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

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

Research output: Contribution to journalArticle

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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

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Doxorubicin
Cyclophosphamide
Mycobacterium bovis
Carcinoma
Neoplasms
Survival
Drug-Related Side Effects and Adverse Reactions
Laparotomy
Lower Extremity
Arm

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Alberts, D. S., Moon, T. E., Stephens, R. A., Wilson, H., Oishi, N., Hilgers, R. D., ... Thigpen, J. T. (1979). Randomized study of chemoimmunotherapy for advanced ovarian carcinoma: A preliminary report of a Southwest Oncology Group study. Cancer Treatment Reports, 63(2), 325-331.

Randomized study of chemoimmunotherapy for advanced ovarian carcinoma : A preliminary report of a Southwest Oncology Group study. / Alberts, David S; Moon, T. E.; Stephens, R. A.; Wilson, H.; Oishi, N.; Hilgers, R. D.; O'Toole, R.; Thigpen, J. T.

In: Cancer Treatment Reports, Vol. 63, No. 2, 1979, p. 325-331.

Research output: Contribution to journalArticle

Alberts, DS, Moon, TE, Stephens, RA, Wilson, H, Oishi, N, Hilgers, RD, O'Toole, R & Thigpen, JT 1979, 'Randomized study of chemoimmunotherapy for advanced ovarian carcinoma: A preliminary report of a Southwest Oncology Group study', Cancer Treatment Reports, vol. 63, no. 2, pp. 325-331.
Alberts, David S ; Moon, T. E. ; Stephens, R. A. ; Wilson, H. ; Oishi, N. ; Hilgers, R. D. ; O'Toole, R. ; Thigpen, J. T. / Randomized study of chemoimmunotherapy for advanced ovarian carcinoma : A preliminary report of a Southwest Oncology Group study. In: Cancer Treatment Reports. 1979 ; Vol. 63, No. 2. pp. 325-331.
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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.",
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N2 - 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.

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