The effect of topical diclofenac 3% and calcitriol 3 μg/g on superficial basal cell carcinoma (sBCC) and nodular basal cell carcinoma (nBCC): A phase II, randomized controlled trial

TY - JOUR

T1 - The effect of topical diclofenac 3% and calcitriol 3 μg/g on superficial basal cell carcinoma (sBCC) and nodular basal cell carcinoma (nBCC)

T2 - A phase II, randomized controlled trial

AU - Brinkhuizen, Tjinta

AU - Frencken, Kiki J A

AU - Nelemans, Patty J.

AU - Hoff, Marlou L S

AU - Kelleners-Smeets, Nicole W J

AU - Hausen, Axel zur

AU - van der Horst, Michiel P J

AU - Rennspiess, Dorit

AU - Winnepenninckx, Véronique J L

AU - van Steensel, Maurice A M

AU - Mosterd, Klara

PY - 2016/7

Y1 - 2016/7

N2 - Background: Nonsteroidal anti-inflammatory drugs and vitamin-D derivatives can target signaling pathways activated in basal cell carcinoma (BCC). Objective: We investigated the efficacy of topically applied diclofenac sodium 3% gel, calcitriol 3 μg/g ointment, and a combination of both in superficial BCC (sBCC) and nodular BCC. Methods: Patients with a primary, histologically proven sBCC (n = 64) or nodular BCC (n = 64) were randomized to topical diclofenac, calcitriol, combination of both, or no topical treatment (control group). After self-application twice daily under occlusion (8 weeks), tumors were excised. Primary outcome was posttreatment expression levels of proliferation (Ki-67) and antiapoptosis (B-cell lymphoma [Bcl-2]) immunohistochemical markers. Secondary outcomes were histologic clearance, adverse events, application-site reactions, and patient compliance. Results: sBCC treated with diclofenac showed a significant decrease in Ki-67 (P <.001) and Bcl-2 (P = .001), and after combination therapy for Ki-67 (P = .012). Complete histologic tumor regression was seen in 64.3% (P = .0003) of sBCC (diclofenac) and 43.8% (P = .007) of sBCC (combination therapy) compared with 0.0% of controls. No significant changes were found in nodular BCC. Application-site reactions were mostly mild to moderate. Limitations: The sample size was small. Conclusion: Our results suggest that topical diclofenac is a promising new treatment for sBCC. Its mode of action differs from available noninvasive therapies, and thus has an additive value.

AB - Background: Nonsteroidal anti-inflammatory drugs and vitamin-D derivatives can target signaling pathways activated in basal cell carcinoma (BCC). Objective: We investigated the efficacy of topically applied diclofenac sodium 3% gel, calcitriol 3 μg/g ointment, and a combination of both in superficial BCC (sBCC) and nodular BCC. Methods: Patients with a primary, histologically proven sBCC (n = 64) or nodular BCC (n = 64) were randomized to topical diclofenac, calcitriol, combination of both, or no topical treatment (control group). After self-application twice daily under occlusion (8 weeks), tumors were excised. Primary outcome was posttreatment expression levels of proliferation (Ki-67) and antiapoptosis (B-cell lymphoma [Bcl-2]) immunohistochemical markers. Secondary outcomes were histologic clearance, adverse events, application-site reactions, and patient compliance. Results: sBCC treated with diclofenac showed a significant decrease in Ki-67 (P <.001) and Bcl-2 (P = .001), and after combination therapy for Ki-67 (P = .012). Complete histologic tumor regression was seen in 64.3% (P = .0003) of sBCC (diclofenac) and 43.8% (P = .007) of sBCC (combination therapy) compared with 0.0% of controls. No significant changes were found in nodular BCC. Application-site reactions were mostly mild to moderate. Limitations: The sample size was small. Conclusion: Our results suggest that topical diclofenac is a promising new treatment for sBCC. Its mode of action differs from available noninvasive therapies, and thus has an additive value.

KW - Basal cell carcinoma

KW - Calcitriol

KW - Diclofenac

KW - Noninvasive

KW - Nonsteroidal anti-inflammatory drugs

KW - Targeted therapy

KW - Topical

KW - Vitamin D

UR - https://www.scopus.com/pages/publications/84962773672

U2 - 10.1016/j.jaad.2016.01.050

DO - 10.1016/j.jaad.2016.01.050

M3 - Article

C2 - 27067393

AN - SCOPUS:84962773672

SN - 0190-9622

VL - 75

SP - 126

EP - 134

JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

IS - 1

ER -