Purchasing of the ALBA Hyperthermia System for the Radiation Oncology Department of S. Camillo Medical Hospital, Rome

Project location: Italy, Rome
Project start date: July 2009 - Project end date: This project covers various years
Project number: 2009-12
Beneficiary: ASPRO Onlus

[2015-012]

 

The aim of this project, which received a grant from the Nando Peretti Foundation, is to extend and to standardize hyperthermia treatments to patients with recurrent cancer breast and melanoma malignance. The radiotherapy is made every day from Monday to Friday. Every Tuesday and Thursday the patients undergo hyperthermia. This treatment is made not more than an hour late from radiotherapy and it lasts 60 minutes. So the patient goes to the room and lay on a couch. The operator put the termocouples (superficial thermometer) to detect the real temperature on the skin and the applicator (warm and radio-frequency delivered) on the chest wall based on the planning made during the first treatment of which we have a photographic documentation. When we get 40° C of superficial temperature, hyperthermia treatment starts. During the treatment the operator follows the curves of the temperature registered by the termocouples on the display, taking care that its value is in the referring range and that the patient doesn't suffer from excessive warm.
In the times from 01/01/2014 to 31/12/2014, 7 patients with breast or chest wall recurrence underwent radio-hyperthermia treatment so Jessica Dognini made 56 superficial hyperthermia's applications.

Tolerance to treatment will be evaluated according to the CTC v3.0 scale of toxicity with an analysis of the acute and late dermal toxicity. Outcomes of the project will be evaluated local control and overall survival improvement.

 

With the introduction of hyperthermia, absolute control rates increase in the order of 20-30%. Several phase III studies showed the results of hyperthermia: the improvement in response rate, local control and survival. Statistical significance was obtained especially for recurrent breast cancer, head and neck cancer, oesophageal cancer and melanoma. The RTOG 8104 showed a total of 307 patients divided into two arms: radiation alone or radiation followed by hyperthermia. No significant differences were noted (CR 30 versus 32% of combined therapy), but there were subgroups in which there was a better response: head and neck or breast chest wall recurrences and DM <3 cm lesions that were localized in the breast, trunk and extremities. Another recent promising study by Jones showed an increase in response rate in HT arm of 23.8%. For breast carcinoma several studies in favour of the association of RT-HT [11, 22, 44] showed a gain in the response rate between RT alone and RT-HT from 6% (for large recurrences) to 20%. There is less evidence that a combined treatment improves overall survival; however, this is not the endpoint of most studies. Radiotherapy can be very effective in the treatment of breast recurrences: our previous results [8] on 19 patients (28 lesions treated) demonstrated an overall response rate (ORR) of about 96.4%, the best results are in the combined treatment (Complete Response 58.8%) compared to radiotherapy (CR 50%) or HT (CR 45.5%) alone. As to malignant melanoma, the randomized trial published by Overgaard [9] on 68 patients with 134 metastatic or recurrent lesions proved the benefit of combined therapy with an improvement of 27% on the local control rate. Our results [45] in relation to combined therapies practised from 1983 to 1994 in 48 patients affected by recurrent primary or metastatic malignant melanoma showed an overall response rate of 72%, with CR 36% and a Local Control 24% at 60 months. In head and neck melanoma recurrences 9 patients (15 lesions) were compared with a group of patients treated with RT alone with a 46.5% CR, 50% PR, and 46.5% NR, 34% LC at 24 months using combined RT-HT, while 37.5% CR, 50% PR and 25% LC at 24 months were observed with RT alone [45]. In particular, from the actual (and the previous) reports it was proved that local HT, in addition to low RT doses (mean 31.8 Gy) improves response rate and local control. In rare cases the possibility of using hyperthermia could help in deciding whether or not to perform re-irradiation even in the absence of literature data.


 

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