Veronesi U, Adamus J, Bandiera D C, Brennhovd I O, Caceres E, Cascinelli N, Claudio F, Ikonopisov R L, Javorskj V V, Kirov S, Kulakowski A, Lacour J, Lejeune F, Mechl Z, Morabito A, Rodé I, Sergeev S, van Slooten E, Szczygiel K, Trapeznikov N N, Wagner R I
Tumori. 1980 Jun 30;66(3):373-96. doi: 10.1177/030089168006600311.
553 patients with stage I malignant melanoma of the limbs entered a prospective randomized clinical trial carried out by the W.H.O. Collaborating Centres for Evaluation of Methods of Diagnosis and Treatment of Melanoma from September 1967 to January 1974. 286 patients were submitted to wide excision of primary and node dissection at the time as appearance of regional lymph node metastases and 267 to wide excision and immediate node dissection. Survival was identical in the 2 groups. Different subsets of patients were evaluated to assess whether some groups of patients may benefit from immediate node dissection. As regards sex, females and a significantly higher survival rate than males (p < 0.05), but results were not improved by immediate node dissection. Maximum diameter and elevation of primary melanoma were significantly related to survival but also in these cases immediate node dissection did not achieve better results. 63 patients had an excisional biopsy of their melanoma within 4 weeks before final treatment. This procedure did not worsen survival and also in this case immediate node dissection did not improve survival. 273 cases were classified according to histologic type: survival of superficial spreading and nodular melanoma was not different at a statistically significant level after the 2 treatment modalities. 325 cases were considered classifiable according to Clark's levels, out of these 165 were submitted to immediate node dissection. Neither level III nor level IV cases showed higher survival rate after immediate node dissection. Maximum tumor thickness according to Breslow was evaluated in 338 cases: 188 were submitted to wide excision and immediate node dissection. In no clusters of thickness did the enlarged surgical procedure achieve better results. The authors conclude that there is good evidence that in stage I melanoma of the extremities delayed dissection.
1967年9月至1974年1月期间，553例肢体I期恶性黑色素瘤患者参加了世界卫生组织黑色素瘤诊断和治疗方法评估协作中心开展的一项前瞻性随机临床试验。286例患者在出现区域淋巴结转移时接受了原发灶广泛切除及淋巴结清扫，267例患者接受了广泛切除及即刻淋巴结清扫。两组患者的生存率相同。对不同亚组患者进行评估，以确定某些患者群体是否可能从即刻淋巴结清扫中获益。在性别方面，女性的生存率明显高于男性（p<0.05），但即刻淋巴结清扫并未改善结果。原发黑色素瘤的最大直径和隆起与生存率显著相关，但在这些情况下，即刻淋巴结清扫也未取得更好的效果。63例患者在最终治疗前4周内对其黑色素瘤进行了切除活检。该操作并未使生存率恶化，在这种情况下，即刻淋巴结清扫也未提高生存率。273例病例根据组织学类型进行分类：两种治疗方式后，浅表扩散型和结节型黑色素瘤的生存率在统计学上无显著差异。325例病例根据克拉克分级被认为可分类，其中165例接受了即刻淋巴结清扫。III级和IV级病例在即刻淋巴结清扫后均未显示出更高的生存率。根据布雷斯洛法评估了338例病例的最大肿瘤厚度：188例接受了广泛切除及即刻淋巴结清扫。在任何厚度组中，扩大的手术操作均未取得更好的效果。作者得出结论，有充分证据表明，在肢体I期黑色素瘤中，延迟清扫是可行的。
