Schallier D C, De Neve W J, De Greve J L, Van Belle S P, De Wasch G J, Dotremont G, Storme G A
Department of Medical Oncology, Academisch Ziekenhuis, Vrije Universiteit Brussel, Belgium.
Clin Exp Metastasis. 1988 Jan-Feb;6(1):39-48. doi: 10.1007/BF01580405.
In order to study the usefulness of treatment with vinblastine (VLB) in the prevention of cancer metastasis in squamous cell lung cancer, 50 patients with locoregional disease were randomized to receive either locoregional RT alone (group A) or a weekly intravenous bolus injection of VLB (6 mg/m2) concurrently with and after locoregional radiotherapy (RT) (55 Gy in 6 weeks) until the appearance of metastases (group B). Neither the incidence of death with metastases, metastasis-free survival (MFS) nor overall survival (S) were significantly affected by treatment with the drug. However, due to the limited number of patients in each group, the power of the statistical test was such to allow only the detection of differences in MFS and S to or more than 80 per cent at the P = 0.05 level. Local tumor response was significantly superior in group B (P less than 0.05). Acute toxicity (dysphagia, myelosuppression) during RT was significantly worse in group B. During long-term therapy with VLB, mild polyneuropathy developed in the majority of patients in group B. Furthermore, seven patients discontinued treatment with VLB during maintenance due to compliance (4) and excessive neurotoxicity (3). This treatment schedule with VLB is not recommended for patients with locoregional squamous cell lung cancer as significant toxicity is present during and after RT and significant increase in MFS and S is lacking. Because of an apparent increase in local response, the combination of VLB and RT merits further investigation in those tumors where local tumor control is crucial.
为研究长春碱（VLB）治疗在预防肺鳞状细胞癌转移中的作用，将50例局部区域病变患者随机分为两组，A组仅接受局部区域放疗，B组在局部区域放疗（6周内55 Gy）期间及之后每周静脉推注VLB（6 mg/m²），直至出现转移。药物治疗对伴有转移的死亡率、无转移生存期（MFS）和总生存期（S）均无显著影响。然而，由于每组患者数量有限，统计检验效能仅能在P = 0.05水平检测到MFS和S中80%及以上的差异。B组局部肿瘤反应显著优于A组（P＜0.05）。放疗期间B组的急性毒性（吞咽困难、骨髓抑制）明显更严重。在VLB长期治疗期间，B组大多数患者出现轻度多发性神经病。此外，7例患者在维持治疗期间因依从性问题（4例）和神经毒性过大（3例）而停止VLB治疗。对于局部区域肺鳞状细胞癌患者，不推荐使用这种VLB治疗方案，因为放疗期间及之后存在明显毒性，且MFS和S无显著增加。由于局部反应明显增加，在局部肿瘤控制至关重要的肿瘤中，VLB与放疗联合应用值得进一步研究。
