Pemetrexed and cisplatin for the treatment of advanced, persistent, or recurrent carcinoma of the cervix

A limited access phase II trial of the Gynecologic Oncology Group

David Scott Miller, John A. Blessing, Lois M. Ramondetta, Huyen Q. Pham, Krishnansu S. Tewari, Lisa M. Landrum, Jubilee Brown, Robert S. Mannel

Research output: Contribution to journalArticle

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Abstract

Purpose: To estimate the antitumor activity of pemetrexed and cisplatin with objective tumor response (partial and complete) in patients with advanced, persistent, or recurrent carcinoma of the cervix and to determine the nature and degree of toxicity of this regimen. Secondarily, this study will determine the effects of this regimen on progression-free survival and overall survival. Patients and Methods: Eligible, consenting patients received pemetrexed 500 mg/m2 and cisplatin 50 mg/m2 intravenously repeated every 21 days until disease progression or adverse events prohibited further therapy. Patients received no prior therapeutic chemotherapy, except when administered concurrently with primary radiation therapy. Subsequent doses were adjusted according to observed toxicity and protocol guidelines. Adverse events were assessed with Common Terminology Criteria for Adverse Events v 3.0. The primary measure of efficacy was tumor response according to Response Evaluation Criteria in Solid Tumors. The study was stratified by prior radiation therapy. Results: From September 2008 to November 2011, 55 patients were enrolled by five Gynecologic Oncology Group member institutions; of those, 54 patients were eligible and assessable. The regimen was well tolerated with 26% receiving more than nine cycles. The most common greater than grade 2 toxicities were neutropenia 35%, leukopenia 28%, and metabolic 28%. The overall response rate was 31% (one complete and 16 partial). The median progression-free survival was 5.7 months, and overall survival was 12.3 months. Conclusion: Pemetrexed in combination with cisplatin demonstrates activity in the treatment of advanced, persistent, or recurrent carcinoma of the cervix.

Original languageEnglish (US)
Pages (from-to)2744-2749
Number of pages6
JournalJournal of Clinical Oncology
Volume32
Issue number25
DOIs
StatePublished - Sep 1 2014

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Pemetrexed
Cervix Uteri
Cisplatin
Carcinoma
Disease-Free Survival
Radiotherapy
Therapeutics
Survival
Leukopenia
Neutropenia
Terminology
Disease Progression
Neoplasms
Guidelines
Drug Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Pemetrexed and cisplatin for the treatment of advanced, persistent, or recurrent carcinoma of the cervix : A limited access phase II trial of the Gynecologic Oncology Group. / Miller, David Scott; Blessing, John A.; Ramondetta, Lois M.; Pham, Huyen Q.; Tewari, Krishnansu S.; Landrum, Lisa M.; Brown, Jubilee; Mannel, Robert S.

In: Journal of Clinical Oncology, Vol. 32, No. 25, 01.09.2014, p. 2744-2749.

Research output: Contribution to journalArticle

Miller, David Scott ; Blessing, John A. ; Ramondetta, Lois M. ; Pham, Huyen Q. ; Tewari, Krishnansu S. ; Landrum, Lisa M. ; Brown, Jubilee ; Mannel, Robert S. / Pemetrexed and cisplatin for the treatment of advanced, persistent, or recurrent carcinoma of the cervix : A limited access phase II trial of the Gynecologic Oncology Group. In: Journal of Clinical Oncology. 2014 ; Vol. 32, No. 25. pp. 2744-2749.
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abstract = "Purpose: To estimate the antitumor activity of pemetrexed and cisplatin with objective tumor response (partial and complete) in patients with advanced, persistent, or recurrent carcinoma of the cervix and to determine the nature and degree of toxicity of this regimen. Secondarily, this study will determine the effects of this regimen on progression-free survival and overall survival. Patients and Methods: Eligible, consenting patients received pemetrexed 500 mg/m2 and cisplatin 50 mg/m2 intravenously repeated every 21 days until disease progression or adverse events prohibited further therapy. Patients received no prior therapeutic chemotherapy, except when administered concurrently with primary radiation therapy. Subsequent doses were adjusted according to observed toxicity and protocol guidelines. Adverse events were assessed with Common Terminology Criteria for Adverse Events v 3.0. The primary measure of efficacy was tumor response according to Response Evaluation Criteria in Solid Tumors. The study was stratified by prior radiation therapy. Results: From September 2008 to November 2011, 55 patients were enrolled by five Gynecologic Oncology Group member institutions; of those, 54 patients were eligible and assessable. The regimen was well tolerated with 26{\%} receiving more than nine cycles. The most common greater than grade 2 toxicities were neutropenia 35{\%}, leukopenia 28{\%}, and metabolic 28{\%}. The overall response rate was 31{\%} (one complete and 16 partial). The median progression-free survival was 5.7 months, and overall survival was 12.3 months. Conclusion: Pemetrexed in combination with cisplatin demonstrates activity in the treatment of advanced, persistent, or recurrent carcinoma of the cervix.",
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