Unrealistic Postsurgical Expectation of Independence Predicts Complex Hospital Discharge.

BACKGROUND: Careful discharge planning for older surgical patients can reduce length of stay, readmission, and cost. We hypothesized that patients who overestimate their self-care ability before surgery are more likely to have complex postoperative discharge planning. MATERIALS AND METHODS: The Vulnerable Elders Surgical Pathways and Outcomes Assessment is a brief preoperative assessment that can identify older (age ≥70) patients with multidimensional geriatric risk, defined by all three of the following: (1) physical or cognitive impairment, (2) living alone, and (3) lack of handicap-accessible home. The Vulnerable Elders Surgical Pathways and Outcomes Assessment also asks a novel postoperative self-care ability question, whether patient can independently provide self-care for several hours after discharge. Classifying patients into four groups based on multidimensional geriatric risk (full versus none or partial) and the self-care ability question (yes or no), we hypothesized those with unrealistic postsurgical expectation of independence (UPSI) (both fully at risk and "yes" to self-care ability question) would be at the increased risk for complex discharge planning. Complex discharge planning was defined as prolonged stay because of nonmedical reasons or multiple changes in discharge plans. RESULTS: In 382 hospitalizations of ≥2 d, 366 had a nonmissing answer to the self-care question; of those 5% had UPSI and 6.3% needed complex discharge planning. The UPSI group was independently associated with greater risk of complex discharge planning compared with the normal group (odds ratio = 4.3 [95% confidence interval, 1.1-16.1]). CONCLUSIONS: Complex discharges were rare, but predictable by preoperative geriatric screening. Patients with UPSI should be targeted for postoperative care planning in advance of surgery.

Addressing Mental Health Needs for Deaf Patients Through an Integrated Health Care Model.

Deaf individuals struggle with accessing mental health services because of language and cultural discordance. Our project's purpose was to design and pilot an accessible, integrated mental health program for the Deaf population, scalable for other health centers interested in serving these individuals. Our team addressed several identified barriers to care. The addition of a language-concordant mental health clinician and telemental health appointments helped us better manage Deaf patients' mental health needs. Individual and clinic level data were collected and analyzed. Results demonstrated a significant improvement in the patients' depression and anxiety scores from their baseline to their last documented visit. Patient satisfaction overall was high. Telemental health appears to be a feasible tool to address some of the mental health gaps in the Deaf community. Further studies are needed to demonstrate how this program can be effective within a larger geographical area.

Primary breast tumor-derived cellular models: characterization of tumorigenic, metastatic, and cancer-associated fibroblasts in dissociated tumor (DT) cultures.

Our goal was to establish primary cultures from dissociation of breast tumors in order to provide cellular models that may better recapitulate breast cancer pathogenesis and the metastatic process. Here, we report the characterization of six cellular models derived from the dissociation of primary breast tumor specimens, referred to as "dissociated tumor (DT) cells." In vitro, DT cells were characterized by proliferation assays, colony formation assays, protein, and gene expression profiling, including PAM50 predictor analysis. In vivo, tumorigenic and metastatic potential of DT cultures was assessed in NOD/SCID and NSG mice. These cellular models differ from recently developed patient-derived xenograft models in that they can be used for both in vitro and in vivo studies. PAM50 predictor analysis showed DT cultures similar to their paired primary tumor and as belonging to the basal and Her2-enriched subtypes. In vivo, three DT cultures are tumorigenic in NOD/SCID and NSG mice, and one of these is metastatic to lymph nodes and lung after orthotopic inoculation into the mammary fat pad, without excision of the primary tumor. Three DT cultures comprised of cancer-associated fibroblasts (CAFs) were isolated from luminal A, Her2-enriched, and basal primary tumors. Among the DT cells are those that are tumorigenic and metastatic in immunosuppressed mice, offering novel cellular models of ER-negative breast cancer subtypes. A group of CAFs provide tumor subtype-specific components of the tumor microenvironment (TME). Altogether, these DT cultures provide closer-to-primary cellular models for the study of breast cancer pathogenesis, metastasis, and TME.

Analytic morphomics corresponds to functional status in older patients.

BACKGROUND: Older patients account for nearly half of the United States surgical volume, and age alone is insufficient to predict surgical fitness. Various metrics exist for risk stratification, but little work has been done to describe the association between measures. We aimed to determine whether analytic morphomics, a novel objective risk assessment tool, correlates with functional measures currently recommended in the preoperative evaluation of older patients. MATERIALS AND METHODS: We retrospectively identified 184 elective general surgery patients aged >70 y with both a preoperative computed tomography scan and Vulnerable Elderly Surgical Pathways and outcomes Assessment within 90 d of surgery. We used analytic morphomics to calculate trunk muscle size (or total psoas area [TPA]) and univariate logistic regression to assess the relationship between TPA and domains of geriatric function mobility, basic and instrumental activities of daily living (ADLs), and cognitive ability. RESULTS: Greater TPA was inversely correlated with impaired mobility (odds ratio [OR] = 0.46, 95% confidence interval [CI] 0.25-0.85, P = 0.013). Greater TPA was associated with decreased odds of deficit in any basic ADLs (OR = 0.36 per standard deviation unit increase in TPA, 95% CI 0.15-0.87, P <0.03) and any instrumental ADLs (OR = 0.53, 95% CI 0.34-0.81; P <0.005). Finally, patients with larger TPA were less likely to have cognitive difficulty assessed by Mini-Cog scale (OR = 0.55, 95% CI 0.35-0.86, P <0.01). Controlling for age did not change results. CONCLUSIONS: Older surgical candidates with greater trunk muscle size, or greater TPA, are less likely to have physical impairment, cognitive difficulty, or decreased ability to perform daily self-care. Further research linking these assessments to clinical outcomes is needed.

The association of breast density with breast cancer mortality in African American and white women screened in community practice.

The effect of breast density on survival outcomes for American women who participate in screening remains unknown. We studied the role of breast density on both breast cancer and other cause of mortality in screened women. Data for women with breast cancer, identified from the community-based Carolina Mammography Registry, were linked with the North Carolina cancer registry and NC death tapes for this study. Cause-specific Cox proportional hazards models were developed to analyze the effect of several covariates on breast cancer mortality-namely, age, race (African American/White), cancer stage at diagnosis (in situ, local, regional, and distant), and breast density (BI-RADS( ® ) 1-4). Two stratified Cox models were considered controlling for (1) age and race, and (2) age and cancer stage, respectively, to further study the effect of density. The cumulative incidence function with confidence interval approximation was used to quantify mortality probabilities over time. For this study, 22,597 screened women were identified as having breast cancer. The non-stratified and stratified Cox models showed no significant statistical difference in mortality between dense tissue and fatty tissue, while controlling for other covariate effects (p value = 0.1242, 0.0717, and 0.0619 for the non-stratified, race-stratified, and cancer stage-stratified models, respectively). The cumulative mortality probability estimates showed that women with dense breast tissues did not have significantly different breast cancer mortality than women with fatty breast tissue, regardless of age (e.g., 10-year confidence interval of mortality probabilities for whites aged 60-69 white: 0.056-0.090 vs. 0.054-0.083). Aging, African American race, and advanced cancer stage were found to be significant risk factors for breast cancer mortality (hazard ratio >1.0). After controlling for cancer incidence, there was not a significant association between mammographic breast density and mortality, adjusting for the effects of age, race, and cancer stage.

Is duct excision still necessary for all cases of suspicious nipple discharge?

Despite the low likelihood of malignancy, it is recommended that all women with pathologic nipple discharge undergo duct excision based on the inadequate sensitivity of diagnostic modalities. However, these data originates prior to recent improvements in breast imaging. We performed a retrospective review of patients evaluated in the setting of modern diagnostic breast imaging. Of 175 women referred to our breast clinic with a primary complaint of nipple discharge, 142 (81%) had suspicious discharge. Of the 23 patients who opted for observation over duct excision, with a mean follow-up of 3.3 years, none have been diagnosed with cancer. Among patients who proceeded with surgery, cancer was diagnosed in seven patients (5%). Six of the seven patients had either an abnormal mammogram or ultrasound. Among 46 patients with suspicious nipple discharge, a normal physical exam and normal diagnostic mammogram/ultrasound, only one malignancy (2%) was identified in a 79-year-old patient with a personal history of breast cancer. In selected patients with suspicious nipple discharge, but normal physical exam and diagnostic imaging, short-term observation with repeat evaluation seems reasonable for patients who do not desire duct excision.

Features associated with successful recruitment of diverse patients onto cancer clinical trials: report from the American College of Surgeons Oncology Group.

BACKGROUND: The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. STUDY DESIGN: We evaluated the accrual patterns for 10 clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999-2009, and analyzed results by race/ethnicity as well as by study design. RESULTS: Eight of 10 protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully recruiting protocols were: (1) studies designed to recruit patients with regional or advanced-stage disease (2 of 2 protocols); and (2) studies that involved some investigational systemic therapy (3 of 3 protocols). DISCUSSION: AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients.

A novel geriatric assessment tool that predicts postoperative complications in older adults with cancer.

INTRODUCTION: Comprehensive geriatric assessment prior to oncologic surgery can help predict surgical outcomes. We tested whether an abbreviated geriatric assessment tool, the Vulnerable Elderly Surgical Pathways and outcomes Assessment (VESPA), would predict post-operative complications among older adults undergoing oncologic surgery. METHOD: From 2008 to 2011, geriatric assessments were completed using the VESPA tool for patients age ≥ 70 seen in a pre-operative clinic. The VESPA assessed functional status, mood, cognition, and mobility, and can be completed in <10 min. We selected the subset of patients who underwent oncologic surgery and evaluated the VESPA's ability to predict post-operative surgical complications, geriatric complications (e.g., delirium), length of stay, and geriatric post-discharge needs (e.g., new functional dependence). RESULTS: A total of 476 patients who underwent oncologic surgery received the assessment using VESPA. Compared to patients with low VESPA scores (<9), patients with high VESPA scores (≥9) had longer length of stay (mean 6.6 vs. 2.0 days; p < .001), more geriatric complications (39.5% vs. 5.7%; p < .001), more surgical complications (29.5% vs. 11.8%; p < .001), and more likely to have post discharge needs (76.0% vs. 31.7%; p < .001). Using logistic regression, each additional point on the VESPA scale was also associated with increased probability of geriatric complications (OR = 1.3; 95% CI = 1.2-1.4), surgical complications (OR = 1.2; 95% CI = 1.1-1.2), and geriatric post-discharge needs (OR = 1.3; 95% CI = 1.2-1.3). CONCLUSION: The VESPA identifies older patients with cancer who are at risk for postoperative surgical and geriatric complications as well as functional needs at hospital discharge.

Residual disease after re-excision lumpectomy for close margins.

INTRODUCTION: While a positive margin after an attempt at breast conservation therapy (BCT) is a reason for concern, there is more controversy regarding close margins. When re-excisions are performed, there is often no residual disease in the new specimen, calling into question the need for the procedure. We sought to examine the incidence of residual disease after re-excision for close margins and to identify predictive factors that may better select patients for re-excision. METHODS: Our IRB-approved prospective breast cancer database was queried for all breast cancer patients who underwent a re-excision lumpectomy for either close or positive margins after an attempt at BCT. Close margins are defined as < or =2 mm for invasive carcinoma and < or =3 mm for DCIS. Clinicopathologic features were correlated with the presence of residual disease in the re-excision specimen. RESULTS: Three hundred three patients (32%) underwent re-operation for either close (173) or positive (130) margins. Overall, 33% had residual disease identified, 42% of DCIS patients and 29% of patients with invasive disease, nearly identical to patients with positive margins. For patients with DCIS, only younger age was significantly related to residual disease. For patients with invasive cancer, only multifocality was significantly associated with residual disease (OR 3.64 [1.26-10.48]). However, patients without multifocality still had a substantial risk of residual disease. DISCUSSION: The presence of residual disease appears equal between re-excisions for close and positive margins. No subset of patients with either DCIS or invasive cancer could be identified with a substantially lower risk of residual disease.

Determinants of breast conservation rates: reasons for mastectomy at a comprehensive cancer center.

Bias in referral patterns and variations in multi-disciplinary management may impact breast conservation therapy (BCT) rates between hospitals. Retrospective studies of BCT rates are limited by their inability to differentiate indicated mastectomies versus those chosen by the patient. Our prospective breast cancer data base was queried for patients with invasive breast cancer who underwent surgical therapy at the University of Michigan over a 3-year period. Demographics, stage and histology were recorded along with the reason mastectomy was performed, categorized as "by need" (contraindication to BCT) or "by choice." Multivariate analysis was used to identify factors significantly associated with mastectomy by choice. BCT was associated with tumor size, histology and nodal status, but not older age, either by choice or by need. Of the 34% of patients initially felt to be poor candidates for BCT, it was absolutely contraindicated in 44%, while 56% were thought to have a tumor-to-breast size ratio too large for successful BCT. Of this latter group, 80% underwent neo-adjuvant chemotherapy in an attempt to downstage the primary tumor and perform BCT, which was successful in over half the patients. For the patients initially thought to be good candidates for BCT, only 15% chose to undergo mastectomy, while 5% eventually required mastectomy due to failed attempts to achieve negative margins. Overall, the BCT rate was 63%, however without the use of neo-adjuvant chemotherapy, the BCT rate would have been only 53%. At a tertiary referral center, BCT rates are driven more by contraindications than patient choice, and may be heavily skewed towards mastectomy due to referral patterns. In addition to tumor factors such as stage and histology, BCT rate can be dramatically impacted by neo-adjuvant chemotherapy or genetic counseling. Examining BCT rates alone as a measure of quality, therefore, is not an appropriate standard across institutions serving diverse populations.

Axillary staging prior to neoadjuvant chemotherapy for breast cancer: predictors of recurrence.

BACKGROUND: The value of axillary staging prior to delivery of neoadjuvant chemotherapy (NEO) for breast cancer is controversial. Our goal was to analyze the prognostic and therapeutic impact of axillary staging on recurrence. METHODS: The study cohort included 161 patients undergoing comprehensive evaluation by a multidisciplinary approach during the period 1996-2006. Clinicopathologic features were assessed before and after delivery of NEO. Patients with node-positive disease before NEO underwent a post-NEO axillary lymph node dissection at time of definitive breast surgery. RESULTS: At presentation, median age was 49 years; mean tumor size was 45 mm. The axilla was negative in 45 (28.6%) patients. Of the 114 pre-NEO node-positive patients, 65 (57%) were staged histologically. At completion of NEO, partial or complete clinical response was observed in 90.6%; complete pathologic response occurred in 23.6%. Mean residual tumor size was 10.5 mm. Of the 112 initially node-positive patients, 36 (31.6%) had no residual axillary disease post NEO. At median follow-up of 38.1 months, 21.7% patients relapsed. The pre-NEO nodal status was the strongest predictor of treatment failure. A significant risk of distant relapse was based on nodal response to NEO: 8.1% in node-negative patients, 13.9% in the downstaged group, and 22.1% in the persistently positive group (P = 0.047). Delivery of nodal irradiation decreased local recurrence in the downstaged group (12.5% versus 3.7%, P = NS). CONCLUSION: Our experience suggests that comprehensive axillary staging with ultrasound and fine-needle aspiration (FNA) and sentinel lymph node biopsy prior to NEO is both prognostically and therapeutically important in predicting those patients at higher risk of recurrence.

Reversal of the estrogen receptor negative phenotype in breast cancer and restoration of antiestrogen response.

PURPOSE: In breast cancer, the presence of estrogen receptor alpha (ER) denotes a better prognosis and response to antiestrogen therapy. Lack of ERalpha correlates with overexpression of epidermal growth factor receptor or c-erbB-2. We have shown that hyperactivation of mitogen-activated protein kinase (MAPK) directly represses ERalpha expression in a reversible manner. In this study, we determine if inhibition of MAPK in established ERalpha(-) breast cancer cell lines and tumors results in reexpression of ERalpha, and further, if reexpression of ERalpha in these ERalpha(-) tumors and cell lines could restore antiestrogen responses. EXPERIMENTAL DESIGN: Established ERalpha(-) breast cancer cell lines, ERalpha(-) breast tumors, and tumor cell cultures obtained from ERalpha(-) tumors were used in this study. Inhibition of hyperactive MAPK was accomplished via the MAPK/ERK kinase 1/2 inhibitor U0126 or via upstream inhibition with Iressa or Herceptin. Western blotting or reverse transcription-PCR for ERalpha was used to assess the reexpression of ERalpha in cells treated with U0126. Growth assays with WST-1 were done to assess restoration of antiestrogen sensitivity in these cells. RESULTS: Inhibition of MAPK activity in ERalpha(-) breast cancer cell lines results in reexpression of ERalpha; upstream inhibition via targeting epidermal growth factor receptor or c-erbB-2 is equally effective. Importantly, this reexpressed ERalpha can now mediate an antiestrogen response in a subset of these ERalpha(-) breast cancer cell lines. Treatment of ERalpha(-) tumor specimens with MAPK inhibitors results in restoration of ERalpha mRNA, and similarly in epithelial cultures from ERalpha(-) tumors, MAPK inhibition restores both ERalpha protein and antiestrogen response. CONCLUSIONS: These data show both the possibility of restoring ERalpha expression and antiestrogen responses in ERalpha(-) breast cancer and suggest that there exist ERalpha(-) breast cancer patients who would benefit from a combined MAPK inhibition/hormonal therapy.

Neoadjuvant docetaxel and capecitabine and the use of thymidine phosphorylase as a predictive biomarker in breast cancer.

PURPOSE: Thymidine phosphorylase (TP) induction by docetaxel is a proposed mechanism for the observed preclinical synergy of docetaxel and capecitabine (DC). We evaluated whether TP protein expression is increased by docetaxel and correlates with pathologic complete response (pCR) in breast cancer patients. EXPERIMENTAL DESIGN: Women with stage II to III breast cancer were given four cycles of neoadjuvant docetaxel 36 mg/m(2) i.v. over 30 min on days 1, 8, and 15 and capecitabine 2,000 mg/d, in two divided doses, on days 5 to 21 of a 28-day cycle. Radiology-directed biopsies of the breast tumors were done at baseline and 5 days after the first dose of docetaxel to evaluate TP expression. Following DC therapy, patients had core breast biopsies, and if residual disease was present, received four cycles of standard dose-dense doxorubin and cyclophosphamide (AC). RESULTS: The pCR rate was 26.9% (95% confidence interval, 11.6-47.8). Up-regulation of TP expression was not observed by either quantitative immunofluorescence (QIF) or immunohistochemistry. Radiology-directed core biopsy after neoadjuvant chemotherapy accurately predicted pathologic response in 88% (95% confidence interval, 69.8-97.6) of the cases. Neither level of TP expression nor TP up-regulation correlated with pCR. Significant toxicity resulted in therapy discontinuation in 3 of 26 patients. CONCLUSIONS: DC chemotherapy exhibited a similar pCR rate compared with standard taxane regimens, with increased toxicity. TP expression was not up-regulated after docetaxel and did not correlate with therapeutic response. Core breast biopsy after neoadjuvant chemotherapy accurately predicted pathologic response.

Why should we still care about oncogenes?

Although oncogenes and their transformation mechanisms have been known for 30 years, we are just now using our understanding of protein function to abrogate the activity of these genes to block cancer growth. The advent of specific small-molecule inhibitors has been a tremendous step in the fight against cancer and their main targets are the cellular counterparts of viral oncogenes. The best-known example of a molecular therapeutic is Gleevec (imatinib). In the early 1990s, IFN-alpha treatment produced a sustained cytologic response in approximately 33% of chronic myelogenous leukemia patients. Today, with Gleevec targeting the kinase activity of the proto-oncogene abl, the hematologic response rate in chronic myelogenous leukemia patients is 95% with 89% progression-free survival at 18 months. There are still drawbacks to the new therapies, such as drug resistance after a period of treatment, but the drawbacks are being studied experimentally. New drugs and combination therapies are being designed that will bypass the resistance mechanisms.

Estimating Risk of Postsurgical General and Geriatric Complications Using the VESPA Preoperative Tool.

IMPORTANCE: As greater numbers of older patients seek elective surgery, one approach to preventing postoperative complications is enhanced assessment of risks during preoperative evaluation. OBJECTIVE: To determine whether a geriatric assessment tool can be implemented in a preoperative clinic and can estimate risk of postoperative complications. DESIGN, SETTING, AND PARTICIPANTS: In this prospective cohort study, patients 70 years of age or older were assessed in a preoperative clinic for elective surgery from July 9, 2008, to January 5, 2011. Patients were screened using the Vulnerable Elders Surgical Pathways and Outcomes Assessment (VESPA) tool developed for this study. Patients were assessed on 5 preoperative activities of daily living recommended by the American College of Surgeons (bathing, transferring, dressing, shopping, and meals), history of falling or gait impairment, and depressive symptoms (2-item Patient Health Questionnaire). Patients also underwent a brief cognitive examination (Mini-Cog) and gait and balance assessment (Timed Up and Go test). A novel question was also asked as to whether patients expected they could manage themselves alone after discharge. Comorbidities and work-related relative value units (categorized into low, moderate, and high tertiles) were also collected. Multivariable logistic regression was performed to estimate risk of postoperative complications. Sustainability of VESPA over time was also evaluated. Medical record review was performed from December 11, 2012, to October 2, 2015, and data analysis was performed from November 15, 2015, to May 18, 2016. MAIN OUTCOMES AND MEASURES: Postoperative surgical and geriatric complications. RESULTS: Of the 770 patients evaluated, 736 (384 women and 352 men; mean [SD] age, 77.7 [5.7] years) underwent 740 operative procedures; of these patients, 711 had complete data for multivariable analysis. In our sample, 105 patients (14.3%) reported 1 or more difficulties with the 5 activities of daily living, and 270 of 707 patients (38.2%) foresaw themselves unable to manage self-care alone. A total of 131 of 740 patients had geriatric complications, and 114 of 740 patients had surgical complications; 187 of 740 patients (25.3%) had either geriatric or surgical complications. On multivariable analysis, the number of difficulties with activities of daily living (odds ratio [OR], 1.3; 95% CI, 1.0-1.6), anticipated difficulty with postoperative self-care (OR, 1.6; 95% CI, 1.0-2.2), Charlson Comorbidity score of 2 or more vs less than 2 (OR, 1.5; 95% CI, 1.0-2.3), male sex (OR, 1.6; 95% CI, 1.1-2.3), and work-related relative value units (moderate vs low: OR, 1.9; 95% CI, 1.1-3.3; high vs low: OR, 8.8; 95% CI, 5.3-14.5) were independently associated with postoperative complications (overall model area under the receiver operating characteristic curve, 0.77). With these results, a whole-point VESPA score used alone to estimate risk of complications also demonstrated excellent fit (area under the curve, 0.76). CONCLUSIONS AND RELEVANCE: Preoperative assessment of older geriatric patients is feasible in the general preoperative clinic and can help identify patients at higher risk of postoperative complications.

A report on accrual rates for elderly and minority-ethnicity cancer patients to clinical trials of the American College of Surgeons Oncology Group.

BACKGROUND: Incidence and mortality rates for cancers vary by ethnic background and patient age. Accrual of diverse patient populations to cancer clinical trials is essential in order to ensure that findings related to new management strategies can be generalized. The goal of this study was to evaluate accrual patterns for patients participating in the American College of Surgeons Oncology Group (ACOSOG) cancer protocols. Ethnic diversity among clinical trial investigators may also influence accrual patterns, so the ethnic background of the ACOSOG membership was also evaluated. STUDY DESIGN: Demographics for the patients registered on ACOSOG breast, thoracic, and colorectal clinical trials were evaluated and compared with data on the general population and the cancer population in the United States. Accrual patterns for patients from other reported cancer clinical trials were also presented, and the self-reported ethnic distribution of the ACOSOG membership was analyzed. RESULTS: Distribution of African Americans, Hispanic Americans, and Asian Americans to the ACOSOG breast and colorectal clinical trials was relatively proportionate to the cancer population. African Americans were underrepresented in the thoracic clinical trials, and this disparity was partially offset by data on the proportion of African Americans with stage-eligible lung cancer. Accrual rates for patients age 65 years and older were better than those reported by most other clinical trialists. CONCLUSIONS: Elderly patients are successfully recruited into surgical clinical trials, and this will provide important data for future analyses regarding cancer outcomes in this growing population of cancer patients. Aggressive outreach to minority-ethnicity cancer patients for accrual into clinical trials should continue.

Mastectomy and concomitant sentinel lymph node biopsy for invasive breast cancer.

BACKGROUND: Although sentinel lymph node biopsy (SNLB) has become a standard ancillary to breast conservation, there remains a hesitancy to perform SLNB concomitant with mastectomy primarily because of concerns regarding reoperation for a positive SLN. METHODS: A retrospective review of 51 patients who underwent SLN biopsy concomitantly with mastectomy for invasive breast cancer was performed. In addition, a survey was sent to surgical oncologists who routinely perform SLNB in conjunction with mastectomy. RESULTS: The SLN was identified in 98% of patients, and an average of 2.4 SLNs/patient were removed. The SLN was positive in 14 patients (27%). Ten patients underwent axillary lymph node dissection as a second procedure; an average of 15.4 +/- 6 nodes were cleared, and there were no complications. Although techniques vary greatly among surgeons, the majority believe that a subsequent ALND procedure does not carry additional risk of morbidity. CONCLUSIONS: Mastectomy and concomitant SLNB is a safe option for well-selected breast cancer patients. Results appear acceptable using a variety of techniques. Patients with a positive SLN can safely undergo completion axillary lymph node dissections. This includes patients who have undergone immediate reconstruction, but proper planning is needed to minimize potential risks.

Sentinel node biopsy prior to neoadjuvant chemotherapy.

BACKGROUND: Several studies have explored sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy, but false negative rates and the loss of pretreatment nodal staging are limitations. Sentinel lymph node biopsy prior to induction chemotherapy may address both. METHODS: Sentinel lymph node biopsy was performed in clinically node negative patients prior to initiating chemotherapy. Standard level I/II axillary lymph node dissection (ALND) was performed at the time of surgery in those patients who had metastases in the sentinel lymph node (SLN). RESULTS: Twenty-five patients had 26 SLNB prior to the initiation of chemotherapy. The SLN was identified in all cases (100%). Twelve patients (48%) were found to be node negative and did not require axillary node dissection after chemotherapy. Of the patients who were SLN positive and underwent completion ALND, residual nodal disease was identified in 60%. There were no surgical complications or delay of chemotherapy. CONCLUSIONS: Sentinel lymph node biopsy prior to neoadjuvant chemotherapy can avoid the morbidity of ALND without compromising the accuracy of axillary staging. It allows for identification of node positive patients subsequently rendered disease free in the regional nodes, which can assist in planning additional chemotherapy or radiation.