外用甲基氨基乙酰丙酸光动力疗法与手术治疗结节性基底细胞癌的随机前瞻性试验的五年随访

Five-year follow-up of a randomized, prospective trial of topical methyl aminolevulinate photodynamic therapy vs surgery for nodular basal cell carcinoma.

作者信息

Rhodes Lesley E, de Rie Menno A, Leifsdottir Ragna, Yu Raymond C, Bachmann Ingeborg, Goulden Victoria, Wong Gavin A E, Richard Marie-Aleth, Anstey Alex, Wolf Peter

机构信息

Photobiology Unit, Department of Dermatology, University of Manchester, Salford Royal Foundation Hospital, Manchester M6 8HD, England.

出版信息

Arch Dermatol. 2007 Sep;143(9):1131-6. doi: 10.1001/archderm.143.9.1131.

DOI:10.1001/archderm.143.9.1131

PMID:17875873

Abstract

OBJECTIVE

To compare 5-year lesion recurrence rates in primary nodular basal cell carcinoma treated with topical methyl aminolevulinate photodynamic therapy (PDT) or simple excision surgery.

DESIGN

Prospective, randomized, multicenter study.

SETTING

University hospital dermatology departments.

PATIENTS

A total of 97 patients, 50 with 53 lesions treated with methyl aminolevulinate PDT and 47 with 52 lesions treated by excision surgery, were included in the per protocol analysis. Of the lesions treated with methyl aminolevulinate PDT and surgery, 49 and 52, respectively, showed complete clinical response at 3 months after treatment and were observed for long-term outcome evaluation.

INTERVENTIONS

Topical methyl aminolevulinate cream, 160 mg/g, applied for 3 hours before illumination (75 J/cm(2) of red light at 570 to 670 nm) on 2 or 4 occasions (12 [23%] of 53 lesions); or excision surgery.

MAIN OUTCOME MEASURES

Histologically confirmed lesion recurrence, sustained lesion complete response rate (time-to-event analysis), and investigator assessment of cosmetic outcome, 5 years after the last treatment.

RESULTS

At 5 years, recurrence was documented in 7 (14%) of 49 lesions (95% confidence interval [CI], 6%-27%) treated with methyl aminolevulinate PDT vs 2 (4%) of 52 lesions (95% CI, 1%-13%) treated with excision surgery (P = .09). Estimated sustained lesion complete response rates were 76% (95% CI, 59%-87%) and 96% (95% CI, 84%-99%), respectively (P = .01). More patients treated with methyl aminolevulinate PDT than surgery had an excellent or good cosmetic outcome: 27 (87%) of 31 patients (95% CI, 70%-96%) vs 19 (54%) of 35 patients (95% CI, 37%-71%) (P = .007).

CONCLUSIONS

Long-term follow-up indicates superior efficacy of surgery to methyl aminolevulinate PDT in nodular basal cell carcinoma. However, methyl aminolevulinate PDT is also an effective treatment for this indication and exhibits a more favorable cosmetic outcome.

摘要

目的

比较外用甲基氨基酮戊酸光动力疗法（PDT）或单纯切除手术治疗原发性结节性基底细胞癌的5年病灶复发率。

设计

前瞻性、随机、多中心研究。

地点

大学医院皮肤科。

患者

共有97例患者纳入符合方案分析，其中50例患者的53个病灶接受甲基氨基酮戊酸PDT治疗，47例患者的52个病灶接受切除手术治疗。在接受甲基氨基酮戊酸PDT和手术治疗的病灶中，分别有49个和52个在治疗后3个月显示出完全临床缓解，并进行长期结局评估。

干预措施

外用160mg/g甲基氨基酮戊酸乳膏，在光照（570至670nm波长的红光，75J/cm²）前涂抹3小时，进行2次或4次治疗（53个病灶中的12个[23%]）；或切除手术。

主要观察指标

最后一次治疗5年后经组织学证实的病灶复发、持续病灶完全缓解率（事件发生时间分析）以及研究者对美容效果的评估。

结果

5年后，接受甲基氨基酮戊酸PDT治疗的49个病灶中有7个（14%）出现复发（95%置信区间[CI]，6%-27%），而接受切除手术治疗的52个病灶中有2个（4%）出现复发（95%CI，1%-13%）（P = 0.09）。估计的持续病灶完全缓解率分别为76%（95%CI，59%-87%）和96%（95%CI，84%-99%）（P = 0.01）。接受甲基氨基酮戊酸PDT治疗的患者中，美容效果为优或良的患者比接受手术治疗的患者更多：31例患者中有27例（87%）（95%CI，70%-96%），而35例患者中有19例（54%）（95%CI，37%-71%）（P = 0.007）。