Whole-body hyperthermia (WBH) in combination with carboplatin in patients with recurrent ovarian cancer - A phase II study

Objective. Despite considerable progress in the front-line treatment in patient with advanced ovarian cancer, the outcome of patients with recurrent or refractory disease is still poor. Based on promising results of a pilot study, we initiated a phase II study with WBH and carboplatin in pretreated patients with advanced ovarian cancer to investigate the toxicity and efficacy of WBH in combination with carboplatin. Methods. 47 patients with histologically confirmed epithelial ovarian carcinoma were enrolled in the study. Patients were pretreated with at least one palliative chemotherapy regimen. Of 47 patients 24 were classified as platinum refractory or resistant and 16 as platinum sensitive. Results. Main toxicity was hematological with grade 3/4 anaemia, leukopenia and thrombocytopenia occurring in 49%, 49% and 65%, respectively. Cardiac complications occurred with grade 112 in 22 of 47 (47%) patients and with grade 3 in 1 patient (2%). In 35 patients evaluable for response, the overall response rate was 45% [CR: 4/35 (11%), PR: 12/35 (34%), NC: 9/35 (26%)]. In platinum refractory and resistant patients we observed CR in 6%, PR in 24% and NC in 24%. The median overall survival and progression free survival were 61.5 weeks and 29 weeks, respectively. Conclusion. This study confirms that WBH in combination with carboplatin is an active salvage treatment option in patients with advanced ovarian cancer. However, significant hematological toxicity has to be considered and renders this regimen less suitable for palliative care setting. There is no evidence yet, that whole-body hyperthermia contributes to any clinical improvement beyond chemotherapy alone. This question can only be addressed in a randomized phase III trial. (C) 2008 Elsevier Inc. All rights reserved.