Phase I trial of esorubicin (4'deoxydoxorubicin)

H. S. Garewal, A. Robertone, S. E. Salmon, S. E. Jones, David S Alberts, R. Brooks

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

A phase I study of 4'deoxydoxorubicin (esorubicin) was performed on an every-21-day bolus intravenous (IV) schedule in 36 patients with advanced cancer. Thirty-four patients were evaluable for toxicity analysis. Toxicity included mild nausea, occasional local skin reactions, and mild to moderate alopecia. Myelo-suppression was dose limiting. Clinically evident congestive heart failure was not observed. However, two patients developed premature ventricular contractions. Overall, esorubicin was better tolerated than doxorubicin at equally potent doses. Although response analysis was not the primary objective of this phase I study, minor responses were observed in melanoma, breast cancer, lymphoma, and gastric cancer. On the basis of this study, a starting dose of 30 mg/m2 IV every 21 days is recommended for good-risk patients with escalation to 32.5 mg/m2 depending on bone marrow tolerance. For patients with poor bone marrow reserve, a starting dose of 25 mg/m2 every 21 days is recommended. Phase II trials with esorubicin in this dosage schedule are clearly warranted in a wide variety of metastatic neoplasms including a substantial population of patients who have not received prior chemotherapy.

Original languageEnglish (US)
Pages (from-to)1034-1039
Number of pages6
JournalJournal of Clinical Oncology
Volume2
Issue number9
StatePublished - 1984
Externally publishedYes

Fingerprint

Stomach Neoplasms
Appointments and Schedules
Bone Marrow
Ventricular Premature Complexes
Alopecia
Doxorubicin
Nausea
esorubicin
Melanoma
Lymphoma
Neoplasms
Heart Failure
Breast Neoplasms
Drug Therapy
Skin
Population

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Garewal, H. S., Robertone, A., Salmon, S. E., Jones, S. E., Alberts, D. S., & Brooks, R. (1984). Phase I trial of esorubicin (4'deoxydoxorubicin). Journal of Clinical Oncology, 2(9), 1034-1039.

Phase I trial of esorubicin (4'deoxydoxorubicin). / Garewal, H. S.; Robertone, A.; Salmon, S. E.; Jones, S. E.; Alberts, David S; Brooks, R.

In: Journal of Clinical Oncology, Vol. 2, No. 9, 1984, p. 1034-1039.

Research output: Contribution to journalArticle

Garewal, HS, Robertone, A, Salmon, SE, Jones, SE, Alberts, DS & Brooks, R 1984, 'Phase I trial of esorubicin (4'deoxydoxorubicin)', Journal of Clinical Oncology, vol. 2, no. 9, pp. 1034-1039.
Garewal HS, Robertone A, Salmon SE, Jones SE, Alberts DS, Brooks R. Phase I trial of esorubicin (4'deoxydoxorubicin). Journal of Clinical Oncology. 1984;2(9):1034-1039.
Garewal, H. S. ; Robertone, A. ; Salmon, S. E. ; Jones, S. E. ; Alberts, David S ; Brooks, R. / Phase I trial of esorubicin (4'deoxydoxorubicin). In: Journal of Clinical Oncology. 1984 ; Vol. 2, No. 9. pp. 1034-1039.
@article{218c3899cd8f48e8a5e2e784209c5af6,
title = "Phase I trial of esorubicin (4'deoxydoxorubicin)",
abstract = "A phase I study of 4'deoxydoxorubicin (esorubicin) was performed on an every-21-day bolus intravenous (IV) schedule in 36 patients with advanced cancer. Thirty-four patients were evaluable for toxicity analysis. Toxicity included mild nausea, occasional local skin reactions, and mild to moderate alopecia. Myelo-suppression was dose limiting. Clinically evident congestive heart failure was not observed. However, two patients developed premature ventricular contractions. Overall, esorubicin was better tolerated than doxorubicin at equally potent doses. Although response analysis was not the primary objective of this phase I study, minor responses were observed in melanoma, breast cancer, lymphoma, and gastric cancer. On the basis of this study, a starting dose of 30 mg/m2 IV every 21 days is recommended for good-risk patients with escalation to 32.5 mg/m2 depending on bone marrow tolerance. For patients with poor bone marrow reserve, a starting dose of 25 mg/m2 every 21 days is recommended. Phase II trials with esorubicin in this dosage schedule are clearly warranted in a wide variety of metastatic neoplasms including a substantial population of patients who have not received prior chemotherapy.",
author = "Garewal, {H. S.} and A. Robertone and Salmon, {S. E.} and Jones, {S. E.} and Alberts, {David S} and R. Brooks",
year = "1984",
language = "English (US)",
volume = "2",
pages = "1034--1039",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "9",

}

TY - JOUR

T1 - Phase I trial of esorubicin (4'deoxydoxorubicin)

AU - Garewal, H. S.

AU - Robertone, A.

AU - Salmon, S. E.

AU - Jones, S. E.

AU - Alberts, David S

AU - Brooks, R.

PY - 1984

Y1 - 1984

N2 - A phase I study of 4'deoxydoxorubicin (esorubicin) was performed on an every-21-day bolus intravenous (IV) schedule in 36 patients with advanced cancer. Thirty-four patients were evaluable for toxicity analysis. Toxicity included mild nausea, occasional local skin reactions, and mild to moderate alopecia. Myelo-suppression was dose limiting. Clinically evident congestive heart failure was not observed. However, two patients developed premature ventricular contractions. Overall, esorubicin was better tolerated than doxorubicin at equally potent doses. Although response analysis was not the primary objective of this phase I study, minor responses were observed in melanoma, breast cancer, lymphoma, and gastric cancer. On the basis of this study, a starting dose of 30 mg/m2 IV every 21 days is recommended for good-risk patients with escalation to 32.5 mg/m2 depending on bone marrow tolerance. For patients with poor bone marrow reserve, a starting dose of 25 mg/m2 every 21 days is recommended. Phase II trials with esorubicin in this dosage schedule are clearly warranted in a wide variety of metastatic neoplasms including a substantial population of patients who have not received prior chemotherapy.

AB - A phase I study of 4'deoxydoxorubicin (esorubicin) was performed on an every-21-day bolus intravenous (IV) schedule in 36 patients with advanced cancer. Thirty-four patients were evaluable for toxicity analysis. Toxicity included mild nausea, occasional local skin reactions, and mild to moderate alopecia. Myelo-suppression was dose limiting. Clinically evident congestive heart failure was not observed. However, two patients developed premature ventricular contractions. Overall, esorubicin was better tolerated than doxorubicin at equally potent doses. Although response analysis was not the primary objective of this phase I study, minor responses were observed in melanoma, breast cancer, lymphoma, and gastric cancer. On the basis of this study, a starting dose of 30 mg/m2 IV every 21 days is recommended for good-risk patients with escalation to 32.5 mg/m2 depending on bone marrow tolerance. For patients with poor bone marrow reserve, a starting dose of 25 mg/m2 every 21 days is recommended. Phase II trials with esorubicin in this dosage schedule are clearly warranted in a wide variety of metastatic neoplasms including a substantial population of patients who have not received prior chemotherapy.

UR - http://www.scopus.com/inward/record.url?scp=0021187006&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0021187006&partnerID=8YFLogxK

M3 - Article

C2 - 6470753

AN - SCOPUS:0021187006

VL - 2

SP - 1034

EP - 1039

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 9

ER -