Prospective Oral Mucositis Audit (POMA): Occurrence and Consequences of Severe Oral Mucositis in High Dose Melphalan and BEAM Conditioning.

Oral mucositis (OM) is an adverse effect of myeloablative regimens which seriously affects patient well-being and may increase risk of systemic infection and delay recovery. Trial-based reports of OM occurrence vary widely, with evidence of underreporting, and data on the incidence and impact of OM in routine practice are limited. Initiated by the European Group for Blood and Marrow Transplantation, this study observed pts. with multiple myeloma (MM) or non-Hodgkin lymphoma (NHL) from 25 transplant centres across 13 European countries, receiving high dose melphalan or BEAM followed by autologous stem-cell transplant. Aims were to assess duration and incidence of severe (WHO oral toxicity scale Grade III–IV) OM and ulcerative (Grade II–IV) OM, medical resource use for OM prevention and treatment, and associations with infection and duration of hospitalisation. Prospective OM assessments were conducted daily from the start of conditioning until 30 days post transplant or hospital discharge. To achieve high and consistent quality of OM assessment, nurse assessors underwent a multimedia-assisted face-to-face training before study initiation. Of 197 evaluable pts., 110 (56%) had MM and 87 (44%) had NHL. Mean age at enrolment ± SD was 57 ± 8 years for MM and 50 ± 13 years for NHL. Women accounted for 36% of the MM sample and 51% of the NHL sample. In both sub-samples, 94% of pts. had ECOG status ≤ 1. The incidence of severe OM was 46% (95% CI 37–56%) for MM and 41% (95% CI 31–52%) for NHL. Severe OM episodes had a mean duration of 5.4 ± 3.3 days (95% CI 4.6–6.3 days) in MM and 5.3 ± 3.2 days (95% CI 4.3–6.4 days) in NHL. Ulcerative OM occurred in 67% (95% CI 58–76%) of MM pts. and 60% (95% CI 49–70%) of NHL pts., with a mean duration of 6.6 ± 4.4 days (95% CI 5.6–7.6 days) and 6.5 ± 3.8 days (95% CI 5.6–7.7 days), respectively. WHO scale results and indicators of specific OM symptoms showed very similar temporal patterns, reaching their maximum around day 12 after the start of conditioning in both groups. Clinically relevant associations with type of disease/conditioning or gender were not detected. A non-statistically significant trend hinted at an association of OM duration with age. The incidence of fever ≥ 38° C was 68% in pts. with severe OM vs. 47% in pts. without (univariate p = 0.004; odds ratio 2.4, 95% CI 1.3–4.4). Mean length of stay ± SD (truncated at 30 days post transplant) was 21.1 ± 4.0 days in pts. with severe OM vs. 19.9 ± 4.8 days in pts. without (univariate p = 0.023). Preliminary multivariate analysis adjusting for other potential predictors confirmed these effects. Based on a close collaboration of nurses and physicians, this study showed severe OM to be a substantial clinical problem in pts. receiving high dose melphalan or BEAM conditioning chemotherapy. Associations with fever occurrence and length of stay indicate potentially harmful clinical sequelae and relevant economic consequences. Associations with confirmed infection, and resource use for OM management, remain to be assessed.