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Aimee H M M Arits - 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
    Journal of Investigative Dermatology, 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
    Journal of Investigative Dermatology, 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
    British Journal of Dermatology, 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.

Claus Rodel - One of the best experts on this subject based on the ideXlab platform.

  • oxaliplatin added to Fluorouracil based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer the german cao aro aio 04 study final results of the multicentre open label randomised phase 3 trial
    Lancet Oncology, 2015
    Co-Authors: Ralfdieter Hofheinz, Claus Rodel, Rainer Fietkau, W Hohenberger, Torsten Hothorn, Ullrich Graeven, Dirk Arnold, Michael Ghadimi
    Abstract:

    Summary Background Preoperative chemoradiotherapy with infusional Fluorouracil, total mesorectal excision surgery, and postoperative chemotherapy with Fluorouracil was established by the German CAO/ARO/AIO-94 trial as a standard combined modality treatment for locally advanced rectal cancer. Here we compare the previously established regimen with an investigational regimen in which oxaliplatin was added to both preoperative chemoradiotherapy and postoperative chemotherapy. Methods In this multicentre, open-label, randomised, phase 3 study we randomly assigned patients with rectal adenocarcinoma, clinically staged as cT3–4 or any node-positive disease, to two groups: a control group receiving standard Fluorouracil-based combined modality treatment, consisting of preoperative radiotherapy of 50·4 Gy in 28 fractions plus infusional Fluorouracil (1000 mg/m 2 on days 1–5 and 29–33), followed by surgery and four cycles of bolus Fluorouracil (500 mg/m 2 on days 1–5 and 29); or to an investigational group receiving preoperative radiotherapy of 50·4 Gy in 28 fractions plus infusional Fluorouracil (250 mg/m 2 on days 1–14 and 22–35) and oxaliplatin (50 mg/m 2 on days 1, 8, 22, and 29), followed by surgery and eight cycles of oxaliplatin (100 mg/m 2 on days 1 and 15), leucovorin (400 mg/m 2 on days 1 and 15), and infusional Fluorouracil (2400 mg/m 2 on days 1–2 and 15–16). Randomisation was done with computer-generated block-randomisation codes stratified by centre, clinical T category (cT1–3 vs cT4), and clinical N category (cN0 vs cN1–2) without masking. The primary endpoint was disease-free survival, defined as the time between randomisation and non-radical surgery of the primary tumour (R2 resection), locoregional recurrence after R0/1 resection, metastatic disease or progression, or death from any cause, whichever occurred first. Survival and cumulative incidence of recurrence analyses followed the intention-to-treat principle; toxicity analyses included all patients treated. Enrolment of patients in this trial is completed and follow-up is ongoing. This study is registered with ClinicalTrials.gov, number NCT00349076. Findings Of the 1265 patients initially enrolled, 1236 were assessable (613 in the investigational group and 623 in the control group). With a median follow-up of 50 months (IQR 38–61), disease-free survival at 3 years was 75·9% (95% CI 72·4–79·5) in the investigational group and 71·2% (95% CI 67·6–74·9) in the control group (hazard ratio [HR] 0·79, 95% CI 0·64–0·98; p=0·03). Preoperative grade 3–4 toxic effects occurred in 144 (24%) of 607 patients who actually received Fluorouracil and oxaliplatin during chemoradiotherapy and in 128 (20%) of 625 patients who actually received Fluorouracil chemoradiotherapy. Of 445 patients who actually received adjuvant Fluorouracil and leucovorin and oxaliplatin, 158 (36%) had grade 3–4 toxic effects, as did 170 (36%) of 470 patients who actually received adjuvant Fluorouracil. Late grade 3–4 adverse events in patients who received protocol-specified preoperative and postoperative treatment occurred in 112 (25%) of 445 patients in the investigational group, and in 100 (21%) of 470 patients in the control group. Interpretation Adding oxaliplatin to Fluorouracil-based neoadjuvant chemoradiotherapy and adjuvant chemotherapy (at the doses and intensities used in this trial) significantly improved disease-free survival of patients with clinically staged cT3–4 or cN1–2 rectal cancer compared with our former Fluorouracil-based combined modality regimen (based on CAO/ARO/AIO-94). The regimen established by CAO/ARO/AIO-04 can be deemed a new treatment option for patients with locally advanced rectal cancer. Funding German Cancer Aid (Deutsche Krebshilfe).

  • preoperative chemoradiotherapy and postoperative chemotherapy with Fluorouracil and oxaliplatin versus Fluorouracil alone in locally advanced rectal cancer initial results of the german cao aro aio 04 randomised phase 3 trial
    Lancet Oncology, 2012
    Co-Authors: Claus Rodel, Torsten Liersch, H Becker, Rainer Fietkau, W Hohenberger, Torsten Hothorn, Ullrich Graeven, Dirk Arnold, Marga Langwelzenbach
    Abstract:

    Summary Background Preoperative chemoradiotherapy, total mesorectal excision surgery, and adjuvant chemotherapy with Fluorouracil is the standard combined modality treatment for rectal cancer. With the aim of improving disease-free survival (DFS), this phase 3 study (CAO/ARO/AIO-04) integrated oxaliplatin into standard treatment. Methods This was a multicentre, open-label, randomised, phase 3 study in patients with histologically proven carcinoma of the rectum with clinically staged T3–4 or any node-positive disease. Between July 25, 2006, and Feb 26, 2010, patients were randomly assigned to two groups: a control group receiving standard Fluorouracil-based combined modality treatment, consisting of preoperative radiotherapy of 50·4 Gy plus infusional Fluorouracil (1000 mg/m 2 days 1–5 and 29–33), followed by surgery and four cycles of bolus Fluorouracil (500 mg/m 2 days 1–5 and 29; Fluorouracil group); and an experimental group receiving preoperative radiotherapy of 50·4 Gy plus infusional Fluorouracil (250 mg/m 2 days 1–14 and 22–35) and oxaliplatin (50 mg/m 2 days 1, 8, 22, and 29), followed by surgery and eight cycles of adjuvant chemotherapy with oxaliplatin (100 mg/m 2 days 1 and 15), leucovorin (400 mg/m 2 days 1 and 15), and infusional Fluorouracil (2400 mg/m 2 days 1–2 and 15–16; Fluorouracil plus oxaliplatin group). Randomisation was done with computer-generated block-randomisation codes stratified by centre, clinical T category (cT1–4 vs cT4), and clinical N category (cN0 vs cN1–2) without masking. DFS is the primary endpoint. Secondary endpoints, including toxicity, compliance, and histopathological response are reported here. Safety and compliance analyses included patients as treated, efficacy endpoints were analysed according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT00349076. Findings Of the 1265 patients initially enrolled, 1236 were evaluable (613 in the Fluorouracil plus oxaliplatin group and 623 in the Fluorouracil group). Preoperative grade 3–4 toxic effects occurred in 140 (23%) of 606 patients who actually received Fluorouracil and oxaliplatin during chemoradiotherapy and in 127 (20%) of 624 patients who actually received Fluorouracil chemoradiotherapy. Grade 3–4 diarrhoea was more common in those who received Fluorouracil and oxaliplatin during chemoradiotherapy than in those who received Fluorouracil during chemoradiotherapy (73 patients [12%] vs 52 patients [8%]), as was grade 3–4 nausea or vomiting (23 [4%] vs nine [1%]). 516 (85%) of the 606 patients who received Fluorouracil and oxaliplatin-based chemoradiotherapy had the full dose of chemotherapy, and 571 (94%) had the full dose of radiotherapy; as did 495 (79%) and 601 (96%) of 624 patients who received Fluorouracil-based chemoradiotherapy, respectively. A pathological complete response was achieved in 103 (17%) of 591 patients who underwent surgery in the Fluorouracil and oxaliplatin group and in 81 (13%) of 606 patients who underwent surgery in the Fluorouracil group (odds ratio 1·40, 95% CI 1·02–1·92; p=0·038). In the Fluorouracil and oxaliplatin group, 352 (81%) of 435 patients who began adjuvant chemotherapy completed all cycles (with or without dose reduction), as did 386 (83%) of 463 patients in the Fluorouracil group. Interpretation Inclusion of oxaliplatin into modified Fluorouracil-based combined modality treatment was feasible and led to more patients achieving a pathological complete response than did standard treatment. Longer follow-up is needed to assess DFS. Funding German Cancer Aid (Deutsche Krebshilfe).

Torsten Hothorn - One of the best experts on this subject based on the ideXlab platform.

  • oxaliplatin added to Fluorouracil based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer the german cao aro aio 04 study final results of the multicentre open label randomised phase 3 trial
    Lancet Oncology, 2015
    Co-Authors: Ralfdieter Hofheinz, Claus Rodel, Rainer Fietkau, W Hohenberger, Torsten Hothorn, Ullrich Graeven, Dirk Arnold, Michael Ghadimi
    Abstract:

    Summary Background Preoperative chemoradiotherapy with infusional Fluorouracil, total mesorectal excision surgery, and postoperative chemotherapy with Fluorouracil was established by the German CAO/ARO/AIO-94 trial as a standard combined modality treatment for locally advanced rectal cancer. Here we compare the previously established regimen with an investigational regimen in which oxaliplatin was added to both preoperative chemoradiotherapy and postoperative chemotherapy. Methods In this multicentre, open-label, randomised, phase 3 study we randomly assigned patients with rectal adenocarcinoma, clinically staged as cT3–4 or any node-positive disease, to two groups: a control group receiving standard Fluorouracil-based combined modality treatment, consisting of preoperative radiotherapy of 50·4 Gy in 28 fractions plus infusional Fluorouracil (1000 mg/m 2 on days 1–5 and 29–33), followed by surgery and four cycles of bolus Fluorouracil (500 mg/m 2 on days 1–5 and 29); or to an investigational group receiving preoperative radiotherapy of 50·4 Gy in 28 fractions plus infusional Fluorouracil (250 mg/m 2 on days 1–14 and 22–35) and oxaliplatin (50 mg/m 2 on days 1, 8, 22, and 29), followed by surgery and eight cycles of oxaliplatin (100 mg/m 2 on days 1 and 15), leucovorin (400 mg/m 2 on days 1 and 15), and infusional Fluorouracil (2400 mg/m 2 on days 1–2 and 15–16). Randomisation was done with computer-generated block-randomisation codes stratified by centre, clinical T category (cT1–3 vs cT4), and clinical N category (cN0 vs cN1–2) without masking. The primary endpoint was disease-free survival, defined as the time between randomisation and non-radical surgery of the primary tumour (R2 resection), locoregional recurrence after R0/1 resection, metastatic disease or progression, or death from any cause, whichever occurred first. Survival and cumulative incidence of recurrence analyses followed the intention-to-treat principle; toxicity analyses included all patients treated. Enrolment of patients in this trial is completed and follow-up is ongoing. This study is registered with ClinicalTrials.gov, number NCT00349076. Findings Of the 1265 patients initially enrolled, 1236 were assessable (613 in the investigational group and 623 in the control group). With a median follow-up of 50 months (IQR 38–61), disease-free survival at 3 years was 75·9% (95% CI 72·4–79·5) in the investigational group and 71·2% (95% CI 67·6–74·9) in the control group (hazard ratio [HR] 0·79, 95% CI 0·64–0·98; p=0·03). Preoperative grade 3–4 toxic effects occurred in 144 (24%) of 607 patients who actually received Fluorouracil and oxaliplatin during chemoradiotherapy and in 128 (20%) of 625 patients who actually received Fluorouracil chemoradiotherapy. Of 445 patients who actually received adjuvant Fluorouracil and leucovorin and oxaliplatin, 158 (36%) had grade 3–4 toxic effects, as did 170 (36%) of 470 patients who actually received adjuvant Fluorouracil. Late grade 3–4 adverse events in patients who received protocol-specified preoperative and postoperative treatment occurred in 112 (25%) of 445 patients in the investigational group, and in 100 (21%) of 470 patients in the control group. Interpretation Adding oxaliplatin to Fluorouracil-based neoadjuvant chemoradiotherapy and adjuvant chemotherapy (at the doses and intensities used in this trial) significantly improved disease-free survival of patients with clinically staged cT3–4 or cN1–2 rectal cancer compared with our former Fluorouracil-based combined modality regimen (based on CAO/ARO/AIO-94). The regimen established by CAO/ARO/AIO-04 can be deemed a new treatment option for patients with locally advanced rectal cancer. Funding German Cancer Aid (Deutsche Krebshilfe).

  • preoperative chemoradiotherapy and postoperative chemotherapy with Fluorouracil and oxaliplatin versus Fluorouracil alone in locally advanced rectal cancer initial results of the german cao aro aio 04 randomised phase 3 trial
    Lancet Oncology, 2012
    Co-Authors: Claus Rodel, Torsten Liersch, H Becker, Rainer Fietkau, W Hohenberger, Torsten Hothorn, Ullrich Graeven, Dirk Arnold, Marga Langwelzenbach
    Abstract:

    Summary Background Preoperative chemoradiotherapy, total mesorectal excision surgery, and adjuvant chemotherapy with Fluorouracil is the standard combined modality treatment for rectal cancer. With the aim of improving disease-free survival (DFS), this phase 3 study (CAO/ARO/AIO-04) integrated oxaliplatin into standard treatment. Methods This was a multicentre, open-label, randomised, phase 3 study in patients with histologically proven carcinoma of the rectum with clinically staged T3–4 or any node-positive disease. Between July 25, 2006, and Feb 26, 2010, patients were randomly assigned to two groups: a control group receiving standard Fluorouracil-based combined modality treatment, consisting of preoperative radiotherapy of 50·4 Gy plus infusional Fluorouracil (1000 mg/m 2 days 1–5 and 29–33), followed by surgery and four cycles of bolus Fluorouracil (500 mg/m 2 days 1–5 and 29; Fluorouracil group); and an experimental group receiving preoperative radiotherapy of 50·4 Gy plus infusional Fluorouracil (250 mg/m 2 days 1–14 and 22–35) and oxaliplatin (50 mg/m 2 days 1, 8, 22, and 29), followed by surgery and eight cycles of adjuvant chemotherapy with oxaliplatin (100 mg/m 2 days 1 and 15), leucovorin (400 mg/m 2 days 1 and 15), and infusional Fluorouracil (2400 mg/m 2 days 1–2 and 15–16; Fluorouracil plus oxaliplatin group). Randomisation was done with computer-generated block-randomisation codes stratified by centre, clinical T category (cT1–4 vs cT4), and clinical N category (cN0 vs cN1–2) without masking. DFS is the primary endpoint. Secondary endpoints, including toxicity, compliance, and histopathological response are reported here. Safety and compliance analyses included patients as treated, efficacy endpoints were analysed according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT00349076. Findings Of the 1265 patients initially enrolled, 1236 were evaluable (613 in the Fluorouracil plus oxaliplatin group and 623 in the Fluorouracil group). Preoperative grade 3–4 toxic effects occurred in 140 (23%) of 606 patients who actually received Fluorouracil and oxaliplatin during chemoradiotherapy and in 127 (20%) of 624 patients who actually received Fluorouracil chemoradiotherapy. Grade 3–4 diarrhoea was more common in those who received Fluorouracil and oxaliplatin during chemoradiotherapy than in those who received Fluorouracil during chemoradiotherapy (73 patients [12%] vs 52 patients [8%]), as was grade 3–4 nausea or vomiting (23 [4%] vs nine [1%]). 516 (85%) of the 606 patients who received Fluorouracil and oxaliplatin-based chemoradiotherapy had the full dose of chemotherapy, and 571 (94%) had the full dose of radiotherapy; as did 495 (79%) and 601 (96%) of 624 patients who received Fluorouracil-based chemoradiotherapy, respectively. A pathological complete response was achieved in 103 (17%) of 591 patients who underwent surgery in the Fluorouracil and oxaliplatin group and in 81 (13%) of 606 patients who underwent surgery in the Fluorouracil group (odds ratio 1·40, 95% CI 1·02–1·92; p=0·038). In the Fluorouracil and oxaliplatin group, 352 (81%) of 435 patients who began adjuvant chemotherapy completed all cycles (with or without dose reduction), as did 386 (83%) of 463 patients in the Fluorouracil group. Interpretation Inclusion of oxaliplatin into modified Fluorouracil-based combined modality treatment was feasible and led to more patients achieving a pathological complete response than did standard treatment. Longer follow-up is needed to assess DFS. Funding German Cancer Aid (Deutsche Krebshilfe).

Klara Mosterd - 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
    Journal of Investigative Dermatology, 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
    Journal of Investigative Dermatology, 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
    British Journal of Dermatology, 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.

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
    Journal of Investigative Dermatology, 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
    Journal of Investigative Dermatology, 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
    British Journal of Dermatology, 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.

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