Evaluation of naloxone furnishing community pharmacies in San Francisco.

OBJECTIVES: In 2017, the Centers for Disease Control and Prevention reported more than 47,600 deaths as a result of opioid overdose in the United States. In an effort to reduce these deaths, California passed legislation providing pharmacists with the ability to furnish naloxone without a prescription. Our study examined pharmacies in San Francisco that furnished naloxone and provided guidance for pharmacies seeking to develop similar programs. The study aims were to (1) identify the legal, structural, social-environmental, and financial components of a pharmacy model that allows for successful naloxone distribution, (2) evaluate the attitudes and beliefs of pharmacy staff members toward patients receiving or requesting naloxone, and (3) assess relationships between these attitudes and beliefs and naloxone furnishing at the pharmacy. METHODS: This cross-sectional study used a series of semistructured interviews of pharmacy staff in San Francisco conducted April-October 2019. Through a thematic, inductive analysis of collected data, emerging themes were mapped to the primary study aims. RESULTS: We interviewed 14 pharmacists and pharmacy technicians at 4 community pharmacies. We identified 4 factors for success in implementing a naloxone furnishing protocol: administrative-led efforts, pharmacist-led efforts, increasing pharmacist engagement, and increasing patient engagement. The respondents also discussed the approaches they used to overcome previously identified barriers: cost, time, expectations of unwanted clientele, and patients' feelings of stigma. CONCLUSION: Pharmacists' approaches to implementing naloxone furnishing had common features across locations, suggesting many of these strategies could be replicated in other community pharmacies.

Provider Information Provision and Breast Cancer Patient Well-Being.

Research continues to delineate and clarify specific communication behaviors associated with improved patient outcomes. In the context of breast cancer surgery, this exploratory study examined the effect of breast surgeon information provision on the immediate post-visit outcomes of patients' anxious preoccupation, intention to adhere to treatment recommendations, and treatment plan satisfaction. Participants included 51 newly diagnosed breast cancer patients receiving care from one breast surgeon at a National Cancer Institute-designated cancer center in the northeastern United States. Participants completed pre- and post-visit questionnaires. Medical interactions were recorded, transcribed, and analyzed via multidimensional analysis, a method of linguistic analysis that uses exploratory factor analysis to identify how specific types of words are patterned and work to accomplish communicative goals (Biber, 1988). The multidimensional analysis identified constellations of language used by providers and patients. Although five linguistic dimensions emerged, one dimension, impersonal information provision, is of unique interest in understanding how providers communicate with patients. Impersonal information provision encompasses the ways in which the provider, using an impersonal tone, discussed the logistics, details, and implications of treatment options. Increased impersonal information provision was associated with patients' decreased anxious preoccupation (ß = -.22, t = -2.82, p = .007), increased treatment plan satisfaction (ß = .36, t = 2.54, p = .012), and increased intention to adhere to treatment recommendations (ß = .34, t = 2.45, p = .018). Findings suggest that specific provider behavior and types of information provided have unique and important effects on patients' health outcomes.

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

BACKGROUND: 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. METHODS: Working from transcripts of videotaped, treatment decision making consultations between breast cancer patients and surgeons, we identify all questions (by patients and companions) and then use grounded theory techniques to determine the most recurrent question-asking themes. RESULTS: Sample includes 132 recently diagnosed (M = 8.9 days), late-middle-aged (M = 61.2 years), female patients with predominantly early stage (0-1; 78%), first-time breast cancer (92.4%) consulting with one of nine surgeons in community based offices. Transcripts contained 2,781 questions (1,929 by patients, 852 by companions; Cohen's Kappa = 0.90), which generated 15 patient question asking themes that were represented (i.e., asked about) at least once in >20% of all consultations. CONCLUSION: Question asking themes are a concrete index of what patients want to know more about prior to treatment. Identified themes specify, modify, and extend prior findings based on self-report data. Findings potentially increase surgeons' levels of patient centered care by improving surgeons' abilities to satisfactorily address patients' information needs, which has the potential to improve both patient outcomes and clinical practice guidelines. J. Surg. Oncol. 2016;114:922-929. © 2016 Wiley Periodicals, Inc.

Comparative Toxicity of Tapentadol and Tramadol Utilizing Data Reported to the National Poison Data System.

BACKGROUND: Tapentadol (TAP) and tramadol (TRA) provide pain relief through similar monoaminergic and opioid agonist properties. OBJECTIVE: To compare clinical effects and medical outcomes between TAP and TRA exposures reported to the National Poison Data System of the American Association of Poison Control Centers. METHODS: A retrospective cohort study was conducted analyzing national data for single medication TAP or TRA cases reported from June 2009 through December 2011. Case outcomes, dichotomized as severe versus mild; clinical effects; and use of naloxone were compared. RESULTS: There were 217 TAP and 8566 TRA cases. Significantly more severe outcomes were associated with TAP exposures for an all-age comparison (relative risk [RR] = 1.24; 95% CI = 1.04-1.48), and for the <6-year-old age group (RR = 5.76; 95% CI = 2.20-15.11). Patients with TAP exposures had significantly greater risk of respiratory depression (RR = 5.56; 95% CI = 3.50-8.81), coma (RR = 4.16; 95% CI = 2.33-7.42), drowsiness/lethargy (RR = 1.38; 95% CI = 1.15-1.66), slurred speech (RR = 3.51; 95% CI = 1.98-6.23), hallucination/delusion (RR = 7.25; 95% CI = 3.61-14.57), confusion (RR = 2.54; 95% CI = 1.56-4.13) and use of naloxone (RR = 3.80; 95% CI = 2.96-4.88). TRA exposures had significantly greater risk of seizures (RR = 7.94; 95% CI = 2.99-20.91) and vomiting (RR = 1.96; 95% CI = 1.07-3.60). CONCLUSION: TAP was associated with significantly more toxic clinical effects and severe outcomes consistent with an opioid agonist. TRA was associated with significantly higher rates of seizures and vomiting.

Predictors of Death and Prolonged Renal Insufficiency in Ethylene Glycol Poisoning.

BACKGROUND: We assessed the predictive value of selected factors on the outcomes of death and prolonged renal insufficiency (RI) from ethylene glycol poisoning. METHODS: Retrospective, observational California Poison Control System study, over a 10-year period (1999-2008). We compared 2 groups. The first group (D/RI) included 59 patients who died (9 patients) or had prolonged RI (50 patients). Prolonged RI was defined as kidney injury in which dialysis was required for greater than 3 days after presentation. The second group (RECOV) of 62 patients had an uncomplicated recovery. Secondarily, we evaluated the association of time to antidote (ethanol and/or fomepizole) and time to dialysis with these outcomes. RESULTS: The D/RI group was more likely than the RECOV group to present comatose, have seizures, and require intubation. The D/RI group had a lower mean initial arterial pH of 7.03 (standard deviation [SD] 0.20), compared to 7.27 (SD 0.14) for the RECOV group. The D/RI group had a higher initial creatinine (1.7 mg/dL, SD 0.71) than that of the RECOV group (1.0 mg/dL, SD 0.33). Patients with a time to antidote greater than 6 hours had a higher odds of dying or having prolonged RI (OR 3.34, 95% CI : 1.21-9.26) Patients with a time to dialysis greater than 6 hours had a lower odds of dying or having prolonged RI (OR 0.36, 95% CI : 0.15-0.87). CONCLUSION: Compared to survivors with an uncomplicated recovery, patients poisoned with ethylene glycol who died or had prolonged RI were more likely to exhibit clinical signs such as coma, seizures, and acidosis. Antidote administration within 6 hours is associated with better outcomes, unlike earlier time to dialysis.

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.

Pepper spray injury severity: ten-year case experience of a poison control system.

BACKGROUND: Pepper spray is a common lacrimator used by law enforcement and the public to subdue individuals and for self-defense. The risk factors for severe injury due to pepper spray exposure are not well documented and there is a lack of guidelines to identify patients that require transport and medical evaluation in an emergency department. OBJECTIVE: The aim of this study was to determine the prevalence of and circumstances associated with symptoms suggestive of tissue injury beyond transient irritation in persons exposed to pepper spray. METHODS: We reviewed all human exposures to pepper spray reported to a poison control system between 2002 and 2011. Cases were differentiated into 2 outcome groups: minor or self-limiting symptoms versus those with more severe symptoms suggestive of tissue injury that warranted a medical evaluation. A comparison of the variables between the outcome groups was performed using odds ratios (ORs), 95% confidence intervals (CIs), and associated P values. RESULTS: A total of 4,544 cases were identified and 3,671 met the inclusion criteria. Of these, 249 cases (6.8%) were found to have more severe symptoms that warranted a medical evaluation. There were no reported deaths. The cases with more severe symptoms most commonly involved the ocular (53.8%), respiratory (31.7%), and dermal (17.7%) organ systems. Factors with largest independent associations with more severe outcomes were use for law enforcement training (OR, 7.39; 95% CI, 2.98-18.28), direct intentional exposure for purposeful use to incapacitate (OR, 3.02; 95% CI, 1.80-5.06), and for law enforcement on individual target suspects or crowd control (OR, 2.45; 95% CI, 1.42-4.23). CONCLUSIONS: There was a low 1 in 15 potential risk for more severe adverse health effects in persons exposed to pepper spray that warranted a medical evaluation. The risk was highest when used for training of law enforcement personnel and involved severe ocular symptoms. This suggests that routine use of pepper spray for training of law enforcement or military personnel be reconsidered. Protective goggles may be an option when direct spraying into the face of trainees. Transport for medical evaluation should be considered for exposed persons that manifest persistent ocular or respiratory symptoms.

Dosimetric feasibility and acute toxicity in a prospective trial of ultrashort-course accelerated partial breast irradiation (APBI) using a multi-lumen balloon brachytherapy device.

BACKGROUND: Shorter courses of APBI, including single-fraction intraoperative therapy, are under active investigation. We designed a prospective trial to identify and address the potential radiobiological and logistical shortcomings of single-fraction APBI. METHODS: We designed a single-arm, multi-institutional, prospective phase II trial that sequentially treats 3 cohorts of women (each n = 30) with 3 progressively hypofractionated schedules. Eligible women were age ≥50 years with unifocal invasive or in situ tumors ≤3.0 cm, excised with negative margins, and with negative lymph nodes and positive hormone receptors. We defined strict dosimetric criteria for appropriateness. RESULTS: A total of 30 patients were enrolled at the 7 Gy × 4 fractions dose-level and followed for 6 months. The median skin dose as a percent of prescription dose (PD) was 84 % (40-100), and the median rib dose was 71 % (16-119). Also, 95 % of the PTV_eval received a median of 95 % of PD (range 85-103). The V150 (range 14-48 cc) and V200 (range 0-29 cc) criteria were met in all cases. One breast infection occurred and was treated; 2 cases of symptomatic fat necrosis and 2 cases of symptomatic seromas occurred. CONCLUSION: Short-course APBI is dosimetrically feasible using the Contura MLB and appears to be tolerable in terms of acute toxicities. Our approach is based on well-defined radiobiological parameters and allows for an abbreviated course of treatment that is guided by full pathological review and the ability to objectively achieve and validate acceptable dosimetric criteria in each case. We have opened enrollment to the next schedule of 8.25 Gy for 3 fractions.

Lumpectomy closure technique does not affect dosimetry in patients undergoing external-beam-based accelerated partial breast irradiation.

BACKGROUND: During the breast lumpectomy procedure, surgeons traditionally elect to use either a superficial or full-thickness closure when sealing the wound depending on surgeon preference as well as desired outcomes. The purpose of this study was to examine dosimetric endpoints in patients with superficial versus full-thickness closures with accelerated partial breast irradiation (APBI). METHODS: Patients who underwent breast conservation surgery followed by 3D conformal external-beam APBI were identified (n = 45) and were separated according to the type of cavity closure performed: superficial and full thickness. Data gathered from the retrospective review of patient charts was analyzed according to criteria in the NSABP B-39 protocol in order to quantify the amount of radiation delivered to organs at risk. The patient seroma cavity was further given a cavity visualization score to assess the impact of wound closure on treatment planning. RESULTS: There was no significant difference in the mean CVS score for the 2 groups. There were no statistical differences in all dosimetric endpoints compared for the 2 types of closure, and both groups met NSABP B-39 guidelines for the ipsilateral breast, heart, and ipsilateral lung dosimetry. CONCLUSIONS: We found no significant difference in dosimetric outcomes in either the superficial or deep closure treatment groups. Breast surgeons should not alter their preferred closure strategy in anticipation of 3D-CRT APBI.

Consulting with a surgeon before breast cancer surgery: patient question asking and satisfaction.

Research has found a negative association between patient question asking and aspects of their satisfaction. In the context of surgical oncology, the aim of this exploratory study was to test the association between patient question asking and 3 indices of their satisfaction. Participants included 51 women who were newly diagnosed with breast cancer engaged in presurgical consultations with a surgical oncologist from a National Cancer Institute-designated cancer center in the Northeastern United States. Outcomes were patients' postconsultation reports of their satisfaction with the treatment plan, intentions to adhere to the treatment plan, and satisfaction with the surgeon. The main predictor was the frequency of patients' self-initiated questions coded from videotapes of consultations. The frequency of patients' self-initiated questions was negatively associated with their satisfaction with the treatment plan (p = .02), intentions to adhere to the treatment plan (p = .02), and satisfaction with the surgeon (p = .07). Results can be explained in terms of patients' perceptions that the surgeon's information was insufficient or inadequate. Future research needs to identify the specific content of patients' questions and how such content might be associated with satisfaction.

Investigating the reliability of substance toxicity information found on the Internet in pediatric poisonings.

OBJECTIVES: The Internet may be the first source of information used by parents during a suspected poisoning of their children. Our primary aim was to assess the reliability of the Internet as a resource for information for parents to initially manage a suspected poisoning involving their child without outside consultation. METHODS: We distributed a self-administered survey to English-speaking parents to evaluate their Internet access behaviors so we could emulate their search strategies for a poisoning. A panel of clinical toxicologists performed an evaluation of Websites to determine the proportion that provided accurate and adequate information on common substances involved in poisonings. RESULTS: Of 21 parents surveyed, 15 (71%) used the Internet daily, with Google and Yahoo being the most commonly used search engines. Seven parents (39%) were somewhat to very likely to utilize the Internet during a poisoning scenario with prescription medications involving their child. Overall, only 27 (38%) of the Websites reviewed advised the user to call the poison center with the proper 800 telephone number, whereas no Website provided adequate information to manage the poisoning without outside consultation. Few Websites provided information on the toxic dose (13%), how to determine whether to manage the poisoning at home or in a hospital (22%), or first aid (28%). CONCLUSIONS: The information provided on the Internet for substances involved in poisonings is variable and often incomplete. Reliance on the Internet for poisonings could create needless delays and inappropriate assessments and actions to manage a pediatric poisoning incident.

Modelling admission lengths within psychiatric intensive care units.

OBJECTIVES: To examine whether discharge destination is a useful predictor variable for the length of admission within psychiatric intensive care units (PICUs). METHODS: A clinician-led process separated PICU admissions by discharge destination into three types and suggested other possible variables associated with length of stay. Subsequently, a retrospective study gathered proposed predictor variable data from a total of 368 admissions from four PICUs. Bayesian models were developed and analysed. RESULTS: Clinical patient-type grouping by discharge destination displayed better intraclass correlation (0.37) than any other predictor variable (next highest was the specific PICU to which a patient was admitted (0.0585)). Patients who were transferred to further secure care had the longest PICU admission length. The best model included both patient type (discharge destination) and unit as well as an interaction between those variables. DISCUSSION: Patient typing based on clinical pathways shows better predictive ability of admission length than clinical diagnosis or a specific tool that was developed to identify patient needs. Modelling admission lengths in a Bayesian fashion could be expanded and be useful within service planning and monitoring for groups of patients. CONCLUSION: Variables previously proposed to be associated with patient need did not predict PICU admission length. Of the proposed predictor variables, grouping patients by discharge destination contributed the most to length of stay in four different PICUs.

Adverse drug events associated with yohimbine-containing products: a retrospective review of the California Poison Control System reported cases.

BACKGROUND: Herbal supplements are classified as foods rather than drugs and are not required to undergo premarketing review by the Food and Drug Administration. Yohimbine is an alpha(2)-antagonist available in both prescription and herbal supplement products. OBJECTIVE: To determine the prevalence and severity of yohimbine-related adverse drug events (ADEs) reported to the California Poison Control System (CPCS). METHODS: A retrospective review of the CPCS electronic database of cases within a 7-year period (2000-2006) was conducted. Cases involving adults aged 18 and older who were symptomatic following exposure to a yohimbine-containing product, with a causality rating of possible or better on the Naranjo scale, were included. RESULTS: A total of 238 cases were identified. There was a substantial increase in the annual prevalence of yohimbine-associated ADEs reported to the CPCS between 2000 and 2006; specifically, the prevalence (per 10,000 total adult exposures) increased from 1.8 cases in 2000 to 8.0 cases in 2006). The majority (98.7%) of cases involved herbal (vs prescription) yohimbine products. Common reasons for use included sexual enhancement (27.7%), weight loss (9.2%), and stimulant effects (7.6%). Common ADEs reported included: gastrointestinal distress (46%), tachycardia (43%), anxiety/agitation (33%), and hypertension (25%). Yohimbine exposures were associated with a significantly greater proportion of severe outcomes and were more likely to require management at a health-care facility than the average substance exposure reported to the CPCS (odds ratios [95% CIs] were 5.81 [4.43 to 7.64] and 2.35 [1.82 to 3.04], respectively). CONCLUSIONS: A substantial increase in the prevalence of ADEs associated with yohimbine herbal products was seen between 2000 and 2006. These ADEs were associated with significantly more serious outcomes than the average exposures reported to the CPCS. A reexamination of whether yohimbine should be considered a "safe" dietary supplement under the Dietary Supplement Health and Education Act is warranted.

Topical antacid therapy for capsaicin-induced dermal pain: a poison center telephone-directed study.

PURPOSE: The study aimed to assess the effects of topical antacids for treatment of capsaicin-induced dermal pain after exposure to capsaicin containing hot peppers, personal protection sprays, or topical creams. PROCEDURES: Participants of the study were California Poison Control System (CPCS) hotline callers 12 years or older with dermal pain from exposure to capsaicin-containing products or plants. Participants were instructed to apply a topical antacid and assessed for perceived pain (using a 0-10 scale) pre- and posttreatment. A positive response was defined as a sustained reduction of pain 33% or more within 30 minutes or achieving a pain score of 0 to 1. MAIN FINDINGS: Of 93 eligible patients, 64 applied antacids and had outcome data available. Patients contacted the CPCS a median of 1 hour postexposure with a median initial pain score of 7.5/10. Thirty-six (56%) were exposed to unrefined (natural) peppers and 28 (44%) to refined capsaicin (eg, capsaicin-containing cream). Before calling the CPCS, 57 (89%) attempted at least one treatment. Forty-five (70%) reported positive response to antacid treatment as a 33% reduction in pain in 30 minutes (n = 17), a reduction in pain to a score of 0 to 1 (n = 3), or both (n = 25). A 33% reduction in pain within 30 minutes was associated with exposure to refined capsaicin (odds ratio, 3.37; 95% confidence interval, 0.98-11.66). Concomitant refined capsaicin exposure and early treatment (<1 hour of symptoms) was associated with even greater odds of response (odds ratio, 5.4; 95% confidence interval, 1.4-21.2). CONCLUSION: Topical application of antacids for capsaicin-induced pain is effective, particularly in early treatment of exposure to refined capsaicin.

Differentiation of benign and malignant breast lesions by mechanical imaging.

Mechanical imaging yields tissue elasticity map and provides quantitative characterization of a detected pathology. The changes in the surface stress patterns as a function of applied load provide information about the elastic composition and geometry of the underlying tissue structures. The objective of this study is the clinical evaluation of breast mechanical imager for breast lesion characterization and differentiation between benign and malignant lesions. The breast mechanical imager includes a probe with pressure sensor array, an electronic unit providing data acquisition from the pressure sensors and communication with a touch-screen laptop computer. We have developed an examination procedure and algorithms to provide assessment of breast lesion features such as hardness related parameters, mobility, and shape. A statistical Bayesian classifier was constructed to distinguish between benign and malignant lesions by utilizing all the listed features as the input. Clinical results for 179 cases, collected at four different clinical sites, have demonstrated that the breast mechanical imager provides a reliable image formation of breast tissue abnormalities and calculation of lesion features. Malignant breast lesions (histologically confirmed) demonstrated increased hardness and strain hardening as well as decreased mobility and longer boundary length in comparison with benign lesions. Statistical analysis of differentiation capability for 147 benign and 32 malignant lesions revealed an average sensitivity of 91.4% and specificity of 86.8% with a standard deviation of +/-6.1%. The area under the receiver operating characteristic curve characterizing benign and malignant lesion discrimination is 86.1% with the confidence interval ranging from 80.3 to 90.9%, with a significance level of P = 0.0001 (area = 50%). The multisite clinical study demonstrated the capability of mechanical imaging for characterization and differentiation of benign and malignant breast lesions. We hypothesize that the breast mechanical imager has the potential to be used as a cost effective device for cancer diagnostics that could reduce the benign biopsy rate, serve as an adjunct to mammography and to be utilized as a screening device for breast cancer detection.

An interprofessional clinical toxicology advanced pharmacy practice experience.

BACKGROUND AND PURPOSE: Clinical toxicology is a blend of science, research, and patient management practices involving human poisonings from exposure to natural and synthetic toxins. The objective of this study was to describe the components of an elective advanced pharmacy practice experience (APPE) in clinical toxicology at California Poison Control System (CPCS). EDUCATIONAL ACTIVITY AND SETTING: The APPE requirements included a mix of active participation in case management and supplemental educational exercises, case presentations and consultations, and a structured self-study component consisting of readings and on-line modules. In addition, there were two active learning activities, high acuity poisoning simulation scenarios utilizing a high-fidelity mannequin, and an antidote tasting session. FINDINGS: From April 2012 to October 2017, 82 student pharmacists completed this APPE. Pharmacy students completed 85 pre-simulation surveys and 80 post-simulation surveys. Survey results showed an increase in pharmacy student beliefs that a clinical pharmacist should be involved in the differential diagnosis and management of patients (60% pre-simulation vs. 78.8% post-simulation, p = 0.009). APPE pharmacy students completed an evaluation of the preceptors(s), site, and learning experience. The average score for all areas on the preceptor and site evaluations was >4.5 on a 5-point Likert scale. Qualitative data themes included student satisfaction with opportunities, feedback, and the interprofessional and collaborative environment. SUMMARY: An APPE in the CPCS was successfully designed and implemented. The APPE provides an interprofessional collaborative learning environment that allows student pharmacists to understand the unique role of the pharmacist in this setting.

Breast-conservation Therapy After Neoadjuvant Chemotherapy Does Not Compromise 10-Year Breast Cancer-specific Mortality.

OBJECTIVES: Neoadjuvant chemotherapy can increase the rate of breast-conserving surgery by downstaging disease in patients with breast cancer. The aim of this study was to determine whether patients who received neoadjuvant chemotherapy have equal survival after breast-conservation therapy compared with mastectomy. MATERIAL AND METHODS: Using the New Jersey State Cancer Registry (NJSCR) patients with a primary breast cancer diagnosed between 1998 and 2003 who underwent neoadjuvant chemotherapy were selected (n=1,468). Of those, only patients who received lumpectomy plus radiation (n=276) or mastectomy without radiation (n=442) were included in the analysis. The main outcome measured included 10-year breast cancer-specific mortality, with 90% of patients with known vital status through the end of 2011. RESULTS: Baseline characteristics did not differ significantly between the breast-conservation and mastectomy without radiation groups except with respect to summary stage and lymph node involvement. After propensity score matching these differences were no longer statistically significant; however, both estrogen and progesterone status achieved statistical significance. The Kaplan-Meier survival curve showed that the breast-conservation group had significantly higher breast cancer-specific survival than the mastectomy group (P=0.0046). After adjusting for the propensity score in the regression model, the breast-conservation group continued to show significantly better survival than the mastectomy group (hazard ratios, 0.46; 95% confidence interval, 0.27-0.78). CONCLUSIONS: This study is consistent with previous research showing that breast-conserving surgery after neoadjuvant chemotherapy does not reduce breast cancer-specific survival. In fact, patients undergoing breast-conservation after neoadjuvant therapy appeared to have better survival than patients undergoing mastectomy without radiation.

Current application and research directions for partial-breast irradiation.

Breast-conservation therapy (BCT), consisting of lumpectomy followed by whole-breast irradiation (WBI), is the standard of care for women with early-stage breast cancer. However, many women who are candidates for BCT either choose mastectomy or lumpectomy alone for myriad reasons. Accelerated partial-breast irradiation (APBI) is a collection of radiotherapy techniques that deliver higher daily doses of radiation to the surgical cavity with margin over a shorter time than WBI, reducing total treatment time from 6-6.5 weeks to 1-2 weeks. Advocates of APBI state that early results of this approach demonstrate excellent local control, minimal acute toxicity, and are associated with more convenience for the patient. Phase III randomized clinical trials are currently underway to assess local control, acute and chronic toxicities, and quality of life associated with APBI compared to WBI. In this review, we hope to clarify the rationale behind APBI and discuss in depth data concerning various partial-breast irradiation techniques that are being used throughout the United States and around the world.

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.