Thomas Kearney

Fibrin sealant reduces the duration and amount of fluid drainage after axillary dissection: a randomized prospective clinical trial.

BACKGROUND Patients who have axillary dissections during lumpectomy or modified radical mastectomy for breast carcinoma accumulate serosanguinous fluid, potentially resulting in a seroma. Currently accepted practice includes insertion of one or more drains for fluid evacuation. This multicenter, randomized, controlled, phase II study was undertaken to evaluate whether a virally inactivated, investigational fibrin sealant is safe and effective when used as a sealing agent to reduce the duration and volume of serosanguinous fluid drainage and to determine the dose response of this effect. STUDY DESIGN Patients undergoing lumpectomy or modified radical mastectomy were randomized to treatment with 4, 8, or 16 mL of fibrin sealant or control (no agent) at the axillary dissections site. Patients undergoing modified radical mastectomy also received an additional 4 or 8 mL of fibrin sealant at the skin flap site. Efficacy was evaluated by the number of days required for wound drainage and the volume of fluid drainage compared with control. Safety was confirmed by clinical course, the absence of viral seroconversion, and no major complications attributable to the sealant. RESULTS The 4-mL axillary dissection dose of fibrin sealant significantly reduced the duration and quantity of fluid drainage from the axilla following lumpectomy (p < or = 0.05). In the modified radical mastectomy patients, a 16-mL axillary dissection dose combined with an 8-mL skin flap dose was significantly effective in reducing the number of days to drain removal (p < or = 0.05) and fluid drainage (p < or = 0.01). There were no fibrin sealant patient viral seroconversions and no major complications attributable to the sealant. A number of wound infections were noted, although this may represent a center-specific effect. CONCLUSIONS Application of fibrin sealant following axillary dissection at the time of lumpectomy or modified radical mastectomy can significantly decrease the duration and quantity of serosanguinous drainage. The viral safety of the product was also supported.

Improvement in Interobserver Accuracy in Delineation of the Lumpectomy Cavity Using Fiducial Markers

PURPOSE To determine, whether the presence of gold fiducial markers would improve the inter- and intraphysician accuracy in the delineation of the surgical cavity compared with a matched group of patients who did not receive gold fiducial markers in the setting of accelerated partial-breast irradiation (APBI). METHODS AND MATERIALS Planning CT images of 22 lumpectomy cavities were reviewed in a cohort of 22 patients; 11 patients received four to six gold fiducial markers placed at the time of surgery. Three physicians categorized the seroma cavity according to cavity visualization score criteria and delineated each of the 22 seroma cavities and the clinical target volume. Distance between centers of mass, percentage overlap, and average surface distance for all patients were assessed. RESULTS The mean seroma volume was 36.9 cm(3) and 34.2 cm(3) for fiducial patients and non-fiducial patients, respectively (p = ns). Fiducial markers improved the mean cavity visualization score, to 3.6 ± 1.0 from 2.5 ± 1.3 (p < 0.05). The mean distance between centers of mass, average surface distance, and percentage overlap for the seroma and clinical target volume were significantly improved in the fiducial marker patients as compared with the non-fiducial marker patients (p < 0.001). CONCLUSIONS The placement of gold fiducial markers placed at the time of lumpectomy improves interphysician identification and delineation of the seroma cavity and clinical target volume. This has implications in radiotherapy treatment planning for accelerated partial-breast irradiation and for boost after whole-breast irradiation.

Consultations Between Patients With Breast Cancer and Surgeons: A Pathway From Patient-Centered Communication to Reduced Hopelessness

PURPOSE Patient-centered communication (PCC) affects psychosocial health outcomes of patients. However, these effects are rarely direct, and our understanding of such effects are largely based on self-report (v observational) data. More information is needed on the pathways by which concrete PCC behaviors affect specific psychosocial outcomes in cancer care. We hypothesized that PCC behaviors increase the satisfaction of patients with surgeons, which, in turn, reduces the postconsultation hopelessness of patients. PATIENTS AND METHODS In Portland, OR, we videotaped consultations between 147 women newly diagnosed with breast cancer and nine surgeons and administered surveys to participants immediately preconsultation and postconsultation. Consultations were coded for PCC behaviors. Multivariate regression models analyzed the association between PCC and the satisfaction of patients and between satisfaction and hopelessness. RESULTS Levels of hopelessness of patients significantly decreased from preconsultation to postconsultation (P < .001). Two PCC behaviors (ie, patient asserting treatment preference [odds ratio {OR}, 1.50/log unit; 95% CI, 1.01 to 2.23/log unit; P = .042] and surgeon providing good/hopeful news [OR, 1.62/log unit; 95% CI, 1.01 to 2.60/log unit; P = .047]) were independently significantly associated with the satisfaction of patients with surgeons, which, in turn, independently predicted reduced levels of postconsultation hopelessness (linear change, -0.78; 95% CI, 1.44 to -0.12; P = .02). CONCLUSION Although additional research is needed with larger and more-diverse data sets, these findings suggest the possibility that concrete and trainable PCC behaviors can lower the hopelessness of patients with breast cancer indirectly through their effects on patient satisfaction with care.

Hypofractionated Postmastectomy Radiation Therapy Is Safe and Effective: First Results From a Prospective Phase II Trial.

Purpose Conventionally fractionated postmastectomy radiation therapy (PMRT) takes approximately 5 to 6 weeks. Data supporting hypofractionated PMRT is limited. We prospectively evaluated a short course of hypofractionated PMRT, in which therapy was completed in 15 treatment days. Patients and Methods We delivered PMRT at a dose of 36.63 Gy in 11 fractions of 3.33 Gy over 11 days to the chest wall and the draining regional lymph nodes, followed by an optional mastectomy scar boost of four fractions of 3.33 Gy. Our primary end point was freedom from any grade 3 or higher toxicities. We incorporated early stopping criteria on the basis of predefined toxicity thresholds. Results We enrolled 69 women with stage II to IIIa breast cancer, of whom 67 were eligible for analysis. After a median follow-up of 32 months, there were no grade 3 toxicities. There were 29 reported grade 2 toxicities, with grade 2 skin toxicities being the most frequent (16 of 67; 24%). There were two patients with isolated ipsilateral chest wall tumor recurrences (2 of 67; crude rate, 3%). Three-year estimated local recurrence-free survival was 89.2% (95% CI, 0.748 to 0.956). The 3-year estimated distant recurrence-free survival was 90.3% (95% CI, 0.797 to 0.956). Forty-one patients had chest wall reconstructions; three had expanders removed for infection before radiation therapy. The total rate of implant loss or failure was 24% (9 of 38), and the unplanned surgical correction rate was 8% (3 of 38), for a total complication rate of 32%. Conclusion To our knowledge, our phase II prospective study offers one of the shortest courses of PMRT reported, delivered in 11 fractions to the chest wall and nodes and 15 fractions inclusive of a boost. We demonstrated low toxicity and high local control with this schedule. On the basis of our data, we have designed a cooperative group phase III prospective, randomized trial of conventional versus hypofractionated PMRT that will activate soon.

Short-Course Hypofractionated Radiation Therapy With Boost in Women With Stages 0 to IIIa Breast Cancer: A Phase 2 Trial

PURPOSE Conventionally fractionated whole-breast irradiation (WBI) with a boost takes approximately 6 to 7 weeks. We evaluated a short course of hypofractionated (HF), accelerated WBI in which therapy was completed in 3 weeks inclusive of a sequential boost. METHODS AND MATERIALS We delivered a whole-breast dose of 36.63 Gy in 11 fractions of 3.33 Gy over 11 days, followed by a lumpectomy bed boost in 4 fractions of 3.33 Gy delivered once daily for a total of 15 treatment days. Acute toxicities were scored using Common Terminology Criteria for Adverse Events version 4. Late toxicities were scored using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scale. Cosmesis was scored using the Harvard Cosmesis Scale. Our primary endpoint was freedom from locoregional failure; we incorporated early stopping criteria based on predefined toxicity thresholds. Cosmesis was examined as a secondary endpoint. RESULTS We enrolled 83 women with stages 0 to IIIa breast cancer. After a median follow-up of 40 months, 2 cases of isolated ipsilateral breast tumor recurrence occurred (2 of 83; crude rate, 2.4%). Three-year estimated local recurrence-free survival was 95.9% (95% confidence interval [CI]: 87.8%-98.7%). The 3-year estimated distant recurrence-free survival was 97.3% (95% CI: 89.8%-99.3%). Three-year secondary malignancy-free survival was 94.3% (95% CI: 85.3%-97.8%). Twenty-nine patients (34%) had grade 2 acute toxicity, and 1 patient had a late grade 2 toxicity (fibrosis). One patient had acute grade 3 dermatitis, whereas 2 patients experienced grade 3 late skin toxicity. Ninety-four percent of evaluable patients had good or excellent cosmesis. CONCLUSIONS Our phase 2 institutional study offers one of the shortest courses of HF therapy, delivered in 15 fractions inclusive of a sequential boost. We demonstrated expected low toxicity and high local control rates with good to excellent cosmetic outcomes. This fractionation scheme is feasible and well tolerated and offers women WBI in a highly convenient schedule.

Has placement of surgical clips in the lumpectomy bed fallen out of favor

Surgical clips were originally developed in the early 1900s, and initially utilized for hemostasis in intracranial operations. Since then, the clinical applications of surgical clips have broadened to include procedures across all surgical disciplines. In oncologic procedures, surgeons may place clips in the cavity of a tumor bed for a myriad of reasons, with the most common being to control hemostasis; other uses include placement to mark extent of dissection, denote anatomic location during a future operation or for accuracy of postoperative imaging. Another value of surgical clips is technical efficiency, which may allow for decreased operative time. In reality, appreciation for surgical clip application extends beyond the surgical theater. Just as surgeons rely on percutaneously placed clips to target a nonpalpable lesion for wire localization, radiation oncologists rely on clips in the tumor bed to accurately delineate the surgical cavity, as postoperative changes on computed tomography (CT) scans may be difficult to visualize. Typically, surgical clips are made of titanium or steel, both of which are radio opaque and can be visualized on plain film or CT scans. In early-stage breast cancer, clips placed in the surgical bed at time of definitive surgical resection have traditionally been used by radiation oncologists to direct the boost treatment after whole-breast irradiation. More recently, however, with the advent of accelerated partial-breast irradiation (APBI) using external-beam radiation therapy, detection and delineation of the surgical cavity are of even greater importance, given the large radiotherapy fraction doses delivered over a short period of time. Accurate delineation of lumpectomy cavity target volumes by relying on seroma formation or location of lumpectomy incision has been shown to be largely inaccurate. The seroma is a postoperative serous fluid accumulation and is sometimes used to estimate the lumpectomy cavity borders when no metallic marker is present. Seroma formation after lumpectomy, however, is variable, making it difficult to assess the true cavity borders accurately. The lumpectomy incision scar has also been used in an effort to define lumpectomy borders, but accuracy in this technique has also been unsuccessful. In a small, prospective series by Krawczyk and colleagues, measurement from lumpectomy scar to breast tissue border was found to be an inadequate prediction tool for radiation planning. In fact, relying on the lumpectomy scar may result in a significant risk of underdosing of the lumpectomy cavity. From a radiation oncologist perspective, it may be best for clips to be placed along all margins of a cavity to improve targeted radiation therapy. In fact, published data from our group suggest that directed placement of fiducial markers on the walls of the surgical cavity allowed for improved interphysician accuracy in delineation of the lumpectomy cavity. However, in many centers, including ours, surgical clip placement is left to surgeon discretion. To our knowledge, no standard recommendation for clip placement exists, and patterns of variation have prompted discussion amongst radiation oncologist and breast surgical oncologist at our institution. Multiple studies over the past 10–20 years have evaluated the clinical importance of surgical clip placement in radiotherapy planning. In 2008, Coles et al. performed an audit of titanium clip placement utilized in the Society of Surgical Oncology 2011

Breast-Cancer Patients’ Participation Behavior and Coping During Presurgical Consultations: A Pilot Study

In the context of breast-cancer care, there is extremely little research on the association between observed (i.e., taped and coded) communication behaviors and patients’ health outcomes, especially those other than satisfaction. In the context of presurgical consultations between female breast cancer patients and a surgeon, the aim of this exploratory study was to test the association between communication-based participation behaviors and pre–post consultation changes in aspects of patients’ mental adjustment to cancer (i.e., coping). Participants included 51 women newly diagnosed with breast cancer and a surgical oncologist from a National Cancer Institute (NCI)-designated cancer center in the northeastern United States. Outcomes were changes in patients’ fighting spirit, helplessness/hopelessness, anxious preoccupation, cognitive avoidance, and fatalism (measured immediately before and after consultations via survey), and the main predictors were three communication-based participation behaviors coded from videotapes of consultations: patient question asking, patient assertion of treatment preferences, and surgeon solicitation of patient question/concern/opinion. Patients who more frequently asserted their treatment preferences experienced increases in their fighting spirit (p = .01) and decreases in their anxious preoccupation (p = .02). When companions (e.g., sister, spouse) asked more questions, patients experienced decreases in their anxious preoccupation (p = .05). These findings suggest that, in the present context, there may be specific, trainable communication behaviors, such as patients asserting their treatment preferences and companions asking questions, that may improve patients’ psychosocial health outcomes.

Tracking the dynamic seroma cavity using fiducial markers in patients treated with accelerated partial breast irradiation using 3D conformal radiotherapy

PURPOSE The purpose of the present study was to perform an analysis of the changes in the dynamic seroma cavity based on fiducial markers in early stage breast cancer patients treated with accelerated partial breast irradiation (APBI) using three-dimensional conformal external beam radiotherapy (3D-CRT). METHODS A prospective, single arm trial was designed to investigate the utility of gold fiducial markers in image guided APBI using 3D-CRT. At the time of lumpectomy, four to six suture-type gold fiducial markers were sutured to the walls of the cavity. Patients were treated with a fractionation scheme consisting of 15 fractions with a fractional dose of 333 cGy. Treatment design and planning followed NSABP∕RTOG B-39 guidelines. During radiation treatment, daily kV imaging was performed and the markers were localized and tracked. The change in distance between fiducial markers was analyzed based on the planning CT and daily kV images. RESULTS Thirty-four patients were simulated at an average of 28 days after surgery, and started the treatment on an average of 39 days after surgery. The average intermarker distance (AiMD) between fiducial markers was strongly correlated to seroma volume. The average reduction in AiMD was 19.1% (range 0.0%-41.4%) and 10.8% (range 0.0%-35.6%) for all the patients between simulation and completion of radiotherapy, and between simulation and beginning of radiotherapy, respectively. The change of AiMD fits an exponential function with a half-life of seroma shrinkage. The average half-life for seroma shrinkage was 15 days. After accounting for the reduction which started to occur after surgery through CT simulation and treatment, radiation was found to have minimal impact on the distance change over the treatment course. CONCLUSIONS Using the marker distance change as a surrogate for seroma volume, it appears that the seroma cavity experiences an exponential reduction in size. The change in seroma size has implications in the size of the CTV, PTV, and percent of normal breast tissue irradiated when using 3D-CRT.

Breast cancer patients' information seeking during surgical consultations: A qualitative, videotape-based analysis of patients' questions.

Despite data on breast cancer patients’ information needs and their association with patient outcomes, there are currently no data on what U.S. patients actually ask surgeons during primary consultations.

Oncoplastic breast surgery in the setting of breast-conserving therapy: A systematic review

Breast-conserving therapy (BCT), or breast-conserving surgery with adjuvant radiation therapy, has become a standard treatment alternative to mastectomy for women with early-stage breast cancer after many long-term studies have reported comparable rates of overall survival and local control. Oncoplastic breast surgery in the setting of BCT consists of various techniques that allow for an excision with a wider margin and a simultaneous enhancement of cosmetic sequelae, making it an ideal breast cancer surgery. Because of the parenchymal rearrangement that is routinely involved in oncoplastic techniques, however, the targeted tissue can be relocated, thus posing a challenge to localize the tumor bed for radiation planning. The goals of this systematic review are to address the challenges, outcomes, and cosmesis of oncoplastic breast surgery in the setting of BCT.