Phase III Trial of Standard-Dose Intravenous Cisplatin Plus Paclitaxel Versus Moderately High-Dose Carboplatin Followed by Intravenous Paclitaxel and Intraperitoneal Cisplatin in Small-Volume Stage III Ovarian Carcinoma: An Intergroup Study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group

Abstract

An experimental regimen including moderately high-dose IV carboplatin followed by IP paclitaxel and IV cisplatin yielded a significant improvement in progression-free survival when compared with a standard regimen of IV cisplatin and paclitaxel. Because the improvement in overall survival was of borderline statistical significance and toxicity was greater, the experimental arm is not recommended for routine use. However, the results provide direction for further clinical investigation in small-volume ovarian cancer.

The role of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer: A Review

“…[24] In the second study there was a high morbidity in the experimental arm and there was only a marginal benefit in the overall survival. [25] A third trial, GOG 172, randomized 415 patients with residual disease ≤1 cm to receive IV paclitaxel and cisplatin or IV paclitaxel followed by IP cisplatin (day 1) and paclitaxel (day 8). A significant improvement in OS was demonstrated: 65.6 months in the IP arm compared with 49.7 months in the IV arm (P = 0.03).…”

“…[13,14,25,26,[51][52][53][54][55][56][57]. Thus, most of the results obtained with the addition of HIPEC to standard frontline therapy seem to be similar or inferior to the results obtained without the use of HIPEC.…”

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Methodology, Drugs and Bidirectional Chemotherapy

“…Cisplatin HIPEC has been used in mesothelioma, ovarian and gastric cancer with an AUC ration of 7.8 [16]. Cisplatin is a platinum salt, which has shown improved survival when combined with CRS, however is associated with increased toxicity and complications [17], which has resulted in slow acceptance of this treatment modality within the scientific community. Cisplatin HIPEC is associated with an increased incidence of nephrotoxicity, which is found in 5-15 % of patients [18].…”

A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis

“…Since the introduction of platinum compounds in first-line chemotherapy, PFS has not improved much over the years, but OS has risen from about 20 months in the 1980s (Conte et al, 1986;Alberts et al, 1992;Rothenberg et al, 1992;Swenerton et al, 1992;Alberts et al, 1996) to 30 months in the 1990s (McGuire et al, 1996;ICON Collaborators, 1998;Muggia et al, 2000) and 40 months in the last few years (Markman et al, 2001;ICON Collaborators, 2002;Du Bois et al, 2003;Armstrong et al, 2006). In our series, PFS was slightly better than is commonly reported and considering the composition of our population, OS of 54 months is remarkable.…”

“…In our series, PFS was slightly better than is commonly reported and considering the composition of our population, OS of 54 months is remarkable. Comparable results are reported only in trials that enrolled only patients with minimal or no residual disease after the first surgery (Alberts et al, 1996;Markman et al, 2001;ICON Collaborators, 2002;Armstrong et al, 2006), and in other studies that considered the subgroup of patients with this positive prognostic factor (du Bois et al, 2006;Pfisterer et al, 2006).…”