative complications 19 % (n = 6).Conclusions
It is feasible to integrate IORT as a component of radiotherapy in combined modality therapy of gastric cancer. Local control is high in the radiation boosted area, but marginal regional extension (in particular, involving the hepatic hilum) might be considered as part of the anatomic IORT target volume at risk in pN+ patients. 相似文献16.
A. Diakité H. Bakkali A. Tolba H. Mariem N. Mouhajir K. Diabaté M. Nouh B. N’koua S. Boutayeb T. Kebdani B. K. Elgueddari S. Ahid N. Benjaafar 《Journal africain du cancer / African Journal of Cancer》2014,6(2):101-106
Purpose
To evaluate the local control and the tolerance of cervical high-dose-rate (HDR) brachytherapy using an applicator ring.Patients and methods
This is a retrospective study of 105 patients treated in the radiotherapy department for cervical cancer and who received brachytherapy in HDR with an applicator ring in addition to external-beam radiation therapy (EBRT) at the National Institute of Oncology (INO) in Rabat between January 2007 and October 2012.Results
The mean age of our population was 51.7 ± 12.7 years old; According to the International Federation of Gynecology and Obstetrics (FIGO) 52.4% of patients were stage II, 28.6% stage I, and 19% stage III. Dosimetry was in 2D for 83 patients (78.2%) and 3D for 22 patients (22.8%). For 2D dosimetry, the mean dose to point A was 7.66 ± 0.46 Gy, the mean dose to the bladder point was 4.5 ± 1.5 Gy, and the average dose at the rectum point was 2.7 ± 1.4 Gy. The biological equivalent doses (BED) averages were 91.8 ± 23.2 Gy for the bladder and 68 ± 16 Gy for the rectum (including the dose received by the EBRT with α/β = 3 for organs at risk (OAR). In 3D dosimetry the BED averages for the volume 2 cm3 were 5.8 ± 0.5 Gy for the bladder and 3.5 ± 0.7 Gy for the rectum, with an equivalent 2 Gy dose (EQD2) average of 86 ± 6 Gy for the bladder and 65 ± 7 Gy for the rectum. The mean dose to CTV high risk (D90) was 86.44 ± 3.45 Gy. After a median follow-up of 23 months, the evolution was marked by three local recurrences, two lymph node recurrences and one lung metastases; the rate of recurrence-free survival in our population was 83.7%. Side effects found in our patients were as follows: radiation cystitis in 16 cases (69% grade 1 and 31% grade 2) and radiation proctitis in 8 cases 56% of our patients presented vaginal narrowing (synechiae, atresia). No statistically significant correlation was found between the occurrence of complications and the type of dosimetry (2D or 3D).Conclusion
Using the applicator ring in cervical HDR brachytherapy provides good local control with acceptable complications. 相似文献17.
Toita T Kato S Ishikura S Tsujino K Kodaira T Uno T Hatano K Sakurai H Niibe Y Kazumoto T Nishimura T Kitagawa R Fukutani M Oguchi M Umayahara K Hirashima Y Aoki Y Takizawa K;Disease Committee of Radiation Oncology Japanese Gynecologic Oncology Group 《International journal of clinical oncology / Japan Society of Clinical Oncology》2011,16(4):379-386
Background
To assess radiotherapy protocol compliance in a multi-institutional phase II study of concurrent chemoradiotherapy for patients with locally advanced cancer of the uterine cervix (JGOG1066).Methods
For study protocol development, various radiotherapy parameters were examined and consensus was reached by Japanese radiation oncologists with cervical cancer treatment expertise. Quality assurance (QA) was also discussed and included in the protocol. A credentialing process was used to select institutions for participation in the study. Individual case reviews referring to 18 QA items were undertaken for each patient. Radiotherapy data were submitted to the Japanese Gynecologic Oncology Group (JGOG) data center and reviewed by the members of the radiotherapy committee. The QA evaluation was classed as per protocol, deviation, and violation.Results
Individual case reviews were performed on 69 of 72 patients entered in the study. In 24 patients (35%), there were no deviations for any QA items. There were also no deviations seen for 5 of the 18 items in 69 patients evaluated. Deviations of 64 QA items were seen in 45 cases, and violations were seen in 4 cases (4 items). The most common deviation concerned appropriate application for the external beam radiotherapy (EBRT) boost to involved nodes or parametrium (32 cases). The 4 violations were identified in the QA items regarding high-dose rate intracavitary brachytherapy.Conclusions
Radiotherapy protocol compliance was favorable except for the EBRT boost indications. The results of this study validate the quality of radiotherapy in JGOG1066, and indicate that the final analysis will provide meaningful results. 相似文献18.
Masataka Sawaki Naoto Kondo Akiyo Horio Aya Ushio Naomi Gondo Eri Adachi Masaya Hattori Takashi Fujita Hiroyuki Tachibana Takeshi Kodaira Hiroji Iwata 《Breast cancer (Tokyo, Japan)》2014,21(4):415-422
Background
Intraoperative radiation therapy (IORT) is under evaluation in breast-conserving surgery because the feasibility of the IORT procedure including transportation of the patient under general anesthesia is not well established. Thus, this prospective single-center study aimed to test the feasibility of IORT at a single dose of 21 Gy in Japanese breast cancer patients.Methods
The primary endpoint was early toxicity; the secondary endpoint was late toxicity. Patients with histologically or cytologically proven primary early breast cancer were eligible. Inclusion criteria were as follows: (1) T < 2.5 cm; (2) desire for breast-conserving surgery; (3) age >50 years; (4) surgical margin >1 cm; (5) intraoperative pathologically free margins; and (6) sentinel node negative. Exclusion criteria were (1) contraindications to radiation therapy; (2) past radiation therapy for the same breast or chest; (3) extensive intraductal component; and (4) a tumor located in the axillary tail of the breast. All patients gave written informed consent. Partial resection was performed with at least a margin of 1 cm around the tumor. The patient was transported from the surgical suite to the radiation room. Radiation (Clinac® 21EX, Varian Medical Systems, Inc.) at 21 Gy was delivered directly to the mammary gland. Toxicity was evaluated with the Common Terminology Criteria for Adverse Events V4.0.Results
Five patients were enrolled in this pilot study and received 21 Gy. Follow-up ranged from 7.8 to 11.0 months (median 10.2). Intraoperative transportation to the radiation room during the surgical procedure under general anesthesia was performed safely in all patients. Treatment-related toxicities within 3 months were deep connective tissue fibrosis (grade 1, n = 3) and pain (grade 1, n = 3). There was no case of wound infection, wound dehiscence, or soft tissue necrosis. Overall, there was no severe adverse event.Conclusions
The procedure was tolerated very well in this first group of Japanese female patients treated with IORT, as was the case with European women. A longer follow-up is needed for the evaluation of any potential late side effects or recurrences. A phase II study is now being conducted for the next group of patients (UMIN000003578). 相似文献19.