Tirapazamine plus cisplatin in advanced or recurrent carcinoma of the uterine cervix

A Southwest Oncology Group study

H. O. Smith, C. S. Jiang, G. R. Weiss, A. V. Hallum, P. Y. Liu, W. R. Robinson, P. C. Cheng, Sidney A Scudder, M. Markman, D. S. Alberts

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

The objective of this study was to determine objective response and overall survival (OS) and progression-free survival (PFS) following cisplatin plus tirapazamine treatment in eligible consenting patients with metastatic or recurrent squamous or adenosquamous carcinoma of the cervix. Treatment consisted of intravenous tirapazamine, 260 mg/m2, followed by cisplatin, 75 mg/m2, every 21 days for six cycles. Of 56 registered cases, 52 were evaluable for toxicity. There were six grade 4 toxicities (anemia [three], dyspnea [one], neutropenia/granulocytopenia [one], and dehydration [one]). Fifty-three patients were evaluable for response, OS, and PFS. The 6-month OS rate was 56.6% (95% CI 43.3-69.9%). The objective response rate was 32.1% (4 complete [2 confirmed and 2 unconfirmed] and 13 partial [8 confirmed and 5 unconfirmed]). Higher response rates (16/34 [47.1%] vs 1/19 [5.3%], P= 0.0018) were observed in patients who had not previously received radiation-sensitizing chemotherapy, as were OS and PFS (13.9 vs 4.0 months, P < 0.0001; 5.3 vs 1.8 months, P= 0.01). The OS was considered too low to warrant further testing in this disease setting. Despite this, tirapazamine plus cisplatin was active in patients who had not received cisplatin previously. Prior use of radiosensitizing chemotherapy impacted response and survival significantly and should be considered in future clinical trials.

Original languageEnglish (US)
Pages (from-to)298-305
Number of pages8
JournalInternational Journal of Gynecological Cancer
Volume16
Issue number1
DOIs
StatePublished - Jan 2006

Fingerprint

tirapazamine
Cervix Uteri
Cisplatin
Carcinoma
Survival
Disease-Free Survival
Adenosquamous Carcinoma
Drug Therapy
Agranulocytosis
Neutropenia
Dehydration
Dyspnea
Anemia
Squamous Cell Carcinoma
Survival Rate
Clinical Trials
Radiation

Keywords

  • Cervical carcinoma
  • Chemotherapy
  • Cisplatin
  • Tirapazamine

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology
  • Cancer Research

Cite this

Tirapazamine plus cisplatin in advanced or recurrent carcinoma of the uterine cervix : A Southwest Oncology Group study. / Smith, H. O.; Jiang, C. S.; Weiss, G. R.; Hallum, A. V.; Liu, P. Y.; Robinson, W. R.; Cheng, P. C.; Scudder, Sidney A; Markman, M.; Alberts, D. S.

In: International Journal of Gynecological Cancer, Vol. 16, No. 1, 01.2006, p. 298-305.

Research output: Contribution to journalArticle

Smith, H. O. ; Jiang, C. S. ; Weiss, G. R. ; Hallum, A. V. ; Liu, P. Y. ; Robinson, W. R. ; Cheng, P. C. ; Scudder, Sidney A ; Markman, M. ; Alberts, D. S. / Tirapazamine plus cisplatin in advanced or recurrent carcinoma of the uterine cervix : A Southwest Oncology Group study. In: International Journal of Gynecological Cancer. 2006 ; Vol. 16, No. 1. pp. 298-305.
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abstract = "The objective of this study was to determine objective response and overall survival (OS) and progression-free survival (PFS) following cisplatin plus tirapazamine treatment in eligible consenting patients with metastatic or recurrent squamous or adenosquamous carcinoma of the cervix. Treatment consisted of intravenous tirapazamine, 260 mg/m2, followed by cisplatin, 75 mg/m2, every 21 days for six cycles. Of 56 registered cases, 52 were evaluable for toxicity. There were six grade 4 toxicities (anemia [three], dyspnea [one], neutropenia/granulocytopenia [one], and dehydration [one]). Fifty-three patients were evaluable for response, OS, and PFS. The 6-month OS rate was 56.6{\%} (95{\%} CI 43.3-69.9{\%}). The objective response rate was 32.1{\%} (4 complete [2 confirmed and 2 unconfirmed] and 13 partial [8 confirmed and 5 unconfirmed]). Higher response rates (16/34 [47.1{\%}] vs 1/19 [5.3{\%}], P= 0.0018) were observed in patients who had not previously received radiation-sensitizing chemotherapy, as were OS and PFS (13.9 vs 4.0 months, P < 0.0001; 5.3 vs 1.8 months, P= 0.01). The OS was considered too low to warrant further testing in this disease setting. Despite this, tirapazamine plus cisplatin was active in patients who had not received cisplatin previously. Prior use of radiosensitizing chemotherapy impacted response and survival significantly and should be considered in future clinical trials.",
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AU - Hallum, A. V.

AU - Liu, P. Y.

AU - Robinson, W. R.

AU - Cheng, P. C.

AU - Scudder, Sidney A

AU - Markman, M.

AU - Alberts, D. S.

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AB - The objective of this study was to determine objective response and overall survival (OS) and progression-free survival (PFS) following cisplatin plus tirapazamine treatment in eligible consenting patients with metastatic or recurrent squamous or adenosquamous carcinoma of the cervix. Treatment consisted of intravenous tirapazamine, 260 mg/m2, followed by cisplatin, 75 mg/m2, every 21 days for six cycles. Of 56 registered cases, 52 were evaluable for toxicity. There were six grade 4 toxicities (anemia [three], dyspnea [one], neutropenia/granulocytopenia [one], and dehydration [one]). Fifty-three patients were evaluable for response, OS, and PFS. The 6-month OS rate was 56.6% (95% CI 43.3-69.9%). The objective response rate was 32.1% (4 complete [2 confirmed and 2 unconfirmed] and 13 partial [8 confirmed and 5 unconfirmed]). Higher response rates (16/34 [47.1%] vs 1/19 [5.3%], P= 0.0018) were observed in patients who had not previously received radiation-sensitizing chemotherapy, as were OS and PFS (13.9 vs 4.0 months, P < 0.0001; 5.3 vs 1.8 months, P= 0.01). The OS was considered too low to warrant further testing in this disease setting. Despite this, tirapazamine plus cisplatin was active in patients who had not received cisplatin previously. Prior use of radiosensitizing chemotherapy impacted response and survival significantly and should be considered in future clinical trials.

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