Azli N, Fandi A, Bachouchi M, Rahal M, Lianes P, Wibault P, Boussen H, Eschwege F, Armand J P, Cvitkovic E
Institut Gustave Roussy, Savigny Le Temple, France.
Cancer J Sci Am. 1995 Sep-Oct;1(3):222-9.
This article presents an assessment of the combination of bleomycin, epirubicin, and cisplatin as induction chemotherapy before radiotherapy in the treatment of undifferentiated carcinoma of the nasopharyngeal type in patients with recurrent/metastatic disease (group A), and in previously untreated patients with locoregionally advanced disease (UICC-AJCC 87, N2-3, M0) (group B) in terms of toxicity, antitumoral activity, and therapeutic efficacy.
From January 1987 to September 1990, 111 consecutive patients with histologically proven UCNT were treated with six cycles of intravenous cisplatin (100 mg/m2 day 1) epirubicin (80 mg/m2 day 1), and bleomycin (15 mg bolus day 1), followed by 16 mg/m2/day continuous infusion for 5 days, repeated every 21 days for three cycles. Three further cycles without bleomycin were given to 44 patients in group A. In group B (67 patients), only three cycles of the same protocol were given, with a slightly lower dose of epirubicin (70 mg/m2), followed by conventional radiotherapy (70 Gy/7 weeks).
Of 44 patients entered in group A, 38 were evaluable for response. We observed 9 (20%) complete responses and 11 (25%) partial responses, for a 45% overall response rate. In 12 patients not previously given chemotherapy, there were 4 complete responses, compared to 5 complete responses in 32 patients previously treated with chemotherapy. Four patients are alive with no evidence of disease after 53+, 60+, 61+, and 72+ months. In group B the overall response rate to chemotherapy was 98% with 42 complete (62%) and 24 partial responses (36%). Three months after the end of radiotherapy, the overall complete response rate was 94% (63 patients). After a median follow-up time of 77 months (range, 53-94), the 4-year overall survival and disease-free survival rates for this group are 66% and 60%, respectively. The median disease-free survival has not been reached at 90 months.
The results of the BEC combination trial are very encouraging in metastatic and recurrrent UCNT, with durable remissions in this poor-prognosis population. The results in patients with locally advanced disease have motivated prospective phase III testing of the neoadjuvant chemotherapy approach to evaluate its impact on locoregionally advanced disease (> or =N2MO UICC-AJCC 87).
本文评估了博来霉素、表柔比星和顺铂联合作为诱导化疗方案，用于复发性/转移性疾病患者（A组）以及局部晚期未治疗患者（国际抗癌联盟-美国癌症联合委员会第8版，N2-3，M0）（B组）的鼻咽癌未分化型放射治疗前化疗，评估内容包括毒性、抗肿瘤活性和治疗效果。
1987年1月至1990年9月，111例经组织学证实为未分化鼻咽癌患者接受六个周期的静脉化疗，顺铂（100mg/m²，第1天）、表柔比星（80mg/m²，第1天）和博来霉素（15mg静脉推注，第1天），随后以16mg/m²/天持续输注5天，每21天重复一次，共三个周期。A组44例患者再接受三个周期不含博来霉素的化疗。B组（67例患者）仅接受三个周期相同方案化疗，表柔比星剂量略低（70mg/m²），随后进行常规放疗（70Gy/7周）。
A组44例患者中，38例可评估疗效。观察到9例（20%）完全缓解和11例（25%）部分缓解，总缓解率为45%。12例未接受过化疗的患者中有4例完全缓解，32例接受过化疗的患者中有5例完全缓解。4例患者分别在53+、60+、61+和72+个月后存活且无疾病证据。B组化疗总缓解率为98%，42例完全缓解（62%），24例部分缓解（36%）。放疗结束三个月后，总完全缓解率为94%（63例患者）。中位随访时间77个月（范围53-94个月），该组4年总生存率和无病生存率分别为66%和60%。90个月时未达到中位无病生存期。
博来霉素、表柔比星和顺铂联合化疗方案对转移性和复发性未分化鼻咽癌的治疗结果非常令人鼓舞，在这一预后不良人群中能产生持久缓解。局部晚期疾病患者的治疗结果促使对新辅助化疗方法进行前瞻性III期试验，以评估其对局部晚期疾病（国际抗癌联盟-美国癌症联合委员会第8版≥N2M0）的影响。
