Randomized phase III trial of chemoimmunotherapy in patients with previously untreated stages III and IV suboptimal disease ovarian cancer: A Southwest Oncology Group study

David S Alberts, Nancy Mason-Liddil, Robert V. O'Toole, Thomas M. Abbott, Richard Kronmal, Robert D. Hilgers, Earl A. Surwit, Harmon J. Eyre, Laurence H. Baker

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Abstract

Between 1979 and 1984, 185 fully evaluable patients with stage III or IV epithelial type ovarian cancer and suboptimal surgical resections were randomly assigned to treatment with doxorubicin + cyclophosphamide + BCG (DC + BCG) vs doxorubicin + cyclophosphamide + cisplatin (DCP) vs. doxorubicin + cyclophosphamide + cisplatin + BCG (DCP + BCG). Patients with measurable disease (119) were analyzed separately from those with nonmeasurable disease (66). In measurable disease patients the overall clinical complete plus partial response rates for DC + BCG, DCP, and DCP + BCG-treated patients were 36, 57, and 59%, respectively. Although there were no significant patient characteristic differences between the DCP and DCP + BCG treatment groups, the addition of cisplatin to the DC + BCG regimen resulted in significantly prolonged response (P < 0.03) and survival (P < 0.002) durations. To the contrary, the addition of BCG to the DCP regimen did not improve objective response rates or response or survival durations. For patients with non-measurable, suboptimal disease there were no significant differences between the three treatments with respect to response or survival parameters; however, patients in this disease category fared generally better than those with clinically measurable disease. We conclude that cisplatin adds significantly to the efficacy of DC + BCG, but BCG does not add to the efficacy of DCP in patients with measurable, stage III or IV disease.

Original languageEnglish (US)
Pages (from-to)8-15
Number of pages8
JournalGynecologic Oncology
Volume32
Issue number1
DOIs
StatePublished - 1989

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Ovarian Neoplasms
Doxorubicin
Cyclophosphamide
Mycobacterium bovis
Cisplatin
Survival
Therapeutics

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

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Randomized phase III trial of chemoimmunotherapy in patients with previously untreated stages III and IV suboptimal disease ovarian cancer : A Southwest Oncology Group study. / Alberts, David S; Mason-Liddil, Nancy; O'Toole, Robert V.; Abbott, Thomas M.; Kronmal, Richard; Hilgers, Robert D.; Surwit, Earl A.; Eyre, Harmon J.; Baker, Laurence H.

In: Gynecologic Oncology, Vol. 32, No. 1, 1989, p. 8-15.

Research output: Contribution to journalArticle

Alberts, David S ; Mason-Liddil, Nancy ; O'Toole, Robert V. ; Abbott, Thomas M. ; Kronmal, Richard ; Hilgers, Robert D. ; Surwit, Earl A. ; Eyre, Harmon J. ; Baker, Laurence H. / Randomized phase III trial of chemoimmunotherapy in patients with previously untreated stages III and IV suboptimal disease ovarian cancer : A Southwest Oncology Group study. In: Gynecologic Oncology. 1989 ; Vol. 32, No. 1. pp. 8-15.
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abstract = "Between 1979 and 1984, 185 fully evaluable patients with stage III or IV epithelial type ovarian cancer and suboptimal surgical resections were randomly assigned to treatment with doxorubicin + cyclophosphamide + BCG (DC + BCG) vs doxorubicin + cyclophosphamide + cisplatin (DCP) vs. doxorubicin + cyclophosphamide + cisplatin + BCG (DCP + BCG). Patients with measurable disease (119) were analyzed separately from those with nonmeasurable disease (66). In measurable disease patients the overall clinical complete plus partial response rates for DC + BCG, DCP, and DCP + BCG-treated patients were 36, 57, and 59{\%}, respectively. Although there were no significant patient characteristic differences between the DCP and DCP + BCG treatment groups, the addition of cisplatin to the DC + BCG regimen resulted in significantly prolonged response (P < 0.03) and survival (P < 0.002) durations. To the contrary, the addition of BCG to the DCP regimen did not improve objective response rates or response or survival durations. For patients with non-measurable, suboptimal disease there were no significant differences between the three treatments with respect to response or survival parameters; however, patients in this disease category fared generally better than those with clinically measurable disease. We conclude that cisplatin adds significantly to the efficacy of DC + BCG, but BCG does not add to the efficacy of DCP in patients with measurable, stage III or IV disease.",
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