TY - JOUR
T1 - A phase II trial of CPT-11 in recurrent squamous carcinoma of the cervix
T2 - A Gynecologic Oncology Group study
AU - Look, Katherine Y.
AU - Blessing, John A.
AU - Levenback, Charles
AU - Kohler, Matthew
AU - Chafe, Weldon
AU - Roman, Lynda D.
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. Emory University Clinic, University of Southern California Medical Center at Los Angeles, University of Mississippi Medical Center, Indiana University Medical Center, Bowman Gray School of Medicine of Wake Forest University, The Albany Medical College of Union University, University of California Medical Center at Irvine, Eastern Virginia Medical School, The Johns Hopkins Oncology Center, and University of Texas M. D. Anderson Cancer Center.
PY - 1998/9
Y1 - 1998/9
N2 - Objective. To determine the response rate and associated toxicity of weekly CPT-11 in squamous carcinoma of the cervix. Methods. From October 1994 to May 1996, the Gynecologic Oncology Group (GOG) conducted a Phase II trial in patients with recurrent squamous cervix carcinoma. The schedule employed weekly x4 intravenous CPT-11 at 125 mg/m2 followed with a 2-week rest, to be repeated until disease progression or unacceptable toxicity. Eligibility criteria were a GOG performance status of 0-2, adequate bone marrow reserve, adequate liver function, and serum creatinine <2 mg%. None of the patients had received prior chemotherapy other than radiation sensitizers. Standard GOG toxicity and response criteria were used. Results. Fifty-four patients were entered into the trial. Three patients were ineligible because of wrong cell type (N = 2) or inadequate pathology material (N = 1). Two were inevaluable because of inadequate trial of drug. An additional 4 patients were inevaluable for response. Thus, 49 were evaluable for toxicity and 45 were evaluable for response. The median age of patients was 45 years (range, 29-71 years). The median number of weekly doses delivered was 7 (range, 1- 46). The incidence of grade 4 neutropenia and anemia was 6.1 and 4.1%, respectively. Nineteen patients (38.8%) developed gastrointestinal (GI) toxicity including 8 with grade 3 and 11 with grade 4 severity. The overall response rate was 13.3% (6/45). There was 1 patient death from GI toxicity. There was one complete response of 8.8 months duration and 5 partial responses. Conclusion. This schedule of CPT-11 exhibits modest activity with moderate toxicity in patients with recurrent squamous carcinoma of the cervix.
AB - Objective. To determine the response rate and associated toxicity of weekly CPT-11 in squamous carcinoma of the cervix. Methods. From October 1994 to May 1996, the Gynecologic Oncology Group (GOG) conducted a Phase II trial in patients with recurrent squamous cervix carcinoma. The schedule employed weekly x4 intravenous CPT-11 at 125 mg/m2 followed with a 2-week rest, to be repeated until disease progression or unacceptable toxicity. Eligibility criteria were a GOG performance status of 0-2, adequate bone marrow reserve, adequate liver function, and serum creatinine <2 mg%. None of the patients had received prior chemotherapy other than radiation sensitizers. Standard GOG toxicity and response criteria were used. Results. Fifty-four patients were entered into the trial. Three patients were ineligible because of wrong cell type (N = 2) or inadequate pathology material (N = 1). Two were inevaluable because of inadequate trial of drug. An additional 4 patients were inevaluable for response. Thus, 49 were evaluable for toxicity and 45 were evaluable for response. The median age of patients was 45 years (range, 29-71 years). The median number of weekly doses delivered was 7 (range, 1- 46). The incidence of grade 4 neutropenia and anemia was 6.1 and 4.1%, respectively. Nineteen patients (38.8%) developed gastrointestinal (GI) toxicity including 8 with grade 3 and 11 with grade 4 severity. The overall response rate was 13.3% (6/45). There was 1 patient death from GI toxicity. There was one complete response of 8.8 months duration and 5 partial responses. Conclusion. This schedule of CPT-11 exhibits modest activity with moderate toxicity in patients with recurrent squamous carcinoma of the cervix.
KW - CPT-11
KW - Squamous carcinoma of the cervix
UR - http://www.scopus.com/inward/record.url?scp=0032168956&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032168956&partnerID=8YFLogxK
U2 - 10.1006/gyno.1998.5129
DO - 10.1006/gyno.1998.5129
M3 - Article
C2 - 9790784
AN - SCOPUS:0032168956
SN - 0090-8258
VL - 70
SP - 334
EP - 338
JO - Gynecologic oncology
JF - Gynecologic oncology
IS - 3
ER -