Virtual Library
Start Your Search
Carlos Gil Ferreira
Author of
-
+
EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
-
+
EP1.16-42 - Pharmaceutical Follow-Up Program for Patients with Driver Mutation in Non-Small Cells Lung Cancer (Now Available) (ID 2427)
08:00 - 18:00 | Author(s): Carlos Gil Ferreira
- Abstract
Background
Lung cancer has faced important changes in its recent history. With the improvement of main genetic mutations and its discovery evidences, the target-therapy oriented to specific molecular groups have revolutionized that kind of tumour. Those recent discoveries made possible oral drugs administration procedures at anti-lung cancer treatment. Compared to intravenous therapy, the oral medicine administration brought several benefits, which include the treatment in the comfort of patient’s home. However, its use can be frequently associated with some concerns as: treatment adherence, medical conciliation, collateral effects and drug cost. The purpose of this paper is to describe the best practices of follow-up lung cancer patient service model while making use of oral drugs in the household environment.
Method
This article presents a multidisciplinary team’s expertise acting in an oral chemotherapy program, managed by pharmacists between april of 2016 and march of 2019. All patients had driver mutations at non-small lung cancer cells and were being treated at a private medical clinic.
Result
We developed a service program named as Projeto Droga Oral (Oral Drug Project) (Figure 1), in order to contribute to the better management of interdisciplinary team while handling the above mentioned patients. A total number of 77 persons where identified and 9 different drugs where applied: Afatinib, Alectinib, Brigatinib, Ceritinib, Crizotinib, Erlotinib, Gefitinib, Lorlatinib and Osimertinib.
Figure 1: Service flowchart for Oral Drug Project
Of the mentioned patients, 53% presented drug-drug and 43% drug-food interactions. 95% of all interventions where accepted by multidisciplinary team. No hospitalizations due to drug intoxication were registered and only 2% needed to suspend treatment definitely due to 3rd degree of non-manageable toxicity. 56% presented 1st or 2nd degree of toxicity and prematurely managed. All toxicities were identified and there were no patient abandonment during treatment.
Conclusion
The Oral Drug Program is a key factor to guarantee patient correct follow-ups and treatment success. The development of a support program for the patient and caregiver during the administration of target-therapy at household environment granted the main benefits: quality of life improvement, better therapeutic control, better patient adherence and caregiving management, early problem identification related to the drug use, reduction of hospitalization costs and collateral effects. To ensure the project implementation success, institutional protocol and conduct standardization is mandatory as well as qualified workforce participation and correct patient education about his or her treatment plan.
-
+
ES10 - Oncology Drug Approval: Challenges and Opportunities (ID 13)
- Event: WCLC 2019
- Type: Educational Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Caicun Zhou, Alice T. Shaw
- Coordinates: 9/08/2019, 13:30 - 15:00, Toronto (1985)
-
+
ES10.05 - Brazilian Health Regulatory Agency - Agência Nacional de Vigilância Sanitária (Now Available) (ID 3209)
13:30 - 15:00 | Presenting Author(s): Carlos Gil Ferreira
- Abstract
- Presentation
Abstract
Brazil, the largest country in South America, has become the second largest pharmaceutical market in the emerging world. The Brazilian Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria - ANVISA) was created in 1999 with the primary goal to protect and promote public health surveillance over products and services in Brazil. Its hallmarks are administrative independence, financial autonomy, and the stability of its directors. Within the federal public regulatory structure, the agency is linked to the Ministry of Health [1].
Despite major advances in the regulatory process in Brazil, it is important to highlight that a major delay in cancer drugs approval over the last decade has had a negative impact on patient access to novel medications in Brazil. According to Barrios et al., [2] well-established and adequately functional drug approval legislation is indispensable to guarantee a country’s population health. Any malfunctions or delay in such a crucial process have serious consequences. As an example, the drug Crizotinib (Xalcori®Pfizer, NY, USA), which had its approval denied by ANVISA in June 2014 may be seen as a landmark. Assuming different premises, Barrios et al. [2] calculated 1.367 years of life lost over 34 months due to lack of access to Crizotinib between August 2011 (FDA approval) to June 2014 (refusal by ANVISA). Of note, Crizotinib was not approved in Brazil until Feb 2016, what may have added additional 804 years of life lost to final numbers due to this delay. Other example of unexplained delay in drug approval in lenalidomide. The gap between the drug approval in the US and Brazil was 12 years.
Regarding drugs that do require a companion diagnostic, the situation may become more complicated since, unlike the US Food and Drug Administration, no clear mechanism is in place with ANVISA for the simultaneous linking of most companion diagnostic tests with their respective targeted therapeutic drug [3].
In trying to understand the reasons behind this delayed drug approval process, methodological, cultural, political and ideologic reasons may account. At odds with other regulatory agencies such the FDA that allow conditioned approval based on non randomized data for drugs addressing unmet medical needs. For many years ANVISA authorities mandated randomized phase 3 data for a definitive approval, since no conditioned approval was allowed. In this context, having a specific oncology area or committee, such as the FDA Oncology Drug Advisory Committee [4], may be crucial. Fast track approval, breakthrough designation, companion diagnostics, different surrogate endpoints, integration of real world evidence (RWE) into the regulatory process are very specific topics from the oncology field and do require to be analyzed under the perspective of cancer specialists. From a political, cultural and ideologic perspective, althoughit is notorious that Brazil has invested substantially in expanding access to health care for all of its citizens, the country has, essentially, two clear distinct and dissimilar health systems [3]. The public system allows drugs to become commercially available through processes that are different from those in place in the private health-care system. Although difficult to measure those disparities and difficulties to reimburse expensive drugs in the public system, may have influenced the delayed process during the last decade.
Over the last decade, delays at ANVISA’s approval process have been considered the only reason for the inequitable access to oncology care between the USA and Brazil. Yet, this may be a biased conclusion and a more comprehensive analysis in needed. By analyzinga basket of twenty-three oncology products approved by ANVISA after 2002 Bustamante et al. [5] identified that on average there was a difference of 8.6 months (449 X 186 days). However on average, a delay in the manufacturers’ submission for regulatory approval of 1.1 years (393 days between Brazil and the USA) was also identified.
More recently, a trend toward improvements in the drug approval process has been identified (ex. Osimertinib and Durvalumab). Osimertinib was firstly approved by ANVISA in 2017 as a second line treatment in patients who did not respond well to the initial drug. With the new determination, in 2018 ANVISA approved its use as a first therapy to treat locally advanced non-small cell lung cancer. Durvalumab was approved by ANVISA in 2017. Nevertheless there is clear room for a continuous improvement. Increase in the number of ANVISA technicians, continuous training and collaboration with academic institutions and other regulatory agencies elsewhere are mandatory. Close scientific collaboration and open and transparent dialogue between ANVISA and pharmaceutical companies are required. In sum, if we are to have a continuous improvement in the oncology drug approval process, all the stakeholders (ANVISA, drug manufactures, patient advocacy, players at the private and public health systems) must act together.
References
1. Ba KH andSassi AB. ANVISA: an introduction to a new regulatory agency with many challenges. AAPS Open2018; 12 Dec 2018; 4:9.
2. Barrios PM, Debiasi M, Lopes G, Barrios CH. P1.51: Impact of Regulatory Delays in Drug Approval: Mortality and Morbidity Due to With Lack of Access to Crizotinib in Brazil: Track: Supportive Care and Others. IASLC 7th Latin American Conference on Lung Cancer, 25-27 August 2016 • Panama City, Panama; Volume 11, Issue 10, Page S215.
3. Ferreira CG, Achatz MI, Ashton-Prolla P, Begnami MD, Marchini FK, Stefani SD. Brazilian health-care policy for targeted oncology therapies and companion diagnostic testing. Lancet Oncol. 2016 Aug;17(8):e363-e370.
4. Vaccari L.A. The Role of the Oncology Drug Advisory Committee in the FDA Review Process for Oncologic Products. In: Teicher B.A., Andrews P.A. (eds) Anticancer Drug Development Guide. Cancer Drug Discovery and Development. Humana Press, Totowa, NJ, 2004.
5. Martin de Bustamante M, Martin de Bustamante M, Duttagupta S, Beckerman R, Smith NJ, Roitberg F, Lopes G. Regulatory approval for oncology products in brazil: a comparison between the FDA and Anvisa approval timelines. Value in Health 18 (2015) a805–a881. Abstract PCN60.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
P1.07 - Nursing and Allied Professionals (ID 171)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Nursing and Allied Professionals
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
-
+
P1.07-06 - Use of the Nutritional Risk Index as Screening for Malnutrition in Patients with Lung Cancer (Now Available) (ID 2641)
09:45 - 18:00 | Author(s): Carlos Gil Ferreira
- Abstract
Background
Introduction: Malnutrition is a critical condition for patients with lung cancer (LC). High turnover clinics require an easy, fast and good sensitivity screening instrument. Objective: To compare Buzby's Nutritional Risk Index (NRI) tool and to correlate it with nutritional status assessment from anthropometric parameters.
Method
Methodology: This is a cross-sectional study, with patients with clinical stage IV lung adenocarcinoma, followed at a reference oncology clinic in Rio de Janeiro. During the first visit, data on age, sex, current weight, usual weight, height, arm circumference (AC), triceps skinfold thickness (TST) and serum albumin were collected. To assess the nutritional status, calculations of NRI (Busby et al., 1998), body mass index (BMI), AC adequacy and arm muscle circumference (AMC) adequacy were used. Patients were classified as undernourished or undernourished. The data were analyzed through the SPSS program, version 13.0.
Result
Results: 23 patients participated in the study, with a mean age of 66.4 ± 11.3 years, of which 52.2% were female. The percentage of patients considered malnourished by IRN was 52.2% for IRN, 21.7% for BMI, 39.1% for CB adequacy and 26.1% for WBC adequacy. The BMI was the index that most classified individuals as without malnutrition (78.3%). When the INR was crossed with the other evaluation methods used, it was found that there was a very low degree of agreement regarding BMI (Kappa = 0,1), p <0.06.
Conclusion
Conclusion: in this study IRN was more sensitive to identify inadequacy in nutritional status when compared to BMI, CB and CMB. The use of IRN in patients with lung cancer helps to identify the nutritional diagnosis early, favoring nutritional intervention and consequently the quality of life of the patient.
-
+
P2.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 187)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
-
+
P2.16-14 - Survival Rates in Non-Small Cell Lung Cancer Patients in the Brazilian Private Health System: A Cohort Study (ID 2328)
10:15 - 18:15 | Presenting Author(s): Carlos Gil Ferreira
- Abstract
Background
Lung cancer is the leading cause of cancer-related mortality in Brazil. Non-small cell lung cancer (NSCLC) is the most prevalent subtype and is associated with high rates of mortality. Despite being diagnosed in late phases, few studies have addressed the survival rates of such disease in the Brazilian private health system.
Method
An exploratory cohort study based on administrative database claims that included patients with advanced NSCLC diagnosed between 2011 to 2016. The inclusion criteria were defined as having lung cancer diagnosis (ICD-10 code 34 with stage III and IV) and compatible histologic subtype for NSCLC, such as adenocarcinoma, squamous cell, non-squamous cell and others. Non-parametric statistics (Kaplan Meier method, product limit estimator) was used to perform survival analyses, considering diagnosis as index date.
Result
A total of 5,016 patients were included in this study. At time of diagnosis, most patients had stage IV disease (67%) and were 60 to 69 years old (33.7%). Patients took 31 days on average to receive diagnosis after being attended by a health service. The clinical oncologist was the first professional to attend the patient in 44% of cases. The average time to start the treatment was 35 days and where patients received chemotherapy (32%) or chemotherapy plus radiotherapy (21%). The median survival rate for stage III NSCLC was 11 months; while for stage IV, 50% of the population was alive in 6.5 months.
Conclusion
This study suggests a high percentage of patients diagnosed with stage IV disease. The survival rates were very low, comparable to the public healthcare system where the patient doesn’t have access to all medications approved by ANVISA, Brazilian Regulatory Agency, (median overall survival of 8 to 12 months). The results show an opportunity to improve care in private healthcare system.
