Phase II study of intraperitoneal carboplatin with intravenous paclitaxel in patients with suboptimal residual epithelial ovarian or primary peritoneal cancer: A Sankai Gynecology Cancer Study Group Study
ABSTRACT To assess the antitumor efficacy and safety of 2 treatment modalities: intraperitoneal carboplatin combined with intravenous (IV) paclitaxel.
Eligible patients were those with epithelial ovarian carcinoma or primary peritoneal carcinoma stages II to IV who underwent initial surgery and had a residual tumor size of 2 cm or larger. Patients received IV paclitaxel 175 mg/m followed by intraperitoneal carboplatin AUC6. The primary end point was a response. Secondary end points were toxicity, progression-free survival, and overall survival.
Twenty-six patients were enrolled, and 24 patients were eligible for assessment. The response rate was 83.3% (95% CI, 62.6%-95.3%; ). The median progression-free survival was 25 months. The median overall survival had not been reached. Incidences of grade (G) 3/4 hematological toxicities were absolute neutrophil count, 96%; hemoglobin, 29%; and thrombocytopenia, 16%. Nonhematological toxicities included G2 liver function, 4%; G3 sensory neuropathy, 8%; and G3 myalgia and arthralgia, 4%.
Intraperitoneal administration of carboplatin combined with IV paclitaxel was well tolerated and showed satisfactory response in the patients with bulky residual tumor. Large-scale phase III trial comparing with IV carboplatin is warranted in this patient population.
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ABSTRACT: Epithelial ovarian cancer remains the most lethal gynecologic malignancy despite advances in treatment. The standard management generally involves a combination of surgical tumor debulking and chemotherapy. Over the decades, chemotherapy for ovarian cancer has evolved and currently involves a combination of intravenous platinum and taxane chemotherapy. Over the past decade, three randomized phase III trials have been reported, and all have demonstrated a significant survival advantage for intraperitoneal compared with intravenous chemotherapy. However, there are potential barriers and controversies related to the administration of intraperitoneal chemotherapy in ovarian cancer patients. In this review, we discuss the evolution and current management considerations of chemotherapy for the treatment of epithelial ovarian cancer.rapeutic Advances in Medical Oncology, The 05/2010; 2(3):175-87. DOI:10.1177/1758834010361333
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ABSTRACT: To reduce toxicities in cisplatin-based intraperitoneal (IP) chemotherapy, we substituted carboplatin for cisplatin. The purpose of this study was to provide preliminary toxicity data of carboplatin-based IP chemotherapy and to evaluate the feasibility of this chemotherapy regimen in patients with ovarian cancer after primary debulking surgery. The toxicity data of 19 primary ovarian cancer patients (IP group) who underwent carboplatin-based IP and intravenous (IV) combination chemotherapy (IP carboplatin AUC 5 on day 1, IV paclitaxel 175mg/m² on day 2, and IP paclitaxel 60mg/m² on day 8) after primary debulking surgery were retrospectively analyzed and compared to 34 patients (IV group) who were treated with standard platinum-based IV chemotherapy during the same period. The toxicity data in a total of 118 cycles were analyzed. Grade 3 or 4 leukopenia, neutropenia, and pain were more common in the IP group than the IV group. There were seven catheter-related complications. Fourteen patients (73.7%) were able to complete six cycles or more of IP chemotherapy. Survival results in the IP group were compared with those from the IV group; a prolonged progression-free survival was observed (26.6 vs. 20.7 months; p=0.038). Compared to the previous results with cisplatin-based IP chemotherapy, there was no significant difference in hematologic events. However, gastrointestinal, neurologic, and metabolic events in this study were definitely lower compared to those of cisplatin-based IP chemotherapy. Carboplatin-based IP and IV combination chemotherapy is feasible in patients with ovarian carcinoma after primary debulking surgery.European journal of obstetrics, gynecology, and reproductive biology 10/2010; 152(2):195-9. DOI:10.1016/j.ejogrb.2010.05.033 · 1.63 Impact Factor
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ABSTRACT: While intraperitoneal (IP) chemotherapy has shown significant survival benefits, the ability to successfully deliver IP chemotherapy has been limited. In GOG 172, surgically-placed IP catheters had a reported complication rate of 34%. In addition, IP catheters have to be placed surgically. We have developed a novel percutaneous placement technique for IP catheters in patients without ascites. This study was a retrospective analysis of all patients receiving percutaneously-placed IP catheters from 12/2008 to present. Catheters were placed using a two-step technique under conscious sedation. IP access was gained using ultrasound-guided peritoneal puncture over the right lobe of the liver. A 5 Fr catheter was placed into the peritoneal cavity and the abdomen insufflated with carbon dioxide (CO(2)). Access was gained in the RLQ once distention separated the bowel from the abdominal wall. A 14.5 Fr multi-side hole catheter was coiled in the pelvis, and a reservoir tunneled onto the lower anterior chest wall. For this analysis, abstracted data included patient demographics, indication for catheter placement, complications (procedural and with chemotherapy delivery), fluoroscopy time, and timing/indication of catheter removal. Eleven patients received IP catheters. The mean age was 58 years, mean body mass index was 27.1, and mean number of days from surgical debulking was 38. There were two stage 2, and eight stage 3 patients. Two patients had fallopian tube, and nine patients had ovarian cancer. All patients had an optimal debulking procedure. Seven of 11 patients also obtained central intravenous access when the IP port was placed. Follow-up data were as follows: Average fluoroscopy time was 9 min. One patient (9%) had an intra-procedural complication but the catheter was successfully placed. Zero patients had catheter-related complications in the course of receiving chemotherapy. Five of the 11 patients (45%) completed the planned IP chemotherapy treatments, with three additional patients (27%) currently receiving therapy. The remaining three patients (27%) discontinued chemotherapy for reasons unrelated to IP catheter function: two due to chemotherapy side effects, and one with sepsis from a perforated diverticulum. Thus far, our experience with percutaneous placement of IP catheters is associated with a low risk of catheter-related complications and high technical success rates. CO(2) insufflation may make peritoneal puncture easier and potentially safer. This procedure offers an alternative to surgical placement, even in patients without clinically significant ascites.Gynecologic Oncology 08/2011; 123(2):342-5. DOI:10.1016/j.ygyno.2011.07.031 · 3.69 Impact Factor