Weight loss and its impact on outcome in head and cancer patients during chemo-radiation.

BACKGROUND: Weight loss during chemotherapy and its impact on the cancer outcomes have been invariably reported in the literature. We also did a post-hoc analysis of a randomized phase III trial to see the same. MATERIALS AND METHODS: The database of a recently published randomized study comparing cisplatin-radiation with nimotuzumab cisplatin-radiation was used for this analysis. Week-wise weight loss during the course of treatment was noted. The impact of severe weight loss (grade 2-3) on progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) was studied using the Kaplan Meier method. Binary logistic regression analysis was used to see the effect of various factors. RESULTS: Out of a total of 536 patients, weight loss was captured in 524. Out of these 524 patients, any degree of weight loss was seen in 293 (55.91%) patients. Grade 1 weight loss was noted in 192 (36.6%) patients, grade 2 in 96 (18.3%) and grade 3 in 5 (1%) patients. The 2-year PFS was 53% and 57.1% in severe and non-severe weight loss groups respectively (p-value = 0.36). The 2-year LRC was 60% in patients with severe weight loss, while it was 63.5% in those with non-severe weight loss (p-value = 0.47). The 2-year OS was 59.3% versus 62.2% in severe and non-severe weight loss cohorts respectively (p-value = 0.21). None of the factors was found to be associated with severe weight loss. CONCLUSION: Severe weight loss was uncommon in our patients. Weight loss during treatment was not associated with poor survival outcomes.

Post hoc analysis of a randomized controlled trial comparing concurrent chemoradiation with cisplatin versus nimotuzumab-cisplatin, focusing on acute oral mucositis.

BACKGROUND: Acute oral mucositis has been infrequently studied in the patients with head and neck squamous cell carcinoma (HNSCC) receiving once-weekly cisplatin-based chemoradiotherapy (CRT). Hence, this analysis was conducted to explore the various aspects of the same. RESULTS: The overall incidence of mucositis was 96.9% (n = 508) and of grade 3-5 mucositis was 61.3% (n = 321). The overall incidence of oral mucositis was similar in both the arms (CCRT and NCRT) (p value = 0.58) while grade 3-5 mucositis was more common in the NCRT arm (p value = 0.01). Out of all factors listed, the presence of nimotuzumab was the only significant risk factor for the development of grade 3 or more oral mucositis (p value = 0.01); (OR = 1.64, 95%CI 1.15-2.32). Delays in the treatment delivery were similar in both the arms. CONCLUSION: Acute oral mucositis is a common occurrence in locally advanced-HNSCC patients receiving chemoradiotherapy. Nimotuzumab is a significant factor for development of grade 3 and above oral mucositis.

Lymphopenia during chemoradiation-foe or friend.

BACKGROUND: Severe lymphopenia during treatment is considered to be a poor prognostic factor. The current literature lacks information regarding its impact on various outcomes in locally advanced head-and-neck cancer patients in a prospective setting. METHODS: We recently published a randomised study comparing cisplatin-radiation with nimotuzumab cisplatin-radiation. The database of this study was used for the present analysis. The impact of severe lymphopenia (grade 4 lymphopenia) on progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) was studied using the Kaplan-Meier method and Cox regression analysis. The binary logistic regression analysis was used to see the effect of various factors on the development of severe lymphopenia. RESULTS: We had a total of 536 patients, of which 521 patients (97.7%) developed lymphopenia. Grade 1 lymphopenia was noted in 10 (1.9%) patients, grade 2 in 100 (18.8%), grade 3 in 338 (63.1%) and grade 4 in 73 (13.7%) patients. The median PFS was 20.53 and 60.33 months in severe and non-severe lymphopenia, respectively (hazard ratio, 0.797; p-value = 0.208). The median duration of LRC was 56.3 months in severe lymphopenia, whereas it was not reached in non-severe lymphopenia (hazard ratio, 0.81; p-value = 0.337). The median OS was 28.46 versus 47.13 months in severe and non-severe lymphopenia, respectively (hazard ratio, 0.76; p-value = 0.11). Of various risk factors, gender was significantly associated with severe lymphopenia. CONCLUSION: The occurrence of severe lymphopenia was not significantly associated with the outcomes. Gender is the only risk factor significantly linked to severe lymphopenia.