5.1
Research is needed to compare the effectiveness, tolerability, acceptability to patients and costs of the different oxaliplatin plus 5-FU regimens in the adjuvant setting (particularly those that combine oxaliplatin with oral forms of 5-FU).
5 Recommendations for further research
5.2
The optimum duration of adjuvant therapy is not known. Shorter duration might potentially reduce the costs, inconvenience, toxicity and risks of adjuvant therapy, but large trials are required to determine whether there is any reduction in efficacy.
5.3
There is a need for future cancer trial protocols of the adjuvant treatment for stage III (Dukes' C) colon cancer to incorporate more detailed resource data collection strategies and to report summary statistics that are of use within economic valuations. The degree of adherence to treatment particularly needs to be factored in. Trials should also collect data on changes in health-related QoL of participants, especially those related to adverse events.
Ongoing research (non-comprehensive list)
5.4
National Surgical Adjuvant Breast and Bowel Project (NSABP-C-08). Phase III Randomized Study of Adjuvant Chemotherapy Comprising Fluorouracil, Leucovorin Calcium, and Oxaliplatin With Versus Without Bevacizumab in Patients With Resected Stage II or III Adenocarcinoma of the Colon. US. NCT00096278.
5.5
National Cancer Research Institute (NCRI-QUASAR1). Phase III Randomized Study of Adjuvant Chemotherapy with L-Leucovorin and Fluorouracil versus Observation in Patients with Resected Colorectal Cancer. UK. NCT00005586.
5.6
North Central Cancer Treatment Group, National Cancer Institute, Eastern Cooperative Oncology Group. Phase III Randomized Study of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients with Stage III Colon Cancer. US. NCT00079274.
5.7
Schmoll HJ, Tabernero J, Nowacki M et al. Safety findings from a phase III trial of capecitabine plus oxaliplatin (XELOX) versus bolus 5-FU/LV as adjuvant therapy for patients with stage III colon cancer. Abstract 3523, presented at ASCO 2005.
5.8
Wein A, Lehnert T, Liersch T et al. (2004) Toxicity and safety of weekly high-dose 5-FU as 24-h infusion and folinic acid (AIO regimen) in adjuvant therapy of UICC stage III colon cancer. InTACT: A multicenter phase III trial. Journal of Clinical Oncology 22 (14S July 15 Supplement): 3586. ASCO Annual Meeting Proceedings (Post-Meeting Edition).
5.9
Coppola FS, Arca R, Ferro A et al. (2002) A phase III randomized trial (COLON-OXALAD) of adjuvant therapy for very high risk colon cancer (CC) patients (pts) with oxaliplatin (OXA) and bolus 5-fluorouracil (5-FU)/folinic acid (FA): a toxicity report. ASCO Annual Meeting: 656.