Unexpected 5 Year Survival Benefit in Patients Given Oral Cryotherapy During Conditioning for Stem Cell Transplantation. A Prospective Randomized Study

Abstract 4559

Patients receiving high dose chemotherapy (HDC) in connection with bone marrow transplantation (BMT) often are afflicted with severe oral mucositis (OM). OM may affect 75–99% of patients. Oral cryotherapy has been shown to alleviate symptoms of mucositis alleviating oral pain and inability to maintain nutritional status. In a randomised controlled trial we have shown that patients receiving oral cryotherapy had less mucositis, less use of i.v. opioides and fewer doses of total parenteral nutrition (TPN) than a control group receiving routine oral care. Adult patients scheduled for bone marrow transplantation were randomly assigned to experimental (EXP) or control (CTR) group. A stratified randomisation was used with regard to type of transplantation (autologous vs allogeneic/unrelated donor (URD)). Randomisation was performed between January 2002 and August 2004. The final sample consisted of 78 patients, (31 autologous BMT and 8 allogeneic/URD BMT), and 39 constituted the CTR group and received standard treatment (31 autologous BMT and allogeneic/URD BMT). Concern has been raised for a possible protection of tumor cells by cryotherapy which could increase the risk of relapse and reduce survival. Thee aim of the present study was to investigate any difference in survival and relapse rates 5 years post-BMT for the two treatment groups from the randomised study.

After 5 years, 25/39 (64%) of the cryotherapy patients were alive compare to 15/39 (38%) of the control group (odds ratio 0,35, 95 % CI 0,14–0,88, p = 0,025)(Figure 1). No significant difference could be found with regard to the relapse rate between the groups. Most of the deaths were due to relapse.

The study offers no support for the speculation about tumor protection from cryotherapy during high dose chemotherapy conditioning for stem cell transplantation. These data indicate that oral cryotherapy is a safe prophylactic treatment for mucositis during chemotherapy.

Unexpectedly, the cryotherapy group showed a significantly better 5-year survival. Further analyses are needed to explore the difference in survival rate.