Does a dedicated program for young breast cancer patients affect the likelihood of fertility preservation discussion and referral?

PurposeTo assess whether a dedicated program for young breast cancer patients, including a nurse navigator, improves the frequency of: a) fertility discussion documentation and b) fertility preservation (FP) referrals.MethodsA retrospective chart review and prospective survey were undertaken of breast cancer patients diagnosed at age 40 or younger between 2011 and 2013 who received adjuvant or neo-adjuvant chemotherapy at two academic cancer centers in Toronto, Canada. The Odette Cancer Centre (OCC) has a dedicated program for young breast cancer patients while Princess Margaret Cancer Centre (PM) does not. Patient demographics, tumor pathology, treatment and fertility discussion documentation prior to systemic chemotherapy administration were extracted from patient records. Prospective surveys were administered to the same cohort to corroborate data collected.ResultsEighty-one patient charts were reviewed at both OCC and PM. Forty-seven and 49 at OCC and PM returned surveys for a response rate of 58% and 60% respectively. Chart reviews demonstrated no difference in the frequency of fertility discussion documentation (78% versus 75% for OCC and PM, p = 0.71); however, surveys demonstrated higher rates of recall of fertility discussion at OCC (96% versus 80%, p = 0.02). A greater proportion of women were offered FP referrals at OCC, as observed in chart reviews (56% versus 41%, p = 0.09), and surveys (73% versus 51%, p = 0.04). Time to initiation of chemotherapy did not differ between women who underwent FP and those who did not.ConclusionA dedicated program for young breast cancer patients is associated with a higher frequency of FP referrals without delaying systemic therapy.     

Contraception counseling for young breast cancer patients: A practical needs assessment and a survey among medical oncologists

Background/methodsWe analyzed an unselected, consecutive cohort of young breast cancer (BC) patients (≤40 years, n = 100) with regard to the contraceptive methods used at the time of diagnosis. Based on this data, we assessed the individual need for contraceptive counseling before cancer therapy. Secondly, in a study-specific self-report questionnaire, we surveyed 101 medical oncologists with the aim of evaluating attitudes towards contraception and how young patients are being counseled in the practical clinical setting.ResultsIn 62% of our cohort of young BC patients, we identified situations in which contraceptive counseling was necessary at the time of BC diagnosis. The patients did not use contraception or used an ineffective method (TIER III/IV, 42%), or were using hormonal methods (12%) or IUDs (8%).Almost all respondents of the survey (99%) stated that contraception is an important aspect in the surveillance of young BC patients and the vast majority (90%) discussed this item before starting therapy. Only 20% of the respondents reported that they a) inform the patients that reliable contraception is necessary before starting therapy, b) ask whether contraceptive methods are used during ongoing therapy, and c) regularly refer their patients to specialist counseling by a gynecologist.ConclusionsA large proportion of young women require contraceptive counseling after newly diagnosed BC. Oncologists should be aware that the use of reliable contraceptive methods should not only be discussed before starting therapy, but also during ongoing therapy. Oncologists should consider actively referring their young patients to gynecologists to ensure proper contraceptive counseling.     

Pregnancy after breast cancer: The importance of active counselling and planning

AimTo investigate the effect of breast cancer, its treatment and counselling on future pregnancy and fertility.MethodThree hundred and four women 45 years and younger at the time of diagnosis of breast cancer were identified from one breast unit from 1997 to 2006. A questionnaire was sent to all patients asking about pregnancy, counselling and fertility issues.ResultsOf 304 women, 248 were still alive and not lost to follow up. The questionnaire response rate was 66% and the average follow up was 60 months. By questionnaire response, 39 women had wanted children before diagnosis, and 24 still wanted them post treatment, giving a successful pregnancy rate of 75%. Eighteen patients have become pregnant, 4 with more than one pregnancy. 107 patients were specifically counselled about fertility prior to breast cancer treatment. The mortality due to breast cancer was 10% in non-pregnant patients and 6% in patients who became pregnant after breast cancer.ConclusionPregnancy after breast cancer does not confer a poor prognosis. A higher rate of pregnancy than expected was found after treatment, possibly due to newer treatments including fertility preservation and also possibly due to the active counselling programme in this unit. Patients should have active counselling about fertility when planning treatment and fertility conservation can then be incorporated into a treatment plan.     

Prospective study to optimize care and improve knowledge on ovarian function and/or fertility preservation in young breast cancer patients: Results of the pilot phase of the PREgnancy and FERtility (PREFER) study

BackgroundDespite the availability of different strategies for ovarian function and/or fertility preservation in young breast cancer patients candidates for chemotherapy, limited data are available on patients’ actual need of these options.Patients and methodsThe PREFER study is a prospective cohort study including premenopausal women with newly diagnosed early stage breast cancer between the age of 18 and 45 years and candidates for chemotherapy. The study aimed to investigate patients' preferences and their choices of the different available strategies for ovarian function and/or fertility preservation (i.e. acceptance rate) and reasons for refusal.ResultsA total of 131 consecutive patients referred from a single breast unit were included. Median age was 38.9 years with 92 patients (70.3%) diagnosed at ≤ 40 years. The majority of patients (122, 93.1%) were concerned about the risk of treatment-induced premature ovarian insufficiency (POI) and/or infertility. A total of 120 (91.6%) patients underwent temporary ovarian suppression with gonadotropin-releasing hormone agonists during chemotherapy for ovarian function preservation. Among patients with ≤40 years, only 11 (12.0%) decided to access cryopreservation strategies for fertility preservation. The main reason for not accessing the fertility unit was completion of family planning before breast cancer diagnosis; for patients who accessed the fertility unit, fear of the procedure was the main reason to refuse the proposed cryopreservation strategies.ConclusionDespite the majority of young breast cancer patients are concerned about the risk of treatment-induced POI and/or infertility, only a limited number of them required to access the fertility unit to undergo cryopreservation strategies.     

Fertility concerns among breast cancer patients in Mexico

ObjectiveYoung women represent a high proportion of the total number of breast cancer (BC) patients in Mexico; however, no previous studies addressing their attitudes regarding the risk of chemotherapy-induced infertility and its contributing factors are available. The aim of this study was to evaluate the concerns of young women with BC towards the risk of infertility in two referral centers in Mexico with access to public health services.MethodsA cross-sectional study including women with newly or previously detected BC aged 40 years or younger at diagnosis was conducted. Variables regarding concerns about fertility were collected from an adapted version of the Fertility Issues Survey.Results134 consecutive eligible women responded to the in-person paper survey. 55% were partnered, 35.1% had no children, and 48% reported willingness to have children prior to BC diagnosis. Only 3% of patients considered to be able to afford extra expenses. At diagnosis, 44% of women expressed some level of concern about infertility risk. The only factor significantly associated with fertility concern was the desire of having children prior to diagnosis (OR 11.83, p = 0.006). Only 30.6% patients recalled having received information regarding infertility risk from their physicians.ConclusionA minority of young women with breast cancer in Mexico is informed about the risk of BC treatment-induced infertility, despite substantial interest. Informing all patients about infertility risk and available options for fertility preservation should be an essential aspect of the supportive care of young women with BC, even in low-middle income countries such as Mexico.     

Prognosis of HER2-positive pregnancy-associated breast cancer: Analysis from the French CALG (Cancer Associé à La Grossesse) network

IntroductionThe prevalence of pregnancy-associated breast cancer is increasing. HER2-positive breast cancers typically have a poor prognosis. The objective of our study was to compare the prognosis of patients with HER2-positive breast cancer diagnosed during pregnancy (HER2-positive BCP) to young women diagnosed with HER2-positive breast cancer outside of pregnancy (HER2 non-BCP).MethodsData of patients managed for invasive breast carcinoma between January 2005 and 2020 were retrospectively collected from the database of Tenon University Hospital (Paris, France), part of the “Cancer lié à la Grossesse” network.ResultsFifty-one patients with HER2-positive BCP were matched on age at diagnosis with 51 HER2-positive non-BCP patients. Locally advanced disease with axillary lymph node involvement were frequent. Tumors were frequently aggressive with high grade (p = 0.57) and high Ki67 (p = 0.15). Among the HER2-positive BCP patients, the mean term at diagnosis was 19.3 week of gestation (WG). Eighty-four percent of the patients continued their pregnancy with a mean term at delivery of 34.2WG. Chemotherapy modalities differed between the two groups: neoadjuvant chemotherapy was more frequent in the HER2-positive BCP group (p = 0.03) and adjuvant chemotherapy more frequent in the HER2 non-BCP group (p = 0.009). The recurrence rate was 10% (n = 5) and 18% (n = 9) in the HER2-positive BCP and HER2 non-BCP groups, respectively, p = 0.25. Breast cancer-free survival was poorer in the HER2-positive BCP group with earlier recurrence, p = 0.008. No difference in type of recurrence was found between the groups (p = 0.58).ConclusionThis matched case-control study implies that patients with HER2-positive BCP still have a poorer prognosis than non-pregnant HER-positive patients.     

Outcome of breast-conserving treatment for axillary lymph node metastasis from occult breast cancer with negative breast MRI

PurposeWe conducted this study to investigate the prognosis and failure pattern after breast-conserving treatment (BCT) in patients with occult breast cancer (OBC) with negative breast magnetic resonance imaging (MRI) (MRI-OBC).Materials and methodsSurvival rates and failure patterns in 66 patients who received axillary lymph node dissection (ALND) and BCT for MRI-OBC between 2001 and 2013 at seven hospitals were analyzed. OBC was defined as adenocarcinoma in the axillary lymph node (ALN) +/− supraclavicular (SCN) or internal mammary lymph node (IMN) with a negative breast MRI.ResultsFifty-four patients had only ALN metastasis (ALN only), and 12 patients had ALN metastasis along with SCN or IMN metastasis (ALN + SCN/IMN). Median follow-up was 82 months. The 5-year overall, disease-free, and breast cancer-free survival rates were 93.4%, 92.1%, and 96.8%, respectively. Nine patients experienced recurrence: breast (n = 4), regional lymph nodes (RLN, n = 1), distant metastases (DM, n = 2), breast/RLN (n = 1), and breast/RLN/DM (n = 1). Five-year disease-free survival was significantly higher in ALN only patients compared to ALN + SCN/IMN patients (96.1% vs. 75.0%; p = 0.02).ConclusionsPatients with MRI-OBC were successfully treated with BCT. There was a small risk of ipsilateral breast cancer recurrence. Failure patterns depended on the extent of initial disease.     

Strategies for fertility preservation in young early breast cancer patients

Diagnosis of breast cancer in young women poses a threat to fertility. Due to a recent trend of delaying pregnancy, an increasing number of breast cancer patients in reproductive age wish to bear children. Health care providers have the responsibility to know how to manage fertility issues in cancer survivors. Oncofertility counseling is of great importance to many young women diagnosed with cancer and should be managed in a multi-disciplinary background. Most of young breast cancer patients are candidate to receive chemotherapy, which could lead to premature ovarian failure. A baseline evaluation of ovarian reserve may help in considering the different fertility preservation options. The choice of the suitable strategy depends also on age, type of chemotherapy, partner status and patients' motivation. Various options are available, some established such as embryo and oocyte cryopreservation, some still experimental such as ovarian tissue cryopreservation and ovarian suppression with GnRHa during chemotherapy. An early referral to a reproductive specialist should be offered to patients at risk of infertility who are interested in fertility preservation.     

A high neutrophil-lymphocyte ratio and platelet-lymphocyte ratio are associated with a worse outcome in inflammatory breast cancer

IntroductionInflammatory breast cancer (IBC) is an uncommon, but aggressive form of breast cancer that accounts for a disproportionally high fraction of breast cancer related mortality. The aim of this study was to explore the peripheral immune response and the prognostic value of blood-based biomarkers, such as the neutrophil-to-lymphocyte ratio (NLR), in a large IBC cohort.Patients & methodsWe retrospectively identified 127 IBC patients and collected lab results from in-hospital medical records. The differential count of leukocytes was determined at the moment of diagnosis, before any therapeutic intervention. A cohort of early stage (n = 108), locally advanced (n = 74) and metastatic breast cancer patients (n = 41) served as a control population.ResultsThe NLR was significantly higher in IBC compared to an early stage breast cancer cohort, but no difference between IBC patients and locally advanced breast cancer patients was noted. In the metastatic setting, there was also no significant difference between IBC and nIBC. However, a high NLR (>4.0) remained a significant predictor of worse outcome in IBC patients (HR: 0.49; 95% CI: 0.24–1.00; P = .05) and a lower platelet-lymphocyte ratio (PLR) (≤210) correlated with a better disease-free survival (DFS) (HR: 0.51; 95% CI: 0.28–0.93; P = .03).ConclusionPatients with a high NLR (>4.0) have a worse overall prognosis in IBC, while the PLR correlated with relapse free survival (RFS). Since NLR and PLR were not specifically associated with IBC disease, they can be seen as markers of more extensive disease.     

Safety of cyclin-dependent kinase4/6 inhibitor combined with palliative radiotherapy in patients with metastatic breast cancer

IntroductionCyclin-dependent kinase (CDK)4/6 inhibitor is a first-line therapy for metastatic ER+/HER2-breast cancer. However, there are limited data on safety of combined radiotherapy (RT) and CDK4/6 inhibition.MethodsWe conducted a retrospective study of women with metastatic breast cancer who received palliative RT within 14 days of CDK4/6 inhibitor use. The primary endpoint was toxicity per Common Terminology Criteria for Adverse Events v5. Secondary endpoints were pain response and local control based on clinical assessment and imaging.ResultsThirty patients underwent 36 RT courses with palbociclib (n = 34 courses, 94.4%) or abemaciclib (n = 2, 5.6%). RT was delivered before, concurrently or after CDK4/6 inhibitors in 7 (19.4%), 8 (22.2%), and 21 (58.3%) of cases with median 3.5 days from RT to closest CDK4/6 inhibitor administration. Median RT dose was 30Gy (range 8–40.05Gy). Treated sites included brain (n = 5, 11.6%), spine (n = 19, 44.2%), pelvis (n = 9, 20.9%), other bony sites (n = 6, 14.0%) and others (n = 4, 9.3%). No acute grade ≥3 non-hematologic toxicity occurred. No increased hematologic toxicity was attributable to RT with grade 3 hematologic toxicities rates 16.7%, 0%, and 6.7% before, during, and 2 weeks after RT completion. All but one patient (29/30) achieved symptom relief. Local control rates were 94.4%, 91.7% at 6 and 12 months.ConclusionsThe use of RT within 2 weeks of CDK4/6 inhibitors had low acceptable toxicity and high efficacy, suggesting that it is safe for palliation of metastatic breast cancer.     

Does the 21-gene recurrence score have clinical utility in HR+/HER2+ breast cancer?

The 21-gene recurrence score assay has been validated as a predictive biomarker in early-stage HR+ and HER2-breast cancer. It is not indicated for use in HER2+ disease based on national guidelines. In this study, we assessed the value of 21-gene recurrence score (RS), or OncotypeDX (ODX), testing in HR+/HER2+ breast cancer.We used the National Cancer Database to identify patients with stages I-II, HR+/HER2+ breast cancer who received multi-gene testing with ODX. We then explored the prognostic and predictive value of this biomarker through various forms of survival modeling.ODX testing was performed in n = 5,280 patients. N = 2,678 patients (50.7%) had a RS < 26, while n = 2,602 (49.3%) had a RS ≥26. In Kaplan-Meier survival modeling for patients with recurrence scores <26, there was no significant difference in overall survival (p = 0.445) between patients receiving different systemic treatment regimens. However, when recurrence scores were ≥26, there was a statistically-significant difference in overall survival between systemic treatment regimens (p < 0.001). 5-year overall survival was highest (97.4%) for patients receiving triple therapy (anti-HER2 with chemotherapy and endocrine therapy), followed by those receiving dual therapy with endocrine and anti-HER2 (96.7%), and endocrine with chemotherapy (94.9%). Patients receiving endocrine therapy alone exhibited the lowest 5-year overall survival (88.5%).ResultsAnalysis from this large national cancer registry suggests that multigene testing may have predictive value in treatment selection for patients with early-stage, HR+/HER2+ breast cancer. Prospective trials are warranted to identify subgroups of patients with HR+/HER2+ breast cancer who can be spared anti-HER2 treatments and cytotoxic chemotherapy.     

Who are the women who enrolled in the POSITIVE trial: A global study to support young hormone receptor positive breast cancer survivors desiring pregnancy

BackgroundPremenopausal women with early hormone-receptor positive (HR+) breast cancer receive 5–10 years of adjuvant endocrine therapy (ET) during which pregnancy is contraindicated and fertility may wane. The POSITIVE study investigates the impact of temporary ET interruption to allow pregnancy.MethodsPOSITIVE enrolled women with stage I-III HR + early breast cancer, ≤42 years, who had received 18–30 months of adjuvant ET and wished to interrupt ET for pregnancy. Treatment interruption for up to 2 years was permitted to allow pregnancy, delivery and breastfeeding, followed by ET resumption to complete the planned duration.FindingsFrom 12/2014 to 12/2019, 518 women were enrolled at 116 institutions/20 countries/4 continents. At enrolment, the median age was 37 years and 74.9 % were nulliparous. Fertility preservation was used by 51.5 % of women. 93.2 % of patients had stage I/II disease, 66.0 % were node-negative, 54.7 % had breast conserving surgery, 61.9 % had received neo/adjuvant chemotherapy. Tamoxifen alone was the most prescribed ET (41.8 %), followed by tamoxifen + ovarian function suppression (OFS) (35.4 %). A greater proportion of North American women were <35 years at enrolment (42.7 %), had mastectomy (59.0 %) and received tamoxifen alone (59.8 %). More Asian women were nulliparous (81.0 %), had node-negative disease (76.2%) and received tamoxifen + OFS (56.0 %). More European women had received chemotherapy (69.3 %).InterpretationThe characteristics of participants in the POSITIVE study provide insights to which patients and doctors considered it acceptable to interrupt ET to pursue pregnancy. Similarities and variations from a regional, sociodemographic, disease and treatment standpoint suggest specific sociocultural attitudes across the world.     

Adjuvant trastuzumab without chemotherapy for treating early HER2-positive breast cancer in older patients: A propensity score-adjusted analysis of a prospective cohort study

PurposeTo gauge the effects of treatment practices on prognosis for older patients with HER2-positive early breast cancer, particularly to determine whether adjuvant trastuzumab alone can offer benefit over no adjuvant therapy. This is a prospective cohort study which accompanies the RESPECT that is a randomized-controlled trial (RCT).MethodsPatients who declined the RCT were treated based on the physician's discretion. We studied the 1) trastuzumab-plus-chemotherapy group, 2) trastuzumab-monotherapy group, and 3) non-trastuzumab group (no therapy or anticancer therapy without trastuzumab). The primary endpoint was disease-free survival (DFS), which was compared using the propensity-score method. Relapse-free survival (RFS) and health-related quality of life (HRQoL) were assessed.ResultsWe enrolled 123 patients aged over 70 years (median: 74.5). Treatment categories were: trastuzumab-plus-chemotherapy group (n = 36, 30%), trastuzumab-monotherapy group (n = 52, 43%), and non-trastuzumab group (n = 32, 27%). The 3-year DFS was 96.7% in trastuzumab-plus-chemotherapy group, 89.2% in trastuzumab-monotherapy group, and 82.5% in non-trastuzumab group. DFS in non-trastuzumab group was lower than in trastuzumab-plus-chemotherapy and trastuzumab-monotherapy groups (propensity-adjusted hazard ratio; HR: 3.29; 95% CI: 1.15–9.39; P = 0.026). The RFS in non-trastuzumab group was lower than in trastuzumab-plus-chemotherapy and trastuzumab-monotherapy groups (propensity-adjusted HR = 7.80; 95% CI: 2.32–26.2, P < 0.0001). There were no significant intergroup differences in the proportions of patients showing HRQoL deterioration at 36 months (P = 0.717).ConclusionTrastuzumab-treated patients had better prognoses than patients not treated with trastuzumab without deterioration of HRQoL. Trastuzumab monotherapy could be considered for older patients who reject chemotherapy.     

Pregnancy associated breast cancer (PABC): Report from a gestational cancer registry from a tertiary cancer care centre,India

BackgroundPregnancy associated breast cancer (PABC) is a rare entity and defined as breast cancer diagnosed during pregnancy or one-year post-partum. There is sparse data especially from low and middle-income countries (LMIC) and merits exploration.MethodsThe study (2013–2020) evaluated demographics, treatment patterns and outcomes of PABC.ResultsThere were 104 patients, median age of 31 years; 43 (41%) had triple-negative disease, 31(29.8%) had hormone-receptor (HR) positive and HER2 negative, 14 (13.5%) had HER2-positive and HR negative and 16(15.4%) had triple positive disease. 101(97%) had IDC grade III tumors and 74% had delayed diagnosis. 72% presented with early stage (24, EBC) or locally advanced breast cancer (53, LABC) and received either neoadjuvant (n = 49) or adjuvant (n = 26) chemotherapy and surgery. Trastuzumab, tamoxifen, and radiotherapy were administered post-delivery. At a median follow up of 27 (IQR:19–35) months, the estimated 3-year event-free survival (EFS) for EBC and LABC was 82% (95% CI: 65.2–100) and 56% (95% CI: 42–75.6%) and for metastatic 24% (95% CI: 10.1%–58.5%) respectively.Of the 104 patients, 34 were diagnosed antepartum (AP) and 15 had termination, 2 had preterm and 16 had full-term deliveries(FTDs). Among postpartum cohort (n = 70), 2 had termination, 1 had preterm, 67 had FTDs. 83(including 17 from AP) children from both cohorts were experiencing normal milestones.ConclusionData from the first Indian PABC registry showed that the majority had delayed diagnosis and aggressive features(TNBC, higher grade). Treatment was feasible in majority and stage matched outcomes were comparable to non-PABCs.     

False‐negative rate of ultrasound‐guided fine‐needle aspiration cytology for identifying axillary lymph node metastasis in breast cancer patients

Axillary nodal status remains an important determinant of prognosis and of the therapeutic strategy in patients with a newly diagnosed breast cancer. The aim of this study was to assess the false‐negative rate of ultrasound (US)‐guided fine‐needle aspiration cytology (FNAC) in axillary node staging at breast cancer diagnosis. All patients with a newly diagnosed breast cancer who had an indeterminate or suspicious axillary node sampled with an FNAC between 2007 and 2014 were included in the study. FNAC results were compared to the final histopathological results of surgically removed axillary lymph nodes. Patient demographics, tumor, and nodal characteristics were analyzed. Diagnostic accuracy tests were performed using IBM SPSS, version 22. A total of 3515 patients with breast cancer were identified, 675 of whom had ultrasound‐guided FNAC of ipsilateral axillary lymph nodes (mean age: 55 years; Range: 26‐84). A benign (C2) result was observed in 52% (n = 351) and a malignant (C5) result in 35% (n = 238). C1 was obtained in 11% (n = 76), C3 in 0.6% (n = 4), and C4 in 0.9% (n = 6). Of the 238 patients with a malignant (C5) FNAC, 99.6% had confirmed axillary lymph node metastatic disease on histopathology. Of the 351 patients with benign FNAC (C2), 31% (n = 108) of patients had a positive lymph node on histology. The false‐negative rate of preoperative FNAC remains too high (31%) to omit definitive surgical staging of the axilla. The high diagnostic accuracy when a positive FNAC is obtained allows appropriate tailored decisions regarding definitive therapy.     

A case-control study of the joint effect of reproductive factors and radiation treatment for first breast cancer and risk of contralateral breast cancer in the WECARE study

ObjectiveTo examined the impact of reproductive factors on the relationship between radiation treatment (RT) for a first breast cancer and risk of contralateral breast cancer (CBC).MethodsThe Women’s Environmental Cancer and Radiation Epidemiology (WECARE) Study is a multi-center, population-based case-control study where cases are women with asynchronous CBC (N = 1521) and controls are women with unilateral breast cancer (N = 2211). Rate ratios (RR) and 95% confidence intervals (CI) were estimated using conditional logistic regression to assess the independent and joint effects of RT (ever/never and location-specific stray radiation dose to the contralateral breast [0, >0-<1Gy, ≥1Gy]) and reproductive factors (e.g., parity).ResultsNulliparous women treated with RT (≥1Gy dose) were at increased risk of CBC compared with nulliparous women not treated with RT, although this relationship did not reach statistical significance (RR = 1.34, 95% CI 0.87, 2.07). Women treated with RT who had an interval pregnancy (i.e., pregnancy after first diagnosis and before second diagnosis [in cases]/reference date [in controls]) had an increased risk of CBC compared with those who had an interval pregnancy with no RT (RR = 4.60, 95% CI 1.16, 18.28). This was most apparent for women with higher radiation doses to the contralateral breast.ConclusionAmong young female survivors of breast cancer, we found some evidence suggesting that having an interval pregnancy could increase a woman’s risk of CBC following RT for a first breast cancer. While sampling variability precludes strong interpretations, these findings suggest a role for pregnancy and hormonal factors in radiation-associated CBC.     

Intraoperative radiation therapy for breast cancer—Immediate and 30‐month oncological outcomes

There is growing evidence that intraoperative radiation therapy (IORT) may be a viable option in selected patients with early breast cancer. This study reports our 4‐year experience with IORT. The perioperative outcome and imaging data of all patients who underwent IORT for early breast cancer at a tertiary medical center in 2014‐2018 were retrospectively retrieved. The cohort included 158 patients aged 52‐84 years (mean 68) with stage I (n = 137) or II (n = 21) breast cancer. Mean applicator size was 4.13 cm; IORT added a mean of 29 minutes to the operative time. Minor wound infections (n = 18, 11.4%) requiring antibiotics and drainage were the only postoperative complication. In 25 patients (15%), postoperative mammography demonstrated a seroma (n = 22) or fat necrosis (n = 3). The risk of wound infection or a new postoperative imaging finding was unrelated to patient age, operative time, tumor size, or comorbid diabetes or obesity. After a mean of 30 months' follow‐up, none of the patients who met the institutional criteria for IORT had local recurrence, regardless of age, histology, tumor grade, KI67 proliferation index, pathologic stage, Recurrence Score, or additional whole‐breast irradiation or adjuvant treatment. Patients for whom a Recurrence Score was determined (n = 55, 35%) had a significantly higher tumor grade, pathologic stage, and whole‐breast irradiation/adjuvant chemotherapy rate than the remaining patients. IORT may be a safe alternative to traditional external beam radiation in well‐selected patients with early breast cancer, with few minor complications and good 30‐month outcome.     

Concordance rates of biomarkers uPA and PAI-1 results in primary breast cancer vs. consecutive tumor board decision and therapy performed in clinical hospital routine: Results of a prospective multi-center study at certified breast centers

ObjectiveBiomarkers uPA and PAI-1 are guideline recommended by ASCO (USA) and AGO (Germany) in primary breast cancer to avoid unnecessary CTX in patients at medium risk for recurrence. For clinical quality assurance of uPA/PAI-1 testing, analysis of test-therapy concordance was performed.MethodsProspective non-interventional multi-center study over 2 years among six Certified Breast Centers in Germany to investigate uPA/PAI-1 results in consecutive decision making for tumor board recommendation and actual therapy in uninfluenced clinical setting. Concordance and discordance rates of uPA/PAI-1 testing were calculated and individual reasons for decision making analyzed.ResultsAmong n = 93 uPA/PAI-1 tests evaluated n = 42/93 (45.2%) were uPA + PAI-1 negative and n = 51/93 (54.8%) uPA and/or PAI-1 positive. In uPA + PAI-1 negative test results in n = 35/42 (83.3%) CTX was avoided as recommended. But in n = 7/42 (16.7%) CTX was performed despite, resulting in over treatment. In uPA and/or PAI-1 positive test results in n = 26/51 (51.0%) CTX was performed but in n = 25/51 (49.0%) not despite recommendation for CTX which is under treatment. The conformity of uPA/PAI-1 test result vs. tumor board decision was n = 73/93 (78.5%). The overall concordance of uPA/PAI-1 test result vs. consecutive therapy was n = 61/93 (65.6%). A variety of reasons for individual result-deviating decisions were identified.ConclusionsClinical quality assurance of uPA/PAI-1 biomarker testing showed inconsistency of test results with consecutive tumor board decision and/or final therapy performed in up to 1/3 of patients. To close this clinical quality gap in application of uPA/PAI-1 biomarkers, individual analysis of deviations is suggested with process optimization accordingly.     

Breast cancer patients’ most important quality of life themes for a radiotherapy decision aid

Background and aimThe BRASA patient decision aid (BRASA-PtDA) facilitates shared decision making for breast cancer patients (BCPs) facing a radiotherapy treatment decision. During evaluations, patients indicated the wish for quantitative information on side effects. Therefore, this study assessed BCPs opinion on which and how information on side effects should be incorporated in the BRASA-PtDA.MethodsA workshop was organized with BCPs (n = 9), researchers (n = 5) and clinicians (n = 3). Subsequently, a survey was sent to BCPs (n = 744) investigating the generalisability of the workshop findings, and posing additional questions. The survey entailed multiple choice questions on quality of life themes, the use of a decision aid and risk communication.ResultsThe workshop revealed BCPs wish for a layered, all encompassing information system. Information on the impact of side effects on daily life was preferred above the risk of these side effects. The survey revealed that important quality of life (QoL) themes were having energy (81%; n = 605), arm function (61%; n = 452), pain (55%; n = 410). Despite the focus on qualitative effects in the workshop, 89% of the survey respondents also wanted to be informed on individualized risks of side effects. 54% Of the survey respondents had never heard of a PtDA.ConclusionsBCPs preferred information on the impact of side effects, but also their individualized risks on side effects. Most important QoL themes were having enough energy, arm function and pain. Consequently, the BRASA-PtDA should be reshaped, starting with quality of life themes, rather than side effects.