A randomized phase II trial of CX-01 with standard therapy in elderly patients with acute myeloid leukemia (AML).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 7001-7001 ◽  
Author(s):  
Tibor Kovacsovics ◽  
Moshe Yair Levy ◽  
Rachel J. Cook ◽  
Jonathan E. Kolitz ◽  
Peter Westervelt ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Randomized Study ◽  
Dose Finding ◽  
Newly Diagnosed ◽  
Platelet Factor ◽  
Elderly Aml ◽  
Group 3 ◽  
Group 2 ◽  
Poor Outcomes ◽  
Group 1

7001 Background: Elderly AML patients have poor outcomes irrespective of therapy. CX-01 is a low anticoagulant heparin derivative that retains heparin’s ability to alter the activity of the CXCL12/CXCR4 axis, P-selectin, extracellular histones, and Platelet Factor 4. A pilot study of CX-01 combined with standard therapy for AML led to a complete remission (CR) rate of 92% ( Blood Adv 2:381, 2018). We conducted a randomized, dose-finding study of the same combination in newly diagnosed elderly AML patients. Methods: 76 fit patients older than 59 were randomized to induction with idarubicin and cytarabine on a 7+3 schedule only (Group 1); 7+3 with a lower dose of CX-01 (0.125 mg/kg/hour) (Group 2); or 7+3 with a higher dose of CX-01 (0.25 mg/kg/hour) (Group 3). Patients in CR received consolidation therapy consisting of up to 3 cycles of intermediate dose cytarabine (1000 mg/m2 every 12 hours on Days 1, 3, 5) without or with the same dose of CX-01 for Groups 1, 2, and 3, respectively. CX-01 was given as a continuous infusion after a 4 mg/kg bolus until completion of chemotherapy. Results: 66 of 75 treated patients were evaluable for response. Ten patients were not evaluable due to withdrawal of consent (6 patients), introduction of midostaurin after its approval (3 patients), or death due to hepatic sinusoidal obstructive disease at Day 21 (1 patient in Group 2). We present results for evaluable patients and not on an intent to treat basis. Baseline characteristics were similar across groups. The composite CR rate (CR + CRi) was highest for patients in Group 3 with 89% patients achieving a composite CR as compared to 58% and 50% in Groups 1 and 2, respectively. Kaplan-Meier curves indicated a statistically significant improvement in event free survival (EFS) (P = 0.019) and a non-significant trend (P = 0.10) to improvement in OS in Group 3 as compared to Group 1. Groups 1 and 2 were comparable for EFS and OS. CX-01 was well tolerated without increased incidence of bleeding in Groups 2 and 3. Conclusions: The encouraging CR rate and EFS in elderly fit patients with newly diagnosed AML suggests that CX-01 may potentiate the efficacy of standard AML induction therapy. A randomized study to confirm these findings with the higher dose of CX-01 is warranted. Clinical trial information: NCT02873338.

The Relation Between Epicardial Fat Tissue Thickness and TSH Receptor Antibody in Hyperthyroidism

2018 ◽  
Vol 6 (01) ◽  
pp. 37-40
Author(s):  
Rıza Altunbaş ◽  
Mehmet Eren ◽  
İbrahim Altıparmak ◽  
Hüseyin Karaaslan ◽  
Tevfik Sabuncu
Keyword(s):  
Tsh Receptor ◽  
Newly Diagnosed ◽  
Fat Tissue ◽  
Tissue Thickness ◽  
Receptor Antibody ◽  
Tsh Receptor Antibody ◽  
Epicardial Fat Tissue ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Although hyperthyroidism may be associated with atherosclerosis, its pathogenesis is not well known. TSH receptor antibody (TRAb) has been shown to be responsible for increased orbital fat tissue in Graves ophthalmopathy. Epicardial fat tissue thickness (EFT) has been found to be increased in case of overt hyperthyroidism. In our study, we aimed to investigate if TRAb is associated with the increased EFT in newly diagnosed hyperthyroidism. Methods Twenty six TRAb positive (group 1) and 26 TRAb negative (group 2) newly diagnosed patients with hyperthyroidism, and 26 healthy control subjects (group 3) were enrolled. EFT was measured by the same cardiologist using an echocardiography device. Serum TRAb levels were measured by the radio-receptor assay and levels above 1.75 IU/L were considered as positive. Results There was no difference among groups in terms of age, gender and body mass index. Although there was no significant difference between group 1 and 2, both group 1 (0.38±0.15 cm) and group 2 (0.4±0.17 cm) had significantly higher EFT levels when compared to group 3 (0.25±0.06 cm) (p=0.004 and p=0.001, respectively). However we did not find any correlation between TRAb and EFT levels. Conclusion The results of our study suggested that EFT was increased in hyperthyroidism and this increasing was not dependent of TRAb level. EFT elevation might be depending directly to the cardiovascular effects of hyperthyroidism.

Clinical efficacy of tumor-treating fields for newly diagnosed glioblastoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2046-2046
Author(s):  
Yang Liu ◽  
Margie Richardson ◽  
Kwanza Warren ◽  
Myla S. Strawderman ◽  
Nimish Mohile ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Survival Rates ◽  
Extent Of Resection ◽  
Newly Diagnosed ◽  
Cox Models ◽  
Tumor Treating Fields ◽  
Group 3 ◽  
Group 2 ◽  
Group 1 ◽  
Group Comparisons

2046 Background: Recent clinical trials have shown that adding tumor treating fields (TTF) to the Stupp protocol (SP) has increased survival after glioblastoma (GBM) diagnosis. However, whether this regimen improves population-based survival for patients with GBM remains unknown. Methods: We retrospectively identified adult patients with newly diagnosed GBM treated at our institution from January 2000 to July 2017 (n = 438, median age: 63 years).We grouped patients into three time periods for comparison: 2000-2004 (group 1, prior to SP), 2005-2013 (group 2, SP) and 2014-2017 (group 3, adding TTF to SP). The Kaplan-Meier method was used to estimate survival. Statistical analysis included unadjusted group comparisons by Chi-square and Log-rank tests and adjusted group comparisons using logistic and Cox models. Results: Thirty-seven percent (43/117) of patients with GBM in group 3 received TTF with SP therapy; when compared to those who received SP only, these patients had significant improvements in 6-month and 1-year overall survival (OS) rates (100.0% vs. 82.4%, p < 0.01; 86.0% vs. 66.2%, p < 0.05, respectively) (unadjusted for prognostic factors including sex, age, KPS and extent of resection) and an increased trend of median OS (479.0 vs. 448 days, p = 0.269). However, after adjusting for those prognostic factors, we didn’t find a statistically better survival for patients treated with TTF (OR: 6.156, p = 0.097, OR: 2.102, p = 0.185, respectively). Furthermore, multivariate Cox proportion hazards model after adjusting for those prognostic factors showed no significant survival benefits for patients treated with TTF and SP compared to those treated with SP only (HR = 0.797, p = 0.648). In addition, we didn’t find significant increases of 6-month, 1-year survival rates and median OS for patients in group 3 when compared to those in group 2 who had seen increased trends of survival trends when compared to those in group 1. Conclusions: Although adding TTF to SP appeared to benefit patients with GBM, this effect might be due to selection bias, e.g., TTF was offered to those patients with better prognostic factors. Ascertaining the long-term benefits of TTF requires further investigation.

Incidence, Clinical Features and Outcome of Patients with Differentiation Syndrome in Acute Promyelocytic Leukemia Treated with All-Trans Retinoic Acid (ATRA) Alone Versus ATRA Plus Idarubicin Versus ATRA Plus Arsenic Trioxide.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1044-1044
Author(s):  
Sameer A Parikh ◽  
Hagop Kantarjian ◽  
Farhad Ravandi ◽  
Gautam Borthakur ◽  
Stefan Faderl ◽  
...  
Keyword(s):  
Heart Failure ◽  
Weight Gain ◽  
Promyelocytic Leukemia ◽  
Newly Diagnosed ◽  
Trans Retinoic Acid ◽  
All Trans Retinoic Acid ◽  
Group 3 ◽  
Frontline Therapy ◽  
Group 2 ◽  
Group 1

Abstract Abstract 1044 Poster Board I-66 Background: Differentiation Syndrome (DS) in patients (pts) with acute promyelocytic leukemia (APL) remains a source of significant morbidity and mortality. DS is reported in 2-27% of pts with newly diagnosed APL treated with all-trans retinoic acid (ATRA) alone or in combination with idarubicin (IDA). More recently, arsenic trioxide (ATO) has been used in combination with ATRA as frontline therapy to improve rates of complete remission (CR) and overall survival (OS). It has been postulated that with the use of ATO, the risk of DS may decrease. Aim To describe the incidence, characteristics and outcome of differentiation syndrome with various modalities of ATRA-based therapy used for APL. Methods: We reviewed the records of 167 pts with newly diagnosed APL treated at our institution from 1992-2009 with three regimens: ATRA + IDA (Group 1), liposomal ATRA (Group 2) and ATRA plus ATO (Group 3). Patients in Group 1 (n=52; 1992-1997) received induction with ATRA 45mg/m2 orally daily in two divided doses until CR and IDA 12mg/m2 IV daily for 4 days. Group 2 (n=34; 1997-2000) received liposomal ATRA at 90mg/m2 IV every other day until CR. Patients in Group3 (n=82; 2002-2009) received 45mg/m2 ATRA orally daily in two divided doses, 9mg/m2 gemtuzumab ozogamicin if the WBC count exceeded 30 ×109/L in the first 4 weeks of therapy, ATO 0.15mg/kg/day IV starting on day 10 in 47 patients and on day 1 in 35 patients, and methylprednisolone (50 mg daily for 5 days) to prevent DS. A diagnosis of DS was made by the presence of: dyspnea, unexplained fever, weight gain, peripheral edema, unexplained hypotension, acute renal failure or congestive heart failure, and particularly by a chest radiograph demonstrating interstitial pulmonary infiltrates, or pleuropericardial effusion [Sanz MA, Blood. 2009;113(9):1875-91].Patients with ≥4 features were classified as having severe DS and those with ≤3 mild DS. No single sign or symptom was considered sufficient for diagnosis of DS. Patients with a final diagnosis of pneumonia, sepsis, diffuse alveolar hemorrhage and decompensated heart failure were not considered to have DS. Patients who developed DS ≤7 days of starting therapy with ATRA were classified as “early DS” and others as having “late DS”. Results: Forty one patients (24%) were diagnosed with DS: 14 (27%) in Group 1, 12 (35%) in Group 2, and 15 (18%) in Group 3. Baseline characteristics of patients with DS in each group are shown in Table. Dyspnea, weight gain and pulmonary infiltrates were the most common features of DS in all groups. The median number of days to develop DS after starting ATRA was 3 (1-15) in Group 1, 5 (2-18) in Group 2 and 10 (1-18) in Group 3. ATRA was held in 8 pts (57%) in Group 1, 9 pts (75%) in Group 2, and 8 pts (53%) in Group 3. Intravenous corticosteroids were used for treatment of all patients with DS. CR was achieved in 7 (50%) pts in group 1, 10 (83%) in Group 2 and 14 (93%) in Group 3. The number of patients who died during induction therapy was 6, 2 and 1 in Groups 1, 2 and 3 respectively. There were no deaths directly attributable to DS in any groups. Three-year survival was 65% for pts with DS and 83% for those without DS (p-value: 0.07). Conclusion: The incidence of DS is higher when ATRA alone is used as frontline therapy for APL. With ATRA + ATO (and prophylaxis with corticosteroids) there is a trend for decreased frequency and more delayed occurrence of DS. The severity of DS appears lower for patients not receiving chemotherapy with ATRA. With adequate management, a diagnosis of DS during induction therapy for APL does not influence outcomes independent of therapy. Disclosures: Ravandi: Cephalon: Consultancy, Honoraria.

Combined Ayurveda and Yoga Practices for Newly Diagnosed Type 2 Diabetes Mellitus: A Controlled Trial

2017 ◽  
Vol 25 (1) ◽  
pp. 16-23
Author(s):  
Purnima Datey ◽  
Alex Hankey ◽  
H.R. Nagendra
Keyword(s):  
Type 2 Diabetes ◽  
Blood Sugar ◽  
Controlled Trial ◽  
Newly Diagnosed ◽  
Post Intervention ◽  
Group 3 ◽  
Group 2 ◽  
Male Prisoners ◽  
Group 1

Background: The increasing prevalence of type 2 diabetes in India is a cause for national concern, particularly the spiraling cost burden to the country. As one approach to stop its increase, Yoga medicine has been widely implemented, finding popularity with all social strata. Here, we report a study suggesting that treatment with fresh herbal juices and Yoga can improve the levels of blood glucose and hemoglobin A1c (HbA1c) in people with pre-diabetes. Methods: Study design: 3-arm controlled trial 3 months in duration. Participants: 157 male prisoners with newly diagnosed, high fasting blood sugar (FBS) and postprandial blood sugar (PPBS) levels. Group interventions: (1) Rasahara and Yoga, (2) Yoga, (3) no intervention. Assessments: FBS and PPBS levels were measured every 2 weeks; HbA1c and blood lipids were determined pre- and post-intervention. Results: Significant decreases occurred in the FBS (-21.13 ± 21.16 mg/dl) and PPBS levels (-15.02 ± 14.89 mg/dl) in group 1 (both p < 0.0001) and in the FBS level (20.62 ± 32.68 mg/dl) in group 2 (p = 0.0005), while the increases in group 3 attained significance only for the PPBS level (9.62 ± 21.83 mg/dl) (p = 0.0022). Observed changes in HbA1c were: group 1, -0.044 ± 0.059 mg/dl; group 2, +0.024 ± 0.456 mg/dl (not significant); and group 3, +0.365 ± 0.369 mg/dl (p < 0.0001). Conclusions: This study of Yoga for the treatment of diabetes shows that all male prisoners could benefit from the Yoga prison programs. Addition of Yoga programs to state and federal activities at all levels is now national policy in India. Follow-up studies should be carried out to obtain more robust results.

scholarly journals The Risk of Bladder Cancer in Type 2 Diabetes Mellitus with Combination Therapy of SGLT-2 Inhibitors and Pioglitazone

2021 ◽  
Vol 11 (9) ◽  
pp. 828
Author(s):  
Yan-Rong Li ◽  
Chi-Hung Liu ◽  
Wei-Chiao Sun ◽  
Pei-Yi Fan ◽  
Feng-Hsuan Liu ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Combination Therapy ◽  
Reference Group ◽  
Newly Diagnosed ◽  
Group 4 ◽  
All Cause Mortality ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background: Either sodium-glucose cotransporter-2 (SGLT-2) inhibitors or pioglitazone (Pio) has doubtful issues of bladder cancer, especially for the combination therapy with these two drugs. Our study aimed to investigate the risk of bladder cancer under combination therapy of SGLT-2 inhibitors and Pio. Materials and Methods: We included 97,024 patients with type 2 diabetes mellitus (T2DM) in the Chang Gung Research Database in Taiwan from 1 January 2016 to 31 December 2019. The primary outcome was newly diagnosed bladder cancer after combination therapy with SGLT-2 inhibitors and Pio. Group 1 received both study drugs, group 2 received SGLT-2 inhibitors, group 3 received Pio, and group 4 received non-study drugs (the reference group). The secondary outcome in each group was all-cause mortality. Results: In group 1, no newly diagnosed bladder cancer was detected after a mean 2.8-year follow-up and all-cause mortality decreased significantly (adjusted hazard ratio (AHR), 0.70; 95% confidence interval (CI), 0.54–0.92) in comparison to the reference group (group 4). In group 2 and group 3, no trend of increased bladder cancer was observed (group 2: AHR 0.49, 95% CI 0.05–4.94; group 3: AHR 0.48, 95% CI 0.15–1.58) and it still reduced all-cause mortality (group 2: AHR 0.83, 95% CI 0.70–0.99; group 3: AHR 0.90, 95% CI 0.83–0.99). Conclusions: In T2DM patients without previous or active bladder cancer, the combination therapy of SGLT-2 inhibitors and Pio was not associated with newly diagnosed bladder cancer and had lower all-cause mortality.

scholarly journals P115 Quantitative MRI of muscles is different in rheumatoid arthritis patients compared to healthy controls

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Matthew Farrow ◽  
John Biglands ◽  
Steven Tanner ◽  
Elizabeth Hensor ◽  
Maya Buch ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Grip Strength ◽  
Muscle Volume ◽  
Quantitative Mri ◽  
Muscle Pathology ◽  
Healthy Controls ◽  
Newly Diagnosed ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Rheumatoid arthritis (RA) can present with the loss of muscle mass and a decrease in strength and functional capability. Quantitative MRI offers a non-invasive measurement of muscle status which could improve the understanding of muscle pathology in RA. The purpose of this study was to assess whether MRI-based measurements of T2, fat fraction (FF), diffusion tensor imaging and muscle volume can detect differences between the muscles of RA patients and healthy controls in the thigh; and to assess how different stages of the disease present differently. Methods 39 RA patients were recruited, comprised of 3 groups: 13 newly diagnosed treatment naïve (Group 1 - New RA: 10/13 female, mean age 63 years, mean CRP 31.5, mean EMS 71 minutes), 13 in clinical remission DAS28 &lt;2.6 for at least 1 year (Group 2 - Remission RA: 10/13 female, mean age 67 years, mean CRP 12.1, mean disease 74 months, mean EMS 2 minutes), 13 RA with at least 1 year diagnosis, DAS28 &gt;3.2 ± raised CRP/ESR ± DMARD/targeted therapy escalation ± requiring steroid therapy (Group 3 - Resistant RA: 10/13 female, mean age 65, mean CRP 17.4, mean disease 123 months, mean EMS 63 minutes). 13 healthy controls were also recruited. All 4 groups were age and gender matched. MRI of the dominant thigh was performed using a STEAM-EPI imaging sequence to assess diffusion: mean diffusivity (MD) and fractional anisotropy (FA), 2-point Dixon imaging to assess FF and a fat-suppressed turbo-spin echo sequence to measure T2. All participants had knee extension/flexion and grip strength torque measured using isokinetic dynamometer. Results A one-way ANOVA analysis demonstrated significant differences in T2, FF and muscle volume between RA patients and healthy controls, but no difference in MD or FA. There was no significant difference between the RA groups. T2 and FF were higher in RA patients whilst muscle volume was lower. Muscle volume was significantly correlated with early morning stiffness (rs = 0.4, p = 0.001), DAS28 (rs = 0.4, p = 0.001) and grip strength (rs = 0.5, p &lt; 0.001). All RA patients showed weaker strength compared to the healthy controls. Although the patients in remission (group 2) had better results compared to New (group 1) and Resistant RA patients (group 3), they performed worse than the healthy controls in all strength assessments. Conclusion Quantitative MRI can detect changes in the muscles of RA patients, whether they are newly diagnosed, in remission or with persistently active disease. Difference in T2, FF and muscle volume were apparent even at diagnosis, suggesting muscle changes in RA occur early. Despite effective RA therapy, patients in remission show worse MRI parameters and strength compared to healthy individuals. These warrant attention in improving the muscle strength and quality throughout the spectrum of the RA continuum. Disclosures M. Farrow: None. J. Biglands: None. S. Tanner: None. E. Hensor: None. M. Buch: None. P. Emery: None. A. Tan: None.

The Effect of a Charcoal-based Powder for Enamel Dental Bleaching

2020 ◽  
Vol 45 (6) ◽  
pp. 618-623 ◽  
Author(s):  
MC Franco ◽  
JLS Uehara ◽  
BM Meroni ◽  
GS Zuttion ◽  
MS Cenci
Keyword(s):  
Surface Roughness ◽  
Randomized Study ◽  
Dental Enamel ◽  
Control Group ◽  
Dental Bleaching ◽  
Significance Level ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Clinical Relevance Charcoal based-powders are not effective for dental bleaching. SUMMARY Charcoal-based dentifrices for dental whitening are a novelty in the market. Manufacturers claim that such charcoal-based products have whitening, remineralization, antimicrobial, and antifungal properties of charcoal in such products. However, there is no substantial scientific evidence for these claims. This laboratory randomized study was designed to evaluate the whitening properties of a charcoal-based toothpowder. A total of 45 bovine dental enamel discs were randomly distributed into three groups (n=15): group 1, mechanical brushing with a 1450-ppm F toothpaste (control group); group 2, mechanical brushing with an activated charcoal-based powder; group 3, bleaching per the standard protocol using 10% carbamide peroxide. The surface roughness and color of each specimen were analyzed at baseline and after 14 days of experiment. The surface of one randomly selected specimen from each group was examined using a scanning electron microscope (SEM). The Kruskal-Wallis test was used to compare groups at a significance level of 5%. Only group 3 promoted a statistically significant effect on ΔE compared with groups 1 and 2 (p&lt;0.001 and p=0.003, respectively). No statistically significant difference was found between groups for surface roughness (p&gt;0.05). SEM revealed a more irregular surface in group 1 specimens compared with group 2 and 3 specimens. The charcoal-based powder did not seem to have any bleaching effect.

scholarly journals THE USING OF POLYPRENOL-CONTAINING DRUG IN PATIENTS WITH ACUTE CORONARY SYNDROME

2018 ◽  
Vol 33 (2) ◽  
pp. 21-25
Author(s):  
E. I. Tsoi ◽  
E. V. Vyshlov ◽  
V. B. Trusov
Keyword(s):  
Acute Coronary Syndrome ◽  
Standard Therapy ◽  
Control Group ◽  
Study Group ◽  
Double Blind ◽  
Coronary Syndrome ◽  
Group 3 ◽  
Group 2 ◽  
The Right ◽  
Group 1

The article shows the results of the study using drug Ropren in the patients with acute coronary syndrome. Ropren is  a plant drug containing polyprenols — dolichol precursors which take part in dolichol phosphate pathway. The pathology in this pathway leads to disbalance and glycoprotein deficiency. This is the reason of large group of diseases. This study is randomized double blind placebo controlled (No. NCT03122340 at ClinicalTrials.gov). Patients (n=68) with ACS taking standard therapy including atorvastatin 40 mg/day were randomized into to 2 groups: group 1 (n=34) took Ropren  8 drops 3 times per day for 3 week, then 5 drops 3 times per day for 5 weeks; group 2 (n=34) took placebo in the same dose regimen. After two — month therapy there was a positive dynamic (decreasing) in the level of interleukin-6 in the study group whereas in the control group there was no statistically significant change: 4.36 (2.61, 8.95) and 5.5 (3.3; 8.4) pg/ml, respectively (p<0.05). In the group of patients taking Ropren the reduction or cessation of statin was required significantly less than in the placebo group: 3 (8.8%) vs 9 (26.5%), respectively. One patient from the first group had a side effect in the form of gravity in the right hypochondrium. That is why the administration of Ropren in addition to standard therapy is reasonable in patients with ACS.

The effectiveness of different treatment methods in isolated telangiectasia and reticular vein treatment: A single-center prospective randomized study

2021 ◽  
pp. 026835552110307
Author(s):  
Ufuk Aydın ◽  
Mesut Engin ◽  
Tamer Türk ◽  
Yusuf Ata
Keyword(s):  
Medical Treatment ◽  
Randomized Study ◽  
Significant Difference ◽  
Patient Groups ◽  
Group 3 ◽  
The Mean ◽  
Group 2 ◽  
Reticular Veins ◽  
Group 1

Background There are opinions that telangiectasis and reticular veins are asymptomatic and constitute a cosmetic problem only. However, it has been proven that telangiectasis and reticular veins also affect the quality of life and are symptomatic. Methods Ninety consecutive female patients who were admitted to our outpatient clinic and did not have insufficiency in deep, superficial and perforating veins were included in this study. All participants were divided into three groups as the compression group (Group 1), medical treatment group (Group 2), and sclerotherapy group (Group 3). The initial complaint severities of all patients were noted. Except for patient compliance assessment, baseline, 1st month (T1), 3rd month (T2) and 6th month (T3) evaluation records were kept in all three groups. Results The study began with a total of 90 patients, 30 patients in each group. The mean ages of Groups 1, 2 and 3 were 39.73 ± 8.51 years, 39.30 ± 8.67 years, and 40.77 ± 9.45 years, respectively. The rates of decrease in pain, itching, restless leg, and muscle cramps were similar among the patient groups at all times (P > 0.05). The rate of reduction in swelling was similar between the groups at T1 and T2 (P > 0.05), while there was a significant difference between the groups at T3 (P = 0.009). The groups significantly differed in terms of appearance concern at all times (P = 0.002 for T1, P < 0.001 for T2 and T3). Conclusion We showed that symptoms such as swelling and heaviness in leg can be improved with medical treatment, but the patient's cosmetic satisfaction can increase with sclerotherapy.

Clinical Features and Outcome in Newly Diagnosed Hodgkin Lymphoma Patients Presenting with PET/CT-Ascertained Focal Skeletal Lesions.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2637-2637
Author(s):  
Tarec Christoffer El-Galaly ◽  
Martin Hutchings ◽  
Karen Juul Mylam ◽  
Peter de Nully Brown ◽  
Anne Bukh ◽  
...  
Keyword(s):  
Pathological Features ◽  
Newly Diagnosed ◽  
Extranodal Involvement ◽  
Pet Ct ◽  
Extranodal Disease ◽  
Group 3 ◽  
Group 2 ◽  
Lymphatic Organs ◽  
Group 1 ◽  
Skeletal Lesions

Abstract Abstract 2637 Background Hodgkin lymphoma (HL) has traditionally been regarded as a disease primarily affecting the lymphatic organs. The introduction of dual modality [18]F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) may challenge this statement as PET/CT reveals more sites of extranodal disease than CT alone. The aim of this study was to characterize the clinico-pathological and prognostic features of newly diagnosed HL patients with PET/CT-ascertained skeletal involvement. Patients and Methods We performed a retrospective analysis of the pre-therapeutic PET/CT results from newly diagnosed HL patients at four Danish university hospitals. Criteria for inclusion in the study were (a) histologically verified HL, (b) age ≥15 years, and (c) PET/CT-based staging. Clinical information was obtained from the Danish Lymphoma Registry (LYFO) supplemented by review of medical records. Imaging reports were reviewed for extent of disease. Patients were divided into three groups according to their pattern of PET/CT-positivity: HL confined to lymphatic organs (lymph nodes, spleen, thymus, Waldeyer's ring) (group 1); HL with focal skeletal PET/CT lesions as the only extranodal involvement (group 2); HL with any extranodal involvement, including skeletal lesions if other extranodal sites were concurrently involved (group 3). Results A total of 454 patients with newly diagnosed HL were included and the median follow-up time was 34 months (range 1–113). Focal skeletal PET/CT lesions were identified in 82 patients (18%). HL was confined to nodal areas in 336 (74%) patients (group 1). Among the 118 (26%) patients with extranodal disease, 39 had focal skeletal PET/CT lesions as their only extranodal manifestation (group 2), while 79 had involvement of other extranodal sites with or without co-existing skeletal lesions (groups 3). Group 1 patients exhibited the most favorable combination of clinico-pathological features, group 3 patients displayed most adverse combination of clinico-pathological features, whereas group 2 was intermediate (Table). In a 1:1 comparison between group 1 and 2 patients, the latter had significantly lower hemoglobin (Hgb) levels, higher erythrocyte sedimentation rates (ESR) and higher occurrence of B-symptoms. The PFS for group 2 patients was similar to that of group 3 patients (p=0.85), but significantly shorter than that of group 1 patients (p<0.001) (Figure). After adjusting for other risk factors in a multivariate Cox model, the presence of focal skeletal PET/CT lesions remained independently associated with shorter PFS (p=0.009). Conclusions PET/CT-based identification of focal skeletal lesions as the only extranodal involvement in patients with newly diagnosed HL is not uncommon. This group of patients frequently presents with systemic symptoms and elevated ESR. In addition, their PFS is inferior to that of patients with nodal HL, but similar to that of HL patients with other types of extranodal disease. Although rarely histologically verified, these focal skeletal lesions are thus likely to represent extranodal manifestations of HL. Disclosures: Hutchings: Takeda/Millennium: Consultancy.

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