Source: DGNews  |  Posted 3 years ago

By Gabe Waggoner

SAN ANTONIO, Tex -- February 9, 2009 -- A new taxane-platinum chemotherapy doublet combined with bevacizumab is feasible and safe as first-line treatment for advanced ovarian, peritoneal, and fallopian tube cancer, researchers reported here at the Society of Gynecologic Oncology (SGO) 40th Annual Meeting on Women's Cancer.

Thomas J. Herzog, MD, Columbia Presbyterian Medical Center, New York, New York, and colleagues enrolled 132 patients in a study of a novel regimen, which consisted of 85 mg/m² of oxaliplatin, 75 mg/m² of docetaxel, and 15 mg/kg of body weight of bevacizumab for 3 weeks, all for 6 cycles, and then bevacizumab alone at a dosage of 15 mg/kg every 3 weeks to round out 1 year of treatment.

Data for 106 of these 132 subjects were included in a plenary presentation here on February 7. "Preliminary efficacy results are promising," Dr. Herzog stated, "with 1-year progression-free survival of 70%."

The median age of the study participants was 58 years. Eighty-one percent of included patients had ovarian cancer, 8% had cancer of the peritoneum, and 8% had cancer of the fallopian tube. Most patients' tumours (62%) were not well differentiated, having serous adenocarcinoma as the initial pathology cell type. In terms of disease staging, 2.8% had stage IC disease, 5.7% had stage IIC, 4.7% had stage IIIA, 4.7% had stage IIIB, 69% had stage IIIC, and 11% had stage IV. Sixty-three percent of patients had disease that was optimally debulked.

Eighty-five of the 106 patients completed all cycles of chemotherapy with bevacizumab (80 patients began with single-agent bevacizumab). A total of 73 subjects stopped treatment (27 having completed the study treatment period, 25 because of progressing disease, 15 because of an adverse event, 3 by request of investigator or subject, 2 for unknown reasons, and 1 for early withdrawal).

However, nearly three-quarters of patients had at least 1 adverse event, Dr. Herzog noted. Seventy-eight patients (74%) experienced at least 1 grade 3 or 4 adverse event, 32 patients (30%) had at least 1 serious adverse event, all 106 patients had at least 1 chemotherapy-related adverse event, and 95 patients (90%) had at least 1 bevacizumab-related adverse event.

Grade 3 or 4 adverse events included neutropenia (41%), leucopenia (11%), hypertension (8.5%), fatigue (7.5%), nausea (5%), pulmonary embolism (5%), and vomiting (5%). Also, 4 patients experienced grade 3/4 peripheral neuropathy and 1 patient experienced a perforated colon associated with bevacizumab.

[Presentation title: Preliminary Safety Results of TEACO, a Phase 2 Trial of Oxaliplatin, Docetaxel, and Bevacizumab as First-Line Therapy for Advanced Cancer of the Ovary, Peritoneum, and Fallopian Tube. Abstract 48]