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| 交替治疗疗程对头颈部癌症来说是有潜力的 | |
| （瑞典斯德哥尔摩）－研究者於第33届欧洲肿瘤医学会年会中报告，以交替治疗疗程包括化学治疗与放射线治疗，加上cetuxiimab，处理局部进展性头颈部癌症，其研究结果是有潜力的。在这群病患中，可评估的受试者都有反应，除了局部皮肤炎的高发生率之外，其毒性与该族群使用化学治疗及放射线治疗所观察到的差不多。 比利时Libre de Bruxelles大学肿瘤学教授、同时也是欧洲癌症研究与治疗组织总裁Martine Piccart-Gebhart医师表示，这些研究结果是非常有潜力的，现在我们必须进行一项大型研究来证实这些结果是无误的。 研究作者、来自义大利柯奈尔S. Croce综合医院的Marco Merland医师指出，头颈部癌症的治疗在过去几十年来已经有长足进步，且治疗选择越来越多，我们确实需要各学门的整合治疗。 结合化学治疗药物，例如铂金类药物，fluorouracil或是cetuximab，以及放射线治疗已经证实对於局部头颈部癌症有效，但是该疗程与毒性有关。然而，Merlano医师解释，交替化学治疗和放射线治疗已经证实与仅使用放射线治疗的毒性相似。 快速轮替的化学疗法与放射线治疗是同时进行化学放射线治疗的变异，在这项第二期临床研究中，Merland医师与其同事评估45位罹患来自咽喉、口腔与咽喉下的扁皮恶性肿瘤，接受轮替治疗的效果与毒性，大部分的病患（84%）罹患第四期疾病。 化学治疗包括了20 mg/m2的carboplatin 20 mg/m2、fluorouracil 200 mg/m2，在第1、4、7週从第1天投予到第5天；放射线治疗以每週10葛雷，在第2、5、8週，每日分成5次投予，最多达70葛雷。除此之外，在合併疗法时每週加上cetuximab（Erbitux，ImClone系统有限公司/必治妥/默克KGaA）。 研究者於第3个月时评估对於治疗的反应，共有40位病患接受完整的反应评估（其中1位病患拒绝接受评估，而另一位病患过早接受评估）。30位病患观察到完全反应，10位病患观察到部分反应。在这个族群中，免於恶化的存活时间超过21个月，而整体存活时间超过23个月。 毒性的发生机率是相当高的，65%病患发生第三级的口腔炎，29%病患发生第三级的败血症/肺炎。发生第三级血液毒性的机率也显著较高，其中3位病患死於相关毒性。 虽然研究者同意这些不良反应一样可以在头颈部癌症化学放射线治疗上看到，但很大百分比的病患意外地罹患皮肤炎。32位病患罹患第三级局部皮肤炎（佔该族群71%），11位（24%）病患发生第二级皮肤炎。仅有2位病患（4%）发生全身性红疹。 在这项研究的讨论会中，纽西兰Nijmegen Radboud大学Nijmegen医学中心的Carla van Herpen医师，他对於毒性相关死亡事件的高比率感到担忧；她表示，因毒性事件而死亡的事件在第二期临床研究通常是很低的，因为受试者挑选地比第三期临床研究严，因此，在第三期临床研究中，毒性反应的数字将会更高。 Alternating Treatment Regimen Shows Promise in Head and Neck Cancer (Stockholm, Sweden) — Treating locally advanced head and neck cancers with an alternating regimen of chemotherapy and radiotherapy, in addition to cetuximab, has demonstrated promising results, researchers reported here at the 33rd European Society for Medical Oncology Congress. All of the evaluable patients in the cohort experienced a response and, aside from a high rate of localized dermatitis, toxicities were in the range of those generally observed with chemotherapy and radiotherapy in this population. \"These results are very promising but they are not controlled,\" commented Martine Piccart-Gebhart, MD, PhD, professor of oncology at the Universit?Libre de Bruxelles, in Belgium, and current president of the European Organisation for Research and Treatment of Cancer. \"Now we must set up a large trial to prove that these results are valid.\" Treatment for head and neck cancer has evolved over the past decade and an increasing number of options have emerged. \"The treatment of head and neck cancer requires the cooperation of many specialties,\" said study author Marco Merlano, MD, from the S. Croce General Hospital, in Cuneo, Italy. \"We really need a multidisciplinary approach.\" Combining chemotherapeutic agents, such as platinum, fluorouracil, or cetuximab, with concurrent radiotherapy has shown activity in locally advanced head and neck cancers, but the regimen is associated with excessive toxicity. However, explained Dr. Merlano, treatment with alternating chemotherapy and radiation has demonstrated a toxicity profile that is similar to that of radiation therapy alone. Rapidly alternating chemotherapy and radiotherapy is a variation of concurrent chemoradiation, and in this phase?2 trial, Dr. Merlano and colleagues evaluated the efficacy and toxicity of alternating treatment in 45 patients with squamous cell carcinoma tumors arising from the larynx, oral cavity, oropharynx, and hypopharynx. The majority of patients (84%) had stage?4 disease. Chemotherapy consisted of 20?mg/m2 carboplatin and 200?mg/m2 fluorouracil, administered from day 1?to day?5 on weeks 1, 4, and 7. Radiation therapy consisted of 10?Gy/week in 5 daily fractions on weeks 2?, 5?, and 8?0, up to 70?Gy. In addition, cetuximab (Erbitux, ImClone Systems Inc/Bristol-Myers Squibb/Merck KGaA) was added every week during the combination therapy. The researchers assessed patient response to the therapy at 3 months, and 40 patients were available for a full evaluation of response (1 patient refused and it was too early to assess another patient). A complete response was observed in 30 patients, and a partial response in 10 patients. Progression-free survival was more than 21 months and overall survival was more than 23 months in this cohort. The rate of toxicity was fairly high, with 65% experiencing grade?3? stomatitis and 29% experiencing grade 3? sepsis/pneumonia. There were also a significant number of grade?3? hematologic adverse events, and 3?patient deaths were related to toxicity. Although the researchers agree that these adverse events are in line with what can be expected with chemoradiation in head and neck cancer, the large percentage of patients with dermatitis came as a surprise. Grade?3 localized dermatitis was experienced by 32 patients (71% of the cohort), and grade?2 dermatitis was experienced by 11 patients (24%). Only 2 patients (4%) experienced a systemic rash. During a discussion of the study, Carla van Herpen, MD, from Radboud University Nijmegen Medical Center, in Nijmegen, the Netherlands, expressed concern about the high rate of toxic deaths. \"Toxic deaths are usually lower in phase?2 trials because the patient population is more selected than in a phase?3 study,\" she said. \"In a phase?3 trial, then, this rate may be even higher.\" 33rd European Society of Medical Oncology (ESMO) Congress: Abstract 694PD. Presented September 14, 2008. 发布时间：2008年09月24日 |
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