Comparative pharmacokinetics of a proposed biosimilar bevacizumab Bmab-100 and reference product bevacizumab in a multicentre double blind randomized clinical trial in metastatic colorectal carcinoma (mCRC) patients

Abstract

Background: 10-20% of patients with colorectal cancer (CRC) developed lung meta-stases. Numerous series show increased survival in patients undergoing surgery showing an overall 5 year survival (OS) of 50-55%. The aim of this study is analyze the patients treated with curative intent of lung metastases of CRC. Methods: retrospectively reviewed 30 patients underwent pulmonary metastases at the General Hospital of Valencia between December 2009 and March 2017. Patients were followed until 1 May 2017. The different variables were collected in a database and statistical analysis was performed using SPSS version 22 for Windows. Results: 30 patients, 56.7% men and 43.3% women, were analyzed. Mean age of 68.8 6 9.45 years. RAS was analyzed in 23 patients, 47%mutated and 52% native. At diagnosis, 10% were stage I, 26.7% stage II, 36.7% stage III and 26.7% stage IV. Previous hepatic relapse that was operated was found in 11 patients. Regarding pulmonary metastasis, the value of CEA was analyzed in 23 patients and in 22 was less than 10. The metastases were predominantly unilateral (93.3%). One lesion was found in 60% of patients; two lesions in 26.7% and three lesiones in 13.3%. The surgical technique was transegmental resection in 96.7% of cases. Nodal sampling only was performed in 8 patients. No involvement of surgical margins was found in 93.3%. No statistically significant differences have been observed that the number of metastases, unilateral or bilateral involvement , surgical margin involvement, CEA level, type of resection or nodal sampling are factors affecting survival. Second relapse was found in 14 patients (3% liver, 33% lung and 10% other), 8 underwent surgery and 5 of these had third relapse, 2 were reoper-ated. The median OS was 56.6% at 5 years (mean 47.28 months). The disease free interval (DFS) was 25.13 6 5.1 months (CI 95% 15.13 to 35.13). Currently, 19 patients are alive (79% free of disease), 9 have died and 2 has lost tracing. Conclusions: In our series the results are similar to those described in the literature, although our study has limitations. We can consider the pulmonary metastasectomies treatment increases survival. It takes more work to assess the variables that can act as prognostic factors.