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.