Omitting Radiotherapy after Breast-Conserving Surgery in Luminal A Breast Cancer.

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.).

Effect of Supine vs Prone Breast Radiotherapy on Acute Toxic Effects of the Skin Among Women With Large Breast Size: A Randomized Clinical Trial.

Importance: Women with large breast size treated with adjuvant breast radiotherapy (RT) have a high rate of acute toxic effects of the skin. Breast RT in the prone position is one strategy that may decrease these toxic effects. Objective: To determine if breast RT in the prone position reduces acute toxic effects of the skin when compared with treatment in the supine position. Design, Setting, and Participants: This phase 3, multicenter, single-blind randomized clinical trial accrued patients from 5 centers across Canada from April 2013 to March 2018 to compare acute toxic effects of breast RT for women with large breast size (bra band ≥40 in and/or ≥D cup) in the prone vs supine positions. A total of 378 patients were referred for adjuvant RT and underwent randomization. Seven patients randomized to supine position were excluded (5 declined treatment and 2 withdrew consent), and 14 patients randomized to prone position were excluded (4 declined treatment, 3 had unacceptable cardiac dose, and 7 were unable to tolerate being prone). Data were analyzed from April 2019 through September 2020. Interventions: Patients were randomized to RT in the supine or prone position. From April 2013 until June 2016, all patients (n = 167) received 50 Gy in 25 fractions (extended fractionation) with or without boost (range, 10-16 Gy). After trial amendment in June 2016, the majority of patients (177 of 190 [93.2%]) received the hypofractionation regimen of 42.5 Gy in 16 fractions. Main Outcomes and Measures: Main outcome was moist desquamation (desquamation). Results: Of the 357 women (mean [SD] age, 61 [9.9] years) included in the analysis, 182 (51.0%) were treated in the supine position and 175 (49.0%) in prone. There was statistically significantly more desquamation in patients treated in the supine position compared with prone (72 of 182 [39.6%] patients vs 47 of 175 [26.9%] patients; OR, 1.78; 95% CI, 1.24-2.56; P = .002), which was confirmed on multivariable analysis (OR, 1.99; 95% CI, 1.48-2.66; P < .001), along with other independent factors: use of boost (OR, 2.71; 95% CI, 1.95-3.77; P < .001), extended fractionation (OR, 2.85; 95% CI, 1.41-5.79; P = .004), and bra size (OR, 2.56; 95% CI, 1.50-4.37; P < .001). Conclusions and Relevance: This randomized clinical trial confirms that treatment in the prone position decreases desquamation in women with large breast size receiving adjuvant RT. It also shows increased toxic effects using an RT boost and conventional fractionation. Trial Registration: ClinicalTrials.gov Identifier: NCT01815476.

DUCHESS: an evaluation of the ductal carcinoma in situ score for decisions on radiotherapy in patients with low/intermediate-risk DCIS.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Patient and family financial burden associated with cancer treatment in Canada: a national study.

GOAL: To determine patient-reported financial and family burden associated with treatment of cancer in the previous 28 days across Canada. METHODS: A self-administered questionnaire (P-SAFE v7.2.4) was completed by 901 patients with cancer from twenty cancer centres nationally (344 breast, 183 colorectal, 158 lung, 216 prostate) measuring direct and indirect costs related to cancer treatment and foregone care. Monthly self-reported out-of-pocket-costs (OOPCs) included drugs, homecare, homemaking, complementary/ alternative medicines, vitamins/supplements, family care, accommodations, devices, and "other" costs. Travel and parking costs were captured separately. Patients indicated if OOPC, travel, parking, and lost income were a financial burden. RESULTS: Mean 28-day OOPCs were CA$518 (US Purchase Price Parity [PPP] $416), plus CA$179 (US PPP $144) for travel and CA$84 (US PPP $67) for parking. Patients self-reporting high financial burden had total OOPCs (33%), of CA$961 (US PPP $772), while low-burden participants (66%) had OOPCs of CA$300 (US PPP $241). "Worst burden" respondents spent a mean of 50.7% of their monthly income on OOPCs (median 20.8%). Among the 29.4% who took time off work, patients averaged 18.0 days off. Among the 26.0% of patients whose caregivers took time off work, caregivers averaged 11.5 days off. Lastly, 41% of all patients had to reduce spending. Fifty-two per cent of those who reduced spending were families earning < CA$50,000/year. CONCLUSIONS: In our Canadian sample, high levels of financial burden exist for 33% of patients, and the severity of burden is higher for those with lower household incomes.

Implications of Oncoplastic Breast Surgery on Radiation Boost Delivery in Localized Breast Cancer.

Background Oncoplastic partial mastectomy (OPM) is a technique utilized to improve aesthetic and survivorship outcomes in patients with localized breast cancer. This technique leads to breast tissue rearrangement, which can have an impact on target definition for boost radiotherapy (BRT). The aim of this study was to determine if the choice of surgical technique independently affected the decision to deliver a radiation boost. Materials and methods This was a retrospective study of patients treated between January 2017 and December 2018. We selected consecutive patients based on surgical procedure: 50 undergoing standard breast-conserving surgery and 50 having had an OPM. The primary outcome was average treatment effect (ATE) of surgery type on reception of BRT. Secondary outcomes included ATE of surgery type on the time to reception of radiotherapy and incidence of ipsilateral breast tumor recurrence (IBTR). The ratio of boost clinical target volume (CTV) to pathologic tumor size was also compared between the two groups. Treatment effects regression adjustment and inverse-probability weighted analysis was used to estimate ATEs for both primary and secondary outcomes. Results For the entire cohort, the median age was 64 years (range: 37-88 years). The median tumor size was 1.5 cm (range: 0.1-6.5 cm). The majority of patients were with ≤ stage IIA (78%), invasive ductal subtype (80%), negative lymphovascular space invasion (78%), negative margin (90%), and positive ER/PR (estrogen receptor/progesterone receptor) (69%). Overall, surgical technique was not associated with differences in the proportion of patients receiving BRT (ATE: 6.0% [95% CI: -4.5 to 16.0]). There were no differences in delays to radiation treatment between the two groups (ATE: 32.8 days [95% CI: -22.1 to 87.7]). With a median follow-up time of 419 days (range: 30-793 days), there were only five recurrences, with one case of IBTR in each group. There was no difference in the ratio of CTV volume to tumor size between the two groups (p=0.38). Conclusions OPM did not affect the decision to offer localized BRT following standard whole breast radiotherapy or significantly affect treatment times or radiation volumes. The decision to offer OPM should include a multi-disciplinary approach.

Synchronous wearable wireless body sensor network composed of autonomous textile nodes.

A novel, fully-autonomous, wearable, wireless sensor network is presented, where each flexible textile node performs cooperative synchronous acquisition and distributed event detection. Computationally efficient situational-awareness algorithms are implemented on the low-power microcontroller present on each flexible node. The detected events are wirelessly transmitted to a base station, directly, as well as forwarded by other on-body nodes. For each node, a dual-polarized textile patch antenna serves as a platform for the flexible electronic circuitry. Therefore, the system is particularly suitable for comfortable and unobtrusive integration into garments. In the meantime, polarization diversity can be exploited to improve the reliability and energy-efficiency of the wireless transmission. Extensive experiments in realistic conditions have demonstrated that this new autonomous, body-centric, textile-antenna, wireless sensor network is able to correctly detect different operating conditions of a firefighter during an intervention. By relying on four network nodes integrated into the protective garment, this functionality is implemented locally, on the body, and in real time. In addition, the received sensor data are reliably transferred to a central access point at the command post, for more detailed and more comprehensive real-time visualization. This information provides coordinators and commanders with situational awareness of the entire rescue operation. A statistical analysis of measured on-body node-to-node, as well as off-body person-to-person channels is included, confirming the reliability of the communication system.

Improved wait time intervals for prostate cancer patients in a multidisciplinary rapid diagnostic unit compared to a community-based referral pattern.

BACKGROUND: Wait times in cancer diagnosis and treatment may significantly affect a patient's treatment outcome, prognosis and quality of life. The purpose of this study was to capture wait time intervals for patients with prostate cancer treated with radiotherapy (RT) at the Odette Cancer Centre, Toronto, Ontario, Canada and to compare patients diagnosed in a rapid diagnostic unit (RDU) versus the usual community referral process. METHODS: Patients agreed to participate in the study during their RT planning sessions. A semi-structured interview and chart abstraction was conducted to record key wait time milestones. RESULTS: A total of 87 patients participated in the study: 44 RDU patients and 43 community patients. The median overall wait time intervals from suspicion of prostate cancer to RT was 138 and 183 days, respectively (p = 0.046). There were statistically significant differences observed for other key wait time intervals favouring the RDU cohort: suspicion to decision-to-treat (DTT; p = 0.012), urologist visit to diagnosis (p = 0.0094), diagnosis to DTT (p = 0.018), and diagnosis to treatment (p = 0.016). Risk category and Gleason sum was independently predictive of longer intervals from diagnosis to DTT. INTERPRETATION: Wait time intervals from suspicion to treatment are significantly shorter for prostate cancer patients in 2011 to 2012 than in 2003 when patients were diagnosed and referred in the community setting. A prostate-specific RDU further reduced a number of key wait time intervals supporting more multidisciplinary RDUs for common diseases. Further work needs to be done to identify why delays are occurring and to develop new processes to minimize delays.

The development and validation of a quality-of-life questionnaire for head and neck cancer patients with enteral feeding tubes: the QOL-EF.

PURPOSE: To develop a questionnaire that measures the impact of enteral feeding tubes (EFTs) on the quality of life (QOL) of head and neck cancer (HNC) patients METHODS: The development of the questionnaire (QOL-EF) was done in four phases. Phase 1-3 included: (1) literature review and consultation with an expert focus group (item generation), (2) pilot-testing in 12 patients and, (3) judgmental item reduction. In phase 4, the QOL-EF, FACT-H&N, and UW-QOL were administered to a cross-sectional group of HNC patients on active EFT feeding to test the reliability and validity of the QOL-EF. RESULTS: A 20-item QOL-EF was developed. In phase 4, 72 patients were accrued over 2.5 years, 31 of which were part of the test-retest subgroup. Cronbach's α for the QOL-EF was 0.73, and test-retest reliability was 0.83. Moderate correlations were observed between scores for the QOL-EF and both the FACT-H&N (-0.58) and the UW-QOL (-0.42). CONCLUSIONS: The QOL-EF is a treatment-specific QOL instrument developed and validated for use in HNC patients with EFTs. It may become an important tool in evaluating treatment outcomes and complications in these patients.

Retrospective study of palliative radiotherapy in newly diagnosed head and neck carcinoma.

PURPOSE: To examine the patterns of care, outcomes, and prognostic factors for patients with head-and-neck cancer (HNC) treated with palliative radiotherapy (RT). METHODS AND MATERIALS: An institutional HNC anthology and electronic patient records were used to identify patients with previously untreated HNC of mucosal or salivary gland origin who underwent palliative RT at our institution between July 2003 and June 2008. Overall survival was determined from the start date of RT to either the date of death or the date of last follow-up for living patients. The data were censored if the subject was either lost to follow-up or had not been seen for follow-up at our institution for ≥4 months. RESULTS: We identified 148 eligible patients. The median age was 72 years (range, 19-94). Of the 148 patients, 12 had Stage II-III, 39 Stage IVA, 36 Stage IVB, and 54 Stage IVC; for 7 patients, the stage was unknown. Oropharyngeal primary cancer (40) was the most common primary site. The Eastern Cooperative Oncology Group performance status was 0 in 15, 1 in 69, 2 in 40, 3 in 19, and 4 in 5 patients. The Adult Co-morbidity Evaluation-27 scale was 0 in 33, 1 in 47, 2 in 44, and 3 in 21. The median radiation dose was 50 Gy (range, 2-70), the median fraction number was 20 (range, 1-40), and the median total treatment time (including breaks) was 29 days (range, 1-80). At analysis, 108 patients (73%) had died, 20 (13.5%) were alive, and 20 (13.5%) had been censored. The median follow-up was 4.8 months, and the median survival time was 5.2 months. Information on the treatment response was available for 103 patients (70%). On multivariate analysis, the radiation dose was an independent predictor of both overall survival (hazard ratio 0.97, 95% confidence interval 0.96-0.99, p <.01) and treatment response (odds ratio 1.05, 95% confidence interval 1.01-1.08, p <.01). CONCLUSION: For patients considered unsuitable for curative RT, the radiation dose might be an independent predictive factor for both overall survival and treatment response. Additional research is required to more effectively select those patients who might benefit from more aggressive treatment.

Wait times in prostate cancer diagnosis and radiation treatment.

INTRODUCTION: Wait times for cancer diagnosis and treatment are a significant concern for Canadians. Men with prostate cancer experience longer waiting times for diagnosis and treatment than those observed for other cancers. Longer waits are associated with both patient and family psychosocial distress and may be associated with worse prognosis. METHODS: Men referred for treatment of prostate cancer at a single Canadian cancer centre were interviewed. The intervals from suspicion to definitive therapy were calculated, factors associated with delays along this pathway were identified, and common causes of delay identified by patients were described. RESULTS: A total of 41 consecutive patients participated. The median interval from suspicion to the first fraction of radiotherapy for all patients was 247 days (interquartile range [IQR] 168-367 d). The median diagnostic interval was 53 days (IQR 28-166 d). The median treatment interval was 127 days (IQR 100-180 d). Patients under 70 years old and patients with