TY - JOUR
T1 - Intraperitoneal cisplatin and etoposide in the treatment of refractory/recurrent ovarian carcinoma
AU - Reichman, B.
AU - Markman, M.
AU - Hakes, T.
AU - Hoskins, W.
AU - Rubin, S.
AU - Jones, W.
AU - Almadrones, L.
AU - Ochoa, M.
AU - Chapman, D.
AU - Saigo, P.
AU - Lewis, J. L.
PY - 1989
Y1 - 1989
N2 - To determine the efficacy of a 6-month course of combination intraperitoneal (IP) chemotherapy with cisplatin and etoposide in patients with refractory or recurrent advanced ovarian carcinoma, 67 patients were entered into this prospective, nonrandomized, single-institution trial. Cisplatin at 100 mg/m2 and etoposide at 200 mg/m2 were administered IP on day 1 every month for 6 months. Exploratory laparotomy was performed before protocol entry and was planned after the completion of 6 months of IP therapy to surgically document response. All patients had received prior intravenous (IV) chemotherapy with a cisplatin-based regimen. At protocol entry, 18 (27%) patients had surgically defined residual tumor (maximal tumor diameter) > 2.0 cm, 17 (25%) patients > 0.5 cm - ≤ 2.0 cm, and 32 (48%) patients ≤ 0.5 cm. Sixteen patients (24%) who had experienced a treatment-free interval of more than 1 year prior to study entry were considered as having recurrent disease and the remaining 51 (76%) patients were considered as having refractory disease. Toxicity was tolerable: four patients (6%) had nadir fever, three (4%) had culture-documented bacterial peritonitis, five (7%) had IP catheter-related complications, and 27 (40%) had an increase in serum creatinine > 1.5 mg/dL. Among the 57 patients who are fully evaluable for response, the overall surgically defined response rate, complete (CR), and partial response (PR), was 40% (23/57), and the CR rate was 21% (12/57). Among the patients with recurrent disease, eight of 13 (62%) responded, with responses seen among all categories of residual disease. Among the patients with refractory disease, 15 of 44 (34%) had surgically documented responses. However, responses were more frequent in patients with residual disease < 0.5 cm; 11 of 20 (55%) versus four of 24 (17%) with residual > 0.5 cm, P = .019 (χ2, one degree of freedom, Yates correction). The duration of the CRs ranges from 4 to 18+ months. Longer follow-up is needed to determine if there is any impact on survival.
AB - To determine the efficacy of a 6-month course of combination intraperitoneal (IP) chemotherapy with cisplatin and etoposide in patients with refractory or recurrent advanced ovarian carcinoma, 67 patients were entered into this prospective, nonrandomized, single-institution trial. Cisplatin at 100 mg/m2 and etoposide at 200 mg/m2 were administered IP on day 1 every month for 6 months. Exploratory laparotomy was performed before protocol entry and was planned after the completion of 6 months of IP therapy to surgically document response. All patients had received prior intravenous (IV) chemotherapy with a cisplatin-based regimen. At protocol entry, 18 (27%) patients had surgically defined residual tumor (maximal tumor diameter) > 2.0 cm, 17 (25%) patients > 0.5 cm - ≤ 2.0 cm, and 32 (48%) patients ≤ 0.5 cm. Sixteen patients (24%) who had experienced a treatment-free interval of more than 1 year prior to study entry were considered as having recurrent disease and the remaining 51 (76%) patients were considered as having refractory disease. Toxicity was tolerable: four patients (6%) had nadir fever, three (4%) had culture-documented bacterial peritonitis, five (7%) had IP catheter-related complications, and 27 (40%) had an increase in serum creatinine > 1.5 mg/dL. Among the 57 patients who are fully evaluable for response, the overall surgically defined response rate, complete (CR), and partial response (PR), was 40% (23/57), and the CR rate was 21% (12/57). Among the patients with recurrent disease, eight of 13 (62%) responded, with responses seen among all categories of residual disease. Among the patients with refractory disease, 15 of 44 (34%) had surgically documented responses. However, responses were more frequent in patients with residual disease < 0.5 cm; 11 of 20 (55%) versus four of 24 (17%) with residual > 0.5 cm, P = .019 (χ2, one degree of freedom, Yates correction). The duration of the CRs ranges from 4 to 18+ months. Longer follow-up is needed to determine if there is any impact on survival.
KW - Adult
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Cisplatin/administration & dosage
KW - Clinical Trials as Topic
KW - Drug Evaluation
KW - Etoposide/administration & dosage
KW - Female
KW - Humans
KW - Injections, Intraperitoneal
KW - Middle Aged
KW - Neoplasm Recurrence, Local/drug therapy
KW - Ovarian Neoplasms/drug therapy
KW - Prospective Studies
UR - http://www.scopus.com/inward/record.url?scp=0024437232&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:A1989AM61500021&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1200/JCO.1989.7.9.1327
DO - 10.1200/JCO.1989.7.9.1327
M3 - Article
C2 - 2671288
SN - 0732-183X
VL - 7
SP - 1327
EP - 1332
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 9
ER -