title: Effect of recombinant human deoxyribonuclease on oropharyngeal secretions in patients with head-and-neck cancers treated with radiochemotherapy.
abstract: OBJECTIVE
  The current study examined the effect of recombinant human deoxyribonuclease (rhDNase) on quality of life (QOL) measures, clinical improvement, and DNA content of thick oropharyngeal secretions (OPS) in patients with head-and-neck (H&N) cancers.
  
  
  METHODS
  Thirty-six patients with local-regional advanced H&N cancer receiving chemoradiationtherapy (CRT) were randomized to receive either placebo or rhDNase. Endpoints included MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) and Functional Assessment of Cancer Therapy-Head and Neck (FACT-NH) scores, along with clinical assessment and DNA concentration of OPS.
  
  
  RESULTS
  There were no statistically significant differences in patients' QOL outcomes over the study period. Both groups showed an increase in symptom and interference scores, although patients in the rhDNase group showed a greater decline in both scores during the 3 months posttreatment. Similarly, both groups showed a decline in physical and functional well being but recovered in the 3 months posttreatment follow-up, with the rhDNase group exhibiting speedier recovery. Patients in the rhDNase group exhibited significant clinical improvement in OPS, blindly assessed by a physician, compared with the placebo group (67% vs 27%, respectively; P=.046). The rhDNase group showed no change in OPS-DNA concentration, although the placebo group showed a significant increase in DNA concentration during the drug trial (P=.045). There was no differences in acute toxicities between the 2 groups.
  
  
  CONCLUSIONS
  Our preliminary data suggest that rhDNase did not significantly improve study primary endpoints of QOL measures compared with the placebo group. However, there was a significant improvement in secondary endpoints of clinically assessed OPS and DNA concentration compared with placebo in H&N cancer patients treated with CRT. Further investigation in larger numbers of patients is warranted.
authors.affiliation: Department of Radiation Oncology, Northwestern University, Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, USA. bmittal@nmh.org
authors.forename: Bharat B
authors.initials: BB
authors.lastname: Mittal
authors.forename: Edward
authors.initials: E
authors.lastname: Wang
authors.forename: Samir
authors.initials: S
authors.lastname: Sejpal
authors.forename: Mark
authors.initials: M
authors.lastname: Agulnik
authors.forename: Amit
authors.initials: A
authors.lastname: Mittal
authors.forename: Kirk
authors.initials: K
authors.lastname: Harris
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000378:metabolism / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000627:therapeutic use; D004247:DNA / Q000032:analysis / Q000187:drug effects; D003850:Deoxyribonuclease I / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000378:metabolism / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009960:Oropharynx / Q000378:metabolism / Q000528:radiation effects*; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D004247:DNA; D003850:Deoxyribonuclease I; C568813:dornase alfa; D002945:Cisplatin