In patients with malignant pleural mesothelioma, even with standard chemotherapy, these patients have a short survival period. The growth of malignant pleural mesothelioma is highly dependent on the number of blood vessels and the concentration of serum vascular growth factor. Since thalidomide has anti-angiogenic activity, Wieneke A Buikhuisen from the Netherlands Cancer Center in Amsterdam hypothesized that the use of thalidomide in the treatment of patients with malignant pleural mesothelioma during the maintenance phase can improve their clinical prognosis. To verify the above assumptions, they designed relevant research and published the results in the latest online journal of Lancet Oncol in April.
This study is an open-label, multi-center, phase 3 randomized controlled clinical study. The criteria for enrolling the subjects are: previous diagnosis of malignant pleural mesothelioma or peritoneal mesothelioma, receiving at least 4 courses of first-line chemotherapy, treatment The regimen contains pemetrexed, which may or may not contain cisplatin or carboplatin, and the patient's condition has not progressed further after treatment with the above regimen. Subjects who met the above inclusion criteria were randomly divided into 2 groups according to the ratio of 1: 1, and stratified according to the subjects' previous first-line chemotherapy regimen, histological subtype, and hospital received treatment. These subjects either received 200 mg thalidomide daily (including 100 mg daily for 2 weeks) in combination with active support therapy, or received only active support therapy until the disease progressed. Subjects must begin thalidomide treatment within 10 weeks of the end of first-line chemotherapy. Thalidomide has a treatment period of up to 1 year, or until there is a toxic reaction that the subject cannot tolerate. The main endpoint of this study was the time elapsed until disease progression. The researchers used intention-to-treat analysis to analyze the research results. This study has been clinically registered under the registration number ISRCTN13632914.
Between May 11, 2004 and December 23, 2009, the investigators included a total of 222 subjects, 111 subjects in each of the two groups, after one subject in the active support treatment group Withdrew from the study, his relevant data was excluded from the final analysis. At the time of the final analysis, the median follow-up time for these subjects was 33.1 months (IQR 22.3-66.8), and the number of subjects with disease progression reported by clinicians was 104 in the thalidomide group. There were 107 in the active supportive treatment group, 92 patients in the thalidomide group and 93 in the active supportive treatment group. The median time to disease progression was 3.6 months in the thalidomide group (95% confidence interval 3.2-4.1) and 3.5 months in the active supportive treatment group (95% confidence interval 2.3-4.8). The difference was not statistically significant. In the thalidomide group, the researchers observed 43 people (39%) with grade 3 or 4 side reaction events, compared with 31 people (28%) in the active supportive treatment group. Sensory nerve events occurred in 2 people (2%) in the thalidomide group, but did not occur in the active support treatment group, and cardiac events occurred in 2 people (2%) in the thalidomide group. Three people (3%); as for thromboembolic events, there were 3 people (3%) in the thalidomide group, but not in the active supportive treatment group.
The results of this study suggest that maintenance therapy with thalidomide after first-line chemotherapy does not prolong the time to disease progression in patients with malignant mesothelioma. Therefore, we need to apply different treatment strategies to improve the prognosis of patients with malignant mesothelioma.
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