Chronic daily administration of oral etoposide - A phase I trial

J. D. Hainsworth, D. H. Johnson, S. R. Frazier, F. A. Greco

Research output: Contribution to journalArticle

157 Citations (Scopus)

Abstract

In this phase I study, we administered etoposide (VP-16) orally for 21 consecutive days to patients with advanced refractory cancers. All patients had received previous chemotherapy, and 50% of patients had received more than one combination regimen. When given for 21 consecutive days, the maximum-tolerated dose of oral VP-16 was 50 mg/m2/d. Myelosuppression was the dose-limiting toxicity, and occurred between days 21 and 28. In most patients, blood counts had recovered sufficiently by day 35 to begin another 3-week course. WBC count nadirs of < 1,000/μL occurred in four of 20 courses at this dose, and three patients required hospitalization for treatment of neutropenia and fever. Alopecia occurred in most patients; gastrointestinal (GI) and other toxicities were uncommon. Five of 16 patients with measurable tumor had partial responses of 3 to 4 months duration. Four of these five patients had malignancies that are usually unresponsive to VP-16 when administered by previously investigated schedules. This method of VP-16 administration is well tolerated, convenient, and may optimize antitumor efficacy by exploiting the schedule dependency of this drug. Phase II studies are necessary to define the level of activity of this schedule of VP-16.

Original languageEnglish (US)
Pages (from-to)396-401
Number of pages6
JournalJournal of Clinical Oncology
Volume7
Issue number3
StatePublished - 1989

Fingerprint

Etoposide
Oral Administration
Appointments and Schedules
Neoplasms
Maximum Tolerated Dose
Alopecia
Neutropenia
Hospitalization
Fever
Drug Therapy
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Hainsworth, J. D., Johnson, D. H., Frazier, S. R., & Greco, F. A. (1989). Chronic daily administration of oral etoposide - A phase I trial. Journal of Clinical Oncology, 7(3), 396-401.

Chronic daily administration of oral etoposide - A phase I trial. / Hainsworth, J. D.; Johnson, D. H.; Frazier, S. R.; Greco, F. A.

In: Journal of Clinical Oncology, Vol. 7, No. 3, 1989, p. 396-401.

Research output: Contribution to journalArticle

Hainsworth, JD, Johnson, DH, Frazier, SR & Greco, FA 1989, 'Chronic daily administration of oral etoposide - A phase I trial', Journal of Clinical Oncology, vol. 7, no. 3, pp. 396-401.
Hainsworth, J. D. ; Johnson, D. H. ; Frazier, S. R. ; Greco, F. A. / Chronic daily administration of oral etoposide - A phase I trial. In: Journal of Clinical Oncology. 1989 ; Vol. 7, No. 3. pp. 396-401.
@article{230b7b4e8f1f49759004cc26140fc878,
title = "Chronic daily administration of oral etoposide - A phase I trial",
abstract = "In this phase I study, we administered etoposide (VP-16) orally for 21 consecutive days to patients with advanced refractory cancers. All patients had received previous chemotherapy, and 50{\%} of patients had received more than one combination regimen. When given for 21 consecutive days, the maximum-tolerated dose of oral VP-16 was 50 mg/m2/d. Myelosuppression was the dose-limiting toxicity, and occurred between days 21 and 28. In most patients, blood counts had recovered sufficiently by day 35 to begin another 3-week course. WBC count nadirs of < 1,000/μL occurred in four of 20 courses at this dose, and three patients required hospitalization for treatment of neutropenia and fever. Alopecia occurred in most patients; gastrointestinal (GI) and other toxicities were uncommon. Five of 16 patients with measurable tumor had partial responses of 3 to 4 months duration. Four of these five patients had malignancies that are usually unresponsive to VP-16 when administered by previously investigated schedules. This method of VP-16 administration is well tolerated, convenient, and may optimize antitumor efficacy by exploiting the schedule dependency of this drug. Phase II studies are necessary to define the level of activity of this schedule of VP-16.",
author = "Hainsworth, {J. D.} and Johnson, {D. H.} and Frazier, {S. R.} and Greco, {F. A.}",
year = "1989",
language = "English (US)",
volume = "7",
pages = "396--401",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "3",

}

TY - JOUR

T1 - Chronic daily administration of oral etoposide - A phase I trial

AU - Hainsworth, J. D.

AU - Johnson, D. H.

AU - Frazier, S. R.

AU - Greco, F. A.

PY - 1989

Y1 - 1989

N2 - In this phase I study, we administered etoposide (VP-16) orally for 21 consecutive days to patients with advanced refractory cancers. All patients had received previous chemotherapy, and 50% of patients had received more than one combination regimen. When given for 21 consecutive days, the maximum-tolerated dose of oral VP-16 was 50 mg/m2/d. Myelosuppression was the dose-limiting toxicity, and occurred between days 21 and 28. In most patients, blood counts had recovered sufficiently by day 35 to begin another 3-week course. WBC count nadirs of < 1,000/μL occurred in four of 20 courses at this dose, and three patients required hospitalization for treatment of neutropenia and fever. Alopecia occurred in most patients; gastrointestinal (GI) and other toxicities were uncommon. Five of 16 patients with measurable tumor had partial responses of 3 to 4 months duration. Four of these five patients had malignancies that are usually unresponsive to VP-16 when administered by previously investigated schedules. This method of VP-16 administration is well tolerated, convenient, and may optimize antitumor efficacy by exploiting the schedule dependency of this drug. Phase II studies are necessary to define the level of activity of this schedule of VP-16.

AB - In this phase I study, we administered etoposide (VP-16) orally for 21 consecutive days to patients with advanced refractory cancers. All patients had received previous chemotherapy, and 50% of patients had received more than one combination regimen. When given for 21 consecutive days, the maximum-tolerated dose of oral VP-16 was 50 mg/m2/d. Myelosuppression was the dose-limiting toxicity, and occurred between days 21 and 28. In most patients, blood counts had recovered sufficiently by day 35 to begin another 3-week course. WBC count nadirs of < 1,000/μL occurred in four of 20 courses at this dose, and three patients required hospitalization for treatment of neutropenia and fever. Alopecia occurred in most patients; gastrointestinal (GI) and other toxicities were uncommon. Five of 16 patients with measurable tumor had partial responses of 3 to 4 months duration. Four of these five patients had malignancies that are usually unresponsive to VP-16 when administered by previously investigated schedules. This method of VP-16 administration is well tolerated, convenient, and may optimize antitumor efficacy by exploiting the schedule dependency of this drug. Phase II studies are necessary to define the level of activity of this schedule of VP-16.

UR - http://www.scopus.com/inward/record.url?scp=0024505316&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0024505316&partnerID=8YFLogxK

M3 - Article

C2 - 2918334

AN - SCOPUS:0024505316

VL - 7

SP - 396

EP - 401

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 3

ER -