Prevention of Anemia in Patients with Solid Tumors Receiving Platinum-Based Chemotherapy by Recombinant Human Erythropoietin (rHuEpo): A Prospective, Open Label, Randomized Trial by the Hellenic Cooperative Oncology Group

Oncology ◽  
2003 ◽  
Vol 64 (2) ◽  
pp. 102-110 ◽  
Author(s):  
A. Bamias ◽  
G. Aravantinos ◽  
C. Kalofonos ◽  
N. Timotheadou ◽  
V. Siafaka ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Solid Tumors ◽  
Recombinant Human Erythropoietin ◽  
Oncology Group ◽  
Open Label ◽  
Human Erythropoietin ◽  
Platinum Based Chemotherapy

Intravenous Iron Optimizes the Response to Recombinant Human Erythropoietin in Cancer Patients With Chemotherapy-Related Anemia: A Multicenter, Open-Label, Randomized Trial

2004 ◽  
Vol 22 (7) ◽  
pp. 1301-1307 ◽  
Author(s):  
Michael Auerbach ◽  
Harold Ballard ◽  
J. Richard Trout ◽  
Marilyn McIlwain ◽  
Alan Ackerman ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cancer Patients ◽  
Recombinant Human Erythropoietin ◽  
Transferrin Saturation ◽  
Oral Iron ◽  
Iron Dextran ◽  
Iron Group ◽  
Open Label ◽  
Human Erythropoietin ◽  
Iv Iron

PurposeRecombinant human erythropoietin (rHuEPO) is the standard of care for patients with chemotherapy-related anemia. Intravenous (IV) iron improves hemoglobin (Hb) response and decreases dosage requirements in patients with anemia of kidney disease, but its effect has not been studied in randomized trials in cancer patients.MethodsThis prospective, multicenter, open-label, randomized trial enrolled 157 patients with chemotherapy-related anemia (Hb ≤ 105 g/L, serum ferritin ≤ 450 pmol/L or ≤ 675 pmol/L with transferrin saturation ≤ 19%) receiving subcutaneously rHuEPO 40,000 U once weekly to: (1) no-iron; (2) oral iron 325 mg twice daily; (3) iron dextran repeated 100mg IV bolus; or (4) iron dextran total dose infusion (TDI). Hb and quality of life (QOL) were measured at baseline and throughout.ResultsAll groups showed Hb (P < .0001) increases from baseline. Mean Hb increases for both IV iron groups were greater (P < .02) than for no-iron and oral iron groups. The percentage of patients with hematopoietic responses was higher (P < .01) in both IV iron groups (each case 68%) compared with no-iron (25%) and oral iron (36%) groups. IV iron groups showed increases in energy, activity, and overall QOL from baseline, compared with a decrease in energy and activity for no-iron group and no change in activity or overall QOL for oral iron group.ConclusionrHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia. Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added.

scholarly journals Response predicting factors to recombinant human erythropoietin in cancer patients undergoing platinum-based chemotherapy

Cancer ◽  
2002 ◽  
Vol 95 (11) ◽  
pp. 2408-2413 ◽  
Author(s):  
Manolo González-Barón ◽  
Amdio Ordóñez ◽  
Rosa Franquesa ◽  
Manuel Constenla ◽  
Joaquin Montalar ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Recombinant Human Erythropoietin ◽  
Human Erythropoietin ◽  
Predicting Factors ◽  
Platinum Based Chemotherapy

CCTG BR.34: A randomized trial of durvalumab and tremelimumab +/- platinum-based chemotherapy in patients with metastatic (Stage IV) squamous or nonsquamous non-small cell lung cancer (NSCLC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9502-9502 ◽  
Author(s):  
Natasha B. Leighl ◽  
Scott Andrew Laurie ◽  
Glenwood D. Goss ◽  
Brett Gordon Maxwell Hughes ◽  
Martin R. Stockler ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Trial ◽  
Advanced Nsclc ◽  
Smoking Status ◽  
Objective Response ◽  
Stage Iv ◽  
First Line ◽  
Open Label ◽  
Platinum Based Chemotherapy ◽  
Significant Difference

9502 Background: First-line therapy for advanced NSCLC includes PD-1 checkpoint inhibitor (ICI) monotherapy, and in combination with chemotherapy. Combination ICI have also demonstrated better survival compared to chemotherapy (CM-227). In CCTG BR.34, we compared overall survival (OS) in patients with advanced NSCLC receiving first-line durvalumab plus tremelimumab (DT) with or without platinum doublet chemotherapy (CT). Methods: This international, open-label, randomized trial accrued 301 participants from Canada and Australia, with stage IV NSCLC, EGFR/ALK wildtype, ECOG PS 0/1. Patients were randomized to DT for 4 cycles or DT+CT (pemetrexed- or gemcitabine-platinum), with ongoing D or D + pemetrexed (non-squamous) maintenance until disease progression. Stratification factors included histology, stage IVA v. IVB and smoking status. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS), objective response rate (ORR = CR + PR) and adverse events (AEs). Results: At a median follow up of 16.6 months, no significant difference in OS was seen between the two treatment arms, with a median OS of 16.6 months with DT+CT v. 14.1 months with DT, (estimated HR 0.88, 90% CI 0.67-1.16). PFS was significantly improved in the DT+CT arm (stratified HR 0.67, 95% CI 0.52-0.88; medians 7.7 v. 3.2 months). ORR was higher in the DT+CT arm, 28% v. 14%, (odds ratio 2.1, p=0.001). Preplanned subgroup analysis demonstrated no significant differences in treatment outcomes by plasma TMB (<20 v. ≥20 mut/Mb, Guardant OMNI), age, sex, or smoking status. There was a trend to improved OS with DT+CT in the subgroup with PD-L1 TPS≥50%, (HR 0.64, 95% CI 0.40-1.04, p=0.07). Plasma TMB<20 mut/Mb was associated with shorter survival in both treatment groups (HR 1.99, 95% 1.3-3.1). Toxicity was greater in the DT+CT arm, with grade≥3 adverse events in 82% v. 70%, (p=0.02), most commonly dyspnea, nausea and cough. The incidence of immune-related adverse events was similar between arms (colitis 11%, pneumonitis 6%, endocrinopathy 21%). Grade 5 events occurred in 2.7%, (5 with DT+CT, 3 with DT). Conclusions: The addition of CT to first-line DT did not improve OS in advanced NSCLC. CT+DT improved ORR and PFS, and was associated with greater toxicity. No differential effects were seen by PD-L1 TPS nor bTMB. These data suggest that adding chemotherapy to ICI may be beneficial in those with PD-L1 TPS >=50%, and warrant further analysis in independent datasets. Clinical trial information: NCT03057106 .

Recombinant human erythropoietin (rhEPO) in the management of anemia and fatigue associated with solid tumors

1998 ◽  
Vol 4 (4_suppl) ◽  
pp. S18-S24
Author(s):  
Terri G Davidson
Keyword(s):  
Quality Of Life ◽  
Solid Tumors ◽  
Recombinant Human Erythropoietin ◽  
Tumor Response ◽  
Anemia Of Chronic Disease ◽  
Effective Response ◽  
Human Erythropoietin ◽  
Transfusion Requirements ◽  
Serum Erythropoietin

The anemia that is most common in patients with solid tumors is the anemia of chronic disease, which probably occurs because of im paired production and a diminished response to serum erythropoietin (EPO). A number of trials evaluating recombinant human EPO in anemic cancer patients with a variety of solid tumors have demonstrated effective response rates, with increases in hemoglobin (Hb) concentra tion and reduction or elimination of transfusion requirements. The anemia of certain solid tu mors (eg, lung cancer, prostate cancer) appears to respond better to recombinant human EPO therapy than does the anemia associated with other cancers (eg, colon cancer). Both tumor response and increases in Hb concentrations are important factors in improving the quality of life of patients. The greatest contributor to improved quality of life appears to be the nor malization of Hb levels.

Sign in / Sign up

Export Citation Format

Share Document