Will adding alkylating agent to bortezomib improve survival of newly diagnosed AL amyloidosis patients?

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 8517-8517
Author(s):  
Yumeng Zhang ◽  
Lauren Duncanson ◽  
Taiga Nishihori ◽  
Doris K. Hansen ◽  
Jose L. Ochoa-Bayona ◽  
...  

8517 Background: The combination of bortezomib (Bort) and alkylating agent (AA) is a frequently used first-line therapy for AL amyloidosis. Kastritis et al. compared melphalan and dexamethasone with or without bortezomib as primary therapy and demonstrated increased hematologic response rate with the bortezomib and melphalan combination. However, the role of AA is unclear. This study aimed to evaluate if adding AA to Bort improved patient outcomes in AL amyloidosis. Methods: We retrospectively reviewed clinical data on 209 patients with systemic AL Amyloidosis at Moffitt Cancer Center between 2008 and 2020. We excluded patients with localized amyloidosis or amyloid other than AL. Patients were divided into two groups based on upfront therapy: A) Bort and B) Bort + AA. All patients also received dexamethasone. The staging was per Mayo 2012. Organ involvement, response, and progression were defined based on the 2005 criteria. Overall survival (OS) was defined as the time from initial diagnosis until death or last contact. Time to next therapy (TTNT) was calculated in patients with the documented hematologic response from the time of initiation of therapy to time of the next therapy/last follow up/death. Results: Of 209 patients, 36% (n=76) received Bort+AA; 30% (n=62) received Bort. No significant difference in clinical characteristics was seen in both groups except for age (which was higher for arm A: median 65 and 62 years, respectively, p=0.043) (table). In addition, Bort+AA became more commonly used as a frontline therapy after 1/1/2014 (p=0.001). Group A and B had similar median OS (69.9 months [95% CI. 44.7-95.2] and 64.4 mo [95% CI 40.5-88.3] respectively, p=0.60). 86% of patients in group B achieved a hematologic response as compared to 74% of patients in group A (p=0.15). Similarly, 47% of patients in group B achieved an organ response as compared to 34% of patients in group A (p=0.22). TTNT was higher in group A than group B (16.9 mo [95% CI, 0-41.5] and 7.8 mo [95% CI, 3.5-12.0], respectively, p=0.08). Conclusions: While Bort+AA is a commonly used regimen for amyloidosis, the addition of AA to Bort did not result in superior OS, TTNT compared to Bort alone in this retrospective study. This finding should be confirmed in prospective studies. Baseline Characteristics. [Table: see text]

Author(s):  
Shubhatara Swamy ◽  
Vijaya Rajendran ◽  
Durga Prasan ◽  
Pratibha Nadig

Background: Despite advances in symptom management, chemotherapy-induced nausea and vomiting (CINV) remains one of the most dreadful consequences of cancer therapy.Methods: The study was carried out at Medical Oncology Department, Vydehi Institute of Medical Sciences and Research Centre, Bangalore. Hundred and forty-four cancer patients of either sex, aged 18-65 years with adequate blood counts requiring moderately emetogenic chemotherapy (MEC) as per Hesketh classification were included. The patients were prospectively divided into two groups before the initial cycle of chemotherapy. Patients in Group A (n=71) received ondansetron, and dexamethasone along with aprepitant capsules, Whereas, Group B (n=73) received palonosetron, and dexamethasone along with placebo capsules, 30 minutes before chemotherapy. Thereafter the patients were administered with the drugs and observed for nausea and vomiting. The efficiency of both regimens was assessed by adopting validated functional living index emesis (FLIE) questionnaire. Analysis of the data was done using the SPSS 21.0 software.Results: The mean age of the patients was 40.5 years and the male to female ratio was 1:2.4. In all the patients, no changes were detected in the ECG readings after MEC. The nausea and vomiting score were comparable in both groups. No significant difference (p>0.05) was noticed between group A and group B in both mm and in FLIE points. No serious adverse events were found relating to antiemetic treatment.Conclusions: Palonosetron in combination with corticosteroids was non inferior to ondansetron in combination with aprepitant and corticosteroids in controlling acute and delayed stages of CINV in patients requiring MEC. Thus, it can be recommended as first-line therapy for patients treated with MEC.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1786-1786
Author(s):  
Efstathios Kastritis ◽  
Maria Roussou ◽  
Maria Gavriatopoulou ◽  
Magdalini Migkou ◽  
Alexandra Gkougkoutsi ◽  
...  

Abstract Abstract 1786 Novel antimyeloma agents (thalidomide, lenalidomide and bortezomib) may induce high rates of hematologic responses in patients with AL amyloidosis in whom they are increasingly used. Due to the multisystemic involvement many patients with AL are frail and vulnerable to treatment related toxicity and often succumb to their disease early after initiation of therapy, mainly due to complications associated with cardiac amyloidosis. In order to investigate the outcomes of AL patients in the era of novel agents and explore strategies to reduce complications and early mortality, we analyzed 81 consecutive patients in a single center (Department of Clinical Therapeutics, University of Athens, Greece). All patients were assessed and followed rigorously and received similar supportive care according to our institution's practice. Bortezomib (B) was given as first line or salvage therapy after 1/9/2005 and lenalidomide (L) was given as primary therapy or salvage after 1/1/2008. Beginning on 1/1/2011, we follow a risk-adapted strategy, in which previously untreated patients with AL received bortezomib at a dose and schedule adjusted according to performance status (PS), levels of cardiac biomarkers and age (BDa). Patients were divided in those who started therapy from 2005 to 31/12/2007 (23 patients), those who received therapy between 1/1/2008 to 31/12/2010 (36 patients) and those who started therapy after 1/1/2011 (22 patients): 54% received first line therapy with B, 40% with L and 6% received conventional therapy upfront (mostly melphalan with dexamethasone; all received novel agents at later stages of their disease). Most patients (57%) were males; the median age was 67 years (range 42–82 years); 55% had a PS ≥2; the heart was involved in 68% of patients, the kidneys in 70%, the liver in 9%, and the peripheral nerve in 25%. Median eGFR was 70 ml/min and 4% required dialysis at diagnosis. Median NTproBNP was 2318 ng/l (range 36–75000 ng/l) and according to cardiac biomarkers, 26% were Mayo stage 1, 42% stage 2 and 32% stage 3. There were no significant differences in the demographic and disease characteristics between the three groups but 80% of patients, who started therapy from 2005 to 31/12/2007, received upfront BD, 80% of patients, who started therapy from 1/1/2008 to 31/12/2010, received upfront L and 82% of patients after 1/1/2011 received upfront BDa. On intent to treat, 65% of patients achieved hematologic response to first line therapy, including 20% hemCRs. Hematologic response rates were not different between the three groups (p=0.118); however, hemCRs were more frequent in patients treated before 31/12/2007 and after 1/1/2011 (30% and 27% vs. 9% in those treated from 1/2008-12/2010). The respective hemCR rates for patients treated with B vs. L were 32% vs. 6% (p=0.025). On intent to treat, organ responses were achieved by 28% of patients. Hematologic or organ progression or death has occurred in 60.5% of patients; the median PFS was 10 months and the 1-year PFS rate was 50%, 27% and 59% for patients treated in the three consecutive time periods, respectively (p=0.011). For patients treated upfront with B- vs. L-based regimens the respective 1-year PFS rate was 51% vs. 31% (p=0.054). After progression to first line therapy, 21 (26%) patients received second line therapy: 17 received B and 4 L. The median survival of all patients was 34 months; the 1-year survival rate for patients with Mayo stage 1 disease was 94%, for stage 2 was 56% and for stage 3 was 28% (p<0.001); 18 (22%) patients died within the first 3 months from initiation of therapy (all except one had cardiac involvement). The respective early death rates were 17%, 34% and 4% for patients treated in the three time periods, respectively (p=0.024) and were 22% and 25% for B- and L-based regimens (p=0.443), indicating that the reduction of early deaths was mainly due to the risk-adapted treatment strategy after 1/2011. In conclusion, our data indicate that novel agents, and especially bortezomib, resulted in significant response rates in patients with AL amyloidosis; however, 22% of AL patients die within 3 months form initiation of therapy due cardiac amyloidosis-associated complications. A risk-adapted treatment strategy with bortezomib dose and schedule adjusted according to individual patient characteristics may reduce early mortality and allow patients to achieve a hematologic response. Updated results will be presented at the meeting. Disclosures: No relevant conflicts of interest to declare.


2019 ◽  
Vol 1 (4) ◽  
pp. 133-139
Author(s):  
Yasser Hamdy ◽  
Mohammed Mahmoud Mostafa ◽  
Ahmed Elminshawy

Background: Functional tricuspid valve regurgitation secondary to left-sided valve disease is common. DeVega repair is simple, but residual regurgitation with subsequent impairment of the right ventricular function is a concern. This study aims to compare tricuspid valve repair using DeVega vs. ring annuloplasty and their impact on the right ventricle in the early postoperative period and after six months. Methods: This is a prospective cohort study of 51 patients with rheumatic heart disease who underwent tricuspid valve repair for secondary severe tricuspid regurgitation. Patients were divided into two groups: group A; DeVega repair (n=34) and group B; ring annuloplasty repair (n=17). Patients were assessed clinically and by echocardiography before discharge and after six months for the degree of tricuspid regurgitation, right ventricular diameter and tricuspid annular plane systolic excursion (TAPSE). Results: Preoperative echocardiographic assessment showed no difference in left ventricular end-systolic diameter, end-diastolic diameter, ejection fraction and right ventricular diameter, however; group A had significantly better preoperative right ventricular function measured by TAPSE (1.96 ± 0.27 vs1.75 ± 0.31 cm; p=0.02). Group B had significantly longer cardiopulmonary bypass time (127.65 ± 13.56 vs. 111.74 ± 18.74 minutes; p= 0.003) and ischemic time (99.06 ± 11.80 vs. 87.15 ± 16.01 minutes; p= 0.009). Pre-discharge, there was no statistically significant difference in the degree of tricuspid regurgitation, but the right ventricular diameter was significantly lower in group B (2.66 ± 0.41 and 2.40 ± 0.48 cm; p=0.049). After six months of follow up, the degree of tricuspid regurgitation (p= 0.029) and the right ventricular diameter were significantly lower in the ring annuloplasty group (2.56 ± 0.39 and 2.29 ± 0.44 cm; p=0.029). Although there was a statistically significant difference in preoperative TAPSE, this difference disappeared after six months. Conclusion: Both DeVega and ring annuloplasty techniques were effective in the early postoperative period, ring annuloplasty was associated with lesser residual regurgitation and better right ventricular remodeling in severe functional tricuspid regurgitation than DeVega procedure after 6-months of follow up.


2020 ◽  
Vol 35 (3) ◽  
Author(s):  
Tayyaba Gul Malik ◽  
Hina Nadeem ◽  
Eiman Ayesha ◽  
Rabail Alam

Objective: To study the effect of short-term use of oral contraceptive pills on intra-ocular pressures of women of childbearing age.   Methods: It was a comparative observational study, conducted at Arif memorial teaching hospital and Allied hospital Faisalabad for a period of six months. Hundred female subjects were divided into two groups of 50 each. Group A, included females, who had been taking oral contraceptive pills (OCP) for more than 6 months and less than 36 months. Group B, included 50 age-matched controls, who had never used OCP. Ophthalmic and systemic history was taken. Careful Slit lamp examination was performed and intraocular pressures (IOP) were measured using Goldman Applanation tonometer. Fundus examination was done to rule out any posterior segment disease. After collection of data, we analyzed and compared the intra ocular pressures between the two groups by using ANOVA in SPSS version 21.   Results: Average duration of using OCP was 14.9 months. There was no significant difference of Cup to Disc ratios between the two groups (p= 0.109). However, significant difference was noted between the IOP of OCP group and controls. (p=0.000). Conclusion: OCP significantly increase IOP even when used for short time period.


Author(s):  
Rajendra Joshi ◽  
N. B. Mashetti ◽  
Rakesh Kumar Gujar

Dushta Vrana is a common and frequently encountered problem faced in surgical practice. The presence of Dushta Vrana worsens the condition of the patient with different complications and may become fatal. Local factors on wound like slough, infection and foreign body, affect the normal process of healing. A healthy wound in a normal body heals earlier with a minimum scar as compared to a contaminated wound. Therefore in this study all the efforts are made to make a Dushta Vrana into a Shuddha Vrana. Once the Vrana becomes Shuddha, Ropana of the Vrana will start. The objective of the study was to evaluate the clinical efficacy of Jatyadi Taila and Jatyadi Ghrita in Dushta Vrana. Clinically diagnosed 60 Patients of Dushta Vrana were randomly divided into two groups, each consisting of 30 Patients. Group A were treated with the Jatyadi Taila and Group B was treated by Jatyadi Ghrita. The results observed was based on the relief obtained on the subjective and objective parameters taken for consideration for this study viz, size of ulcer, discharge, smell, pain, burning sensation, itching and granulation were found significant (P Lass Than 0.05). On the basis of assessment criteria and overall result of treatment, the patients of Jatyadi Taila group showed better results when compared to Jatyadi Ghrita group. Even though statistically there is no much significant difference between the two groups, but by seeing the effect on individual parameters (subjective and objective) and over all response, Jatyadi Taila seems to be effective when compared to Jatyadi Ghrita. It is having more Ropana qualities when compared to Shodhana.


Author(s):  
Patil Aniket ◽  
Dindore Pallavi ◽  
Arbar Aziz ◽  
Kadam Avinash ◽  
Saroch Vikas

The quest for excellence in mental and physical health is not new. We find various references and formulations in Ayurvedic classics meant for promoting mental and physical health of a child. Suvarna Prashan is one of the formulations explained in age old Ayurvedic classic Kashyap Samhita. This formulation is very widely used now days as a memory and immune booster for children. But there is very little systematic documented study which can be used to evaluate the efficacy of the formulation. Suvarna Bhasma was prepared in Ayurved Rasayani Pharmacy, Pune. Madhu and Ghrita were collected from KLE Ayurveda Pharmacy, Belgaum. Suvarna Bindu Prashan was prepared in KLE Ayurved pharmacy, Belgaum. It contains Suvarna Bhasma, Ghrita and Madhu. Twenty apparently healthy male and female children with age group of three to four years were ready to sign inform consent form were selected into two groups each. Subjects in Group A received Suvarna Bindu Prashan where as Group B (Control group) did not receive any treatment. Both the groups were observed for six months. Children in Suvarna Bindu Prashan group showed significant reduction in the scores of eating habits, behavior, mood, temperament and scores of event of illness. However there was no significant difference in the score of sleeping habit. There was significant increase in IQ percentage.


Author(s):  
Mohamed I. Refaat ◽  
Amr K. Elsamman ◽  
Adham Rabea ◽  
Mohamed I. A. Hewaidy

Abstract Background The quest for better patient outcomes is driving to the development of minimally invasive spine surgical techniques. There are several evidences on the use of microsurgical decompression surgery for degenerative lumbar spine stenosis; however, few of these studies compared their outcomes with the traditional laminectomy technique. Objectives The aim of our study was to compare outcomes following microsurgical decompression via unilateral laminotomy for bilateral decompression (ULBD) of the spinal canal to the standard open laminectomy for cases with lumbar spinal stenosis. Subjects and methods Cases were divided in two groups. Group (A) cases were operated by conventional full laminectomy; Group (B) cases were operated by (ULBD) technique. Results from both groups were compared regarding duration of surgery, blood loss, perioperative complication, and postoperative outcome and patient satisfaction. Results There was no statistically significant difference between both groups regarding the improvement of visual pain analogue, while improvement of neurogenic claudication outcome score was significant in group (B) than group (A). Seventy-three percent of group (A) cases and 80% of group (B) stated that surgery met their expectations and were satisfied from the outcome. Conclusion Comparing ULBD with traditional laminectomy showed the efficacy of the minimally invasive technique in obtaining good surgical outcome and patient satisfaction. There was no statistically significant difference between both groups regarding the occurrence of complications The ULBD technique was found to respect the posterior spinal integrity and musculature, accompanied with less blood loss, shorter hospital stays, and shorter recovery periods than the open laminectomy technique.


Obesity Facts ◽  
2021 ◽  
pp. 1-9
Author(s):  
Serdar Sahin ◽  
Havva Sezer ◽  
Ebru Cicek ◽  
Yeliz Yagız Ozogul ◽  
Murat Yildirim ◽  
...  

<b><i>Introduction:</i></b> The aim of this was to describe the predictors of mortality related to COVID-19 infection and to evaluate the association between overweight, obesity, and clinical outcomes of COVID-19. <b><i>Methods:</i></b> We included the patients &#x3e;18 years of age, with at least one positive SARS-CoV-2 reverse transcriptase-polymerase chain reaction. Patients were grouped according to body mass index values as normal weight &#x3c;25 kg/m<sup>2</sup> (Group A), overweight from 25 to &#x3c;30 kg/m<sup>2</sup> (Group B), Class I obesity 30 to &#x3c;35 kg/m<sup>2</sup> (Group C), and ≥35 kg/m<sup>2</sup> (Group D). Mortality, clinical outcomes, laboratory parameters, and comorbidities were compared among 4 groups. <b><i>Results:</i></b> There was no significant difference among study groups in terms of mortality. Noninvasive mechanical ventilation requirement was higher in group B and D than group A, while it was higher in Group D than Group C (Group B vs. Group A [<i>p</i> = 0.017], Group D vs. Group A [<i>p</i> = 0.001], and Group D vs. Group C [<i>p</i> = 0.016]). Lung involvement was less common in Group A, and presence of hypoxia was more common in Group D (Group B vs. Group A [<i>p</i> = 0.025], Group D vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group B [<i>p</i> = 0.006], and Group D vs. Group C [<i>p</i> = 0.014]). The hospitalization rate was lower in Group A than in the other groups; in addition, patients in Group D have the highest rate of hospitalization (Group B vs. Group A [<i>p</i> &#x3c; 0.001], Group C vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group B [<i>p</i> &#x3c; 0.001], and Group D vs. Group C [<i>p</i> = 0.010]). <b><i>Conclusion:</i></b> COVID-19 patients with overweight and obesity presented with more severe clinical findings. Health-care providers should take into account that people living with overweight and obesity are at higher risk for COVID-19 and its complications.


BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ben Xu ◽  
Si-da Cheng ◽  
Yi-ji Peng ◽  
Qian Zhang

Abstract Background To compare the functional and oncological outcomes between innovative “three-port” and traditional “four-port” laparoscopic radical prostatectomy (LRP) in patients with prostate cancer (PCa). Methods We retrospectively collected the data of PCa patients treated at our institutions from June 2012 to May 2016. According to the inclusion criteria, a total of 234 patients were included in the study, including 112 in group A (four-port) and 122 in group B (three-port). The perioperatively surgical characteristics, functional and oncological outcomes were compared between groups. Results There were no statistical differences in the baseline parameters between these two groups. Compared with group A, the operative time (OT) and estimated blood loss (EBL) were significantly less in group B. On follow-up, the rate of positive surgical margin (PSM), prostate specific antigen (PSA) biochemical recurrence and continence after LRP did not show any statistically significant difference between the groups. An identical conclusion was also received in comparison of overall survival (OS) and biochemical recurrence-free survival (BRFS) between both groups. Conclusions Innovative “three-port” LRP can significantly shorten the OT and reduce the EBL compared with the traditional “four-port” LRP. Meanwhile, it does not increase the rate of PSM and PSA biochemical recurrence. “Three-port” LRP could be popularized in the future in view of its superior surgical technique, considerably better functional outcomes and remarkable oncological control.


2021 ◽  
Vol 15 ◽  
pp. 175346662110042
Author(s):  
Xiaoke Shang ◽  
Yanggan Wang

Aims: The study aimed to compare and analyze the outcomes of high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NPPV) in the treatment of patients with acute hypoxemic respiratory failure (AHRF) who had extubation after weaning from mechanical ventilation. Methods: A total 120 patients with AHRF were enrolled into this study. These patients underwent tracheal intubation and mechanical ventilation. They were organized into two groups according to the score of Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II); group A: APACHE II score <12; group B: 12⩽ APACHE II score <24. Group A had 72 patients and patients given HFNC were randomly assigned to subgroup I while patients given NPPV were assigned to subgroup II (36 patients in each subgroup). Group B had 48 patients and patients given HFNC were randomly assigned to subgroup I while patients given NPPV were assigned to subgroup II (24 patients in each subgroup). General information, respiratory parameters, endpoint event, and comorbidities of adverse effect were compared and analyzed between the two subgroups. Results: The incidence of abdominal distension was significantly higher in patients treated with NPPV than in those treated with HFNC in group A (19.44% versus 0, p = 0.005) and group B (25% versus 0, p = 0.009). There was no significant difference between the HFNC- and NPPV-treated patients in blood pH, oxygenation index, partial pressure of carbon dioxide, respiratory rate, and blood lactic acid concentration in either group ( p > 0.05). Occurrence rate of re-intubation within 72 h of extubation was slightly, but not significantly, higher in NPPV-treated patients ( p > 0.05). Conclusion: There was no significant difference between HFNC and NPPV in preventing respiratory failure in patients with AHRF with an APACHE II score <24 after extubation. However, HFNC was superior to NPPV with less incidence of abdominal distension. The reviews of this paper are available via the supplemental material section.


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