Popis: |
Nine US institutions performed 14,807 Phase I-II treatments of magnetic-induction (Magnetrode [Henry Medical Electronics, Inc., Los Angeles, CA]) hyperthermia in 1170 adults. All had advanced tumors: 20% had untreated inoperable cancer or disease progression despite surgery (10%), radiation therapy (XRT) (3%), chemotherapy (27%), or combinations (40%); 67% had pain; and 79% had reduced activity. Eighteen percent were advanced primaries, 26% were recurrent, and 56% metastatic tumors in the head and neck (7%), body wall (7%), extremity (4%), abdominal cavity (17%), pelvis (17%), lung (15%), or liver (30%); 36% were less than 5 cm and 64% greater than or equal to 5 cm. Treatments were to safe tolerance for 30 to 60 minutes for five or more treatments. Results in 960 evaluable patients were complete response 9% (1-34 months; median, 7 months), partial response 18% (1-39 months; median, 4 months), minimal response 10% (1-15 months; median, 3 months), and no change 33% (1-32 months; median, 3 months), with decreased pain in 30% and improved activity in 21%, independent of histologic type or site. Regression was dependent on treatment type and minimum temperature: heat only, 23%; heat + XRT, 60%; heat + less-than-standard XRT because of prior XRT failure, 39%, heat + intravenous (IV) chemotherapy, 28%; heat + same previously failed IV chemotherapy, 20%; heat + intraarterial (IA) chemotherapy, 28%; heat + same previously failed IA chemotherapy, 15%; heat + standard XRT + chemotherapy, 58%; heat + less-than-standard XRT + chemotherapy, 47%; less than 40 degrees C, 31%; 40 to 40.9 degrees C, 45%; 41 to 41.9 degrees C, 54%; 42 to 42.9 degrees C, 47%; 43 to 43.9 degrees C, 40%; 44 to 44.9 degrees C, 33%; 45 to 45.9 degrees C, 55%; 46 to 46.9 degrees C, 63%; greater than 47 degrees C, 100%. There were 49 (0.33%) skin burns and 2 systemic injuries (stomach ulcer at 1 month; lung fibrosis at 9 months). This trial indicates that localized hyperthermia has a significant role in palliation of human advanced solid cancer. |