Previous clinical trials involving Navelbine® , also known as Vinorelbine, have shown that it not only positively affects mesothelioma tumor growth but is also well tolerated and should be easily combined with other available drugs. This combination drug therapy is being investigated for use as either a first- or second-line treatment for mesothelioma.
New research from the Department of Medical Oncology at St Bartholomew's Hospital built on this premise and previous clinical trials. Researchers there have recently launched a Phase II clinical trial of vinorelbine combined with oxaliplatin as first-line therapy combatting malignant pleural mesothelioma.
Oxaliplatin is a platinum-based chemotherapy drug that has been around since the 1970's. While it has been used extensively in Europe since the 1990's, it was only recently approved by the Federal Drug Administration (FDA) in 2002. Oxaliplatin works by interfering with the DNA of tumor cells. It effectively disrupts the cell replication process and doesn’t allow the tumor to grow.
Vinorelbine on the other hand is a semi-synthetic alkaloid drug that interferes with cell mitosis (division.) Vinorelbine was created in the 1980s and quickly gained FDA approval. It has been used successfully to treat non-small cell lung cancer and breast cancer.
For the purposes of this trial, researchers gathered twenty-six patients. All had confirmed cases of pleural mesothelioma. They were administered injection dose of vinorelbine -30 mg/m(2) on days 1 and 8 of a 21-day-cycle in addition to a single 130 mg/m(2) dose of oxaliplatin on day 1.
The primary method of measuring patient response to these chemotherapy drugs was spiral computed tomography scans (CT Scans). Scans taken prior to treatment were compared with those taken after treatment with special concern paid to tumor size.
This clinical trial showed similar results percentage-wise to the previous clinical trials involving only vinorelbine. Six patients saw partial remissions while seventeen experienced progression-free survival for up to 4.7 months. The overall total response rate was 23%.
The treatment was generally well accepted by patients, though not as well as vinorelbine treatment alone. Side effects were similar to traditional chemotherapy including neutropenia (depressed immune response,) phlebitis (inflammation of veins, usually in the legs,) nausea, vomiting, and constipation.
Patients were also assessed with a self-report quality of life test called the Rotterdam symptom checklist and the results showed improved lung function and improved psychological well-being, even as other physical symptoms deteriorated.
While researchers were pleased with the disease response rates, they were troubled by the slightly increased toxicity they saw. They concluded that this combined treatment really didn’t benefit patients much more than single drug treatment using vinorelbine. However, that did not discourage them from suggesting that viable “doublet” treatments were still available with other drug combinations.