Format

Send to

Choose Destination
See comment in PubMed Commons below
J Clin Oncol. 2014 Feb 10;32(5):458-64. doi: 10.1200/JCO.2013.51.4265. Epub 2014 Jan 6.

Phase III randomized trial of weekly cisplatin and irradiation versus cisplatin and tirapazamine and irradiation in stages IB2, IIA, IIB, IIIB, and IVA cervical carcinoma limited to the pelvis: a Gynecologic Oncology Group study.

Author information

1
Paul A. DiSilvestro and Margaret M. Steinhoff, Women and Infants Hospital, Providence, RI; Shamshad Ali, Roswell Park Cancer Institute, Buffalo; Yi-Chun Lee, State University of New York Health Science Center, Brooklyn, NY; Peter S. Craighead, Tom Baker Cancer Center, Calgary, Alberta, Canada; Joseph A. Lucci, University of Miami School of Medicine, Miami, FL; David E. Cohn, Ohio State University, Columbus, OH; Nicola M. Spirtos, Women's Cancer Center of Nevada, Las Vegas, NV; Krishnasu S. Tewari, University of California Medical Center, Irvine, Orange, CA; Carolyn Muller, University of New Mexico Memorial Medical Center, Albuquerque, NM; Walter H. Gajewski, Zimmer Cancer Center, Wilmington, NC; and Bradley J. Monk, Creighton University School of Medicine, Phoenix, AZ.

Abstract

PURPOSE:

This prospective, randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine (TPZ) to standard cisplatin (CIS) chemoradiotherapy in locally advanced cervix cancer.

PATIENTS AND METHODS:

Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy. Primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS) and tolerability.

RESULTS:

PFS was evaluable in 387 of 402 patients randomly assigned over 36 months, with enrollment ending in September 2009. Because of the lack of TPZ supply, the study did not reach its original target accrual goal. At median follow-up of 28.3 months, PFS and OS were similar in both arms. Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P = .7869). Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5% and 70.6%, respectively (log-rank P = .8333). A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm, with resulting tolerance in both treatment arms.

CONCLUSION:

TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS, although definitive commentary was limited by an inadequate number of events (progression or death). TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00262821.

PMID:
24395863
PMCID:
PMC3912330
DOI:
10.1200/JCO.2013.51.4265
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Atypon Icon for PubMed Central
    Loading ...
    Support Center