A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma
Objectives. Based on single-arm trial data (BOLT), sonidegib was approved in the US and EU to treat locally advanced basal cell carcinomas (BCCs) ineligible for curative surgery or radiotherapy. Vismodegib, the other approved targeted therapy, also was assessed in a single-arm trial (ERIVANCE). We e...
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| Format: | Article |
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Wiley
2017-01-01
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| Series: | Journal of Skin Cancer |
| Online Access: | http://dx.doi.org/10.1155/2017/6121760 |
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| author | Dawn Odom Deirdre Mladsi Molly Purser James A. Kaye Eirini Palaka Alina Charter Jo Annah Jensen Dalila Sellami |
| author_facet | Dawn Odom Deirdre Mladsi Molly Purser James A. Kaye Eirini Palaka Alina Charter Jo Annah Jensen Dalila Sellami |
| author_sort | Dawn Odom |
| collection | DOAJ |
| description | Objectives. Based on single-arm trial data (BOLT), sonidegib was approved in the US and EU to treat locally advanced basal cell carcinomas (BCCs) ineligible for curative surgery or radiotherapy. Vismodegib, the other approved targeted therapy, also was assessed in a single-arm trial (ERIVANCE). We examined the comparative effectiveness of the two drugs using a matching-adjusted indirect comparison (MAIC) versus an unadjusted indirect comparison. Methods. After comparing trials and identifying potential prognostic factors, an MAIC was conducted to adjust for differences in key patient baseline characteristics. Due to BOLT’s small sample size, the number of matching variables was restricted to two. Efficacy results for sonidegib were generated so that selected baseline characteristics matched those from ERIVANCE and were compared with published ERIVANCE results. Results. Matching variables were baseline percentages of patients receiving prior radiotherapy and surgery. After weighting, sonidegib objective response rate (ORR) and median progression-free survival (PFS) were effectively unchanged (prematched versus postmatched ORR and PFS, 56.1% versus 56.7% and 22.1 versus 22.1 months, resp.). Vismodegib’s ORR and PFS were 47.6% and 9.5 months. Conclusions. Comparative effectiveness of sonidegib versus vismodegib remains unchanged after adjusting BOLT patient-level data to match published ERIVANCE baseline percentages of patients receiving prior surgery and radiotherapy. |
| format | Article |
| id | doaj-art-913f225d67ed4cf7be85f833e48ead12 |
| institution | Kabale University |
| issn | 2090-2905 2090-2913 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Skin Cancer |
| spelling | doaj-art-913f225d67ed4cf7be85f833e48ead122025-02-03T05:58:48ZengWileyJournal of Skin Cancer2090-29052090-29132017-01-01201710.1155/2017/61217606121760A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell CarcinomaDawn Odom0Deirdre Mladsi1Molly Purser2James A. Kaye3Eirini Palaka4Alina Charter5Jo Annah Jensen6Dalila Sellami7RTI Health Solutions, 200 Park Offices Dr., Research Triangle Park, NC, USARTI Health Solutions, 200 Park Offices Dr., Research Triangle Park, NC, USARTI Health Solutions, 200 Park Offices Dr., Research Triangle Park, NC, USARTI Health Solutions, 200 Park Offices Dr., Research Triangle Park, NC, USANovartis Pharma AG, Forum 1, Novartis Campus, 4056 Basel, SwitzerlandNovartis Pharma AG, Forum 1, Novartis Campus, 4056 Basel, SwitzerlandNovartis Pharma AG, Forum 1, Novartis Campus, 4056 Basel, SwitzerlandNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USAObjectives. Based on single-arm trial data (BOLT), sonidegib was approved in the US and EU to treat locally advanced basal cell carcinomas (BCCs) ineligible for curative surgery or radiotherapy. Vismodegib, the other approved targeted therapy, also was assessed in a single-arm trial (ERIVANCE). We examined the comparative effectiveness of the two drugs using a matching-adjusted indirect comparison (MAIC) versus an unadjusted indirect comparison. Methods. After comparing trials and identifying potential prognostic factors, an MAIC was conducted to adjust for differences in key patient baseline characteristics. Due to BOLT’s small sample size, the number of matching variables was restricted to two. Efficacy results for sonidegib were generated so that selected baseline characteristics matched those from ERIVANCE and were compared with published ERIVANCE results. Results. Matching variables were baseline percentages of patients receiving prior radiotherapy and surgery. After weighting, sonidegib objective response rate (ORR) and median progression-free survival (PFS) were effectively unchanged (prematched versus postmatched ORR and PFS, 56.1% versus 56.7% and 22.1 versus 22.1 months, resp.). Vismodegib’s ORR and PFS were 47.6% and 9.5 months. Conclusions. Comparative effectiveness of sonidegib versus vismodegib remains unchanged after adjusting BOLT patient-level data to match published ERIVANCE baseline percentages of patients receiving prior surgery and radiotherapy.http://dx.doi.org/10.1155/2017/6121760 |
| spellingShingle | Dawn Odom Deirdre Mladsi Molly Purser James A. Kaye Eirini Palaka Alina Charter Jo Annah Jensen Dalila Sellami A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma Journal of Skin Cancer |
| title | A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma |
| title_full | A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma |
| title_fullStr | A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma |
| title_full_unstemmed | A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma |
| title_short | A Matching-Adjusted Indirect Comparison of Sonidegib and Vismodegib in Advanced Basal Cell Carcinoma |
| title_sort | matching adjusted indirect comparison of sonidegib and vismodegib in advanced basal cell carcinoma |
| url | http://dx.doi.org/10.1155/2017/6121760 |
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