BACKGROUND:Adjuvant radiotherapy is prescribed after breast-conserving surgery to reduce the risk of local recurrence. However, radiotherapy is inconvenient, costly, and associated with both short-term and long-term side effects. Clinicopathologic factors alone are of limited use in the identification of women at low risk for local recurrence in whom radiotherapy can be omitted. Molecularly defined intrinsic subtypes of breast cancer can provide additional prognostic information. METHODS:We performed a prospective cohort study involving women who were at least 55 years of age, had undergone breast-conserving surgery for T1N0 (tumor size <2 cm and node negative), grade 1 or 2, luminal A-subtype breast cancer (defined as estrogen receptor positivity of ≥1%, progesterone receptor positivity of >20%, negative human epidermal growth factor receptor 2, and Ki67 index of ≤13.25%), and had received adjuvant endocrine therapy. Patients who met the clinical eligibility criteria were registered, and Ki67 immunohistochemical analysis was performed centrally. Patients with a Ki67 index of 13.25% or less were enrolled and did not receive radiotherapy. The primary outcome was local recurrence in the ipsilateral breast. In consultation with radiation oncologists and patients with breast cancer, we determined that if the upper boundary of the two-sided 90% confidence interval for the cumulative incidence at 5 years was less than 5%, this would represent an acceptable risk of local recurrence at 5 years. RESULTS:Of 740 registered patients, 500 eligible patients were enrolled. At 5 years after enrollment, recurrence was reported in 2.3% of the patients (90% confidence interval [CI], 1.3 to 3.8; 95% CI, 1.2 to 4.1), a result that met the prespecified boundary. Breast cancer occurred in the contralateral breast in 1.9% of the patients (90% CI, 1.1 to 3.2), and recurrence of any type was observed in 2.7% (90% CI, 1.6 to 4.1). CONCLUSIONS:Among women who were at least 55 years of age and had T1N0, grade 1 or 2, luminal A breast cancer that were treated with breast-conserving surgery and endocrine therapy alone, the incidence of local recurrence at 5 years was low with the omission of radiotherapy. (Funded by the Canadian Cancer Society and the Canadian Breast Cancer Foundation; LUMINA ClinicalTrials.gov number, NCT01791829.).

LBA501 Background: Adjuvant breast RT is usually prescribed following BCS to reduce the risk of local recurrence (LR). However, this treatment is inconvenient, costly, and associated with acute and late toxicity. Traditional clinical pathological factors (CPFs) alone are limited in their ability to identify women with a low enough risk of LR to omit RT. Molecular defined intrinsic subtypes of BC provide additional prognostic information with luminal A having the lowest risk of recurrence. A retrospective analysis of a previous trial suggested that women >60 years with luminal A grade 1-2 T 1 N 0 BC treated by BCS and endocrine therapy alone had a low rate of LR ( JCO 2015; 33:2035). The utility of identifying luminal A subtype combined with CPFs has not been prospectively evaluated for its ability to guide RT decision-making. Methods: A prospective multicenter cohort study was performed. Eligibility criteria were: women ≥ 55 years; having undergone BCS for grade 1-2 T 1 N 0 BC; ≥ 1mm margins of excision; luminal A subtype (defined as: ER ≥ 1%, PR>20%, HER2 negative and Ki67 ≤ 13.25%); and treated with adjuvant endocrine therapy. ER, PR and HER2 were performed locally as per ASCO guidelines. Patients meeting clinical eligibility with ER ≥ 1%, PR>20%, HER2 negative BC were registered and had Ki67 immunohistochemistry performed centrally in one of three Canadian laboratories using International Ki67 Working Group methods. Proficiency testing between laboratories was performed yearly. Patients with Ki67 ≤ 13.25% were enrolled in the trial and were assigned to not receive RT. The primary outcome was LR defined as time from enrollment to any invasive or non-invasive cancer in the ipsilateral breast. Assuming a 5-year LR rate of 3.5%, 500 patients were required to show that the upper bound of a two sided 90% (one-sided 95%) confidence interval (CI) was <5%. Patients were followed every six months for the first two years and then yearly. The probability of LR was estimated using the cumulative incidence function with death as a competing risk. Secondary outcomes were contralateral BC; relapse free survival (RFS) based on any recurrence; disease free survival (DFS) based on any recurrence, second cancer or death; and overall survival (OS). Results: From August 2013 to July 2017, 501 of 727 registered patients from 26 centers had a Ki67 ≤ 13.25% and were enrolled. Median follow-up was 5 years. Median age was 67 and 442 (88%) patients were <75 years. Median tumor size was 1.1 cm. The 5-year rate of LR satisfied our pre-specified boundary (see Table). Conclusions: Women ≥ 55 years with grade 1-2 T 1 N 0 luminal A BC following BCS treated with endocrine therapy alone had very low rates of LR at 5 years and are candidates for omission of RT. Clinical trial information: NCT01791829. [Table: see text]

Identification of women with DCIS who have a very low risk of local recurrence risk (LRR) after breast-conserving surgery (BCS) is needed to de-escalate therapy. We evaluated the impact of 10-year LRR estimates after BCS, calculated by the integration of a 12-gene molecular expression assay (Oncotype Breast DCIS Score®) and clinicopathological features (CPFs), on its ability to change radiation oncologists’ recommendations for RT after BCS for DCIS. Prospective cohort study of women with DCIS treated with BCS. Eligibility criteria were as follows: age > 45 years, tumor ≤ 2.5 cm, and margins ≥ 1 mm. Radiation oncologists provided 10-year LRR estimates without RT and recommendation for RT pre- and post-assay. Primary outcome was change in RT recommendation. 217 patients were evaluable, with mean age = 63 years, mean tumor size = 1.1 cm, and mean DCIS Score = 32; 140 (64%) were in the low-risk (<39), 32 (15%) were in the intermediate-risk (39–54), and 45 (21%) were in the high-risk groups (≥55). The assay led to a change in treatment recommendation in 76 (35.2%) (95%CI 29.1–41.8%) patients. RT recommendations decreased from 79% pre-assay to 50% post-assay (difference = 29%; 95%CI 22–35%) due to a significant increase in the proportion of patients with a predicted low LRR (< 10%) post-assay and recommendations to omit RT for those with a low predicted risk. The assay was associated with improved patient satisfaction and reduced decisional conflict. The DCIS Score assay combined with CPFs identified more women with an estimated low (<10%) 10-yr LR risk after BCS, leading to a significant decrease in recommendations for RT compared to estimates based on CPFs alone.

Abstract Background: Guidelines recommend that breast radiation (RT) can be omitted for patients with a low risk of local recurrence (LR) after breast-conserving surgery (BCS) for DCIS. The inability to identify women at low risk of LR (<10%) at 10 years after BCS has hampered efforts to de-escalate therapy for DCIS. The Oncotype DX Breast DCIS Score® (DS), a 12-gene expression assay, predicts LR risk after BCS. The revised DS report adds information from the DS with clinicopathological features (CPF) (age, tumor size, year) (BCRT 2018;169;358-690) to provide refined estimates of LR risk and can better identify patients with low 10-year LR risk (<10%) after BCS. We evaluated the impact of refined LR risk estimates on its ability to change radiation oncologists’ recommendations for RT in women with low/moderate risk DCIS treated with BCS. Methods: Prospective cohort study of women with low/moderate risk pure DCIS treated with BCS. Cases with age <45 yrs, margins <1mm, tumor >2.5cm, multifocality, or prior breast cancer were excluded. Baseline CPFs, the DS and risk of LR were collected. Pre-assay, the radiation oncologist provided an estimate of 10-year LR risk without RT and a preliminary recommendation for RT. Post-assay, final recommendations were recorded. The primary outcome was change in treatment recommendation by the radiation oncologist. Target sample size was 220 to provide data on 200 evaluable patients with adequate precision. Results: 217 patients were evaluable: mean age, 63 years and mean tumor size, 1.1 cm. Nuclear grade was low in 26 (12%), intermediate in 116 (53%), and high in 75 (35%) of patients. Mean DS = 32; 140 (64%) low (<39), 32 (15%) intermediate (39-54), 45 (21%) high risk DS (≥5). The assay lead to a change in treatment recommendation in 35.2% (76/216) (95% CI: 29.1-41.8) of cases. The proportion of cases recommended to receive RT decreased from 79% (N=171) pre-assay to 50% post-assay (p<.001). This was due to a significant increase in the proportion of cases (46%) with a predicted low risk of LR (<10%) post-assay and recommendations to omit RT for those with low LR risk. Pre-assay, physician estimates of 10-yr LR risks after BCS based on CPFs alone were <10% in 13 (6%) cases, 10-15% in 76 (35%) cases and >15% in 128 (59%) cases. Post-assay, estimated 10-yr LR risk after BCS was <10% in 101 (46%) patients (83% recommended no RT), 10-15% in 67 (31%) (RT recommended in 66%) and >15% in 49 (22%) (RT recommended in 98%). Conclusion: The use of the DCIS Score combined with CPFs identifies more women with an estimated low (<10%) 10-yr LR risk after BCS leading to a significant change in treatment recommendations with a decrease in recommendations for RT following BCS compared to CPFs alone. Table 1.Post-assay 10-yr LR risk<10%10-15%>15%(N=101)(N= 67)(N=49)Pre-assay estimated 10-yr LR risk• <10% (N=13)922• 10-15% (N=76)50188• >15% (N=128)424739RT recommended• Yes17 (17%)44 (66%)48 (98%)• No83 (83%)23 (34%)1 (2%) Citation Format: Eileen Rakovitch, Anne Koch, Laval Grimard, Hany Soliman, Christiaan Stevens, Francisco Perera, Iwa Kong, Senti Senthelal, Margaret Anthes, Ericka Wiebe, Jeffrey Cao, Mira Goldberg, Sally Smith, Luciana Spadafora, Sameer Parpia, Timothy Whelan. Refined local recurrence risk estimates based on a multigene expression assay combined with clinicopathological features significantly impacts radiotherapy recommendation in patients with low/intermediate risk DCIS treated with breast-conserving surgery [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P6-16-01.

Background: Deep learning-based auto-segmented contours (DC) aim to alleviate labour intensive contouring of organs at risk (OAR) and clinical target volumes (CTV). Most previous DC validation studies have a limited number of expert observers for comparison and/or use a validation dataset related to the training dataset. We determine if DC models are comparable to Radiation Oncologist (RO) interobserver variability on an independent dataset. Methods: Expert contours (EC) were created by multiple ROs for central nervous system (CNS), head and neck (H&N), and prostate radiotherapy (RT) OARs and CTVs. DCs were generated using deep learning-based auto-segmentation software trained by a single RO on publicly available data. Contours were compared using Dice Similarity Coefficient (DSC) and 95% Hausdorff distance (HD). Results: Sixty planning CT scans had 2-4 ECs, for a total of 60 CNS, 53 H&N, and 50 prostate RT contour sets. The mean DC and EC contouring times were 0.4 vs 7.7 min for CNS, 0.6 vs 26.6 min for H&N, and 0.4 vs 21.3 min for prostate RT contours. There were minimal differences in DSC and 95% HD involving DCs for OAR comparisons, but more noticeable differences for CTV comparisons. Conclusions: The accuracy of DCs trained by a single RO is comparable to expert inter-observer variability for the RT planning contours in this study. Use of deep learning-based auto-segmentation in clinical practice will likely lead to significant benefits to RT planning workflow and resources. (C) 2019 Elsevier B.V. All rights reserved.

PURPOSE:The Cancer and Leukemia Group B (CALGB) 9343 trial randomized elderly women with estrogen receptor-positive, stage 1 breast cancer to receive either hormone therapy (HT) or HT and radiation therapy (HT-RT) after lumpectomy and showed no difference in survival. After this publication, a practice guideline made HT alone a standard treatment option in British Columbia. The subsequent population-based pattern of practice was studied. METHODS AND MATERIALS:All women aged 70 to 79 years, referred after lumpectomy from 1999 to 2009, with stage 1, estrogen receptor-positive breast cancer were identified. The use of adjuvant HT or HT-RT was evaluated in 2 eras: before (1999-2003) and after (2005-2009) the CALGB publication. The proportion receiving each treatment in these eras was determined. Kaplan-Meier analyses with Cox regression were used for survival endpoints. The Fine and Gray method was used with non-breast cancer death as a competing risk for event-free survival. The Charlson score was used to quantify comorbidity. Adherence was defined as dispensation of 80% of prescribed HT. RESULTS:HT-RT was used in 91% of patients before (n=319) and 89% of patients after (n=403) the CALGB publication (P=.4). In the HT-alone group, the rate of HT adherence was 75% at 1 year and 55% at 4 years. The 10-year locoregional recurrence-free survival rate was 98% with HT-RT and 90% with HT alone (P=.01), whereas the 10-year breast cancer-specific survival rate was 96% with HT-RT and 95% with HT alone (P=.2). Patients with grade 3 histology or lymphovascular invasion were more likely to have low event-free survival. On multivariate analysis, treatment type did not predict overall survival (P=.3). CONCLUSIONS:Our patient outcomes closely matched those of the CALGB trial, suggesting that its results are generalizable to a population of elderly breast cancer patients with typical HT adherence. The CALGB trial results, as well as the resulting practice guideline, did not change the use of adjuvant HT-RT in our population-based cancer program.

Objective To compare the perceptions of breast cancer survivors and primary care physicians (PCPs) about PCPs’ ability to deliver survivorship care in breast cancer. Design Mailed survey. Setting British Columbia. Participants A total of 1065 breast cancer survivors who had completed treatment of nonmetastatic breast cancer within the previous year, and 587 PCPs who had patients with nonmetastatic breast cancer discharged to their care within the preceding 18 months. Main outcome measures Breast cancer survivors’ and PCPs’ confidence ratings of PCPs’ ability to deliver the following aspects of care: screening for recurrence; managing osteoporosis, lymphedema, endocrine therapy, menopausal symptoms, and anxiety about or fear of recurrence; and providing nutrition and exercise counseling, sex and body image counseling, and family counseling. Response options for each question included low, adequate, or good. Responses were summarized as frequencies and compared using χ2 tests. Results Response rates for breast cancer survivors and PCPs were 47% and 59%, respectively. Responses were statistically different in all categories (P Conclusion Breast cancer survivors and PCPs are reasonably confident in a PCP-based model of survivorship care. Primary care physicians are confident in their ability to manage physical effects related to breast cancer, with the exception of lymphedema. Low confidence ratings among both groups in psychosocial aspects of care suggest an area for improvement.

Objective To compare the perceptions of breast cancer survivors and primary care physicians (PCPs) about PCPs’ ability to deliver survivorship care in breast cancer. Design Mailed survey. Setting British Columbia. Participants A total of 1065 breast cancer survivors who had completed treatment of nonmetastatic breast cancer within the previous year, and 587 PCPs who had patients with nonmetastatic breast cancer discharged to their care within the preceding 18 months. Main outcome measures Breast cancer survivors’ and PCPs’ confidence ratings of PCPs’ ability to deliver the following aspects of care: screening for recurrence; managing osteoporosis, lymphedema, endocrine therapy, menopausal symptoms, and anxiety about or fear of recurrence; and providing nutrition and exercise counseling, sex and body image counseling, and family counseling. Response options for each question included low, adequate, or good. Responses were summarized as frequencies and compared using χ2 tests. Results Response rates for breast cancer survivors and PCPs were 47% and 59%, respectively. Responses were statistically different in all categories ( P < .05). Both groups were most confident in the ability of PCPs to screen for recurrence, but breast cancer survivors were 10 times as likely to indicate low confidence (10% of breast cancer survivors vs 1% of PCPs) in this aspect of care. More breast cancer survivors (23%) expressed low confidence in PCPs’ ability to provide counseling about fear of recurrence compared with PCPs (3%). Aspects of care in which both breast cancer survivors and PCPs were most likely to express low confidence included sex and body image counseling (35% of breast cancer survivors vs 26% of PCPs) and family counseling (33% of breast cancer survivors vs 24% of PCPs). Primary care physicians (24%) described low confidence in their ability to manage lymphedema. Conclusion Breast cancer survivors and PCPs are reasonably confident in a PCP-based model of survivorship care. Primary care physicians are confident in their ability to manage physical effects related to breast cancer, with the exception of lymphedema. Low confidence ratings among both groups in psychosocial aspects of care suggest an area for improvement.

To the Editor: We appreciate the comments from Drs Morgan and Vaidya. However, we respectfully disagree with the statement that “with fully informed consent, selected patients … may very well and reasonably be offered TARGIT treatment” in an off-protocol setting. We believe that 10- to 15-year follow-up is needed to appraise the effect of local recurrence on survival ( 1 Darby S. McGale P. Correa C. et al. Effect of radiotherapy after breast conserving surgery on 10-year recurrence and 15-year breast cancer death. Meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011; 378: 1707-1716 Abstract Full Text Full Text PDF PubMed Scopus (2750) Google Scholar ) and that the follow-up times in the available intraoperative radiation therapy trials are much too short to provide meaningful conclusions regarding long-term treatment efficacy and adverse effects. In Regard to Moran et al and Smith et alInternational Journal of Radiation Oncology, Biology, PhysicsVol. 90Issue 4PreviewTo the Editor: Two articles in a recent issue of International Journal of Radiation Oncology, Biology, Physics discuss issues pertaining to the use of radiation therapy in patients undergoing breast-conserving surgery. We find it contradictory that, on one hand, the editorial by Moran and Truong (1) counsels caution before intraoperative radiation therapy (IORT) can be considered in place of conventional external beam whole-breast radiation therapy for any patient, whereas the scientific study by Smith et al (2) investigates whether a group of patients can be identified for whom radiation therapy can be entirely omitted. Full-Text PDF

Purpose: To identify clinical and pathological factors that identify groups of women with stage I breast cancer with a 5-year risk of local recurrence (LR) <= 1.5% after breast-conserving therapy (BCS) plus whole-breast radiation therapy (RT).Methods and Materials: Study subjects were 5974 patients >= 50 years of age whose cancer was diagnosed between 1989 and 2006, and were referred with pT1 pN0 invasive breast cancer treated with BCS and RT. Cases of 5- and 10-year LR were examined using Kaplan-Meier methods. Recursive partitioning analysis was performed in patients treated with and without endocrine therapy to identify combinations of factors associated with a 5-year LR risk <= 1.5%.Results: The median follow-up was 8.61 years. Median age was 63 years of age (range, 50 to 91). Overall 5-year LR was 1.5% (95% confidence interval [CI], 1.2%-1.9%) and 10-year LR was 3.4% (95% CI, 2.8%-4.0%). Of 2830 patients treated with endocrine therapy, patient subsets identified with 5-year LR <= 1.5% included patients with grade 1 histology (n=1038; LR, 0.2%; 95% CI, 0%-0.5%) or grade 2 histology plus >= 60 years of age (n=843; LR, 0.5%; 95% CI, 0%-1.0%). Ten-year LR for these groups were 0.8% (95% CI, 0.1%-1.6%) and 0.9% (95% CI, 0.2%-1.6%), respectively. Of 3144 patients treated without endocrine therapy, patients with grade 1 histology plus clear margins had 5-year LR <= 1.5% (n=821; LR, 0.6%; 95% CI, 0.1%-1.2%). Ten-year LR for this group was 2.2% (95% CI, 1.0%-3.4%).Conclusions: Histologic grade, age, margin status, and use of endocrine therapy identified 45% of a population-based cohort of female patients over age 50 with stage I breast cancer with a 5-year LR risk <= 1.5% after BCS plus RT. Prospective study is needed to evaluate the safety of omitting RT in patients with such a low risk of LR. (C) 2014 Elsevier Inc.

Purpose: To evaluate whether local recurrence (LR) risk has changed over time among women with stage I breast cancer treated with breast-conserving therapy.Methods and Materials: Subjects were 5974 women aged >= 50 years diagnosis with pT1N0 breast cancer from 1989 to 2006, treated with breast-conserving surgery and radiation therapy. Clinicopathologic characteristics, treatment, and LR outcomes were compared among 4 cohorts stratified by year of diagnosis: 1989 to 1993 (n=1077), 1994 to 1998 (n=1633), 1999 to 2002 (n=1622), and 2003 to 2006 (n=1642). Multivariable analysis was performed, with year of diagnosis as a continuous variable.Results: Median follow-up time was 8.6 years. Among patients diagnosed in 1989 to 1993, 1994 to 1998, 1999 to 2002, and 2003 to 2006, the proportions of grade 1 tumors increased (16% vs 29% vs 40% vs 39%, respectively, P<.001). Surgical margin clearance rates increased from 82% to 93% to 95% and 88%, respectively (P<.001). Over time, the proportions of unknown estrogen receptor (ER) status decreased (29% vs 10% vs 1.2% vs 0.5%, respectively, P<.001), whereas ER-positive tumors increased (56% vs 77% vs 86% vs 86%, respectively, P<.001). Hormone therapy use increased (23% vs 23% vs 62% vs 73%, respectively, P<.001), and chemotherapy use increased (2% vs 5% vs 10% vs 13%, respectively, P<.001). The 5-year cumulative incidence rates of LR over the 4 time periods were 2.8% vs 1.7% vs 0.9% vs 0.8%, respectively (Gray's test, P<.001). On competing risk multi-variable analysis, year of diagnosis was significantly associated with decreased LR (hazard ratio, 0.92 per year, P=.0003). Relative to grade 1 histology, grades 2, 3, and unknown were associated with increased LR. Hormone therapy use was associated with reduced LR.Conclusion: Significant changes in the multimodality management of stage I breast cancer have occurred over the past 2 decades. More favorable-risk tumors were diagnosed, and margin clearance and systemic therapy use increased. These changes contributed to the observed declining LR rates among patients treated with breast-conserving therapy. (C) 2014 Elsevier Inc.

PURPOSE:An Institute of Medicine report recommends that patients with cancer receive a survivorship care plan (SCP). The trial objective was to determine if an SCP for breast cancer survivors improves patient-reported outcomes.PATIENTS AND METHODS:Women with early-stage breast cancer who completed primary treatment at least 3 months previously were eligible. Consenting patients were allocated within two strata: less than 24 months and ≥ 24 months since diagnosis. All patients were transferred to their own primary care physician (PCP) for follow-up. In addition to a discharge visit, the intervention group received an SCP, which was reviewed during a 30-minute educational session with a nurse, and their PCP received the SCP and guideline on follow-up. The primary outcome was cancer-related distress at 12 months, assessed by the Impact of Event Scale (IES). Secondary outcomes included quality of life, patient satisfaction, continuity/coordination of care, and health service measures.RESULTS:Overall, 408 survivors were enrolled through nine tertiary cancer centers. There were no differences between groups on cancer-related distress or on any of the patient-reported secondary outcomes, and there were no differences when the two strata were analyzed separately. More patients in the intervention than control group correctly identify their PCP as primarily responsible for follow-up (98.7% v 89.1%; difference, 9.6%; 95% CI, 3.9 to 15.9; P = .005).CONCLUSION:The results do not support the hypothesis that SCPs are beneficial for improving patient-reported outcomes. Transferring follow-up to PCPs is considered an important strategy to meet the demand for scarce oncology resources. SCPs were no better than a standard discharge visit with the oncologist to facilitate transfer.

Background and Objectives: Increasing numbers of women are surviving breast cancer, and survivorship care is becoming more complex. Primary care physicians provide care for most survivors of breast cancer in the Canadian province of British Columbia. The present study offers insight into the confidence of primary care physicians in their abilities to provide such care. It also explores potential ways to assist those providers in enhancing this aspect of their practice. Methods: A questionnaire was mailed to 1000 primary care physicians caring for survivors of breast cancer. The questionnaire explored the perspectives of the responding physicians on their ability to manage various aspects of survivorship care for breast cancer patients, identified preferences for the content and format of communication from oncologists at the time of transition from active oncology treatment to survivorship, and determined the means most commonly used to obtain knowledge about breast cancer. This 1-page, 31-item checkbox and open-answer questionnaire assessed the perceptions of primary care physicians about the care of breast cancer survivors after completion of active treatment and their personal preferences for resources providing information about breast cancer. Results: The questionnaire response rate was 59%. Primary care physicians reported being most confident in screening for recurrence and managing patient anxiety; they were least confident in managing lymphedema and providing psychosocial counselling. Compared with physicians following fewer survivors of breast cancer, those who followed more breast cancer survivors had higher confidence in managing the biomedical aspects of follow-up and in providing counselling about nutrition and exercise. Most physicians found discharge letters from oncologists to be useful. Point-form discharge information was preferred by 43%; detailed description, by 19%; and both formats, by 38%. The most useful information items identified for inclusion in a discharge letter were a diagnosis and treatment summary and the recommended surveillance and endocrine therapy. Continuing medical education events and online resources were the means most commonly used to obtain knowledge about breast cancer. Conclusions: Primary care physicians who provide follow-up for survivors of breast cancer report that they are confident in managing care and satisfied with discharge letters containing a diagnosis and treatment summary, and recommendations for surveillance and endocrine treatment. At the time of patient discharge, additional information about common medical and psychosocial issues in this patient population would be useful to primary care physicians. Preferred means to access current breast cancer information include continuing medical education events and online resources.

Introduction Survivors of breast cancer (SBC) constitute the largest population of cancer survivors. Needs for survivorship care may vary according to life stage and urban/rural place of residence. This study was conducted to better understand patient preferences for survivorship care plans (SCP). Methods Patients were identified through cancer agency electronic records and invited to participate by mail. Sessions were stratified by age and rural/urban place of residence. Participants were asked about preferences for content and format of SCP. Focus groups were conducted using a semi-structured format with interviews being taped, transcribed, cross-checked for accuracy, and analyzed independently, using constant comparative methods. Results Preferred SCP key elements included treatment summary, information on nutrition/exercise, expected side effects, signs and symptoms of recurrence, recommended follow-up schedule, information sent to primary care physician, and updates on changes. SBC emphasized preference for individualized content depending upon physical and psychosocial effects. No difference was observed between preferred SCP content among patients residing in urban/rural areas. Rural participants preferred electronic formats for ongoing information bulletins and communication with health care providers. Discussion/conclusions SBC from all age groups identify common preferences for key SCP elements with individualized content reflecting the wide variation observed among physical and psychosocial effects of breast cancer. Patterns of key psychological, social, and physical effects observed at different life stages may help SCP customization. Implications for cancer survivors Results provide direction for designing key content and format of SCP and also provide information about elements of care planning that should be customized to individual patient needs.

Introduction: Curative treatment of stage I non-small cell lung cancer (NSCLC) in elderly patients represents a therapeutic challenge. Data examining outcomes for the elderly after radical radiotherapy (RT) or surgery in the same geographic population are limited.Methods: Using prospective databases from British Columbia, patients with stage I NSCLC treated curatively with either surgery or RT between 2000 and 2006 were identified. Kaplan-Meier, Cox regression, and competing risk analyses were used to assess overall survival (OS) and disease-specific survival in the elderly, and the relationship between age and survival outcomes.Results: Of a total of 558 patients with stage I disease, 310 (56%) received surgery and 248 (44%) received RT. Elderly patients (age >= 75 years) were less likely to undergo resection than their younger counterparts (43% versus 72%, p < 0.0001). Actuarial OS after surgery for elderly patients was 87% at 2 years and 69% at 5 years. On multivariate analysis, OS after surgery was dependent on tumor stage (p = 0.034) and performance status (p = 0.03), but not age (p = 0.87). After RT, actuarial OS for elderly patients was 53% at 2 years and 23% at 5 years. On multivariate analysis, age did not predict for OS after RT (p = 0.43), whereas tumor stage (p = 0.033), sex (p = 0.044), and dose (p = 0.01) were significant predictors.Conclusions: Survival after radical treatment for stage I NSCLC is dependent on factors such as tumor stage, performance status, sex, and RT dose, but not age. Elderly patients who are sufficiently fit should not be considered ineligible for radical treatment based on age alone.

Purpose: To evaluate comorbidities, patterns of care and outcomes for patients with inoperable stage I and II non-small cell lung cancer (NSCLC).Materials and methods: Patients diagnosed with stage I or II NSCLC in British Columbia between 1996 and 2005 who did not undergo primary surgery and were referred for oncology assessment were identified in a retrospective analysis. Baseline comorbidity and pulmonary function data for patients treated with curative radiotherapy (CurRT; biologically effective dose [BED] >58 Gy(10)) were abstracted by chart review. Kaplan-Meier and Cox regression were used to determine factors associated with overall survival (OS) and cause-specific survival (CSS) based on treatment group [no radiotherapy (NoRT), palliative radiotherapy (PaIIRT), or CurRT].Results: Of 1043 patients identified, approximately 1/3 received CurRT, and these patients had better performance status and lower stage disease than the other groups. There was a high prevalence of comorbid conditions in the CurRT group; 90% of CurRT patients had an age-adjusted Charlson comorbidity index (CCI) score >= 5. CurRT patients had a median survival 1-year longer than patients treated with PaIIRT or NoRT (p < 0.0001). In CurRT patients, CCI was predictive of OS (HR 1.1 per point CCI increase; p = 0.044), but not CSS. Patients receiving PaIIRT with a BED > 50 Gy(10) had significantly longer OS than those receiving PaIIRT of <50 Gy(10) (p < 0.0001).Conclusions: Treatment of medically inoperable early stage NSCLC patients with CurRT is associated with a significantly longer survival, and for these patients CCI is a significant predictor of OS. For patients treated with PaIIRT, higher doses of palliative thoracic RT is associated with improved OS. (C) 2010 Elsevier Ireland Ltd. All rights reserved.

Data from cancer patients, including those with head and neck cancer, suggest that those treated for cure or long-term survival will accept significant morbidity to achieve small survival gains. Even so, almost 25% of patients with head and neck cancer ranked cure as only the second or third most important outcome, with items related to symptoms and functional outcomes, including appearance, ranking among the top three most important. Experienced oncologists understand that for a significant proportion of patients with cancer, maintaining or improving health-related quality of life (HRQOL) is an important objective when considering treatment choices. However, HRQOL is a more abstract notion than is “life or death,” and it is more difficult to measure. Oncologists have tended, particularly in the clinical research domain, to focus on survival as paramount, often at the expense of more relevant clinical outcomes. For example, in a meta-analysis of randomized, controlled trials on the use of palliative chemotherapy for incurable (recurrent and distant metastatic) head and neck cancer, it was found that reports of all studies included survival and tumor response but did not include outcomes that would measure palliative benefits. Several strategies have been explored to address this imbalance and to better align study end points with outcomes that matter to patients. Pain and emotional distress have been promoted as the fifth and sixth vital signs, respectively. Canada has chosen the rebalance focus (now called the cancer journey) as one of the few priority areas for action in its national cancer control strategy. Motivated by the adage “you can’t manage what you don’t measure,” a growing body of literature is promoting the measurement of pain, emotional distress, and HRQOL to focus attention on better managing these relatively neglected areas. In the early 1990s, the National Cancer Institute of Canada Clinical Trials Group instituted HRQOL measurement as a default requirement for all its comparative clinical trials. Clinical teams involved with management of head and neck cancer have benefited from a relatively active focus by researchers on quality-of-life measurement, with several validated instruments now available. This reflects the dramatic effects of the disease itself and the impact of treatment across several HRQOL domains, including physical, social, and emotional. With so much energy spent to refocus the clinical lens on the softer outcomes that matter to patients, it is ironic that the interest and curiosity of clinical oncologists with regard to the value of HRQOL measurement have peaked because of the link between HRQOL and survival, as if the field of HRQOL has gained more credibility because of its association with this outcome. This phenomenon was most obviously illustrated when Spiegel et al reported their observation that a psychosocial intervention designed to address emotional wellbeing in a randomized trial actually had an impact on survival. Despite several attempts, to our knowledge, this observation so far has not been reproduced. In this issue of Journal of Clinical Oncology, Meyer et al report on quality-of-life measurement as an independent prognostic indicator for survival in patients with early-stage (I and II) squamous cell head and neck cancer. This is the fourth in a series of reports emanating from a well-designed and well-executed placebo-controlled, randomized trial. The primary objective of this trial was to evaluate the role of antioxidant medications (ie, beta carotene and vitamin E) in the occurrence of second primary cancers, with overall survival as one of several secondary outcomes. In the three previous reports of this trial, the investigators established that the use of antioxidant medications did not reduce the frequency of second primary cancers, was associated with reduced overall survival, and was not associated with improvement in HRQOL, although there were mixed effects on acute adverse events depending on the subgroup analysis used. In the previous reports in this series, all comparisons were directed at the randomized groups, whereas the report by Meyer et al in this issue of JCO presents results from a pooled analysis of the randomized groups. Multivariate statistics including a Cox proportional hazards model were used to determine the independent contributions of different factors to prognosis, including baseline HRQOL and the change scores at 6 months after completion of radiotherapy. Meyer et al report that for every 10-point difference in baseline HRQOL score, there was a corresponding 13% difference in risk of mortality in the expected direction (ie, favoring better HRQOL). The physical functioning domain was the only change score at 6 months that independently predicted survival, with a mortality hazard ratio of 0.75 at 1 year for every 10 points of change. However, over time, its predictive performance diminished. As appropriately cited by Meyer et al, there have been numerous similar observations of the predictive performance of HRQOL JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 27 NUMBER 18 JUNE 2

Purpose: To determine the rate of change in the cross-sectional area of the masticatory muscles after radiotherapy.Methods and Materials: Eligible patients had undergone unilateral radiotherapy between 1993 and 2000 and had a baseline CT scan, a comparable follow-up CT scan a minimum of 1 year later, and no recurrence of cancer. Fourteen patients had their CT series scanned into digital image files. Two anatomically selected CT slices were bisected by the midline sagittal plane and stored under randomly assigned file names. Three observers measured the masseter and medial pterygoid areas on two occasions.Results: The intraobserver reliability of the muscle area measurements was 96.3% for the masseter and 97.1% for the medial pterygoid. The interobserver reliability of the muscle area measurements was 96.7% for the masseter and 96.3% for the medial pterygoid. On the treated side, the muscles received a median dose of 56 Gy (range 47-63) in 2.0-0.4-Gy fractions. With a median follow-up of 2.9 years (range 1-7.6), mixed-effects regression analysis demonstrated a significant area of reduction of -0.17 cm(2)/y (p = 0001) for the masseter and -0.13 cm(2)/y (p = 0.001) for the medial pterygoid. The controlled rate of muscle atrophy was 3.9%/y (95% confidence interval 1.4-6.4) for the masseter and 2.3%/y (95% confidence interval -0.6 to 5.1) for the medial pterygoid.Conclusion: Standard therapeutic radiation doses appear to cause significant masticatory muscle atrophy. (C) 2003 Elsevier Inc.