Randomized trial of three cisplatin dose schedules in squamous-cell carcinoma of the cervix

A Gynecologic Oncology Group study

P. Bonomi, J. A. Blessing, Frederick Stehman, P. J. DiSaia, L. Walton, F. J. Major

Research output: Contribution to journalArticle

344 Citations (Scopus)

Abstract

The Gynecologic Oncology Group has conducted a randomized prospective trial comparing cisplatin 50 mg/m2 every 21 days (regimen 1), 100 mg/m2 every 21 days (regimen 2), and cisplatin 20 mg/m2 for five consecutive days repeated every 21 days (regimen 3). Four hundred ninety-seven evaluable patients have been accrued on this study. The response rates were 20.7%, 31.4%, and 25.0%, for regimens 1, 2, and 3, respectively; the complete remission rates were 10.0%, 12.7%, and 8.6% for regimens 1, 2, and 3, respectively. The median duration of response ranged from 3.9 to 4.8 months, the median progression-free interval from 3.7 to 4.6 months, and the median survival time from 6.1 to 7.1 months. The difference in response rates for regimens 1 and 2 is statistically significant (P = .015) but less than the magnitude originally considered clinically significant. The differences in complete remission rates, response duration, progression-free interval, and survival times are not statistically significant. The following types of toxicity were observed: serum creatinine level >2 mg/dL and/or BUN level >40 mg/dL was 7%, 14%, and 17% on regimens 1, 2, and 3, respectively; leukocyte count 2 single dose has produced a statistically significant higher response rate than the 50 mg/m2 regimen while producing no appreciable differences in complete remission rate, response duration, progression-free interval, or survival. In addition, the higher dose regimen was associated with greater myelosuppression and nephrotoxicity.

Original languageEnglish (US)
Pages (from-to)1079-1085
Number of pages7
JournalJournal of Clinical Oncology
Volume3
Issue number8
StatePublished - 1985
Externally publishedYes

Fingerprint

Cervix Uteri
Cisplatin
Squamous Cell Carcinoma
Appointments and Schedules
Survival
Blood Urea Nitrogen
Leukocyte Count
Disease-Free Survival
Creatinine
Serum

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Randomized trial of three cisplatin dose schedules in squamous-cell carcinoma of the cervix : A Gynecologic Oncology Group study. / Bonomi, P.; Blessing, J. A.; Stehman, Frederick; DiSaia, P. J.; Walton, L.; Major, F. J.

In: Journal of Clinical Oncology, Vol. 3, No. 8, 1985, p. 1079-1085.

Research output: Contribution to journalArticle

Bonomi, P. ; Blessing, J. A. ; Stehman, Frederick ; DiSaia, P. J. ; Walton, L. ; Major, F. J. / Randomized trial of three cisplatin dose schedules in squamous-cell carcinoma of the cervix : A Gynecologic Oncology Group study. In: Journal of Clinical Oncology. 1985 ; Vol. 3, No. 8. pp. 1079-1085.
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abstract = "The Gynecologic Oncology Group has conducted a randomized prospective trial comparing cisplatin 50 mg/m2 every 21 days (regimen 1), 100 mg/m2 every 21 days (regimen 2), and cisplatin 20 mg/m2 for five consecutive days repeated every 21 days (regimen 3). Four hundred ninety-seven evaluable patients have been accrued on this study. The response rates were 20.7{\%}, 31.4{\%}, and 25.0{\%}, for regimens 1, 2, and 3, respectively; the complete remission rates were 10.0{\%}, 12.7{\%}, and 8.6{\%} for regimens 1, 2, and 3, respectively. The median duration of response ranged from 3.9 to 4.8 months, the median progression-free interval from 3.7 to 4.6 months, and the median survival time from 6.1 to 7.1 months. The difference in response rates for regimens 1 and 2 is statistically significant (P = .015) but less than the magnitude originally considered clinically significant. The differences in complete remission rates, response duration, progression-free interval, and survival times are not statistically significant. The following types of toxicity were observed: serum creatinine level >2 mg/dL and/or BUN level >40 mg/dL was 7{\%}, 14{\%}, and 17{\%} on regimens 1, 2, and 3, respectively; leukocyte count 2 single dose has produced a statistically significant higher response rate than the 50 mg/m2 regimen while producing no appreciable differences in complete remission rate, response duration, progression-free interval, or survival. In addition, the higher dose regimen was associated with greater myelosuppression and nephrotoxicity.",
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