Intraperitoneal mitoxantrone or floxuridine

Effects on time-to-failure and survival in patients with minimal residual ovarian cancer after second-look laparotomy - A randomized phase II study by the southwest oncology group

Franco M. Muggia, P. Y. Liu, David S Alberts, Darryl L. Wallace, Robert V. O'Toole, Keith Y. Terada, Ernest W. Franklin, Grant W. Herrer, David A. Goldberg, Edward V. Hannigan

Research output: Contribution to journalArticle

50 Citations (Scopus)

Abstract

A randomized phase II study of intraperitoneal (ip) mitoxantrone or floxuridine (FUDR) was performed for the treatment of minimal residual epithelial ovarian cancer found at second-look laparotomy after initial platinum-based chemotherapy. Entry was to take place within 30 days of reassessment laparotomies, with documentation of peritoneal metastases either microscopic or gross with cytoreduction to less than or equal to 1 cm in largest diameter. Patients were stratified by the site of the largest disease present (microscopic to 0.5 cm maximum diameter versus greater than 0.5 to 1 cm maximum diameter), by time of registration (<14 days versus up to 30), and by serum CA-125 (≤35 versus >35 units/ml) prior to randomization to either ip mitoxantrone 10 mg/ m2 every 2 weeks × 9 or ip floxuridine (FUDR) 3 g (total dose)/ day × 3 days every 3 weeks × 6 cycles. Implantable ip systems and 1.5-2 liters of normal saline were used to deliver the drugs of 83 patients registered between December 1988 and January 1994; there were 6 pathology exclusions and 9 surgical exclusions, and 1 nonevaluable patient for a total of 39 evaluable on mitoxantrone and 28 on FUDR being evaluable. FUDR is the choice for further study because of a progression-free survival exceeding 15% at 1 year over mitoxantrone and a median overall survival of 38 months. It should be emphasized again that the goal of a randomized phase II selection design is to select a winner for phase III testing should there be a substantial difference between the treatments with respect to the primary endpoint. Comparative conclusions between the treatment arms should not be attempted due to the inherently much smaller sample sizes. This should reemphasize the limitations in a comparison of efficacy; however, the toxicologic differences still emerge quite clearly,

Original languageEnglish (US)
Pages (from-to)395-402
Number of pages8
JournalGynecologic Oncology
Volume61
Issue number3
DOIs
StatePublished - Jun 1996

Fingerprint

Floxuridine
Mitoxantrone
Residual Neoplasm
Ovarian Neoplasms
Laparotomy
Survival
Random Allocation
Platinum
Documentation
Sample Size
Disease-Free Survival
Therapeutics
Pathology
Neoplasm Metastasis
Drug Therapy
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Intraperitoneal mitoxantrone or floxuridine : Effects on time-to-failure and survival in patients with minimal residual ovarian cancer after second-look laparotomy - A randomized phase II study by the southwest oncology group. / Muggia, Franco M.; Liu, P. Y.; Alberts, David S; Wallace, Darryl L.; O'Toole, Robert V.; Terada, Keith Y.; Franklin, Ernest W.; Herrer, Grant W.; Goldberg, David A.; Hannigan, Edward V.

In: Gynecologic Oncology, Vol. 61, No. 3, 06.1996, p. 395-402.

Research output: Contribution to journalArticle

Muggia, Franco M. ; Liu, P. Y. ; Alberts, David S ; Wallace, Darryl L. ; O'Toole, Robert V. ; Terada, Keith Y. ; Franklin, Ernest W. ; Herrer, Grant W. ; Goldberg, David A. ; Hannigan, Edward V. / Intraperitoneal mitoxantrone or floxuridine : Effects on time-to-failure and survival in patients with minimal residual ovarian cancer after second-look laparotomy - A randomized phase II study by the southwest oncology group. In: Gynecologic Oncology. 1996 ; Vol. 61, No. 3. pp. 395-402.
@article{c7b04bc15c4641cabe1c9e98152e449d,
title = "Intraperitoneal mitoxantrone or floxuridine: Effects on time-to-failure and survival in patients with minimal residual ovarian cancer after second-look laparotomy - A randomized phase II study by the southwest oncology group",
abstract = "A randomized phase II study of intraperitoneal (ip) mitoxantrone or floxuridine (FUDR) was performed for the treatment of minimal residual epithelial ovarian cancer found at second-look laparotomy after initial platinum-based chemotherapy. Entry was to take place within 30 days of reassessment laparotomies, with documentation of peritoneal metastases either microscopic or gross with cytoreduction to less than or equal to 1 cm in largest diameter. Patients were stratified by the site of the largest disease present (microscopic to 0.5 cm maximum diameter versus greater than 0.5 to 1 cm maximum diameter), by time of registration (<14 days versus up to 30), and by serum CA-125 (≤35 versus >35 units/ml) prior to randomization to either ip mitoxantrone 10 mg/ m2 every 2 weeks × 9 or ip floxuridine (FUDR) 3 g (total dose)/ day × 3 days every 3 weeks × 6 cycles. Implantable ip systems and 1.5-2 liters of normal saline were used to deliver the drugs of 83 patients registered between December 1988 and January 1994; there were 6 pathology exclusions and 9 surgical exclusions, and 1 nonevaluable patient for a total of 39 evaluable on mitoxantrone and 28 on FUDR being evaluable. FUDR is the choice for further study because of a progression-free survival exceeding 15{\%} at 1 year over mitoxantrone and a median overall survival of 38 months. It should be emphasized again that the goal of a randomized phase II selection design is to select a winner for phase III testing should there be a substantial difference between the treatments with respect to the primary endpoint. Comparative conclusions between the treatment arms should not be attempted due to the inherently much smaller sample sizes. This should reemphasize the limitations in a comparison of efficacy; however, the toxicologic differences still emerge quite clearly,",
author = "Muggia, {Franco M.} and Liu, {P. Y.} and Alberts, {David S} and Wallace, {Darryl L.} and O'Toole, {Robert V.} and Terada, {Keith Y.} and Franklin, {Ernest W.} and Herrer, {Grant W.} and Goldberg, {David A.} and Hannigan, {Edward V.}",
year = "1996",
month = "6",
doi = "10.1006/gyno.1996.0163",
language = "English (US)",
volume = "61",
pages = "395--402",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "3",

}

TY - JOUR

T1 - Intraperitoneal mitoxantrone or floxuridine

T2 - Effects on time-to-failure and survival in patients with minimal residual ovarian cancer after second-look laparotomy - A randomized phase II study by the southwest oncology group

AU - Muggia, Franco M.

AU - Liu, P. Y.

AU - Alberts, David S

AU - Wallace, Darryl L.

AU - O'Toole, Robert V.

AU - Terada, Keith Y.

AU - Franklin, Ernest W.

AU - Herrer, Grant W.

AU - Goldberg, David A.

AU - Hannigan, Edward V.

PY - 1996/6

Y1 - 1996/6

N2 - A randomized phase II study of intraperitoneal (ip) mitoxantrone or floxuridine (FUDR) was performed for the treatment of minimal residual epithelial ovarian cancer found at second-look laparotomy after initial platinum-based chemotherapy. Entry was to take place within 30 days of reassessment laparotomies, with documentation of peritoneal metastases either microscopic or gross with cytoreduction to less than or equal to 1 cm in largest diameter. Patients were stratified by the site of the largest disease present (microscopic to 0.5 cm maximum diameter versus greater than 0.5 to 1 cm maximum diameter), by time of registration (<14 days versus up to 30), and by serum CA-125 (≤35 versus >35 units/ml) prior to randomization to either ip mitoxantrone 10 mg/ m2 every 2 weeks × 9 or ip floxuridine (FUDR) 3 g (total dose)/ day × 3 days every 3 weeks × 6 cycles. Implantable ip systems and 1.5-2 liters of normal saline were used to deliver the drugs of 83 patients registered between December 1988 and January 1994; there were 6 pathology exclusions and 9 surgical exclusions, and 1 nonevaluable patient for a total of 39 evaluable on mitoxantrone and 28 on FUDR being evaluable. FUDR is the choice for further study because of a progression-free survival exceeding 15% at 1 year over mitoxantrone and a median overall survival of 38 months. It should be emphasized again that the goal of a randomized phase II selection design is to select a winner for phase III testing should there be a substantial difference between the treatments with respect to the primary endpoint. Comparative conclusions between the treatment arms should not be attempted due to the inherently much smaller sample sizes. This should reemphasize the limitations in a comparison of efficacy; however, the toxicologic differences still emerge quite clearly,

AB - A randomized phase II study of intraperitoneal (ip) mitoxantrone or floxuridine (FUDR) was performed for the treatment of minimal residual epithelial ovarian cancer found at second-look laparotomy after initial platinum-based chemotherapy. Entry was to take place within 30 days of reassessment laparotomies, with documentation of peritoneal metastases either microscopic or gross with cytoreduction to less than or equal to 1 cm in largest diameter. Patients were stratified by the site of the largest disease present (microscopic to 0.5 cm maximum diameter versus greater than 0.5 to 1 cm maximum diameter), by time of registration (<14 days versus up to 30), and by serum CA-125 (≤35 versus >35 units/ml) prior to randomization to either ip mitoxantrone 10 mg/ m2 every 2 weeks × 9 or ip floxuridine (FUDR) 3 g (total dose)/ day × 3 days every 3 weeks × 6 cycles. Implantable ip systems and 1.5-2 liters of normal saline were used to deliver the drugs of 83 patients registered between December 1988 and January 1994; there were 6 pathology exclusions and 9 surgical exclusions, and 1 nonevaluable patient for a total of 39 evaluable on mitoxantrone and 28 on FUDR being evaluable. FUDR is the choice for further study because of a progression-free survival exceeding 15% at 1 year over mitoxantrone and a median overall survival of 38 months. It should be emphasized again that the goal of a randomized phase II selection design is to select a winner for phase III testing should there be a substantial difference between the treatments with respect to the primary endpoint. Comparative conclusions between the treatment arms should not be attempted due to the inherently much smaller sample sizes. This should reemphasize the limitations in a comparison of efficacy; however, the toxicologic differences still emerge quite clearly,

UR - http://www.scopus.com/inward/record.url?scp=9344260298&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=9344260298&partnerID=8YFLogxK

U2 - 10.1006/gyno.1996.0163

DO - 10.1006/gyno.1996.0163

M3 - Article

VL - 61

SP - 395

EP - 402

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

IS - 3

ER -