High-intensity focused ultrasound for the targeted destruction of uterine tissues: experiences from a pilot study using a mobile HIFU unit.

BACKGROUND: High intensity focused ultrasound (HIFU) is a novel method which offers the non-invasive ablation of tissues without harming overlying organs or skin. It has been introduced successfully in urology for the ablation of prostatic hyperplasia and seems to be promising in the treatment of uterine fibroids. In this study we aimed to examine the feasibility and possible side effects of HIFU treatment of uterine tissues using an experimental mobile HIFU unit with ultrasound guidance. METHODS: For these experiments, a 1.07 MHz ultrasound source was used which allows treatment depths between 0 and 10 cm. In 12 patients scheduled to have abdominal hysterectomy, 5-60 impulses of HIFU were applied through the intact skin upon uterine tissues directly prior to the surgical procedure. Tissue intensities lay between 3,200 and 6,300 W/cm(2) and a fixed pulse length of 4 s was used. RESULTS: No side effects were encountered other than one first-degree skin burn and the treatment was well tolerated. Histology showed clearly demarcated coagulative necrosis in the targeted tissues. Treatment was concluded in less than 45 min for each patient. CONCLUSION: Focused ultrasound is an effective method to selectively destroy tissue within the uterus and the transabdominal access route is very feasible. This study shows that a mobile ultrasound source can be used safely and effectively to destroy uterine tissues, such as fibroids, without major side effects.

Long-term toxicity of an intraoperative radiotherapy boost using low energy X-rays during breast-conserving surgery.

PURPOSE: Intraoperative radiotherapy (IORT) as a boost for breast cancer delivers a high single dose of radiation to a late-reacting tissue; therefore late toxicity is of particular interest, and long-term follow-up is warranted. To date there are only limited data available on breast cancer patients treated with IORT using low energy X-rays. We analyzed toxicity and cosmesis after IORT as a boost with a minimum follow-up of 18 months. METHODS AND MATERIALS: A total of 73 patients treated with IORT (20 Gy/50 kV X-rays; INTRABEAM [Carl Zeiss Surgical, Oberkochen, Germany]) to the tumor bed during breast-conserving surgery as a boost followed by whole-breast radiotherapy (WBRT, 46 Gy) underwent a prospective, predefined follow-up (median, 25 months; range 18-44 months), including clinical examination and breast ultrasound at 6-months and mammographies at 1-year intervals. Toxicities were documented using the common toxicity criteria (CTC)/European Organization for Research and Treatment of Cancer and the LENT-SOMA score. Cosmesis was evaluated with a score from 1 to 4. RESULTS: The IORT in combination with WBRT was well tolerated, with no Grade 3 or 4 skin toxicities and no telangiectasias. Fibrosis of the entire breast was observed in 5% of the patients. A circumscribed fibrosis around the tumor bed was palpable in up to 27% with a peak around 18 months after therapy and a decline thereafter. The observed toxicitiy rates were not influenced by age, tumor stage, or systemic therapy. The cosmetic outcome was good to excellent in>or=90% of cases. CONCLUSIONS: After IORT of the breast using low-energy X-rays, no unexpected toxicity rates were observed during long-term-follow-up.

Intraoperative radiotherapy (IORT) as a boost in patients with early-stage breast cancer -- acute toxicity.

BACKGROUND: We report on acute toxicities as well as the early cosmetic outcome of patients receiving intraoperative radiotherapy (IORT) followed by whole-breast radiotherapy (WBRT) compared to patients treated with standard WBRT alone. PATIENTS AND METHODS: From 2/2002 until 2/2005, 84 breast cancer patients were treated with IORT during breast-conserving surgery (BCS) as a boost (20 Gy/50 kV X-rays) followed by WBRT. After wound healing, all IORT patients were treated with WBRT at a total dose of 46 Gy. For the purpose of comparison, 53 patients treated consecutively between 1/2003 and 12/2004 in our institution with BCS followed by WBRT at a total dose of 50-66 Gy, were analyzed. All patients had a defined followup schedule. Toxicities were prospectively documented using the CTC/EORTC Score. Cosmesis was evaluated after 6 months using a 1-4 score. RESULTS: Treatment was well tolerated with no grade 3/4 acute toxicity. Rare adverse effects following IORT included wound healing problems (2%), erythema grade I-II (3%), palpable seroma (6%) and mastitis (2-4%). The number of patients with induration of the tumor bed was comparably low. CONCLUSION: IORT with the IntrabeamTM system applied as a boost during BCS, followed by 46 Gy WBRT, exerts similar acute toxicity as standard WBRT. Further follow-up is needed to assess long-term toxicity and efficacy.

Intraoperative radiotherapy (IORT) for breast cancer using the Intrabeam system.

INTRODUCTION: Intraoperative radiotherapy (IORT) with low-energy X-rays (30-50 KV) is an innovative technique that can be used both for accelerated partial breast irradiation (APBI) and intraoperative boosting in patients affected by breast cancer. Immediately after tumor resection the tumor bed can be treated with low-distance X-rays by a single high dose. Whereas often a geographic miss in covering the boost target occurs with external beam boost radiotherapy (EBRT), the purpose of IORT is to cover the tumor bed safely. This report will focus on the feasibility and technical aspects of the Intrabeam device and will summarize our experience with side effects and local control. MATERIALS AND METHODS: Between February 2002 and June 2003 57 breast cancer patients, all eligible for breast conserving surgery (BCS), were treated at the Mannheim Medical Center with IORT using the mobile X-ray system Intrabeam. The patient population in this feasibility study was not homogeneous consisting of 49 patients with primary stage I or II breast cancer, seven with local recurrence after previous EBRT and one with a second primary in a previously irradiated breast. The selection criteria for referral for IORT included tumor size, tumor cavity size, margin status and absence of an extensive intraductal component. The previously irradiated patients with local recurrences and 16 others received IORT as single modality. In all other cases IORT was followed by EBRT with a total dose of 46 Gy in 2-Gy fractions. The intraoperatively delivered dose after tumor resection was 20 Gy prescribed to the applicator surface. EBRT was delivered with a standard two-tangential-field technique using linear accelerators with 6- or 18-MV photons. Patients were assessed every three months by their radiation oncologist or surgeon during the first year after treatment and every six months thereafter. Breast ultrasound for follow-up was done every six months and mammographies once yearly. Acute side effects were scored according to the CTC/EORTC score and late side effects according to the Lent-Soma classification. RESULTS: Twenty-four patients received IORT only; eight patients because they had received previous radiotherapy, 16 because of a very favorable risk profile or their own preference. Thirty-three patients with tumor sizes between 1 and 30 mm and no risk factors were treated by IORT as a boost followed by EBRT. The Intrabeam system was used for IORT. The Intrabeam source produces 30-50 KV X-rays and the prescribed dose is delivered in an isotropic dose distribution around spherical applicators. Treatment time ranged between 20 and 48 minutes. No severe acute side effects or complications were observed during the first postoperative days or after 12 months. One local recurrence occurred 10 months after surgery plus IORT followed by EBRT. In two patients distant metastases were diagnosed shortly after BCS. DISCUSSION: IORT with the Intrabeam system is a feasible method to deliver a single high radiation dose to breast cancer patients. As a preliminary boost it has the advantage of reducing the EBRT course by 1.5 weeks, and as APBI it might be a promising tool for patients with a low risk of recurrence. The treatment is well tolerated and does not cause greater damage than the expected late reaction in normal tissue.

Caesarean section on demand: influence of personal birth experience and working environment on attitude of German gynaecologists.

OBJECTIVE: We performed a survey among German obstetricians and gynecologists in order to evaluate the influence of biographic data, working environment and personal birth experience on the attitude towards Cesarean Section on demand. MATERIAL AND METHODS: All 2106 board-certified gynecologists in Baden-Württemberg received an anonymous questionnaire in 2002-2003 concerning attitude towards C-section on demand, biographical data, personal birth experience and working environment. Seven hundred and nineteen questionnaires were returned and entered into statistical analysis. RESULTS: General approval of C-section was in 59% of all participants, with huge statistically significant variations according to age, personal birth experience and working field. When asked for their preferred way of delivery for themselves or their partner after a low-risk pregnancy, 90% of the responding gynecologists opted for vaginal delivery. The approval depended statistically significant on parenthood, personal birth experience and working environment. CONCLUSIONS: Biographical data, personal birth experience and working environment influence the attitude towards elective Cesaran section. Although 90% would chose vaginal delivery for themselves or their partner as best medical practice, 59% of the physicians approve of the general opportunity of C-section on demand. This shows, that not only best medical practice, but also patient autonomy and forensic aspects seem to play an important role.

Water birth: microbiological colonisation of the newborn, neonatal and maternal infection rate in comparison to conventional bed deliveries.

INTRODUCTION: The risk of infectious complications after water birth which might be due to water contaminated by faecal bacteria or environmental microbes from the water supply system is still in discussion. MATERIALS AND METHODS: We performed a microbiological study comparing neonatal bacterial colonisation after water birth to conventional bed deliveries with or without relaxation bath. In all three groups (96 deliveries) we isolated most frequently from ear and palate of the newborns Staphylococcus epidermidis, E. coli and enterococci, which belong to the normal vaginal flora. RESULTS: Neonatal outcome, infants and maternal infection rate did not differ between the three groups.