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| |  Oxaliplatin Plus Chemoradiation Increases Toxicity Without Affecting Tumour Response in Patients With Advanced Rectal Cancer: Presented at ASCO By Deborah Brauser ORLANDO, Fla -- June 1, 2009 -- Adding oxaliplatin to standard preoperative fluorouracil (FU)-based pelvic chemoradiation in patients with locally advanced rectal cancer increases toxicity but not tumour shrinkage when compared with standard care alone, and may reduce the number of distant metastases, according to a phase 3 trial presented here at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). Carlo Aschele, MD, Department of Medical Oncology and Cancer Prevention at E.O. Ospedali Galliera, Genova, Italy, presented the results here on May 30 on behalf of the Studio Terapia Adiuvante Retto (STAR) Network Investigators. The study enrolled 747 patients between December 2003 and August 2008 at 41 sites in Italy. Patients were randomised to preoperative infused FU chemoradiation alone (n = 379; 68% male; median age, 63 years) or to weekly doses of oxaliplatin 60 mg/m2 x 6 (n = 368; 66% male; median age 62 years). Surgery for all patients was scheduled 6 to 8 weeks after completing chemoradiation. Although the primary endpoint was overall survival, the results presented here were for the secondary endpoint of tumour response. At the end of the study, no significant difference in tumour reduction was found between the 2 groups, as 16% of patients in both groups had no tumour present at the time of surgery, and 27% of patients in the combination group had mildly invasive tumours (T1 or T2) without nodal involvement compared with 25% of patients in the standard care group. In addition, there was no significant difference in the number of patients who had cancer in the lymph nodes (27% in with the combination group vs 25% in the standard care only group). However, grade 3/4 toxicity rates, especially diarrhoea, were much higher in the combination group at 24% vs 8% in the chemoradiation only group (P < .001). “Although toxicity was significantly increased, it was manageable and mortality was not affected,” reported Dr. Aschele. In an unplanned analysis that resulted from examining intra-abdominal disease spread at the time of surgical removal of the primary tumour, the investigators found that only 0.5% (n = 2) of those in the oxaliplatin group had distant metastases compared with 3% (n = 11) in the standard-care group (P = .014). “Although adding oxaliplatin did not improve tumour response rates, we found that it was associated with a reduced number of early distant metastases in the abdomen in a very small number of patients,” said Dr. Aschele. “The numbers are small and the analysis was unplanned and exploratory. However, the difference is significant. Longer follow-up is ongoing to assess whether treatment with oxaliplatin will impact disease-free and overall survival.” [Presentation title: Preoperative Fluorouracil (FU)-Based Chemoradiation With and Without Weekly Oxaliplatin in Locally Advanced Rectal Cancer: Pathologic Response Analysis of the Studio Terapia Adiuvante Retto (STAR)-01 Randomized Phase III trial. Abstract CRA4008]
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