belotecan and Peritoneal-Neoplasms

This study was designed to determine the maximum tolerated dose and toxicity profile of belotecan in combination with oral etoposide in patients with platinum-resistant or heavily treated ovarian cancer, fallopian tubal cancer, and primary peritoneal cancer. Belotecan (0.5 mg/m/day) was administered daily (days 1-5) followed by etoposide (50, 75 mg/day) for up to 5 days (days 6-10) every 3 weeks. Dose-limiting toxicities (DLT) were defined as follows: grade 4 neutropenia less than 1 week; either neutropenic fever less than 24 h or sepsis; grade 4 thrombocytopenia; and grade of at least 3 nonhematologic toxicity except alopecia. At the first dose level (50 mg) of etoposide, none of the three patients developed DLT, whereas DLT was observed in two of three patients at the next dose level. Thus, the dose level was reduced to 50 mg, and another three patients were enrolled. DLT was found in one of six patients who received etoposide at the dose level of 50 mg/m. Thus, the maximum tolerated dose was reached (50 mg of oral etoposide) and the trial was terminated. The response was evaluable in nine patients and an objective response was observed in four patients (44%) including two complete responses. The combined regimen of belotecan followed by oral etoposide showed promising activity in platinum-resistant or heavily pretreated ovarian cancer patients at the dose level of 50 mg of oral etoposide.

Topics: Administration, Oral; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Drug Resistance, Neoplasm; Etoposide; Fallopian Tube Neoplasms; Female; Humans; Maximum Tolerated Dose; Middle Aged; Neutropenia; Ovarian Neoplasms; Peritoneal Neoplasms; Thrombocytopenia; Treatment Outcome

The efficacy of second-line chemotherapy for relapsed primary peritoneal serous carcinoma has been numerously reported, but reports on durable response after second-line therapy have been rare. We report the case of a 66-year-old woman with relapsed primary peritoneal serous carcinoma who showed durable response after just one cycle of second-line belotecan-based therapy. The response might be a complete pathologic remission. Considering the fact that our patient suffered from neutropenic sepsis during her treatment, we concluded that belotecan-based chemotherapy could be a good option for second-line chemotherapy in some selected patients, so patient selection should be carefully performed due to the toxicity of belotecan.

Topics: Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Carcinoma; Cisplatin; Female; Humans; Neoplasm Recurrence, Local; Peritoneal Neoplasms; Peritoneum; Topoisomerase I Inhibitors; Treatment Outcome