Regional abdominal hyperthermia combined with systemic chemotherapy for the treatment of patients with ovarian cancer relapse: Results of a pilot study

Publishing house: International Journal of Hyperthermia
Main author: Jalid Sehouli
Other authors: Christina Fotopoulou, Chie Hee Cho, Robert Kraetschell, Johanna Gellermann, Peter Wust, Werner Lichtenegger
Date: 2009-09-28

DOI: 10.3109/02656730903369200

Language: english

Publication class: Pilot study

Research type: Prospective, 1/2 phases

Number of patients: 36

HT type: LRHT RF

Description of HT type: Local HT, deep, radio waves

Device: BSD-2000

Disease entity: Ovarian cancer

Symbol of disease entity: OCR

Stage:  –

Types of combination with HT:  HT+CT

CT type:  Pegylated liposomal doxorubicin, Topotecane, Treosulfan, Paclitaxel/docetaxel, Gemcitabine, Cyclophosphamide, Carboplatin, Carboplatinum-based combination, Platinum sensitive, Platinum resistant

Abstract. Purpose: Due to the poor prognosis of patients with ovarian cancer relapse (OCR), newer strategies are warranted to improve the therapeutic index. We performed a prospective phase I/II-study of regional abdominal hyperthermia (RHT) combined with systemic chemotherapy in OCR patients in order to evaluate outcome, efficacy and tolerance.
Materials and methods: OCR patients with an Eastern Cooperative Oncology Group status <2, without any thromboembolic disease or severe cardiovascular co-morbidities, and pre-treated with at least one systemic chemotherapy regimen due to epithelial ovarian cancer were enrolled into the present study. RHT was applied using a SIGMA 60 applicator and a Hybrid-System SIGMA-Eye/MRT composed of a 1.5T-MRT and a Sigma-Eye-applicator.
Results: Overall, 36 OCR patients were enrolled. The majority of the patients (480%) were classified as platinum resistant. The most common chemotherapeutic agent applied was pegylated-liposomal-doxorubicin (47.2%) followed by carboplatin (16.6%) and topotecan (13.9%). One patient (2.8%) achieved a complete remission (CR), 12 patients (33.3%) yielded a partial remission (PR) and 16 patients (44.4%) developed a progressive disease (PD). In platinum-sensitive patients we observed higher response (57.1% versus 31%) and lower progression rates (28.6% versus 48.3%) than in platinum-resistant patients. Eleven patients (30.5%) discontinued treatment due to toxicity. The main toxicity was a haematological one with grade 3/4 anaemia, leucopenia and thrombocytopenia occurring in 13.9%, 5.6% and 8.3%, respectively. Median overall survival was 12 months (range: 1–48), while median progression-free survival was 5 months (range: 0.5–34).
Conclusions: Our results demonstrate the feasibility of RHT combined with systemic treatment. Prospective phase III trials are warranted to evaluate the benefit and efficacy in heavily pre-treated patients with OCR.

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