A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis

TY - JOUR

T1 - A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis

AU - Mahner, Sven

AU - Oskay-Özcelik, Gülten

AU - Heidrich-Lorsbach, Elke

AU - Fuxius, Stefan

AU - Sommer, Harald

AU - Klare, Peter

AU - Belau, Antje

AU - Ruhmland, Birgit

AU - Heuser, Thomas

AU - Kölbl, Heinz

AU - Markmann, Susanne

AU - Sehouli, Jalid

PY - 2012/8/1

Y1 - 2012/8/1

N2 - BACKGROUND: Treosulfan, an alkylating agent, has demonstrated activity in recurrent ovarian carcinoma. It is equieffective as oral (p.o.) and intravenous (i.v.) formulation. To explore the preference and compliance of elderly patients regarding p.o. or i.v. treosulfan for the treatment of relapsed ovarian carcinoma, women aged 65 years or older were included in this prospective multicenter study. Since elderly patients usually have several concomitant diseases and experience more treatment toxicity, an interim safety analysis was planned and performed after 25 patients finished therapy to assess the tolerability of the treatment regimens.METHODS: Patients had a free choice of treosulfan i.v. (7,000 mg/m(2) day 1 of a 28-day cycle) or p.o. (600 mg/m(2) day 1-28 of a 56-day cycle) 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: Twenty-five of 51 recruited patients completed therapy at the time of the planned interim analysis (median age, 75 years; range, 70-82). Median ECOG was 1, and median number of prior chemotherapy regimens was 2. A median number of 4 cycles (range, 1-12) were administered per patient. Anemia was the most common hematological toxicity (88 % of patients). Most frequent non-hematological toxicities were nausea (76 %), constipation (68 %), and fatigue (64 %).CONCLUSION: Treatment was generally well tolerated despite the fact that most patients suffered from multiple comorbidities and were heavily pretreated. There were no unexpected hematological or non-hematological toxicities. Based on this safety analysis, the next step of study recruitment was continued.

AB - BACKGROUND: Treosulfan, an alkylating agent, has demonstrated activity in recurrent ovarian carcinoma. It is equieffective as oral (p.o.) and intravenous (i.v.) formulation. To explore the preference and compliance of elderly patients regarding p.o. or i.v. treosulfan for the treatment of relapsed ovarian carcinoma, women aged 65 years or older were included in this prospective multicenter study. Since elderly patients usually have several concomitant diseases and experience more treatment toxicity, an interim safety analysis was planned and performed after 25 patients finished therapy to assess the tolerability of the treatment regimens.METHODS: Patients had a free choice of treosulfan i.v. (7,000 mg/m(2) day 1 of a 28-day cycle) or p.o. (600 mg/m(2) day 1-28 of a 56-day cycle) 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: Twenty-five of 51 recruited patients completed therapy at the time of the planned interim analysis (median age, 75 years; range, 70-82). Median ECOG was 1, and median number of prior chemotherapy regimens was 2. A median number of 4 cycles (range, 1-12) were administered per patient. Anemia was the most common hematological toxicity (88 % of patients). Most frequent non-hematological toxicities were nausea (76 %), constipation (68 %), and fatigue (64 %).CONCLUSION: Treatment was generally well tolerated despite the fact that most patients suffered from multiple comorbidities and were heavily pretreated. There were no unexpected hematological or non-hematological toxicities. Based on this safety analysis, the next step of study recruitment was continued.

KW - Aged

KW - Aged, 80 and over

KW - Alopecia

KW - Anemia

KW - Antineoplastic Agents, Alkylating

KW - Busulfan

KW - Constipation

KW - Drug Administration Schedule

KW - Fatigue

KW - Female

KW - Humans

KW - Leukopenia

KW - Neoplasm Recurrence, Local

KW - Neoplasm Staging

KW - Ovarian Neoplasms

KW - Prospective Studies

KW - Quality of Life

KW - Questionnaires

KW - Recurrence

KW - Treatment Outcome

U2 - 10.1007/s00432-012-1221-3

DO - 10.1007/s00432-012-1221-3

M3 - SCORING: Journal article

C2 - 22526159

VL - 138

SP - 1413

EP - 1419

JO - J CANCER RES CLIN

JF - J CANCER RES CLIN

SN - 0171-5216

IS - 8

ER -