A prospective randomized study comparing concurrent chemoradiation with weekly and 3 weekly cisplatin in locally advanced oropharyngeal carcinoma

Abstract

Introduction: The chemotherapy schedules with cytotoxic dose or weekly regimes are still challenging, weighing the benefits versus toxicities. This prospective randomized study is an attempt to assess the efficacy of two schedules of cisplatin in management of locally advanced HNSCC. Objectives: The objectives of this study was to evaluate tolerance, tumour response and toxicities of concurrent chemoradiation with cisplatin in weekly and three weekly regimes. Methods: Locally advanced oropharyngeal squamous cell carcinoma patients fit for concurrent chemoradiation with cisplatin 40 mg/m2 (weekly) and 100 mg/m2 (3 weekly) were randomized to Arm A and B concurrently with radiotherapy of 70Gy/35frs/7 weeks. Statistical Analysis: Chi-square/ Fisher Exact test has been used to find the significance of study parameters on categorical scale between the groups. The statistical software SPSS 15.0 was used. Results: Between December 2010 and January 2013, 60 patients were enrolled. The median cycles of cisplatin in Arm-A was 5 and 2 in Arm-B. The complete response of 80.9% vs 75% and partial response of 14.3% vs 12.5% was observed in both arms respectively. There was no statistical difference in acute radiation and hematological toxicities between the two groups. With median follow up of 28 months, the 2 and 5 years overall survival was 55% and 58%; 41.6% and 32.3% in arms A and B respectively. Conclusion: In our study of locally advanced oropharyngeal carcinoma treated with radical radiotherapy comparing concurrent chemotherapy with cisplatin weekly vs 3 weekly had no significant difference in overall response, complete response and acute toxicities.

Survival and toxicity of weekly cisplatin chemoradiotherapy versus three-weekly cisplatin chemoradiotherapy for head and neck cancer: A systematic review and meta-analysis endorsed by the Italian Association of Radiotherapy and Clinical Oncology (AIRO)

“…The main characteristics of the retrieved studies are summarized in Table 2. Overall, six RCTs, reporting on 554 patients, were included in the final analysis (Nanda et al, 2019a;Nair et al, 2017;Nanda et al, 2019b;Noronha et al, 2018;Tsan et al, 2012;Rawat et al, 2016). Five studies were conducted in India (Nanda et al, 2019a;Nair et al, 2017;Nanda et al, 2019b;Tsan et al, 2012;Rawat et al, 2016) and one in Taiwan (Noronha et al, 2018).…”

“…Overall, six RCTs, reporting on 554 patients, were included in the final analysis (Nanda et al, 2019a;Nair et al, 2017;Nanda et al, 2019b;Noronha et al, 2018;Tsan et al, 2012;Rawat et al, 2016). Five studies were conducted in India (Nanda et al, 2019a;Nair et al, 2017;Nanda et al, 2019b;Tsan et al, 2012;Rawat et al, 2016) and one in Taiwan (Noronha et al, 2018). Weekly cisplatin regimen included 30 mg/m 2 (n = 2 studies (Nanda et al, 2019b;Rawat et al, 2016)), 35 mg/m 2 (n = 1 study (Tsan et al, 2012)) and 40 mg/m 2 (n = 3 studies (Nanda et al, 2019a;Nair et al, 2017;Noronha et al, 2018)), respectively.…”

“…Five studies were conducted in India (Nanda et al, 2019a;Nair et al, 2017;Nanda et al, 2019b;Tsan et al, 2012;Rawat et al, 2016) and one in Taiwan (Noronha et al, 2018). Weekly cisplatin regimen included 30 mg/m 2 (n = 2 studies (Nanda et al, 2019b;Rawat et al, 2016)), 35 mg/m 2 (n = 1 study (Tsan et al, 2012)) and 40 mg/m 2 (n = 3 studies (Nanda et al, 2019a;Nair et al, 2017;Noronha et al, 2018)), respectively. In total, four RCTs (465 patients) were available for the OS and PFS outcomes (Nanda et al, 2019a;Nair et al, 2017;Noronha et al,…”

“…We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. 2018), six RCTs (554 patients) for the acute toxicity evaluation (Nanda et al, 2019a;Nair et al, 2017;Nanda et al, 2019b;Noronha et al, 2018;Tsan et al, 2012;Rawat et al, 2016) and four RCTs (224 patients) for the treatment tolerability analysis (Nanda et al, 2019a;Nair et al, 2017;Noronha et al, 2018;Tsan et al, 2012). Subgroup analysis on both adjuvant and HPV-related groups and meta-analysis on late toxicity were not performed because of the limited number of trials and patients (Sahoo et al, 2017;Perez et al, 2017).…”

“…further randomized trial was published and no significant differences in terms of overall response, complete response and acute toxicities were recorded (Nanda et al, 2019a). The Association of Radiotherapy and Clinical Oncology (AIRO) decided to perform a systematic review and a meta-analysis to address the clinical questions related to cisplatin regimen in SCCHN.…”