Essa Hoda H, Azzam Mohammed
The Departments of Oncology and Otolaryngology, Faculty of Medicine, Assuit University, Egypt.
J Egypt Natl Canc Inst. 2010 Sep;22(3):165-73.
Concurrent chemoradiotherapy is the standard of care for patients with unresectable locally advanced squamous cell carcinoma of head and neck (LASCCHN). The optimal chemotherapy agents and their dose schedules have yet to be defined. Cisplatin improves the anti-tumour efficacy of radiation therapy (RT) with 5-year loco-regional control rates between 35-70%. The last decade witnessed the introduction of new chemotherapeutic agents. Among these, taxane-based chemotherapies emerged as one of the most powerful compounds that might improve loco-regional control. The aim of this study was to compare the outcome and toxicity of weekly paclitaxel with weekly cisplatin-based concurrent chemoradiation in LA-SCCHN.
Fifty two untreated patients with LA-SCCHN were enrolled in a chemoradiation feasibility study in the Oncology Department, Assuit University Hospital, between the time period from November 2006 to September 2008 of whom forty one patients were eligible for the study. The patients were randomized into 2 groups; group I (21 patients) who received paclitaxel 30mg/m2 I.V 1 hour infusion weekly and group II (20 patients) received Cisplatin 30mg/m2, I.V 2 hours infusion weekly, both during the course of radiation therapy. All patients received 66-70Gy concurrent radiation using a linear accelerator with 6mv photons, at the rate of 2Gy/day, 5 fractions/week, over a period of 6-7 weeks. Response was assessed according to WHO criteria and toxicity according to Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria and NCI-CTC version 2.
Complete response was achieved in 57.1% of patients in group I and 50% of patients in group II while partial response was achieved in 28.6% in group I and 25% in group II. Thus, the objective overall response was 85.7% in group I versus 75% in group II with no statistically significant difference (p=0.3). The median duration of follow-up was 15 months in group I (range 9- 28 months) while it was 16.5 months for group II (range7- 29 months). The median progression free survival (PFS) was 26 months for group I and 22 months for group II. The 1-year PFS was 80.7% and 64% for group I and group II while the 2-year PFS were 52.2 and 41.1% for group I and group II respectively with no statistically significant difference (p=0.5). The median survival was 27 and 25 months for group I and II respectively. The1-year overall survival (OS) was 80.7% and 64.6% for group I and II while the 2-year OS was 58.4 and 46% for group I and group II respectively with no statistically significant difference (p=0.41). Treatment toxicities including skin reactions, mucositis and dysphagia were comparable in both groups and tolerable.
The results of weekly paclitaxel schedule in the treatment of LA-SCCHN were comparable to those of weekly cisplatin schedule with no additional efficacy. So, concurrent chemoradiotherapy with weekly paclitaxel is feasible when contraindication to cisplatin exists as in cases of fear of hearing loss or renal disease.
Chemoradiation - Paclitaxel - Cisplatin - Locally advanced head and neck cancers.
同步放化疗是不可切除的局部晚期头颈部鳞状细胞癌(LASCCHN)患者的标准治疗方案。最佳化疗药物及其剂量方案尚未确定。顺铂可提高放射治疗(RT)的抗肿瘤疗效,5年局部区域控制率在35%-70%之间。过去十年引入了新的化疗药物。其中,紫杉烷类化疗药物成为可能改善局部区域控制的最有效化合物之一。本研究的目的是比较每周紫杉醇与每周顺铂同步放化疗在LA-SCCHN中的疗效和毒性。
2006年11月至2008年9月期间,52例未经治疗的LA-SCCHN患者在阿斯尤特大学医院肿瘤科参加了一项放化疗可行性研究,其中41例患者符合研究条件。患者被随机分为2组;第一组(21例患者)每周静脉输注紫杉醇30mg/m²,输注1小时,第二组(20例患者)每周静脉输注顺铂30mg/m²,输注2小时,均在放射治疗过程中进行。所有患者使用6MV光子的直线加速器进行66-70Gy的同步放疗,剂量率为2Gy/天,每周5次,持续6-7周。根据WHO标准评估反应,根据放射治疗肿瘤学组(RTOG)急性放射发病率评分标准和NCI-CTC第2版评估毒性。
第一组57.1%的患者和第二组50%的患者达到完全缓解,而第一组28.6%的患者和第二组25%的患者达到部分缓解。因此,第一组的客观总缓解率为85.7%,第二组为75%,无统计学显著差异(p=0.3)。第一组的中位随访时间为15个月(范围9-28个月),第二组为16.5个月(范围7-29个月)。第一组的中位无进展生存期(PFS)为26个月,第二组为22个月。第一组和第二组的1年PFS分别为80.7%和64%,而第一组和第二组的2年PFS分别为52.2%和4;1%,无统计学显著差异(p=0.5)。第一组和第二组的中位生存期分别为27个月和25个月。第一组和第二组的1年总生存期(OS)分别为80.7%和64.6%,而第一组和第二组的2年OS分别为58.4%和46%,无统计学显著差异(p=0.41)。两组的治疗毒性包括皮肤反应、粘膜炎和吞咽困难具有可比性且可耐受。
每周紫杉醇方案治疗LA-SCCHN的结果与每周顺铂方案相当,无额外疗效。因此,当存在顺铂禁忌证(如担心听力丧失或肾病)时,每周紫杉醇同步放化疗是可行的。
放化疗;紫杉醇;顺铂;局部晚期头颈部癌