Basset-Seguin et al 2008

Title: Topical Methyl Aminolaevulinate Photodynamic Therapy versus Cryotherapy for Superficial Basal Cell Carcinoma: a 5 Year Randomized Trial

Author: Basset-Séguin N, Ibbotson SH, Emtestam L, Tarstedt M, Morton C, Maroti M, et al.

Journal Reference: Eur J Dermatol 2008;18(5):547-53 (by clicking on this link you will be leaving this site - Galderma is not responsible for the content)

Key statements:

  • MAL-PDT is as effective as cryotherapy with respect to lesion complete response and recurrence rate for sBCC, while giving a superior cosmetic outcome.
  • The lesion complete response is comparable at 3 months, and, over time, up to 5 years (75% with MAL-PDT vs. 74% with cryotherapy).
  • The recurrence rate is also comparable at any time during follow-up, with rates at 5 years of 22% with MAL PDT and 20% with cryotherapy.
  • Cosmetic outcome is significantly superior with MAL-PDT compared with cryotherapy, demonstrating an excellent outcome of 30% vs. 4% at 3 months and 60% vs. 16% at 5 years, respectively.
  • Treatment with MAL-PDT was well tolerated, with reported adverse events (AEs) at a similar level as with cryotherapy.

Objective: To compare the efficacy, safety and cosmetic outcome of Metvix® with cryotherapy for the treatment of primary superficial BCC, including lesion response and recurrence rates at 1, 2, 3, 4 and 5 years after last treatment.

Design: a multicenter (13 centers in seven European countries), randomized, parallel-group, prospective study.

  • Patients with up to 10 lesions (primary superficial basal cell carcinoma [sBCC]).
  • Metvix® (methyl aminolevulinate photodynamic therapy [MAL-PDT]): one treatment session (study conducted prior to
  • European regulatory approval of the treatment procedure of basal cell carcinoma [BCC] with two sessions 7 days apart).
  • Cryotherapy: double freeze/thaw cycle.

Lesion response evaluation (at 3 months):

  • Complete: complete disappearance of a lesion.
  • Non-complete: demarcated erythema, infiltration and crust. Lesions with non-complete response were treated again with either 2 Metvix® sessions 7 days apart or repeat double freeze-thaw cryotherapy and then evaluated 3 months later.

Clinical evaluation of lesion response and recurrence was performed at 1, 2, 3, 4 and 5 years after last treatment for all patients with lesions in complete response 3 months after the last treatment.

Cosmetic outcome was assessed for all patients who had shown a complete response in all lesions at 3 months after last treatment by both the investigator and patient at 3 months and 1 and 2 years, and by the investigator at 3, 4 and 5 years. Outcome was rated using a 4-point scale: excellent, good, fair and poor.

Key Results:

  • Lesion complete response rate was similar irrespective of lesion size or whether one or repeat treatments were given: 3 months, 97.1% with MAL PDT vs. 94.9% with cryotherapy; 5 years, 75% with MAL-PDT vs. 74% with cryotherapy.
  • Lesion recurrence rates: the two groups did not differ significantly at any time during follow-up. Recurrence rates at 5 years are 22% with Metvix® and 20% with cryotherapy. Recurrence rates 2 years after one treatment in sBCC (17%) were higher than those with nevoid basal cell carcinoma (nBBC) after two treatments (10%), as per Rhodes et al. (2004). This suggests that lesions treated with a single treatment are more vulnerable to recurrence than those initially treated with two sessions. Given that nBBC are more severe than sBCC, we could expect the sBBC recurrence rate with two treatments to go below the reported 10%.
  • Cosmetic outcome at any time from 3 months to 5 years was much better with Metvix® than cryotherapy.
  • Safety and tolerability: 73% of patients treated with Metvix® and 79% of patients treated with cryotherapy reported AEs.

Conclusion: the study provides evidence to support the use of Metvix® as an effective, non-invasive, selective treatment for superficial BCC with favorable cosmesis.