Clinical Newswire, Sep 24, 2009 (Berlin, Germany) - Soft-tissue sarcoma patients at high rist of metastasis were 30% more likely to survive cancer free almost 3 years after start of treatment if their tumors received targeted heat therapy at the time of chemotherapy treatment, according to research presented at the largest cancer congress in Europe, ECCO15-34th ESMO. The study, presented by lead author Rolf Issels, a professor of medical oncology at Klinikum Grosshadern Medical Center at the University of Munich in Germany, is the first to show that any treatment other than surgery followed by radiation can prolong survival in this type of patient.
Soft tissue sarcomas account for approximately 3% of all cancers and include cancers that start in the soft tissues of the body, such as muscle, fat, nerves, blood vessels, tendons and deep layers of the skin. They are more common in children and young adults. The primary treatment is surgical, and radiotherapy and chemotherapy are also often used, since these tumors are sometimes difficult to remove completely. However, in localised disease the benefits of chemotherapy are limited. Survival of sarcoma patients varies widely depending on location and severity of the tumor, with abdominal sarcomas being the most deadly.
The phase III study involved 341 patients treated at several centers in Europe and the United States between July 1997 and November 2006 for locally advanced soft tissue sarcomas at high risk of recurrence or spread. More than half of the tumors were abdominal sarcomas. Patients were randomized to receive chemotherapy alone (etoposide, ifosfamide and adriamycin for 4 cycles every 3 weeks) or in combination with targeted heat therapy before and after local therapy (surgery and radiotherapy). Targeted heat therapy, or regional hyperthermia (RHT), uses focused electromagnetic energy to warm the tissue in and around the tumor to 40-43 degrees Celsius. The heat has multiple effects on the tumor: it directly kills cancer cells, and also improves blood flow which allows more chemotherapy to get to the tumor. The improved blood flow also brings more oxygen to the tumor, making it more sensitive to radiation.
“The patients receiving the targeted heat therapy fared better on all outcome measures,” Prof Issels said. After an average follow-up of 34 months, they were 42% less likely to experience a recurrence of their cancer at the same site or to die than those receiving chemotherapy alone, surviving an estimated 120 months before local disease progression, compared to an estimated 75 months for those receiving chemotherapy alone, which was a statistically significant difference (p=0.003). Disease-free survival (DFS) was also longer at 32 months in the patient group that got both treatments, compared with 18 months in the group that got chemotherapy alone (p=0.011), which was a 30% improvement. The improvement in overall survival (OS) was not statistically significant when all patients were analysed, however among the 269 patients who completed the initial 4 cycles of their assigned induction therapy, OS was significantly improved in the RHT plus chemotherapy group, with patients 44% less likely to die during the follow-up period than those who got chemotherapy alone (p=0.038).
The most frequent side effect of the heat therapy was mild to moderate discomfort, reported in 45% of the patients. One patient experienced severe burns, and 17.8 experienced blisters.
“This is the first clear evidence that targeted heat therapy adds to chemotherapy”, said Prof Issels. The researchers expect that these findings will encourage other researchers to test the approach in other locally advanced cancers. Targeted heat therapy has already shown promising results in recurrent breast and locally advanced cervical cancer in combination with radiation. According to Prof Issels, “This strategy has been in development for about 20 years, with about 150 leading groups studying it, but the clear results of this trial show that the field has now matured to the point where we must step up efforts to explore its potential to offer an entirely new way of treating locally advanced disease in several major cancers.”
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