Background Cancer is one of the most expensive and exhaustive medical conditions with a huge impact on the financial condition of the patient and their family members. A lot of advancements have led to improvement in the survival of the patients but at a raised cost. Comprehensive Score for financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST - FACIT Version 2) is one such validated and widely used tool. Assessing the financial burden in our country is still far more challenging as COST - FACIT is available in the English language but not in any regional language. Hence, we decided to validate this tool in Hindi and Marathi languages. Material and Methods A single-center, cross-sectional study was conducted in the Department of Uro-Oncology at the Tata Memorial Hospital. The original version of the COST - FACIT (Version 2) was translated from English into Hindi and Marathi languages, following the FACIT translation method and tested for content validity that included two forward translations, followed by reconciliation and a backward translation. The questionnaires were then approved by the FACIT team, and pilot testing was done for 20 patients (10 for each Hindi and Marathi language). Each of these 20 patients, after filling up the questionnaire themselves, was interviewed for any difficulty encountered during answering the questionnaire. Based on the suggestions or interpretations of this pilot testing, the necessary changes were incorporated in the final Hindi and Marathi questionnaires. Results A total of 20 patients (10 each for Hindi and Marathi) were included for pilot testing of the questionnaire. The median age of the entire cohort was 61 years (27–79). The questionnaires showed good content and face validity and demonstrated a high internal consistency (Cronbach's α: 0.85 for Hindi, 0.89 for Marathi). Conclusion The questionnaire COST - FACIT (Version 2) has been approved and validated in Hindi and Marathi languages by the FACIT team for use in clinical practice and studies.
Introduction This trial was conducted to compare the efficacy of low dose once‐a‐week cisplatin and once‐every‐3‐weeks cisplatin with radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). The current analysis focuses on the quality of life (QoL) of patients in this trial. Methods In this phase III randomized trial, patients with nonmetastatic LAHNSCC were randomized to receive cisplatin 30 mg/m2 once‐a‐week or 100 mg/m2 once every‐ 3‐weeks concurrently with radiotherapy. The primary endpoint was locoregional control. QoL was a key secondary endpoint. QoL was assessed using EORTC QLQ‐C30 and QLQ‐H&N35. QoL data were assessed at baseline, days 22 and 43 during treatment; and at 6, 12, 24 months. The linear mixed‐effects model was used for longitudinal analysis of QoL to determine the impact of treatment (arm) and time on QoL. Results Three hundred patients were enrolled, data of 150 patients with available baseline QoL were analyzed. There was no significant difference in the global health status/QoL of the two treatment arms (p = 0.8664). There was no significant difference in the longitudinal QoL scores between the two treatment arms in all scales except constipation (p = 0.0096), less sexuality (p = 0.0002,), and financial difficulty (p = 0.0219). There was a worsening of the QoL scores in all scales in both arms during treatment, which improved after treatment completion in most scales. Conclusion The use of once‐every‐3‐weeks cisplatin did not adversely impact QoL as compared to once‐a‐week cisplatin in combination with radiotherapy in LAHNSCC.
LBA6016 Background: The regimens approved for the treatment of advanced head and neck squamous cell carcinoma (HNSCC) are accessible to only 1-3% of patients in low and middle-income countries due to cost. In our previous study, metronomic chemotherapy (MC) improved survival in this setting. Retrospective data suggest that a low dose of nivolumab may be efficacious. Hence, we aimed to assess whether the addition of low dose nivolumab to MC improved the overall survival. Methods: This was a randomised phase 3 superiority open-label study. Adult patients with relapsed -recurrent or newly diagnosed advanced HNSCC being treated with palliative intent with ECOG PS 0-1 were eligible. Patients were randomised 1:1 to MC consisting of methotrexate 15 mg/m2 PO weekly, celecoxib 200 mg PO daily and erlotinib 150 mg PO daily, or MC with intravenous nivolumab 20 mg flat dose once-every-3-weeks. Therapy was continued until disease progression or intolerable adverse events. Response assessment (RECIST version 1.1) was performed every 2 months. The primary endpoint was 1-year overall survival (OS) and this was a pre-specified interim analysis with the nominal p-value for efficacy being 0.006. Results: 151 patients were randomised, 75 in MC and 76 in the MC-I arm respectively. The addition of low dose nivolumab led to an improvement in the 1-year overall survival from 16.3% (95%CI 7.95-27.4) to 43.4% (95% CI 30.8-52.3) [Hazard ratio-0.545; 95%CI 0.362-0.82; P=0.00358]. The median overall survival in MC and MC-I arms was 6.7 months (95%CI 5.83 -8.07) and 10.1 months (95%CI 7.37-12.63) respectively (P=0.0052). The median progression-free survival in MC and MC-I arms was 4.57 months (95%CI 4.2 -5.3) and 6.57 months (95%CI 4.43-8.9) respectively (P=0.0021). Response rate in MC and MC-I arm were 49.3% (95% CI 37.8-60.8) and 65.2% (95%CI 53.4-75.4) respectively (P=0.085). The rate of grade 3 and above adverse events was 50% and 46.1% in MC and MC-I arm respectively (P=0.744). Conclusions: In this first-ever randomised study, the addition of low dose nivolumab led to improved overall survival and is an alternative standard of care for those who cannot access full dose nivolumab. Clinical trial information: CTRI/2020/11/028953.
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