Anneke T. Schroen

Impact of Patient Distance to Radiation Therapy on Mastectomy Use in Early-Stage Breast Cancer Patients

PURPOSE Treatment access underlies quality cancer care. We hypothesize that mastectomy rates in a rural state are independently influenced by distance to radiation therapy (XRT) and by changing XRT access through opening new facilities. PATIENTS AND METHODS Early-stage breast cancer patients diagnosed from 1996 to 2000 were identified in the Virginia state registry. Distance from patient zip code to nearest XRT facility was calculated with geographical software. Distance to XRT facility (< or = 10, > 10 to 25, > 25 to 50, and > 50 miles), American Joint Committee on Cancer tumor stage, age, race, and diagnosis year were evaluated for influencing mastectomy rate. Mastectomy use within 15 miles of five new facilities was assessed before and after opening. RESULTS Among 20,094 patients, 43% underwent mastectomy, 53% underwent lumpectomy, and therapy of 4% of patients is unknown. Twenty-nine percent of patients lived more than 10 miles from XRT facility. Mastectomy increased with distance to XRT facility (43% at < or = 10 miles, 47% at > 10 to 25 miles, 53% at > 25 to 50 miles, and 58% at > 50 miles; P < .001). Among 11,597 patients with T1 (< 2 cm) tumors, mastectomy also varied by distance (31% at < or = 10 miles, 36% at > 10 to 25 miles, 41% at > 25 to 50 miles, and 49% at > 50 miles; P < .001). In multivariate analysis, mastectomy use was independently influenced by XRT distance after adjusting for age, race, T stage, and diagnosis year. Over the study period, mastectomy rates declined from 48% to 43% across Virginia, and there were similar declines in a 15-mile area around four new radiation facilities in urban settings. However, mastectomies decreased from 61% to 45% around a new XRT facility in a rural setting. CONCLUSION Distance to XRT facility significantly impacts mastectomy use. Opportunities for increasing breast-conservation rates through improved XRT access exist.

Women in Academic General Surgery

Purpose. To portray the professional experiences of men and women in academic general surgery with specific attention to factors associated with differing academic productivity and with leaving academia. Method. A 131-question survey was mailed to all female (1,076) and a random 2:1 sample of male (2,152) members of the American College of Surgeons in three mailings between September 1998 and March 1999. Detailed questions regarding academic rank, career aspirations, publication rate, grant funding, workload, harassment, income, marriage and parenthood were asked. A five-point Likert scale measured influences on career satisfaction. Responses from strictly academic and tenure-track surgeons were analyzed and interpreted by gender, age, and rank. Results. Overall, 317 surgeons in academic practice (168 men, 149 women) responded, of which 150 were in tenure-track positions (86 men, 64 women). Men and women differed in academic rank, tenure status, career aspirations, and income. Women surgeons had published a median of ten articles compared with 25 articles for men (p < .001). Marriage or parenthood did not influence numbers of publications for women. Overall career satisfaction was high, but women reported feeling career advancement opportunities were not equally available to them as to their male colleagues and feeling isolation from surgical peers. Ten percent to 20% of surgeons considered leaving academia, with women assistant professors (29%) contemplating this most commonly. Conclusion. Addressing the differences between men and women academic general surgeons is critical in fostering career development and in recruiting competitive candidates of both sexes to general surgery.

Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials

Background A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. Purpose We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. Methods A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Results Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (<35% actual/predicted accrual rate) were consistently closed due to insufficient accrual. Limitations This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Conclusion Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining accrual benchmarks for early trial termination or redesign is feasible, but better accrual prediction methods are critically needed. Future studies should focus on identifying trial factors that allow more accurate accrual predictions and strategies that can salvage open trials experiencing slow accrual. Clinical Trials 2010; 7: 312—321. http://ctj.sagepub.com

The effect of intraoperative specimen inking on lumpectomy re-excision rates

BackgroundLumpectomy re-excision to obtain negative margins is common. We compare the effect of two specimen orientation approaches on lumpectomy re-excision rates.MethodsAll women undergoing lumpectomy for breast cancer by a single surgeon between 03/2007 - 02/2009 were included. Lumpectomies underwent standard inking (SI) after surgery by a pathologist from 03/2007-02/2008 while intraoperative inking (II) with direct surgeon input was done from 03/2008-02/2009. Rates of margin positivity and re-excision were compared between these methods.Results65 patients were evaluated, reflecting SI in 39 and II in 26 cases. Margin positivity rates of 46% [SI] vs. 23% [II] (p = 0.06) and re-excision rates of 38% [SI] vs. 19% [II] were observed. Residual disease at re-excision was found in 27% [SI] vs. 67% [II] of cases.ConclusionsIntraoperative inking in this practice offered a simple way to reduce re-excision rates after lumpectomy and affect an improvement in quality of patient care.

Achieving Sufficient Accrual to Address the Primary Endpoint in Phase III Clinical Trials from U.S. Cooperative Oncology Groups

Purpose: Assessing impact of poor accrual on premature trial closure requires a relevant metric. We propose defining accrual sufficiency on apparent ability to address primary endpoints (PE) rather than attaining accrual targets. Experimental Design: All phase III trials open January 1, 1993, to December 31, 2002, by five U.S. oncology Clinical Trials Cooperative Groups (CTCG) were evaluated for accrual sufficiency and scientific results. Sufficient accrual included meeting accrual target, CTCGs documentation attesting adequate accrual, or conclusive results at interim analysis; insufficient accrual included poor accrual as cited closure reason or other reasons rendering a trial unable to address its primary endpoints. Closure rates based on our accrual sufficiency definition are compared with rates of meeting accrual targets and addressing the primary endpoints. A percentage of target accrual above which trials commonly answer the intended scientific question was identified to serve as an alternative to meeting full target accrual in designating accrual success. Results: Of 238 eligible trials, 158 (66%) closed with sufficient accrual. Among 80 trials with insufficient accrual, 70 (29%) closed specifically because of poor accrual. Inadequate accrual rates are overemphasized when defining accrual success solely by meeting accrual targets. Nearly 75% of trials conclusively addressed the primary endpoints with positive results in 39% of trials. Exceeding 80% of target accrual serves as a reliable proxy for answering the intended scientific question. Conclusions: Approximately one third of phase III trials closed with insufficient accrual to address the primary endpoints, primarily due to poor accrual. Defining accrual sufficiency broader than meeting accrual targets represents a fairer account of trial closures. Clin Cancer Res; 18(1); 256–62. ©2011 AACR.

Travel Distance to Mammography and the Early Detection of Breast Cancer

To the Editor: Early breast cancer detection through mammography screening has contributed to improved survival rates (1). Only 61.5% of American women over age 40 obtained a mammogram in 2001, as recommended by the American Cancer Society (2). Reasons for not adhering to mammography screening recommendations include lack of physician recommendation, cultural preferences, and socioeconomic barriers (3). Geographic access to mammography facility has also been evaluated in relationship to screening rates and to disease stage at diagnosis with inconsistent results (4–7). Prior studies have focused on geographic access and mammography rates or geographic access on a county level and tumor stage at diagnosis. We examined the relationship of an easily understandable geographic access measure, namely driving distance, with the ultimate goal of breast cancer screening, namely early detection, in a statewide population. For our analysis, all incident, primary, female breast cancer cases diagnosed in Virginia in 2000–01 were collected from the Virginia Cancer Registry (VCR). Exclusion criteria included age at diagnosis younger than 40 since mammography screening recommendations do not apply, missing tumor size or stage data, and tumor size greater than 10 cm. Tumor size categories were based on AJCC definitions. Patient age at diagnosis, race, and home address as latitude ⁄ longitude were obtained from VCR. Race was coded as white people, black people, or other. Socioeconomic status (SES) was approximated using per capita income (PCI) data from the 2000 US Census (8), categorized as <

A theory-based decision aid for patients with cancer: Results of feasibility and acceptability testing of DecisionKEYS for cancer

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Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials.

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Construct Validation of a Cost-Effective Vessel Ligation Benchtop Simulator

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Research incentive program for clinical surgical faculty associated with increases in research productivity

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