Open access Editorial Two-way traffic: aligning expectations with current realities in oncology. Mid- term ESMO Presidency considerations Josep Tabernero To cite: Tabernero J. As we arrive mid-term of my ESMO presi- we move this rapidly evolving field forward Two-way traffic: aligning dency, I find myself reflecting on the current was recently highlighted in the specialised expectations with current realities in oncology. Mid- state of oncology and the necessity to more literature.2 term ESMO Presidency successfully bridge existing gaps between considerations. ESMO Open expectations and today’s realities, for our 2019;4:e000494. doi:10.1136/ patients as well as our profession. It really Spreading the word esmoopen-2019-000494 is a matter of two-way considerations and As the Nobel Prize in Physiology or Medicine a delicate balancing act demanding reality 2018 was awarded jointly to James P Allison Received 18 January 2019 and transparency in equal measure. Happily, and Tasuku Honjo “for their discovery of Revised 22 January 2019 in many areas we are delivering on expecta- cancer therapy by inhibition of negative Accepted 22 January 2019 immune regulation”, an interesting article tions by translating them into proven reali- in The Guardian3 addressed the promise and ties. Other issues, however, require a lot more Published online current pitfalls of this potentially break- work or a rethink. 31 January 2019 through therapy for an increasing number At the research level, we have witnessed of patients. The author argued for a better tremendous progress over the past decade balance between the hype and proven hypoth- driven by increased focus on prevention and eses in terms of established clinical benefit early diagnosis, and an expanding portfolio across patient populations. of powerful anti-cancer therapies that are We are reporting important progress in being more precisely matched to individual counteracting disease progression, resistance cancers. For example, from 2011 to 2016, 68 to cancer therapies and halting metastatic new cancer medicines were approved for 22 cell spread. These advancements have largely indications,1 including immune-based thera- been driven by better screening, prevention pies that have significantly improved patient strategies and earlier diagnosis. Our efforts outcomes across many cancers, including aimed at identifying predictive biomarkers melanoma and non-small cell lung cancer as well as developing more precise targeted (NSCLC). The emergence of PD-1 inhibitors, therapies and combinatorial approaches— with pembrolizumab and nivolumab taking which in many cases are also proving less centre stage back in 2014 for treating mela- toxic for our patients—have also led to noma, has been followed by others, including certain improvements to cancer incidence CAR T-cell therapies and therapeutic anti- and mortality. bodies, with a welcome expansion across Reflecting some of these pioneering many tumour types. research trends, out of the 18 defined abstract They are most certainly here to stay as categories for the ESMO 2018 Congress, the © Author (s) (or their employer(s)) 2019. Re-use we investigate further how to empower and topics Immunotherapy of cancer and Biomarkers permitted under CC BY-NC. No personalise this anti-cancer armoury to were among the top six receiving the most commercial re-use. Published unleash the power of the immune system to accepted submissions. by BMJ on behalf of the attack disease. European Society for Medical Similarly, three of the top five studies to Oncology. That said, the heightened expectations of make the most headlines during the meeting Vall d'Hebron University Hospital our patients must be carefully managed as were as follows: atezolizumab in combina- and Institute of Oncology we seek to understand why some cancers do tion with chemotherapy against metastatic (VHIO), Universitat Autònoma de not respond or eventually become resistant to triple-negative breast cancer (IMpassion Barcelona, Barcelona, Spain the treatments, as well as establish predictive 130 trial)4; the power of tumour genomics Correspondence to markers of response to identify those indi- in improving outcomes for breast cancer Dr Josep Tabernero; ​ viduals who would be most likely to benefit. patients (SOLAR-1 trial)5; and potentially jtabernero@​vhio.​net The call to better manage expectations as practice-changing data from a study6 7 Tabernero J. ESMO Open 2019;4:e000494. doi:10.1136/esmoopen-2019-000494 1 Open access showing that maintenance therapy with olaparib extends appointed expert groups, ESMO’s global and regional progression-free survival (PFS) by 3 years in over 50% public policy committees, are drawing up recommenda- of patients with newly diagnosed and advanced ovarian tions for policymakers, regulators, payers and pharma- cancer (SOLO1 study). ceutical companies and translating them into models To translate and apply this progress successfully for facilitating interaction between stakeholders at the the clinical benefit of our cherished patients, we all rely regional level. on timely access to the latest research results and expect In our commitment to monitor the fair pricing of anti- equal opportunity to engage in the essential conversations cancer treatments, several value framework tools and plat- that continue to shape the future of cancer discovery and forms have been launched (and refined) to identify the the practice of oncology. proven (as opposed to merely promising) performance ESMO congresses are renowned for facilitating a and clinical benefit of various treatments. Two of these superb platform for this vital exchange of ideas. Impor- important value frameworks are ESMO’s Magnitude of tantly too, in today’s era of personalised medicine that Clinical Benefit Scale (ESMO-MCBS) and the American demands multidisciplinary approaches, they succeed in Society of Clinical Oncology (ASCO) Value Framework growing their reach, scope and appeal, year on year. Net Health Benefit Score (ASCO-NHB), both launched Last year’s ESMO Congress in Munich drew a record in 2015. attendance with 28 000 participants, up 16.8% on Born out of a shared commitment to align their the previous year. Indeed, attendance has grown by a respective scoring systems by championing concordance phenomenal 72.4% since 2012—a reality that surely through shared standards, findings from a study published delivers on expectations! The top 10 submitting countries this year9 found that both scales are largely in concor- of the 3350 plus abstracts that we received spanned North dance regarding assessment outcomes, despite adopting America, Europe and Asia. different criteria and approaches to develop a clinical Speaking of Asia, ESMO is especially dedicated to benefit or net health benefit score. In the instances of delivering on its educational agenda without borders. non-convergence, the report proposed several potential Launched in 2015, the ESMO Asia annual congress factors including varying means of evaluating relative drew an attendance of over 3000 delegates last year. This and absolute gain for overall survival (OS) and PFS, and statistic perfectly justifies ESMO’s action of introducing application of toxicity penalties. Importantly, the authors this series of educational opportunities to keep oncology offered a four-point plan to further improve the two plat- professionals in the Asia-Pacific region updated with forms. These findings will be key to potentiating current the rapid pace of oncology science as well as promote tools for assessing clinical gain of cancer medicines based networking opportunities with international colleagues. on common parameters while upholding responsibility While such successes must be applauded, we still have a for reasonableness. In short, both platforms represent long way to travel if we are to extend these breakthroughs essential intelligence, particularly in guiding policy- and make them truly accessible to an increasing number makers to ensure the appropriate allocation of limited of our patients, across borders. funds towards delivering affordable and accessible cancer I am optimistic that personalised medicine in oncology care globally. is starting to happen in practice, but expectations must be Critically, these increasingly robust scoring systems managed. Very real challenges stand in our way, including will strive to only positively grade those treatments with the hotly debated issue of expensive treatments carrying proven clinical benefit. In so doing, they will better facil- disproportionate price tags, buckling healthcare systems, itate decision making as well as provide cancer patients the burden on treasury and the disparity of reimburse- and their families with independent, balanced informa- ment policies across countries. tion as they consult with their physicians. In 2016 there were 17.2 million cancer cases worldwide Also rallying for real change, ESMO’s Global Policy and 8.9 million deaths.8 Cancer cases are forecast to rise and ASCO’s International Affairs Committees joined by 75% over the next 20 years. Added to the mix are the forces last year to push the agenda in improving cancer skyrocketing costs of oncotherapeutics and supportive services and reducing cancer deaths. On the occasion of care medicines. Global oncology costs are predicted to the United Nations High-Level Meeting on Non-Com- soar to over $147 billion even as patent expiries and the municable Diseases (NCDs), ESMO and ASCO issued a advent of biosimilars are helping to reduce this unsustain- joint statement10 calling on governments to renew their able burden on the global purse strings. Equally daunting political commitment in scaling-up their actions and is the disparity in terms of access to new cancer medicines investments to meet the targets in reducing deaths from across even developed countries.1 non-communicable diseases, with cancer as a top priority. We are working to avert the pending catastrophe in terms of access to essential medicines and novel therapies for too many patients worldwide, as well as help deliver The real world on ESMO’s mission of facilitating equal access to optimal While these achievements are welcome, we must collec- cancer care to all cancer patients. Our Cancer Medi- tively review the worrisome realities that still fall far short cines Committee, in close collaboration with especially of our expectations. In so doing, I believe that we can 2 Tabernero J. ESMO Open 2019;4:e000494. doi:10.1136/esmoopen-2019-000494 Open access reverse such trends and bring about real change towards Serono, Merrimack, Merus, Molecular Partners, Novartis, Peptomyc, Pfizer, improved outcomes for all stakeholders in oncology. Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, F. Hoffmann-La Roche Ltd, Sanofi, SeaGen, Seattle Genetics, Servier, Symphogen, Taiho, VCN Biosciences, One particular area of focus where we are not yet Biocartis, Foundation Medicine, HalioDX SAS and Roche Diagnostics. JT declares delivering on expectations is closing the gender gap in institutional financial interest in the form of financial support for clinical trials or oncology. Two recently published reports11 12 led by the contracted research for Agendia BV, Amgen SA, Debiopharm International SA, ESMO Women for Oncology (W4O) Committee have Janssen-Cilag SA, Mologen AG, Novartis Farmacéutica SA, Pharma Mar, Roche Farma SA, Laboratorios Servier SL and Symphogen A/S. revealed the realities in terms of how far we have come in Patient consent for publication Not required. addressing gender disparity within our field. Paired with an accompanying editorial,13 findings show that we are Provenance and peer review Not commissioned; internally peer reviewed. falling short of expectations. While an increasing number Open access This is an open access article distributed in accordance with the of women are undoubtedly pursuing careers in the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, healthcare sector—up to 75% of the workforce in some and license their derivative works on different terms, provided the original work is countries—the limited access to the upper tiers indicates properly cited, any changes made are indicated, and the use is non-commercial. that more senior positions largely remain out of reach for See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. our female colleagues. With few exceptions, the problem is global. Theory does not necessarily translate in practice. This References is sometimes true of the disclosure and proper manage- 1. IQVIA. Global oncology trends 2017. Advances, complexity and cost. Report by the QuintilesIMS Institute (now the IQVIA Institute ment of declarations of interest in biomedicine. While the for human data science). Available: https://www.​iqvia.​com/​institute/​ policies and procedures in place should be second nature reports 2. The Lancet Oncology. Immunotherapy: hype and hope. Lancet Oncol to us all—part of our DNA as practising physicians and 2018;19. cancer researchers—the history books show that proper 3. The Guardian. A cure for cancer: how to kill a killer. Available: https:// disclosure can fall far short of what we naturally expect. www.​theguardian.​com/​science/​2018/​nov/​04/​a-​cure-​for-​cancer-​how-​ to-​kill-​a-​killer-​revolutionary-​immune-​system-​immunotherapy To help safeguard research quality and trust, as well as 4. ESMO, 2018. Some patients with metastatic triple negative breast protect the essential collaborations and precious relation- cancer can live longer with immunotherapy. Available: https://www.​ esmo.​org/​Press-​Office/​Press-​Releases/​IMpassion130-​atezolizumab-​ ships between academia and industry in oncology, ESMO nab-​pac-​triple-​negative-​breast-​cancer-​Schmid has launched a Compliance Committee. 5. ESMO, 2018. Targeting specific genomic mutation in breast cancer improves outcomes, first study shows. Available: https://www.​esmo.​ This new addition to ESMO’s expert infrastructure will org/​Press-​Office/​Press-​Releases/​SOLAR-​aplelisib-​fulvestrant-​breast-​ seek to trigger the bigger conversations that clearly need cancer-​Andre to be added. As a priority, one of these will need to centre 6. ESMO, 2018. Olaparib maintenance extends progression-free survival by estimated 3 years in advanced ovarian cancer. Available: on disclosures. By engaging all relevant stakeholders https://www.​esmo.​org/​Press-​Office/​Press-​Releases/​SOLO-​FIGO-​ including the publishers, professional cancer societies olaparib-​ovarian-​cancer-​brca-​Moore 7. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in as well as patient advocates, I strongly believe that we patients with newly diagnosed advanced ovarian cancer. N Engl J can resolve the concerns surrounding the influence of Med 2018;379:2495–505. competing interests in cancer research and treatment. 8. Global Burden of Disease Cancer Collaboration, Fitzmaurice C, Akinyemiju TF, et al. Global, regional, and National cancer incidence, In our efforts to advance the practice of oncology and mortality, years of life lost, years lived with disability, and disability- deliver optimal cancer care across borders, we can and adjusted life-years for 29 cancer groups, 1990 to 2016: a systematic analysis for the global burden of Disease Study. JAMA Oncol will do better. We must all work together as we continue to 2018;4:1553–68. translate current challenges in oncology into opportunity 9. Cherny NI, Dafni U, Bogaerts J, et al. ESMO-Magnitude of clinical benefit scale version 1.1. J Clin Oncol 2017;28:2366. for the most deserved stakeholders of all—our patients. 10. American Society of Clinical Oncology. ESMO-ASCO joint statement Our environment, the world in which we live and work, for the 3rd high-level meeting of the UN General Assembly on the is a mirror of our attitudes and expectations—Earl prevention and control of non-communicable diseases on the actions required by governments for the reduction of premature mortality Nightingale, radio speaker and author 1921–1989. from cancer. Available: https://www.​esmo.​org/​content/​download/​ 134270/​2496239/​file/​ESMO-​ASCO-​Statement-​3rd-​UN-​High-​Level-​ Contributors I am the sole contributor. Meeting-​on-​Non-​communicable-​Diseases.​pdf 11. Hofstädter-Thalmann E, Dafni U, Allen T, et al. Report on the status Funding The authors have not declared a specific grant for this research from any of women occupying leadership roles in oncology. ESMO Open funding agency in the public, commercial or not-for-profit sectors. 2018;3:e000423. 12. Banerjee S, Dafni U, Allen T, et al. Gender-related challenges facing Competing interests JT reports personal financial interest in form of scientific oncologists: the results of the ESMO women for oncology Committee consultancy role for Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer survey. ESMO Open 2018;3:e000422. Ingelheim, Chugai, Genentech, Inc, Genmab A/S, Halozyme, Imugene Limited, 13. Tabernero J. All change: closing the gender gap in oncology. ESMO Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Open 2018;3:e000448. Tabernero J. ESMO Open 2019;4:e000494. doi:10.1136/esmoopen-2019-000494 3