MM-130: Tolerability and Efficacy of Daratumumab in Patients with Plasma Cell Disorder with Poor Performance Status or Good Performance Status with CKD and/or CHF

2020 ◽  
Vol 20 ◽  
pp. S295
Author(s):  
Hameem Kawsar ◽  
Jordan Snyder ◽  
Leyla Shune ◽  
Joseph McGuirk ◽  
Siddhartha Ganguly ◽  
...  
2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 194-194
Author(s):  
Krzysztof Krzemieniecki ◽  
Krzysztof Simon ◽  
Krzysztof Zieniewicz ◽  
Pawel Pecilo

194 Background: Due to chronic hepatitis and cirrhosis as main risk factors of HCC – patients in Poland can be treated either by oncologists or by gastroenterologists. As no data exist on HCC patient flow between these specialities, this registry was set up. We also wanted to know the differences in both specialities’ approach to targeted therapies. Methods: Data of patients treated by oncologists (LIVER 2) and gastroenterologists (LIVER 1) were recorded. Descriptive statistical methods and U-Mann-Whitney and Fisher tests were used. Results: 478 patients were included into registry from 2009 until the end of 2010. 70% of patients were male. In 42% cases HCC was caused by HCV and in 24% by HBV. LIVER 2 recorded more patients with unknown HCC aetiology than LIVER 1 (35% vs 15%). The HCC diagnosis was made based on CT scan (80%, ns), US scan (74% in LIVER 1 vs 47% in LIVER 2, p<0,0001) or biopsy (72% LIVER 2 vs 48% LIVER 1, p<0,0001). Patients with advanced stage of HCC according to BCLC scale and poor performance status were more frequently seen by oncologists (LIVER 2), similar prevalence in Child Pugh status was observed in both groups (p<0,05 for all). Registry showed differences in frequency of extrahepatic lesions (10% LIVER 1 42% in LIVER 2, p<0,05). Most common co morbidities were diabetes (32%), liver disorders (39%), hypertension (61%), coronary disease (24%). Median AFP level was 100 ng/ml in LIVER 1 and 219 in LIVER 2 (p=0,057). Registry showed that for gastroenterologists reasons to consider sorafenib as next step in therapy was in 47% cases HCC progression, in 51% good performance status and in 55% sorafenib was found as the only one therapy suitable due to contraindications for other treatments. Oncologists consider sorafenib therapy in 56% cases due to HCC progression and in 72% cases due to good performance status. Among patients considered for targeted therapy, approximately 20% presented Child Pugh B status. Conclusions: This is the first detailed HCC registry in Poland covering the different therapeutic area specialists. Patients with more advanced HCC and worse performance status are more frequently treated by oncologists (p<0,05). The data shows need of early HCC detection interdisciplinary system referring patients to the oncologist.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5652-5652
Author(s):  
Arif Alam ◽  
Khaled al Qawasmeh ◽  
Maria Aamir ◽  
Philip L. McCarthy

Abstract Introduction: Plasma cell disorders are a heterogeneous group of disease ranging from Monocloncal gammopathy of unknown significance to Multiple myeloma (MM) and the highly lethal plasma cell leukemia. The prognosis and therapy of MM has been revolutionized in the past two decades with the introduction of proteasome inhibitors, immunomodulatory drugs (IMiDs) and the monoclonal antibodies. The standard of care for induction has been become a triplet regimen lately. Here we describe our experience with the management of MM patients. Methods: This is a retrospective analysis of Thirty-five patients who were seen with diagnosis with plasma cell disorders from January 1, 2016 till June 30th 2018 at our center in the UAE. Patients with solitary plasmacytoma and plasma cell leukemia were excluded from further analysis (N=3). Thirty-two patients were included in the analysis. Results: The median age was 58 years (range 26 to 94 years). Male to female ratio was 3:1. Biochemical classification showed ten patients with light chain disease only. Twelve patients had IgG kappa disease, eight had IgG lambda while there was one with IgA lambda disease and one was non-secretory with diffuse plasmacytomas. ISS staging (based on albumin and Beta 2 microglobulin) showed ISS stage 1=7, ISS stage 2= 13, ISS stage 3=8 and data was not available for four patients (diagnosed elsewhere). Cytogenetic risk stratification was not possible due to lack of access to interphase FISH. Seven patients did not receive any therapy either due to refusal for further investigation and therapy or poor performance status and comorbidities. Four of these seven have expired while the other three have been lost to follow-up. Twenty-four patients were given induction therapy with a Bortezomib (V)-based regimen while one received IMIDs-based treatment. Regimens and patient numbers are as follows: RVd (Lenalidomide/V/dexamethasone) (N=16), PVd (pomalidomide instead of R due to renal insufficiency) (N=1), V/thalidomide (T) (N=1), VCd (N=2; one for secondary amyloidosis) and Vd (N=4) (poor performance status and/or comorbidities). All patients were given zoledronic acid as well as herpes zoster prophylaxis. Venous thromboembolism (VTE) prophylaxis was prescribed based on published guidelines. Response evaluation was performed in patients receiving at least four cycles of therapy: CR(N=7); Very Good Partial Remission (VGPR) (N=6); Partial Response (PR) (N=5) and not evaluable for response due to lack of data (N=7). Five patients were documented to have received autologous stem cell transplant (autoSCT). Seven patients, lost to follow up after induction presumably received an autoSCT. Conclusion: This is the first report on the management of MM patients in UAE. With a median follow-up of 216 days (range 3 to 839 days) the response rate to induction therapy was 72% (CR+ VGPR). We are unable to report progression free survival due to short follow-up. This response rate of 72% (VGPR or better) is less than the reported in the literature. This may partly be due to lack of patient data regarding induction therapy elsewhere, the use of double over triplet regimens and the absence of autoSCT facilities. Outcome measurement is a difficult task due to tendency of local citizens to travel outside UAE for treatment and the transient nature of the large expatriate population (88% of the total population of approximately 5.4 million) We are working on developing an infrastructure for consistent testing (CD138-selected FISH, consistent staging, use of PET-CT and bone marrow MRI as well as developing auto SCT facilities). We have formulated a uniform treatment plan based on weekly RVd based therapy for 16 weeks as induction followed by recommendation for Auto SCT. If auto SCT is not possible then patients will continue RVd therapy for a total of 12 cycles followed by maintenance lenalidomide till progression. The standardization of diagnosis, therapeutic approach and follow-up should optimize the care and outcomes of UAE MM patients. Disclosures McCarthy: Bristol Myers Squibb: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Karyopharm: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Janssen: Consultancy, Honoraria.


Blood ◽  
1998 ◽  
Vol 91 (10) ◽  
pp. 3662-3670 ◽  
Author(s):  
Raymond L. Comenzo ◽  
Evan Vosburgh ◽  
Rodney H. Falk ◽  
Vaishali Sanchorawala ◽  
Johann Reisinger ◽  
...  

Abstract AL (amyloid light-chain) amyloidosis is an uncommon plasma cell disorder in which depositions of amyloid light-chain protein cause progressive organ failure and death in a median of 13 months. Autologous stem-cell transplantation is effective therapy for multiple myeloma and therefore, we evaluated its efficacy for AL amyloidosis. Patients with adequate cardiac, pulmonary, and renal function had stem cells mobilized with granulocyte-colony stimulating factor and were treated with dose-intensive intravenous melphalan (200 mg/m2). Response to therapy was determined by survival and improvement of performance status, complete response or persistence of the clonal plasma cell disorder, and change in the function of organs involved with amyloid at baseline. We enrolled 25 patients with a median age of 48 years (range, 29-60), all of whom had biopsy-proven amyloidosis with clonal plasma cell disorders. Twenty-two (88%) were Southwest Oncology Group performance status 1 or 2 within a year of diagnosis, and 16 (64%) had received no prior therapy. Predominant amyloid-related organ involvement was cardiac (n = 8), renal (n = 7), hepatic (n = 6), neuropathic (n = 3), and lymphatic (n = 1). Fifteen patients had one or two organ systems involved, whereas 10 had three or more involved. With a median follow-up of 24 months (12-38), 17 of 25 patients (68%) are alive, and the median survival has not been reached. Thirteen of 21 patients (62%) evaluated 3 months posttransplant had complete responses of their clonal plasma cell disorders. Currently, two thirds of the surviving patients (11 of 17) have experienced improvements of amyloid-related organ involvement in all systems, whereas 4 of 17 have stable disease. The improvement in the median performance status of the 17 survivors at follow-up (0 [range, 0-3]) is statistically significant versus baseline (2 [range, 1-3]; P < .01). Significant negative prognostic factors with respect to overall survival include amyloid involvement of more than two major organ systems and predominant cardiac involvement. Three patients have experienced relapses of the clonal plasma cell disorder at 12 and 24 months. Dose-intensive therapy should currently be considered as the preferred therapy for patients with AL amyloidosis who meet functional criteria for autologous transplantation.


2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A240-A240
Author(s):  
Hameem Kawsar ◽  
Pramod Gaudel ◽  
Nahid Suleiman ◽  
Mohammed Al-Jumayli ◽  
Chao Huang ◽  
...  

BackgroundImmunotherapy has shown survival benefit as both frontline and subsequent therapy in multiple cancers. However, its efficacy in patients with poor performance status is unknown since they are excluded from the clinical trials. We conducted a retrospective study to investigate the effect of poor performance status (PS) on survival in patients with non-small cell lung cancer (NSCLC) who received immunotherapy as a subsequent line of treatment.MethodsWe reviewed the medical records of 341 patients with NSCLC receiving immunotherapy as between July 2013 and June 2018. Progression-free survival and overall survival was calculated using Kaplan-Meier curve.ResultsThe average age of patients was 66 years (range: 39–90 years), with a male predominance (57%). Majority of the patients were Caucasian (87%), followed by African-American (12%), and Asian (1%). Most of the patients were former smoker (72%), followed by current smoker (19%) and never smoker (7%). Adenocarcinoma and squamous cell carcinoma was diagnosed in 206 (60%) patients and 112 (33%) patients, respectively. The ECOG-PS was 0, 1, 2 and 3 in 46 (13%), 175 (51%), 86 (25%) and 34 (10%), respectively. Four different immunotherapies were used, namely atezolizumab in 10 (3%), durvalumab in 34 (10%), nivolumab in 152 (44%) and pembrolizumab in 144 (42%) patients. Average number of cycles of atezolizumab received by the patient was 6 (range 2–22 cycles), durvalumab 15 (range 1–29 cycles), nivolumab 11 (range 1–112 cycles), and pembrolizumab 12 (range 1–52 cycles). Patients were grouped in good performance status (ECOG 0–1) and poor performance status (ECOG ≥2). The median progression free survival (PFS) was 7 months (95% CI 6.3–8.2) in patients with good PS and 3 months (95% CI 1.8–4.6) in patients with poor performance status (p<0.001). The median overall survival (OS) for patients with good performance status was 30 months (95% CI 16.6–42.3) and 4 months (95% CI 3.2–8.1) in patients with poor PS (figure 1). Adverse effects were recorded in a total of 83 (24%) patients, 18 (5%) patients had ECOG-PS 0, 50 (14%) patients had ECOG-PS 1, 18 (4%) patients had ECOG-PS 2 and 3 (1%) patients had ECOG-PS of 3. Most common adverse effects were pneumonitis (28%), diarrhea (8%) and hypothyroidism (8%).Abstract 221 Figure 1Progression free survival (PFS) and overall survival (OS) in patients with good performance status (ECOS PS 0–1) and poor performance status (ECOG ≥2) treated with immunotherapy in NSCLCConclusionsOur data suggests that while the patients with poor PS tolerated the immunotherapy. However, poor PS was associated with significantly lower PFS and OS. Further studies are required to evaluate the effect of PS on survival in frontline immunotherapy.AcknowledgementsWe thank Dr. Saqib Abbasi for helpful discussions.Trial RegistrationN/AEthics ApprovalThe study was approved by the Institution Review Board at KUMC, #CR00009003.ReferencesN/A


Blood ◽  
1998 ◽  
Vol 91 (10) ◽  
pp. 3662-3670 ◽  
Author(s):  
Raymond L. Comenzo ◽  
Evan Vosburgh ◽  
Rodney H. Falk ◽  
Vaishali Sanchorawala ◽  
Johann Reisinger ◽  
...  

AL (amyloid light-chain) amyloidosis is an uncommon plasma cell disorder in which depositions of amyloid light-chain protein cause progressive organ failure and death in a median of 13 months. Autologous stem-cell transplantation is effective therapy for multiple myeloma and therefore, we evaluated its efficacy for AL amyloidosis. Patients with adequate cardiac, pulmonary, and renal function had stem cells mobilized with granulocyte-colony stimulating factor and were treated with dose-intensive intravenous melphalan (200 mg/m2). Response to therapy was determined by survival and improvement of performance status, complete response or persistence of the clonal plasma cell disorder, and change in the function of organs involved with amyloid at baseline. We enrolled 25 patients with a median age of 48 years (range, 29-60), all of whom had biopsy-proven amyloidosis with clonal plasma cell disorders. Twenty-two (88%) were Southwest Oncology Group performance status 1 or 2 within a year of diagnosis, and 16 (64%) had received no prior therapy. Predominant amyloid-related organ involvement was cardiac (n = 8), renal (n = 7), hepatic (n = 6), neuropathic (n = 3), and lymphatic (n = 1). Fifteen patients had one or two organ systems involved, whereas 10 had three or more involved. With a median follow-up of 24 months (12-38), 17 of 25 patients (68%) are alive, and the median survival has not been reached. Thirteen of 21 patients (62%) evaluated 3 months posttransplant had complete responses of their clonal plasma cell disorders. Currently, two thirds of the surviving patients (11 of 17) have experienced improvements of amyloid-related organ involvement in all systems, whereas 4 of 17 have stable disease. The improvement in the median performance status of the 17 survivors at follow-up (0 [range, 0-3]) is statistically significant versus baseline (2 [range, 1-3]; P < .01). Significant negative prognostic factors with respect to overall survival include amyloid involvement of more than two major organ systems and predominant cardiac involvement. Three patients have experienced relapses of the clonal plasma cell disorder at 12 and 24 months. Dose-intensive therapy should currently be considered as the preferred therapy for patients with AL amyloidosis who meet functional criteria for autologous transplantation.


Author(s):  
Alvin J. X. Lee ◽  
Karin Purshouse

AbstractThe SARS-Cov-2 pandemic in 2020 has caused oncology teams around the world to adapt their practice in the aim of protecting patients. Early evidence from China indicated that patients with cancer, and particularly those who had recently received chemotherapy or surgery, were at increased risk of adverse outcomes following SARS-Cov-2 infection. Many registries of cancer patients infected with SARS-Cov-2 emerged during the first wave. We collate the evidence from these national and international studies and focus on the risk factors for patients with solid cancers and the contribution of systemic anti-cancer treatments (SACT—chemotherapy, immunotherapy, targeted and hormone therapy) to outcomes following SARS-Cov-2 infection. Patients with cancer infected with SARS-Cov-2 have a higher probability of death compared with patients without cancer. Common risk factors for mortality following COVID-19 include age, male sex, smoking history, number of comorbidities and poor performance status. Oncological features that may predict for worse outcomes include tumour stage, disease trajectory and lung cancer. Most studies did not identify an association between SACT and adverse outcomes. Recent data suggest that the timing of receipt of SACT may be associated with risk of mortality. Ongoing recruitment to these registries will enable us to provide evidence-based care.


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yosuke Namba ◽  
Yuzo Hirata ◽  
Shoichiro Mukai ◽  
Sho Okimoto ◽  
Seiji Fujisaki ◽  
...  

Abstract Background The occurrence of postoperative ileus leads to increased patient morbidity, longer hospitalization, and higher healthcare costs. No clear policy on postoperative ileus prevention exists. Therefore, we aim to evaluate the clinical factors involved in the development of postoperative ileus after elective surgery for colorectal cancer. Methods We retrospectively analyzed patients who underwent elective surgery involving bowel resection with or without re-anastomosis for colon cancer between April 2015 and March 2020. The primary readout was the presence or absence of postoperative ileus. Univariate and multivariate analyses were used to identify pre- and intraoperative risk factors, and the incidence of postoperative ileus was assessed using independent factors. Results Postoperative ileus occurred in 48 out of 356 patients (13.5%). In multivariate analysis, male sex poor performance status, and intraoperative in–out balance per body weight were independently associated with postoperative ileus development. The incidence of postoperative ileus was 2.5% in the cases with no independent factors; however, it increased to 36.1% when two factors were observed and 75.0% when three factors were matched. Conclusions We discovered that male gender, poor performance status, and intraoperative in–out balance per body weight were associated with the development of postoperative ileus. Of these, intraoperative in–out balance per body weight is a controllable factor. Hence it is important to control the intraoperative in–out balance to lower the risk for postoperative ileus.


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