Tasisulam at a target C(max) of 420 μg/mL on day 1 of 21-day cycles demonstrated modest activity as second-/third-line treatment in patients with STS. Grade 4 hematologic toxicity posed some challenges in these heavily pre-treated patients. Tasisulam dosing continues to be refined.

The administration of a triple combination produced promising objective responses with acceptable toxicity but does not seem to produce an evident benefit in time-related parameters.

BACKGROUND The targeted therapy cetuximab [directed at the epidermal growth factor receptor (EGFR)] in combination with 5-fluorouracil and platinum-based chemotherapy (the EXTREME regimen) has shown substantial efficacy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Thus, this scheme has been established as the preferred first-line option for these patients. However, more recently, a new strategy combining platinum, taxanes, and cetuximab (the TPEx regimen) has demonstrated similar efficacy with a more favorable toxicity profile in clinical trials. AIM To evaluate the safety and efficacy of the TPEx scheme as first-line therapy in advanced SCCHN in a multicenter cohort study. METHODS This retrospective multicenter cohort study included patients with histologically confirmed recurrent or metastatic SCCHN treated with first-line TPEx at five medical centers in Argentina between January 1, 2017 and April 31, 2020. Chemotherapy consisted of four cycles of docetaxel, cisplatin, and cetuximab followed by cetuximab maintenance therapy. Clinical outcomes and toxicity profiles were collected from medical charts. Treatment response was assessed by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (version 1.1). Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). RESULTS Twenty-four patients were included. The median age at diagnosis was 58 years (range: 36-77 years). The majority of patients (83.3%) received at least four chemotherapy cycles in the initial phase. In the included group, the overall response rate was 62.5%, and 3 patients achieved a complete response (12.5%). The median time to response was 2.4 mo [95% confidence interval (CI): 1.3-3.5]. With a median follow-up of 12.7 mo (95%CI: 8.8-16.6), the median progression-free survival (PFS) was 6.9 mo (95%CI: 6.5-7.3), and the overall survival rate at 12 mo was 82.4%. Patients with documented tumor response showed a better PFS than those with disease stabilization or progression [8.5 mo (95%CI: 5.5-11.5) and 4.5 mo (95%CI: 2.5-6.6), respectively; P = 0.042]. Regarding the safety analysis, two-thirds of patients reported at least one treatment-related adverse event, and 25% presented grade 3 toxicities. Of note, no patient experienced grade 4 adverse events. CONCLUSION TPEx was an adequately tolerated regimen in our population, with low incidence of grade 3-4 adverse events. The median PFS were consistent with those in recent reports of clinical trials evaluating this treatment combination. This regimen may be considered an attractive therapeutic strategy due to its simplified administration, decreased total number of chemotherapy cycles, and treatment tolerability.

Background:Osteoporosis predominantly affects post-menopausal women. There is an important percentage of the population that have additional risk factors that decrease bone mineral density. Patients with Systemic Lupus Erythematosus (SLE) have an increased risk for osteoporosis due to corticosteroid use and chronic inflammation. This population could have a higher prevalence of osteoporosis when compared to post-menopausal women of equal or older age. There is a paucity of information regarding bone mineral density and SLE in Latin America.Objectives:To describe the prevalence and incidence of osteoporosis and osteoporotic fractures in a Colombian population with Systemic Lupus ErythematosusMethods:We collected 464 clinical records of patients who met either the American College of Rheumatology 1997 or Systemic Lupus International Collaborating Clinics (SLICC) 2012 classification criteria for systemic lupus erythematosus between January 2015 and June 2019. The clinical and immunoserological characteristics, and damage accrual were monitored for one year. The diagnosis of osteoporosis was confirmed with densitometry by energy x-ray absorptiometry (DXA) and the presence of fragility fractures according to the rheumatologist’s report in the clinical history. The description of proportions and incidence rate of osteoporosis and fragility fracture is performed.Results:The mean age was 45 years, 96.5% were women and the mean disease duration was 12 years. Others clinical characteristics in table 1. The prevalence of osteoporosis was 13.8% with an incidence of 1.1 fractures / 100 person-months in the general population with SLE. In postmenopausal women, over 50 years the prevalence of osteoporosis was 28.4% with an incidence of 0.8 fractures / 100 months person. In the densitometric characteristics, the mean bone mineral density was 0.772 gr / cm2, T-score spine -2.9 and T-score femoral -2.6. SLEDAI mean 1.5 (SD 2.92) and SLICC mean 1.Table 1.clinical characteristicsn%Active Smoking8317.9Premature gonadal failure81.7Lupic Nephritis17838.4Proteinuria >2.5grams/24hours347.3End Stage Renal Disease163.4Anti-dsDNA14631.4Anti-Sm11023.7Anti-Ro13829.7Prednisone Cumulative Dose2.8grAntimalarial5712Conclusion:Low bone mineral density and severe osteoporosis are prevalent in our cohort with SLE. We have found a fracture rate of 1080 per 100.000 people, which is well over what has been reported in the general population (53-443 per 100.000 people in women). Osteoporotic fractures are part of damage accrual and thus have an association with morbidity and mortality. Data regarding osteoporotic fractures are necessary in order to develop guidance and health policy in the region. SLE is an important risk factor for severe osteoporosis and must be kept in mind when developing guidance and health policyReferences:[1]Jumei Xia, Ran Luo, Shuiming Guo, et al. Prevalence and Risk Factors of Reduced Bone Mineral Density in Systemic Lupus Erythematosus Patients: A Meta-Analysis. BioMed Research International. Volume 2019, Article ID 3731648, 10 pages.[2]Irene E.M. Bultinka, Willem F. Lemsa. Lupus and fractures. Curr Opin Rheumatol 2016, 28:426–432.Disclosure of Interests:Juan camilo Diaz-Coronado: None declared, Sebastian Herrera Speakers bureau: academic conference, Deicy Hernandez-Parra: None declared, Laura Betancur-Vasquez: None declared, Daniel Gonzalez-Hurtado: None declared, Juanita Gonzalez-Arango: None declared, laura Uribe-Arango: None declared, Maria Fernanda Saavedra Chacón: None declared, Jorge Lacouture-Fierro: None declared, Sebastian Guerra-Zarama: None declared, Santiago Monsalve: None declared, Jose David Serna Giraldo: None declared, Juan david Serna: None declared, Julian Barbosa: None declared, Ricardo Pineda.Tamayo: None declared