Impact of Positive Resection Margins on Recurrence and Survival Following Resection and Adjuvant Chemotherapy in Pancreatic Cancer: Results of the PRODIGE 24-CCTG PA-6 Randomized Controlled Trial.

OBJECTIVE: This study investigated the correlation between positive resection margins and outcomes in patients with pancreatic ductal adenocarcinoma who underwent surgery and adjuvant chemotherapy according to the pivotal trial PRODIGE 24-CCTG PA-6. BACKGROUND: The primary focus is on elucidating the prognostic significance of specific resection margins, including those associated with the superior-mesenteric vein (SMV), medial, and posterior pancreas. METHODS: The analysis involved 400 patients across multiple centers in France and Canada. Surgical resection and subsequent adjuvant chemotherapy were core interventions. This study assessed the prognostic impact of resection margins, highlighting the significance of standardized pathology assessments. Additionally, the influence of chemotherapy regimen choice, comparing gemcitabine to mFOLFIRINOX, on the implications of positive resection margins was examined. RESULTS: Only three margins, SMV (HR=1.48 95% CI [1.11;1.96], P<.001), medial (HR=1.92 95% CI [1.36;2.73], P<.001) and posterior (HR=1.65 95% CI [1.21;2.24], P=.002), had a significant prognostic impact on disease-free survival and were sufficient compared with the seven recommended margins (Kappa=0.90 95% CI [0.87; 0.94]). R1 status was significant independent prognostic factor for poorer survival in gemcitabine-treasted patients (HR=1.97 95% CI [1.23;3.16], P=.005) but lost its significance with mFOLFIRINOX (HR=1.46 95% CI [0.91;2.35], P=.114). CONCLUSIONS: All efforts should be made to evaluate the three margins of the highest prognostic value, with the others being secondary. A key finding of this study is the likely effect of mFOLFIRINOX on local invasion in operated patients, which seems to correct the impairment related to margin involvement, probably explaining the improvements in DFS and OS.

Prevalence and Risk Factors for Metamorphopsia after Successful Retinal Detachment Surgery.

INTRODUCTION: The aim of the study was to determine the prevalence of metamorphopsia following rhegmatogenous retinal detachment (RRD) surgery, as well as associated predictive factors. METHODS: A total of 107 eyes successfully operated for RRD underwent metamorphopsia severity assessment using M-CHARTS, and foveal microstructure analysis by spectral domain optical coherence tomography, at 1 and 6 months postoperatively. Univariate and multivariate logistic regression rendered evaluation of preoperative risk factors. The correlation between metamorphopsia score and outer retinal layer (ORL) integrity was investigated and preoperative risk factors evaluated. RESULTS: The prevalence of postoperative metamorphopsia decreased from 51.4 to 29.9% and the median metamorphopsia score significantly improved (0.5, 95% CI: 0.3; 0.9, to 0.2, 95% CI: 0; 0.5, p < 0.001) from 1 to 6 months, respectively. Preoperative macular detachment was the only predictor found (OR 11.0, 95% CI: 3.1; 39.4, p < 0.001). Metamorphopsia severity was significantly associated with outer nuclear layer thickness and the status of the ellipsoid and cone interdigitation zones. One-month M-CHARTS had 81% sensitivity and 87% specificity in predicting full metamorphopsia recovery at 6 months (0.45 cut-off score). CONCLUSION: The prevalence of metamorphopsia decreased in parallel to ORL restoration, thus demonstrating the etiological role of photoreceptor-level morphological changes. M-CHARTS allowed for monitoring and predicting metamorphopsia recovery after RRD.

Impact of surgery and chemotherapy in ovarian sex cord-stromal tumors from the multicentric Salomé study including 469 patients. A TMRG and GINECO group study.

OBJECTIVE: Identifying prognostic factors and evaluating the impact of adjuvant chemotherapy in patients with sex cord stromal tumors (SCST) is crucial. In this study, we aimed to address these challenges. METHODS: We conducted a retrospective analysis of data from 13 centers of the French Rare malignant gynecological tumors (TMRG) network. We enrolled 469 adult patients with malignant SCST who received upfront surgery since 2011 to July 2015. RESULTS: 75% were diagnosed with adult Granulosa cell tumors, and 23% had another subtype. With a median follow-up of 6.4 years, 154 patients (33%) developed a first recurrence, 82 (17%) two recurrences, and 49 (10%) three recurrences. Adjuvant chemotherapy was administered in 14.7% of patients at initial diagnosis. In relapse, perioperative chemotherapy was administered in 58.5%, 28.2%, and 23.8% of patients, respectively, in the first, second, and third relapse. In the first-line therapy, age under 70 years, FIGO stage, and complete surgery were associated with longer progression-free survival (PFS). Chemotherapy had no impact on PFS in early-stage disease (FIGO I-II). The PFS was similar using BEP or other chemotherapy regimens (HR 0.88 [0.43; 1.81]) in the first-line therapy. In case of recurrence, PFS was statistically prolonged by complete surgery, but perioperative chemotherapy use did not impact PFS. CONCLUSION: Chemotherapy use did not impact survival in the first-line or relapse setting in SCST. Only surgery and its quality demonstrated benefit for PFS in ovarian SCST in any lines of treatment.

Comparison of surgical procedures for benign prostatic hyperplasia of medium-volume prostates: evaluation of the causes of rehospitalization from the French National Hospital Database (PMSI-MCO).

PURPOSE: In France, transurethral resection of the prostate (TURP) is still the most commonly used surgical treatment for medium sized benign prostatic hyperplasia (BPH), but the Holmium Laser Enucleation of the Prostate (HoLEP) and laser vaporization procedures are becoming more common. For these three surgical procedures, we evaluate the initial complications, the short term (3 months) and the 4-12-month postoperative complications necessitating re-hospitalization. METHODS: From the French national hospital data base (PMSI-MCO), all hospitalizations for BPH treatment in 2018 were extracted. We document the complications during the initial hospitalization and any subsequent rehospitalizations during the one-year postoperative period. RESULTS: In 2018, 67,220 patients were treated for BPH: 46,242 TURP, 13,509 HoLEP and 7469 laser vaporization. Age and anticoagulation medications were similar for men treated by the three procedures, but TURP patients were more often hypertensive. Infections and hemorrhagic complications were the most common complications at the initial hospitalization: 17%, 10%, 13% for infections and 15%, 8.1%, 11% for hemorrhagic complications respectively, and TURP performed worse than the other two procedures at the initial hospitalization. During the first three months and then the subsequent nine months, there were fewer complications than initially, with little difference between the three procedures, all differences being less than 1%. CONCLUSION: Laser vaporization techniques led to fewer complications. However, the PMSI-MCO only registers complications during hospitalizations. This study should be extended to non-hospitalized, more minor complications.

Routine first-line detection of breast cancer therapy-related cardiotoxicity by serial, fast and ultra-low-dose equilibrium radionuclide angiography.

BACKGROUND: This study assesses a first-line left ventricular ejection fraction (LVEF) monitoring provided by an ultra-low-dose equilibrium radionuclide angiography (ERNA) in breast cancer women treated with potentially cardiotoxic drugs and analyzes patient outcome based on the ERNA results. METHODS: Breast cancer women treated with anthracyclines, followed or not by trastuzumab, were monitored using ERNA with a high-sensitivity CZT-camera. Calibrated LVEF measurements were obtained with an almost threefold reduction of radiation doses and 10-min recording times. RESULTS: During a mean 24 ± 6 months follow-up, 552 ERNAs with a mean effective dose of 2.3 ± 0.6 mSv were performed in 195 women, among whom 22 (11%) presented both ERNA criteria of cardiotoxicity (LVEF < 50% and > 10% drop from baseline; Tox + group), 35 (18%) only one criterion (Tox ± group), and 138 (71%) neither (Tox - group). This ERNA-based classification correlated with trastuzumab-anthracycline treatment (p = 0.001), prior cardiovascular disease (p = 0.018), and cardiac outcome, with a 30-month survival with no cardiotoxicity-driven drug regimen changes of 97 ± 2% in Tox -, 60 ± 13% in Tox ± and 36 ± 13% in Tox + (p < 0.001) groups. CONCLUSION: First-line detection of breast cancer therapy-related cardiotoxicity by ultra-low-dose ERNA provides consistent results, confirming the excellent cardiac outcome for the greatest majority of women with no ERNA cardiotoxicity criteria.

Visual outcomes of macular melanocytic lesions after early or delayed proton beam therapy.

PURPOSE: During their initial management, some macular melanocytic lesions can be closely monitored to wait for a documented growth before advocating a treatment by irradiation. However, the visual outcomes of this strategy have not yet been assessed. This study compares the visual outcomes of macular melanocytic lesions that underwent delayed proton beam therapy (PBT) after an initial observation to those treated early. METHODS: A total of 162 patients with suspicious melanocytic lesions whose margins were located within 3 mm of the fovea were recruited from two French ocular oncology centers. RESULTS: Overall, 82 patients treated with PBT within 4 months after the initial visit (early PBT group) were compared to 24 patients treated with delayed PBT (delayed PBT group) and 56 patients not treated with PBT (observation group). Visual acuity was not significantly different between baseline and last visit in the observation group (p = 0.325). Between baseline and last visit, the median [IQR] loss in visual acuity was significant in both the early (0.7 [0.2; 1.8], p < 0.001) and the delayed (0.5 [0.2; 1.5], p < 0.001) PBT groups. After irradiation, there was no significant difference between the early and delayed PBT groups for visual loss (p = 0.575), diameter reduction (p = 0.190), and thickness lowering (p = 0.892). In multivariate analysis, history of diabetes mellitus and Bruch's membrane rupture remained significantly associated with greater visual loss (p = 0.036 and p = 0.002, respectively). CONCLUSION: For small lesions in which there is no clear diagnosis of malignant melanoma, an initial close monitoring to document tumor growth does not impact visual prognosis, despite the potential complications associated with the untreated tumor. However, the survival should remain the main outcome of the treatment of these lesions.

Complications after partial nephrectomy: robotics overcomes open surgery and laparoscopy: the PMSI French national database.

PURPOSE: To evaluate three partial nephrectomies (PN) procedures: open (OPN), standard laparoscopy (LPN), and robot-assisted laparoscopy (RAPN), for the risk of initial complications and rehospitalization for two years after the surgery. MATERIALS AND METHODS: From the French national hospital database (PMSI-MCO), every hospitalization in French hospitals for renal tumor PN in 2016-2017 were extracted. Complications were documented from the initial hospitalization and any rehospitalization over two years. Chi-square and ANOVA tests compared the frequency of complications and length of initial hospitalization between the three surgical procedures. Relative risks (RR) and 95% confidence intervals were computed. RESULTS: The 9119 initial hospitalizations included 4035 OPN, 1709 LPN, and 1900 RAPN; 1475 were excluded as the laparoscopic procedure performed was not determined. The average length of hospitalization was 8.1, 6.2, and 4.5 days for OPN, LPN, and RAPN, respectively. Compared to OPN, there were fewer complications at the time of initial hospitalization for the mini-invasive procedures: 29% for OPN vs. 20% for LPN (0.70 [0.63;0.78]) and 12% for RAPN (RR=0.43, 95%CI [0.38;0.49]). For RAPN compared to LPN, there were fewer haemorrhages (RR=0.55 [0.43;0.72]), anemia (0.69 {0.48;0.98]), and sepsis (0.51 [0.36;0.71]); during follow up, there were fewer urinary tract infections (0.64 [0.45;0.91]) but more infectious lung diseases (1.69 [1.03;2.76]). Over the two-year postoperative period, RAPN was associated with fewer acute renal failures (RR=0.73 [0.55;0.98]), renal abscesses (0.41 [0.23;0.74]), parietal complications (0.69 [0.52;0.92]) and urinary tract infections (0.54 [0.40;0.73]) than for OPN. CONCLUSIONS: Conservative renal surgery is associated with postoperative morbidity related to the surgical procedure fashion. Mini-invasive procedures, especially robot-assisted surgery, had fewer complications and shorter hospital lengths of stay.

Impact of HPV status in T1-2 oropharyngeal squamous cell carcinoma with bulky N3 nodes: a multicenter GETTEC study.

PURPOSE: The purpose of our study was to investigate the impact of HPV status in oncologic outcomes in patients with T1-2 oropharyngeal SCC associated with bulky N3 nodes, and to determine progression prognosis factors aiming to define the best therapeutic strategies for these patients. METHODS: This multicenter retrospective study included patients with T1-2 oropharyngeal SCC with N3 nodes treated between 2010 and 2015 in 8 French comprehensive cancer centers. HPV status was determined with P16 hyperexpression in immunohistochemistry. HPV-positive patients were separated into 2 groups according to the associated smoking history (HPV + T +) or not (HPV + T-). We compared the oncological outcomes of patients according to HPV-status and smoking history. RESULTS: Of 67 patients with T1-2 N3 oropharyngeal SCC, 36 patients (53.7%) were HPV negative and 31 patients (46.3%) HPV positive. 2-year PFS was significantly better in HPV + T- group (p = 0.036). The risk of death or progression was significantly reduced in HPV + T- comparatively to HPV- (HR 0.25 95%CI [0.07; 0.89]). 2-year OS was significantly better in HPV + T- group than in the other two groups (p = 0.017). CONCLUSION: In patients with T1-2 oropharyngeal SCC associated with bulky N3 nodes, HPV positive patients without smoking history had better OS and PFS than HPV positive patients with smoking history and HPV negative patients. Thus, HPV status is a significant prognostic factor for survival but this benefit is altered when smoking history is associated. N3 HPV positive patients with smoking history have to be classified as high-risk.

Acute skin toxicity of conventional fractionated versus hypofractionated radiotherapy in breast cancer patients receiving regional node irradiation: the real-life prospective multicenter HYPOBREAST cohort.

BACKGROUND: Large-scale trials have shown that hypofractionated adjuvant breast radiotherapy was as effective in terms of survival and local control as conventional fractionated radiotherapy, and acute toxicity was reduced with hypofractionated radiotherapy. However, there is a lack of data about the toxicity of breast with regional nodal irradiation (RNI). The aim of this study was to assess the effect of fractionation on radiation-related acute skin toxicity in patients receiving RNI in addition to whole-breast or chest wall irradiation, using real-life data. METHODS: We conducted a prospective, multicenter cohort study with systematic computerized data collection integrated into Mosaiq®. Three comprehensive cancer centers used a standardized form to prospectively collect patient characteristics, treatment characteristics and toxicity. RESULTS: Between November 2016 and January 2022, 1727 patients were assessed; 1419 (82.2%) and 308 (17.8%) patients respectively received conventional fractionated and hypofractionated radiation therapy. Overall, the incidence of acute grade 2 or higher dermatitis was 28.4% (490 patients). Incidence was lower with hypofractionated than with conventional fractioned radiation therapy (odds ratio (OR) 0.34 [0.29;0.41]). Two prognostic factors were found to increase the risk of acute dermatitis, namely 3D (vs IMRT) and breast irradiation (vs chest wall). CONCLUSION: Using real-life data from unselected patients with regional nodal irradiation, our findings confirm the decreased risk of dermatitis previously reported with hypofractionated radiation therapy in clinical trials. Expansion of systematic data collection systems to include additional centers as well as dosimetric data is warranted to further evaluate the short- and long-term effects of fractionation in real life.

International assessment of interobserver reproducibility of flap delineation in head and neck carcinoma.

Background: Several reports have suggested that radiotherapy after reconstructive surgery for head and neck cancer (HNC), could have deleterious effects on the flaps with respect to functional outcomes. To predict and prevent toxicities, flap delineation should be accurate and reproducible. The objective of the present study was to evaluate the interobserver variability of frequent types of flaps used in HNC, based on the recent GORTEC atlas.Materials and methods: Each member of an international working group (WG) consisting of 14 experts delineated the flaps on a CT set from six patients. Each patient had one of the five most commonly used flaps in HNC: a regional pedicled pectoralis major myocutaneous flap, a local pedicled rotational soft tissue facial artery musculo-mucosal (FAMM) (2 patients), a fasciocutaneous radial forearm free flap, a soft tissue anterolateral thigh (ALT) free flap, or a fibular free flap. The WG's contours were compared to a reference contour, validated by a surgeon and a radiologist specializing in HNC. Contours were considered as reproducible if the median Dice Similarity Coefficient (DSC) was > 0.7.Results: The median volumes of the six flaps delineated by the WG were close to the reference contour value, with approximately 50 cc for the pectoral, fibula, and ALT flaps, 20 cc for the radial forearm, and up to 10 cc for the FAMM. The volumetric ratio was thus close to the optimal value of 100% for all flaps. The median DSC obtained by the WG compared to the reference for the pectoralis flap, the FAMM, the radial forearm flap, ALT flap, and the fibular flap were 0.82, 0.40, 0.76, 0.81, and 0.76, respectively.Conclusions: This study showed that the delineation of four main flaps used for HNC was reproducible. The delineation of the FAMM, however, requires close cooperation between radiologist, surgeon and radiation oncologist because of the poor visibility of this flap on CT and its small size.

QUANTITATIVE ANALYSIS OF CHORIOCAPILLARIS ALTERATIONS IN SWEPT-SOURCE OPTICAL COHERENCE TOMOGRAPHY-ANGIOGRAPHY DURING RADIATION RETINOPATHY.

PURPOSE: To evaluate choriocapillaris alterations following proton beam therapy irradiation using swept-source optical coherence tomography-angiography, and to assess their correlation with the grade of radiation retinopathy (RR). METHODS: Eyes with uveal melanoma evaluated before and after irradiation with proton beam therapy were included, as well as the healthy fellow eye. The gradation of RR was based on a previously published classification. Choriocapillaris flow voids area was analyzed using Phansalkar thresholding. Retinal vascularization was described by foveal avascular zone (FAZ) perimeter, FAZ area, FAZ circularity index, and percentage of nonperfusion area (PAN) in the superficial capillary plexus (SCP) or deep capillary plexus. RESULTS: A total of 157 eyes of 83 patients were analyzed. Overall, there was a significant difference between the control group, the uveal melanoma before proton beam therapy group, and the grades of RR in the uveal melanoma after proton beam therapy group for FAZ perimeter ( P < 0.001), FAZ area ( P < 0.001), FAZ-circularity index ( P < 0.001), PAN-SCP ( P < 0.001), PAN-deep capillary plexus ( P < 0.001), and choriocapillaris flow voids area ( P < 0.001). Moreover, choriocapillaris flow voids area was significantly increased in the early stages of RR ( P = 0.003) and was further significantly correlated with FAZ perimeter ( P < 0.001), FAZ area ( P < 0.001), FAZ-circularity index ( P = 0.010), PAN-SCP ( P < 0.001), and PAN-deep capillary plexus ( P < 0.001). CONCLUSION: Quantitative optical coherence tomography-angiography alterations in the choriocapillaris microvascularization are an early biomarker of RR and are correlated to the severity of the disease.

Effect of Duration of Silicone Oil Tamponade on Retinal Structure after Rhegmatogenous Retinal Detachment Surgery.

PURPOSE: The aim of the study was to investigate the effect of tamponade duration on retinal changes induced by silicone oil (SO) in patients who underwent successful rhegmatogenous retinal detachment (RRD) surgery. METHODS: Retrospective comparative case series of 68 patients who underwent SO tamponade for RRD. Patients were divided into 2 groups based on timing of SO removal: <6 months (group 1, n = 34) versus ≥6 months (group 2, n = 34). The main outcome measure was the change in central macular, inner, and outer retinal layer thickness (CMT, IRLT, and ORLT) before and after SO removal (SOR). RESULTS: The median tamponade duration was 4 [Clin Ophthalmol. 2016;10:471-6, Zhonghua Yan Ke Za Zhi. 1997 Jan;33(1):39-41] months in group 1 and 8 [Arch Ophthalmol. 1994 Jun;112(6):778-85, Retina. 2004 Dec;24(6):871-7] months in group 2 (p < 0.001). The mean CMT significantly increased from 245.3 ± 22.2 µm and 238.8 ± 41.6 µm under SO to 281.3 ± 60.2 µm and 259.0 ± 43.5 µm after SOR in group 1 (p = 0.009) and in group 2 (p = 0.007), respectively. Automated segmentation measurement revealed a significant increase in mean IRLT (p = 0.014 and p = 0.013) but no change in mean ORLT (p = 0.080 and p = 0.257) in both groups. After adjustment, there was no difference between the 2 groups in terms of mean final CMT, IRLT, and ORLT and mean retinal thickness changes after SOR. There was also no correlation between the tamponade duration and macular microstructural changes or visual recovery. CONCLUSION: SO tamponade causes a thinning of all retinal layers, mainly affecting the inner retinal layer. However, these changes resolved following SO extraction and were not affected by longer tamponade duration.

Cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) vs CRS alone for treatment of endometrial cancer with peritoneal metastases: a multi-institutional study from PSOGI and BIG RENAPE groups.

OBJECTIVE: To investigate the benefit of cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) for the treatment of endometrial peritoneal carcinomatosis compared to CRS alone. METHODS: We conducted a retrospective multicentre study of patients from experienced centres in treating peritoneal malignancies from 2002 to 2015. Patients who underwent surgery for peritoneal evolution of endometrial cancer (EC) were included. Two groups of 30 women were matched and compared: "CRS + HIPEC" which used HIPEC after CRS, and "CRS only" which did not use HIPEC. We analysed clinical, pathologic and treatment data for patients with peritoneal metastases from EC. The outcome measures were morbidity, overall survival (OS), and progression-free survival (PFS). RESULTS: In "CRS plus HIPEC" group, 96.7% of women were treated for recurrence, while in "CRS only" 83.3 were treated for primary disease. There was no significant difference between Peritoneal Carcinomatosis Index at laparotomy or Completeness of Cytoreduction score. Grade III and IV complications rates did not significantly differ between "CRS plus HIPEC" group and "CRS only" group (20.7% vs 20.7%, p = 0.739). Survival analysis showed no statistical difference between both groups. Median OS time was 19.2 months in "CRS plus HIPEC" group and 29.7 months in "CRS only" group (p = 0.606). Median PFS survival time was 10.7 months in "CRS plus HIPEC" group and 13.1 months in "CRS only" group (p = 0.511). CONCLUSION: The use of HIPEC combined to CRS did not have any significance as regard the DFS and OS over CRS alone in patients with primary or recurrent peritoneal metastasis of endometrial cancer.

High prevalence of anterior pituitary deficiencies after cranial radiation therapy for skull base meningiomas.

BACKGROUND: Cranial irradiation represents one of the first line treatment proposed in skull base meningiomas. While cranial irradiation is associated with a high risk of secondary hypopituitarism, few studies focused on the specific location of skull base meningiomas. METHODS: Fifty-two adults receiving photon-beam therapy for skull base meningiomas between 2003 and 2014 in our Institution were included. Anterior pituitary (ACTH, FSH, GH, LH, TSH and prolactin) as well as corresponding peripheral hormones (8 am-Cortisol, IGF-1, fT3, fT4, 17ßestradiol or testosterone) were biologically screened before radiotherapy (baseline), then yearly until March 2019. The pituitary gland (PG) was delineated on CT and the mean dose delivered to it was calculated. RESULTS: Mean age at diagnosis was 56 +/- 14 years. Median follow-up was 7 years. Up to 60% of patients developed at least ≥2 pituitary deficiencies, 10 years after radiotherapy. Gonadotroph, thyrotroph, corticotroph and somatotroph deficiencies occurred in 37, 28, 18 and 15% of patients, respectively. Hyperprolactinemia was found in 13% of patients. None patient had only one pituitary deficiency. In the multivariate analysis, a delivered dose to the PG ≥ 50 Gy or a meningioma size ≥40 mm significantly increased the risk of developing hypopituitarism. CONCLUSIONS: Over a long-term follow-up, cranial radiation therapy used in skull base meningiomas led to a high prevalence of hypopituitarism, further pronounced in case of tumor ≥4 cm. These results advocate for an annual and prolonged follow-up of the pituitary functions in patients with irradiated skull base meningiomas.

Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS).

BACKGROUND: Stereotactic Body Radiation Therapy (SBRT) is an innovative modality based on high precision planning and delivery. Cancer with bone metastases and oligometastases are associated with an intermediate or good prognosis. We assume that prolonged survival rates would be achieved if both the primary tumor and metastases are controlled by local treatment. Our purpose is to demonstrate, via a multicenter randomized phase III trial, that local treatment of metastatic sites with curative intent with SBRT associated of systemic standard of care treatment would improve the progression-free survival in patients with solid tumor (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases compared to patients who received systemic standard of care treatment alone. METHODS: This is an open-labeled randomized superiority multicenter phase III trial. Patients with up to 3 bone-only metastases will be randomized in a 1:1 ratio.between Arm A (Experimental group): Standard care of treatment & SBRT to all bone metastases, and Arm B (Control group): standard care of treatment. For patients receiving SBRT, radiotherapy dose and fractionation depends on the site of the bone metastasis and the proximity to critical normal structures. This study aims to accrue a total of 196 patients within 4 years. The primary endpoint is progression-free survival at 1 year, and secondary endpoints include Bone progression-free survival; Local control; Cancer-specific survival; Overall survival; Toxicity; Quality of life; Pain score analysis, Cost-utility analysis; Cost-effectiveness analysis and Budget impact analysis. DISCUSSION: The expected benefit for the patient in the experimental arm is a longer expectancy of life without skeletal recurrence and the discomfort, pain and drastic reduction of mobility and handicap that the lack of local control of bone metastases eventually inflicts. TRIALS REGISTRATION: ClinicalTrials.gov NCT03143322 Registered on May 8th 2017. Ongoing study.

Maximum slope using ultrafast breast DCE-MRI at 1.5 Tesla: a potential tool for predicting breast lesion aggressiveness.

OBJECTIVES: We evaluated the relationship between the maximum slope (MS) based on ultrafast breast DCE-MRI sequences, and the clinical parameters and routine prognostic factors of breast cancer. METHODS: 210 lesions were retrospectively evaluated: 150 malignant (30 each of luminal A invasive carcinoma, luminal B invasive carcinoma, HER2 overexpression (HER2), triple negative (TN), invasive lobular carcinoma (ILC)), and 60 benign. For each lesion, the MS was obtained with an ultrafast sequence and semi-quantitative curves were classified into three types with a conventional DCE sequence. The correlation between MS and age, body mass index (BMI), menopause, and routine prognostic factors were analyzed. RESULTS: A MS cut-off at 6.5%/s could discriminate benign from malignant lesions, with sensitivity and specificity of 84% and 90%, respectively, whereas analysis of semi-quantitative curves showed sensitivity and specificity of 89.3% and 55%, respectively. In multivariate analysis, MS values decreased with BMI increasing (p = 0.035), postmenopausal status (p < 0.001), and positive ER status (p < 0.001) and increased with tumor size (p < 0.001). The MS was significantly lower for the pooled luminal A + ILC group than for the pooled luminal B + HER2 + TN group featuring tumors with poorer prognoses (p < 0.001). With a threshold of 11%/s, the sensitivity and specificity to identify invasive carcinoma subtypes with poorer prognoses were 71% and 68%, respectively. CONCLUSION: The MS allows better tumor characterization and identifies factors of poor prognosis for breast cancer. KEY POINTS: • Maximum slope calculated from ultrafast breast DCE-MRI differentiates benign from malignant breast lesions better than semi-quantitative curves of conventional DCE-MRI. • Maximum slope calculated from ultrafast breast DCE-MRI identifies breast cancers with poor prognoses. • In the case of multiple lesions, the most aggressive may be identified and targeted by measuring the maximum slope.

Synchronous BI-RADS category 3 lesions detected by preoperative breast MRI in patients with breast cancer: may follow-up be adequate?

OBJECTIVE: The purpose of this study was to analyze the rate of malignancy of synchronous Breast Imaging Reporting and Data System (BI-RADS) category 3 lesions identified by preoperative magnetic resonance imaging (MRI) in patients with breast cancer that were followed up rather than biopsied. METHODS: From electronic medical records, we identified 99 patients treated in our institution for whom preoperative breast MRI identified synchronous BI-RADS 3 lesions. Lesion characteristics, rate of second-look ultrasonography (US), rate of collegial decision-making, and rate of biopsies performed during the period of monitoring were analyzed. RESULTS: Second-look US was performed in 96 of 99 patients and did not reveal any lesion. Collegial decision-making for follow-up validation was asked in 32%. The median time to last MRI was 24.4 months (interquartile range [IQR] [19.3; 36.3]). The median follow-up was 39 months (IQR [28; 52]). Two cancers were diagnosed, one at 5 months and one at 26 months of follow-up. The incidence of malignancy of followed up synchronous BI-RADS category 3 lesions was 1.0% (95% CI [0.1%; 7.1%]) at 6 months and 2.2% (95% CI [0.6%; 8.6%]) at 30 months. CONCLUSION: Monitoring could be proposed for synchronous BI-RADS category 3 lesions detected in preoperative breast cancer patients. A continued follow-up beyond 2 years could be of benefit. KEY POINTS: • Follow-up can be proposed for MRI BI-RADS category 3 lesions not detected at second-look ultrasound, possibly after a collegial decision. • Follow-up should be continued annually since cancer may occur beyond 2 years.

Added-value of advanced magnetic resonance imaging to conventional morphologic analysis for the differentiation between benign and malignant non-fatty soft-tissue tumors.

OBJECTIVES: To evaluate the added value of DWI, qualitative proton MR spectroscopy (H-MRS) and dynamic contrast-enhanced perfusion (DCE-P) to conventional MRI in differentiating benign and malignant non-fatty soft tissue tumors (NFSTT). METHODS: From November 2009 to August 2017, 288 patients with NFSTT that underwent conventional and advanced MRI were prospectively evaluated. The study was approved by the local ethics committee. All patients signed an informed consent. A musculoskeletal (R1) and a general (R2) radiologist classified all tumors as benign, malignant, or indeterminate according to morphologic MRI features. Then, DWI, H-MRS, and DCE-P data of indeterminate tumors were analyzed by two additional radiologists (R3 and R4). Advanced techniques were considered individually and in combination for tumor benign-malignant differentiation using histology as the gold standard. RESULTS: There were 104 (36.1%) malignant and 184 (63.9%) benign tumors. Conventional MRI analysis classified 99 tumors for R1 and 135 for R2 as benign or malignant, an accuracy for the identification of malignancy of 87.9% for R1 and 83.7% for R2, respectively. There were 189 indeterminate tumors for R1. For these tumors, the combination of DWI and H-MRS yielded the best accuracy for malignancy identification (77.4%). DWI alone provided the best sensitivity (91.8%) while the combination of DCE-P, DWI, and H-MRS yielded the best specificity (100%). The reproducibility of the advanced imaging parameters was considered good to excellent (Kappa and ICC > 0.86). An advanced MRI evidence-based evaluation algorithm was proposed allowing to characterize 28.1 to 30.1% of indeterminate non-myxoid tumors. CONCLUSION: The prioritized use of advanced MRI techniques allowed to decrease by about 30% the number of non-myxoid NFSTT deemed indeterminate after conventional MRI analysis alone. KEY POINTS: • When morphological characterization of non-fatty soft tissue tumors is possible, the diagnostic performance is high and there is no need for advanced imaging techniques. • Following morphologic analysis, advanced MRI techniques reduced by about 30% the number of non-myxoid indeterminate tumors. • DWI is the keystone of advanced imaging techniques yielding the best sensitivity (91.8%). Optimal specificity (> 90%) is obtained by a combination of advanced techniques.

Non-technical skills in robotic surgery and impact on near-miss events: a multi-center study.

BACKGROUND: Robotic surgery requires a set of non-technical skills (NTS), because of the complex environment. We aim to study relationship between NTS and near-miss events in robotic surgery. METHODS: This is an observational study in five French centers. Three robotic procedures were observed and filmed by one of expert trainers in NTS. They established and scored a non-technical skills in robotic surgery (NTSRS) score, that included eight items, each scored from 1 to 5, to assess the whole surgical teams. The surgical teams also self-assessed their work. The number of near-miss events was recorded and classified as minor, or major but no harm incidents, independently by two surgeons. Correlations were Spearman coefficients. RESULTS: Of the 26 procedures included, 15 were prostatectomy (58%), 9 nephrectomy (35%), and 2 pyeloplasty (7.7%). Half of procedures (n = 13) were performed by surgeons with extensive RS experience (more than 150 procedures). Per procedure, there was a median (quartiles) of 9 (7; 11) near-miss events. There was 1 (0; 2) major near-miss events, with no harm. The median NTSRS score was 18 (14; 21), out of 40. The number of near-miss events was strongly correlated with the NTSRS score (r = - 0.92, p < 0.001) but was not correlated with the surgeon's experience. The surgeons for fifteen (58%) procedures, and the bed-side surgeons for 11 (42%) procedures, felt that there was no need for an improvement in the quality of their NTS. None of the surgeons gave a negative self-evaluation for any procedure; in three procedures (12%), the bed-side surgeons self-assessed negatively, on ergonomics. CONCLUSION: Occurrence of near-miss events was reduced in teams managing NTS. Specific NTS surgical team training is essential for robotic surgery as it may have a significant impact on risk management.

COMPARATIVE EFFECTIVENESS OF PROTON BEAM VERSUS PHOTODYNAMIC THERAPY TO SPARE THE VISION IN CIRCUMSCRIBED CHOROIDAL HEMANGIOMA.

PURPOSE: The aim of this study was to compare the functional and anatomical effectiveness of photodynamic therapy (PDT) versus proton beam therapy (PBT) in a real-life setting for the treatment of circumscribed choroidal hemangioma. METHODS: A total of 191 patients with a diagnosis of circumscribed choroidal hemangioma and treated by PBT or PDT were included for analyses. RESULTS: The 119 patients (62.3%) treated by PDT were compared with the 72 patients treated by PBT. The final best-corrected visual acuity did not differ significantly between the two groups (P = 0.932) and final thickness was lower in the PBT compared with the PDT group (P = 0.001). None of the patients treated by PBT needed second-line therapy. In comparison, 53 patients (44.5%) initially treated by PDT required at least one other therapy and were associated with worse final best-corrected visual acuity (P = 0.037). In multivariate analysis, only an initial thickness greater than 3 mm remained significant (P = 0.01) to predict PDT failure with an estimated odds ratio of 2.72, 95% confidence interval (1.25-5.89). CONCLUSION: Photodynamic therapy and PBT provide similar anatomical and functional outcomes for circumscribed choroidal hemangioma ≤3 mm, although multiple sessions are sometimes required for PDT. For tumors >3 mm, PBT seems preferable because it can treat the tumor in only 1 session with better functional and anatomical outcomes.