Shin D M, Glisson B S, Khuri F R, Ginsberg L, Lawhorn K, Hong W K, Lippman S M
Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
Semin Oncol. 1997 Dec;24(6 Suppl 19):S19-33-S19-37.
Current chemotherapeutic approaches to recurrent or metastatic head and neck cancer have yielded response rates of 10% to 20% for single agents and 30% to 40% for combination chemotherapy. Median survival for patients with recurrent or metastatic disease treated with single agents or combination chemotherapy is between 4 and 6 months. Investigation of new drugs, therefore, has high priority among clinicians and researchers. One new agent that has been effective as single-agent therapy is paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ). We tested the combination of paclitaxel, ifosfamide, and cisplatin in recurrent or metastatic head and neck cancer. The starting dose of paclitaxel was 175 mg/m2 as a 3-hour infusion on day 1, ifosfamide 1 g/m2 as a 2-hour infusion on days 1 to 3, and cisplatin 60 mg/m2 via 2-hour infusion on day 1. This schedule was repeated every 3 weeks. Sixty-five patients were entered into the study and 62 patients are currently evaluable for response and toxicity in the phase I and phase II portions of this study. We observed 10 (16%) complete responses and 24 (39%) partial responses. The overall response rate was 55% in phases I/II of this interim analysis. In the phase II part alone, we have observed eight (16%) complete responses and 22 (44%) partial responses to date among 50 evaluable patients. Median survival times were 8.9 months for all patients and 9.7 months for patients in the phase II part of the study. Preliminary results demonstrate significant antitumor activity in patients with recurrent or metastatic head and neck cancer. The paclitaxel/ifosfamide/cisplatin regimen was well tolerated. Chemotherapy with paclitaxel/ifosfamide/cisplatin should be tested as an induction regimen in patients with locally advanced head and neck cancer. It also warrants testing in a randomized setting to compare it with a standard regimen, such as the combination of 5-fluorouracil and cisplatin.
目前针对复发性或转移性头颈癌的化疗方法，单药治疗的缓解率为10%至20%，联合化疗的缓解率为30%至40%。接受单药或联合化疗的复发性或转移性疾病患者的中位生存期在4至6个月之间。因此，新药研究在临床医生和研究人员中具有高度优先性。一种作为单药治疗有效的新药是紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）。我们测试了紫杉醇、异环磷酰胺和顺铂联合用于复发性或转移性头颈癌的疗效。紫杉醇的起始剂量为175mg/m²，在第1天静脉输注3小时，异环磷酰胺1g/m²，在第1至3天静脉输注2小时，顺铂60mg/m²在第1天静脉输注2小时。该方案每3周重复一次。65例患者进入本研究，目前有62例患者可在本研究的I期和II期部分进行疗效和毒性评估。我们观察到10例（16%）完全缓解和24例（39%）部分缓解。在本次中期分析的I/II期，总缓解率为55%。仅在II期部分，在50例可评估患者中，迄今为止我们观察到8例（约16%）完全缓解和22例（44%）部分缓解。所有患者的中位生存时间为8.9个月，研究II期部分患者的中位生存时间为9.7个月。初步结果表明，该方案对复发性或转移性头颈癌患者具有显著的抗肿瘤活性。紫杉醇/异环磷酰胺/顺铂方案耐受性良好。紫杉醇/异环磷酰胺/顺铂化疗应作为局部晚期头颈癌患者的诱导方案进行测试。它也有必要在随机对照试验中进行测试，以与标准方案（如5-氟尿嘧啶和顺铂联合方案）进行比较。
