| | Partial breast irradiation as sole therapy for low risk breast carcinoma: Early toxicity, cosmesis and quality of life results of a MammoSite brachytherapy phase II studyReceived 28 August 2007; received in revised form 23 May 2008; accepted 18 June 2008. published online 11 August 2008. Abstract PurposeThe MammoSite is a device that was developed with the goal of making breast-conserving surgery (BCT) more widely available. Our objective was to evaluate the MammoSite device performances after an open cavity placement procedure and quality of life in highly selected patients with early-stage breast cancer. Methods and materialsFrom March 2003 to March 2005, 43 patients with T1 breast cancer were enrolled in a phase II study. The median age was 72 years. Twenty-five (58%) patients were treated with high-dose rate brachytherapy using the MammoSite applicator to deliver 34 Gy in 10 fractions. The main disqualifying factor was pathologic sentinel node involvement (10/43; 23%). There were no device malfunctions, migration or rupture of the balloon. ResultsAfter a median follow-up of 13 months, there were no local recurrences and one contralateral lobular carcinoma. Seventeen (68%), 13 (52%), 8 (32%), 5 (20%) and 2 (8%) patients had erythema, seroma, inflammation, hematoma and sever infection, respectively. Only 2 patients developed telangiectasia. At 1 year the rate of “good to excellent” cosmetic results was 84%. Significant changes in QoL were observed for emotional and social well-being between 3 and 12 months. At 24 months, only emotional well-being subscore changes were statistically significant (p=0.015). ConclusionsOur data in patients older than 60 years support the previously published data. Histologic features were the main disqualifying criteria. With higher skin spacing levels we observed very low incidence of telangiectasia. QoL evaluation indicates that baseline scores were satisfactory. Changes concerned emotional and social well-being. Over the past decade, interest in accelerated partial breast irradiation (APBI) after breast conservative surgery (BCS) has increased due to many factors. Those factors include both clinical and pathologic data of questioning the need of whole breast irradiation (WBI) in selected patients as well as factors including patient convenience, access and acceptance of radiation therapy (RT). In patients aged more than 70 years [1] and another selected group of patients >60 years with lesions <10mm [2], the addition of RT to tamoxifen did not impact survival and deaths were mainly due to other causes than breast cancer. Thus, in this category of patients, APBI delivered over 5 days instead of 5–6 weeks could be a serious therapeutic option allowing an increase of quality of life (QoL) and observance of RT [3]. The methods employed in PBI have used interstitial brachytherapy (using low-dose rate (LDR) [4], [5], [6], [7], [8] or high-dose rate (HDR) [4], [8], [9], [10], [11], [12], [13], [14], [15], [16]), external beam RT (using photons [17], [18], [19], [20], electrons and/or proton beams [21]) and intraoperative RT [22], [23], [24]. The results of APBI using HDR or LDR brachytherapy techniques show a 0–4.4% rate of in-breast recurrences when the patients are highly selected. When appropriate selection of patients and clear margins are not ensured, unacceptable recurrence rates ranged between 6.7% and 37% [5], [9], [10], [25], [26]. The results of these studies in terms of local cosmetic outcome after 11–82 months of follow-up period are acceptable, ranging between 67% and 100%. The MammoSite® brachytherapy applicator (Cytyc Corporation, Marlborough, MA) received clearance for market from the US Food and Drugs Administration in May 2002. Since clearance, 20,000 patients have been treated with MammoSite in the US. Our single institution prospective phase II study is one of the first studies initiated in Europe to evaluate the performances of the device used for APBI as a sole post-operative modality after BCS. We report our experience in terms of feasibility, acute reactions, late toxicity, cosmetic results and QoL using the MammoSite device in a highly selected population of patients. Materials and methods  Patients Between March 2003 and March 2005, 43 patients were enrolled in this study. All patients were specifically and explicitly informed that efficacy of APBI has not been established yet. All have signed informed consent. The institutional review board and ethical committee approved the study. Eligibility criteria were age ⩾60 years, histology tumor size ⩽2cm, invasive ductal histology, ductal carcinoma in situ component <25%, hormone receptors positive, applicator placement intraoperatively after lumpectomy, surgical margins ⩾5mm, sentinel node negative including immunohistochemical (IHC) evaluation, balloon surface to skin distance ⩾7mm. The median age was 72 years (range: 60–75). Patients’ characteristics are listed in Table 1. | a Outer n=11 (44%). bLumpectomy followed by lateral open cavity technique placement of the MammoSite device. cAll patients had node negative in immunohistochemical evaluation. dUnder general anesthesia intraoperatively after lumpectomy and clear margins confirmation (⩾5mm). eTreatment stopped at day 4 because of abscess development. |
Patients were enrolled before lumpectomy for an open implant procedure. Cancer and surrounding healthy tissue margin are removed down to the pectoralis fascia, creating a full-thickness resection. Glandular tissue around the residual cavity is mobilized by superficial and posterior dissection. A small drain (6 or 8G) is applied on muscular fascia before the balloon implant (Fig. 1). The mobilized margins of the residual cavity are shifted to cover the balloon. Assessment of adverse events, cosmetic results and quality of life All patients completing APBI underwent evaluation of adverse events, cosmesis and QoL at each visit: 48h, 1, 3, 6 and 12 months and every year thereafter. The cosmetic evaluation included clinical examination by the surgeon and radiation oncologist and adverse events were scored using the CTC v3.0 scale [27]. The investigator for the final assessment systematically reviewed at least two photographs, frontal and profile views according to the Harvard scale [28]. Patients completed a QoL (Functional Assessment of Cancer Therapy for Breast [FACT-B], version 4) [29] before surgery, at the end of brachytherapy and at each visit thereafter. The mean scores (±SD) for physical, social, emotional and functional well-being and the breast subscale were calculated for each visit and were compared to baseline before surgery. Statistical analyses Synergos Inc. (USA), an independent full service Contract Research Organization (CRO) provided services to manage and analyze the data. Standard statistical methods were employed to analyze all data. The following techniques were used: descriptive statistics, McNemar’s test, Fisher’s Exact test and Wilcoxon Signed Rank and Rank Sum tests. All tests were declared statistically significant if the calculated p-value was less than or equal to 0.05. All tests appear as two-sided p-values. Results Twenty-five out of the 43 (58%) enrolled patients were qualified for HDR brachytherapy delivery. Among the 18 (42%) non-treated patients, one patient discontinued treatment after the two first fractions because of significant deformation of the balloon by its contact with the chest wall. In the remaining 17 patients, disqualifying criteria were mainly related to histologic issues: 10 patients had the device placed and explanted secondary after final histologic report. All the disqualified patients received standard WBI (50Gy in 25 fractions). Discussion The number of reports on MammoSite procedure used as a sole therapy after conservative surgery for invasive breast carcinoma is increasing. After a median follow-up ranging between 11 and 48 months, acute skin reactions, infections and seromas were observed in 5–52%, 0–16% and 26–49%, respectively. “Good to excellent” results are reported in 67–97% of the patients. Before the MammoSite brachytherapy it is important to select patients. The rates of patients who are explanted for disqualifying criteria range between 4% and 30% [13], [30], [31], [32], [33], [34], [35]. This rate seems to be highly influenced by the placement technique. In the American Society of Breast Surgeons (ASBS) MammoSite breast brachytherapy registry, among the 1403 patients, 619 (44%) had the catheter balloon at time of lumpectomy, 576 (41%) after surgery with ultrasound (US) guidance and 197 (14%) using the scar entry technique [34]. The authors reported that the implant‘ technique was not associated with age, tumor size, bra size, catheter size, skin spacing, radiation recall, cosmesis or recurrence. The premature removal rates were 10%, 6% and 10%, after open cavity, US-guided and scare entry techniques, respectively. However, when the pathology-related reasons for removal were analyzed separately, there was a significant difference between the three techniques. In contrast to post-operative techniques the disqualifying pathology caused no explant. Hypothetical review at an independent breast center [31] showed that if the device had been placed at the time of lumpectomy, 29% of patients would have required device removal for disqualifying histology. In the Tufts-New England Medical (Boston) review of studies (n=204), 31 (15%) patients were not treated and the rate of such failures was lower for patients having post-operative placement of the device (9%) than those undergoing intraoperative placement (19%, p=0.07) [35]. In their initial study [36], the device related issues were the main cause of device removal (26%). In an early review of the ASBS Registry Study, Gittlemann et al. [30] report on 106 patients where the rate of disqualified patients was similar (14%), mainly due to another surgery-related parameter, inadequate skin distance (4%) and poor conformance of the balloon to the cavity (3%). When considering studies including patients with similar criteria to those advised by the ASBS consensus, or either more restrictive, the rates may be higher. In a recent multicenter study from Europe [37], brachytherapy was not performed in 9 out of 32 patients (28%), including 8 (25%) patients because of pathological issues. In our experience the overall rate of disqualified patients after a lateral intraoperative placement of the balloon was high, 42%. However, in 34% of the patients the reasons were related to the final histologic issues that were highly restricted. Indeed, IHC evaluation of sentinel node was systemically required before inclusion conversely to numerous other studies where node involvement patients were illegible [13], [31], [32], [33], [34]. Conversely in a recent report from Tsai et al. [38], using an intraoperative placement technique, only 5 out of 51 patients (9.8%) were explanted because of unfavorable final pathological findings. However, inclusion criteria were not restrictive. With regard to other reports, the high rate of disqualified patients in our study is related to most restrictive inclusion parameters, particularly in terms of pathological criteria including margins >5mm and micro metastases or tumor cells in the sentinel node after IHC evaluation. However, for low risk of axillary recurrence (<2%) and absence of any survival benefit recently reported in patients older than 60 years treated without axillary dissection [39], these exclusion criteria should be discussed. In our study, in addition to the restrictive inclusion criteria, disqualifying parameters were mainly related to histologic issues obtained from the final pathology report. Such restrictive criteria may limit the feasibility of the open cavity procedure. In addition, predictive factors for recurrence are still unknown. For example, none of the 10 patients with positive sentinel node had axillary nodal involvement after axillary dissection. Another concern with the device placement technique is the significant size of air pockets that may result in poor conformance and dose variations for the breast tissues surrounding the cavity [37]. It is known that when the balloon conforms to the lumpectomy cavity, the prescribed dose extends to 1cm beyond the balloon surface. Although the effective radiation penetration may be closer to 2cm, dosimetric studies revealed that with the 4cm-balloon device only 35% of the initial brachytherapy dose extend to 3cm. Critics of balloon brachytherapy caution that the rapid decline in the radial dose of irradiation from the source may preclude treatment of an adequate volume surrounding breast tissue [40]. While, randomized studies are needed to determine whether this concern is valid, the conformance of the balloon to the cavity seems to be a prerequisite for dose homogeneity in the surrounding tissue. By improving conformance index, the drain use can also shorten the time to start RT delivery, thereby allowing more rapid completion of local therapy and reduce the risk of infection and also the mean time to start APBI (from 7.2 to 5.1 days; p=0.003) [38]. In our experience, the use of a drain placed intraoperatively around the balloon (Fig. 1) has allowed for a decrease in the formation of air pockets and infections. In our series antibiotics were not systematically prescribed after implant. The overall rate of breast infections was 8%. Harper et al. reported a wound infection rate of 16.2%, in their first 37 patients, prior to implementing consistent use of prophylactic antibiotics and stringent wound care recommendations [41]. Without antibiotic administration during brachytherapy, Niehoff et al. [37] also reported abscesses before systematic administration of antibiotics that allowed an overall rate of infections of 8.5% in addition to the 4% of mastitis. Using an open cavity technique, other authors [32], [37], [41], [42], [43], [44], [45] have reported 0–16% of infections (including sometimes mastitis). Agarwal et al. [45] reported wound infection and abscesses in 12% and 2%, respectively, despite the systematic use of antibiotics. For abscesses, the relation to infected seroma is also not clearly established. Theoretically, larger volume of excision, particularly an excision volume larger than maximal balloon fill volume, could result in air pockets, drainage, seroma and high risk of infections. In the US FDA initial experience reported by Keisch et al. [13], the catheter site drainage and seroma were observed in 52% and 11%, respectively. In the European multicenter study [37], with a drain placement in 1/3 of the patients, the rate of seroma was much greater, up to 43% after a mean follow-up of 20 months. The type of exploration during follow-up can modify the rates of asymptomatic seromas. In our study, all patients were followed using ultrasound at each visit after treatment. This may explain the high rate of seromas observed after a median follow-up of 13 months (52%). Additionally, cosmetic results during the first year of follow-up were not influenced by seroma development. Conversely, Evans et al. [46] reported from 38 patients who had intraoperative placement of the MammoSite device higher rate of excellent results (83%) in patients without seroma compared to those who developed seroma (61%). In that series, using clinical exam, mammograms and ultrasound for seroma evaluation, the rate of seroma was even higher (76%) than in our experience. The high weight of patients was reported as the sole unfavorable prognostic factor for seroma development (p=0.04). Agarwal et al. [45] reported only 26% of clinically diagnosed seromas at 6 months, suggesting an underestimation of the rate by clinical exam compared to ultrasound. Besides seroma, skin reactions may influence cosmetic results. The majority of skin reactions are erythema or moist desquamation grade 1 or 2. Their incidence ranges between 30% and 91% [13], [30], [37], [38]. In our series, 68% of the patients experienced grade 1–2 erythema without any impact on cosmetic outcome. The impact of early skin reactions on cosmetic results is uncertain. However, two studies have showed that 67% and 91% of “good to excellent” cosmetic results were observed, respectively, in 91% [37] and 37% [13] of patients who previously presented with acute skin reaction. “Good to excellent” cosmetic results may be influenced by other parameters such as placement technique, skin spacing and subcutaneous fibrosis. In the US FDA initial experience [13] and the updated report [47], the “good to excellent” results, with the open cavity technique and skin spacing >5mm, decreased following time. The rates were 88%, 83% and 76% after 21, 36 and 48 months, respectively. These rates were highly correlated to the skin spacing [47]. In our experience, while the rates of “good to excellent” cosmetic results were low (only 56%) during the first 3 months, this rate increased to 84% and to 78% at 12 and 24 months, respectively. Cosmetic results have to be evaluated rigorously according to patients and treatment characteristics. Niehoff et al. [37] reported only 67% of “good to excellent” cosmetic results at 12 months. However, in that study of 32 patients, treatment was completed using the MammoSite device in 23 (72%) patients (either as a boost in addition to WBI in 11 patients or as sole therapy technique for brachytherapy delivery in 12 patients). Additionally, while the last group received 34Gy in 10 fractions twice daily, in the “boost group” the total dose was 7.5, 10 and 15Gy in 1, 3, and 9 patients, respectively. With these schedules, they also reported 26% of telangiectasia at 20 months. All telangiectasia occurred in the patients with balloon-skin distance of 7 to 12mm. Interestingly no telangiectasia was seen in the patients with distance >15mm. In the updated US FDA experience [47], 40% of the patients had telangiectasia after a median follow-up of 48 months. They occurred in 67% and 29% of the patients with skin spacing of 5–7mm and >7mm (p=0.04), respectively. In addition, skin spacing influenced cosmesis significantly (with 89% of good to excellent if skin distance ⩾8mm versus 58% for 5–6mm; p=0.04). In this study, we report the highest median skin distance of the literature (20mm; range: 12–54mm) which resulted in the lowest rate of telangiectasia (2 out 25 patients; 8%). While, an interval of 5 years is generally reported before occurrence of telangiectasia [48], this delay seems to be shorter with the MammoSite device use for HDR brachytherapy [37], [45]. This is probably related to maximum skin dose equivalent to 77Gy (alpha/beta=3) for skin distance <10mm (180%) and to 47Gy when skin distance is >10mm (110%) [37]. To our knowledge, in addition to the highest ranges of skin spacing data analyses, our study is also the first prospective report on QoL evaluation after the use of MammoSite brachytherapy after BCS in patients ⩾60 years of age. QoL after diagnosis of breast cancer varies across individuals [49] and also according to age [50]. However, QoL domains like physical, social and psychological well-being have been found to be comparable to those of women without disease [51]. Initially, women with breast cancer, especially younger women, tend to suffer substantial disruption in their physical functioning, mental health and well-being [52], [53]. In a recent report from Pandey et al. [49] the distance traveled by a patient to the treatment center influenced the breast specific QoL and emotional well-being. Another study has previously identified the significant reduction of the RT observance in elderly patients [3]. Thus, APBI is considered as an option for reducing the time of both travel and treatment during the 5–6 weeks of standard WBI. It can at least preserve the QoL of elderly patients particularly when they suffer from other co-morbidities [3]. The mean baseline values of the QoL scale and subscale in our population aged ⩾60 years were (Fig. 2) slightly higher than the scores reported recently in women with a median age of 47 years undergoing breast cancer treatment with curative intent [49]. The significant changes from baseline concerned emotional and social/family well-being at 3, 6 and 12 months, and only emotional well-being subscores at 24 months. In a series of younger patients, less than 50 years of age, global QoL was significantly lower than non-patient sample of older women (p<0.001). Thus, younger breast cancer survivors are at risk for impaired QoL up to several years after diagnosis [50]. Age is not the only parameter that could influence QoL changes. In postmenopausal women, QoL after tamoxifen or exemestane administration is generally good and stable over a period of 2 years follow-up [54]. In our study, the type of endocrine therapy after BCS did not influence the QoL profiles changes. Conversely, Pandey et al. [55] reported that changes of QoL are observed after initial surgery with a significant decrease of scores after total mastectomy with or without endocrine therapy [53], [55]. In conclusion, to our knowledge, this is the first study since the initial FDA clinical study showing the feasibility of MammoSite brachytherapy procedure following an open cavity technique as a sole therapy in highly selected patients older than 60 years. This is also the first report on QoL during and after APBI using HDR brachytherapy with a MammoSite device. In addition, a rigorous selection and evaluation of such technique in a homogeneous population is essential. We recently addressed such issue [56] in a letter to editor regarding Niehoff et al. report [37] in which heterogeneous selection of patients and treatments resulted in a decrease of cosmetic results. Thus, we believe that, as for all innovations, any haphazard evaluation may induce doubts compromising the destiny of a technique that might be optimally applied in many patients. Acknowledgements The authors knowledge Carol Wernecke and Cytyc Corporation for supporting this study. We also thank John Mabie (Synergos Inc., USA) for statistical assistance and Yvette Vendel for handling data and monitoring. We also thank Veronique Cheval for her excellent assistance in the planning and during brachytherapy procedure. References [1]. [1]Hughes KS, Schnaper LA, Berry D, et al.Radiation Therapy Oncology Group; Eastern Cooperative Oncology Group Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. N Engl J Med. 2004;351:971–977.
CrossRef
[2]. [2]Fyles AW, McCready DR, Manchul LA, et al. Tamoxifen with or without breast irradiation in women 50 years of age or older with early breast cancer. N Engl J Med. 2004;351:963–970.
CrossRef
[3]. [3]Ballard-Barbash R, Potosky AL, Harlan LC, Nayfield SG, Kessler LG. Factors associated with surgical and radiation therapy for early stage breast cancer in older women. J Natl Cancer Inst. 1996;88:716–726. MEDLINE |
CrossRef
[4]. [4]King TA, Bolton JS, Kuske RR, Fuhrman GM, Scroggins TG, Jiang XZ. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T(is,1,2) breast cancer. Am J Surg. 2000;180:299–304. Abstract | Full Text |
Full-Text PDF (171 KB)
|
CrossRef
[5]. [5]Fentiman I, Poole C, Tong D, et al. Inadequacy of iridium implant as sole radiation treatment for operable breast cancer. Eur J Cancer. 1996;32:417–420. Abstract |
Full-Text PDF (370 KB)
|
CrossRef
[6]. [6]Cionini L, Pacini P, Marzano S, et al. Exclusive brachytherapy after conservative surgery in cancer of the breast. Lyon Chir. 1993;89:128;. [7]. [7]Krishnan L, Jewell WR, Tawfik OW, Krishnan EC. Breast conservation therapy with tumor bed irradiation alone in a selected group of patients with stage I breast cancer. Breast J. 2001;7:91–96.
CrossRef
[8]. [8]Vicini FA, Baglan KL, Kestin LL, et al. Accelerated treatment of breast cancer. J Clin Oncol. 2001;19:1993–2001. [9]. [9]Clarke DH, Vicini F, Jacobs H, et al. High dose rate brachytherapy for breast cancer. In: Armonk NS editors. High dose rate brachytherapy: a textbook. New York: Futura Publishing; 1994;. [10]. [10]Polgar C, Major T, Fodor J, et al. High-dose brachytherapy alone versus whole breast radiotherapy with or without tumor bed boost after breast-conserving: seven year results of a comparative study. Int J Radiat Oncol Biol Phys. 2004;60:1173–1181. Abstract | Full Text |
Full-Text PDF (135 KB)
|
CrossRef
[11]. [11]Perera F, Engel J, Holliday R, et al. Local resection and brachytherapy confined to the lumpectomy site for early breast cancer: a pilot study. J Surg Oncol. 1997;65:263–267. MEDLINE |
CrossRef
[12]. [12]Ott OJ, Pötter R, Hammer J, et al. Accelerated partial breast irradiation with iridium-192 multicatheter PDR/HDR brachytherapy: preliminary results of the German-Austrian multicenter trial. Strahlenther Onkol. 2004;180:642–649. MEDLINE |
CrossRef
[13]. [13]Keisch M, Vicini F, Kuske RR, et al. Initial clinical experience with the mammosite breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys. 2003;55:289–293. Abstract | Full Text |
Full-Text PDF (87 KB)
|
CrossRef
[14]. [14]Wazer DE, Kaufman S, Cuttino L, DiPetrillo T, Arthur DW. Accelerated partial breast irradiation: analysis of the variables associated with late toxicity and long-term cosmetic outcome after high-dose rate interstitial brachytherapy. Int J Radiat Oncol Biol Phys. 2006;64:489–495. Abstract | Full Text |
Full-Text PDF (106 KB)
|
CrossRef
[15]. [15]Kuske RR, Winter K, Arthur DW, et al. Phase II trial brachytherapy alone after lumpectomy for select breast cancer: toxicity analysis of RTOG 95–17. Int J Radiat Oncol Biol Phys. 2006;65:45–51. Abstract | Full Text |
Full-Text PDF (95 KB)
|
CrossRef
[16]. [16]Chen PY, Vicini FA, Benitez P, et al. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for treatment of early-stage breast carcinoma. Cancer. 2006;106:991–999. [17]. [17]Formenti SC, Rosenstein B, Skinner KA, Jozsef G. T1 stage breast cancer: adjuvant hypofractionated conformal radiation therapy to tumor bed in selected postmenopausal breast cancer patients-pilot feasibility study. Radiology. 2002;222:171–178. MEDLINE |
CrossRef
[18]. [18]Vicini FA, Remouchamps V, Wallace M, et al. Ongoing clinical experience utilizing 3D conformal external beam radiotherapy to deliver partial-breast irradiation in patients with early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys. 2003;57:1247–1253. Abstract | Full Text |
Full-Text PDF (406 KB)
|
CrossRef
[19]. [19]Baglan KL, Sharpe MB, Jaffray D, et al. Partial breast irradiation using 3D conformal radiation therapy (3D-CRT). Int J Radiat Oncol Biol Phys. 2003;55:302–311. Abstract | Full Text |
Full-Text PDF (266 KB)
|
CrossRef
[20]. [20]Vicini F, Winter K, Straube W, et al. A phase I/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for stage I/II breast carcinoma: initial report of faisibility and reproducibility of radiation therapy oncology group study (RTOG) 0139. Int J Radiat Oncol Biol Phys. 2005;63:1531–1537. Abstract | Full Text |
Full-Text PDF (142 KB)
|
CrossRef
[21]. [21]Taghian AG, Kozak KR, Adams J, et al. Accelerated partial breast irradiation (APBI) using protons for patients with early-stage breast cancer: a comparison to 3D conformal photon/electrons based treatment. Proc Int J Radiat Oncol Biol. 2005;63:15;. [22]. [22]Veronesi U, Orecchia R, Luini A, et al. A preliminary report of intraoperative radiotherapy (IORT) in limited-stage breast cancers that are conservatively treated. Eur J Cancer. 2001;37:2178–2183. Abstract | Full Text |
Full-Text PDF (191 KB)
|
CrossRef
[23]. [23]Vaidya JS, Baum M, Tobias JS, et al. Targeted intra-operative radiotherapy (Targit): an innovative method of treatment for early breast cancer. Ann Oncol. 2001;12:1075–1080. MEDLINE |
CrossRef
[24]. [24]Vaidya JS, Baum M, Tobias JS, Morgan S, D’Souza D. The novel technique of delivering targeted intraoperative radiotherapy (Targit) for early breast cancer. EJSO. 2002;28:447–454. Abstract |
Full-Text PDF (2537 KB)
|
CrossRef
[25]. [25]Fentiman IS, Poole C, Tong D, et al. Iridium implant treatment without external radiotherapy for operable breast cancer: a pilot study. Eur J Cancer. 1991;27:447–450. MEDLINE [26]. [26]Poti Z, Nemeskeri C, Fekeshazy A, et al. Partial breast irradiation with interstitial 60CO brachytherapy results in frequent grade 3 or 4 toxicity. Evidence based on a 12-year follow-up of 70 patients. Int J Radiat Oncol Biol Phys. 2004;58:1022–1033. Abstract | Full Text |
Full-Text PDF (282 KB)
|
CrossRef
[27]. [27]Trotti A, Colevas AD, Setser A, et al. CTCAEv3.0: development of a comprehensive grading for the adverse effects of cancer treatment. Sem Radiat Oncol. 2003;13:176–181. [28]. [28]Olivotto IA, Rose MA, Osteen RT, et al. Late cosmetic outcome after conservative surgery and radiotherapy: analysis of causes of cosmetic failure. Int J Radiat Oncol Biol Phys. 1989;17:747–753. MEDLINE |
CrossRef
[29]. [29]Brady MJ, Cella DF, Mo F, et al. Reliability and validity of the functional assessement of cancer therapy-breast quality-of-life instrument. J Clin Oncol. 1997;14:974–986. [30]. [30]Gittleman M, Vigneri , Carlson DJ, et al. Clinical evaluation of the MammoSite breast brachytherapy: an analysis of technical reproducibility, acute toxicity and patients demographics. Int J Radiat Oncol Biol Phys. 2003;57:S365–S366. Full Text |
Full-Text PDF (70 KB)
|
CrossRef
[31]. [31]Zannis JJ, Walker LC, Barclay-Wite B, Quiet CA. Post-operative ultra-sound-guided percutaneous placement of a new breast balloon catheter. Am J Surg. 2003;186:383–385. Abstract | Full Text |
Full-Text PDF (180 KB)
|
CrossRef
[32]. [32]Richards GM, Berson AM, Rescigno J, et al. Acute toxicity of high-dose intracavitary brachytherapy with mammosite applicator in patients with early-stage breast cancer. Ann Surg Oncol. 2004;11:739–746. MEDLINE |
CrossRef
[33]. [33]Dowlatshahi K, Snider HC, Gittleman MA, et al. Early experience with balloon brachytherapy for breast cancer. Arch Surg. 2004;139:603–608. MEDLINE |
CrossRef
[34]. [34]Zannis V, Beitsch P, Vicini F, et al. Descriptions and outcomes of insertion techniques of a breast brachytherapy balloon catheter in 1403 patients enrolled in the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Am J Surg. 2005;190:530–538. Abstract | Full Text |
Full-Text PDF (347 KB)
|
CrossRef
[35]. [35]Shah NM, Wazer DE. The MammoSite balloon brachytherapy catheter for accelerated partial breast irradiation. Sem Radiat Oncol. 2005;15:100–107. [36]. [36]Shah NM, Tenenholz T, DiPetrillo T, et al. Initial cosmesis and toxicity with MammoSite brachytherapy for partial-breast irradiation in breast-conserving therapy for women with early-stage breast cancer. Brachytherapy. 2003;2:60–62.
Full-Text PDF (72 KB)
|
CrossRef
[37]. [37]Niehoff P, Polgar C, Ostertag H, et al. Clinical experience with the MammoSite radiation therapy system for brachytherapy of breast cancer: results from an international phase II trial. Radiother Oncol. 2006;79:316–320. Abstract | Full Text |
Full-Text PDF (142 KB)
|
CrossRef
[38]. [38]Tsai PI, Ryan M, Meek K, et al. Accelerated partial breast irradiation using the MammoSite device: early technical experience and short-term clinical follow-up. Am Surg. 2006;72:929–934. MEDLINE [39]. [39]Martelli G, Boracchi P, De Palo M, et al. A randomized trial comparing axillary dissection to no axillary dissection in older patients with T1N0 breast cancer: results after 5 years of follow-up. Ann Surg. 2005;242:1–6. MEDLINE |
CrossRef
[40]. [40]Pawlick TM, Perry A, Strom EA, et al. Potential applicability of balloon catheter-based accelerated partial breast irradiation after conservative surgery for breast carcinoma. Cancer. 2004;100:490–498. [41]. [41]Harper J, Jenrette JM, Vanek KN, Aguero EG, Gillanders WE. Acute complications of MammoSite brachytherapy: a single institution initial clinical experience. Int J Radiat Oncol Biol Phys. 2005;61:169–174. Abstract | Full Text |
Full-Text PDF (171 KB)
|
CrossRef
[42]. [42]Vicini FA, Beitsch P, Quiet C, et al. First analysis of patient demographics and technical reproducibility, cosmesis, and early toxicity: results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial. Cancer. 2005;104:1138–1148. [43]. [43]Stolier AJ, Fuhrman GM, Scroggins TG, Boyer CI. Post lumpectomy insertion of the MammoSite brachytherapy device using the scare entry technique: initial experience and technical considerations. Breast J. 2005;11:199–203.
CrossRef
[44]. [44]Dickler A, Kirk MC, Choo J, et al. Cosmetic outcome and incidence of infection with the MammoSite breast brachytherapy applicator. Breast J. 2005;11:303–305.
CrossRef
[45]. [45]Agrawal A, Beriwal S, Heron D, et al. Accelerated partial breast irradiation: single institutional experience of 100 patients using MammoSite brachytherapy. Proc Int J Radiat Oncol Biol. 2005;63:11;. [46]. [46]Evans SB, Kaufman SA, Price LL, Cardarelli G, Dipetrillo TA, Wazer DE. Persistent seroma after intraoperative placement of MammoSite for accelerated partial breast irradiation: incidence, pathologic anatomy, and contributing factors. Int J Radiat Biol Phys. 2006;65:333–339. [47]. [47]Keisch M, Vicini F, Scroggins T, et al. Thirty-nine month results with the MammoSite brachytherapy applicator: details regarding cosmesis, toxicity and local control in partial breast irradiation. Proc Int J Radiat Oncol Biol. 2005;63:10;. [48]. [48]Turreson I. Individual variation and dose dependency in the progression rate of skin teleangiectasia. Int J Radiat Oncol Biol Phys. 1990;19:1569–1574. MEDLINE |
CrossRef
[49]. [49]Pandey M, Thomas BC, SreeRekha P, et al. Quality of life determinants in women with breast cancer undergoing curative intent. World J Surg Oncol. 2005;3:63–70. [50]. [50]Avis NE, Crawford S, Manuel J. Quality of life among younger women with breast cancer. J Clin Oncol. 2005;23:3322–3330.
CrossRef
[51]. [51]Ganz PA, Rowland JH, Desmond K, Meyerowitz BE, Wyatt GE. Life after breast cancer: understanding women’s health-related quality of life and sexual functioning. J Clin Oncol. 1998;16:501–514. [52]. [52]Vinokur AD, Threatt BA, Vinokur-Kaplan D, Satariano WA. The process of recovery from breast cancer for young and older patients: changes during the first year. Cancer. 1990;65:1242–1254. [53]. [53]Levy SM, Haynes LT, Herberman RB, Lee J, McFeeley S, Kirkwood J. Mastectomy versus breast conservation surgery: mental health effects on long-term follow-up. Health Psychol. 1992;11:349–354. MEDLINE |
CrossRef
[54]. [54]Fallowfield LJ, Bliss JM, Porter LS, et al. Quality of life in the intergroup exemestane study: a randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in post menopausal women with primary breast cancer. J Clin Oncol. 2006;24:910–917.
CrossRef
[55]. [55]Pandey M, Thomas BC, Ramdas K, Ratheesan K. Early effect of surgery on quality of life in women with operable breast cancer. Jpn J Clin Oncol. 2006;36:468–472. MEDLINE |
CrossRef
[56]. [56]Belkacemi Y, Vicini F. High-dose brachytherapy using MammoSite applicator: “our doubts are traitors, and makes us lose the good we oft might win, by fearing to attempt!. Radiother Oncol. 2006;82:354–355. Full Text |
Full-Text PDF (45 KB)
|
CrossRef
a Department of Radiation Oncology, Oscar Lambret Anti-Cancer Center, Cedex, France b Breast Cancer Unit, Oscar Lambret Center, Cedex, France c Department of Radiology, Oscar Lambret Center, Cedex, France d Department of Pathology, Oscar Lambret Center, Lille, France e Lille II University, Lille, France  Corresponding author. Department of Radiation Oncology, Henri Mondor Hospital, 51 av Marchal de Lattre de Tassigny, 94000 Créteil, France.
PII: S0167-8140(08)00329-0 doi:10.1016/j.radonc.2008.06.004 © 2008 Elsevier Ireland Ltd. All rights reserved. | |
|
FULL TEXT
