Phase II study of carboplatin and paclitaxel in elderly women with newly diagnosed ovarian, peritoneal, or fallopian tube cancer

Abstract

5590 Background: More than 50% of cases of ovarian cancer occur in the older patient population (>65), the only group with an increasing incidence. The elderly with ovarian cancer are thought to have a worse prognosis with possible causative factors being more aggressive biology, inability to tolerate aggressive debulking surgery and chemotherapy, and comorbidities. Carboplatin and paclitaxel remains the standard of care for newly diagnosed patients with suboptimally debulked epithelial ovarian cancer. Methods: The primary objective was to determine the completion rate of six cycles of carboplatin/paclitaxel in an elderly population, and evaluate clinical parameters that predict completion of treatment including VES-13 score, Charlson co-morbidity index, nutritional status, and pharmacokinetics of paclitaxel. Eligibility: Age 70 or older. Treatment: carboplatin AUC 5 IV and paclitaxel 175 mg/m2 IV over three hours, q21 days. Results: 12 patients were enrolled with a median age 82 (75–86), with ECOG performance score 0(n=2), 1(n=8), and 2(n=2). The study was formally audited when 3 of the patients died on study, and the study was closed. One 84-yo died of toxicity complicating PD after #1 with a combination of progression and toxicity with nausea and vomiting leading to dehydration and ARF, an 82-yo died suddenly #6 day 5 in CR, and a 75-yo died of aspiration after vomiting during #2. Grade 3/4 toxicity included cognitive disturbance, constipation, enteritis, fatigue (2), febrile neutropenia (2), obstipation, hypoxia, infection, and vomiting. Only 3 patients were able to complete treatment, one with cognitive impairment and only 2 without dose delays or reductions. Conclusions: Standard chemotherapy in vulnerable populations can be associated with unacceptable excess toxicity. Reported series with positive outcomes in geriatric populations likely reflect significant selection bias. Careful consideration should be given to initial treatment with reduced doses (Carboplatin AUC 4 and paclitaxel 135 mg/m2) and escalation as tolerated. No significant financial relationships to disclose.