de Castro Gilberto, Snitcovsky Igor Moisés Longo, Gebrim Eloísa Maria Mello Santiago, Leitão Glauber Moreira, Nadalin Wladimir, Ferraz Alberto Rossetti, Federico Miriam Hatsue Honda
Centro de Oncologia-InRad, Hospital das Clínicas da Faculdade de Medicina da USP, Av. Dr. Ovídio Pires de Campos, s/n-2o andar, São Paulo, SP, 05403-010, Brazil.
Eur Arch Otorhinolaryngol. 2007 Dec;264(12):1475-82. doi: 10.1007/s00405-007-0395-9. Epub 2007 Jul 21.
Unresectable head and neck squamous cell carcinoma (HNSCC), non-metastatic, comprises a heterogeneous group of patients (pts), formed of stage III and IV pts. Since the available literature had not distinguished among these two groups, we prospectively addressed whether the recommended regimen involving cisplatin 100 mg/m2 concurrent to conventionally delivered radiotherapy (RT) is feasible in stage IV pts, based on the efficacy and safety of this regimen. A total of 30 pts were enrolled onto this study. Chemoradiation (CRT) consisted of RT 70 Gy, delivered in 35 daily fractions of 2 Gy, in 7 weeks, concurrent to cisplatin 100 mg/m2 on days 1, 22 and 43. Supportive treatment was provided as needed. Twenty-eight pts had tumors staged as T4 and 20 had N2 or N3 cervical involvement. The most common primary sites were the oral cavity and the oropharynx (23 pts). We observed six complete responses and 12 partial responses, with an overall response rate of 60%. A high rate of treatment-related toxicities was observed, with three deaths during CRT, and 26 pts suffering from one or more grade 3/4 toxicities, mainly dysphagia, mucositis, dermatitis, vomiting, infection or anemia. A prolonged treatment time was observed (63 days), as a result of unplanned treatment breaks. The lack of requirement of red blood cell transfusion was favorably related to the response to the treatment (93% vs. 50%, P=0.033). For the whole population, with a median follow-up of 20.8 months, the median progression-free survival (PFS) was 8.0 months, and the median overall survival (OS) was 17.3 months. Longer median PFS and OS were seen in responding pts (12.8 vs. 4.1 months, P=0.0001; and not reached (NR) vs. 10.4 months, P=0.0037, respectively), as well as in those pts not requiring red blood cell transfusion (12.8 vs. 3.9 months, P=0.0162; and NR vs. 10.4 months, P=0.0176, respectively). In conclusion, this concurrent CRT regimen is hardly delivered in stage IV, unresectable, locally advanced HNSCC pts, due to treatment-related toxicities and longer RT duration. As a subset of pts may benefit from this regimen, adequate patient selection and aggressive supportive measures are essential.
不可切除的非转移性头颈部鳞状细胞癌（HNSCC）患者群体异质性较高，包括III期和IV期患者。由于现有文献未对这两组患者进行区分，我们基于该方案的疗效和安全性，前瞻性地探讨了推荐的顺铂100mg/m²与传统放疗（RT）同步进行的方案在IV期患者中是否可行。共有30例患者纳入本研究。放化疗（CRT）包括7周内每天2Gy分35次给予70Gy的放疗，同时在第1、22和43天给予顺铂100mg/m²。根据需要提供支持性治疗。28例患者肿瘤分期为T4，20例有N2或N3颈部淋巴结受累。最常见的原发部位是口腔和口咽（23例）。我们观察到6例完全缓解和12例部分缓解，总缓解率为60%。观察到较高的治疗相关毒性发生率，CRT期间有3例死亡，26例患者出现一种或多种3/4级毒性反应，主要为吞咽困难、黏膜炎、皮炎、呕吐、感染或贫血。由于计划外的治疗中断，观察到治疗时间延长（63天）。无需输注红细胞与治疗反应呈正相关（93%对50%，P =0.033）。对于总体人群，中位随访20.8个月，中位无进展生存期（PFS）为8.0个月，中位总生存期（OS）为17.3个月。缓解患者的中位PFS和OS更长（分别为12.8对4.1个月，P =0.0001；未达到（NR）对10.4个月，P =0.0037），无需输注红细胞的患者也是如此（分别为12.8对3.9个月，P =0.0162；NR对10.4个月，P =0.0176）。总之，由于治疗相关毒性和较长的放疗持续时间，这种同步CRT方案在IV期不可切除的局部晚期HNSCC患者中难以实施。由于部分患者可能从该方案中获益，因此进行充分的患者选择和积极的支持措施至关重要。
