The ethics of induction of labor at 39 weeks in low-risk nulliparas in research and clinical practice.

The "A Randomized Trial of Induction Versus Expectant Management" trial (ARRIVE trial) published in 2018 suggested that induction of labor can be considered a "reasonable option" for low-risk nulliparous women at ≥39 weeks of gestation. The study results led some professional societies to endorse the option for elective induction of labor at 39 weeks of gestation in low-risk nulliparas, and this has begun to change obstetrical practice. The ARRIVE trial provided valuable information supporting the benefits of induction of labor; however, the trial is insufficient to serve as the primary justification for widespread elective induction of labor at 39 weeks of gestation in low-risk nulliparas because of concerns about external validity. Thus, the French ARRIVE trial was designed to test the hypothesis in a different setting that elective induction of labor at 39 weeks of gestation in low-risk nulliparas leads to a lower cesarean delivery rate than expectant management. This ongoing trial has been criticized as "pseudoscientific" and telling "women where, when, and how to give birth." We reject these allegations and extensively examine the ethical framework that should govern clinical and research interventions, including elective induction of labor at 39 weeks of gestation in low-risk nulliparas. This study aimed to discuss the ethical issues that emerge from randomized trials of elective induction of labor at 39 weeks of gestation in low-risk nulliparas and the ethics of the clinical practice itself. The analysis of existing evidence shows the importance of further research on induction of labor at 39 weeks of gestation in low-risk women. Certain aspects of research ethics in this area, particularly the consent of pregnant women in a context where autonomy remains fragile, call for vigilance. In addition, we emphasize that childbirth is not only a medical object but also a social phenomenon that cannot be regarded only from the perspective of a health risk to be managed by clinical research. Further research on this issue is needed to allow pregnant women to make informed decisions, and the results should be integrated with social issues. The perspective of women is required in constructing, evaluating, and implementing medical interventions in childbirth, such as induction of labor at 39 weeks of gestation.

Abiraterone acetate versus docetaxel for metastatic castration-resistant prostate cancer: a cohort study within the French nationwide claims database.

OBJECTIVES: To conduct the direct comparison of abiraterone acetate and docetaxel for first-line treatment of metastatic castration-resistant prostate cancer (mCRPC) in real-life settings. METHODS: Data were extracted from the French nationwide claims database (SNDS) on all men aged ≥40 years starting first-line treatment with abiraterone acetate or docetaxel for mCRPC in 2014. A high-dimensional propensity score including 100 baseline characteristics was used to match patients of both groups and form two comparative cohorts. Three-year overall survival and treatment discontinuation-free survival were determined using Kaplan-Meier analysis. RESULTS: In 2014, 2,444 patients started abiraterone for treatment of mCRPC and 1,214 started docetaxel. After trimming and matching, 716 patients were available in each group. Median overall survival tended to be longer in the abiraterone acetate cohort (23.8 months, 95% confidence interval = [21.5; 26.0]) than in the docetaxel cohort (20.3 [18.4; 21.6] months). Survival at 36 months was 34.6% for abiraterone acetate and 27.9% for docetaxel (p = 0.0027). Treatment discontinuation-free median was longer in the abiraterone acetate cohort compared to the docetaxel cohort (10.8 [10.1; 11.7] versus 7.4 [7.0; 8.0] months). CONCLUSION: The findings underline the interest of oral abiraterone acetate over intravenous docetaxel as the first-line treatment option in mCRPC.

The Multidimensional Nature of Research Ethics: Letters Issued by a French Research Ethics Committee Included Similar Proportions of Ethical and Scientific Queries.

Debate is ongoing concerning the activities and functioning of Research Ethics Committees (REC), especially a possible science-or-ethics dichotomy in research ethics review. We retrospectively analyzed 145 letters issued by a French REC over 18 months. All queries were classified in three levels: qualification (definition of the problem), category (aggregation of broader topics) and finally fields (ethical, scientific, or administrative). Overall, 971 queries were identified, of which 407 (42%), 379 (39%), and 135 (14%) were deemed ethical, scientific, and administrative queries, respectively. The most frequent concern was about participants' information. The main influencing factor was the profession of the reporting readers-scientific queries were more frequently raised by a methodologist, whereas ethical queries were more frequently raised by an ethicist. These results indicate that research ethics review is a multidimensional task that should be considered a collaborative effort.

Epidemiology of metastatic castration-resistant prostate cancer: A first estimate of incidence and prevalence using the French nationwide healthcare database.

BACKGROUND: There is a lack of information about the burden of metastatic castration-resistant prostate cancer (mCRPC). The present work aims to estimate the incidence and prevalence of mCRPC in 2014 using the French nationwide healthcare database (SNDS). METHODS: Prevalence and incidence were estimated based on an SNDS extraction of men covered by the general healthcare insurance (86 % of the French population), and aged ≥40. Patients with mCRPC were identified amongst prostate cancer cases using an algorithm estimating a date of first metastasis management and a date of castration resistance. This algorithm was validated by clinical experts through a blind review of 200 anonymized medical charts from SNDS data. Prevalence and incidence were standardized on the European Standard Population (2013 edition). RESULTS: Prevalence and incidence of mCRPC were estimated as, respectively, 62 and 21 cases per 100 000 men in 2014. Less than one mCRPC case per 100 000 was observed in men aged 40-49. Maximum mCRPC incidence was in men aged 80-89 (175 per 100 000). The algorithm used for mCRPC identification had 97 % positive and 99 % negative predictive values. CONCLUSION: The good performances of the algorithm for mCRPC identification and the consistency of the generated results with the existing data highlight the robustness of these first estimates of mCRPC prevalence and incidence. Future updates will call for algorithm adjustment as practices evolve over time. These first real-life data will serve for future follow-up of the impact of changes in the management of prostate cancer.

Current management and future perspectives of penile cancer: An updated review.

Penile cancer (PeCa) is a rare disease worldwide, accounting for less than one percent of all malignancies in men. It usually presents as a painless ulcer or lump on the head of the penis. Squamous cell carcinoma represents the most common histological subtype of PeCa, with pathogenesis intimately linked to chronic Human Papilloma Virus (HPV) infection. Surgery is the cornerstone for the treatment of primary PeCa with potential mutilating outcome depending on the nodal extension of the disease. However, in case of extensive lymph node involvement, multidisciplinary treatment including perioperative chemotherapy and inclusion in clinical trial should be considered. To date, advanced or metastatic disease still have poor prognosis and are a therapeutic challenge with limited options, highlighting the need of new treatments and further investigations. Growing efforts to identify molecular alterations, understand the role of HPV and characterize immune contexture have expanded over the past years, providing further perspectives in prognostication, predictive biomarkers and therapeutic intervention. In this review, we provide an updated overview of current management of PeCa focusing on perioperative strategy. We discuss about new insights of the biology of PeCa and comment future directions in the field.

Is clinical examination for prostate cancer becoming redundant?

Prostate cancer is a paradigmatic example of the impact of technological change on current medical practice, because biological and radiological assessments appear more reliable compared to clinical examination. Thus, the prostate specific antigen blood-test is the key factor for patients' follow-up and for medical decisions. In this context, the possibility arises of medicine without clinical examination; and if, indeed, it would be ethical to perform clinical examinations such as digital rectal examination if it has no direct consequences for care. However, clinical examination could have a residual value for clinical practice, no more as a central factor for medical decision making, but as a key element in shaping the patient-physician relationship. Attention must be focused on identifying the changing role of clinical examination and on discussing its ethical acceptability.

Keywords: Prostate cancer, screening, urooncology, clinical examination, digital rectal examination, care relationship.

Treatment of spinal metastases in renal cell carcinoma: A critical review.

Kidney cancer is the 9th most common cancer in men and the 14th most common in women worldwide. Renal cell carcinoma (RCC) constitutes 90% of all malignancies of the kidney. RCC, is known to be highly vascular and relatively radioresistant. Bone metastases are one of the most common metastatic sites and occur in around 30% of RCCs. They significantly impact the quality of life of patients causing pain and pathological fractures. Spinal metastases represent a particular case with regard to symptoms and treatment. Indeed, neurological pain is often added to the nociceptive pain caused by metastases. More importantly, neurological impairment can be seen, caused by spinal cord or nerve root compression (MSCC). Due to close contact with the spinal cord, the treatment of spinal bone metastases is challenging and requires a multidisciplinary approach. Specific treatment is currently focused on 4 main avenues which are surgery, radiotherapy, interventional radiology and systemic treatment. In June 2017 we carried out an extensive search on PubMed, Web of Science, and Cochrane Library to review the various treatment options and to establish a treatment strategy. This article presents the result of our critical review of the literature, given our expertise in the field.

T2 Star-weighted Angiography (SWAN) Allows to Concomitantly Assess the Prostate Contour While Detecting Fiducials Before MR-based Intensity-modulated Radiation Therapy in Prostate Carcinoma.

PURPOSE: To evaluate the performance of T2 star-weighted angiography (SWAN) to concomitantly assess the prostate contour while detecting fiducials before magnetic resonance (MR)-based intensity-modulated radiation therapy (IMRT) in prostate carcinoma. MATERIALS AND METHODS: Forty patients (mean age: 73.1 ± 7.5 years; average Gleason score: 7 ± 1; average prostate-specific antigen: 14.7 ± 11.6 ng/mL) underwent MR and computed tomography imaging before fiducial-based IMRT. MR protocol included SWAN, T2-weighted (T2w) and diffusion-weighted imaging in a first group (n = 20) and SWAN, T2w and T2-star weighted imaging in a second group (n = 20). In group 1, the depiction of fiducials, image sharpness and visibility of prostate boundaries were independently evaluated by 2 readers on SWAN, T2w or diffusion-weighted images. In group 2, a similar evaluation was performed by 2 other readers on SWAN and T2-star images only. Depiction of fiducials was compared to computed tomography findings. RESULTS: The median scores of visibility of prostate boundaries, image sharpness and depiction of fiducials by SWAN were above average to excellent for all readers. In group 1, readers correctly located 56 of 57 (98.2%) and 47 of 57 (82.5%) fiducials, respectively; and 50 of 51 (98%), and 48 of 51 (88.2%) fiducials in group 2, respectively. CONCLUSION: By allowing adequate visualization of the prostate boundaries and high depiction of fiducial markers concomitantly, SWAN might be used for treatment planning of IMRT. The use of this sequence might simplify the registration process and limit any errors associated with image fusion.

Accuracy of (18) FDG PET-CT for treatment evaluation 3 months after completion of chemoradiotherapy for head and neck squamous cell carcinoma: 2-year minimum follow-up.

BACKGROUND: The purpose of this study was to assess the accuracy of (18) F-fluorodeoxyglucose positron emission tomography ((18) FDG PET)-CT in detecting residual or recurrent disease after nonsurgical treatment for head and neck squamous cell carcinoma (HNSCC). METHODS: We conducted a retrospective analysis of patients with oral cavity, oropharynx, larynx, hypopharynx, or cervical lymph node location of SCC treated with chemoradiotherapy. Twelve weeks posttreatment, (18) FDG PET-CT results were compared to histology if residual disease was suspected. Patients with complete response received a minimum of 24-month follow-up. RESULTS: Forty-seven patients were included with 40 months of median follow-up: 46 with a squamous cell carcinoma (SCC) at the primary site and 43 in the neck. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 86.7%, 90%, 76.5%, and 93.1%, respectively, at the primary site and 100%, 97.2%, 87.5%, 100%, respectively, in the neck. CONCLUSION: (18) FDG PET-CT seems effective in detecting residual disease and in predicting recurrent disease within the first 2 years of follow-up after nonsurgical treatment. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1271-E1276, 2016.

[Delays in the diagnosis and treatment of lung cancer for patients treated with radiation therapy]. / Délais de prise en charge initiale des patients atteints de cancer bronchique traités en radiothérapie.

OBJECTIVE: To describe delays in diagnosis and treatment of lung cancer in patients treated by radiotherapy from the first abnormal imaging to the first day of treatment. PATIENTS AND METHODS: Our retrospective single-center study included all patients treated for primary lung cancer in our center receiving radiotherapy alone or in association to chemotherapy or surgery, between 1st May and 15th September 2011. RESULTS: We included 40 patients. Mean age was 65.3 years and sex ratio was 4 (32 males). In 72.5% (n = 29) of the cases, the objective of the treatment was palliative. Median delay between the first abnormal imaging to the first day of treatment was 75.5 days (CI 95% [63.6-134.4]). Median diagnostic delay to obtain a pathological proof was 38 days (CI 95% [27.9-100]). Median therapeutic delay to start treatment was 31 days (CI 95% [24.6-38.5]). When considering radiotherapy, median delay between multidisciplinary staff decision and first radiotherapy session was 26 days (CI 95% [22.4-33.3]). CONCLUSION: The study of the delays in diagnosis and treatment is the first step to reduce them. Detailed analysis helps to propose some measures to improve these delays.