Grégoire V, Beauduin M, Humblet Y, Hamoir M, Longueville J, Majois F, Remacle F M, Rousseau F, Salamon E, Wambersie A
Department of Radiation Oncology, Cliniques Universitaires St-Luc, Brussels; Belgium.
J Clin Oncol. 1991 Aug;9(8):1385-92. doi: 10.1200/JCO.1991.9.8.1385.
Eighty-three patients (median age, 56 years and Karnofsky performance status greater than or equal to 70) were treated with carboplatin (Carbo) and fluorouracil (5Fu) for stage III and IV head and neck squamous cell carcinoma (HNSCC). 5Fu (1 g/m2/d) was administered from day 1 to 4 by continuous infusion. Carbo was given on day 1 and, in order to evaluate its maximum-tolerated dose (MTD), the dose level was progressively increased from 250 mg/m2 to 450 mg/m2. The effectiveness of this association and its potential role in local control were also evaluated. Three patients received Carbo at a dose of 250 mg/m2, 13 received 300 mg/m2, one received 330 mg/m2, 12 received 350 mg/m2, six received 375 mg/m2, 26 received 400 mg/m2, 18 received 420 mg/m2, and four received 450 mg/m2. Two (13 of 83) or three courses (64 of 83), repeated every 4 weeks, were administered. The overall (primary tumor and node) response and complete response (CR) rates were 33% and 14%, respectively. For primary tumor, the response rate (RR) was 57% with 32% CR and 18% pathologic complete response (PCR); the RR was higher for patients with oropharyngeal tumor (76%, P = .037) and for patients treated with Carbo greater than or equal to 350 mg/m2 (65%, P = .02); the tumor size (T1 + T2 v T3 + T4) was a good prognostic factor for RR (90% v 46%, P = .001), CR (65% v 20%, P less than .001), and PCR (45% v 8%, P less than .001). For nodes, the RR was 33% with 11% CR. Grade 3-4 neutropenia and thrombocytopenia were experienced by 17% and 28% of the patients treated with 420 mg/m2 of Carbo and by 50% of the patients treated with 450 mg/m2. The MTD can be fixed at 420 mg/m2 and the proposed dose at 400 mg/m2. Thirty-eight patients were treated with surgery plus radiotherapy, 33 with radiotherapy alone, and seven with surgery alone. The median follow-up is 12 months. The 18-month disease-free survival (DFS) is 78% for overall complete responders and 39% for the others (P = .04). There is no primary tumor recurrence among the 12 patients with a primary tumor PCR treated by radiotherapy alone for tumor control (median follow-up, 17.3 months). The association of Carbo-5Fu is a safe induction chemotherapy regimen for HNSCC. The proposed dose of Carbo for future treatment is 400 mg/m2.(ABSTRACT TRUNCATED AT 400 WORDS)
83例患者（中位年龄56岁，卡氏评分≥70）接受卡铂（Carbo）和氟尿嘧啶（5Fu）治疗III期和IV期头颈部鳞状细胞癌（HNSCC）。5Fu（1 g/m²/天）于第1天至第4天持续输注给药。卡铂于第1天给药，为评估其最大耐受剂量（MTD），剂量水平从250 mg/m²逐步增至450 mg/m²。还评估了这种联合用药的有效性及其在局部控制中的潜在作用。3例患者接受250 mg/m²的卡铂，13例接受300 mg/m²，1例接受330 mg/m²，12例接受350 mg/m²，6例接受375 mg/m²，26例接受400 mg/m²，18例接受420 mg/m²，4例接受450 mg/m²。每4周重复进行两（83例中的13例）或三疗程（83例中的64例）治疗。总体（原发肿瘤和淋巴结）缓解率和完全缓解（CR）率分别为33%和14%。对于原发肿瘤，缓解率（RR）为57%，CR为32%，病理完全缓解（PCR）为18%；口咽肿瘤患者的RR更高（76%，P = 0.037），接受卡铂≥350 mg/m²治疗的患者RR更高（65%，P = 0.02）；肿瘤大小（T1 + T2与T3 + T）是RR（90%对46%，P = 0.001）、CR（65%对20%，P < 0.001）和PCR（45%对8%，P < 0.001）的良好预后因素。对于淋巴结，RR为33%，CR为11%。接受420 mg/m²卡铂治疗的患者中17%出现3 - 4级中性粒细胞减少和血小板减少，接受450 mg/m²治疗的患者中50%出现。MTD可确定为420 mg/m²，建议剂量为400 mg/m²。38例患者接受手术加放疗，33例仅接受放疗，7例仅接受手术。中位随访时间为12个月。总体完全缓解者的18个月无病生存率（DFS）为78%，其他患者为39%（P = 0.04）。在仅接受放疗以控制肿瘤（中位随访17.3个月）的12例原发肿瘤PCR患者中无原发肿瘤复发。卡铂 - 5Fu联合是HNSCC安全的诱导化疗方案。未来治疗建议的卡铂剂量为400 mg/m²。（摘要截断于400字）
