title: Acute toxicity of second generation HIV protease-inhibitors in combination with radiotherapy: a retrospective case series.
abstract: BACKGROUND
  There is little data on the safety of combining radiation therapy and human immunodeficiency virus (HIV) protease inhibitors to treat cancers in HIV-positive patients. We describe acute toxicities observed in a series of HIV-positive patients receiving modern radiation treatments, and compare patients receiving HIV protease inhibitors (PI) with patients not receiving HIV PIs.
  
  
  METHODS
  By reviewing the clinical records beginning January 1, 2009 from the radiation oncology department, we identified 29 HIV-positive patients who received radiation therapy to 34 body sites. Baseline information, treatment regimen, and toxicities were documented by review of medical records: patient age, histology and source of the primary tumor, HIV medication regimen, pre-radiation CD4 count, systemic chemotherapy, radiation therapy dose and fractionation, irradiated body region, toxicities, and duration of follow-up. Patients were grouped according to whether they received concurrent HIV PIs and compared using Pearson's chi-square test.
  
  
  RESULTS
  At baseline, the patients in the two groups were similar with the exception of HIV medication regimens, CD4 count and presence of AIDS-defining malignancy. Patients taking concurrent PIs were more likely to be taking other HIV medications (p = 0.001) and have CD4 count >500 (p = 0.006). Patients taking PIs were borderline less likely to have an AIDS-defining malignancy (p = 0.06). After radiation treatment, 100 acute toxicities were observed and were equally common in both groups (64 [median 3 per patient, IQR 1-7] with PIs; 36 [median 3 per patient, IQR 2-3] without PIs). The observed toxicities were also equally severe in the two groups (Grades I, II, III respectively: 30, 30, 4 with PIs; 23, 13, 0 without PIs: p = 0.38). There were two cases that were stopped early, one in each group; these were not attributable to toxicity.
  
  
  CONCLUSIONS
  In this study of recent radiotherapy in HIV-positive patients taking second generation PIs, no difference in toxicities was observed in patients taking PIs compared to patients not taking PIs during radiation therapy. This suggests that it is safe to use unmodified doses of PIs and radiation therapy in HIV cancer patients, and that it is feasible to use PIs as a radiosensitizer in cancer therapy, as has been suggested by pre-clinical results.
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins Hospital, Baltimore, MD 21231, USA.
authors.forename: Alfred P
authors.initials: AP
authors.lastname: See
authors.forename: Jing
authors.initials: J
authors.lastname: Zeng
authors.forename: Phuoc T
authors.initials: PT
authors.lastname: Tran
authors.forename: Michael
authors.initials: M
authors.lastname: Lim
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000532:radiotherapy; D017320:HIV Protease Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000453:epidemiology; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D017320:HIV Protease Inhibitors