RADIORYTHMIC: Phase III, Opened, Randomized Study of Postoperative Radiotherapy Versus Surveillance in Stage IIb/III of Masaoka Koga Thymoma after Complete Surgical Resection.

INTRODUCTION: Thymomas are rare intrathoracic malignancies that may be aggressive and difficult to treat. Knowledge and level of evidence for treatment strategies are mainly based on retrospective studies or expert opinion. Currently there is no strong evidence that postoperative radiotherapy after complete resection of localized thymoma is associated with survival benefit in patients. RADIORYTHMIC is a phase III, randomized trial aiming at comparing postoperative radiotherapy versus surveillance after complete resection of Masaoka-Koga stage IIb/III thymoma. Systematic central pathologic review will be performed before patient enrollment as per the RYTHMIC network pathway. PATIENTS AND METHODS: Three hundred fourteen patients will be included; randomization 1:1 will attribute either postoperative radiotherapy (50-54 Gy to the mediastinum using intensity-modulated radiation therapy or proton beam therapy) or surveillance. Stratification criteria include histologic grading (thymoma type A, AB, B1 vs B2, B3), stage, and delivery of preoperative chemotherapy. Patient recruitment will be mainly made through the French RYTHMIC network of 15 expert centers participating in a nationwide multidisciplinary tumor board. Follow-up will last 7 years. The primary endpoint is recurrence-free survival. Secondary objectives include overall survival, assessment of acute and late toxicities, and analysis of prognostic and predictive biomarkers. RESULTS: The first patient will be enrolled in January 2021, with results expected in 2028.

[Short-term results of video-assisted lung cancer surgery in octogenarians]. / Morbi-mortalité de la résection pulmonaire pour cancer par chirurgie vidéo-assistée chez l'octogénaire.

INTRODUCTION: Due to an increase in life expectancy, onco-pulmonologists and thoracic surgeons are more frequently faced with octogenarian patients with lung cancer. In this age group, treatment modalities may need to be revised because of the increasing presence of comorbidities. Surgery remains the reference treatment for early stage disease, but mortality rates and postoperative complications are higher in this group of patients. One of the solutions to reduce the operative risk would be to develop videoassisted thoracoscopic pulmonary resection surgery. The aim of this study was to evaluate the results of this form of lung cancer surgery in octogenarians. METHODS: All patients 80 years old or more who underwent videoassisted lung cancer surgery from 2014 to 2018 at Lyon University Hospital were included. Wedge resections and diagnostic procedures were excluded. RESULTS: Nineteen patients (13 men, 6 women) were included. The median age was 82 years old. All patients had undergone videoassisted lobectomy. Three patients required conversion to thoracotomy (15.8%). All patients underwent complete resection (R0). One patient had N1 lymph node involvement, all others were N0. The postoperative complication rate was 68.4%, the majority of which were grade II of the Clavien classification. Perioperative mortality was 5.3%. CONCLUSIONS: Videoassisted lung cancer resection in a selected population of octogenarians is associated with satisfactory short-term results. It is reasonable to favour minimally invasive techniques in this population, even if the proof of their superiority has not yet been firmly established.

Use of analgesics in France, following dextropropoxyphene withdrawal.

BACKGROUND: In 2009, the European Medicines Agency recommended withdrawal of dextropropoxyphene (DXP); in March 2011 it was withdrawn from the market in France. Up until that time the combination dextropropoxyphene-paracetamol (DXP/PC) was widely used for analgesia. At withdrawal, French regulators recommended that DXP/PC be replaced by other step 2 analgesics, i.e. tramadol, codeine, or opium-containing drugs, or by PC for a weak level of pain. To investigate prescribing behaviours after DXP/PC withdrawal, dispensations of analgesics before and after withdrawal were analysed. METHODS: Aggregated dispensation data of analgesics prescribed between January 2009 and December 2012 in the Rhône-Alpes region were obtained from the general health insurance claims data; changes in analgesic dispensation over time were analysed with the ATC/DDD methodology. Pre (Jan-June 2009) and post-withdrawal (Jan-June 2012) changes of DDDs where computed for each analgesic step. RESULTS: The dispensations of DXP/PC experienced a two-step decrease until 2011. Over the withdrawal period 2009-2012, there was a 14% decrease in the overall use of analgesic (from 109 to 94 DDDs), while the use of step 2 analgesics declined by 46% (- 22 DDDs, from 47 to 25 DDDs). This latter decline included a cessation of use of DXP/PC (29 DDDs in 2009) that were only in part (+ 7 DDDs, from 18 to 25 DDDs) compensated by increased use of codeine, tramadol and opium, in monotherapy or combined with PC. For step 1 analgesics, use increased with 9%, mostly PC (+ 8 DDDs, from 31 to 39 DDDs). Step 3 analgesics dispensations remained largely unchanged over this period (around 3 DDDs). CONCLUSIONS: In the Rhône-Alpes region, DXP/PC withdrawal was accompanied in part by an increased use of same level analgesics, and in part by an increased use of PC in monotherapy. The extent of DXP/PC use before withdrawal, and the increased use of PC after DXP withdrawal, underline the complexity of pain management.

What are the therapeutic alternatives to dextropropoxyphene in France? A prescribers' survey.

About a year after dextropropoxyphene (DXP) withdrawal from the French market, we conducted a survey among members of the French Society of Anesthesia & Intensive Care Medicine (Sfar) and of the French Society of the Study and Treatment of Pain (SFETD) to identify the indications for which this WHO level II analgesic had been prescribed, the prescriber's feedback following withdrawal, and the substitutive analgesics prescribed. DXP had been prescribed by more than 75% of the 430 anaesthesiologists and 230 pain specialists interviewed, mainly for acute and chronic non-cancer pain of moderate intensity. While two thirds of pain specialists were not satisfied with DXP withdrawal, this decision did not affect the majority of anaesthesiologists. In both groups, the main substitutive analgesic was tramadol combined with acetaminophen, while only 24% of prescribers considered acetaminophen alone as a substitute.

Anti-osteoporotic treatments in France: initiation, persistence and switches over 6 years of follow-up.

Limited information is available on anti-osteoporotic treatment initiation patterns in France. In 2006-2013, the most frequently prescribed first-line treatment class for osteoporosis was represented by bisphosphonates (alendronic acid and risedronic acid), followed by strontium ranelate. Persistence with anti-osteoporotic treatment was low, with high proportions of treatment discontinuations and switches. INTRODUCTION: This epidemiological, longitudinal study described first-line treatment initiation, persistence, switches to second-line treatment, and medical care consumption in osteoporotic patients in France during the 2007-2013 period. METHODS: Patients aged ≥50 years, who were recorded in a French claims database and did not die during the observation period, were included if they met ≥1 inclusion criteria for osteoporosis in 2007 (≥1 reimbursement for anti-osteoporotic treatment, hospitalisation for osteoporotic fracture (spine, hip, femur, forearm bones, humerus, wrist), or ≥1 reimbursement for long-term osteoporosis-associated status). We collected data on consumption of anti-osteoporotic treatment (alendronic acid, ibandronic acid, risedronic acid, zoledronic acid, raloxifene, strontium ranelate, teriparatide) and of osteoporosis-related medical care after the date of first reimbursement for anti-osteoporotic treatment. RESULTS: We obtained 2219 patients with a 6-year follow-up and 1387 who initiated an anti-osteoporotic treatment in 2007 and who can be selected for the treatment regimen analysis. The most frequently used first-line treatments were alendronic acid (32.7 %), risedronic acid (22.4 %), strontium ranelate (19.3 %), ibandronic acid (13.1 %) and raloxifene (12.2 %). Among patients who received these treatments, the highest persistence after 6 years was observed for raloxifene (37.3 %), alendronic acid (35.1 %) and risedronic acid (32.3 %). Treatment discontinuations were reported for 35.5 % (raloxifene) to 53.4 % (strontium ranelate) and treatment switches for 27.4 % (alendronic acid) to 56.6 % (ibandronic acid) of these patients. CONCLUSIONS: This study showed that persistence with anti-osteoporotic treatment was relatively low in France, with high proportions of treatment discontinuations and switches, and that patients with osteoporosis were insufficiently monitored by bone specialists.

Costs of perennial allergic rhinitis and allergic asthma increase with severity and poor disease control.

BACKGROUND: Perennial allergic rhinitis (PAR) represents a global and public health problem, due to its prevalence, morbidity, and impact on the quality of life. PAR is frequently associated with allergic asthma (AA). Costs of PAR with or without AA are poorly documented. OBJECTIVE: Our study aimed to detail medical resource utilization (MRU) and related direct cost for PAR, with or without concomitant AA, in France. METHODS: Using Electronic Health Records (EHRs), we identified in 2010 two cohorts of PAR patients, based on General Practitioners' diagnoses and prescribing data, with and without concomitant AA. For each patient, the EHRs were linked to corresponding claims data with MRU and costs during years 2011 to 2013. Predefined subgroup analyses were performed according to severity of PAR and level of AA control. RESULTS: The median annual cost reimbursed by social security system for a patient with PAR, and no AA was 159€ in 2013. This varied from 111€ to 188€ depending on PAR severity. For patients with PAR and concomitant AA, the median annual cost varied between 266€ and 375€, and drug treatment accounted for 42-55% of the costs, depending on asthma control. CONCLUSION: This study linking diagnoses from EHRs to claims data collected valid information on PAR management, with or without concomitant AA, and on related costs. There was a clear increase in costs with severity of PAR and control of AA.

[Radiotherapy of chloroma or granulocytic sarcoma: A literature review]. / Radiothérapie des chloromes ou sarcomes granulocytiques: revue de la littérature.

Granulocytic sarcoma, or chloroma, is a rare clinical entity, usually associated with a blood disease, including acute myeloid leukemia. Management strategies are based on the combination of systemic therapy and local therapy (surgery or radiation). Data for radiotherapy dose are derived from retrospective studies and case reports. We conducted a literature review using the Pubmed search engine to clarify the terms and indications for radiotherapy of chloromas.