Management of Anemia in Patients with Hematological Malignancies Treated with Erythropoiesis Stimulating Agents (ESAs): Findings from the European Anemia Cancer Treatment (A.C.T.) Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4672-4672
Author(s):  
Heinz Ludwig ◽  
Pierre Soubeyran ◽  
Matti Aapro ◽  
Carsten Bokemeyer ◽  
Michael Muenzberg ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Iron Supplementation ◽  
Hematological Malignancies ◽  
Performance Status ◽  
Response Rates ◽  
Treatment Patterns ◽  
Target Range ◽  
Ecog Performance Status ◽  
Iv Iron ◽  
Hematopoietic Response

Abstract BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated for hematological malignancies. Variability in treatment patterns, outcomes, and response rates in daily clinical practice need to be further investigated. OBJECTIVE. To examine anemia treatment patterns, outcomes, and response rates in the subsample of A.C.T. patients with hematological malignancies. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with at least 3 time points at approximately 1 month intervals, with visit 1 coinciding with start of ESA treatment. 152 centers in 13 European countries contributed 630 pts with hematological malignancies who were anemic (hemoglobin [Hb] ≤11g/dL) and treated with an ESA (14.8% of total European sample). MEASUREMENTS. All data collected through retrospective chart review. Key variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise ≥1g/dL, Hb rise ≥1g/dL within 8 weeks, hematopoietic response (Hb rise ≥2g/dL or Hb ≥12g/dL achieved), Hb rise ≥2g/dL, and Hb target range of 12.0–12.9g/dL achieved by visit 3. RESULTS. Pts ranged in age from 18 to 92 years (62.4±15.3). 94.4% of pts were on chemotherapy, of which 89.1% on standard vs. 10.9% on high dose; and 12.8% on platinum vs. 87.2% on nonplatinum. Types of ESA prescribed included epoetin alfa (14.4%), epoetin beta (44.8%), darbepoetin alfa (40.8%). Results are summarized in Table 1.No severe adverse events were reported. Table 1 Treatment Patterns & Outcomes Visit 1 Visit 2 Visit 3 P Mean (SD) ESA dose (IU/wk) 31067 (7247) 32354 (9418) 32309 (9638) 0.001 Median ESA dose (IU/wk) 30000 30000 30000 n.s. Mean (SD) Hb (g/dL) 9.3 (1.0) 10.2 (1.5) 10.9 (1.7) <0.001 WHO/ECOG performance status 1.11 (0.84) 0.92 (0.71) 0.88 (0.76) <0.001 % pts on iron 16.5% 16.2% 13.7% n.s. % pts on iron who are on IV iron 24.5% 34.5% 32.7% n.s. % pts with ESA dose escalation 6.5% 2.5% 0.028 Response Rates Hb↑≥1g/dL Hb↑≥1g/dL within 8 wks Hematopoietic response Hb↑≥2g/dL Hb 12-12.9 g/dL 70% 64.4% 47.5% 43.3% 21.1% CONCLUSIONS. The slight increase in ESA dose was not in accordance with the stable median ESA dose across the three visits. Hb increased from visit 1 from visit 3 with a concomitant rise in performance status. Iron supplementation with, in particular, IV iron was consistently low. Dose escalation rates were low, perhaps reflecting that this be an individualized patient decision. An increase in Hb of 1g/dL over the course of treatment is an attainable goal in over two-thirds of pts with hematological malignancies who are anemic. Adding time constraints, increasing the threshold level to 2g/dL, and/or setting an evidence-based target range of 12–12.9g/dL is associated with lower response rates. In pts with hematological malignancies, the therapeutic Hb goal to be achieved may need to be determined under consideration of multiple factors, however the general effectiveness of ESAs in this population is evident.

Management of Anemia in Lymphoma Patients Treated with Erythropoiesis Stimulating Agents (ESAs): Findings from the European Anemia Cancer Treatment (A.C.T.) Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4706-4706
Author(s):  
Heinz Ludwig ◽  
Carsten Bokemeyer ◽  
Pierre Soubeyran ◽  
Matti Aapro ◽  
Michael Muenzberg ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Iron Supplementation ◽  
Performance Status ◽  
Response Rates ◽  
Treatment Patterns ◽  
Target Range ◽  
High Dose ◽  
Ecog Performance Status ◽  
Iv Iron ◽  
Hematopoietic Response

Abstract BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated for lymphoma. Variability in treatment patterns, outcomes, and response rates in daily clinical practice need to be further investigated. OBJECTIVE. To examine anemia treatment patterns, outcomes, and response rates in the subsample of A.C.T. patients with lymphoma. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with at least 3 time points at approximately 1 month intervals, with visit 1 coinciding with start of ESA treatment. 128 centers in 13 European countries contributed 324 multiple myeloma pts who were anemic (hemoglobin [Hb] 11g/dL) and treated with an ESA (14.8% of total European sample). MEASUREMENTS. All data collected through retrospective chart review. Key variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise ≥1g/dL, Hb rise ≥1g/dL within 8 weeks, hematopoietic response (Hb rise ≥2g/dL or Hb≥12g/dL achieved), Hb rise ≥2g/dL, and Hb target range of 12.0–12.9g/dL achieved by visit 3. RESULTS. Pts ranged in age from 18 to 92 years (58.4±17.6). 96.1% of pts were on chemotherapy, of which 83.4% on standard vs. 16.6% on high dose; and 17.8% on platinum vs. 82.2% on nonplatinum. Types of ESA prescribed included epoetin alfa (13.0%), epoetin beta (43.5%), darbepoetin alfa (43.5%). Results are summarized in Table 1. No severe adverse events were reported. Table 1 Treatment patterns and outcomes Visit 1 Visit 2 Visit 3 P Mean (SD) ESA dose (IU/week) 31851 (6912) 33844 (10296) 33610 (10199) 0.002 Median ESA dose (IU/week) 30000 30000 30000 n.s. Mean (SD) Hb (g/dL) 9.3 (1.0) 10.2 (1.4) 10.9 (1.7) <0.001 WHO/ECOG performance status 1.04 (0.83) 0.98 (0.75) 0.90 (0.79) 0.002 % pts on iron 19.2% 18.1% 15.2% n.s. % pts on iron who are on IV iron 16.4% 23.3% 20.0% n.s. % pts with ESA dose escalation 8.4% 2.5% n.s. Response rates Hb↑≥1g/dL Hb↑≥1g/dL within 8wks Hematopoietic response Hb↑≥2g/dL 12–12.9g/dL % pts 67.9% 60.8% 44.4% 39.8% 20.7% CONCLUSIONS. The slight increase in ESA dose was not in accordance with the stable median ESA dose across the three visits. Hb increased from visit 1 from visit 3 with a concomitant rise in performance status. Iron supplementation with, in particular, IV iron was consistently low. Dose escalation rates were low, perhaps reflecting that this be an individualized patient decision. An increase in Hb of 1g/dL over the course of treatment is an attainable goal in two-thirds of lymphoma pts with anemia. Adding time constraints, increasing the threshold level to 2g/dL, and/or setting an evidence-based target range of 12–12.9g/dL is associated with lower response rates. In lymphoma pts, the therapeutic Hb goal to be achieved may need to be determined under consideration of multiple factors, however the general effectiveness of ESAs in this population is evident.

Management of Anemia in Multiple Myeloma Patients Treated with Erythropoiesis Stimulating Agents (ESAs): Findings from the European Anemia Cancer Treatment (A.C.T.) Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4716-4716
Author(s):  
Heinz Ludwig ◽  
Matti Aapro ◽  
Carsten Bokemeyer ◽  
Pierre Soubeyran ◽  
Michael Muenzberg ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Dose Escalation ◽  
Iron Supplementation ◽  
Performance Status ◽  
Response Rates ◽  
Treatment Patterns ◽  
Target Range ◽  
High Dose ◽  
Iv Iron ◽  
Hematopoietic Response

Abstract BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated for multiple myeloma. Variability in treatment patterns, outcomes, and response rates in daily clinical practice need to be further investigated. OBJECTIVE. To examine anemia treatment patterns, outcomes, and response rates in the subsample of A.C.T. patients with multiple myeloma. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with at least 3 time points at approximately 1 month intervals, with visit 1 coinciding with start of ESA treatment. 111 centers in 10 European countries contributed 306 multiple myeloma pts who were anemic (hemoglobin [Hb] ≤11g/dL) and treated with an ESA (14.0% of total European sample). MEASUREMENTS. All data collected through retrospective chart review. Key variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise ≥1g/dL, Hb rise ≥1g/dL within 8 weeks, hematopoietic response (Hb rise ≥2g/dL or Hb≥12g/dL achieved), Hb rise ≥2g/dL, and Hb target range of 12.0–12.9g/dL achieved by visit 3. RESULTS. Pts ranged in age from 26 to 91 years (66.6 11.0). 92.5% of pts were on chemotherapy, of which 94.6% on standard vs. 5.4% on high dose; and 6.7% on platinum vs. 93.3% on nonplatinum. Types of ESA prescribed included epoetin alfa (16.0%), epoetin beta (46.1%), darbepoetin alfa (37.9%). Results are summarized in Table 1. No severe adverse events were reported. Table 1. Treatment patterns & outcomes Visit 1 Visit 2 Visit 3 p Mean (SD) ESA dose (IU/wk) 30237 (7509) 30676 (8012) 30760 (8698) n.s. Median ESA dose (IU/wk) 30000 30000 30000 n.s. Mean (SD) Hb (g/dl) 9.2 (1.0) 10.3 (1.5) 11.0 (1.7) <0.001 WHO/ECOG (SD) performance status 1.17 (0.84) 0.87 (0.66) 0.86 (0.73) <0.001 % pts on iron 13.7% 9.2% 7.8% n.s. % pts on iron who are on IV iron 36.6% 46.4% 45.8% n.s. % pts with ESA dose escalation 4.4% 2.5% n.s. Response Rates Hb↑≥ 1g/dl Hb↑≥1g/dl within 8wks Hematopoietic response Hb↑≥ 2g/dl 12– 12.9g/dl % pts 72.2% 68.5% 50.7% 47.1% 21.6% CONCLUSIONS. Mean and median dose did not change over time. Hb increased from visit 1 from visit 3 with a concomitant rise in performance status. Iron supplementation with, in particular, IV iron was consistently low. Dose escalation rates were low, perhaps reflecting that this be an individualized patient decision. An increase in Hb of ≥1g/dL over the course of treatment is an attainable goal in almost three-quarters of multiple myeloma pts with anemia. Adding time constraints, increasing the threshold level to ≥ 2g/dL, and/or setting an evidence-based target range of 12–12.9g/dL is associated with lower response rates. In multiple myeloma pts, the therapeutic Hb goal to be achieved may need to be determined under consideration of multiple factors, however the general effectiveness of ESAs in this population is evident.

Comparison of the Management of Anemia in Patients with Solid Versus Hematological Malignancies Treated with Erythropoiesis Stimulating Agents (ESAs): Findings from the European Anemia Cancer Treatment (A.C.T.) Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4715-4715
Author(s):  
Heinz Ludwig ◽  
Matti Aapro ◽  
Carsten Bokemeyer ◽  
Pierre Soubeyran ◽  
Michael Muenzberg ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Hematological Malignancies ◽  
Performance Status ◽  
Response Rates ◽  
Target Range ◽  
Tumor Type ◽  
Epoetin Alfa ◽  
Ecog Performance Status ◽  
Iv Iron ◽  
Hematopoietic Response

Abstract BACKGROUND. The A.C.T. study has shown that in Europe more cancer patients (pts) with anemia are being treated with ESAs than 7 years ago. ESAs are indicated in solid and hematological malignancies. Variability in treatment patterns, outcomes, and response rates in these tumor categories needs to be further explored. OBJECTIVE. To examine differences in anemia treatment patterns, outcomes, and response rates between patients with solid vs. hematological malignancies. DESIGN & PATIENTS. Multicenter, longitudinal retrospective study with 3 time points at approximately 1 month intervals; start of ESA treatment at visit 1. 307 centers in 13 European countries contributed 2192 pts (n=630 with hematological tumors; n=1562 with solid tumors) who were anemic (hemoglobin [Hb] 11g/dL) and treated with an ESA. MEASUREMENTS. Retrospective chart review. Variables reported here: age, chemotherapy regimen, Hb, WHO/ECOG performance status, ESA type, ESA dose incl. escalation, and iron supplementation. Response to ESA Rx: Hb rise≥1g/dl within 8 weeks, hematopoietic response (Hb rise≥2g/dl or Hb≥12g/dl achieved), Hb rise≥2g/dl, and Hb target range of 12.0–12.9g/dl achieved by visit 3. RESULTS. Pts ranged in age from 18 to 94 years (61.5 12.7) with no difference between groups (p=ns). 95.2% of pts were on chemotherapy, of which 92.9% on standard vs. 7.1% on high dose (solid 94.3% and 5.7% vs. hemato 89.1% and 10.9%, p=0.001); and 40.5% on platinum vs. 59.5% on nonplatinum (solid 49.1% and 50.9% vs. hemato 12.8% and 87.2%, p=<0.001). Types of ESA included epoetin alfa (solid 23.2% vs. hemato 14.4%), epoetin beta (solid 41.7% vs. hemato 44.8%), darbepoetin alfa epoetin alfa (solid 34.6% vs. hemato 40.8%), and other epoetin alfa (solid 0.4% vs. hemato 0.0%; overall differences p<0.001). Table 1. Visit 1 Visit 2 Visit 3 p p p Solid Hemato p Solid Hemato p Solid Hemato p (tumor type) (visit) (tumor type X visit) Mean (SD) ESA dose (IU/wk) 32601 (10037) 31067 (7247) <0.001 33455 (11011) 32354 (9418) 0.034 33680 (11757) 32309 (9638) 0.027 0.023 <0.001 n.s. Median ESAdose (IU/wk) 30000 30000 NA 30000 30000 NA 30000 30000 NA NA NA NA Mean (SD) Hb (g/dl) 9.6 (0.9) 9.3 (1.0) <0.001 10.4 (1.2) 10.2 (1.5) 0.033 10.9 (1.4) 10.9 (1.7) n.s. 0.002 <0.001 <0.001 WHO/ECOG performance status 0.89 (0.73) 1.11 (0.87) <0.001 0.77 (0.71) 0.92 (0.71) 0.002 0.76 (0.75) 0.88 (0.76) 0.013 <0.001 <0.001 0.004 % pts on iron 32.3% 16.5% <0.001 22.6% 16.2% 0.006 22.4% 13.7% <0.001 <0.001 n.s. NA % pts on iron who are on IV iron 16.9% 24.5% n.s. 27.2% 34.5% n.s. 24.9% 32.7% n.s. n.s. n.s. NA % pts with 
 ESA dose escalation 5.2% 6.5% n.s. 3.2% 2.5% n.s. n.s. n.s. NA Table 2. Hb ↑ ≥1g/dL Hb ↑ ≥1g/dL within 8 wks Hematopoietic response Hb ↑ ≥2g/dL Hb target 12–12.9g/dL Solid Hemato Solid Hemato Solid Hemato Solid Hemato Solid Hemato % of pts 63.0% 70.0% 53.4% 64.4% 35.5% 47.5% 29.8% 43.3% 17.9% 21.1% p 0.002 <0.001 <0.001 <0.001 n.s. CONCLUSIONS. Slight increase in mean ESA dose between tumor types and across visits was not in accordance with the stable median ESA dose. Hb increased from visit 1 from visit 3 for all pts, but more so for pts with hematological malignancy, who moreover started out at lower Hb levels. Performance status increased in parallel with Hb, but more so for hematological patients. Hb levels were found to be an interaction of tumor type and time. A concomitant pattern was observed for performance status. Iron supplementation with esp. IV iron was consistently low, however with more hematological pts receiving esp. IV iron. Dose escalation rates were low, perhaps reflecting that this be an individualized patient decision. Response rates for pts with hematological malignancies were consistently higher than those for solid tumors, except for reaching Hb target of 12–12.9 g/dl. Hematological pts tended to have ESA Rx initiated at lower Hb levels thus showing more room for Hb improvement and therefore greater likelihood to fall in various responder categories. Overall, an increase of 1g/dl is achievable for the majority of pts. Adding time constraints, increasing the threshold level to ≥2g/dl, and/or setting an evidence-based target range of 12–12.9g/dl is associated with lower response rates in both groups, with slight advantage for hematological patients within caution above. ESAs are effective and safe in the management of cancer-related anemia for pts with hematological malignancies and solid tumors.

Safe use of Peripherally Inserted Central Catheters for chemotherapy of solid malignancies in adult patients: A 1-year monocentric, prospectively-assessed, unselected cohort of 482 patients

2020 ◽  
pp. 112972982096290
Author(s):  
Alessio Piredda ◽  
Davide Radice ◽  
Claudia Zencovich ◽  
Martina Cerri ◽  
Lucia Aventino ◽  
...  
Keyword(s):  
Hematological Malignancies ◽  
Blood Stream Infection ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Adult Patients ◽  
Time Interval ◽  
Ecog Performance Status ◽  
Peripherally Inserted Central Catheters ◽  
Central Catheters ◽  
Unselected Cohort

Introduction: Aim of this study was to analyze the overall complication and failure rates of Peripherally Inserted Central Catheters (PICCs), in a 1-year consecutive unselected cohort of 482 adult patients, affected by non-hematological malignancies undergoing chemotherapy. Methods: Adult outpatients (aged 18–75 years), with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, bearing solid tumors and candidates for intravenous chemotherapy were eligible for the study. Exclusion criteria were active infections, coagulopathy (defined as platelet count <50,000/μL and/or prothrombin time more than 18 s), life expectancy <6 months, or inability to give written informed consent. Devices were all implanted in an outpatients’ hospital facility, following predefined evidence-based institutional guidelines and protocols by a PICC-dedicated team at the European Institute of Oncology in Milan, Italy, during the 12-month period from January 1 to December 31, 2019. Results: Five-hundred PICCs were implanted in a cohort of 482 patients during the time interval of this study. Thirty devices were overall removed (6.2%), 23 as a consequence of a complication occurred, and seven inadvertently. The inserted PICCs accounted for a total of 49,718 catheter days in situ, median duration was 85.5 days [interquartile range (IQR): 56–146]. Overall there were 42 (8.7%) complications, corresponding to 0.84 catheter-adverse events (CAE)/1000 PICC-days (95% CI: 0.61–1.14). There were N = 13 (2.7%) thromboses, N = 11 (2.3%) irreversible occlusions, N = 7 (1.5%) accidental removals, N = 5 (1.0%) infections [two Catheter Related Blood Stream Infection (CRBSI) and three exit site/local infection], N = 3 (0.6%) ruptures and N = 3 (0.6%) primary or secondary malpositions. Conclusion: This large prospective study supports the increasing use of PICCs in adult oncology outpatients treated in specialized centers with chemotherapy for non-hematological malignancies. In this clinical setting, PICC failure occurred in 6% only of the inserted devices.

R-CHOP in the Treatment of DLBCL: Single Institution Experience from North India.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4773-4773
Author(s):  
Ashok K. Vaid ◽  
Sachin Gupta ◽  
Dinesh C. Doval ◽  
Vineet Talwar ◽  
Rajeev Gupta ◽  
...  
Keyword(s):  
Performance Status ◽  
B Cell Lymphoma ◽  
Response Rates ◽  
North India ◽  
Base Line ◽  
Extranodal Involvement ◽  
Ecog Performance Status ◽  
Chop Regimen ◽  
Bulky Disease ◽  
2D Echocardiography

Abstract Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of NHL. Different chemotherapy regimens tested in the past showed RR of appx 80% with no improvement in prognosis & OS. CHOP regimen has been the standard treatment for these patients (pts). Rituximab has improved response rates & survival in CD20 positive lymphoma pts, especially elderly (GELA trial: CR 73% vs. 63%). We retrospectively evaluated pts of DLBCL treated with R-CHOP regimen between April 2001 & June 2005. All pts had biopsy and IHC of lymph node/extranodal site, & CT scan of neck, chest, abdomen; BM biopsies; CBC, serum chemistries; 2D echocardiography/MUGA scans. All pts received Rituximab (375mg/m2) & CHOP 3 weekly for a maximum of 8 cycles. Pts who received at least 1 & 3 cycles of R-CHOP were evaluable for toxicity and response respectively. In total, 36 pts were included for analysis. The median age was 53 years, 10/36 pts (27.8%) were >60 years. 25/36 were male (69.4%). ECOG performance status: 0–1 in 30/36, and 2–4 in 6/36. 11/36 had B-symptoms, 16/36 had high LDH, 6/36 had bulky disease. Extranodal involvement was present in 19/36; 10/36 had ≥2 sites of extranodal involvement. Lymph nodal swelling was most common presentation in 24/36 (66.7%), followed by pain 10/36 (27.8%), weight loss 9/36 (25%), fever 7/36 (19.4%), skin nodules 3/36 (8.3%). Extranodal sites were: bone marrow 5/36, bone 4/36, skin 3/36, GIT 3/36, pleural effusion 2/36, lungs 2/36, other soft tissue 2/36, and parotid, nasopharynx, orbit, adrenal, testes, kidneys-1 each. Gallium scan at base line, done in 12/36, was positive in 11 pts (91%). Stage distribution was as follows: stage-I none, stage-II 10/36 (27.8%), stage-III 13/36 (36.1%), stage-IV 13/36 (36.1%). IPI scoring was-low risk 13/36 (36.1), low intermediate 9/36 (25.0%), high intermediate 13/36 (36.1) & high risk 1/36 (2.8%). A total of 199 cycles of R-CHOP were administered with a median of 6 cycles per patient. Of the 33 pts evaluable for response, 22 achieved CR (66.7%), 9 PR (27.3%), 1 each SD & PD. There were 2 treatment related mortalities. Toxicities were: grade III/IV neutropenia in 12/36 (33.3%), thrombocytopenia 4/36 (11.1%), peripheral neuropathy 2/36 (5.6%). Mild hypersensitivity to Rituximab was seen in 2/36 (5.6%) pts. Only 1 patient had cardiac toxicity in form of CHF. Our study showed response rates (94%) and toxicity profile similar to what has been reported in other studies with R-CHOP. The follow-up is too short to evaluate survival rates. Keywords: DLBCL, Rituximab, CHOP.

Final results of a prospective, observational study of the effectiveness of darbepoetin alfa administered every three weeks for the treatment of chemotherapy-induced anaemia in elderly patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20654-e20654
Author(s):  
G. Esquerdo ◽  
M. Doménech ◽  
J. C. Bermejo ◽  
P. López ◽  
C. Pedro ◽  
...  
Keyword(s):  
Darbepoetin Alfa ◽  
Performance Status ◽  
Specific Treatment ◽  
Red Blood Cell Transfusion ◽  
Fixed Dose ◽  
Ecog Performance Status ◽  
Myeloid Malignancies ◽  
Treatment Data ◽  
Practice Methods ◽  
Hematopoietic Response

e20654 Background: Cancer incidence is increasing in elderly but specific treatment data in this population is not often available. The objectives of this study were to evaluate the effectiveness and safety of darbepoetin alfa (DA) administered once every 3 weeks (Q3W) for the treatment of chemotherapy-induced anaemia (CIA) in elderly within routine clinical practice. Methods: Prospective, observational, single-arm, multicentre study performed in 28 centres across Spain. Eligible patients (pts):≥65 years, anaemic (haemoglobin [Hb] 11 g/dl), with non-myeloid malignancies, and scheduled to receive ≥9 weeks (wks) of chemotherapy. Pts were treated with a fixed dose of DA 500 μg Q3W and treatment stopped if Hb levels exceeded 13g/dl. Primary endpoint was hematopoietic response (Hb increase ≥2g/dl or Hb ≥12g/dl without transfusions in the previous 28 days). Secondary endpoints included percentage of pts achieving target Hb (>11g/dl from wk 5 till end of treatment without red blood cell transfusion within 28 days), changes in the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale and the incidence of adverse reactions. Results: Data were prospectively collected from 153 pts: women (56.86%), mean (SD) age 73.43 (5.77) years, ECOG Performance Status 0–1 (65.36%) with solid tumors (66.67%) and lymphoproliferative malignancies (33.33%) and stage III/IV (63.40%). Most pts (90.20%) had baseline Hb levels between 9–11g/dL. DA was administered for a median of 9.0 wks (range: 1–22.57). The Kaplan-Meier percentage (KM; 95% CI) of pts who achieved hematopoietic response was 69.70% (56.06–83.34) and 72.22% (57.5–86.94) for pts who achieved target Hb (>11g/dL). FACT-F median score at baseline was 29.00 and 33.00 at the end of the study. Only one (0.7%) non-serious adverse reaction (cutaneous eruption) was reported. Conclusions: These results suggest that DA given at 500 μg Q3W to elderly pts with non-myeloid malignancies is an effective and well-tolerated treatment for CIA. [Table: see text]

BEZ235 in combination with everolimus for advanced solid malignancies: Preliminary results of a phase Ib dose-escalation study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e13518-e13518 ◽  
Author(s):  
Mohamad Adham Salkeni ◽  
Olivier Rixe ◽  
Nagla Abdel Karim ◽  
Sue Ogara ◽  
Monica Feiler ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Dose Escalation ◽  
Mtor Inhibitor ◽  
Mononuclear Cells ◽  
Performance Status ◽  
Ecog Performance Status ◽  
Dose Escalation Study ◽  
Peripheral Blood Mononuclear ◽  
Phase Ib ◽  
Solid Malignancies

e13518 Background: The mammalian target of rapamycin (mTOR) is a critical signaling pathway in many tumors including cancers of the breast and colon, glioblastoma multiforme, and hepatocellular carcinoma (HCC). Preclinical studies demonstrated the combination of BEZ235, a competitive dual phosphatidylinositide 3-kinase (PI3K)/mTOR inhibitor, and the mTOR inhibitor, everolimus led to greater regression of a carcinogen-induced HCC than treatment with higher doses of either drug alone. Based on this, we initiated a study of BEZ235 combined with everolimus in patients with advanced solid tumors. Methods: A single institution phase Ib dose-escalation study. Patients with advanced solid malignancies, no available standard of care treatment option, and ECOG performance status 0-2 were eligible. Prior treatment with PI3K inhibitors was not allowed. Sequential cohorts of 3-6 patients were treated. The starting dose was everolimus 2.5 mg and BEZ235 200 mg daily in an oral sachet formulation. Cohort 2 received everolimus 2.5 mg and BEZ235 400 mg daily. Pharmacokinetic and pharmacodynamic studies were performed during the first cycle. The phosphorylation of specific downstream effectors of the mTOR pathway was assessed in peripheral blood mononuclear cells (PBMC). Results: Eleven patients, median age 58 (36-73 years) were treated. Tumors included non-small cell lung cancer, colon cancer, and glioblastoma, hepatocellular carcinoma, pancreatic cancer, esophageal cancer, adenoid cystic carcinoma of the larynx, and appendiceal carcinoma. Four patients were treated on cohort 1. None experienced dose-limiting toxicity. Seven patients were treated on the second dose cohort. One patient withdrew necessitating replacement and another developed grade 3 stomatitis from herpes virus requiring cohort expansion. The most common adverse events were thrombocytopenia, lymphopenia, transaminitis, diarrhea, nausea and fatigue. No tumor responses were noted. PBMC showed a decrease in 4E-BP1S65 phosphorylation on day 28 in 2 of 3 patients in cohort 1. Conclusions: The combination of BEZ235 and everolimus was well tolerated at these doses. The trial remains open to accrual. Clinical trial information: NCT01508104.

Treatment patterns and outcomes among patients with advanced cutaneous squamous cell carcinoma (CSCC) in a US community oncology setting.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21033-e21033 ◽  
Author(s):  
C. Lance Cowey ◽  
Nicholas J. Robert ◽  
Kalatu Davies ◽  
Janet L. Espirito ◽  
Jennifer R. Frytak ◽  
...  
Keyword(s):  
Response Rate ◽  
Systemic Treatment ◽  
Performance Status ◽  
Locally Advanced ◽  
Organ Transplant ◽  
Treatment Patterns ◽  
Unknown Primary ◽  
Ecog Performance Status ◽  
Data Set ◽  
Ecog Ps

e21033 Background: Advanced CSCC is a term that encompasses the locally advanced (laCSCC) and metastatic (mCSCC) condition. For advanced CSCC patients who receive conventional anticancer systemic treatment, there are limited data regarding treatment patterns and clinical outcomes. Methods: This was a retrospective, observational study of adult patients with laCSCC and mCSCC who initiated first-line (1L) systemic treatment from 1/1/2008 to 12/31/2015, with follow-up to 9/30/2017. Data were abstracted from the US Oncology Network’s iKnowMedSM electronic health record database, supplemented by chart review. ECOG performance status (PS) of 0 or 1 was required for inclusion. Exclusion criteria included tumor of unknown primary site, treatment with an anti-PD-1/anti-PD-L1 agent, participation in clinical trial, and concurrent primary cancer. Duration of therapy (DOT) and overall survival (OS) were analyzed by Kaplan-Meier method. Response rate was calculated as the proportion of patients who achieved physician assessed-response. Results: 82 patients met inclusion criteria (17 laCSCC and 65 mCSCC). Median age at start of 1L treatment was 75y; 85% were male, 79% Caucasian, 88% of patients had an ECOG PS of 1, 90% had prior surgery, 84% prior radiotherapy, and 8.5% had prior organ transplant. The most common 1L regimens were carboplatin + paclitaxel (27% of patients) and cetuximab monotherapy (24%). Median 1L DOT was 2.4 mo for the overall population; 4.1 mo for laCSCC, 2.3 mo for mCSCC. Physician-assessed response rate for 1L therapy was 18.3% overall; 17.6% for laCSCC, and 18.5% for mCSCC. Median OS from the start of 1L treatment was 15.3 mo (95% CI, 10.4-21.0) overall; 16.2 mo for laCSCC, and 15.3 mo for mCSCC. Only 24 patients (29%) received 2L therapy. Conclusions: This is the largest retrospective data set regarding advanced CSCC patients treated with conventional chemotherapy. Efficacy was low in both laCSCC and mCSCC. These data provide historic benchmarks for outcomes in advanced CSCC patients prior to the FDA approval of cemiplimab-rwlc.

scholarly journals Treatment Patterns and Outcomes Among Elderly Glioblastoma Patients at KFMC, Riyadh.

2021 ◽  
Author(s):  
Amal Maire ◽  
Ahmed M. Maklad ◽  
Abdullah Altwairqi ◽  
Wafaa AlShakweer ◽  
Mohamed Senosi ◽  
...  
Keyword(s):  
Adjuvant Treatment ◽  
Performance Status ◽  
Treatment Options ◽  
Univariate Analysis ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Treatment Patterns ◽  
Subtotal Resection ◽  
Ecog Performance Status ◽  
Significant Factors

Abstract IntroductionManagement of elderly patients with cancer is a controversial scenario and needs careful assessment and selection for aggressive radical treatment and chemotherapy protocols versus short-course radiotherapy without chemotherapy. Of note, definitions of the elderly vary in the glioblastoma (GBM) literature, with most of the randomized trials including patients aged 60, 65, or 70 years or older.Aim of the workTo evaluate treatment patterns and outcome among elderly GBM patients treated in KFMC, Riyadh. The primary endpoint is overall survival (OS) and the Secondary endpoint is progression-free survival (PFS) in relation to different treatment options and prognostic factors. MethodsThis is a retrospective study, included elderly GBM patients treated at KFMC, Riyadh, KSA between 1/2008 till 1/2018. 59 patients diagnosed with GBM ≥ 60 years were reviewed regarding radiotherapy (Rth) fractionation modalities, surgery, and chemotherapy (CTR) given in correlation to PFS, OS.Results59 patients were recruited in our study with median age 66 range (60-81) years, 47 (80%) were males. 37 patients (62.7%) had Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2, and 22 patients (37.3%) had PS < 2. Gross total resection (GTR) and subtotal resection (STR) was done in 49 (82.9%) patients, and the median follow-up was 12 months.38 (64%) patients received conventional Rth 60 Gray (Gy)/30 fractions or equal doses and 21 (36%) patients received hypofractionation Rth (40 Gy/15, 25 Gy/5 or 30 Gy/10 fractions).The median OS was 12 months (95% CI,9.52-14.48). For univariate analysis, receiving a conventional Rth and completion of 6 months adjuvant CTR were significant factors for O.S (P= 0.043 and 0.026) respectively. For multivariate those were also significant (P=0.035 and 0.002) respectively.The median PFS was 9 months (95% CI, 6.13-11.87). For univariate analysis PS, time to start adjuvant treatment, and completion of 6 months CTR were significant factors for PFS. For multivariate analysis starting adjuvant treatment within 2 months and completed CTR 6 months were significant factors (P=0.032 and 0.04) respectively. ConclusionElderly GBM patients who received conventional Rth and completed adjuvant 6 months CTR achieved a better OS, while starting adjuvant treatment earlier than 2 months and completed adjuvant CTR 6 months were associated with a better PFS, further prospective studies are needed to confirm our finding.

Safety and efficacy of axitinib in pretreated patients with metastatic renal cell carcinoma: A single center experience of the Medical University of Vienna, Austria.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15535-e15535
Author(s):  
Ursula Maria Vogl ◽  
Lothar Ponhold ◽  
Gottfried J Locker ◽  
Christoph Zielinski ◽  
Christoph Klingler ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Renal Cell ◽  
Performance Status ◽  
Cell Cancer ◽  
Objective Response ◽  
Progression Free Survival ◽  
Second Line ◽  
Ecog Performance Status ◽  
Single Center Experience ◽  
Metastatic Sites

e15535 Background: Axitinib is a highly selective inhibitor of VEGFR-1, 2 and 3 and has recently been approved for second-line treatment of metastatic renal cell cancer (mRCC). We present data of 43 patients treated with axitinib in second-line and beyond. Methods: Medical records of all patients who were treated with axitinib between July 2009 and December 2012 were retrospectively reviewed. Axitinib was prescribed at a dose of 5 mg bid and escalated to 7 or 10 mg bid in the absence of hypertension and other dose-limiting toxicities. Objective response rate (ORR) was assessed by RECIST. Progression free survival (PFS) and overall survival (OS) were calculated from the first day of axitinib until progression and/or death, respectively. Results: Fourty-three patients with a median age of 65 years (range: 17-84) are currently evaluable for analysis. The majority of patients (58.1%) had an ECOG Performance status of 0 and were classified MSKC- intermediate risk (62.8%). All patients had undergone surgery for the primary tumor and 53.5% had three or more metastatic sites. Fifty-five percent of the patients received axitinib in third or fourth-line (14% and 41.9%, respectively). Prior therapies included sunitinib (86%), everolimus (35%) and pazopanib (35%) and 62.8% had progressed on sunitinib before axitinib was initiated. Objective remission and disease stabilization were observed in 14.3% and 40% of the entire population. The median PFS and OS were 6.8 months (95% CI: 5.5 – 8.0) and 17.2 months (95% CI: 10.8 – 23.6), respectively. Dose escalation to 7 or 10 mg bid was feasible in 40% of the patients. Fatigue (76.7%), hypertension (65.1%) and hypothyroidism (53.5%) were among the most commonly observed all grade toxicities. Conclusions: Axitinib showed considerable efficacy in both second-line and beyond second-line patients. Generous dose escalation based on a “treat to hypertension”-concept may have led to a longer PFS than previously reported from a purely VEGFR-TKI-refractory patient population.

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