Phase II trial of intraperitoneal cisplatin combined with intravenous paclitaxel in patients with ovarian, primary peritoneal and fallopian tube cancer

作者：Landrum Lisa M^*; Hyde Johnny Jr; Mannel Robert S; McMeekin D Scott; Moore Kathleen N; Walker Joan L

来源：Gynecologic Oncology, 2011, 122(3): 527-531.

DOI：10.1016/j.ygyno.2011.05.022

• Outpatient
• Ototoxicity
• Intraperitoneal catheter
• Ovarian carcinoma
• Cisplatin

Background. The objective of this study was to determine the toxicity of cisplatin-based intraperitoneal (IF)! intravenous (IV) treatment using a modified version of the IP/IV arm of GOG 172.
Methods. Patients with stage IC-IV and recurrent ovarian cancer were treated with D1 paclitaxel (IV at 135 mg/m(2), 3-h infusion) and cisplatin (IP at 50 mg/m(2)) and D8 cisplatin (IF at 50 mg/m2) every 21 days for 6 cycles. The primary outcome measure was completion of 6 cycles. Toxicity was assessed using the CTCAE, v.3.0 as well as subjective reporting by patients after each cycle.
Results. Twenty-one patients completed 87 cycles of chemotherapy with IF cisplatin and intravenous (IV) paclitaxel. Eleven patients (52%) were able to complete all 6 cycles. Reasons for failing to complete treatment: progression of disease (n = 3), grade 3-4 ototoxicity (n =2), II' port complication (n = 1), grade 4 fatigue (n = 1). small bowel obstruction (n = 1), severe paclitaxel reaction (n = 1) and one patient refused further treatment (n = 1). Dose reductions of paclitaxel (135 mg/m(2) to 110 mg/m2) were implemented per protocol for neutropenia (n =3) at a frequency of 3.75%. Dose delays were noted prior to 9 cycles for neutropenia (n = 6), thrombocytopenia (n = 1), elevated creatinine (n = I). and grade 3 rash (n = 1) at a frequency of 10%.
Conclusions. Although only 52% of patients were able to complete 6 cycles of cisplatin-based IF chemotherapy. significant reductions in cisplatin-related metabolic toxicity and catheter-related complications were noted.

• 出版日期2011-9