Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. Myeloma Aredia Study Group.

1998 ◽  
Vol 16 (2) ◽  
pp. 593-602 ◽  
Author(s):  
J R Berenson ◽  
A Lichtenstein ◽  
L Porter ◽  
M A Dimopoulos ◽  
R Bordoni ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Pathologic Fracture ◽  
Treated Group ◽  
Cord Compression ◽  
Stage Iii ◽  
Lytic Lesion ◽  
The Mean ◽  
To Receive ◽  
Skeletal Event

PURPOSE To determine the efficacy and safety of 21 monthly cycles of pamidronate therapy in patients with advanced multiple myeloma. PATIENTS AND METHODS Patients with stage III myeloma and at least one lytic lesion received either placebo or pamidronate 90 mg intravenously administered as a 4-hour infusion monthly for 21 cycles. At study entry, the patients were stratified according to whether they were to receive first-line (stratum 1) or second-line (stratum 2) antimyeloma chemotherapy. Skeletal events (pathologic fracture, radiation or surgery to bone, and spinal cord compression) and hypercalcemia were assessed monthly. RESULTS The results of the first nine previously reported cycles are extended to 21 cycles. Of the 392 randomized patients, efficacy could be evaluated in 198 who received pamidronate and 179 who received placebo. After 21 cycles, the proportion of patients who developed any skeletal event was lower in the pamidronate-group (P = .015). The mean number of skeletal events per year was less in the pamidronate-group (1.3) than in placebo-treated patients (2.2; P = .008). Although survival was not different between the pamidronate-treated group and placebo patients overall, stratum 2 patients who received pamidronate lived longer than those who received placebo (14 v 21 months, P = .041). Pamidronate was safe and well tolerated during the 21 cycles of therapy. CONCLUSION Long-term monthly infusions of pamidronate as an adjunct to chemotherapy are superior to chemotherapy alone in reducing skeletal events in stage III multiple myeloma patients, and may improve the survival of patients on salvage therapy.

scholarly journals A randomized, comparative, open clinical trial for evaluating the efficacy of PP/JLN/107/09-10 Syrup in the management of Functional Constipation

2020 ◽  
Vol 5 (06) ◽  
pp. 43-50
Author(s):  
M. Ramadas ◽  
Padmanabha Rugvedi ◽  
Pankaj Kumar Gupta ◽  
Rajiva Kumar Rai ◽  
JLN Sastry
Keyword(s):  
Functional Constipation ◽  
Abdominal Distension ◽  
Prospective Clinical Study ◽  
Rome Ii Criteria ◽  
Herbal Formulation ◽  
Associated Symptoms ◽  
The Mean ◽  
Trial Drug ◽  
To Receive

Context: Functional constipation which has no underlying organic causes is difficult to be allopathic treatment for long term due to its side effects and undeniable effect, thus a natural balanced and compatible formulation needs to be validated. Objectives: Current study aimed to assess a poly-herbal formulation in management of functional constipation. Material and Methods: This study was 28 days, two armed, randomized, open labeled, prospective clinical study. 60 clinically confirmed cases of functional constipation patients randomized to receive orally either 2 teaspoonful of PP/JLN/107/09-10 Syrup or 1 teaspoonful of 5- 6 gm of Isabgol powder. Results were analyzed as per Rome II criteria and other associated symptoms like headache, acidity, belching, barborgysmy, flatulence and abdominal dis tension or bloating which are recorded on VAS score. Results: PP/JLN/107/09-10 scored over Isabgol on four out of six parameters of Rome II Criteria viz., frequency of bowel movement, straining at defecation, lumpy I har dstool formation, feeling of incomplete evacuation, feeling of ano-rectal blockage and manual maneuvers (p less than 0.001). Trial drugs showed comparable effects (p > 0.05) in reducing the mean scores of associated symptoms like headache, acidity, belching, borgorgysmy, flatulence and abdominal distension. However, trial drug was found to perform statistically significant result in more number of parameters in comparison to Isabgol. Conclusion: PP/JLN/107/09-10 was found to be effective and safe in reliving functional constipation.

scholarly journals The Prognosis and Oncological Predictor of Urachal Carcinoma of the Bladder: A Large Scale Multicenter Cohort Study Analyzed 203 Patients With Long Term Follow-Up

2021 ◽  
Vol 11 ◽  
Author(s):  
Young Dong Yu ◽  
Young Hwii Ko ◽  
Jong Wook Kim ◽  
Seung Il Jung ◽  
Seok Ho Kang ◽  
...  
Keyword(s):  
Large Scale ◽  
Survival Rates ◽  
Stage Iii ◽  
Pathological Stage ◽  
Urachal Carcinoma ◽  
Multicenter Cohort ◽  
Long Term Follow Up ◽  
The Mean

AimThis study evaluated the prognosis and survival predictors for bladder urachal carcinoma (UC), based on large scale multicenter cohort with long term follow-up database.MethodsA total 203 patients with bladder UC treated at 19 hospitals were enrolled. Clinical parameters on carcinoma presentation, diagnosis, and therapeutic methods were reviewed for the primary cancer and for all subsequent recurrences. The stage of UC was stratified by Mayo and Sheldon pathological staging system. Oncological outcomes and the possible clinicopathological parameters associated with survival outcomes were investigated.ResultsThe mean age of the patients was 54.2 years. Among the total of 203 patients, stages I, II, III, and IV (Mayo stage) were 48 (23.8%), 108 (53.5%), 23 (11.4%), and 23 (11.4%), respectively. Gross hematuria and bladder irritation symptoms were the two most common initial symptoms. The mean follow-up period was 65 months, and 5-year overall survival rates (OS), cancer-specific survival rates (CSS), and recurrence-free survival rates (RFS) were 88.3, 83.1, and 63.9%, respectively. For the patients with Mayo stage ≥III, OS, CSS, and RFS were significantly decreased to 38.0, 35.2, and 28.4%, respectively. The higher pathological stage (Mayo stage ≥III, Sheldon stage ≥IIIc), positive surgical margin (PSM), and positive lymphovascular invasion (PLM) were independent predictors of shorter OS, CSS, and RFS.ConclusionThe pathological stage, PSM, and PLM were significantly associated with the survival of UC patients, emphasizing an importance of the complete surgical resection of tumor lesion.

scholarly journals Subspecialty Second-Opinion in Multiple Myeloma CT: Emphasis on Clinically Significant Lytic Lesions

Medicina ◽  
2020 ◽  
Vol 56 (4) ◽  
pp. 195
Author(s):  
Alberto Stefano Tagliafico ◽  
Liliana Belgioia ◽  
Alessandro Bonsignore ◽  
Federica Rossi ◽  
Giulia Succio ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Multiple Myeloma ◽  
Lesion Detection ◽  
Second Opinion ◽  
Lytic Lesion ◽  
Focal Lesion ◽  
Years Of Experience ◽  
Focal Lesions ◽  
Lytic Lesions ◽  
The Mean

Background and objectives: In order to increase the accuracy of lytic lesion detection in multiple myeloma, a dedicated second-opinion interpretation of medical images performed by subspecialty musculoskeletal radiologists could increase accuracy. Therefore, the purpose of this study is to evaluate the added value (increased accuracy) of subspecialty second-opinion (SSO) consultations for Computed Tomography (CT) examinations in Multiple Myeloma (MM) patients undergoing stem cell transplantation on standard computed tomography with a focus on focal lesion detection. Materials and Methods: Approval from the institutional review board was obtained. This retrospective study included 70 MM consecutive patients (mean age, 62 years ± 11.3 (standard deviation); range, 35–88 years) admitted in the last six years. Pre-transplant total-body CT (reported by general radiologists) was the only inclusion criteria. Each of these CT examinations had a second-opinion interpretation by two experienced subspecialty musculoskeletal (MSK) radiologists (13 years of experience and 6 years of experience, mean: 9.5 years), experts in musculoskeletal radiology and bone image interpretation with a focus on lytic lesions. Results: Per lesion intra- and inter-observer agreement between the two radiologists was calculated with K statistics and the results were good (K = 0.67: Confidence Inteval (CI) 95%: 0.61–0.78). When the initial CT reports were compared with the re-interpretation reports, 46 (65%) of the 70 cases (95% CI: 37–75%) had no discrepancy. There was a discrepancy in detecting a clinically unimportant abnormality in 10/70 (14%) patients (95% CI: 7–25%) unlikely to alter patient care or irrelevant to further clinical management. A discrepancy in interpreting a clinically important abnormality was registered in 14/70 (21%) patients for focal lesions. The mean diameter of focal lesions was: 23 mm (95% CI: 5–57 mm). The mean number of focal lesions per patient was 3.4 (95% CI). Conclusions: subspecialty second-opinion consultations in multiple myeloma CT is more accurate to identify lesions, especially lytic lesions, amenable to influence patients’ care.

Direct transition to long-acting risperidone - analysis of long-term efficacy

2005 ◽  
Vol 19 (5_suppl) ◽  
pp. 15-21 ◽  
Author(s):  
W. Kissling ◽  
S. Heres ◽  
K. Lloyd ◽  
E. Sacchetti ◽  
P. Bouhours ◽  
...  
Keyword(s):  
Symptom Control ◽  
Extension Phase ◽  
Direct Transition ◽  
Treatment Change ◽  
The Mean ◽  
Long Acting ◽  
To Receive ◽  
Treatment Endpoint ◽  
Severity Criteria

This report presents data from the extension phase of a 6-month trial that evaluated the efficacy of risperidone long-acting injectable (RLAI) in stable psychotic patients requiring a treatment change. Patients continued to receive RLAI every 2 weeks for a maximum of 12 months from study entry. Symptoms were assessed using the PANSS after 1, 3, 6, 9 and 12 months of treatment (or treatment endpoint). Remission of severity criteria were defined as ≤3 points in all PANSS items suggested by the Remission in Schizophrenia Working Group. 715 patients (63% male) entered the extension phase and 508 completed the 12-month study. The mean PANSS total score at Day 0 was 74.9±22.7. This was significantly reduced after 1 month (67.7 ±22.3, p≤0.001), with continued improvements over the 12 months of the study until treatment endpoint (59.7±21.9). Significant improvements from Day 0 to endpoint were also seen in the scores for all PANSS subscales and symptom factors. The proportion of patients who met the PANSS severity criteria for remission increased from 29% at Day 0 to 60% at endpoint, and the proportion of patients who met these criteria for ≤ 6 months increased from 24% at Month 6 to 45% at endpoint. Treatment with RLAI for up to 12 months provided significant and sustained improvements in symptom control in patients with schizophrenia. These improvements may help patients to achieve and remain in remission.

scholarly journals Incidence of spinal disease and role of spinal radiotherapy in multiple myeloma

2018 ◽  
Vol 25 (6) ◽  
Author(s):  
A. M. Sharma ◽  
M. Sackett ◽  
D. Bueddefeld ◽  
P. Lambert ◽  
A. Dubey ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Systemic Therapy ◽  
Cox Regression ◽  
Cord Compression ◽  
Newly Diagnosed ◽  
Spinal Disease ◽  
Kaplan Meier ◽  
Long Term Survivors

Background Spinal disease (spd) in multiple myeloma (mm) can be a major source of morbidity in newly diagnosed patients and long-term survivors. We retrospectively assessed the incidence of spinal disease in patients newly diagnosed with myeloma, its effect on survival, and the possible effect of spinal radiation therapy (rt).Methods Patients diagnosed with mm between 2010 and 2014 were identified through the provincial cancer registry. Plain radiography, computed tomography, and magnetic resonance imaging were reviewed to detect and document the type of spd. Data related to rt and systemic therapy were collected. Kaplan–Meier and time-varying Cox regression models were used to describe overall survival.Results Of 306 identified patients with newly diagnosed mm, 51% had spd, including 17% with lytic disease, 68% with compression fractures, and 15% with spinal cord compression. Of the patients with spd, 61% received spinal rt. Of those patients, 84% received spinal rt within 3 months after their diagnosis. Median dose was 20 Gy. Most patients (89.2%) received chemotherapy, and 22.5% underwent autologous stem-cell transplantation. Only 6 of the patients treated with spinal rt received re-irradiation to the same site. Overall survival was similar for patients with and without spd. On multivariate analysis, spinal rt had no effect on survival.Conclusions In patients newly diagnosed with mm, spd is a common presentation. With current systemic therapy, the presence of spd had no adverse effect on overall survival. The effect of spinal rt on overall survival was nonsignificant.

Primary adrenocortical carcinoma: A retrospective review of The Cleveland Clinic Foundation experience between 1995 to 2002

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18614-18614
Author(s):  
N. J. Tirgan ◽  
A. H. Hamrahian
Keyword(s):  
Adrenocortical Carcinoma ◽  
Malignant Tumors ◽  
Cleveland Clinic ◽  
Stage Iv ◽  
Distant Metastases ◽  
Treated Group ◽  
Stage Ii ◽  
Stage Iii ◽  
Entire Group ◽  
The Mean

18614 Background: Primary adrenocortical carcinoma (PAC) is a rare disease with a incidence of 1 per million. PAC’s are highly malignant tumors with guarded prognosis. Radical surgery is the treatment of choice. Methods: The pathology database and medical charts of these patients were retrospectively reviewed. Results: There were 14 females, 8 males, and 95% were caucasion. The mean age was 49.2 ± 11.8 years (females 51.6 years, males 45 years). The mean size of the tumor was 12.6 ± 5.1 cm (range of 3.6 to 25 cm). Thirteen patients (59.1%) presented with left and nine (40.9%) with right sided PAC. Seventy- two percent of the patients had abdominal, back, and/or flank pain. Forty five percent of patients had symptoms related to hypercortisolism and/or hyperandrogenism. Twelve patients (55%) had functional tumors (hypercortisolism 67%, hyperandrogenism 42%, and DHEA-S hypersecretion 42%) and ten were non-functional. Five percent of the tumors were classified as stage I, 33% were stage II, 38% were stage III, and 24% were stage IV. Twelve patients (55%) had distant metastases (liver 75%, lung 67%, retroperitoneum 33%, kidney 17%, contra-lateral adrenal gland 17%). All 22 patients had adrenalectomies (open 91%; laparoscopic 9%). The microscopic margin of resection were negative in 14 and positive in 6 patients. The information for 18 patients were evaluable for treatment. Eight patients received post-op therapy. Four patients received Mitotane (o,p’-DDD) alone (three died at 2, 29, and 213 months; and one is alive at 38 months after diagnosis). Three patients received both Mitotane and chemotherapy (two died at 3 and 43 months, one is alive at 140 months). One patient received only chemotherapy and died at 8 months. Ten patients received no post-op therapy. The estimated 5-year survival for the entire group was 48% (Kaplan-Meier survival estimate, 95% confidence interval). The estimated 5-year survival for stage III was 33%, and for stage IV was 30%. There were no deaths in patients with stage II group. The estimated 5-year survival for the treated group (8 patients) was 33% and 58% for the untreated group (10 patients). Conclusions: In PACs, surgery remains the main method of therapy. In our experience, Mitotane with or without chemotherapy did not improve survival. No significant financial relationships to disclose.

scholarly journals Long-Term Effects of Nilvadipine against Progression of the Central Visual Field Defect in Retinitis Pigmentosa: An Extended Study

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Mitsuru Nakazawa ◽  
Yukihiko Suzuki ◽  
Tadashi Ito ◽  
Tomomi Metoki ◽  
Takashi Kudo ◽  
...  
Keyword(s):  
Visual Field ◽  
Retinitis Pigmentosa ◽  
Visual Field Defect ◽  
Treated Group ◽  
Control Group ◽  
Long Term Effects ◽  
Central Visual Field ◽  
The Mean ◽  
Field Defect

Purpose. To assess the long-term effects of nilvadipine on the progression of central visual field defect in retinitis pigmentosa (RP).Methods. Patients with RP were randomly divided into a treated group receiving oral nilvadipine and a control group. Progression of RP was evaluated with MD slope and the average sensitivity of the central 2° (ΔCENT4).Results. The mean MD slopes were −0.55/−0.39 (right/left eyes,n=19) dB/year in the treated group and −1.37/−1.15 (right/left eyes,n=22) dB/year in the control group (P=0.016/0.050, resp.). In both eyes, however, no statistical difference was observed between the two groups for the ΔCENT4 values.Conclusion. Although we confirmed that nilvadipine significantly retarded the progression of the average of MD value defects in the central 10°, it was not specific for the central 2° of the visual field in RP.

Plasma Cell Myeloma Causing Hyperammonemia Associated with High Inpatient Mortality

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 5002-5002
Author(s):  
Anthony Pham ◽  
John L. Reagan ◽  
Jorge J Castillo
Keyword(s):  
Multiple Myeloma ◽  
Plasma Cell ◽  
Mental Status ◽  
Altered Mental Status ◽  
Ammonia Level ◽  
Stage Iii ◽  
Inpatient Mortality ◽  
Medline Search ◽  
Hyperammonemic Encephalopathy ◽  
The Mean

Abstract Abstract 5002 INTRODUCTION: Hyperammonemia is commonly associated with severe liver cirrhosis. However, reports have described plasma cell myeloma (PCM)-induced hyperammonic encephalopathy. We present a retrospective case series of patients with PCM who present with altered mental status and hyperammonemia without signs of hepatic dysfunction over a twelve-year period. Additionally, we performed a systematic review of the literature looking for additional cases. METHODS: A retrospective chart review was performed of patients >18 years diagnosed with PCM between January 2000 and January 2012. A diagnosis of PCM-induced hyperammonemia was made in PCM patients with altered mental status, elevated serum ammonia levels (>50 umol/L) and no other cause of altered mental status including hepatic dysfunction, electrolyte and metabolic abnormalities or intracranial processes. The primary outcome was to examine factors predisposing these patients to hyperammonemia. Additionally, we performed a systematic MEDLINE search using multiple myeloma, ammonia and hyperammonemia looking for case reports and series on patients with PCM-induced hyperammonic encephalopathy meeting the above criteria. Available clinical characteristics were gathered from these reports. Characteristics are presented descriptively. RESULTS: Our retrospective study included 27 individual patients diagnosed with PCM with elevated ammonia levels in the context of presenting with altered mental status. Six out of the 27 patients had hyperammonemic encephalopathy without other known etiology. The mean age was 76 years with a 5:1 male-to-female ratio. All had stage III based on the International Staging Scale (ISS). Bone marrow biopsies demonstrated 54–98% (mean 69%) plasma cell infiltration. IgA subtype was seen in 50% (n=3), IgG in 33% (n=2) and biclonal IgG/IgA in 17% (n=1). The mean ammonia level was 113 umol/L (range: 50–171 umol/L). Each of these patients had stable hemoglobin, normal electrolytes, liver and kidney function tests, and INR. No intracranial processes were detected on imaging. Three patients had improvement in mental status and decreased ammonia levels after chemotherapy; the other three patients declined further interventions. Inpatient mortality was over 66%. Our MEDLINE search revealed 20 articles originating from the United States and Japan detailing a total of 32 patients who were diagnosed with PCM-induced hyperammonemic encephalopathy. The mean age was 52 years (range 23–89 years) with an equal distribution between men and women. The average ammonia level amongst these patients was 121 umol/L (range: 50–299 umol/L). All of these patients had stage III disease by the ISS or the Durie-Salmon system. IgG was the most common subtype at 44% (n=12), followed by IgA with 37% (n=10), light chain multiple myeloma with 11% (n=3), and IgD with 7% (n=2). Of the 25 patients that received chemotherapy, 15 (60%) survived until discharge. The inpatient mortality was 40% (n=10). Those patients who did not receive chemotherapy had a lower rate of survival at 25%. CONCLUSION: Multiple myeloma hyperammonemic encephalopathy is a rare disease process that typically occurs in patients with stage III disease. Hospitalization mortality is high for these patients despite chemotherapy and even higher without chemotherapy administration. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Refractive outcomes of laser-treated and non-laser-treated retinopathy of prematurity at Hospital Selayang: a 2-year retrospective review

2021 ◽  
Vol 3 (4) ◽  
pp. 210-222
Author(s):  
Aasiah Ahmad Sharifuddin ◽  
Fiona Lee Min Chew ◽  
Irina Effendi-Tenang ◽  
Amir Samsudin
Keyword(s):  
Retinopathy Of Prematurity ◽  
Retrospective Review ◽  
High Myopia ◽  
Laser Photocoagulation ◽  
Treated Group ◽  
Refractive Outcomes ◽  
Zone Ii ◽  
The Mean ◽  
The Difference

Objective: To compare the refractive outcomes of laser-treated and non-laser-treated retinopathy of prematurity (ROP) infant, at 2 years of age in Hospital Selayang.Methods: Retrospective review involving patients born between 2016 and 2018. They were divided into those who were treated with laser photocoagulation, and those who were observed. Laser treatment was given to infants with threshold and high-risk, pre-threshold disease. Refractive error was identified by cycloplegic refraction at 2 years of age.Results: There were 22 eyes from 11 infants in the laser-treated group, all of which had zone II ROP with plus disease; of these, four had stage 2 ROP and 18 had stage 3 ROP. There were 53 eyes from 28 patients in the non-laser-treated group. The mean birth weight for the laser-treated and non-laser-treated groups was 966.9 ± 92.6 g and 1019.3 ± 282.0 g, respectively (P = 0.398). Mean gestational age for the laser-treated and non-laser-treated groups was 28.2 ± 2.2 weeks and 27.7 ± 2.2 weeks, respectively (P = 0.390). At 2 years, the mean spherical equivalence for the laser-treated and non-laser treated groups was -0.55 ± 2.49 D and +0.17 ± 1.43 D, respectively, although the difference was not statistically significant (P = 0.120). Myopia was commoner in the laser-treated group (six eyes [27%] vs five eyes [9%], P = 0.047), and two eyes from two different infants (10%) from this group also developed high myopia (> -6.00 D). For hypermetropia and astigmatism, there were no statistically significant differences between the groups (all P > 0.05). High myopia was strongly related to the post-conceptual age when receiving laser therapy (P = 0.025). In the laser-treated group, two infants (9%) had amblyopia and one (5%) had exotropia at 2 years of age. None of the eyes developed structural retinal sequelae.Conclusion: Despite successful treatment of ROP, a significant number of laser-treated eyes developed myopia. This highlights the need for long-term refractive screening in these patients.

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