The Arthroscopic Subscapular Sling Procedure Results in Low Recurrent Anterior Shoulder Instability at 24 Months of Follow-Up.

PURPOSE: To analyze the results of the subscapular sling procedure developed for anterior shoulder instability in patients with less than 10% anterior glenoid bone loss. METHODS: Patients were treated surgically with the arthroscopic subscapular sling procedure. A semitendinosus graft was used to reconstruct the anterior labrum and to establish a sling suspension around the upper part of the subscapularis tendon. The patients were followed up with radiographs (at 12 and 24 months). Magnetic resonance imaging (MRI) of the shoulder region and clinical examinations were performed at 3, 12, and 24 months. Recurrent dislocation was the primary endpoint. The Western Ontario Shoulder Instability Index (WOSI) and MRI results were secondary outcome measures. An independent physiotherapist assessed residual instability and range of motion. RESULTS: Fifteen patients were included with a dislocation rate of 0% after 24 months follow-up. There was a significant clinical improvement of the WOSI score from 57% (904) at baseline to 88% (241) at 24 months (P < .001). The proportion of patients with an improvement in the WOSI Total score larger than the estimated minimal clinically important difference was 100% both at 12 and 24 months. MRI showed an intact sling in all patients. External rotation was not significantly reduced (52° at baseline vs 47° at 24 months, P = .211). Flexion and abduction were significantly improved from 152° to 174° (P = .001) and 141° to 170° (P < .001) after 24 months. The surgical procedures were completed without any intraoperative complications. CONCLUSIONS: The subscapular sling procedure resulted in low recurrent shoulder instability and improved patient-reported outcome measures at 24 months of follow-up. LEVEL OF EVIDENCE: Level IV, case series.

Digital breast tomosynthesis in mammographic screening: false negative cancer cases in the To-Be 1 trial.

OBJECTIVES: The randomized controlled trial comparing digital breast tomosynthesis and synthetic 2D mammograms (DBT + SM) versus digital mammography (DM) (the To-Be 1 trial), 2016-2017, did not result in higher cancer detection for DBT + SM. We aimed to determine if negative cases prior to interval and consecutive screen-detected cancers from DBT + SM were due to interpretive error. METHODS: Five external breast radiologists performed the individual blinded review of 239 screening examinations (90 true negative, 39 false positive, 19 prior to interval cancer, and 91 prior to consecutive screen-detected cancer) and the informed consensus review of examinations prior to interval and screen-detected cancers (n = 110). The reviewers marked suspicious findings with a score of 1-5 (probability of malignancy). A case was false negative if ≥ 2 radiologists assigned the cancer site with a score of ≥ 2 in the blinded review and if the case was assigned as false negative by a consensus in the informed review. RESULTS: In the informed review, 5.3% of examinations prior to interval cancer and 18.7% prior to consecutive round screen-detected cancer were considered false negative. In the blinded review, 10.6% of examinations prior to interval cancer and 42.9% prior to consecutive round screen-detected cancer were scored ≥ 2. A score of ≥ 2 was assigned to 47.8% of negative and 89.7% of false positive examinations. CONCLUSIONS: The false negative rates were consistent with those of prior DM reviews, indicating that the lack of higher cancer detection for DBT + SM versus DM in the To-Be 1 trial is complex and not due to interpretive error alone. CRITICAL RELEVANCE STATEMENT: The randomized controlled trial on digital breast tomosynthesis and synthetic 2D mammograms (DBT) and digital mammography (DM), 2016-2017, showed no difference in cancer detection for the two techniques. The rates of false negative screening examinations prior to interval and consecutive screen-detected cancer for DBT were consistent with the rates in prior DM reviews, indicating that the non-superior DBT performance in the trial might not be due to interpretive error alone. KEY POINTS: • Screening with digital breast tomosynthesis (DBT) did not result in a higher breast cancer detection rate compared to screening with digital mammography (DM) in the To-Be 1 trial. • The false negative rates for examinations prior to interval and consecutive screen-detected cancer for DBT were determined in the trial to test if the lack of differences was due to interpretive error. • The false negative rates were consistent with those of prior DM reviews, indicating that the lack of higher cancer detection for DBT versus DM was complex and not due to interpretive error alone.

Fatal and non-fatal breast cancers in women targeted by BreastScreen Norway: a cohort study.

BACKGROUND: Many breast cancer survivors experience anxiety related to dying from their disease even if it is detected at an early stage. We aimed to increase knowledge about fatal and non-fatal breast cancer by describing how histopathological tumour profiles and detection modes were associated with 10-year breast cancer-specific survival. METHODS: This cohort study included data from women targeted by BreastScreen Norway (aged 50-69) and diagnosed with invasive breast cancer during 1996-2011. Breast cancer was classified as fatal if causing death within 10 years after diagnosis and non-fatal otherwise. We described histopathologic characteristics of fatal and non-fatal cancers, stratified by mode of detection. Recursive partitioning identified subgroups with differing survival profiles. RESULTS: In total, 6.3% of 9954 screen-detected cancers (SDC) were fatal, as were 17.4% of 3205 interval cancers (IC) and 20.9% of 3237 cancers detected outside BreastScreen Norway. Four to five subgroups with differing survival profiles were identified within each detection mode. Women with lymph node-negative SDC or Grade 1-2, node-negative IC without distant metastases had the highest 10-year survival (95-96%). CONCLUSIONS: Two subgroups representing 53% of the cohort had excellent (95-96%) 10-year breast cancer-specific survival. Most women with SDC had excellent survival, as did nearly 40% of women diagnosed with IC.

True and Missed Interval Cancer in Organized Mammographic Screening: A Retrospective Review Study of Diagnostic and Prior Screening Mammograms.

RATIONALE AND OBJECTIVES: To explore radiological aspects of interval breast cancer in a population-based screening program. MATERIALS AND METHODS: We performed a consensus-based informed review of mammograms from diagnosis and prior screening from women diagnosed with interval cancer 2004-2016 in BreastScreen Norway. Cases were classified as true (no findings on prior screening mammograms), occult (no findings at screening or diagnosis), minimal signs (minor/non-specific findings) and missed (obvious findings). We analyzed mammographic findings, density, time since prior screening, and histopathological characteristics between the classification groups. RESULTS: The study included 1010 interval cancer cases. Mean age at diagnosis was 61 years (SD = 6), mean time between screening and diagnosis 14 months (SD = 7). A total of 48% (479/1010) were classified as true or occult, 28% (285/1010) as minimal signs and 24% (246/1010) as missed. We observed no differences in mammographic density between the groups, except from a higher percentage of dense breasts in women with occult cancer. Among cancers classified as missed, about 1/3 were masses and 1/3 asymmetries at prior screening. True interval cancers were diagnosed later in the screening interval than the other classification categories. No differences in histopathological characteristics were observed between true, minimal signs and missed cases. CONCLUSION: In an informed review, 24% of the interval cancers were classified as missed based on visibility and mammographic findings on prior screening mammograms. Three out of four true interval cancers were diagnosed in the second year of the screening interval. We observed no statistical differences in histopathological characteristics between true and missed interval cancers.

The novel arthroscopic subscapular quadriceps tendon-bone sling procedure provides increased stability in shoulder cadavers with severe glenoid bone loss.

PURPOSE: Treatment of anterior glenoid bone loss in patients with recurrent anterior shoulder instability is a challenge. The subscapular sling method with quadriceps tendon bone (QTB) graft is a modification of the subscapular sling with a semitendinosus (ST) graft. The aim of the study was to test the biomechanical stability of the QTB sling procedure in human shoulder cadavers with severe anterior glenoid bone loss. METHODS: Fourteen cadaveric shoulders were tested with a force-moment-guided robot in three conditions: physiologically intact, anterior glenoid bone resection, and the subscapular sling procedure with a QTB graft. Joint stability was measured in anterior, anterior inferior and inferior directions in four glenohumeral joint positions: 0° and 60° of glenohumeral abduction, with each at 0° and 60° of external rotation. Maximum external rotation was measured at 0° and 60° glenohumeral abduction. Computer tomography scans were obtained preoperatively to plan the glenoid bone resection, as well as postoperatively to calculate the proportion of the glenoid bone actually resected. RESULTS: Significantly decreased translations were observed in the shoulders with the QTB sling compared to the intact joint and the glenoid bone loss model. No significant differences in maximum external rotation were observed between the three different conditions. CONCLUSION: This biomechanical study revealed a significant stabilizing effect of the arthroscopic subscapular QTB graft sling procedure in human shoulder cadavers without compromising external rotation. Clinical trials may reveal the usefulness of this experimental method.

Radiological review of prior screening mammograms of screen-detected breast cancer.

OBJECTIVE: To perform a radiological review of mammograms from prior screening and diagnosis of screen-detected breast cancer in BreastScreen Norway, a population-based screening program. METHODS: We performed a consensus-based informed review of mammograms from prior screening and diagnosis for screen-detected breast cancers. Mammographic density and findings on screening and diagnostic mammograms were classified according to the Breast Imaging-Reporting and Data System®. Cases were classified based on visible findings on prior screening mammograms as true (no findings), missed (obvious findings), minimal signs (minor/non-specific findings), or occult (no findings at diagnosis). Histopathologic tumor characteristics were extracted from the Cancer Registry of Norway. The Bonferroni correction was used to adjust for multiple testing; p < 0.001 was considered statistically significant. RESULTS: The study included mammograms for 1225 women with screen-detected breast cancer. Mean age was 62 years ± 5 (SD); 46% (567/1225) were classified as true, 22% (266/1225) as missed, and 32% (392/1225) as minimal signs. No difference in mammographic density was observed between the classification categories. At diagnosis, 59% (336/567) of true and 70% (185/266) of missed cancers were classified as masses (p = 0.004). The percentage of histological grade 3 cancers was higher for true (30% (138/469)) than for missed (14% (33/234)) cancers (p < 0.001). Estrogen receptor positivity was observed in 86% (387/469) of true and 95% (215/234) of missed (p < 0.001) cancers. CONCLUSIONS: We classified 22% of the screen-detected cancers as missed based on a review of prior screening mammograms with diagnostic images available. One main goal of the study was quality improvement of radiologists' performance and the program. Visible findings on prior screening mammograms were not necessarily indicative of screening failure. KEY POINTS: • After a consensus-based informed review, 46% of screen-detected breast cancers were classified as true, 22% as missed, and 32% as minimal signs. • Less favorable prognostic and predictive tumor characteristics were observed in true screen-detected breast cancer compared with missed. • The most frequent mammographic finding for all classification categories at the time of diagnosis was mass, while the most frequent mammographic finding on prior screening mammograms was a mass for missed cancers and asymmetry for minimal signs.

Second Cancers in Patients With Locally Advanced Prostate Cancer Randomized to Lifelong Endocrine Treatment With or Without Radical Radiation Therapy: Long-Term Follow-up of the Scandinavian Prostate Cancer Group-7 Trial.

BACKGROUND: Curative radiation therapy (RT) constitutes a cornerstone in prostate cancer (PC) treatment. We present long-term follow-up estimates for second cancer (SC) risk and overall survival (OS) in patients randomized to hormone therapy (ET) alone or combined with 70 Gy prostatic RT in the Scandinavian Prostate Cancer Group-7 (SPCG-7) study. We explored the effect of salvage RT (≥60 Gy to the ET group) and reported causes of death. METHODS AND MATERIALS: The SPCG-7 study (1996-2002) was a randomized controlled trial that included 875 men with locally advanced nonmetastatic PC. In this analysis, including data from the Norwegian and Swedish Cancer and Cause of Death registries for 651 Norwegian and 209 Swedish study patients, we estimated hazard ratios (HRs) for SC and death, and cumulative incidences of SC. RESULTS: Median follow-up of the 860 (431 ET and 429) ET + RT patients was 12.2 years for SC risk analysis and 12.6 years for the OS analysis. Eighty-three of the Norwegian ET patients received salvage RT, and median time to salvage RT was 5.9 years. We found 125 and 168 SCs in the ET and ET + RT patients, respectively. With ET alone as reference, ET + RT patients had an HR of 1.19 (95% confidence interval [CI], 0.92-1.54) for all SCs and 2.54 (95% CI, 1.14-5.69) for urinary bladder cancer (UBC). The total number of UBC was 31 (23 in ET + RT; 8 in ET), and the vast majority (85%) were superficial. The HR for SC in salvage RT patients was 0.48 (95% CI, 0.24-0.94). Median OS was 12.8 (95% CI, 11.8-13.8) and 15.3 (95%, CI 14.3-16.4) years in the ET and ET + RT groups, respectively. Compared with ET alone, the risk of death was reduced in ET + RT patients (HR, 0.73; 95% CI, 0.62-0.86) and in ET patients receiving salvage RT (HR, 0.44; 95% CI, 0.30-0.65). CONCLUSIONS: Although the risk of UBC was increased in PC patients who received RT in addition to ET, this disadvantage is outweighed by the OS benefit of RT confirmed in our study. The risk of SC, and especially UBC, should be discussed with patients and be reflected in follow-up programs.

Influence of Mammography Volume on Radiologists' Performance: Results from BreastScreen Norway.

Background Several European screening mammography programs that use independent double reading with consensus recommend an annual minimum reading volume of 5000 mammograms per radiologist. This recommendation is based only on expert opinion, and the influence of reading volume on performance in such programs is unknown. Purpose To examine the influence of annual and cumulative reading volume on radiologists' reading performance for digital mammography in a screening program that uses independent double reading with consensus. Materials and Methods This retrospective study included data from digital mammographic examinations in BreastScreen Norway obtained from 2006 to 2016. Multilevel mixed-effects models were used to determine how sensitivity, rate of screening-detected breast cancer (SDC), and false-positive rate (FPR) before and after consensus meeting related to annual and cumulative reading volume. Results The study included 2 373 433 readings performed by 121 radiologists. The median annual reading volume ranged from 153 to 19 500 mammograms, and the median cumulative reading volume was 30 566 mammograms. Sensitivity and SDC rate were relatively stable at 87% to 90% and 4.9 to 4.7 per 1000 readings (0.49% and 0.47%), respectively, between 100 and 10 000 annual readings and at 88% to 89% and 4.8 to 4.9 per 1000 readings (0.48% and 0.49%) between 500 and 100 000 cumulative readings. There was a decreasing trend with higher annual volumes (P for trend < .001 for both) to a sensitivity of 81% and SDC rate of 3.9 per 1000 readings (0.39%) at 18 000 readings. There was a decreasing trend in FPR before and after consensus with higher annual and cumulative volumes (P for trend < .001 for all). FPRs before consensus meeting were 5.3% at 100 annual readings and 4.0% at 4000 annual readings and were 6.7% at 500 cumulative readings and 3.6% at 20 000 cumulative readings. FPRs after consensus meeting were 2.5% at 100 annual readings and 2.3% at 4000 annual readings and were 2.7% at 500 cumulative readings and 2.2% at 20 000 cumulative readings. Conclusion Annual reading volumes between 4000 and 10 000 mammograms and cumulative reading volumes greater than 20 000 mammograms may be the most optimal volumes for achieving high reading performance in a screening program with independent double reading. © RSNA, 2019 See also the editorial by Rosenberg and Seidenwurm in this issue.

Volumetric Mammographic Density, Age-Related Decline, and Breast Cancer Risk Factors in a National Breast Cancer Screening Program.

Background: Volumetric mammographic density (VMD) measures can be obtained automatically, but it is not clear how these relate to breast cancer risk factors.Methods: The cohort consisted of 46,428 women (ages 49-71 years) who participated in BreastScreen Norway between 2007 and 2014 and had information on VMD and breast cancer risk factors. We estimated means of percent and absolute VMD associated with age, menopausal status, body mass index (BMI), and other factors.Results: The associations between VMD and most breast cancer risk factors were modest, although highly significant. BMI was positively associated with absolute VMD, whereas inversely associated with percent VMD. Percent VMD was inversely associated with a 5-year older age at screening in premenopausal and postmenopausal women (-0.18% vs. -0.08% for percent VMD and -0.11 cm3 vs. -0.03 cm3 for absolute VMD). This difference was largest among postmenopausal women with BMI < 25 kg/m2 (P for interaction with percent VMD < 0.0001), never users of postmenopausal hormone therapy (P for interaction < 0.0001), and premenopausal women with a family history of breast cancer (P for interaction with absolute VMD = 0.054).Conclusions: VMD is associated with several breast cancer risk factors, the strongest being BMI, where the direction of the association differs for percent and absolute VMD. The inverse association with age appears modified by menopausal status and other breast cancer risk factors.Impact: Because VMD methods are becoming widely available in screening and clinical settings, the association between VMD measures and breast cancer risk factors should be investigated further in longitudinal studies. Cancer Epidemiol Biomarkers Prev; 27(9); 1065-74. ©2018 AACR.

Does Prophylactic Radiation Therapy to Avoid Gynecomastia in Patients With Prostate Cancer Increase the Risk of Breast Cancer?

PURPOSE: Prostate cancer (PC) patients who undergo antiandrogen monotherapy are offered prophylactic radiation therapy (PRT) to the breast buds to avoid gynecomastia. The aim of the present study was to evaluate whether the risk of breast cancer (BC) in men with PC as their first cancer diagnosis was influenced by PRT. METHODS AND MATERIALS: From the Norwegian Cancer Registry, we collected data from all patients with PC as their first cancer diagnosis from 1997 to 2014. We registered all RT given to the patients in the same period and the occurrence of BC diagnosed ≥3 months after the PC diagnosis. The histopathologic diagnoses of all BC cases were collected. Subdistribution hazard ratios for the risk of BC in the PRT and non-PRT groups were estimated. A standardized incidence ratio for BC was calculated by comparing our cohort to the standard male population. RESULTS: We analyzed 59,169 patients with PC, of whom 7864 (13.3%) had received PRT. The median follow-up time was 4 years. Of the 12 men with a diagnosis of BC, 3 had received PRT, and 2 of the 3 were phyllodes tumors. The risk of BC was not significantly different statistically for the patients given PRT compared with the non-PRT group (subdistribution hazard ratio 1.62, 95% confidence interval 0.41-5.62, adjusted for age and time of diagnosis). The standardized incidence ratio was 0.996 (95% confidence interval 0.57-1.75). CONCLUSIONS: In this registry-based study, we did not find an increased risk of BC in PC patients who received PRT. The number of BC cases in our study was low, and the risk of secondary BC after PRT seems to be negligible. The incidence of BC could, however, increase with additional follow-up. Also, 2 patients who had received PRT developed a malignant phyllodes tumor, an extremely rare type of BC associated with gynecomastia.

Mammographic density and histopathologic characteristics of screen-detected tumors in the Norwegian Breast Cancer Screening Program.

BACKGROUND: High mammographic density might mask breast tumors, resulting in delayed diagnosis or missed cancers. PURPOSE: To investigate the association between mammographic density and histopathologic tumor characteristics (histologic type, size, grade, and lymph node status) among women screened in the Norwegian Breast Cancer Screening Program. MATERIAL AND METHODS: Information about 1760 screen-detected ductal carcinoma in situ (DCIS) and 7366 invasive breast cancers diagnosed among women aged 50-69 years, 1996-2010, was analyzed. The screening mammograms were classified subjectively according to the amount of fibroglandular tissue into fatty, medium dense, and dense by breast radiologists. Chi-square test was used to compare the distribution of tumor characteristics by mammographic density. Odds ratio (OR) of tumor characteristics by density was estimated by means of logistic regression, adjusting for screening mode (screen-film and full-field digital mammography), and age. RESULTS: Mean and median tumor size of invasive breast cancers was 13.8 and 12 mm, respectively, for women with fatty breasts, and 16.2 and 14 mm for those with dense breasts. Lymph node positive tumors were identified among 20.6% of women with fatty breasts compared with 27.2% of those with dense breasts (P < 0.001). The proportion of DCIS was significantly lower for women with fatty (15.8%) compared with dense breasts (22.0%). Women with dense breasts had an increased risk of large (OR, 1.44; 95% CI, 1.18-1.73) and lymph node positive tumors (OR, 1.26; 95% CI, 1.05-1.51) compared with women with fatty and medium dense breasts. CONCLUSION: High mammographic density was positively associated with tumor size and lymph node positive tumors.

Mammographic performance in a population-based screening program: before, during, and after the transition from screen-film to full-field digital mammography.

PURPOSE: To compare performance measures before, during, and after the transition from screen-film mammography (SFM) to full-field digital mammography (FFDM) in a population-based screening program. MATERIALS AND METHODS: No institutional review board approval was required for this analysis involving anonymized data for women aged 50-69 years enrolled in the Norwegian Breast Cancer Screening Program during 1996-2010. The χ(2) test was used to examine the equality of proportions of recall rates, positive predictive value of recall examinations and of invasive procedures, in addition to rates of screening-detected and interval cancers in women initially screened with SFM and FFDM and for women subsequently screened with SFM after SFM, FFDM after SFM, and FFDM after FFDM. RESULTS: The recall rate was 3.4% (47 091 of 1 391 188) for SFM and 2.9% (13 130 of 446 172) for FFDM (P < .001). The biopsy rate was 1.4% (19 776 of 1 391 188) for SFM and 1.1% (5108 of 446 172) for FFDM (P < .001). The rate of screening-detected ductal carcinoma in situ was higher (P = .019) while the rate of invasive breast cancer was lower (P < .001) for FFDM compared with those for SFM. The rate of both invasive screening-detected and interval breast cancer remained stable during the transition from SFM to FFDM (when the previous examination was SFM) and after FFDM was firmly established (when the previous examination was FFDM, >25 months after FFDM adoption) (P < .05). The positive predictive value of recall examinations and of invasive procedures increased from 19.3% (4559 of 23 598) and 48.3% (4651 of 9623) to 22.7% (681 of 2995) and 57.5% (689 of 1198), respectively, after adoption of FFDM (P < .001). CONCLUSION: After the initial transitional phase from SFM to FFDM, population-based screening with FFDM is associated with less harm because of lower recall and biopsy rates and higher positive predictive values after biopsy than screening with SFM.

Missed and true interval and screen-detected breast cancers in a population based screening program.

RATIONALE AND OBJECTIVES: To increase radiologic knowledge, the distribution of mammographic features on prior screening mammograms of missed interval and screen-detected cancers was compared to the distribution on diagnostic mammograms of screen-detected cancers. The same variables were compared on mammograms of discordant and concordant screen-detected cancers. MATERIALS AND METHODS: The study was performed in Møre og Romsdal County, Norway, as a part of the quality assurance of the Norwegian Breast Cancer Screening Program. Women were screened using analog techniques and diagnosed from 2002 to 2008. Prior and diagnostic mammograms of 81 interval and 123 screen-detected breast cancers in women aged 50 to 71 years were retrospectively reviewed and classified as either missed or true by four experienced breast radiologists. Mammographic features were classified according to a modified Breast Imaging Reporting and Data System. RESULTS: Thirty percent (24 of 81) of the interval cancers and 21% (26 of 123) of the screen-detected cancers were classified as missed. Calcifications, alone or in association with mass or asymmetry, tended to be more common on prior mammograms of missed cancers compared to diagnostic mammograms of screen-detected cancers (34% [17 of 50] vs 21% [26 of 123], P = .114), whereas an opposite trend was seen for mass (54% [27 of 50] vs 68% [84 of 123], P = .109). Similar results were seen when comparing discordant and concordant cancers. CONCLUSIONS: Calcifications represent a challenge in the interpretation of screening mammograms. For educational purposes, the importance of reviewing both interval and screen-detected cancers is obvious. Knowledge gained from systematic reviews might reduce the number of missed cancers on mammographic screening. Performing reviews according to established guidelines would make it possible to compare results across screening programs.