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Nise Yamaguchi
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MS 09 - Global Perspectives in Eliminating the Major Cause of Lung Cancer (ID 531)
- Event: WCLC 2017
- Type: Mini Symposium
- Track: Epidemiology/Primary Prevention/Tobacco Control and Cessation
- Presentations: 1
- Moderators:Carolyn Dresler, William Kenneth Evans
- Coordinates: 10/16/2017, 15:45 - 17:30, Room 315
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MS 09.06 - Tobacco Industry Interference in Low and Middle Income Countries (ID 7687)
17:00 - 17:15 | Presenting Author(s): Nise Yamaguchi
- Abstract
- Presentation
Abstract:
The 2016 FCTC Report of the Conference of Parties (COP 2016) alerts that tobacco is the only legal non-prescription product that can kill between 33% and 50% of consumers when used as recommended by the tobacco industry [[1]]. The tobacco industry is also the only industry that, due to the potential lethality of its products and their impact on public health, has elicited a legally-binding intergovernmental treaty for protecting public health policies from the interference by the industry and by those who act to protect their interests. Besides the heavy political lobbying for blocking, delaying or weakening public health policies on tobacco control, the industry frequently resorts to legal disputes on the basis of international free trade agreements and bilateral agreements to revert governmental policies1. During the 6th COP, in 2014, the FCTC adhering State Parties have declared that the tobacco industry interference in public health policy for tobacco control continues to represent the main hindrance for full implementation of FCTC articles [[2,3]]. According to the WHO’s global report on tobacco industry interference of 2012, the most common tactics used by the industry are [[4]]: • maneuvering to hijack the political and legislative process; • exaggerating the economic importance of the industry; • manipulating public opinion to gain the appearance of respectability; • fabricating support through front groups; • discrediting proven science; • intimidating governments with litigation or the threat of litigation. Despite the tobacco industry claiming otherwise, the Director-General of the World Trade Organization (WTO) has declared that there is no inherent conflict between FCTC implementation by the ratifying countries and the WTO rules [[5]]. He enlightens that there are two WTO principles that should be respected: the non-discrimination and the necessity principles. The first one implies that the implemented tobacco-control policy does not treat an imported product differently than its domestic equivalent; whereas the necessity principle states that such measure, law or provision “must be necessary for complying with the proposed health goal and that it should not be more restrictive than necessary on trade in order to achieve this goal”[[6]]. Furthermore, according to the WTO, a “Member States have the right to determine the level of health protection that they wish to promote…” and, “when considering the less restrictive alternatives, these must meet the regulatory goal and be reasonably available, as well as genuinely alternative and not complementary measures”[[6]]. As far as bilateral agreements are concerned, the industry has used them in some countries to revert or impede the FCTC provision on cigarette packaging and labeling, by claiming that it breaches bilateral trade provisions that protect trademark and property rights [[6]]. Therefore, legislators should consider four basic principles when implementing tobacco control regulations: 1), to make sure that the law “only restricts property rights to the extent of achieving a public health objective”; 2), to avoid raising expectations of tobacco-industry investors that they will not be subjected to the regulation in question; 3), to ensure legislation’s compliance with the principles of due process and natural justice; and 4), to make sure that the new regulation will not be discriminatory. The careful application of these principles in the legislation wording and form will not only reduce international litigation but also protect the FCTC-ratifying Party from having to pay the tobacco industry compensation for damages [[6]]. In 2014, the COP participants unanimously decided to accelerate the full implementation in all public administration sectors and diplomatic missions of Article 5.3 and its guidelines [[3]]. Article 5.3 of the Framework Convention for Tobacco Control (FCTC) offers essential guidelines that were unanimously approved by the FCTC-ratifying countries in 2008. Article 5.3 thereby obligates ratifying countries to protect their health policies from tobacco manufacturers’ interference and to recognize that the tobacco industry bears fundamental and irreconcilable conflict of interests with public health and the FCTC implementation. In fact, Article 5.3 guidelines are the backbone of the FCTC treaty and help to prevent and reduce litigations aiming at reversing or halting the implementation of further anti-tobacco policies [[1]]. According to Article 5.3, countries should refuse to treat tobacco companies as “collaborators” in public health policy making; should not invest in the tobacco industry; should not receive contributions or grants from the tobacco industry; should not partner with tobacco industry either for health or other purposes – including their so-called social responsibility programs; should not celebrate non-binding or non-enforceable agreements; nor admit tobacco industry representatives on FCTC delegations or on other tobacco-control administrative agencies. Another relevant provision of Article 5.3 concerns transparency[[7]] in the interactions between government agencies and the tobacco industry by promoting afore public notices and free public access to reports, records, and documents about such interactions, besides promoting public hearings about the meetings. Moreover, it recommends the disclosure or registration of tobacco-affiliated organizations, advocacy groups and lobbyists; legal penalties on tobacco business for disseminating false or misleading information or propaganda; disclosure of tobacco industry business, such as market share, revenues, production, manufacture, relationship with tobacco farmers, investments in marketing, analysis of tobacco products chemical contents, and “social responsibility” actions and related activities; obligatory disclosure of current or past work with tobacco industry by applicants to jobs in governmental bodies involved in health policy-making, policy execution or surveillance[[7]]. The 2016 PAHO Report for the Region of Americas alerts that there are more than one billion smokers in the world and that 11.4% of them live in the Region of the Americas, which represents a population of 127 million smokers in our continent [[1]]. Prevalence shows that 21.2% of adults or teenagers older than 15 are smokers [[1]], which poses a heavy burden on public health, especially because it is among the youth and the lower income segments that the prevalence is higher. However far we had already progressed in fighting smoking and the consumption of other tobacco products, we are still very far from eradicating this addiction that responds for the vast majority of lung cancer cases, not to mention Head & Neck tumors and cardiovascular diseases. The implementation by all ratifying Parties of the FCTC six provisions that comprise the MPOWER package may drastically reduce in the coming two decades the morbidity and mortality associated with tobacco consumption. Our struggle is just beginning. References Pan American Health Organization. WHO FCTC. Report on Tobacco Control for the Region of the Americas. Who Framework Convention on Tobacco Control: 10 Years Later. Washington DC: PAHO, 2016. World Health Organization. FCTC/COP6/16, Implementation of Art. 5.3 of the WHO Framework Convention on Tobacco Control: questions related to tobacco industry interference. Report of the Secretariat of the Convention. Conference of the Parties in the WHO Framework Convention on Tobacco Control, 6th Meeting; 13-18 October; Moscow, Russian Federation. Geneva: WHO; 2014. Available at: . Accessed on June 10, 2017.
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P3.03 - Chemotherapy/Targeted Therapy (ID 719)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.03-019 - Activity of PARP Inhibitor in NSCLC with Germline and Somatic Mutation and in Silico Chemotherapy Lethality (ID 9740)
09:30 - 09:30 | Author(s): Nise Yamaguchi
- Abstract
Background:
Challenges in Precision and Personalized Medicine with interpatient variation needs individualized protocols. PARP Inhibition may be one modality of treatment of NSCLC, as coadjutant to chemotherapy.
Method:
A 66 years old male has been diagnosed with lung adenocarcinoma since 02-06-2016, c T4 c N1 c M1a (pleura and pericardium), had been exposed to carboplatin and pemetrexed for 6 cycles (January to March 2016) with disease progression, and peripheral neuropathy. He didn’t have EGFR mutation, ALK translocation, MET/RET or ROS-1 FISH alterations. He had been treated with radiation therapy from September to November 2016 with 60 Gy, IMRT, and after he received Nivolumab, from November 2016 to Abril 2017 with radiological progression. He had been tested by RCGG in May 2017 looking for circulating tumor cells in vitro (the culture contains all substances measured to apoptotic ability using oncogene apoptosis kit; the result is confirmed by cultures of the tumor or circulating tumor cells), Idengen (inherited hot-spot mutations), and Guardiant 360 by liquid biopsy (circulating DNA sequencing somatic mutations).
Result:
With the Idengene test, he has had PALB2 inherited mutation germline with possible pathogenic significance, BRCA1 and BRCA2 with unknown pathogenic significance. Also, he had NBN, PTCH2, and PTEN as possible pathogenic significance. With the Guardiant 360 test, he had BRCA1, C24Y, NF1, R416Q somatic mutations. With the RGCC test, the specific tumor appears to have resisting populations because of the MDR1 overexpression that can be reversed using inhibitors of ABCG2 pumps. Also, the neoplastic cells have the greatest sensitivity in the alkylating agent (cisplatin, mitomycin), in the tubulin dimmer polymerization inhibitors (Vinorelbine). Inhibitor of Akt/mTOR pathway can be used, as Everolimus, temsirolimus. He has partial sensibility to nucleus spindle stabilizer I (paclitaxel, docetaxel), II (vincristine, vinblastine), and nucleoside analogues (methotrexate, gemcitabine, pemetrexed). Therefore he has been exposed to oral Olaparib 300 mg BID, intravenous Gemcitabine 600 mg/m2, and oral vinorelbine 60mg/m2 weekly both., with good tolerability, and improvement of Performance Status.
Conclusion:
PARP Inhibitor can be a target therapy in personalized medicine, guided by PALB2 / BRCA 1 / 2 mutations in codons inherited and / or somatic mutations, in addition to gemcitabine and vinorelbine in lung adenocarcinoma resistant to platinum/pemetrexed. The addition of Olaparib was possible in this patient, and feasible with a good tolerability, maybe impacting the outcome. More studies related to PARP inhibitor and NSCLC need to be developed.
