TY - JOUR
T1 - Evaluation of vinorelbine in persistent or recurrent nonsquamous carcinoma of the cervix
T2 - A Gynecologic Oncology Group Study
AU - Muggia, Franco M.
AU - Blessing, John A.
AU - Waggoner, Steven
AU - Berek, Jonathan S.
AU - Monk, Bradley J.
AU - Sorosky, Joel
AU - Pearl, Michael L.
N1 - Funding Information:
This study was supported by National Cancer Institute grants of the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical Office (CA 37517). The following Gynecologic Oncology Group institutions participated in this study: University of Mississippi Medical Center, University of California Medical Center at Los Angeles, Hospital of the University of Pennsylvania, The Milton S. Hershey School of Medicine of the Pennsylvania State University, University of Cincinnati College of Medicine, University of Iowa Hospitals and Clinics, Indiana University Medical Center, Wake Forest University School of Medicine, The Albany Medical College of Union University, University of California, Irvine Medical Center, Tufts New England Medical Center, Clinical Cancer Outreach Program, The Johns Hopkins Oncology Center, State University of New York at Stony Brook, Fox Chase Cancer Center, University of Chicago, Case Western Reserve University, Tampa Bay Cancer Consortium, and Ellis Fischel Cancer Center.
PY - 2005/1
Y1 - 2005/1
N2 - The Gynecologic Oncology Group (GOG) has studied a number of drugs to determine their activity in patients with previously treated squamous and nonsquamous cancer arising in the uterine cervix. A Phase II study with intravenous vinorelbine was initiated for this purpose in patients with Stage IVB, recurrent, or persistent nonsquamous carcinomas who had received one prior chemotherapy or were not eligible for other studies. Eligible patients had to have measurable disease, GOG performance status of 0-2 and adequate bone marrow, liver, and renal function. The treatment consisted of vinorelbine 30 mg/m 2 on days 1 and 8, repeated every 21 days. Tumor measurements and toxicities were recorded every treatment cycle. Thirty patients were enrolled with 28 patients deemed eligible and evaluable. Only two confirmed partial responses (7.1%) were noted. Neutropenia was the most common toxicity with 9 of 28 (32%) experiencing either grade 3 or 4 changes. Anemia was severe in seven. Neuropathy was more than mild in three patients. Severe events, such as fatigue, hypertension, or pulmonary changes attributed to drug administration, occurred only in one or two instances. With the dose schedule and assessment criteria employed, vinorelbine had only minimal activity in nonsquamous cancer of the cervix.
AB - The Gynecologic Oncology Group (GOG) has studied a number of drugs to determine their activity in patients with previously treated squamous and nonsquamous cancer arising in the uterine cervix. A Phase II study with intravenous vinorelbine was initiated for this purpose in patients with Stage IVB, recurrent, or persistent nonsquamous carcinomas who had received one prior chemotherapy or were not eligible for other studies. Eligible patients had to have measurable disease, GOG performance status of 0-2 and adequate bone marrow, liver, and renal function. The treatment consisted of vinorelbine 30 mg/m 2 on days 1 and 8, repeated every 21 days. Tumor measurements and toxicities were recorded every treatment cycle. Thirty patients were enrolled with 28 patients deemed eligible and evaluable. Only two confirmed partial responses (7.1%) were noted. Neutropenia was the most common toxicity with 9 of 28 (32%) experiencing either grade 3 or 4 changes. Anemia was severe in seven. Neuropathy was more than mild in three patients. Severe events, such as fatigue, hypertension, or pulmonary changes attributed to drug administration, occurred only in one or two instances. With the dose schedule and assessment criteria employed, vinorelbine had only minimal activity in nonsquamous cancer of the cervix.
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U2 - 10.1016/j.ygyno.2004.09.028
DO - 10.1016/j.ygyno.2004.09.028
M3 - Article
C2 - 15589588
AN - SCOPUS:10044278053
SN - 0090-8258
VL - 96
SP - 108
EP - 111
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 1
ER -
