A comparative, nonrandomized, multicenter, and prospective analysis were performed between April 2004 and June 2008 in 20 French centers in order to compare clinical aspects of respiratory-gated conformal radiotherapy (RGRT) during breast cancer irradiation versus conventional conformal radiotherapy. The final results based on 233 evaluable patients at 48 months confirm the feasibility and good reproducibility of the RGRT systems. The main results demonstrated a marked reduction of dosimetric parameters predictive of lungs and cardiac toxicities in the RGRT group; especially the dose delivered to the heart during irradiation of the left breast; mostly observed with deep inspiration breath-hold techniques.
A149Objectives: To estimate the cost-effectiveness of sunitinib as first-line treatment for metastatic renal-cell carcinoma (mRCC) from the Colombian health system perspective. MethOds: A Markov model was developed to compare the quality-adjusted life-years (QALYs) of three strategies as first-line treatment for (mRCC): sunitinib (50 mg per day for 4 weeks followed by 2 weeks off-treatment), bevacizumab (10 mg/kg every 2 weeks) combined with interferon alfa-2a (9 MIU subcutaneously three times a week), and pazopanib (800 mg once daily). The efficacy, safety and utility data were taken from published studies. Bayesian mixed treatment comparison method was applied for the indirect comparison among treatments related to efficacy and safety. We used 5 years as time horizon. An annual discounted rate of 5% was applied. All currency units are in USD$ (1 USD$ = COP 2,640). Costs of drug treatment, disease progression and best supportive care were estimated using official tariffs and databases from Colombia. We used as threshold three times the GDP per capita (USD$ 17,043). Results were tested using deterministic and probabilistic sensitivity analyses. Results: The total expected costs per patient were: bevacizumab combined with interferon alfa-2a USD$ 65,302; sunitinib USD$ 62,074 and pazopanib USD$ 61,793. The results for each alternative in terms of QALY were: bevacizumab combined with interferon alfa-2a (1.62); sunitinib (2.28) and pazopanib (2.22). Bevacizumab combined with interferon alfa-2a was a dominated alternative. The ICER/QALY of sunitinib compared to pazopanib was USD$ 4,685. cOnclusiOns: These results suggest that sunitinib as first-line treatment for (mRCC) is cost-effective in Colombia, taking into account the stablished threshold.Objectives: To estimate the potential cost effectiveness of maintenance therapy to prevent disease progression following chemotherapy for malignant mesothelioma (MM). MethOds: Decision analytic modeling was performed using a Markov cohort approach to estimate the incremental cost effectiveness of a post-chemotherapy maintenance therapy for MM, measured as cost per quality-adjusted life years gained. The perspective of the payer was taken. Entering the model were 100 males, age 65 years, having non-progressed MM following completion of a standard regimen chemotherapy. Rate of progression and overall survival were derived from a phase III trial with pemetrexed plus cisplatin, and cycles were 1 month in length. Health utilities represented values used in similar studies, applied to patients with non-progressed and progressed MM health states. We assumed that the maintenance therapy would reduce the rate of disease progression by 25%. As U.S. data regarding health care utilization among patients with MM is lacking, published cost estimates for lung cancer were applied. Outcomes and costs were discounted at 3.5% annually. Sensitivity analyses examined the robustness of the model when varying values were used for the costs of care and medication, and for treatment effectiveness. Resu...
Background: CDK4/6 inhibitors have been approved in the recent years for the treatment of advanced hormone receptor-positive breast cancer. For patients with resistance to previous endocrine therapy, the approval is based on the results of the PALOMA-3 trial testing palbociclib in addition to fulvestrant observing a progression-free survival (PFS) of 9.2 months. Nevertheless, in this study no previous treatment with fulvestrant was allowed and no information had been reported of efficacy after everolimus administration. Patients and methods: We collected information from patients treated with palbociclib + fulvestrant in the context of a French compassionate access. We aimed at determining the benefit of this treatment in a real population to provide information about PFS in non-selected patients as well as efficacy of palbociclib and fulvestrant in patients previously treated with fulvestrant and/or everolimus. Median PFS were assessed by Kaplan-Meier survival analysis and compared with log-rank test. Results: 206 patients were identified from 5 institutions. Mean age at treatment was 61 years (range 28 – 85). 55% presented with visceral disease. Lines at where palbociclib + fulvestrant treatment was administered were as follows: 1% 1st line, 8.3% 2nd line, 19.4% 3rd line, 13.6% 4th line, 10.2% 5th lignes and the remaining 47.6% had received ≥6 lines (median: 5 lines, range 1 to 15). A total of 48% patients had previously been treated with fulvestrant. In a subsample of patient where the information was available (n=146), 67.8% patients had received everolimus in combination with endocrine therapy before palbociclib administration. A total of 77 patients were still on treatment. Median PFS on fulvestrant-palbociclib treatment at the date of data cut-off was of 5.46 months (95% CI; 4.6 to 6.6 months). In a univariate analysis, there were no significant differences in median PFS for patients treated or not with previous fulvestrant, suggesting a potential effect of palbociclib to recover sensitivity to fulvestrant (4.7 months for previous fulvestrant treatment [95% CI 4.07 - 6.3 months] vs 6.1 months for no previous fulvestrant [95% CI; 6.3 - 8.02 months], p=0.3559). Similarly, in the subsample of n=146 patients where information about previous everolimus treatment was available at data cut-off, benefit from palbociclib-fulvestrant was not affected by previous everolimus treatment (median PFS 4.8 months for previously treated [95% CI; 4.01 -7.8 months] vs 5.4 months for the untreated everolimus group [95% CI; 4.07 - 9.59 months], p=0.374). Conclusions: Fulvestrant-palbociclib in the real life is associated with a median PFS of 5.5 months, which is below the results provided in the PALOMA-3 trial, reflecting a much more advanced population. Importantly, neither previous everolimus treatment nor fulvestrant therapy affected benefit from fulvestrant-palbociclib in this population in univariate analyses suggesting a potential recovery of fulvestrant sensitivity with CDK4/6 inhibition. Results from multivariate analyses and more detailed information about patients' characteristics and benefit from previous therapies will be provided. Citation Format: Arnedos M, Rusquec P, Morelle M, Lebreton C, Jacquet E, Emile G, Aires J, Debled M, Frenel J-S, Augereau P, Cheaib B, Levy C, Bachelot T. Benefit from palbociclib and fulvestrant based on previous fulvestrant and/or everolimus treatment. Based on a cohort of over 200 patients treated in a French compassionate program [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-21-11.
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