TY - JOUR
T1 - The effect of topical diclofenac 3% and calcitriol 3 mg/g on superficial basal cell carcinoma (sBCC) and nodular basal cell carcinoma (nBCC): A phase II, randomized controlled trial
AU - Brinkhuizen, Tjinta
AU - Frencken, Kiki J. A.
AU - Nelemans, Patricia
AU - Hoff, Marlou L. S.
AU - Kelleners-Smeets, Nicole W. J.
AU - zur Hausen, Axel
AU - van der Horst, Michiel P. J.
AU - Rennspiess, Dorit
AU - Winnepenninckx, Veronique 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 mu g/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 mu g/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
U2 - 10.1016/j.jaad.2016.01.050
DO - 10.1016/j.jaad.2016.01.050
M3 - Article
C2 - 27067393
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 -