Amy R. Quillo

Readmission rates after abdominal surgery: the role of surgeon, primary caregiver, home health, and subacute rehab.

Objective:To prospectively evaluate predictive factors of hospital readmission rates in patients undergoing abdominal surgical procedures. Background:Recommendations from MedPAC that the Centers for Medicare and Medicaid Services (CMS) report upon and determine payments based in part on readmission rates have led to an attendant interest by payers, hospital administrators and far-sighted physicians. Methods:Analysis of 266 prospective treated patients undergoing major abdominal surgical procedures from September 2009 to September 2010. All patients were prospectively evaluated for underlying comorbidities, number of preop meds, surgical procedure, incision type, complications, presence or absence of primary and/or secondary caregiver, their education level, discharge number of medications, and discharge location. Univariate and multivariate analyses were performed. Results:Two hundred twenty-six patients were reviewed with 48 (18%) gastric-esophageal, 39(14%) gastrointestinal, 88 (34%) liver, 58 (22%) pancreas, and 33 (12%) other. Seventy-eight (30%) were readmitted for various diagnoses the most common being dehydration (26%). Certain preoperative and intraoperative factors were not found to be significant for readmission being, comorbidities, diagnosis, number of preoperative medications, patient education level, type of operation, blood loss, and complications. Significant predictive factors for readmission were age (≥69 years), number of discharged (DC) meds (≥9 medications), ⩽50% oral intake (52% vs. 23%), and DC home with a home health agency (62% vs. 11%) Conclusion:Readmission rates for surgeons WILL become a quality indicator of performance. Quality parameters among Home Health agencies are nonexistent, but will reflect on surgeons performance. Greater awareness regarding predictors of readmission rates is necessary to demonstrate improved surgical quality.

A Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation: First Report of Acute Toxicity, Feasibility, and Patient Satisfaction

PURPOSE To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS). METHODS AND MATERIALS Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23). RESULTS Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity-pain requiring a course of narcotic analgesics-was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period. CONCLUSIONS The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes.

Delay of adjuvant chemotherapy after elective mastectomy and immediate reconstruction in breast-conservation candidates: a matched-pair analysis.

Objectives:To analyze factors that influence the timing of adjuvant chemotherapy in patients who are candidates for breast-conservation therapy (BCT) but elect mastectomy with immediate reconstruction (M-IR). Methods:We identified 35 consecutively treated patients with stage I or II breast cancer between 2004 and 2009 who underwent M-IR and adjuvant chemotherapy from the University of Louisville Cancer Registry. We matched these patients for age and AJCC stage to 35 controls who underwent BCT and adjuvant chemotherapy. We examined the timing and delay of initiation of chemotherapy using univariate logistic regression and McNemar test for matched pairs. Results:For the 70 patients evaluated, the median age was 46 years (range, 30 to 65 y), and the distribution for stage I, IIA, and IIB was 22.9%, 65.7%, and 11.4%, respectively. The 2 groups were well balanced in terms of race, rural/urban status, smoking, diabetes, insurance coverage, and histology. For BCT and M-IR, the median time to chemotherapy initiation was 38 days (range, 25 to 103 d) and 55 days (range, 30 to 165 d), respectively. Patients undergoing M-IR were more likely to experience any delay (>45 d; 54.3% vs. 22.9%; P<0.001) and/or significant delay (>90 d; 20.0% vs. 2.9%; P<0.001). On univariate logistic regression analysis, surgery type had a major impact on delay of chemotherapy (odds ratio=8.35; 95% confidence interval, 2.86-24.4; P<0.001). Conclusions:The use of M-IR in breast-conservation candidates independently predicts for delay in initiation of adjuvant chemotherapy. Further study is needed to qualify the causes and clinical significance of these delays.

Unique prognostic factors in acral lentiginous melanoma

BACKGROUND This study was performed to identify clinicopathologic factors associated with survival in acral lentiginous melanoma. METHODS A post hoc analysis of a prospective clinical trial and local database was performed in all patients with acral lentiginous melanomas. Multivariate analyses of factors associated with a tumor-positive sentinel lymph node (SLN) biopsy, disease-free survival (DFS), overall survival (OS), and local and in-transit recurrence-free survival (LITRFS) were performed. Kaplan-Meier survival analyses were performed. RESULTS Eighty-five patients were identified. Age younger than 59 years and Breslow thickness (BT) of 2.0 mm or greater were independent risk factors for a positive SLN. SLN status was the only independent risk factor for DFS and LITRFS on multivariate analysis. A BT of 2.0 mm or greater was the only independent risk factor for OS. SLN status distinguished differences in DFS, OS, and LITRFS on Kaplan-Meier analysis. CONCLUSIONS SLN status is the dominant factor for recurrence and survival in acral lentiginous melanoma. BT and ulceration are less important in this histologic subtype.

Occult metastases in node-negative breast cancer: A Surveillance, Epidemiology, and End Results-based analysis.

INTRODUCTION The role of immunohistochemistry (IHC) for detecting occult lymph node disease in patients initially found to be node-negative by routine pathology is controversial. In this study, we evaluated trends associated with overall survival in node-negative breast cancer patients staged by IHC. METHODS The Surveillance, Epidemiology, and End Results database was queried for all patients with invasive breast adenocarcinoma and negative lymph nodes on routine pathology between 2004 and 2011 who underwent IHC to evaluate for occult nodal disease. Overall survival stratified by N-stage was compared with Kaplan-Meier analysis. Multivariate analysis was performed using a Cox proportional hazards model. RESULTS Overall, 93,070 patients were identified, including 4,657 patients with isolated tumor cells (<0.2 mm diameter or <200 cells) and 6,720 patients with micrometastases (0.2-2 mm diameter). Kaplan-Meier curves demonstrated a difference in overall survival across all groups (P < .0001). On multivariate analysis, micrometastases remained an independent predictor for survival compared with IHC-negative patients (hazard ratio 1.40, 95% confidence interval 1.28-1.53), whereas isolated tumor cells were not a significant predictor (hazard ratio 1.05, 95% confidence interval 0.92-1.20). CONCLUSION Patients with occult micrometastases in axillary lymph nodes found via IHC demonstrated a significant overall survival difference, but isolated tumor cells have no prognostic significance.

Outcomes and prognostic factors in nodular melanomas

BACKGROUND The nodular subtype of cutaneous melanoma has a more pronounced vertical phase and less of a radial growth phase compared with other histologic subtypes. This study was performed to determine prognostic factors and outcomes for nodular melanomas. METHODS A post hoc analysis of a prospective clinical trial was performed in all patients with nodular histologic subtype. Univariate and multivariate analyses of factors associated with disease-free survival (DFS), overall survival (OS), and local and in-transit recurrence-free survival (LITRFS) were performed. Kaplan-Meier survival analyses were performed. RESULTS There were 736 patients available for analysis, and 189 (25.7%) were sentinel lymph node (SLN) positive. Breslow thickness of ≥2.3 mm, presence of ulceration, nonextremity tumor location, positive SLN, and non-SLN-positive status were independent risk factors for worse OS and DFS. Kaplan-Meier analysis demonstrated that ulceration predicted worse OS and DFS in all nodular melanoma patients, and in both SLN-positive and -negative subsets. The presence of ulceration and a positive SLN together predicted significantly worse DFS and OS. CONCLUSION The most important risk factors that determine prognosis in nodular melanomas are SLN status and ulceration. The presence of both a positive SLN and ulceration significantly affect DFS and OS, and to a lesser degree LITRFS.

Outcomes and prognostic factors in superficial spreading melanoma

BACKGROUND Prognostic factors and risk factors for positive sentinel lymph node (SLN) biopsy results are important to identify in superficial spreading melanoma (SSM). METHODS A single-center database and a prospective clinical trial database were reviewed for all patients with diagnoses of SSM. Logistic regression, Kaplan-Meier survival analysis, and univariate and multivariate Cox models were used. RESULTS A total of 1,643 patients with SSM were identified. Independent risk factors for positive SLN biopsy results were Breslow thickness (BT) ≥2.0 mm, age <60 years, and presence of ulceration. BT ≥2.0 mm, ulceration, lymphovascular invasion, and positive SLN and positive non-SLN biopsy results were independent risk factors for worse disease-free survival. Independent overall survival risk factors included BT ≥2.0 mm, age ≥60 years, ulceration, nonextremity tumor location, lymphovascular invasion, and positive SLN biopsy results. CONCLUSIONS BT, ulceration, lymphovascular invasion, and SLN and non-SLN status are important risk factors for SSM.

Acute toxicity and early cosmetic outcome in patients treated with multilumen balloon brachytherapy with skin spacing ≤ 7.0 millimeters

Purpose To review institutional experience treating patients who underwent breast conserving surgery and adjuvant accelerated partial breast irradiation with multilumen balloon brachytherapy (MLB) with close skin spacing (≤7 mm). Material and methods Since July 2009, 26 patients with skin spacing ≤ 7.0 mm were treated with breast-conserving therapy and adjuvant MLB brachytherapy. Patients were treated with either the Contura or MammoSite ML catheter to a total dose of 34 Gy in 10 fractions. Patients were assessed for acute toxicity at the completion of treatment and 1-month post treatment. Cosmesis and late toxicity were assessed at three-month intervals thereafter. Results The median age of the patients was 56 years and median follow-up was 9 months. Sixteen patients had skin spacing of 5.0–7.0 mm, 10 with < 5.0 mm (median 5.8). The median percentage of the target (PTV_EVAL) receiving ≥ 95% of the prescription dose was 95.6%. The median volume of PTV_EVAL receiving ≥ 200% of the prescription dose was 6.1 cc. The maximum skin dose was 118.2% (median). The most commonly observed acute toxicity was grade 1-2 dermatitis (65.4%). The rate of post-treatment seroma and infection was 38.5% and 3.8%, respectively. Excellent/good cosmetic outcomes seen at the time of last follow-up was 92.3%. Conclusions MLB brachytherapy is safe and feasible in patients with close skin spacing, with acute toxicity and early cosmesis similar to other published series. These devices may broaden the application of balloon brachytherapy in patients previously excluded from this treatment based on anatomy.

Prognostic factors in melanoma patients with tumor-negative sentinel lymph nodes.

BACKGROUND Sentinel lymph node (SLN) biopsy for melanoma results in accurate nodal staging, which guides treatment decisions. Patients with a negative SLN biopsy in general have a favorable prognosis, but certain subsets are at increased risk for recurrence and death. This study aimed to identify risk factors predictive of prognosis in patients with a tumor-negative SLN biopsy for cutaneous melanoma. METHODS In this post-hoc analysis of data from a multicenter prospective randomized trial, clinicopathologic data of patients with cutaneous melanoma ≥1.0 mm Breslow thickness and tumor-negative SLN were analyzed. Disease-free survival, overall survival (OS), and local and in-transit recurrence-free survival were compared by Kaplan-Meier analysis. Risk factors for worse survival were identified with Cox proportional hazard models. RESULTS This analysis included 1,998 patients with tumor-negative SLN with a median follow-up of 70 months. Ulceration, Breslow thickness, nonextremity tumor location, and age ≥45 years were independent risk factors for worse disease-free survival and OS. Breslow thickness and ulceration were the only factors on multivariate analysis that predicted local and in-transit recurrence-free survival. Estimated 5-year OS rates ranged from 55.5 to 95.4% on the basis of the defined risk factors. CONCLUSION There is a wide range of prognosis among patients with tumor-negative SLN. Breslow thickness, ulceration, age, and anatomic location of the primary melanoma are important independent factors predicting survival and recurrence among such patients. These factors can be used to stratify prognosis among patients with tumor-negative SLN to formulate rational long-term follow-up strategies as well as identify high-risk, SLN-negative patients for clinical trials of adjuvant therapy.

The lymph node ratio has limited prognostic significance in melanoma

BACKGROUND The importance of the lymph node ratio (LNR) after regional lymphadenectomy for cutaneous melanoma is unknown. MATERIALS AND METHODS A post hoc analysis was performed for patients after the completion of lymphadenectomy for cutaneous melanoma. LNR was calculated as the number of tumor-positive nodes divided by the total number of lymph nodes. Comparison of disease-free survival (DFS) and overall survival (OS) and univariate and multivariate analyses with regard to LNR was performed. Comparison of the performance of LNR to other measurements of lymph node disease was performed. RESULTS A LNR of 0.10 was a significant cutoff point for determining DFS and OS. On multivariate analysis, LNR >0.10 was an independent predictor of DFS and OS without other measures of lymph node disease burden. Patients with LNR >0.10 had worse DFS and OS. Absolute counts of tumor-positive lymph nodes differentiated survival differences better than LNR. LNR was not a significant predictor of survival in patients with neck or axillary dissections but was for inguinal dissections. In multivariate analysis of alternative nodal measures, LNR was an inferior prognostic factor. CONCLUSIONS A LNR >0.10 has a negative prognostic significance when it is the only measurement of lymph node disease considered but is an inferior prognostic factor to alternative measures of lymph node disease.