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BackgroundUse of the Oncotype DX recurrence score (RS) has been widely adopted in women with early-stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER−) breast cancer (BC). Validation studies on the use of RS in male BC (MBC) are lacking.ObjectiveThe aim of this study was to identify the utilization of RS and association with chemotherapy recommendations in early-stage MBC compared with female BC (FBC).MethodsUsing the National Cancer Database (NCDB), a retrospective review was performed for patients with T1/T2, node-negative, HR+/HER2− BC between 2010 and 2014. Patients were stratified by demographics, tumor characteristics, RS, and chemotherapy use comparing MBC with FBC over the allotted time period.ResultsA total of 358,497 patients—3068 (0.8%) males and 355,429 (99.1%) females—met the inclusion criteria. A smaller proportion of MBC patients received RS testing compared with FBC patients (32% vs. 35%, p < 0.001). Male patients who had RS were younger, had T2 tumors, lymphovascular invasion, and private insurance. The distribution of RS was similar in both groups. Only 4% of MBC patients with low RS received adjuvant chemotherapy, compared with 4.9% of FBC patients. Overall chemotherapy rates were similar in MBC and FBC patients.ConclusionsOur results showed that RS has not been completely embraced in the management of MBC, although when performed in MBC, chemotherapy recommendations vary based on RS. Whether the use of RS affects the clinical outcomes of MBC is unknown. A prospective registry would help clarify and evaluate the impact of RS on clinical outcomes in MBC.

Whether surgical axillary staging as part of breast-conserving therapy can be omitted without compromising survival has remained unclear. In this prospective, randomized, noninferiority trial, we investigated the omission of axillary surgery as compared with sentinel-lymph-node biopsy in patients with clinically node-negative invasive breast cancer staged as T1 or T2 (tumor size, ≤5 cm) who were scheduled to undergo breast-conserving surgery. We report here the per-protocol analysis of invasive disease-free survival (the primary efficacy outcome). To show the noninferiority of the omission of axillary surgery, the 5-year invasive disease-free survival rate had to be at least 85%, and the upper limit of the confidence interval for the hazard ratio for invasive disease or death had to be below 1.271. A total of 5502 eligible patients (90% with clinical T1 cancer and 79% with pathological T1 cancer) underwent randomization in a 1:4 ratio. The per-protocol population included 4858 patients; 962 were assigned to undergo treatment without axillary surgery (the surgery-omission group), and 3896 to undergo sentinel-lymph-node biopsy (the surgery group). The median follow-up was 73.6 months. The estimated 5-year invasive disease-free survival rate was 91.9% (95% confidence interval [CI], 89.9 to 93.5) among patients in the surgery-omission group and 91.7% (95% CI, 90.8 to 92.6) among patients in the surgery group, with a hazard ratio of 0.91 (95% CI, 0.73 to 1.14), which was below the prespecified noninferiority margin. The analysis of the first primary-outcome events (occurrence or recurrence of invasive disease or death from any cause), which occurred in a total of 525 patients (10.8%), showed apparent differences between the surgery-omission group and the surgery group in the incidence of axillary recurrence (1.0% vs. 0.3%) and death (1.4% vs. 2.4%). The safety analysis indicates that patients in the surgery-omission group had a lower incidence of lymphedema, greater arm mobility, and less pain with movement of the arm or shoulder than patients who underwent sentinel-lymph-node biopsy. In this trial involving patients with clinically node-negative, T1 or T2 invasive breast cancer (90% with clinical T1 cancer and 79% with pathological T1 cancer), omission of surgical axillary staging was noninferior to sentinel-lymph-node biopsy after a median follow-up of 6 years. (Funded by the German Cancer Aid; INSEMA ClinicalTrials.gov number, NCT02466737.).

The benefit of regional nodal irradiation in the treatment of breast cancer is well established for patients with pathologically positive axillary nodes, but whether it is also beneficial for patients whose nodes become pathologically tumor free (ypN0) after neoadjuvant chemotherapy remains unclear. We evaluated whether regional nodal irradiation improves outcomes in patients with biopsy-proven, node-positive breast cancer who reach ypN0 status after neoadjuvant chemotherapy. Patients with breast cancer with a clinical stage of T1 to T3 (tumor size, ≤2 cm to >5 cm), N1, and M0 (indicating spread to one to three axillary lymph nodes but no distant metastasis) who had ypN0 status after neoadjuvant chemotherapy were randomly assigned to receive regional nodal irradiation or no regional nodal irradiation. The primary end point was the interval of freedom from invasive breast cancer recurrence or death from breast cancer (invasive breast cancer recurrence-free interval). Secondary end points included the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival, and overall survival. Safety was also assessed. A total of 1641 patients were enrolled in the trial; 1556 were included in the primary-event analysis: 772 in the irradiation group and 784 in the no-irradiation group. After a median follow-up of 59.5 months, 109 primary end-point events (50 in the irradiation group and 59 in the no-irradiation group) had occurred. Regional nodal irradiation did not significantly increase the invasive breast cancer recurrence-free interval (hazard ratio, 0.88; 95% confidence interval, 0.60 to 1.28; P = 0.51). Point estimates of survival free from the primary end-point events were 92.7% in the irradiation group and 91.8% in the no-irradiation group. Regional nodal irradiation did not increase the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival, or overall survival. No deaths related to the protocol-specified therapy were reported, and no unexpected adverse events were observed. Grade 4 adverse events occurred in 0.5% of patients in the irradiation group and 0.1% of those in the no-irradiation group. The addition of adjuvant regional nodal irradiation did not decrease the risk of invasive breast cancer recurrence or death from breast cancer in patients who had negative axillary nodes after neoadjuvant chemotherapy. (Funded by the National Institutes of Health; NSABP B-51-Radiation Therapy Oncology Group 1304 ClinicalTrials.gov number, NCT01872975.).

The appropriate age range for breast cancer screening remains a matter of debate. We aimed to estimate the effect of mammographic screening at ages 40–48 years on breast cancer mortality. We did a randomised, controlled trial involving 23 breast screening units across Great Britain. We randomly assigned women aged 39–41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen at approximately age 50 years (control group). Women in the intervention group were recruited by postal invitation. Women in the control group were unaware of the study. The primary endpoint was mortality from breast cancers (with breast cancer coded as the underlying cause of death) diagnosed during the intervention period, before the participant's first NHSBSP screen. To study the timing of the mortality effect, we analysed the results in different follow-up periods. Women were included in the primary comparison regardless of compliance with randomisation status (intention-to-treat analysis). This Article reports on long-term follow-up analysis. The trial is registered with the ISRCTN registry, ISRCTN24647151. 160 921 women were recruited between Oct 14, 1990, and Sept 24, 1997. 53 883 women (33·5%) were randomly assigned to the intervention group and 106 953 (66·5%) to the control group. Between randomisation and Feb 28, 2017, women were followed up for a median of 22·8 years (IQR 21·8–24·0). We observed a significant reduction in breast cancer mortality at 10 years of follow-up, with 83 breast cancer deaths in the intervention group versus 219 in the control group (relative rate [RR] 0·75 [95% CI 0·58–0·97]; p=0·029). No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79–1·22]; p=0·86). Yearly mammography before age 50 years, commencing at age 40 or 41 years, was associated with a relative reduction in breast cancer mortality, which was attenuated after 10 years, although the absolute reduction remained constant. Reducing the lower age limit for screening from 50 to 40 years could potentially reduce breast cancer mortality. National Institute for Health Research Health Technology Assessment programme.

Artificial intelligence (AI) in mammography screening has shown promise in retrospective evaluations, but few prospective studies exist. PRAIM is an observational, multicenter, real-world, noninferiority, implementation study comparing the performance of AI-supported double reading to standard double reading (without AI) among women (50–69 years old) undergoing organized mammography screening at 12 sites in Germany. Radiologists in this study voluntarily chose whether to use the AI system. From July 2021 to February 2023, a total of 463,094 women were screened (260,739 with AI support) by 119 radiologists. Radiologists in the AI-supported screening group achieved a breast cancer detection rate of 6.7 per 1,000, which was 17.6% (95% confidence interval: +5.7%, +30.8%) higher than and statistically superior to the rate (5.7 per 1,000) achieved in the control group. The recall rate in the AI group was 37.4 per 1,000, which was lower than and noninferior to that (38.3 per 1,000) in the control group (percentage difference: −2.5% (−6.5%, +1.7%)). The positive predictive value (PPV) of recall was 17.9% in the AI group compared to 14.9% in the control group. The PPV of biopsy was 64.5% in the AI group versus 59.2% in the control group. Compared to standard double reading, AI-supported double reading was associated with a higher breast cancer detection rate without negatively affecting the recall rate, strongly indicating that AI can improve mammography screening metrics. In a large-scale prospective study run across 12 sites in Germany and involving 463,094 women and 119 radiologists, AI-supported screening increased breast cancer detection rates by a significant margin without affecting the recall rate.

Background This pilot trial aimed to study the feasibility and effects on quality of life (QOL) and well-being of short-term fasting (STF) during chemotherapy in patients with gynecological cancer. Methods In an individually-randomized cross-over trial patients with gynecological cancer, 4 to 6 planned chemotherapy cycles were included. Thirty-four patients were randomized to STF in the first half of chemotherapies followed by normocaloric diet (group A; n  = 18) or vice versa (group B; n  = 16). Fasting started 36 h before and ended 24 h after chemotherapy (60 h-fasting period). QOL was assessed by the FACIT-measurement system. Results The chemotherapy-induced reduction of QOL was less than the Minimally Important Difference (MID; FACT-G = 5) with STF but greater than the MID for non-fasted periods. The mean chemotherapy-induced deterioration of total FACIT-F was 10.4 ± 5.3 for fasted and 27.0 ± 6.3 for non-fasted cycles in group A and 14.1 ± 5.6 for non-fasted and 11.0 ± 5.6 for fasted cycles in group B. There were no serious adverse effects. Conclusion STF during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. Trial registration This trial was registered at clinicaltrials.gov: NCT01954836 .

This trial showed that the addition of abdominopelvic CT to routine measures in patients with unprovoked venous thrombosis did not detect additional occult cancers. The incidence of cancer in first unprovoked venous thrombosis was 4%, not 10% as had been previously reported. Venous thromboembolism, which comprises deep-vein thrombosis and pulmonary embolism, is the third most common cardiovascular disorder. 1 – 3 It is classified as provoked when it is associated with a transient risk factor (e.g., trauma, surgery, prolonged immobility, or pregnancy or the puerperium) and as unprovoked when it is associated with neither a strong transient risk factor nor overt cancer. Unprovoked venous thromboembolism may be the earliest sign of cancer 4 , 5 ; up to 10% of patients with unprovoked venous thromboembolism receive a diagnosis of cancer in the year after their diagnosis of venous thromboembolism. 6 More than 60% of occult cancers are . . .

It is not known which supplemental imaging technique is most beneficial for women with dense breasts attending breast screening. This study compares abbreviated MRI, automated whole breast ultrasound (ABUS), and contrast-enhanced mammography versus standard of care in women with dense breasts and a negative mammogram. We report on interim results from the first round of supplemental imaging. In this UK randomised controlled trial, at ten breast screening sites, women (aged 50–70 years) were independently allocated by batches (day/mobile screening van) to either abbreviated MRI, ABUS, or contrast-enhanced mammography or standard of care (full-field digital mammography) varied by modality availability at each centre. Women were invited if their mammogram was negative and they had dense breasts. Primary outcome was detection rate, defined as the percentage of women with a positive result on supplemental imaging that resulted in histologically confirmed breast cancer. Analysis was by imaging received (intention to treat) using network meta-analysis, treating each site as a study in the meta-analysis, with two analyses carried out: one using only the three active intervention arms (primary analysis) that compared the three supplemental imaging techniques with respect to cancer detection, recall, and biopsy rates in addition to those resulting from full-field digital mammography alone; and one with the addition of the observational data from Cambridge on full-field digital mammography alone. This trial is closed for recruitment and is registered with ClinicalTrials.gov, NCT04097366. From October 18, 2019, to March 30, 2024, 9361 eligible women were recruited and randomly assigned (2318 to abbreviated MRI, 2240 to ABUS, 2235 to contrast-enhanced mammography, and 2568 to standard of care). Of those, 6305 completed supplementary imaging (2130 in the abbreviated MRI, 2141 in the ABUS, and 2035 in the contrast-enhanced mammography) and were included in the outcome analysis. The cancer detection rate was 17·4 (95% CI 12·2–23·9, n=37) per 1000 examinations for abbreviated MRI, 4·2 (1·9–8·0, n=9) per 1000 examinations for ABUS, and 19·2 (13·7–26·1, n=39) per 1000 examinations for contrast-enhanced mammography, of which 15·0 (10·3–21·1, n=32) per 1000 women for abbreviated MRI, 4·2 (1·9–8·0, n=9) per 1000 examinations for ABUS, and 15·7 (10·8–22·1, n=32) per 1000 examinations for contrast-enhanced mammography were invasive cancers. The detection rates for abbreviated MRI were significantly higher than for ABUS (p=0·047) and non-significantly higher than for contrast-enhanced mammography (p=0·62). There was one case of extravasation in the abbreviated MRI arm (0·5 events per 1000 examinations), no adverse events in the ABUS arm, and 24 iodinated contrast reactions (17 minor [8·4 events per 1000 examinations], six moderate [2·9 events per 1000 examinations], and one severe [0·5 events per 1000 examinations]) and three extravasations (1·5 extravasations per 1000 examinations) in the contrast-enhanced mammography arm. Abbreviated MRI and contrast-enhanced mammography detected three times as many invasive cancers compared with ABUS, with cancers being half the size. This study shows that supplemental imaging could lead to earlier detection of cancer in women with dense breasts but does not estimate the level of overdiagnosis. Cancer Research UK, GE Healthcare, and Bayer Healthcare.

AbstractObjectiveTo test the efficacy of screening by clinical breast examination in downstaging breast cancer at diagnosis and in reducing mortality from the disease, when compared with no screening.DesignProspective, cluster randomised controlled trial.Setting20 geographically distinct clusters located in Mumbai, India, randomly allocated to 10 screening and 10 control clusters; total trial duration was 20 years (recruitment began in May 1998; database locked in March 2019 for analysis).Participants151 538 women aged 35-64 with no history of breast cancer.InterventionsWomen in the screening arm (n=75 360) received four screening rounds of clinical breast examination (conducted by trained female primary health workers) and cancer awareness every two years, followed by five rounds of active surveillance every two years. Women in the control arm (n=76 178) received one round of cancer awareness followed by eight rounds of active surveillance every two years.Main outcome measuresDownstaging of breast cancer at diagnosis and reduction in mortality from breast cancer.ResultsBreast cancer was detected at an earlier age in the screening group than in the control group (age 55.18 (standard deviation 9.10) v 56.50 (9.10); P=0.01), with a significant reduction in the proportion of women with stage III or IV disease (37% (n=220) v 47% (n=271), P=0.001). A non-significant 15% reduction in breast cancer mortality was observed in the screening arm versus control arm in the overall study population (age 35-64; 20.82 deaths per 100 000 person years (95% confidence interval 18.25 to 23.97) v 24.62 (21.71 to 28.04); rate ratio 0.85 (95% confidence interval 0.71 to 1.01); P=0.07). However, a post hoc subset analysis showed nearly 30% relative reduction in breast cancer mortality in women aged 50 and older (24.62 (20.62 to 29.76) v 34.68 (27.54 to 44.37); 0.71 (0.54 to 0.94); P=0.02), but no significant reduction in women younger than 50 (19.53 (17.24 to 22.29) v 21.03 (18.97 to 23.44); 0.93 (0.79 to 1.09); P=0.37). A 5% reduction in all cause mortality was seen in the screening arm versus the control arm, but it was not statistically significant (rate ratio 0.95 (95% confidence interval 0.81 to 1.10); P=0.49).ConclusionsThese results indicate that clinical breast examination conducted every two years by primary health workers significantly downstaged breast cancer at diagnosis and led to a non-significant 15% reduction in breast cancer mortality overall (but a significant reduction of nearly 30%in mortality in women aged ≥50). No significant reduction in mortality was seen in women younger than 50 years. Clinical breast examination should be considered for breast cancer screening in low and middle income countries.Trial registrationClinical Trials Registry of India CTRI/2010/091/001205; ClinicalTrials.gov NCT00632047.

Mammography is the only proven method for breast cancer screening that reduces mortality, although it is inaccurate in young women or women with dense breasts. We investigated the efficacy of adjunctive ultrasonography. Between July, 2007, and March, 2011, we enrolled asymptomatic women aged 40–49 years at 42 study sites in 23 prefectures into the Japan Strategic Anti-cancer Randomized Trial (J-START). Eligible women had no history of any cancer in the previous 5 years and were expected to live for more than 5 years. Randomisation was done centrally by the Japan Clinical Research Support Unit. Participants were randomly assigned in 1:1 ratio to undergo mammography and ultrasonography (intervention group) or mammography alone (control group) twice in 2 years. The primary outcome was sensitivity, specificity, cancer detection rate, and stage distribution at the first round of screening. Analysis was by intention to treat. This study is registered, number UMIN000000757. Of 72 998 women enrolled, 36 859 were assigned to the intervention group and 36 139 to the control group. Sensitivity was significantly higher in the intervention group than in the control group (91·1%, 95% CI 87·2–95·0 vs 77·0%, 70·3–83·7; p=0·0004), whereas specificity was significantly lower (87·7%, 87·3–88·0 vs 91·4%, 91·1–91·7; p<0·0001). More cancers were detected in the intervention group than in the control group (184 [0·50%] vs 117 [0·32%], p=0·0003) and were more frequently stage 0 and I (144 [71·3%] vs 79 [52·0%], p=0·0194). 18 (0·05%) interval cancers were detected in the intervention group compared with 35 (0·10%) in the control group (p=0·034). Adjunctive ultrasonography increases sensitivity and detection rate of early cancers. Ministry of Health, Labour and Welfare of Japan.