1 oktober 2008: Bron: 1: Am J Surg. 2007 Oct;194(4):456-62.
Five-year results: the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer.
Department of Surgery, William Beaumont Hospital, 3577 W. 13 Mile Rd, Suite 201, Beaumont Cancer Center, Royal Oak, MI 48073, USA. pbenitez@beaumont.edu
OBJECTIVE: Patients with early-stage invasive ductal breast cancer were prospectively evaluated using MammoSite RTS balloon brachytherapy (RTS Cytyc Corp, Marlborough, MA) as the sole modality for delivering accelerated partial breast irradiation to the lumpectomy bed with breast-conserving surgery. This report presents the 5-year results of the treated patients.
METHODS: From May 2000 to October 2001, 70 patients were enrolled in this prospective study. Forty-three patients completed accelerated partial breast irradiation with MammoSite brachytherapy following lumpectomy and axillary staging. Thirty-six patients have been followed for a median of 5.5 years (mean 65.2 months). Criteria for entry into the study were unifocal invasive ductal carcinoma, tumor size < or = 2 cm, age > or = 45 years, absence of extensive intraductal component, cavity size > or = 3 cm in 1 dimension, node-negative, and final margins negative per National Surgical Adjuvant Breast and Bowel Project definition. A minimum balloon-to-skin surface distance of 5 mm was required. A dose of 34 Gy was delivered in 10 fractions over 5 days prescribed to 1 cm from the applicator surface using iridium-192 high-dose-rate brachytherapy. Data on infection, seromas, cosmetic outcome, and toxicities were collected at 3 and 6 months and at yearly intervals. Local recurrences, both true recurrences in the lumpectomy bed and failures outside the initially treated target volume (elsewhere failures), were recorded. Contralateral breast failure rates were noted.
RESULTS: The catheter was not implanted in 16 of the 70 enrolled patients due to cavity size not amenable to balloon placement (n = 10), ineligible by criteria (n = 4), and skin spacing (n = 2). Fifty-four patients were implanted and 43 were successfully treated with MammoSite balloon brachytherapy. Reasons for catheter explantation in 11 patients were poor cavity conformance in 7, inadequate skin spacing in 2, positive node in 1 and age less than 45 years in 1. Of the 43 patients who completed treatment, the infection rate was 9.3%. Seroma formation occurred in 32.6% of patients, of which 12% were symptomatic requiring aspiration. Asymptomatic fat necrosis was identified in 4 of the 43 patients, noted from time of catheter removal at 11, 14, 42, and 63 months. Good-excellent cosmetic outcomes were achieved in 83.3% of the 36 patients with more than 5 years of follow-up. Cosmetic outcomes were improved, with increased skin spacing having statistical significance at skin spacing > or = 7 mm. The only serious adverse events were 2 infections: mastitis and abscess. Seven of the 43 treated patients have been discontinued from follow-up. None had a local recurrence recorded at last visit. Reasons for exit from the study were death from metastatic disease (n = 3), lost to follow-up (n = 2), and placed in hospice for other medical conditions (n = 2). No local recurrences (either at the tumor bed or elsewhere in the breast) or regional recurrences have occurred in the 36 patients who have been followed for a median of 5.5 years. No contralateral cancers have developed.
CONCLUSIONS: MammoSite balloon brachytherapy as a sole modality for delivering radiation to the tumor bed has been successful in achieving excellent local control in this initial clinical study of patients with early-stage invasive ductal breast cancer. This has been achieved with minimal toxicities and good-excellent cosmetic outcomes in 83.3%. Accelerated partial breast irradiation using the MammoSite balloon in a carefully selected group of patients has demonstrated 5-year local recurrence results comparable to those achieved with conventional whole breast radiation therapy and interstitial catheter brachytherapy as reported at 5-year data points in studies of these treatment modalities. Poor cavity conformance and inadequate skin distance were the main factors limiting use of the MammoSite device. Extended follow-up will be required to determine the long-term efficacy of this treatment modality.
PMID: 17826055 [PubMed - indexed for MEDLINE]
1: Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):32-40. Epub 2007 Apr 30.
Analysis of treatment efficacy, cosmesis, and toxicity using the MammoSite breast brachytherapy catheter to deliver accelerated partial-breast irradiation: the william beaumont hospital experience.
Department of Radiation Oncology, Beaumont Cancer Institute, William Beaumont Hospital, Royal Oak, MI 48072, USA.
PURPOSE: To review our institution's experience of treating patients with the MammoSite (Cytyc Corp., Marlborough, MA) breast brachytherapy catheter to deliver accelerated partial-breast irradiation (APBI), for determining short-term treatment efficacy, cosmesis, and toxicity.
METHODS AND MATERIALS: From January 2000 to April 2006, 80 patients treated with breast-conserving therapy (BCT) received adjuvant radiation using the MammoSite (34 Gy in 3.4-Gy fractions prescribed to 1.0 cm from the balloon surface). Twenty-three patients (29%) had Stage 0 breast cancer, 46 (57%) had Stage I breast cancer, and 11 (14%) had Stage II breast cancer. The median follow-up was 22.1 months.
RESULTS: Two ipsilateral breast-tumor recurrences (IBTRs) (2.5%) developed for a 3-year actuarial rate of 2.9% (no regional failures were observed). On molecular-based clonality assay evaluation, both recurrences were clonally related. Younger age at diagnosis was the only variable associated with IBTR (continuous variable, p = 0.044; categorical variable [<55 years vs. >/=55 years], p = 0.012). The percentages of patients with good/excellent cosmetic results at 12 and 36 months were 96.9% and 88.2%, respectively (p = NS). Patients with applicator-to-skin spacing <7 mm and those who received adjuvant systemic chemotherapy exhibited lower rates of good/excellent cosmetic results, though the association was not statistically significant. The overall incidence of symptomatic seromas and any seromas was 10% and 45%, respectively. The overall incidence of fat necrosis and infections was 8.8% and 11.3%, respectively.
CONCLUSIONS: Early-stage breast-cancer patients treated with adjuvant APBI using the MammoSite catheter exhibited a 3-year treatment efficacy, cosmesis, and toxicity similar to those observed with other forms of interstitial APBI at this length of follow-up.
PMID: 17467920 [PubMed - indexed for MEDLINE]
d.d. 18 september 2003:
Een langjarige enkelvoudige, maar wel gerandomiseerde studie onder resp. 120 en 79 vrouwen met borstkanker stadium I en II heeft uitgewezen dat brachytherapie - lokale operatie en lokale bestraling door een inplant van inwendige bestralingsbron - dezelfde uitkomsten geeft betreffende recidiefkansen op langere termijn dan totale borstamputatie en totale bestraling bij vrouwen voor hun borstkanker stadium I en II. Het voordeel hiervan is, naast het feit dat totale borstamputatie ingrijpender is dan lokale operatie van de tumor, dat vrouwen minder bloot worden gesteld aan de bijwerkingen op zowel korte als lange termijn van bestralingen en de bestraling/Brachytherapie ook nog eens patiëntvriendelijker is. Maar zoals bij veel van deze mooie vindingen wordt er wel bij gezegd dat nog veel en langdurig onderzoek nodig is, ook omdat een recidief van borstkanker vaak op langere termijn voorkomt en een veilige marge van tien jaar wordt aangehouden. Overigens wordt brachytherapie - inwendige bestraling - al wel al enkele jaren toegepast ook in Nederlandse ziekenhuizen.
Bron van dit verhaal de website van Veritas. www.veritasmedicine.com waaruit ik enkele citaten citeer:
Emerging Role of Partial Breast Radiation in the Treatment of Early Stage Breast Cancer. 09/12/2003
.......Large randomized clinical trials with long follow-ups have established that breast conservation therapy that includes localized excision of the tumor with clear margins followed by radiation therapy to the breast is equivalent to mastectomy in the treatment of early stage breast cancer.
...... One strategy to deliver localized radiation therapy to the site of the excised tumor is to use brachytherapy. This involves the temporary placement of a radiation source directly in the lumpectomy site. The nature of the radioactive material used allows intense radiation of the tissue immediately around the source. However this radiation only penetrates a few centimeters into the surrounding tissue, and thus spares much of the rest of the breast and body from significant radiation exposure. Thus an effective dose can be delivered to a localized region around the excised tumor rather quickly. A provocative recent study published in the Journal of the National Cancer Institute suggests that the use of this brachytherapy strategy may lead to outcomes that are identical to standard whole breast radiation therapy.
.......In this study, authored by Dr. Vicini and colleagues at the William Beaumont Hospital in Royal Oak MI, 199 consecutive patients with early stage breast cancer that had been excised with clear margins, and did not involve the axillary lymph nodes were treated with limited-field radiation therapy using brachytherapy at the excision site. The women either were treated with a localized radiation implant that was placed for 96 hours (120 women) or with a course of intermittent treatments over 3- 4 days (79 women). Adjuvant chemotherapy and/or hormonal therapy was given as needed using local guidelines, and the women were followed for about 5 years.
.......The study found that the rate of local recurrence at 5 years in the localized radiation group was low (1%) and not significantly different from that seen in the matched group that received standard whole breast radiation. The authors conclude that limited breast radiation using brachytherapy may be equally effective as standard whole breast radiation in selected patients with early stage breast cancer.
.........Based on the encouraging early results of this and other similar trials, large randomized clinical trials examining several approaches to limited breast radiation in early stage breast cancer are currently underway. Such trials are important to the continuing refinement of breast cancer treatment and essential to developing treatment strategies that maximize the efficacy of cancer therapy and minimize its burden on the patient.
Reference:
Frank A. Vicini, Larry Kestin, Peter Chen, Pamela Benitez, Neal S. Goldstein, and Alvaro Martinez. Limited-Field Radiation Therapy in the Management of Early-Stage Breast Cancer J Natl Cancer Inst 2003; 95: 1205-1210
Nieuwe vorm van diagnose borstkanker superieur aan conventionele mammografie, die gemiddeld 10 tot 20% van borstkankertumoren mist, blijkt uit studie in Colorado universiteit.
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