Recurrent ovarian cancer and management of elderly patients: Results of a prospective trial of treosulfan focusing on patient's preference and clinical outcome (NOGGO-Preference-Study).

Abstract

e15520 Background: There is an increasing interest in the management of elderly patients in oncology. Treosulfan is effective as oral (p.o.) and intravenous (i.v.) formultion for recurrent ovarian carcinoma. Primary aim of this study was to explore the individual preference and compliance of elderly patients (≥ 65 years) for p.o. or i.v.-treosulfan. Secondary aims were to evaluate the ADL-score, toxicity, response and survival. We present the final analysis of patient’s characteristics and treatment choice, compliance of the treatment and toxicities for 123 included patients. Methods: Patients with platinum sensitive and resistant ovarian cancer had free choice of treosulfan i.v. (7000 mg/m² d1, q28d) or p.o. (600 mg/m² d1-28, q56d) for a maximum of 12 cycles (i.v.) or 12 months (p.o.). Indecisive patients were randomized. Toxicity was evaluated according to the NCI-CTC version 2.0. Results: 123 recruited patients received therapy and were able for analysis (median age 72 years, range 65-87). 102 patients chose i.v. and 17 p.o., 3 were randomized to i.v and 1 to p.o. Median ECOG was 1 (n=0-2), and median number of prior chemotherapy-regimens was 3 (n=1-6). Most common hematological toxicities (grade 3/4) were thrombopenia (18.7%), leukopenia (15.4%) and anemia (3.6%). Most frequent non-hematological toxicities (grade 3/4) were abdominal pain (7.3%), fatigue (5.7%) and constipation (4.9%). The median progressive-free survival was 116 days, and the median overall-survival was 239 days. There was no difference in survival and activities of daily life (ADL) score between i.v. and p.o. treosulfan. Conclusions: Although heavily pre-treated most elderly patients with recurrent ovarian cancer (85%) preferred the i.v.-treosulfan administration following their individual preference. Treosulfan therapy was generally well tolerated. There were no differences in the patient’s characteristics, survival and ADL-scores in both groups.