Objective: To synthesise the evidence on efficacy of hyperthermia in combination with radio- or chemotherapy in breast-, bladder-, cervix carcinoma and soft tissue sarcoma patients.
Methods: Based on two previous systematic reviews, a systematic literature search in four databases with identical search terms was carried out in order to find randomised clinical trials.
Results: 2 RCTs for breast cancer, 2 RCTs for bladder cancer, 3 RCTs for cervix carcinoma, 1 RCT for bladder and cervix and 1 RCT for soft tissue sarcoma were found. Overall, of the 1265 patients 656 were allocated to receive treatment with hyperthermia in combination with radio- or chemotherapy. Where CR or PR was assessed (in 6 from 9 trials) hyperthermia showed statistical significant outcomes. Some of the trials assessed DFS (3/9) or PFS (2/9): all of them show superiority of the hyperthermia arm. Of the 9 publications providing OS data only 1 shows a statistical significant improvement in overall survival, thus proposing that the surrogate endpoints do not translate into a survival benefit and that hyperthermia leads to temporal effects only. QoL was not assessed in any of the trials. The reporting of safety data was consistent across the studies showing a trend towards an inferior safety profile within the hyperthermia arms.
Conclusion: Due to the heterogeneity of the trials in terms of technique, protocol, reporting of outcomes, control interventions, but also tumour characteristics within the same indication, there is a high degree of uncertainty and the available evidence must be considered as insufficient. Large confirmatory RCTs are required.