Aspiration Pneumonia In Head And Neck Cancer Patients Undergoing Concurrent Chemoradiation From India: Findings From A Post Hoc Analysis Of A Phase 3 Study

Background There are limited data from low- to middle-income countries (LMIC) on the incidence, risk factors, treatment outcomes, and antibiotic susceptibility spectrum of aspiration pneumonia (AsP). Methods We conducted a post hoc analysis of a randomized control trial in which adult patients with locally advanced head and neck cancers had received 66-70 Gy of radiation combined with cisplatin 30 mg/m(2) weekly for 6-7 weeks or cisplatin at the same dose with nimotuzumab 200 mg once weekly till the completion of radiation. The following data were extracted and analyzed-the incidence of AsP, time to the onset of AsP, risk factors, treatment outcomes of AsP, and its impact on progression-free survival (PFS), locoregional control (LRC) rates, and overall survival (OS). Results Out of 536 patients enrolled in the study, 151 (28.3%, 95% confidence interval [CI] 24.5-2.1) patients developed AsP. The median time to develop AsP was 39 days (95% CI 34-44). Only baseline dysphagia (odds ratio = 3.76, 95% CI 1.05-13.51, p = 0.042) was associated with a significant risk of development of AsP. Among the patients in which pathogenic organism was isolated (69 patients), gram-negative species was isolated in 63 patients (89%). Cisplatin at 200 mg/m(2) or more was delivered in 312 (81%) patients in the non-AsP cohort versus 107 (70.9%) patients in AsP cohort (p = 0.014). There was no statistical difference in LRC (hazard ratio [HR] = 1.057; 95% CI 0.771-1.448), PFS (HR = 1.176; 95% CI 0.89-1.553), and OS (HR = 1.233; 95% CI 0.939-1.618) between the two cohorts. Conclusion Aspiration pneumonia is a common complication in head and neck malignancies and patients with baseline dysphagia are at high risk. Gram-negative bacteria are the predominant causative agents. The use of broad-spectrum antibiotics results in resolution of symptoms.