Pandey Kailash Chandra, Revannasiddaiah Swaroop, Pant Nirdosh Kumar, Nautiyal Vipul, Rastogi Madhup, Gupta Manoj Kumar
Department of Radiotherapy, Swami Rama Cancer Hospital & Research Institute, Government Medical College- Haldwani, Nainital, Uttarakhand, India.
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.
Indian J Palliat Care. 2013 Sep;19(3):139-45. doi: 10.4103/0973-1075.121522.
Among patients with locally advanced head and neck squamous cell cancers (LAHNSCC), the prognosis after nonresponse or progression despite induction chemotherapy (IC) is dismal, and further treatment is often palliative in intent. Given that nonresponse to chemotherapy could indicate subsequent radioresistance, we intended to assess the outcomes with two different fractionation schemes.
To compare the outcomes of two fractionation schemes- 'standard' (consisting 3GyX5 daily fractions for 2 consecutive weeks) versus 'hybrid' (6GyX3 fractions on alternate days during the 1(st) week, followed by 2GyX5 daily fractions in the 2(nd) week).
Prospective randomized controlled two-arm unblinded trial.
Patients with locally advanced oropharyngeal, laryngeal, and hypopharyngeal cancers treated with a minimum of two cycles of taxane, platinum, and fluorouracil-based IC were eligible if residual disease volume amounted <30 cm(3). Kaplan-Meier survival curves were compared by the log-rank test. Response rates were compared using the unpaired t-test. Quality of life (QOL) was measured via patient reported questionnaires.
Of the initially enrolled 51 patients, 45 patients (24 from standard arm, and 21 from the hybrid arm) were eligible for analysis. Despite being underpowered to attain statistical significance, there still seemed to be a trend towards improvement in progression-free (Hazard ratio (HR) for progression: 0.5966; 95% CI 0.3216-1.1066) and overall survival (HR for death: 0.6062; 95% CI 0.2676-1.3734) with the hybrid arm when compared to the standard arm. Benefits were also observed with regards to response rates and QOL. Rate of complications were similar in both arms.
In comparison to the routinely used palliative fractionation scheme of 30 Gray (Gy) in 10 fractions (Fr), the use of hybrid fractionation which integrates hypofractionation in the 1(st) week, followed by conventional fractionation in the 2(nd) week, could possibly offer better response rates, QOL increments, and potential survival benefits among LAHNSCC patients even after failing to respond to IC.
在局部晚期头颈部鳞状细胞癌(LAHNSCC)患者中,尽管进行了诱导化疗(IC)但无反应或病情进展后的预后很差,进一步治疗往往旨在缓解症状。鉴于对化疗无反应可能表明随后存在放射抵抗,我们打算评估两种不同分割方案的疗效。
比较两种分割方案的疗效——“标准”方案(连续2周每天5次分割,每次3Gy)与“混合”方案(第1周隔日3次分割,每次6Gy,随后第2周每天5次分割,每次2Gy)。
前瞻性随机对照双臂非盲试验。
接受至少两个周期基于紫杉烷、铂和氟尿嘧啶的IC治疗的局部晚期口咽癌、喉癌和下咽癌患者,若残余病灶体积小于30 cm³则符合条件。通过对数秩检验比较Kaplan-Meier生存曲线。使用未配对t检验比较缓解率。通过患者报告的问卷测量生活质量(QOL)。
最初纳入的51例患者中,45例患者(标准组24例,混合组21例)符合分析条件。尽管样本量不足无法达到统计学显著性,但与标准组相比,混合组在无进展生存期(进展风险比(HR):0.5966;95%可信区间0.3216 - 1.1066)和总生存期(死亡风险比(HR):0.6062;95%可信区间0.2676 - 1.3734)方面仍似乎有改善趋势。在缓解率和生活质量方面也观察到了益处。两组的并发症发生率相似。
与常规使用的10次分割共30格雷(Gy)的姑息性分割方案相比,采用第1周大分割随后第2周常规分割的混合分割方案,可能为LAHNSCC患者提供更好的缓解率、生活质量改善以及潜在的生存益处,即使这些患者对IC治疗无反应。