- 作者：Bharat B. Mittal ; Edward Wang ; Samir Sejpal ; Mark Agulnik ; Amit Mittal ; Kirk Harris
- 刊名：International Journal of Radiation Oncology*Biology*Physics
- 出版年：2013
- 出版时间：1 October, 2013
- 年：2013
- 卷：87
- 期：2
- 页码：282-289
- 全文大小：1002 K
Purpose
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 and Materials
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.