scholarly journals Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Gabriel Tremblay ◽  
Patrick Daniele ◽  
Janis Breeze ◽  
Lingling Li ◽  
Jatin Shah ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Myeloma ◽  
Nuclear Export ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Difference Threshold ◽  
Open Label ◽  
Ecog Ps

Abstract Background Selinexor is an oral, selective nuclear export inhibitor. STORM was a phase 2b, single-arm, open-label, multicenter trial of selinexor with low dose dexamethasone in patients with penta-exposed relapsed/refractory multiple myeloma (RRMM) that met its primary endpoint, with overall response of 26% (95% confidence interval [CI], 19 to 35%). Health-related quality of life (HRQoL) was a secondary endpoint measured using the Functional Assessment of Cancer Therapy – Multiple Myeloma (FACT-MM). This study examines impact of selinexor treatment on HRQoL of patients treated in STORM and reports two approaches to calculate minimal clinically important differences for the FACT-MM. Methods FACT-MM data were collected at baseline, on day 1 of each 4-week treatment cycle, and at end of treatment (EOT). Changes from baseline were analyzed for the FACT-MM total score, FACT-trial outcome index (TOI), FACT-General (FACT-G), and the MM-specific domain using mixed-effects regression models. Two approaches for evaluating minimal clinically important differences were explored: the first defined as 10% of the instrument range, and the second based on estimated mean baseline differences between Eastern Cooperative Oncology Group performance status (ECOG PS) scores. Post-hoc difference analysis compared change in scores from baseline to EOT for treatment responders and non-responders. Results Eighty patients were included in the analysis; the mean number of prior therapies was 7.9 (standard deviation [SD] 3.1), and mean duration of myeloma was 7.6 years (SD 3.4). Each exploratory minimal clinically important difference threshold yielded consistent results whereby most patients did not experience HRQoL decline during the first six cycles of treatment (range: 53.9 to 75.7% for the first approach; range: 52.6 to 72.9% for the second). Treatment responders experienced less decline in HRQoL from baseline to EOT than non-responders, which was significant for the FACT-G, but not for other scores. Conclusion The majority of patients did not experience decline in HRQoL based on minimal clinically important differences during early cycles of treatment with selinexor and dexamethasone in the STORM trial. An anchor-based approach utilizing patient-level data (ECOG PS score) to define minimal clinically important differences for the FACT-MM gave consistent results with a distribution-based approach. Trial registration This trial was registered on ClinicalTrials.gov under the trial-ID NCT02336815 on January 8, 2015.

Regorafenib (REG) in patients with hepatocellular carcinoma (HCC) progressing following sorafenib: An ongoing randomized, double-blind, phase III trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS4163-TPS4163
Author(s):  
Ann-Lii Cheng ◽  
Richard S. Finn ◽  
Masatoshi Kudo ◽  
Josep M. Llovet ◽  
Shukui Qin ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Open Label ◽  
Double Blind ◽  
Sorafenib Treatment ◽  
Phase Iii Trial ◽  
Ecog Ps

TPS4163 Background: Sorafenib is the accepted first-line systemic therapy for HCC, but no standard option is available for patients with tumor progression following sorafenib. An open-label phase II study suggested that REG, a multikinase inhibitor, had an acceptable safety profile and showed evidence of antitumor activity in patients with progressive HCC (Bolondi et al. Eur J Cancer 2011; 47 [Suppl 1]: abstract 6.576): disease control was achieved in 26/36 patients (72%) and median time to progression (TTP) was 4.3 months; median overall survival (OS) was 13.8 months. On the basis of these promising data, a phase III trial was designed. Methods: This randomized, double-blind, placebo (PBO)-controlled, multinational study (ClinicalTrials.gov identifier NCT01774344) will assess the efficacy and tolerability of REG vs PBO in patients with HCC that has progressed following sorafenib treatment (target n=530). Inclusion criteria include Barcelona Clinic Liver Cancer stage B or C disease, Child–Pugh A liver function, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. Patients who discontinued sorafenib ≥8 weeks before study entry or who received other previous systemic therapy for HCC will be excluded. Patients will be randomized in a 2:1 ratio to receive REG 160 mg or matching PBO OD for weeks 1–3 of each 4-week cycle; all patients will also receive best supportive care. Treatment will continue until disease progression, death, intolerable toxicity, or patient/investigator decision to stop. Doses of study drug may be delayed or reduced to manage clinically significant drug-related toxicities. The primary endpoint is OS; secondary endpoints are TTP, progression-free survival, tumor response, and safety. Analysis will be according to randomized group, stratified by geographic region (Asia vs rest of world), ECOG PS (0 vs 1), alfa-fetoprotein level (<400 vs ≥400 ng/ml), extrahepatic disease (yes vs no), and macrovascular invasion (yes vs no). In addition, blood, plasma, and archival tissue will be assessed for pharmacokinetic and biomarker analyses, and health-related quality of life and health utility will be measured. Clinical trial information: NCT01774344.

Development and validation of the Comprehensive Quality of Life Outcome (CoQoLo) inventory for patients with advanced cancer

2015 ◽  
Vol 9 (1) ◽  
pp. 75-83 ◽  
Author(s):  
Mitsunori Miyashita ◽  
Makoto Wada ◽  
Tatsuya Morita ◽  
Mayumi Ishida ◽  
Hideki Onishi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Group Performance ◽  
Medical Center ◽  
Performance Status ◽  
Intraclass Correlation ◽  
Eastern Cooperative Oncology Group ◽  
Reliability And Validity ◽  
Cross Sectional

BackgroundThe purpose of this study was to develop a scale capable of measuring comprehensive quality of life (QOL) outcomes based on the concept of a good death for patients with advanced cancer.MethodsWe conducted an anonymous cross-sectional questionnaire survey on inpatients being treated at the Oncology Clinic in Saitama Medical University International Medical Center and seven palliative units throughout Japan.ResultsA total of 405 patients with cancer participated in this study. Factor analysis of scores on the Comprehensive Quality of Life Outcome (CoQoLo) inventory revealed 28 items and the following 10 subscales: physical and psychological comfort; staying in a favourite place; maintaining hope and pleasure; good relationships with medical staff; not being a burden to others; good relationships with family; independence; environmental comfort; being respected as an individual; and having a fulfilling life. The total CoQoLo score was moderately correlated with satisfaction (r=0.34) and overall QOL (r=0.34), and moderately correlated with feelings of support and security regarding cancer care (r=0.44). Cronbach's α and the intraclass correlation coefficient of the total score were 0.90 and 0.79, respectively. No significant correlation was found between the total CoQoLo score and self-reported Eastern Cooperative Oncology Group performance status (r=−0.01).ConclusionsThese results suggest that the CoQoLo has sufficient reliability and validity and therefore provides an accurate measure of QOL outcomes independent of the general physical condition of the patient.

Percutaneous cervical cordotomy for cancer-related pain: prospective multimodal outcomes evaluation

2020 ◽  
pp. bmjspcare-2019-002084
Author(s):  
Aimee Doyle ◽  
Manohar Lal Sharma ◽  
Manish Gupta ◽  
Andreas Goebel ◽  
Kate Marley
Keyword(s):  
Quality Of Life ◽  
Group Performance ◽  
Breakthrough Pain ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Oral Morphine ◽  
Opioid Dose ◽  
Oral Morphine Equivalent ◽  
Global Impression Of Change

BackgroundPercutaneous cervical cordotomy (PCC) offers pain relief to patients with unilateral treatment-refractory cancer-related pain. There is insufficient evidence about any effects of this intervention on patients’ quality of life.MethodComprehensive multimodal assessment to determine how PCC affects pain, analgesic intake and quality of life of patients with medically refractory, unilateral cancer-related pain.This study was set in a multidisciplinary, tertiary cancer pain service. Patient outcomes immediately following PCC were prospectively recorded. Patients were also followed up at 4 weeks.ResultsOutcome variables collected included: background and breakthrough pain numerical rating scores before PCC, at discharge and 4 weeks postprocedure; oral morphine equivalent opioid dose changes, Patient’s Global Impression of Change, Eastern Cooperative oncology group performance status and health related quality of life score, that is, EuroQol-5 dimension-5 level (EQ-5D).ConclusionsDespite significant improvement in pain and other standard outcomes sustained at 4 weeks, there was little evidence of improvement in EQ-5D scores. In patients with terminal cancer, improved pain levels following cordotomy for cancer-related pain does not appear to translate into improvements in overall quality of life as assessed with the generic EQ-5D measure.

scholarly journals Prospective cohort study of surgical outcome for spinal metastases in patients aged 70 years or older

2020 ◽  
Vol 102-B (12) ◽  
pp. 1709-1716
Author(s):  
Yutaro Kanda ◽  
Kenichiro Kakutani ◽  
Yoshitada Sakai ◽  
Takashi Yurube ◽  
Shingo Miyazaki ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Spinal Metastases ◽  
Palliative Surgery ◽  
Advanced Age ◽  
Health State ◽  
Survival Times ◽  
The Mean

Aims With recent progress in cancer treatment, the number of advanced-age patients with spinal metastases has been increasing. It is important to clarify the influence of advanced age on outcomes following surgery for spinal metastases, especially with a focus on subjective health state values. Methods We prospectively analyzed 101 patients with spinal metastases who underwent palliative surgery from 2013 to 2016. These patients were divided into two groups based on age (< 70 years and ≥ 70 years). The Eastern Cooperative Oncology Group (ECOG) performance status (PS), Barthel index (BI), and EuroQol-5 dimension (EQ-5D) score were assessed at study enrolment and at one, three, and six months after surgery. The survival times and complications were also collected. Results In total, 65 patients were aged < 70 years (mean 59.6 years; 32 to 69) and 36 patients were aged ≥ 70 years (mean 75.9 years; 70 to 90). In both groups, the PS improved from PS3 to PS1 by spine surgery, the mean BI improved from < 60 to > 80 points, and the mean EQ-5D score improved from 0.0 to > 0.7 points. However, no significant differences were found in the improvement rates and values of the PS, BI, and EQ-5D score at any time points between the two groups. The PS, BI, and EQ-5D score improved throughout the follow-up period in approximately 90% of patients in each group. However, the improved PS, BI, and EQ-5D scores subsequently deteriorated in some patients, and the redeterioration rate of the EQ-5D was significantly higher in patients aged ≥ 70 than < 70 years (p = 0.027). Conclusion Palliative surgery for spinal metastases improved the PS, activities of daily living, and quality of life, regardless of age. However, clinicians should be aware of the higher risk of redeterioration of the quality of life in advanced-age patients. Cite this article: Bone Joint J 2020;102-B(12):1709–1716.

scholarly journals Axitinib plus avelumab in the treatment of recurrent glioblastoma: a stratified, open-label, single-center phase 2 clinical trial (GliAvAx)

2020 ◽  
Vol 8 (2) ◽  
pp. e001146
Author(s):  
Gil Awada ◽  
Laila Ben Salama ◽  
Jennifer De Cremer ◽  
Julia Katharina Schwarze ◽  
Lydia Fischbuch ◽  
...  
Keyword(s):  
Adverse Events ◽  
Group Performance ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
Synergistic Activity ◽  
Open Label ◽  
Corticosteroid Dose

BackgroundNo treatment demonstrated to improve survival in patients with recurrent glioblastoma (rGB) in a randomized trial. Combining axitinib with the programmed cell death ligand 1 blocking monoclonal antibody avelumab may result in synergistic activity against rGB.MethodsAdult patients with rGB following prior surgery, radiation therapy and temozolomide chemotherapy were stratified according to their baseline use of corticosteroids. Patients with a daily dose of ≤8 mg of methylprednisolone (or equivalent) initiated treatment with axitinib (5 mg oral two times per day) plus avelumab (10 mg/kg intravenous every 2 weeks) (Cohort-1). Patients with a higher baseline corticosteroid dose initiated axitinib monotherapy; avelumab was added after 6 weeks of therapy if the corticosteroid dose could be tapered to ≤8 mg of methylprednisolone (Cohort-2). Progression-free survival at 6 months (6-m-PFS%), per immunotherapy response assessment for neuro-oncology criteria, served as the primary endpoint.ResultsBetween June 2017 and August 2018, 54 patients (27 per cohort) were enrolled and initiated study treatment (median age: 55 years; 63% male; 91% Eastern Cooperative Oncology Group Performance Status 0–1). Seventeen (63%) patients treated in Cohort-2 received at least one dose of avelumab. The 6-m-PFS% was 22.2% (95% CI 6.5% to 37.9%) and 18.5% (95% CI 3.8% to 33.2%) in Cohort-1 and Cohort-2, respectively; median overall survival was 26.6 weeks (95% CI 20.8 to 32.4) in Cohort-1 and 18.0 weeks (95% CI 12.5 to 23.5) in Cohort-2. The best objective response rate was 33.3% and 22.2% in Cohort-1 and Cohort-2, respectively, with a median duration of response of 17.9 and 19.0 weeks. The most frequent treatment-related adverse events were dysphonia (67%), lymphopenia (50%), arterial hypertension and diarrhea (both 48%). There were no grade 5 adverse events.ConclusionThe combination of avelumab plus axitinib has an acceptable toxicity profile but did not meet the prespecified threshold for activity justifying further investigation of this treatment in an unselected population of patients with rGB.

scholarly journals Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline BRCA/PALB2 Mutation

2020 ◽  
Vol 38 (13) ◽  
pp. 1378-1388 ◽  
Author(s):  
Eileen M. O’Reilly ◽  
Jonathan W. Lee ◽  
Mark Zalupski ◽  
Marinela Capanu ◽  
Jennifer Park ◽  
...  
Keyword(s):  
Phase Ii ◽  
Group Performance ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
High Response Rate ◽  
Open Label ◽  
Free Survival ◽  
Palb2 Mutation

PURPOSE Five percent to 9% of pancreatic ductal adenocarcinomas (PDACs) develop in patients with a germline BRCA1/2 or PALB2 (g BRCA/PALB2+) mutation. Phase IB data from a trial that used cisplatin, gemcitabine, and veliparib treatment demonstrated a high response rate (RR), disease control rate (DCR), and overall survival (OS) in this population. We designed an open-label, randomized, multicenter, two-arm phase II trial to investigate cisplatin and gemcitabine with or without veliparib in g BRCA/PALB2+ PDAC. PATIENTS AND METHODS Eligible patients had untreated g BRCA/PALB2+ PDAC with measurable stage III to IV disease and Eastern Cooperative Oncology Group performance status of 0 to 1. Treatment for patients in arm A consisted of cisplatin 25 mg/m2 and gemcitabine 600 mg/m2 intravenously on days 3 and 10; treatment for patients in arm B was the same as that for patients in arm A, and arm A also received veliparib 80 mg orally twice per day on days 1 to 12 cycled every 3 weeks. The primary end point was RRs of arm A and arm B evaluated separately using a Simon two-stage design. Secondary end points were progression-free survival, DCR, OS, safety, and correlative analyses. RESULTS Fifty patients were evaluated by modified intention-to-treat analysis. The RR for arm A was 74.1% and 65.2% for arm B ( P = .55); both arms exceeded the prespecified activity threshold. DCR was 100% for arm A and 78.3% for arm B ( P = .02). Median progression-free survival was 10.1 months for arm A (95% CI, 6.7 to 11.5 months) and 9.7 months for arm B (95% CI, 4.2 to 13.6 months; P = .73). Median OS for arm A was 15.5 months (95% CI, 12.2 to 24.3 months) and 16.4 months for arm B (95% CI, 11.7 to 23.4 months; P = .6). Two-year OS rate for the entire cohort was 30.6% (95% CI, 17.8% to 44.4%), and 3-year OS rate was 17.8% (95% CI, 8.1% to 30.7%). Grade 3 to 4 hematologic toxicities for arm A versus arm B were 13 (48%) versus seven (30%) for neutropenia, 15 (55%) versus two (9%) for thrombocytopenia, and 14 (52%) versus eight (35%) for anemia. CONCLUSION Cisplatin and gemcitabine is an effective regimen in advanced g BRCA/PALB2+ PDAC. Concurrent veliparib did not improve RR. These data establish cisplatin and gemcitabine as a standard approach in g BRCA/ PALB2+ PDAC.

Complications following symptom-limited thoracentesis using suction

2020 ◽  
Vol 56 (5) ◽  
pp. 1902356 ◽  
Author(s):  
Ala Eddin S. Sagar ◽  
Maria F. Landaeta ◽  
Andres M. Adrianza ◽  
Grecia L. Aldana ◽  
Leonardo Pozo ◽  
...  
Keyword(s):  
Pleural Fluid ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Chest Discomfort ◽  
Mediastinal Shift ◽  
Increased Risk ◽  
Procedural Complications ◽  
Ecog Ps ◽  
Current Guidelines

BackgroundThoracentesis using suction is perceived to have increased risk of complications, including pneumothorax and re-expansion pulmonary oedema (REPO). Current guidelines recommend limiting drainage to 1.5 L to avoid REPO. Our purpose was to examine the incidence of complications with symptom-limited drainage of pleural fluid using suction and identify risk factors for REPO.MethodsA retrospective cohort study of all adult patients who underwent symptom-limited thoracentesis using suction at our institution between January 1, 2004 and August 31, 2018 was performed, and a total of 10 344 thoracenteses were included.ResultsPleural fluid ≥1.5 L was removed in 19% of the procedures. Thoracentesis was stopped due to chest discomfort (39%), complete drainage of fluid (37%) and persistent cough (13%). Pneumothorax based on chest radiography was detected in 3.98%, but only 0.28% required intervention. The incidence of REPO was 0.08%. The incidence of REPO increased with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥3 compounded with ≥1.5 L (0.04–0.54%; 95% CI 0.13–2.06 L). Thoracentesis in those with ipsilateral mediastinal shift did not increase complications, but less fluid was removed (p<0.01).ConclusionsSymptom-limited thoracentesis using suction is safe even with large volumes. Pneumothorax requiring intervention and REPO are both rare. There were no increased procedural complications in those with ipsilateral mediastinal shift. REPO increased with poor ECOG PS and drainage ≥1.5 L. Symptom-limited drainage using suction without pleural manometry is safe.

Optimizing Treatment for Elderly Patients With Newly Diagnosed Multiple Myeloma: A Personalized Approach

2016 ◽  
Vol 34 (30) ◽  
pp. 3600-3604 ◽  
Author(s):  
Alessandra Larocca ◽  
Antonio Palumbo
Keyword(s):  
Multiple Myeloma ◽  
Group Performance ◽  
Performance Status ◽  
Relevant Literature ◽  
Eastern Cooperative Oncology Group ◽  
Staging System ◽  
Phase Iii ◽  
Bone Lesions ◽  
Best Response ◽  
Personalized Approach

The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors’ suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice. An 84-year-old woman presented with bone pain and lytic bone lesions in April 2010. Diagnosis of multiple myeloma was based on the presence of an immunoglobulin G lambda serum M protein (4,784 mg/dL) and confirmed by the findings of bone marrow plasma cell infiltration, with t(11;14) chromosomal abnormality detected by fluorescence in situ hybridization analysis. The patient’s medical history was significant for hypertension; she had an Eastern Cooperative Oncology Group performance status of 1, International Staging System (ISS) stage of 1, and Durie–Salmon stage of IIIA. In May 2010, the patient was enrolled in a randomized phase III trial comparing different lenalidomide-based treatments and received induction with lenalidomide plus dexamethasone (nine cycles) followed by lenalidomide maintenance. The patient started treatment with lenalidomide 25 mg per day for 21 days and reduced-dose dexamethasone 20 mg per week per protocol because of age. Induction was well tolerated; no relevant complications occurred, except for grade 1 fatigue and grade 1 diarrhea. Best response was partial response. In March 2011, she started maintenance with lenalidomide 10 mg per day. A dose reduction of lenalidomide 5 mg per day was required because of grade 2 diarrhea. In July 2015, the patient experienced relapse, with painful collapse of L3 vertebral body.

Variations in Multiple Myeloma Disease Presentation By Race

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5618-5618
Author(s):  
Mark A Fiala ◽  
Tanya M Wildes ◽  
Michael Slade ◽  
Jesse Keller ◽  
Keith Stockerl-Goldstein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Myeloma ◽  
Disease Burden ◽  
Plasma Cells ◽  
Performance Status ◽  
Symptom Burden ◽  
Pain Scale ◽  
Black Patients ◽  
Social Functioning Scale

Abstract Background: Black patients with multiple myeloma (MM) have poorer outcomes than their white counterparts. This has largely been attributed to reduced access to health care; however, little data exists comparing the disease and overall health status at MM presentation between the two races. More severe disease burden, symptom burden, or comorbidities could also explain the differences in outcome. Objective: To compare disease burden, symptom burden, and comorbidities between black and white patients with MM. Methods: Two datasets were analyzed: 1) the Multiple Myeloma Research Foundation (MMRF) CoMMpass study interim analysis 6, and 2) the Surveillance, Epidemiology, and End Results-Medicare Health Outcomes Survey (SEER-MHOS) 2015 dataset (SEER years 1973-2011; MHOS years 1998-2013). The CoMMpass dataset included 625 patients who completed the EORTC QLQ-C30 and QLQ-MY20 at MM diagnosis. The SEER-MHOS dataset included 377 patients who completed the HOS survey the year of or year prior to MM diagnosis. All patients identified as a race other than white or black/African American were excluded. Data was analyzed using SPSS 21. Categorical variables were compared using χ2, continuous with the Mann-Whitney U test. Results: CoMMpass: 585 patients were eligible for analysis. 477 (82%) were white, 108 (19%) were black. Whites and blacks were similar in median age, but a significantly higher percentage of white patients were female (p=0.027). Overall, black patients were more likely to be stage III (p=0.041), have higher LDH (p=0.006) and creatinine (p=0.001), and lower hemoglobin (p<0.001), but were more likely to have CD117+ MM cells (p=0.049). While quality of life measures were similar between the two races, white race was associated with better performance status (p=0.021). Results are summarized in Table 1. SEER-MHOS: 275 patients were eligible for analysis. 234 (85%) were white, 41 (15%) were black. Whites and blacks were similar in median age and sex distribution; there were no significant (p<0.05) differences in quality of life measures or comorbidities between the two races. Results are summarized in Table 2. Conclusions: The presentation of MM was similar between blacks and whites, but black patients tended to have a higher disease burden than whites. Despite this, both races reported similar symptom burden. Further studies are required to determine if higher disease burden account for part of the outcome disparities seen between the two races. Table 1. CoMMpass Whiten= 477 Black n = 108 p Demographics Age in years 65 63 NS Female 63% 49% 0.027 Disease Burden ISS Stage 0.041 Stage I/II 71% 61% Stage III 29% 40% Heavy Chain NS IgG 78% 81% IgA 22% 19% Light Chain NS Kappa 60% 73% Lambda 38% 27% Biclonal 2% 0% Serum M-Protein g/dL 2.9 2.5 NS LDH ukat/L 2.8 3.0 0.006 Bone Marrow Plasma Cells* 9% 9% NS Circulating Plasma Cells* 0% 0% NS Calcium mmol/L 2.4 2.4 NS Creatinine umol/L 93 111 0.001 Hgb mmol/L 6.7 6.0 <0.001 Platelets x109/L 213 207 NS Bone Lesions 56% 51% NS Molecular Characteristics Abnormal Karyotype 43% 39% NS Deletion 13 31% 32% NS Deletion 17p 20% 16% NS Translocation 11;14 19% 14% NS Translocation 4;14 10% 8% NS Phenotype** CD13+ 22% 27% NS CD20+ 17% 10% NS CD33+ 27% 29% NS CD52+ 12% 10% NS CD56+ 78% 79% NS CD117+ 56% 67% 0.049 FGFR3+ 15% 13% NS Symptom Burden/Quality of Life ECOG Performance Status 0.021 0-1 87% 78% 2-4 13% 22% Global Health Scale 58 66 NS Physical Functioning Scale 80 73 NS Cognitive Functioning Scale 83 83 NS Emotional Functioning Scale 75 83 NS Social Functioning Scale 66 66 NS Role Functioning Scale 66 50 NS Disease Symptom Scale 22 27 NS Fatigue Scale 33 33 NS Pain Scale 33 33 NS Median presented unless specified *- CD38+/CD138+ by flow cytometry **- performed on CD38+/CD138+ bone marrow cells Table 2. SEER-MHOS Whiten= 234 Black n = 41 p Demographics Age in years 77 75 NS Female 46% 41% NS Symptom Burden/Quality of Life General Health Scale 54 59 NS Physical Functioning Scale 58 70 NS Emotional Well-Being Scale 80 82 NS Social Functioning Scale 75 88 NS Role Limitation Physical Scale 25 50 NS Role Limitation Emotional Scale 100 100 NS Energy/Fatigue Scale 50 55 NS Pain Scale 51 57 NS Comorbidities Prior Malignancy 21% 10% NS Hypertension 60% 68% NS Coronary Artery Disease 16% 8% NS Congestive Heart Failure 7% 0% NS Myocardial Infarction 12% 10% NS Cerebral Vascular Accident 10% 10% NS Chronic Obstructive Pulmonary Disease 13% 12% NS Diabetes 81% 78% NS Obesity 20% 11% NS Median presented unless specified Disclosures Vij: Takeda, Onyx: Research Funding; Celgene, Onyx, Takeda, Novartis, BMS, Sanofi, Janssen, Merck: Consultancy.

A multicenter phase II study of thalidomide in combination with interleukin-2 (IL-2) in patients with previously untreated metastatic renal cell carcinoma (MRCC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14636-14636 ◽  
Author(s):  
D. Farray ◽  
J. I. Clark ◽  
T. Kuzel ◽  
J. P. Dutcher
Keyword(s):  
Phase Ii ◽  
Low Dose ◽  
Group Performance ◽  
Clear Cell ◽  
Phase Ii Study ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Interleukin 2 ◽  
Open Label ◽  
Anti Tumor Activity

14636 Background: Thalidomide, a drug with immune modulating and anti-angiogenic properties has shown activity in relapsed/refractory MRCC; furthermore, early phase I data of oral thalidomide with subcutaneous low-dose IL-2 showed the combination to be safe. The potential anti-tumor activity of this combination formed the basis of this study. Methods: The aim of this multi-center, open label, phase II study was to determine the efficacy and safety of thalidomide and IL-2 given in combination. Patients (pts) with untreated clear cell MRCC with measurable disease and previous nephrectomy were eligible. Two 6-week cycles of thalidomide and IL-2 were planned. Each cycle consisted of thalidomide started at 200 mg orally daily and titrated to 400 mg daily on the 4th day for 6 weeks; IL-2 was started one week post initiation of thalidomide at a dose of 7mIU/m2 subcutaneously days 1–5 for 4 weeks, followed by 2 weeks off therapy. Therapy was to be continued until progression, if there was at least stable disease (SD). Planned accrual was 53 patients. Results: 11 pts were enrolled. The trial was terminated early due to lack of responses. Median age was 57 years (51–66). All pts had an Eastern Cooperative Oncology Group performance status of 2 or better. The only grade 3 toxicities were fatigue (3 pts), neuropathy (1 pt), anorexia (1 pt), dyspnea (1 pt), edema (1 pt); these required dose reductions as per protocol. There were no objective responses: 3 pts had SD, 8 pts had progressive disease (PD). The 3 pts with SD completed 4, 4, and 6 cycles of therapy respectively; of the 8 pts with PD, 3 completed two cycles, and 5 completed one cycle of therapy. Conclusions: The combination of thalidomide and low-dose IL-2 was well tolerated, but in this trial did not show anti-tumor activity in patients with clear cell MRCC. We thank Celgene for support of this trial. No significant financial relationships to disclose.

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