TY - JOUR
T1 - Intraperitoneal interferon-α in residual ovarian carcinoma
T2 - A phase II gynecologic oncology group study
AU - Berek, Jonathan S.
AU - Markman, Maurie
AU - Stonebraker, Bette
AU - Lentz, Samuel S.
AU - Adelson, Mark D.
AU - DeGeest, Koen
AU - Moore, David
N1 - Funding Information:
This study was supported by National Cancer Institute grants from 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 Alabama at Birmingham, Oregon Health Sciences Center, Abington Memorial Hospital, University of Rochester Medical Center, Walter Reed Army Medical Center, University of Mississippi Medical Center, Colorado Foundation for Medical Care, University of California Medical Center at Los Angeles, University of Miami School of Medicine, Georgetown University Hospital, University of Iowa Hospitals and Clinics, University of Texas Health Science Center at Dallas, Indiana University Medical Center, Bowman Gray School of Medicine of Wake Forest University, State University of New York at Syracuse, University of California Medical Center at Irvine, Tufts New England Medical Center, Rush–Presbyterian–St. Lukes Medical Center, University of Kentucky, Eastern Virginia Medical School, The Johns Hopkins Oncology Center, Washington University School of Medicine, Columbus Cancer Council, University of Massachusetts Medical Center, Medical University of South Carolina and Women’s Cancer Center, and University of Oklahoma Health Science Center.
PY - 1999/10
Y1 - 1999/10
N2 - Objective. The purpose of this study was to confirm the activity of interferon-α intraperitoneally in minimal residual epithelial ovarian cancer in a Phase II multi-institutional trial and to investigate the activity of the agent based on prior response to first-line platinum compounds. Methods. Ninety-two patients with minimal residual (<0.5 cm) epithelial ovarian cancer at reassessment laparotomy were entered into a multicenter trial of intraperitoneal interferon-α given for 12 cycles unless disease progression or unacceptable toxicity occurred first. Patients were considered favorable if they were platinum sensitive and/or relapsed 6 months or longer after completing treatment and unfavorable if they were platinum insensitive and/or relapsed shorter than 6 months after completing treatment and/or had stable or progressive disease during initial therapy. A third-look laparotomy was performed within 12 weeks of completion of treatment in those patients who were in clinical remission. Results. Eighty patients were clinically evaluable for toxicity only (48 favorable, 32 unfavorable) and 46 of them were evaluable for response, of whom 25 were favorable (platinum sensitive) and 21 unfavorable (platinum resistant). In the favorable group, there was a 28% surgically documented response rate (7/25 patients): 16% (4/25) had complete responses (negative reassessment operation), 12% (3/25) had partial responses, 32% (8/25) were nonresponders, and 40% (10 patients) developed progressive disease before planned reassessment operation. In the unfavorable group, there were no responding patients: 6 were nonresponders at reassessment operation and 15 developed progressive disease before planned reassessment operation. Of the 80 patients evaluable for toxicity, the most common adverse effects that were more than grade 2 were gastrointestinal (12; 15%), fever (8; 10%), neutropenia (7; 9%), and leukopenia (6; 8%). Grade 4 toxicity was seen in 5 patients; each had fever and gastrointestinal toxicity, and 1 each had neutropenia and thrombocytopenia. Conclusions. Interferon-α is an active and generally well-tolerated agent in favorable patients with minimal residual epithelial ovarian cancer at second-look surgery. These results are comparable to those achieved with cytotoxic chemotherapy. If Phase III trials are considered in the patients with minimal residual ovarian cancer, they should be limited to the platinum-sensitive patient population.
AB - Objective. The purpose of this study was to confirm the activity of interferon-α intraperitoneally in minimal residual epithelial ovarian cancer in a Phase II multi-institutional trial and to investigate the activity of the agent based on prior response to first-line platinum compounds. Methods. Ninety-two patients with minimal residual (<0.5 cm) epithelial ovarian cancer at reassessment laparotomy were entered into a multicenter trial of intraperitoneal interferon-α given for 12 cycles unless disease progression or unacceptable toxicity occurred first. Patients were considered favorable if they were platinum sensitive and/or relapsed 6 months or longer after completing treatment and unfavorable if they were platinum insensitive and/or relapsed shorter than 6 months after completing treatment and/or had stable or progressive disease during initial therapy. A third-look laparotomy was performed within 12 weeks of completion of treatment in those patients who were in clinical remission. Results. Eighty patients were clinically evaluable for toxicity only (48 favorable, 32 unfavorable) and 46 of them were evaluable for response, of whom 25 were favorable (platinum sensitive) and 21 unfavorable (platinum resistant). In the favorable group, there was a 28% surgically documented response rate (7/25 patients): 16% (4/25) had complete responses (negative reassessment operation), 12% (3/25) had partial responses, 32% (8/25) were nonresponders, and 40% (10 patients) developed progressive disease before planned reassessment operation. In the unfavorable group, there were no responding patients: 6 were nonresponders at reassessment operation and 15 developed progressive disease before planned reassessment operation. Of the 80 patients evaluable for toxicity, the most common adverse effects that were more than grade 2 were gastrointestinal (12; 15%), fever (8; 10%), neutropenia (7; 9%), and leukopenia (6; 8%). Grade 4 toxicity was seen in 5 patients; each had fever and gastrointestinal toxicity, and 1 each had neutropenia and thrombocytopenia. Conclusions. Interferon-α is an active and generally well-tolerated agent in favorable patients with minimal residual epithelial ovarian cancer at second-look surgery. These results are comparable to those achieved with cytotoxic chemotherapy. If Phase III trials are considered in the patients with minimal residual ovarian cancer, they should be limited to the platinum-sensitive patient population.
UR - http://www.scopus.com/inward/record.url?scp=0032878097&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032878097&partnerID=8YFLogxK
U2 - 10.1006/gyno.1999.5532
DO - 10.1006/gyno.1999.5532
M3 - Article
C2 - 10502418
AN - SCOPUS:0032878097
SN - 0090-8258
VL - 75
SP - 10
EP - 14
JO - Gynecologic oncology
JF - Gynecologic oncology
IS - 1
ER -