Objective: The objective of this phase III trial was to compare chemotherapy combined with bevacizumab versus chemotherapy alone in the treatment of patients with advanced colorectal cancer. Methods: From September 2004 till September 2008, 222 treatment-naive patients were enrolled and divided into 2 arms: 114 arm A patients were treated with leucovorin, 5-fluorouracil plus irinotecan in combination with bevacizumab, and 108 arm B patients were treated as above without bevacizumab. All patients were stage IV with histologically confirmed adenocarcinoma. Results: The median overall survival of arm A patients was 22.0 months (95% CI: 18.1–25.9) and 25.0 months (CI: 18.1–31.9) for arm B patients. There was no statistically significant difference between the 2 arms (p = 0.1391). No statistically significant difference between the 2 arms regarding the response ratewas observed: partial response, 42 patients (36.8%) and 38 patients (35.2%) for arms A and B, respectively. Hematologic toxicity did not differ in the comparison of the 2 arms. Nonhematologic toxicity in arm A involved hypertension in 23 (20.2%) of the patients and proteinuria in 7 (6.1%); 3 patients experienced hemorrhage and 1 patient intestinal perforation. None of these side effects was observed in arm B patients. Conclusion: No statistically significant difference in median overall survival in patients with advanced colorectal cancer treated with bevacizumab plus a combination therapy (arm A) and those treated with the combination only, without bevacizumab (arm B), was observed.
Advanced metastatic renal cancer is an incurable disease, unless a successful excision of metastatic lesions can be performed. No effective treatment has yet been found. In the last few years, targeting therapies have been developed. In the past, the main treatment was based on cytokines (interferon-α or interleukin-2). Our objective was to determine the median and overall survival in the 66 patients who were studied and reviewed. All had histologically confirmed advanced renal cancer. There were 41 male and 25 female patients, with a median age of 60 years. In 68.18% of the patients, the treatment was mainly interferon-α (IFN-α) given 3 times a week for a median time duration of 6 months (range 3-12 months). Four patients received interleukin-2 (IL-2) and 17 patients received chemotherapy, 15 of whom had hormonal treatment. Eleven patients underwent palliative radiation therapy (in the bone or brain). Seven patients received no treatment apart from supportive care. A partial response was achieved in 11.11% of the patients treated with IFN-α. No response was observed in patients treated with chemotherapy or hormonal therapy. The median survival of all the patients was 20 months (95% CI 14.96-25.04). These results are discussed in comparison with the survival results of modern targeting treatment studies. In the latter studies, despite the high response rates (31-40%), the survival was 16.4 months. Our data indicate that the response rate as a criterion is not adequate in determining drug effectiveness.
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