Urba S G, Forastiere A A, Wolf G T, Esclamado R M, McLaughlin P W, Thornton A F
University of Michigan Medical Center, Division of Oncology, Ann Arbor 48109-0374.
J Clin Oncol. 1994 May;12(5):946-53. doi: 10.1200/JCO.1994.12.5.946.
We designed a protocol to evaluate the possibility of organ preservation in patients with advanced, resectable carcinoma of the head and neck. The regimen consisted of intensive chemotherapy followed by radiation therapy alone for patients with good response to treatment. The end points of the study were response rate, organ preservation, toxicity, and survival.
Forty-two eligible patients with carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, and paranasal sinuses were enrolled. Induction chemotherapy consisted of three cycles of mitoguazone, fluorouracil (5-FU), and high-dose continuous infusion cisplatin. Patients who had a complete response to chemotherapy, or whose tumor was downstaged to T1N1, were treated with definitive radiation therapy, to a total dose of 66 to 73.8 Gy. Patients with residual disease greater than T1N1 underwent surgery and postoperative radiation.
The overall response rate to chemotherapy was 84%, with a 43% complete response rate, and a 68% complete response rate at the primary tumor site. Sixty-nine percent of patients (29 of 42) were initially spared surgery to the primary tumor site, and four of these patients (14%) required neck dissection only, after radiation therapy. These tumor sites included oral cavity, oropharynx, hypopharynx, larynx, and sinuses. Eventually, five of these patients (17%) required salvage surgery and eight patients (28%) had unresectable or metastatic relapses. With a median follow-up duration of 38.5 months, 36% of all patients have had preservation of the primary tumor site and remain disease-free. The median survival duration is 26.8 months. Toxicity was substantial, with a 70% incidence of grade 3 to 4 granulocytopenia and two septic deaths.
Organ preservation without apparent compromise of survival was achieved in patients with selected nonlaryngeal sites of head and neck carcinoma. Larger site-specific trials with less toxic regimens conducted in randomized fashion are required to extend these data.
我们设计了一项方案，以评估晚期可切除头颈部癌患者器官保留的可能性。该方案包括强化化疗，对治疗反应良好的患者随后仅接受放射治疗。研究的终点为缓解率、器官保留情况、毒性和生存率。
纳入42例符合条件的口腔、口咽、下咽、喉和鼻窦癌患者。诱导化疗包括三个周期的丙脒腙、氟尿嘧啶（5-FU）和大剂量持续输注顺铂。对化疗完全缓解或肿瘤降期至T1N1的患者接受根治性放射治疗，总剂量为66至73.8 Gy。残留疾病大于T1N1的患者接受手术及术后放疗。
化疗的总体缓解率为84%，完全缓解率为43%，原发肿瘤部位的完全缓解率为68%。69%的患者（42例中的29例）最初无需对原发肿瘤部位进行手术，其中4例患者（14%）在放疗后仅需进行颈部清扫。这些肿瘤部位包括口腔、口咽、下咽、喉和鼻窦。最终，这些患者中有5例（17%）需要挽救性手术，8例患者（28%）出现不可切除或转移性复发。中位随访时间为38.5个月，36%的患者保留了原发肿瘤部位且无疾病复发。中位生存时间为26.8个月。毒性反应较大，3至4级粒细胞减少的发生率为70%，有2例患者死于败血症。
在部分非喉部位的头颈部癌患者中实现了器官保留且未明显影响生存率。需要进行更大规模的、采用毒性较小方案的特定部位随机试验来拓展这些数据。
