Clinical Evidence by Indication

Highlight of several hyperthermia clinical studies organized by indication

Bladder cancer was the ninth most common cancer in the world according to the World Cancer Research Fund International. With more than 430,000 new cases diagnosed each year, bladder cancer is three times more common worldwide in men compared with women.

Level 1b Clinical results like the one below reveal that both Chemotherapy and Radiation treatment are more effective when combined with Hyperthermia.  Hyperthermia warms the tumor to temperatures in the "fever range" which makes the cancer cells more sensitive to treatment. Normal healthy cells recover while cancer cells die.

Clinical Information:

bladder dfs chart

Tumor Entity:

Non Muscle Invasive Superficial Bladder Cancer Tumor Stage Ta & T1, Grade G1 – G3

Treatment Modality:

Chemotherapeutic intravesical instillation of Mitomycin-C (MMC) combined with intravesical hyperthermia applied preoperatively or postoperatively. 8 weekly followed by 4 monthly treatment sessions of 60 minutes each combining MMC instillation dosed as 20 mg MMC solved in 50 ml distilled water with intravesical or external regional deep hyperthermia at 42 °C +/- 2 °C.


Clinical Results as preoperative complete remission for 52 pts (Colombo 1996):

  • MMC chemotherapy alone 22 %
  • MMC chemotherapy with hyperthermia 66 %

Clinical Results for postoperative 10 y disease-free survival for 83 pts in multicenter randomized clinical trial (Colombo 2003 & 2010):

  • MMC chemotherapy alone 15 %
  • MMC chemotherapy with hyperthermia 53 %

Endorsement as Level Ib evidence by

Chemotherapy and Hyperthermia:

When hyperthermia is combined with chemotherapy, general treatment guidelines of the ESHO European Society of Hyperthermic Oncology recommend:

  • Target volume for hyperthermia: The target volume for hyperthermia is the gross tumor volume.
  • Sequence of treatment modalities: Hyperthermia is given simultaneously with chemotherapy during cytostasis.
  • Duration of hyperthermia treatment: Superficial hyperthermia total 60 minutes, deep hyperthermia total 90 minutes (including 30 minutes heating-up time)

References:

Hyperthermia improves Clinical Outcome

Randomized clinical trials (RCT’s) have been shown significant improvement in clinical outcome when hyperthermia was added to radiotherapy and/or chemotherapy. In 2004 experts in clinical hyperthermia held a consensus meeting (Kadota Fund International Forum 2004) about the evidence of the published clinical results of the RCT’s. Level 1 evidence was found for bladder cancer, breast cancer, cervical cancer, cancer of the esophagus, lymph nodes of head and neck tumors, rectum cancer, soft tissue sarcoma, malignant melanoma, glioblastoma multiform, and various superficial cancers.

Meanwhile more RCT’s have been published (e. g. for chest wall recurrences of breast cancer, soft tissue sarcoma, bladder cancer, ovarian cancer, pediatric germ cell tumors). These RCT’s are also classified as level 1 evidence and have been collected up to 2013.
Reference:
Van der Zee et al. The Kadota Fund International Forum 2004 – Clinical group consensus. Int J Hyperthermia. 2008 March;24(2):111-122
* Pediatric cancer statistics from non-randomized study.