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Klara Mosterd - One of the best experts on this subject based on the ideXlab platform.

  • surgery versus combined treatment with curettage and Imiquimod for nodular basal cell carcinoma one year results of a noninferiority randomized controlled trial
    2020
    Co-Authors: Kelly A E Sinx, Patty J Nelemans, Nicole W J Kellenerssmeets, Veronique Winnepenninckx, Aimee H M M Arits, Klara Mosterd
    Abstract:

    Purpose Nodular basal cell carcinoma (nBCC) is mostly treated with surgical excision. Interest in minimally invasive treatment of these low-risk tumors is increasing. We assessed the effectiveness of nBCC treatment with curettage and Imiquimod cream compared with surgical excision. Methods Patients with nBCC included in this randomized, controlled noninferiority trial were randomly assigned to either a curettage and Imiquimod cream group or a surgical excision group. The primary endpoint was the proportion of patients free from treatment failure 1 year after the end of treatment. A prespecified noninferiority margin of 8% was used. A modified intention-to-treat and a per-protocol analysis was performed ( ClinicalTrials.gov identifier NCT02242929 ). Results One hundred forty-five patients were randomized: 73 to the curettage and Imiquimod cream group and 72 to the surgical excision group. The proportion of patients free of recurrence after 12 months was 86.3% (63/73) for the curettage and Imiquimod group and 100% (72/72) for the surgical excision group. The difference in efficacy was −13.7% (95% confidence interval −21.6% to −5.8%; 1-sided P = .0004) favoring surgical excision. Conclusion Noninferiority of curettage and Imiquimod cream cannot be concluded. Given the still high efficacy of curettage and Imiquimod cream and the indolent growth pattern of nBCC, curettage and Imiquimod could still be a valuable treatment option with the possibility to prevent overuse of excisions. However, it cannot replace surgical excision.

  • five year results of a randomized controlled trial comparing effectiveness of photodynamic therapy topical Imiquimod and topical 5 fluorouracil in patients with superficial basal cell carcinoma
    2017
    Co-Authors: Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Anja Sommer, Maud H E Jansen, Brigitte A B Essers
    Abstract:

    For the treatment of superficial basal cell carcinoma, a prospective, noninferiority, randomized controlled multicenter trial with 601 patients showed that 5% Imiquimod cream was superior and 5-fluorouracil cream not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) at 1 and 3 years after treatment. No definite conclusion could be drawn regarding the superiority of Imiquimod over 5-fluorouracil. We now present the 5-year follow-up results according to the intention-to-treat analysis. Five years after treatment, the probability of tumor-free survival was 62.7% for methyl aminolevulinate photodynamic therapy (95% confidence interval [CI] = 55.3–69.2), 80.5% for Imiquimod (95% CI = 74.0–85.6), and 70.0% for 5-fluorouracil (95% CI = 62.9–76.0). The hazard ratio for treatment failure of Imiquimod and 5-fluorouracil were 0.48 (95% CI = 0.32–0.71, P

  • three year follow up results of photodynamic therapy vs Imiquimod vs fluorouracil for treatment of superficial basal cell carcinoma a single blind noninferiority randomized controlled trial
    2016
    Co-Authors: Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Brigitte A B Essers, Anja Sommer, Michette J M De Rooij, Patricia J F Quaedvlieg
    Abstract:

    A randomized controlled trial including 601 patients previously showed that the effectiveness of Imiquimod and fluorouracil cream were not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) in patients with superficial basal cell carcinoma after 1 year of follow-up. We now present the 3-year follow-up results. The probability of tumor-free survival at 3 years post-treatment was 58.0% for MAL-PDT (95% confidence interval [CI] = 47.8–66.9), 79.7% for Imiquimod (95% CI = 71.6–85.7), and 68.2% for fluorouracil (95% CI = 58.1–76.3). The hazard ratio for treatment failure comparing Imiquimod with MAL-PDT was 0.50 (95% CI = 0.33–0.76, P  = 0.001). Comparison of fluorouracil with MAL-PDT and fluorouracil with Imiquimod showed hazard ratios of 0.73 (95% CI = 0.51–1.05, P  = 0.092) and 0.68 (95% CI = 0.44–1.06, P  = 0.091), respectively. Subgroup analysis showed a higher probability of treatment success for Imiquimod versus MAL-PDT in all subgroups with the exception of elderly patients with superficial basal cell carcinoma on the lower extremities. In this subgroup, the risk difference in tumor-free survival was 57.6% in favor of MAL-PDT. In conclusion, according to results at 3 years post-treatment, Imiquimod is superior and fluorouracil not inferior to MAL-PDT in treatment of superficial basal cell carcinoma.

  • photodynamic therapy vs topical Imiquimod for treatment of superficial basal cell carcinoma a subgroup analysis within a noninferiority randomized controlled trial
    2015
    Co-Authors: Patty J Nelemans, Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Peter M Steijlen, Nicole W J Kellenerssmeets
    Abstract:

    SummaryBackground A recent noninferiority randomized controlled trial (RCT) indicated that Imiquimod can be considered as superior to methylaminolevulinate photodynamic therapy (MAL-PDT) in the treatment of superficial basal cell carcinoma (sBCC). Knowledge of treatment effectiveness in subgroups of patients is of great value in clinical practice to select the most effective treatment for an individual patient with sBCC. Objectives To explore whether the relative treatment effect of MAL-PDT and Imiquimod is consistent across subgroups defined by patient and tumour characteristics. Methods Data were derived from a single-blinded, noninferiority, multicentre RCT comparing MAL-PDT, topical Imiquimod and fluorouracil (ISRCTN79701845). Treatment success was defined as free of tumour recurrence at 12-month follow-up. Subgroup analyses were performed for subgroups defined by sex, age, tumour location and tumour size. Results Two hundred and two patients received MAL-PDT and 198 received Imiquimod. The superiority of Imiquimod vs. MAL-PDT was observed in subgroups of females, sBCC on the trunk and large tumours with risk differences in favour of Imiquimod of 18·4% [95% confidence interval (CI) 7·8–29·0%], 21·0% (95% CI 10·9–31·1%) and 18·9% (95% CI 7·1–30·7%), respectively. Higher probability of treatment success for Imiquimod vs. MAL-PDT was consistently found in all other subgroups with the exception of sBCC localized on the lower extremities in older patients. In the latter subgroup, the risk difference at the expense of Imiquimod was −57·3% (95% CI −81·7% to −32·9%). Conclusions Imiquimod remains the first-choice treatment for sBCC in terms of effectiveness. In older patients with sBCC on the lower extremities MAL-PDT might be preferred. Results should be interpreted carefully as subgroup analyses were exploratory and not driven by prior hypotheses.

  • cost effectiveness of topical Imiquimod and fluorouracil vs photodynamic therapy for treatment of superficial basal cell carcinoma
    2014
    Co-Authors: Patty J Nelemans, Nicole W J Kellenerssmeets, Aimee H M M Arits, Klara Mosterd, E Spoorenberg, Brigitte A B Essers
    Abstract:

    Background A recent noninferiority randomized trial showed that in terms of clinical effectiveness Imiquimod was superior and topical fluorouracil noninferior to methylaminolaevulinate photodynamic therapy (MAL-PDT) for treatment of superficial basal-cell carcinoma (sBCC). Although it was expected that MAL-PDT would be more costly than either cream, a full cost-effectiveness analysis is necessary to determine the balance between effectiveness and costs. Objective To determine whether Imiquimod or topical fluorouracil are cost-effective treatments for sBCC compared with MAL-PDT. Methods An economic evaluation was performed from a healthcare perspective. Data on resource use and costs were collected alongside the randomized clinical trial. The incremental cost-effectiveness ratio was expressed as the incremental costs per additional patient free of tumour recurrence. Results At 12 months follow-up, the total mean costs for MAL-PDT were (sic)680, for Imiquimod cream (sic)526 and for topical fluorouracil cream (sic)388. Both Imiquimod and topical fluorouracil were cost-effective treatments compared with MAL-PDT. Comparing costs and effectiveness of both creams led to a incremental investment of (sic)4451 to achieve an additional patient free of tumour recurrence. The acceptability curve showed that, for a threshold value of _ 4451, the probability of Imiquimod being more cost-effective than topical fluorouracil was 50%. Conclusion Based on the 12 months follow-up results, Imiquimod and topical fluorouracil cream are more cost-effective than MAL-PDT for treatment of sBCC. Hence, substituting MAL-PDT with either Imiquimod or topical fluorouracil results in cost savings; these savings will be larger for topical fluorouracil. Longterm follow-up effectiveness data are necessary to confirm the cost-effectiveness of Imiquimod vs. topical 5-fluorouracil cream.

Aimee H M M Arits - One of the best experts on this subject based on the ideXlab platform.

  • surgery versus combined treatment with curettage and Imiquimod for nodular basal cell carcinoma one year results of a noninferiority randomized controlled trial
    2020
    Co-Authors: Kelly A E Sinx, Patty J Nelemans, Nicole W J Kellenerssmeets, Veronique Winnepenninckx, Aimee H M M Arits, Klara Mosterd
    Abstract:

    Purpose Nodular basal cell carcinoma (nBCC) is mostly treated with surgical excision. Interest in minimally invasive treatment of these low-risk tumors is increasing. We assessed the effectiveness of nBCC treatment with curettage and Imiquimod cream compared with surgical excision. Methods Patients with nBCC included in this randomized, controlled noninferiority trial were randomly assigned to either a curettage and Imiquimod cream group or a surgical excision group. The primary endpoint was the proportion of patients free from treatment failure 1 year after the end of treatment. A prespecified noninferiority margin of 8% was used. A modified intention-to-treat and a per-protocol analysis was performed ( ClinicalTrials.gov identifier NCT02242929 ). Results One hundred forty-five patients were randomized: 73 to the curettage and Imiquimod cream group and 72 to the surgical excision group. The proportion of patients free of recurrence after 12 months was 86.3% (63/73) for the curettage and Imiquimod group and 100% (72/72) for the surgical excision group. The difference in efficacy was −13.7% (95% confidence interval −21.6% to −5.8%; 1-sided P = .0004) favoring surgical excision. Conclusion Noninferiority of curettage and Imiquimod cream cannot be concluded. Given the still high efficacy of curettage and Imiquimod cream and the indolent growth pattern of nBCC, curettage and Imiquimod could still be a valuable treatment option with the possibility to prevent overuse of excisions. However, it cannot replace surgical excision.

  • five year results of a randomized controlled trial comparing effectiveness of photodynamic therapy topical Imiquimod and topical 5 fluorouracil in patients with superficial basal cell carcinoma
    2017
    Co-Authors: Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Anja Sommer, Maud H E Jansen, Brigitte A B Essers
    Abstract:

    For the treatment of superficial basal cell carcinoma, a prospective, noninferiority, randomized controlled multicenter trial with 601 patients showed that 5% Imiquimod cream was superior and 5-fluorouracil cream not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) at 1 and 3 years after treatment. No definite conclusion could be drawn regarding the superiority of Imiquimod over 5-fluorouracil. We now present the 5-year follow-up results according to the intention-to-treat analysis. Five years after treatment, the probability of tumor-free survival was 62.7% for methyl aminolevulinate photodynamic therapy (95% confidence interval [CI] = 55.3–69.2), 80.5% for Imiquimod (95% CI = 74.0–85.6), and 70.0% for 5-fluorouracil (95% CI = 62.9–76.0). The hazard ratio for treatment failure of Imiquimod and 5-fluorouracil were 0.48 (95% CI = 0.32–0.71, P

  • three year follow up results of photodynamic therapy vs Imiquimod vs fluorouracil for treatment of superficial basal cell carcinoma a single blind noninferiority randomized controlled trial
    2016
    Co-Authors: Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Brigitte A B Essers, Anja Sommer, Michette J M De Rooij, Patricia J F Quaedvlieg
    Abstract:

    A randomized controlled trial including 601 patients previously showed that the effectiveness of Imiquimod and fluorouracil cream were not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) in patients with superficial basal cell carcinoma after 1 year of follow-up. We now present the 3-year follow-up results. The probability of tumor-free survival at 3 years post-treatment was 58.0% for MAL-PDT (95% confidence interval [CI] = 47.8–66.9), 79.7% for Imiquimod (95% CI = 71.6–85.7), and 68.2% for fluorouracil (95% CI = 58.1–76.3). The hazard ratio for treatment failure comparing Imiquimod with MAL-PDT was 0.50 (95% CI = 0.33–0.76, P  = 0.001). Comparison of fluorouracil with MAL-PDT and fluorouracil with Imiquimod showed hazard ratios of 0.73 (95% CI = 0.51–1.05, P  = 0.092) and 0.68 (95% CI = 0.44–1.06, P  = 0.091), respectively. Subgroup analysis showed a higher probability of treatment success for Imiquimod versus MAL-PDT in all subgroups with the exception of elderly patients with superficial basal cell carcinoma on the lower extremities. In this subgroup, the risk difference in tumor-free survival was 57.6% in favor of MAL-PDT. In conclusion, according to results at 3 years post-treatment, Imiquimod is superior and fluorouracil not inferior to MAL-PDT in treatment of superficial basal cell carcinoma.

  • photodynamic therapy vs topical Imiquimod for treatment of superficial basal cell carcinoma a subgroup analysis within a noninferiority randomized controlled trial
    2015
    Co-Authors: Patty J Nelemans, Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Peter M Steijlen, Nicole W J Kellenerssmeets
    Abstract:

    SummaryBackground A recent noninferiority randomized controlled trial (RCT) indicated that Imiquimod can be considered as superior to methylaminolevulinate photodynamic therapy (MAL-PDT) in the treatment of superficial basal cell carcinoma (sBCC). Knowledge of treatment effectiveness in subgroups of patients is of great value in clinical practice to select the most effective treatment for an individual patient with sBCC. Objectives To explore whether the relative treatment effect of MAL-PDT and Imiquimod is consistent across subgroups defined by patient and tumour characteristics. Methods Data were derived from a single-blinded, noninferiority, multicentre RCT comparing MAL-PDT, topical Imiquimod and fluorouracil (ISRCTN79701845). Treatment success was defined as free of tumour recurrence at 12-month follow-up. Subgroup analyses were performed for subgroups defined by sex, age, tumour location and tumour size. Results Two hundred and two patients received MAL-PDT and 198 received Imiquimod. The superiority of Imiquimod vs. MAL-PDT was observed in subgroups of females, sBCC on the trunk and large tumours with risk differences in favour of Imiquimod of 18·4% [95% confidence interval (CI) 7·8–29·0%], 21·0% (95% CI 10·9–31·1%) and 18·9% (95% CI 7·1–30·7%), respectively. Higher probability of treatment success for Imiquimod vs. MAL-PDT was consistently found in all other subgroups with the exception of sBCC localized on the lower extremities in older patients. In the latter subgroup, the risk difference at the expense of Imiquimod was −57·3% (95% CI −81·7% to −32·9%). Conclusions Imiquimod remains the first-choice treatment for sBCC in terms of effectiveness. In older patients with sBCC on the lower extremities MAL-PDT might be preferred. Results should be interpreted carefully as subgroup analyses were exploratory and not driven by prior hypotheses.

  • cost effectiveness of topical Imiquimod and fluorouracil vs photodynamic therapy for treatment of superficial basal cell carcinoma
    2014
    Co-Authors: Patty J Nelemans, Nicole W J Kellenerssmeets, Aimee H M M Arits, Klara Mosterd, E Spoorenberg, Brigitte A B Essers
    Abstract:

    Background A recent noninferiority randomized trial showed that in terms of clinical effectiveness Imiquimod was superior and topical fluorouracil noninferior to methylaminolaevulinate photodynamic therapy (MAL-PDT) for treatment of superficial basal-cell carcinoma (sBCC). Although it was expected that MAL-PDT would be more costly than either cream, a full cost-effectiveness analysis is necessary to determine the balance between effectiveness and costs. Objective To determine whether Imiquimod or topical fluorouracil are cost-effective treatments for sBCC compared with MAL-PDT. Methods An economic evaluation was performed from a healthcare perspective. Data on resource use and costs were collected alongside the randomized clinical trial. The incremental cost-effectiveness ratio was expressed as the incremental costs per additional patient free of tumour recurrence. Results At 12 months follow-up, the total mean costs for MAL-PDT were (sic)680, for Imiquimod cream (sic)526 and for topical fluorouracil cream (sic)388. Both Imiquimod and topical fluorouracil were cost-effective treatments compared with MAL-PDT. Comparing costs and effectiveness of both creams led to a incremental investment of (sic)4451 to achieve an additional patient free of tumour recurrence. The acceptability curve showed that, for a threshold value of _ 4451, the probability of Imiquimod being more cost-effective than topical fluorouracil was 50%. Conclusion Based on the 12 months follow-up results, Imiquimod and topical fluorouracil cream are more cost-effective than MAL-PDT for treatment of sBCC. Hence, substituting MAL-PDT with either Imiquimod or topical fluorouracil results in cost savings; these savings will be larger for topical fluorouracil. Longterm follow-up effectiveness data are necessary to confirm the cost-effectiveness of Imiquimod vs. topical 5-fluorouracil cream.

Terry L Fox - One of the best experts on this subject based on the ideXlab platform.

  • vehicle controlled double blind randomized study of Imiquimod 5 cream applied 3 days per week in one or two courses of treatment for actinic keratoses on the head
    2007
    Co-Authors: Joseph L Jorizzo, Scott M Dinehart, Terry L Fox, Robert Matheson, Jeffrey Moore, Mark Ling, Scott Mcrae, Sandra Fielder, James H Lee
    Abstract:

    Background A shorter dosing regimen of Imiquimod for the treatment of actinic keratosis may be effective, with long-term clinical benefits. Objective Imiquimod in one or two shorter courses of treatment was evaluated. Methods Patients with actinic keratosis lesions on the head applied Imiquimod or vehicle cream 3×/wk for 4 weeks (course 1). Patients with remaining lesions received another course of treatment. Complete and partial clearance rates were evaluated after course 1, after course 2 (overall), and 1 year later. Results Complete clearance rates were 26.8% (course 1) and 53.7% (overall). Partial clearance rates were 36.6% (course 1) and 61.0% (overall). One-year follow-up recurrence rates were 39% (Imiquimod) and 57% (vehicle). Limitations Blinded investigators may have been biased toward patients treated with Imiquimod identified by treatment site reactions. Conclusion Imiquimod 3×/wk in one or two courses of treatment appears to be effective for the treatment of actinic keratoses on the head, providing long-term clinical benefits. Some recurrences do occur, so long-term follow-up is recommended.

  • Imiquimod 5 cream for the treatment of actinic keratosis results from a phase iii randomized double blind vehicle controlled clinical trial with histology
    2004
    Co-Authors: Rolfmarkus Szeimies, James H Lee, Terry L Fox, M J P Gerritsen, G Gupta, Jean Paul Ortonne, Stefano Serresi, Jens Bichel, Agustin Alomar
    Abstract:

    Abstract Background Increasing evidence suggests Imiquimod may be a safe therapeutic option for the treatment of actinic keratosis (AK). The diagnosis and assessment of most AK lesions is made clinically, without histologic confirmation. Objective A phase III, randomized, double-blind, parallel group, vehicle-controlled study evaluated the efficacy of Imiquimod 5% cream compared with vehicle in the treatment of AK lesions on the face and balding scalp including pretreatment and posttreatment biopsy specimens. Methods A total of 286 patients at 18 centers in 6 European countries with histologically confirmed AK were randomized to either Imiquimod 5% cream or vehicle cream. Study cream was applied once per day, 3 days per week, for 16 weeks. Clearance of AK lesions was clinically and histologically assessed at an 8-week posttreatment visit. Results The complete clearance rate for the Imiquimod group was 57.1% versus 2.2% for the vehicle group ( P P Conclusion Imiquimod 5% cream used 3 times per week for 16 weeks is an effective treatment for AK. Clinical clearance was established by both clinical observation and histologic analysis.

  • Imiquimod 5 cream for the treatment of actinic keratosis results from two phase iii randomized double blind parallel group vehicle controlled trials
    2004
    Co-Authors: Mark Lebwohl, Scott M Dinehart, David A Whiting, Peter K Lee, Naji Tawfik, Joseph L Jorizzo, James H Lee, Terry L Fox
    Abstract:

    Abstract Background The immune system plays a critical role in the development and pathogenesis of actinic keratosis (AK). Imiquimod has been shown to stimulate the cutaneous immune response and be effective for the treatment of nonmelanoma skin cancers. Objective Two phase III, randomized, double-blind, vehicle-controlled studies evaluated the efficacy of Imiquimod 5% cream compared with vehicle in the treatment of AK lesions on the face and balding scalp. Methods A total of 436 participants at 24 centers in the United States and Canada were randomized to either Imiquimod 5% or vehicle cream. Study cream was applied one time per day, 2 days per week for 16 weeks. Clearance of AK lesions was clinically assessed at an 8-week posttreatment visit. Results The complete clearance rate was 45.1% for the Imiquimod group and 3.2% for the vehicle group. The difference in complete clearance rates (Imiquimod minus vehicle) was 41.9% with a 95% confidence interval of 34.9% to 49%. The partial (≥75%) clearance rate was 59.1% for the Imiquimod group and 11.8% for the vehicle group. The difference in partial clearance rates (Imiquimod minus vehicle) was 47.3% with a 95% confidence interval of 39.5% to 55.1%. The median percent reduction in AK lesions was 83.3% for the Imiquimod group and 0% for the vehicle group. Local skin reactions were common. Severe erythema was reported by 17.7% of participants who received Imiquimod and 2.3% of participants who received vehicle. Overall, Imiquimod was very well tolerated. Conclusion Imiquimod 5% cream used 2 times per week for 16 weeks is an effective and well-tolerated treatment for AK.

  • Imiquimod, a Patient-Applied Immune-Response Modifier for Treatment of External Genital Warts
    1998
    Co-Authors: Karl R. Beutner, Terry L Fox, Stephen K. Tyring, Kenneth F. Trofatter, John M. Douglas, Spotswood L. Spruance, Mary L. Owens, Andrina J. Hougham, Kathy A. Schmitt
    Abstract:

    Genital human papillomavirus infection is one of the most common sexually transmitted diseases. Imiquimod is a new agent, an immune-response modifier, that has been demonstrated to have potent in vivo antiviral and antitumor effects in animal models. The present prospective, multicenter, double-blind, randomized, vehicle-controlled trial evaluated the efficacy and safety of daily patient-applied Imiquimod for up to 16 weeks for the treatment of external genital warts. Wart recurrence was investigated during a 12-week treatment-free follow-up period. In the intent-to-treat analysis, baseline warts cleared from 49 of 94 (52%) patients treated with 5% Imiquimod cream, 13 of 90 (14%) patients treated with 1% Imiquimod cream, and 3 of 95 (4%) vehicle-treated patients; the differences between the groups treated with vehicle and Imiquimod were significant (P < 0.0001). For subjects who completed the follow-up period, recurrence rates after a complete response were 19% (9 of 48 patients) in the 5% Imiquimod cream group, 17% (2 of 12) in the 1% Imiquimod cream group, and 0% (0 of 3) in the vehicle-treated group. There were no systemic reactions, although local skin reactions (generally of mild or moderate severity) were common, particularly in the 5% Imiquimod cream group. Local reactions caused two patients to discontinue treatment. The most frequently reported local skin reactions were erythema, excoriation or flaking, and erosion. Patient-applied 5% Imiquimod cream is effective for the treatment of external genital warts and has a favorable safety profile.

  • treatment of genital warts with an immune response modifier Imiquimod
    1998
    Co-Authors: Karl R. Beutner, Terry L Fox, Spotswood L. Spruance, Mary L. Owens, Andrina J. Hougham, John M. Douglas
    Abstract:

    Abstract Background: Genital warts are a common sexually transmitted disease caused by human papillomavirus. Imiquimod is a novel immune-response modifier capable of inducing a variety of cytokines, including interferon alfa, tumor necrosis factor–a, as well as interleukins 1, 6, and 8. In animal models Imiquimod has demonstrated antiviral, antitumor, and adjuvant activity. In vitro, Imiquimod has no antiviral or antitumor activity. Objective: Our purpose was to determine the safety and efficacy of topical Imiquimod for the treatment of external genital warts. Methods: This prospective double-blind, placebo-controlled, parallel design clinical trial was performed in three outpatient centers, a public health clinic, a university-based clinic, and a private practice. One hundred eight patients with external genital warts (predominantly white men) were entered into the trial. Fifty-one patients were randomly selected to receive 5% Imiquimod cream; 57 patients were randomly chosen to receive placebo cream. Study medication was applied three times weekly for up to 8 weeks. Patients whose warts cleared completely were observed for up to 10 weeks to determine recurrence rates. Results: In the intent-to-treat analysis, the warts of 37% (19 of 51) of the Imiquimod-treated patients and 0% (0 of 57) of the placebo group cleared completely ( p p p Conclusion: Topical 5% Imiquimod cream appears to have a significant therapeutic effect in the treatment of external genital warts. (J Am Acad Dermatol 1998;38:230-9.)

Marieke H Roozeboom - One of the best experts on this subject based on the ideXlab platform.

  • five year results of a randomized controlled trial comparing effectiveness of photodynamic therapy topical Imiquimod and topical 5 fluorouracil in patients with superficial basal cell carcinoma
    2017
    Co-Authors: Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Anja Sommer, Maud H E Jansen, Brigitte A B Essers
    Abstract:

    For the treatment of superficial basal cell carcinoma, a prospective, noninferiority, randomized controlled multicenter trial with 601 patients showed that 5% Imiquimod cream was superior and 5-fluorouracil cream not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) at 1 and 3 years after treatment. No definite conclusion could be drawn regarding the superiority of Imiquimod over 5-fluorouracil. We now present the 5-year follow-up results according to the intention-to-treat analysis. Five years after treatment, the probability of tumor-free survival was 62.7% for methyl aminolevulinate photodynamic therapy (95% confidence interval [CI] = 55.3–69.2), 80.5% for Imiquimod (95% CI = 74.0–85.6), and 70.0% for 5-fluorouracil (95% CI = 62.9–76.0). The hazard ratio for treatment failure of Imiquimod and 5-fluorouracil were 0.48 (95% CI = 0.32–0.71, P

  • three year follow up results of photodynamic therapy vs Imiquimod vs fluorouracil for treatment of superficial basal cell carcinoma a single blind noninferiority randomized controlled trial
    2016
    Co-Authors: Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Brigitte A B Essers, Anja Sommer, Michette J M De Rooij, Patricia J F Quaedvlieg
    Abstract:

    A randomized controlled trial including 601 patients previously showed that the effectiveness of Imiquimod and fluorouracil cream were not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) in patients with superficial basal cell carcinoma after 1 year of follow-up. We now present the 3-year follow-up results. The probability of tumor-free survival at 3 years post-treatment was 58.0% for MAL-PDT (95% confidence interval [CI] = 47.8–66.9), 79.7% for Imiquimod (95% CI = 71.6–85.7), and 68.2% for fluorouracil (95% CI = 58.1–76.3). The hazard ratio for treatment failure comparing Imiquimod with MAL-PDT was 0.50 (95% CI = 0.33–0.76, P  = 0.001). Comparison of fluorouracil with MAL-PDT and fluorouracil with Imiquimod showed hazard ratios of 0.73 (95% CI = 0.51–1.05, P  = 0.092) and 0.68 (95% CI = 0.44–1.06, P  = 0.091), respectively. Subgroup analysis showed a higher probability of treatment success for Imiquimod versus MAL-PDT in all subgroups with the exception of elderly patients with superficial basal cell carcinoma on the lower extremities. In this subgroup, the risk difference in tumor-free survival was 57.6% in favor of MAL-PDT. In conclusion, according to results at 3 years post-treatment, Imiquimod is superior and fluorouracil not inferior to MAL-PDT in treatment of superficial basal cell carcinoma.

  • photodynamic therapy vs topical Imiquimod for treatment of superficial basal cell carcinoma a subgroup analysis within a noninferiority randomized controlled trial
    2015
    Co-Authors: Patty J Nelemans, Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Peter M Steijlen, Nicole W J Kellenerssmeets
    Abstract:

    SummaryBackground A recent noninferiority randomized controlled trial (RCT) indicated that Imiquimod can be considered as superior to methylaminolevulinate photodynamic therapy (MAL-PDT) in the treatment of superficial basal cell carcinoma (sBCC). Knowledge of treatment effectiveness in subgroups of patients is of great value in clinical practice to select the most effective treatment for an individual patient with sBCC. Objectives To explore whether the relative treatment effect of MAL-PDT and Imiquimod is consistent across subgroups defined by patient and tumour characteristics. Methods Data were derived from a single-blinded, noninferiority, multicentre RCT comparing MAL-PDT, topical Imiquimod and fluorouracil (ISRCTN79701845). Treatment success was defined as free of tumour recurrence at 12-month follow-up. Subgroup analyses were performed for subgroups defined by sex, age, tumour location and tumour size. Results Two hundred and two patients received MAL-PDT and 198 received Imiquimod. The superiority of Imiquimod vs. MAL-PDT was observed in subgroups of females, sBCC on the trunk and large tumours with risk differences in favour of Imiquimod of 18·4% [95% confidence interval (CI) 7·8–29·0%], 21·0% (95% CI 10·9–31·1%) and 18·9% (95% CI 7·1–30·7%), respectively. Higher probability of treatment success for Imiquimod vs. MAL-PDT was consistently found in all other subgroups with the exception of sBCC localized on the lower extremities in older patients. In the latter subgroup, the risk difference at the expense of Imiquimod was −57·3% (95% CI −81·7% to −32·9%). Conclusions Imiquimod remains the first-choice treatment for sBCC in terms of effectiveness. In older patients with sBCC on the lower extremities MAL-PDT might be preferred. Results should be interpreted carefully as subgroup analyses were exploratory and not driven by prior hypotheses.

Brigitte A B Essers - One of the best experts on this subject based on the ideXlab platform.

  • five year results of a randomized controlled trial comparing effectiveness of photodynamic therapy topical Imiquimod and topical 5 fluorouracil in patients with superficial basal cell carcinoma
    2017
    Co-Authors: Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Anja Sommer, Maud H E Jansen, Brigitte A B Essers
    Abstract:

    For the treatment of superficial basal cell carcinoma, a prospective, noninferiority, randomized controlled multicenter trial with 601 patients showed that 5% Imiquimod cream was superior and 5-fluorouracil cream not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) at 1 and 3 years after treatment. No definite conclusion could be drawn regarding the superiority of Imiquimod over 5-fluorouracil. We now present the 5-year follow-up results according to the intention-to-treat analysis. Five years after treatment, the probability of tumor-free survival was 62.7% for methyl aminolevulinate photodynamic therapy (95% confidence interval [CI] = 55.3–69.2), 80.5% for Imiquimod (95% CI = 74.0–85.6), and 70.0% for 5-fluorouracil (95% CI = 62.9–76.0). The hazard ratio for treatment failure of Imiquimod and 5-fluorouracil were 0.48 (95% CI = 0.32–0.71, P

  • three year follow up results of photodynamic therapy vs Imiquimod vs fluorouracil for treatment of superficial basal cell carcinoma a single blind noninferiority randomized controlled trial
    2016
    Co-Authors: Aimee H M M Arits, Klara Mosterd, Marieke H Roozeboom, Brigitte A B Essers, Anja Sommer, Michette J M De Rooij, Patricia J F Quaedvlieg
    Abstract:

    A randomized controlled trial including 601 patients previously showed that the effectiveness of Imiquimod and fluorouracil cream were not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) in patients with superficial basal cell carcinoma after 1 year of follow-up. We now present the 3-year follow-up results. The probability of tumor-free survival at 3 years post-treatment was 58.0% for MAL-PDT (95% confidence interval [CI] = 47.8–66.9), 79.7% for Imiquimod (95% CI = 71.6–85.7), and 68.2% for fluorouracil (95% CI = 58.1–76.3). The hazard ratio for treatment failure comparing Imiquimod with MAL-PDT was 0.50 (95% CI = 0.33–0.76, P  = 0.001). Comparison of fluorouracil with MAL-PDT and fluorouracil with Imiquimod showed hazard ratios of 0.73 (95% CI = 0.51–1.05, P  = 0.092) and 0.68 (95% CI = 0.44–1.06, P  = 0.091), respectively. Subgroup analysis showed a higher probability of treatment success for Imiquimod versus MAL-PDT in all subgroups with the exception of elderly patients with superficial basal cell carcinoma on the lower extremities. In this subgroup, the risk difference in tumor-free survival was 57.6% in favor of MAL-PDT. In conclusion, according to results at 3 years post-treatment, Imiquimod is superior and fluorouracil not inferior to MAL-PDT in treatment of superficial basal cell carcinoma.

  • cost effectiveness of topical Imiquimod and fluorouracil vs photodynamic therapy for treatment of superficial basal cell carcinoma
    2014
    Co-Authors: Patty J Nelemans, Nicole W J Kellenerssmeets, Aimee H M M Arits, Klara Mosterd, E Spoorenberg, Brigitte A B Essers
    Abstract:

    Background A recent noninferiority randomized trial showed that in terms of clinical effectiveness Imiquimod was superior and topical fluorouracil noninferior to methylaminolaevulinate photodynamic therapy (MAL-PDT) for treatment of superficial basal-cell carcinoma (sBCC). Although it was expected that MAL-PDT would be more costly than either cream, a full cost-effectiveness analysis is necessary to determine the balance between effectiveness and costs. Objective To determine whether Imiquimod or topical fluorouracil are cost-effective treatments for sBCC compared with MAL-PDT. Methods An economic evaluation was performed from a healthcare perspective. Data on resource use and costs were collected alongside the randomized clinical trial. The incremental cost-effectiveness ratio was expressed as the incremental costs per additional patient free of tumour recurrence. Results At 12 months follow-up, the total mean costs for MAL-PDT were (sic)680, for Imiquimod cream (sic)526 and for topical fluorouracil cream (sic)388. Both Imiquimod and topical fluorouracil were cost-effective treatments compared with MAL-PDT. Comparing costs and effectiveness of both creams led to a incremental investment of (sic)4451 to achieve an additional patient free of tumour recurrence. The acceptability curve showed that, for a threshold value of _ 4451, the probability of Imiquimod being more cost-effective than topical fluorouracil was 50%. Conclusion Based on the 12 months follow-up results, Imiquimod and topical fluorouracil cream are more cost-effective than MAL-PDT for treatment of sBCC. Hence, substituting MAL-PDT with either Imiquimod or topical fluorouracil results in cost savings; these savings will be larger for topical fluorouracil. Longterm follow-up effectiveness data are necessary to confirm the cost-effectiveness of Imiquimod vs. topical 5-fluorouracil cream.