Cost-effectiveness of front-line trials in metastatic colorectal cancer: Integrating the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) with the costs of drugs.

Abstract

6622 Background: In Western Countries, colorectal cancer (CRC) is the second most common cause of death from cancer. In light of the relevant expenses of drugs it might be interesting to make a balance between the cost of the drugs and clinical parameters of interest such as progression free survival (PFS). Methods: Phase III randomized clinical trials (RCTs) that compared at least two front-line chemotherapy regimens for mCRC patients were evaluated. Differences in PFS between the different arms were calculated and compared with the pharmacological costs (at the Pharmacy of our Hospital) needed to get one month of PFS. Subsequently we applied the ESMO-MCBS (a 1 to 5 scale) to the above phase III RCTs. Results: Overall 28 phase III RCTs, including 19 958 patients, were analyzed. The FOLFOX resulted the least expensive (56 € per month of PFS gained) while the addition of irinotecan to FOLFOX (FOLFOXIRI) increased only marginally the costs (90 € per month of PFS gained). Treatments including the monoclonal antibodies showed a cost per month of PFS gained of 2823 € (FOLFIRI with cetuximab in KRAS wild-type patients and liver-only metastases), of € 15 822 (FOLFOX with panitumumab in KRAS wild type) and of 13 383 € (FOLFOX with bevacizumab). According to the ESMO-MCBS the treatments including an EGFR-inhibitor (cetuximab or panitunumab) were associated with a score of 4 while the inclusion of bevacizumab reached a score of 3. The remaining phase III RCTs obtained a low (grade 1-2) score.Dividing the costs per month of PFS gained with the grade of ESMO-MCBS, for each RCTs, we obtained the costs of each point of ESMO-MCBS per month of PFS gained. FOLFOX was confirmed as being the least expensive (18.7 €) while among treatments including a targeted biological agent panitunumab in combination with FOLFOX in K-RAS wild type patients was less expensive (3955 €) than the combinations FOLFOX-bevacizumab (13 383 €) and FOLFIRI-cetuximab in K-RAS wild type patients (21 854.6 €). Conclusions: Our data demonstrate a huge difference in cost per month of PFS gained and per each point of the ESMO-MCBS in modern front line treatments in mCRC.