Comparing the efficacy and safety of fixed versus weight-based dosing of epoetin α in anemic cancer patients receiving platinum-based chemot

Cristina Granetto, Sergio Ricci, Andrea Martoni, Giuseppe Pezzella, Franco Testore, Rodolfo Mattioli, Maria Lampignano, Fiorenzo Tacconi, Stella Porrozzi, Giampietro Gasparini, Giovanni Mantovani

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Fixed dosing is potentially more convenient than weight-based dosing for both patients and physicians. Therefore, this open-label, randomized (1:1), multicenter study was conducted to compare the effectiveness, safety, and quality-of-life benefits of fixed vs. weight-based dosing of epoetin α in anemic cancer patients undergoing chemotherapy. Five hundred forty-six anemic patients undergoing platinum-based chemotherapy for solid malignancies were enrolled. Patients received epoetin α, either a fixed dose of 10,000 IU or a weight-based dose of 150 IU/kg, administered subcutaneously 3 times weekly for up to 12 weeks. Endpoints were transfusion requirements over days 29-84, change in hemoglobin (Hb) level from baseline, and change in quality-of-life (QOL) scores from baseline as measured using the Cancer Linear Analog Scale (CLAS). Five hundred and thirty-two patients received at least 1 dose of epoetin α, and 510 of these (255 in each treatment group) were considered evaluable for efficacy. At day 84, rates for freedom from transfusion were similar between the fixed-dose and the weight-based dose group (84% vs. 87%, respectively, p=0.32), as calculated by the lifetable method. These rates were also similar between patients in the 45-63 kg weight group receiving the fixed 10,000 IU dose or 7,000-9,000 IU on a per-weight basis (83% vs. 87%, respectively), and those in the 70-100 kg weight group receiving the fixed 10,000 IU dose or 11,000-15,000 IU on a per-weight basis (85% vs. 83%, respectively). Mean Hb increases from baseline to last observation were 2.10 g/dl [95% confidence intervals (CI95) 1.85-2.35] in the 10,000 IU group (from 9.64-11.74 g/dl) and 2.06 g/dl (CI95 1.82-2.30) in the 150 IU/kg group (from 9.70-11.76 g/dl). QOL results were similar for both groups and cumulative data have been reported. For 275 patients (in both groups combined) with CLAS QOL scores both at baseline and 29-98 days thereafter, the QOL index (average of scores for the 3 QOL parameters: energy level, ability to do daily activities and overall QOL) increased by 10.4 mm (CI95 7.5-13.2), from 46.2 mm at baseline to 56.6 mm at the final observation. QOL improvements were directly associated with Hb increases (p

Original languageEnglish
Pages (from-to)1289-1296
Number of pages8
JournalOncology Reports
Volume10
Issue number5
Publication statusPublished - Sep 2003

Fingerprint

Platinum
Quality of Life
Safety
Weights and Measures
Neoplasms
Hemoglobins
Observation
Drug Therapy
Quality Improvement
Multicenter Studies
Confidence Intervals
Physicians

Keywords

  • Anemia
  • Cancer
  • Epoetin α

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Granetto, C., Ricci, S., Martoni, A., Pezzella, G., Testore, F., Mattioli, R., ... Mantovani, G. (2003). Comparing the efficacy and safety of fixed versus weight-based dosing of epoetin α in anemic cancer patients receiving platinum-based chemot. Oncology Reports, 10(5), 1289-1296.

Comparing the efficacy and safety of fixed versus weight-based dosing of epoetin α in anemic cancer patients receiving platinum-based chemot. / Granetto, Cristina; Ricci, Sergio; Martoni, Andrea; Pezzella, Giuseppe; Testore, Franco; Mattioli, Rodolfo; Lampignano, Maria; Tacconi, Fiorenzo; Porrozzi, Stella; Gasparini, Giampietro; Mantovani, Giovanni.

In: Oncology Reports, Vol. 10, No. 5, 09.2003, p. 1289-1296.

Research output: Contribution to journalArticle

Granetto, C, Ricci, S, Martoni, A, Pezzella, G, Testore, F, Mattioli, R, Lampignano, M, Tacconi, F, Porrozzi, S, Gasparini, G & Mantovani, G 2003, 'Comparing the efficacy and safety of fixed versus weight-based dosing of epoetin α in anemic cancer patients receiving platinum-based chemot', Oncology Reports, vol. 10, no. 5, pp. 1289-1296.
Granetto, Cristina ; Ricci, Sergio ; Martoni, Andrea ; Pezzella, Giuseppe ; Testore, Franco ; Mattioli, Rodolfo ; Lampignano, Maria ; Tacconi, Fiorenzo ; Porrozzi, Stella ; Gasparini, Giampietro ; Mantovani, Giovanni. / Comparing the efficacy and safety of fixed versus weight-based dosing of epoetin α in anemic cancer patients receiving platinum-based chemot. In: Oncology Reports. 2003 ; Vol. 10, No. 5. pp. 1289-1296.
@article{8be7335ea8e642609e0d9f4f19e5a7b7,
title = "Comparing the efficacy and safety of fixed versus weight-based dosing of epoetin α in anemic cancer patients receiving platinum-based chemot",
abstract = "Fixed dosing is potentially more convenient than weight-based dosing for both patients and physicians. Therefore, this open-label, randomized (1:1), multicenter study was conducted to compare the effectiveness, safety, and quality-of-life benefits of fixed vs. weight-based dosing of epoetin α in anemic cancer patients undergoing chemotherapy. Five hundred forty-six anemic patients undergoing platinum-based chemotherapy for solid malignancies were enrolled. Patients received epoetin α, either a fixed dose of 10,000 IU or a weight-based dose of 150 IU/kg, administered subcutaneously 3 times weekly for up to 12 weeks. Endpoints were transfusion requirements over days 29-84, change in hemoglobin (Hb) level from baseline, and change in quality-of-life (QOL) scores from baseline as measured using the Cancer Linear Analog Scale (CLAS). Five hundred and thirty-two patients received at least 1 dose of epoetin α, and 510 of these (255 in each treatment group) were considered evaluable for efficacy. At day 84, rates for freedom from transfusion were similar between the fixed-dose and the weight-based dose group (84{\%} vs. 87{\%}, respectively, p=0.32), as calculated by the lifetable method. These rates were also similar between patients in the 45-63 kg weight group receiving the fixed 10,000 IU dose or 7,000-9,000 IU on a per-weight basis (83{\%} vs. 87{\%}, respectively), and those in the 70-100 kg weight group receiving the fixed 10,000 IU dose or 11,000-15,000 IU on a per-weight basis (85{\%} vs. 83{\%}, respectively). Mean Hb increases from baseline to last observation were 2.10 g/dl [95{\%} confidence intervals (CI95) 1.85-2.35] in the 10,000 IU group (from 9.64-11.74 g/dl) and 2.06 g/dl (CI95 1.82-2.30) in the 150 IU/kg group (from 9.70-11.76 g/dl). QOL results were similar for both groups and cumulative data have been reported. For 275 patients (in both groups combined) with CLAS QOL scores both at baseline and 29-98 days thereafter, the QOL index (average of scores for the 3 QOL parameters: energy level, ability to do daily activities and overall QOL) increased by 10.4 mm (CI95 7.5-13.2), from 46.2 mm at baseline to 56.6 mm at the final observation. QOL improvements were directly associated with Hb increases (p",
keywords = "Anemia, Cancer, Epoetin α",
author = "Cristina Granetto and Sergio Ricci and Andrea Martoni and Giuseppe Pezzella and Franco Testore and Rodolfo Mattioli and Maria Lampignano and Fiorenzo Tacconi and Stella Porrozzi and Giampietro Gasparini and Giovanni Mantovani",
year = "2003",
month = "9",
language = "English",
volume = "10",
pages = "1289--1296",
journal = "Oncology Reports",
issn = "1021-335X",
publisher = "Spandidos Publications",
number = "5",

}

TY - JOUR

T1 - Comparing the efficacy and safety of fixed versus weight-based dosing of epoetin α in anemic cancer patients receiving platinum-based chemot

AU - Granetto, Cristina

AU - Ricci, Sergio

AU - Martoni, Andrea

AU - Pezzella, Giuseppe

AU - Testore, Franco

AU - Mattioli, Rodolfo

AU - Lampignano, Maria

AU - Tacconi, Fiorenzo

AU - Porrozzi, Stella

AU - Gasparini, Giampietro

AU - Mantovani, Giovanni

PY - 2003/9

Y1 - 2003/9

N2 - Fixed dosing is potentially more convenient than weight-based dosing for both patients and physicians. Therefore, this open-label, randomized (1:1), multicenter study was conducted to compare the effectiveness, safety, and quality-of-life benefits of fixed vs. weight-based dosing of epoetin α in anemic cancer patients undergoing chemotherapy. Five hundred forty-six anemic patients undergoing platinum-based chemotherapy for solid malignancies were enrolled. Patients received epoetin α, either a fixed dose of 10,000 IU or a weight-based dose of 150 IU/kg, administered subcutaneously 3 times weekly for up to 12 weeks. Endpoints were transfusion requirements over days 29-84, change in hemoglobin (Hb) level from baseline, and change in quality-of-life (QOL) scores from baseline as measured using the Cancer Linear Analog Scale (CLAS). Five hundred and thirty-two patients received at least 1 dose of epoetin α, and 510 of these (255 in each treatment group) were considered evaluable for efficacy. At day 84, rates for freedom from transfusion were similar between the fixed-dose and the weight-based dose group (84% vs. 87%, respectively, p=0.32), as calculated by the lifetable method. These rates were also similar between patients in the 45-63 kg weight group receiving the fixed 10,000 IU dose or 7,000-9,000 IU on a per-weight basis (83% vs. 87%, respectively), and those in the 70-100 kg weight group receiving the fixed 10,000 IU dose or 11,000-15,000 IU on a per-weight basis (85% vs. 83%, respectively). Mean Hb increases from baseline to last observation were 2.10 g/dl [95% confidence intervals (CI95) 1.85-2.35] in the 10,000 IU group (from 9.64-11.74 g/dl) and 2.06 g/dl (CI95 1.82-2.30) in the 150 IU/kg group (from 9.70-11.76 g/dl). QOL results were similar for both groups and cumulative data have been reported. For 275 patients (in both groups combined) with CLAS QOL scores both at baseline and 29-98 days thereafter, the QOL index (average of scores for the 3 QOL parameters: energy level, ability to do daily activities and overall QOL) increased by 10.4 mm (CI95 7.5-13.2), from 46.2 mm at baseline to 56.6 mm at the final observation. QOL improvements were directly associated with Hb increases (p

AB - Fixed dosing is potentially more convenient than weight-based dosing for both patients and physicians. Therefore, this open-label, randomized (1:1), multicenter study was conducted to compare the effectiveness, safety, and quality-of-life benefits of fixed vs. weight-based dosing of epoetin α in anemic cancer patients undergoing chemotherapy. Five hundred forty-six anemic patients undergoing platinum-based chemotherapy for solid malignancies were enrolled. Patients received epoetin α, either a fixed dose of 10,000 IU or a weight-based dose of 150 IU/kg, administered subcutaneously 3 times weekly for up to 12 weeks. Endpoints were transfusion requirements over days 29-84, change in hemoglobin (Hb) level from baseline, and change in quality-of-life (QOL) scores from baseline as measured using the Cancer Linear Analog Scale (CLAS). Five hundred and thirty-two patients received at least 1 dose of epoetin α, and 510 of these (255 in each treatment group) were considered evaluable for efficacy. At day 84, rates for freedom from transfusion were similar between the fixed-dose and the weight-based dose group (84% vs. 87%, respectively, p=0.32), as calculated by the lifetable method. These rates were also similar between patients in the 45-63 kg weight group receiving the fixed 10,000 IU dose or 7,000-9,000 IU on a per-weight basis (83% vs. 87%, respectively), and those in the 70-100 kg weight group receiving the fixed 10,000 IU dose or 11,000-15,000 IU on a per-weight basis (85% vs. 83%, respectively). Mean Hb increases from baseline to last observation were 2.10 g/dl [95% confidence intervals (CI95) 1.85-2.35] in the 10,000 IU group (from 9.64-11.74 g/dl) and 2.06 g/dl (CI95 1.82-2.30) in the 150 IU/kg group (from 9.70-11.76 g/dl). QOL results were similar for both groups and cumulative data have been reported. For 275 patients (in both groups combined) with CLAS QOL scores both at baseline and 29-98 days thereafter, the QOL index (average of scores for the 3 QOL parameters: energy level, ability to do daily activities and overall QOL) increased by 10.4 mm (CI95 7.5-13.2), from 46.2 mm at baseline to 56.6 mm at the final observation. QOL improvements were directly associated with Hb increases (p

KW - Anemia

KW - Cancer

KW - Epoetin α

UR - http://www.scopus.com/inward/record.url?scp=2142858255&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=2142858255&partnerID=8YFLogxK

M3 - Article

C2 - 12883695

AN - SCOPUS:2142858255

VL - 10

SP - 1289

EP - 1296

JO - Oncology Reports

JF - Oncology Reports

SN - 1021-335X

IS - 5

ER -