RESUMEN
BACKGROUND & AIMS: The average five-year survival of metastatic renal cell carcinoma (mRCC) is 71%. However, there is significant variability in patient prognosis. Immune checkpoint inhibitors (ICIs) have been introduced into the treatment landscape of mRCC. This meta-analysis aimed to estimate progression-free and overall survival probabilities and identify possible outcome predictors of mRCC patients treated with ICI combination as first-line treatment. METHODS: Studies comparing the combination of ICI combinations versus standard of therapy for first-line treatment of advanced renal-cell carcinoma were searched in MEDLINE, CANCERLIT, the Cochrane Controlled Trials Register, and the Cochrane Library from inception through September 2023. Data on patient populations and outcomes were extracted from each study by three independent observers and combined using the DerSimonian and Laird methods. RESULTS: Six studies met the inclusion criteria. Globally, 5121 patients were included in this meta-analysis: 2556 patients treated with immune checkpoint inhibitors and 2565 with sunitinib as control. The ICI combination was associated with improved PFS (hazard ratio (HR) 0.68; 95 % confidence interval (CI), 0.56-0.81, p < 0.0001). Furthermore, ICI combination was also associated with OS improvement (HR 0.85; 95 % CI, 0.78-0.92, p = 0.001). There is no statistical increase in adverse events. CONCLUSIONS: Our findings show that PFS and OS are statistically increased in mRCC with ICI combination treatment by 32% and 15%, respectively.
Asunto(s)
Carcinoma de Células Renales , Inhibidores de Puntos de Control Inmunológico , Neoplasias Renales , Humanos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Células Renales/tratamiento farmacológico , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Neoplasias Renales/tratamiento farmacológico , Neoplasias Renales/patología , Ensayos Clínicos Controlados Aleatorios como Asunto , Sunitinib/uso terapéuticoAsunto(s)
Neoplasias del Colon , Neoplasias Colorrectales , Pirrolidinas , Neoplasias del Recto , Timina , Humanos , Bevacizumab/uso terapéutico , Trifluridina/uso terapéutico , Análisis Costo-Beneficio , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Combinación de Medicamentos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Uracilo/uso terapéuticoRESUMEN
The aim of this paper was to assess the cost-effectiveness of pembrolizumab in first-line for microsatellite-instability-high or mismatch-repair-deficient metastatic colorectal cancer. We have considered the pivotal phase III randomized controlled trial of pembrolizumab in first-line for microsatellite-instability-high mismatch-repair-deficient metastatic colorectal cancer. The last available update of each trial was considered as the original source. Incremental cost-effectiveness ratio was calculated as the ratio between the difference of the costs in the intervention and in the control groups (pharmacy costs) and the difference between the effect in the intervention and in the control groups (progression-free survival). The costs of drugs are at the Pharmacy of the Mater Salutis Hospital of Legnago (VR, Italy) and are expressed in euros (). Three hundred and seven patients were considered in the pivotal phase III randomized controlled trial. Pembrolizumab obtained a cost per month progression-free survival gained ranged from 6471 towards mFOLFOX (5-FU, oxaliplatin and leucovorin) plus cetuximab to 7886 towards mFOLFOX. To sum up, combining pharmacological costs of drugs with the measure of efficacy represented by progression-free survival, at the actual prize pembrolizumab cannot be considered cost-effectiveness for first-line treatment for microsatellite-instability-high mismatch-repair-deficient metastatic colorectal cancer. A reduction in pharmacological costs is mandatory.
Asunto(s)
Anticuerpos Monoclonales Humanizados , Neoplasias Colorrectales , Humanos , Análisis Costo-Beneficio , Anticuerpos Monoclonales Humanizados/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/genética , Neoplasias Colorrectales/patología , Repeticiones de Microsatélite , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéuticoRESUMEN
Metastatic gastric cancer (mGC) represents an economic and societal burden worldwide. The present study has two aims. Firstly, it evaluates the benefits and the added value of the introduction of trifluridine/tipiracil (FTD/TPI) in the Italian clinical practice, defining the comparative efficacy and safety profiles with respect to the other available treatment options (represented by the best supportive care (BSC) and FOLFIRI (5-FU, irinotecan, and leucovorin) regimens). Secondly, it assesses the potential economic and organizational advantages for hospitals and patients, focusing on third- and fourth-line treatments. For the achievement of the above objective, a health technology assessment study was conducted in 2021, assuming the NHS perspective within a 3-month time horizon. The literature reported a better efficacy of FTD/TPI with respect to both BSC and FOLFIRI regimens. From an economic perspective, despite the additional economic resources that would be required, the investment could positively impact the overall survival rate for the patients treated with the FTD/TPI strategy. However, the innovative molecule would lead to a decrease in hospital accesses devoted to chemotherapy infusion, ranging from a minimum of 34% to a maximum of 44%, strictly dependent on FTD/TPI penetration rate, with a consequent opportunity to take on a greater number of oncological patients requiring drug administration for the treatment of any other cancer diseases. According to experts' opinions, lower perceptions of FTD/TPI emerged concerning equity aspects, whereas it would improve both individuals' and caregivers' quality of life. In conclusion, the results have demonstrated the strategic relevance related to the introduction of FTD/TPI regarding the coverage of an important unmet medical need of patients with metastatic gastric cancer who were refractory to at least two prior therapies, with important advantages for patients and hospitals, thus optimizing the clinical pathway of such frail patients.
Asunto(s)
Neoplasias Colorrectales , Demencia Frontotemporal , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/tratamiento farmacológico , Calidad de Vida , Evaluación de la Tecnología Biomédica , Neoplasias Colorrectales/patología , Combinación de Medicamentos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéuticoRESUMEN
The introduction of inhibitors of poly-(ADP-ribose) polymerase (PARP) for the treatment of women with epithelial ovarian cancers (EOC) has radically changed the treatment in maintenance setting after responding to first- and second-line chemotherapy. The aim of this paper was to assess the pharmacological costs of PARP inhibitors (olaparib, niraparib, rucaparib and veliparib) in maintenance treatment after responding to first-line chemotherapy in EOC. Incremental cost-effectiveness ratio (ICER) was calculated as the ratio between the difference of the costs in the intervention and in the control groups (pharmacy costs) and the difference between the effect in the intervention and in the control groups (progression-free survival (PFS)). We have considered the pivotal phase III randomized controlled trials (RCTs). Three different populations were considered: the overall population, patients with germline BRCA mutation (gBRCA) and homologous recombination deficiency (HRD) patients non-gBRCA mutation. Three thousand four hundred and twenty patients and 1209 patients were considered in maintenance treatment after responding to first- and second-line chemotherapy in EOC, respectively. At the actual price, the treatment with PARP inhibitors is not cost-effective in maintenance treatment after responding to first-line and second-line chemotherapy in EOC. A reduction in pharmacological costs is mandatory.
Asunto(s)
Neoplasias Ováricas , Inhibidores de Poli(ADP-Ribosa) Polimerasas , Humanos , Femenino , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Neoplasias Ováricas/tratamiento farmacológico , Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Análisis Costo-Beneficio , Adenosina Difosfato Ribosa/uso terapéutico , Quimioterapia de MantenciónAsunto(s)
Neoplasias Colorrectales , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Camptotecina/uso terapéutico , Cetuximab/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/genética , Neoplasias Colorrectales/patología , Análisis Costo-Beneficio , Fluorouracilo/uso terapéutico , Humanos , Irinotecán , Leucovorina/uso terapéutico , Metástasis de la Neoplasia/tratamiento farmacológicoAsunto(s)
Neoplasias Colorrectales , Trifluridina , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Combinación de Medicamentos , Humanos , Pirrolidinas , Sobrevivientes , Timina/uso terapéutico , Trifluridina/farmacologíaRESUMEN
Introduction: The aim of this paper was to assess the cost-effectiveness of alectinib and brigatinib in first-line for anaplastic lymphoma kinase mutation-positive (ALK+) advanced non-small cell lung cancer (NSCLC). Pivotal phase III RCTs were considered. Four hundred and eighty-two patients were included. Both trials, which compared alectinib and brigatinib versus (vs.) crizotinib (control group), respectively, showed a gain in pharmacological costs, compared to the control group, of 194.80 for alectinib and 648.48 for brigatinib for an entire treatment of a single patient. Brigatinib was the less expensive, with a cost of 269.78 for each month of PFS for both intention-to-treat (ITT) population that patients with baseline brain metastases (BBM). In conclusion, combining pharmacological costs of drugs with the measure of efficacy represented by PFS, both alectinib and brigatinib are cost-effective treatments in first-line for ALK+ NSCLC. In the BBM population brigatinib seems to be the most cost-effectiveness.
Asunto(s)
Neoplasias Encefálicas , Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Quinasa de Linfoma Anaplásico/genética , Neoplasias Encefálicas/tratamiento farmacológico , Neoplasias Encefálicas/genética , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/genética , Carcinoma de Pulmón de Células no Pequeñas/patología , Análisis Costo-Beneficio , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patología , Mutación , Compuestos Organofosforados/uso terapéutico , Inhibidores de Proteínas Quinasas/uso terapéutico , PirimidinasRESUMEN
INTRODUCTION: The aim of this analysis is to assess the pharmacological costs of trifluridine/tipiracil as first-line treatment in metastatic colorectal cancer (mCRC) patients who were not candidates for combination with cytotoxic chemotherapies. DISCUSSION: TASCO1 Trial was considered (153 patients). Differences in costs between the 2 arms (trifluridine/tipiracil plus bevacizumab vs. capecitabine plus bevacizumab) was 9113 (10 264 USD), with a cost savings of 1982 (2232 USD) per month of overall survival (OS)-gain. CONCLUSION: Trifluridine/tipiracil could be consider a cost-effective treatment also in first-line for mCRC patients who were not candidates for combination with cytotoxic chemotherapies.
Asunto(s)
Neoplasias del Colon , Neoplasias Colorrectales , Neoplasias del Recto , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bevacizumab/uso terapéutico , Neoplasias del Colon/tratamiento farmacológico , Neoplasias Colorrectales/patología , Análisis Costo-Beneficio , Combinación de Medicamentos , Humanos , Pirrolidinas , Neoplasias del Recto/tratamiento farmacológico , Timina , Trifluridina , UraciloAsunto(s)
Neoplasias Colorrectales , Protocolos de Quimioterapia Combinada Antineoplásica , Bevacizumab/uso terapéutico , Cetuximab/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Análisis Costo-Beneficio , Fluorouracilo/uso terapéutico , Humanos , Leucovorina/uso terapéutico , Metástasis de la Neoplasia , Años de Vida Ajustados por Calidad de VidaRESUMEN
The introduction of targeted agents (lenvatinib) and immune-based therapies (atezolizumab in combination with bevacizumab) for first-line advanced hepatocellular carcinoma provided new therapeutic options. The aim of this paper was to assess the cost-effectiveness of lenvatinib and the combination of atezolizumab plus bevacizumab in first-line for advanced hepatocellular carcinoma. Pivotal phase III randomized controlled trials were considered. Incremental cost-effectiveness ratio was calculated as the ratio between the difference of the costs in the intervention and in the control groups (pharmacy costs) and the difference between the effect in the intervention and in the control groups (progression free survival). One thousand four hundred and fifty five patients were included. The lowest cost for month of progression free survival-gain was associated with lenvatinib, with 139.24 per month progression free survival-gained. Combining pharmacological costs of drugs with the measure of efficacy represented by progression free survival, lenvatinib is a cost-effective treatment in first-line for advanced hepatocellular carcinoma.
Asunto(s)
Antineoplásicos , Carcinoma Hepatocelular , Neoplasias Hepáticas , Antineoplásicos/uso terapéutico , Bevacizumab/uso terapéutico , Carcinoma Hepatocelular/tratamiento farmacológico , Análisis Costo-Beneficio , Humanos , Neoplasias Hepáticas/tratamiento farmacológicoRESUMEN
Recently, the introduction of encorafenib in combination with cetuximab was considered as a practice changing in BRAFV600-mutated metastatic colorectal cancer. The aim of this paper was to assess the cost-effectiveness of encorafenib plus cetuximab in the second-line treatment of BRAFV600-mutated metastatic colorectal cancer. BEACON CRC Trail was considered. Incremental cost-effectiveness ratio was calculated as the ratio between the difference of the costs in the intervention and in the control groups (pharmacy costs) and the difference between the effect in the intervention and in the control groups (overall survival). Four hundred forty-one patients were included. Differences in costs between the two arms (encorafenib plus cetuximab vs FOLFIRI plus cetuximab) was 59 501 , with a cost of 17 500 per month of overall survival-gain. Combining pharmacological costs of drugs with the measure of efficacy represented by overall survival, at the actual prize encorafenib cannot be considered cost-effectiveness for second-line treatment of BRAFV600-mutated metastatic colorectal cancer.