A retrospective review of the frequency and nature of acute hypersensitivity reactions at a medium-sized infusion center: comparison to reported values and inconsistencies found in literature.

Purpose: To evaluate acute hypersensitivity reactions at the UCSD Moores Cancer Center in San Diego, compare our findings to those reported previously in the literature, and examine the effectiveness of the objective grading scale as represented by the Common Terminology Criteria for Adverse Events (CTCAE).

Patients And Methods: Using the available pharmacy and electronic medical record data from 2006-2010, we examined our reported hypersensitivity reactions (HSRs) using the CTCAE v.3.0 and v.4.0. A thorough literature review was also performed to compare our findings with those previously reported.

Results: We found 222 cases of HSRs, of which 50% were due to immunotherapeutics. Most were grade 1 or 2 by any CTCAE criteria. The clinical presentation of HSRs varied between drug classes. Using different versions of grading schema led to inconsistencies in ~50% of all HSRs. Fifty-two percent of all cases not due to blood products were rechallenged on the same day. The reported literature HSR frequencies for each causative agent showed a striking variability, possibly indicating that previous studies used a wide variety of grading and reporting systems for adverse events.

Conclusion: HSRs are common in clinical practice, and most are mild or moderate. There are inconsistencies in reporting HSRs between studies. The existence of several grading schema and subjective definitions of hypersensitivity could be contributing to poor clinical generalizability. Along with an improved system of reporting HSRs to minimize underreporting, a standard system of objectively assessing HSRs is necessary for purposes of research and clinical practice.