A clinical trial in Japan is testing the theory that high levels of chemotherapy delivered before other treatments may pave the way for more successfulmesothelioma surgery.
The administration of very high levels of chemotherapy drugs as a first-line cancer treatment is known as induction chemotherapy. The goal of induction chemotherapy is to kill most of the cancer cells up front, reducing or even eliminating the need for further rounds of chemotherapy or other types of treatment. Because mesothelioma is such a virulent cancer, even induction chemotherapy is not usually enough to kill all of the cancer. But the Japanese researchers believe it may be enough to dramatically improve surgical outcomes.
When the 2-year trial, which began in September 2012, is at full capacity, it will involve 24 newly-diagnosed patients whose malignant pleural mesothelioma is considered resectable (operable). The primary endpoint for the study is the “macroscopic complete resection rate,” or how much of each patient’s primary mesothelioma tumor can be successfully removed. This applies regardless of which type of mesothelioma surgical technique is used (pleurectomy/decortication or extrapleural pneumonectomy) to remove the tumor.
The trial will use the most popular mesothelioma chemotherapy drug combination, pemetrexed (Alimta) and the platinum-based drug, cisplatin. After their induction chemotherapy, patients will undergo either pleurectomy/decortication (PD) or extrapleural pneumonectomy (EPP). During PD, the bulk of the mesothelioma tumor is removed and any remaining mesothelioma cells are scraped off other internal surfaces. EPP goes a step further, removing not only the primary tumor, but also the nearest lung, all or part of the diaphragm, and other effected membranes.
In addition to measuring how thorough each patient’s post-chemo surgery is, the study will also compare the success of the two types of surgery, the number of complications, the response rate to chemotherapy, pulmonary function after surgery, and the 3-year overall survival rate.