Clinical Study On The Safety Of Folfiri Regimen For Elderly Colorectal Cancer

Objective:Irinotecan is an active drug in the first and subsequent lines of chemotherapy for patients with advanced colorectal cancer. The irinotecan-based combinations therapy for patients with advanced colorectal cancer has been proved to be safe and effective in randomized large-scale clinical trials in overseas, but uncertainty exists about whether elderly patients benefit the same extent from the combinations therapy as younger patients. The objective of this trial was to evaluate the adverse effects and clinical efficacy of irinotecan combined with 5-Fu/CF in treatment of elderly colorectal cancer.Methods:The subjects came from the medical oncology in First Affilliated Hospital of Anhui Medical University. The 68 patients with colorectal cancer who received FOLFIRI regimen from September, 2007 to March, 2009 were divided into the elderly group (≥65 years) and middle-aged group (<65 years). CTCAE Version 3.0 was used to evaluate the adverse reactions and MCIRS-G was used to measure the comorbidities. The difference of the chemotherapy adverse reactions, the MCIRS-G score and curative effect were compared between the two groups. The difference of chemotherapy adverse reaction rates were analyzed according to the MCIRS-G score. All the data was processed through the software SPSS 10.0.Results:1. Until March, 2009, 31 patients in the elderly group, including 17 men and 14 women. 19 patients were colonic cancer and 12 patients were rectal cancer. Their age ranged from 65 to 81 (68.6±3.9) years. There were 37 patients in the middle-aged group, including 20 men and 17 women. 22 patients were colonic cancer and 15 patients were rectal cancer. Their age ranged from 23 to 63 (47.4±10.9). All the cases received the chemotherapy of FOLFIRI regimen.2. The main gradeⅢ/Ⅳadverse reactions of the two groups were myelotoxicity and diarrhea. The differences between adverse reaction rates of the two groups were not significant (P>0.05). 5 patients in the two groups, including 3 elder patients and 2 middle-aged patients, receive reduced doses about 30% because of the gradeⅣmyelotoxicity, the symptom was relieved after adjusting, and no case was discontinued chemotherapy because of severe adverse events.3. The curative effect indicated that the response rate was 28.0% and disease control rate was 64.0% in the elderly group, the response rate was 31.0% and disease control rate was 58.6% in the middle-aged group. The efficacy of the two groups was similar. The difference between the two groups was not significant.4. There were 30 patients in the elderly group and 22 patients in the middle-aged group had the comorbidity. The common comorbidities in the elderly were hypertension and diabetic, while they were chronical gastritis,hepatitis b and cholelithiasis.5. The incidences of myelotoxicity increased (P=0.012) in the elderly group along with the increased score of MCIRS-G, while no differences were observed about the adverse reactions of the middle-aged group.Conclusion: FOLFIRI is a safe and effective regimen for the elderly patients with colorectal cancer, and the risk of toxicity was similar between the two groups. The incidences of myelotoxicity increased in the elderly group in paralled with the increased score of MCIRS-G.