Randomized study of chemoimmunotherapy for advanced ovarian carcinoma: A preliminary report of a Southwest Oncology Group study

D. S. Alberts, T. E. Moon, R. A. Stephens, H. Wilson, N. Oishi, R. D. Hilgers, R. O'Toole, J. T. Thigpen

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28 Scopus citations

Abstract

The authors have studied the effect of adding bacillus Calmette-Guerin (BCG) to adriamycin-cyclophosphamide (A-C) for the treatment of stage III and IV or recurrent epithelial type ovarian carcinoma. One hundred and fifty-four patients with no prior chemotherapy and measurable disease have been randomly assigned to receive A-C or A-C + BCG. Adriamycin at a dose of 40 mg/m 2 on Day 1 and cyclophosphamide at a dose of 200 mg/m 2/day on Days 3-6 were given every 3-4 weeks to a total adriamycin dose of 500 mg/m 2. BCG was administered by scarification to alternating upper and lower extremity sites on Days 8 and 15. There was a similar distribution between the two study arms of patients with stage IV disease with respect to bulky tumors, types of surgical procedures, performance status, and prior radiation therapy exposure. Although a panel of Southwest Oncology Group pathologists have thus far reviewed histologic sections from only 41% of registered patients, there appears to be an even distribution between the A-C and A-C + BCG groups with respect to histologic tumor types and grades. All of the 24 patients who received A-C + BCG were found to have high-grade tumors. The complete response (CR) (i.e., pathologically proven) plus partial response (PR) (i.e., clinical CRs plus PRs) rate of 53% for A-C + BCG patients is significantly different (P = 0.05) from the CR plus PR rate of 36% observed in the A-C group. Seven (12%) of the evaluable A-C + BCG patients and only one (2%) A-C patient have had pathologically proven CRs on the basis of negative 'second-look' exploratory laparotomies. Thirty-three (54%) of 61 patients in the A-C group have died compared to only 22 (39%) of the A-C + BCG group. The median survival duration of the A-C + BCG patients (23.5 months) was statistically better than that of patients receiving only A-C (13.1 months) (P< 0.004). Therapy was well-tolerated. There were no drug-related deaths and no serious systemic BCG toxicity. Thus, the addition of BCG to the standard A-C treatment for far-advanced ovarian carcinoma appears to have increased response rates and increased overall survival duration without markedly adding to drug toxicity.

Original languageEnglish (US)
Pages (from-to)325-331
Number of pages7
JournalCancer Treatment Reports
Volume63
Issue number2
StatePublished - 1979

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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