Background

Cancer diagnosis and therapy can be associated with patients' physical, emotional and financial burdens. While much attention is being paid to physical and emotional distress, there is only limited data about financial effects on cancer patients in countries with universal healthcare system. In order to tailor support for financial distress to patient reported outcomes it is crucial to better model and understand financial effects. This study aims to define a conceptual model of financial effects of a tumor disease for the German health care context.

Methods

A systematic literature review was conducted to identify risk factors associated with experiencing subjective financial distress. Furthermore, semi-structured interviews were conducted with n=18 tumor patients from the University Hospitals Heidelberg (National Center for Tumor Diseases) and Jena. Additionally, focus groups with representatives from social services and HTA-institutions/payers were held. Qualitative content analysis was used to identify key dimensions and topics.

Results

The developed model accounts for the country-specific objective financial burden in Germany and highlights the individual component regarding assessment of and coping with possible financial effects. It consists of experienced and expected objective burdens (income loss and direct costs), behavioural and cognitive coping strategies, risk factors and subjective distress occurring in six areas of life (employment; health; social integration; social participation; living; across life areas).

Conclusions

Financial effects of a tumor disease in a universal healthcare setting are a multidimensional phenomenon. Hence, a differentiated instrument for measuring financial effects in Germany is needed. The results are the basis for developing such an instrument for a patient-reported outcome of financial effects across different cancer patient groups and treatment trajectories. These are necessary to better understand, communicate and address the financial impact of a cancer disease in the future.

Clinical trial identification

NCT05319925.

Legal entity responsible for the study

University Hospital Heidelberg.

Funding

Deutsche Krebshilfe (German Cancer Aid).

Disclosure

All authors have declared no conflicts of interest.

Background

Distant metastases at initial diagnosis signifiy important causes of morbidity and leads to a higher mortality among patients with breast cancer. Racial disparities in cancer management have been well documented but estimates of racial differences in metastatic breast cancer at initial diagnosis are lacking.

Methods

We obtained data using the publicly available database of Surveillance, Epidemiology, and End Results Program (SEER) to export data from SEER Research Database (8 reg; Nov 2021 Submission) for women diagnosed with breast cancer between 1975 and 2019. Data including race, age at diagnosis, summary stage, and survival were exported for analysis in SPSS.

Results

Between 1975 and 2019, 294,886 cases were diagnosed with breast cancer (25,405, 234,415, and 35,066 of black, white, and other races, respectively). In total, 15,779 cases had distant metastasis at time of initial diagnosis. Black patients had a significantly higher prevalence of metastatic disease at initial diagnosis (8.5%, 5% and 5.1% in black, white, and other races, respectively, P<0.001). An exploratory analysis of age distribution revealed a higher prevalence of early-onset breast cancer in black patients compared to other groups (Table). Black patients with metastatic breast cancer had a significantly shorter mean overall survival months (27.1, 32.7, and 32.5 for black, white, and other races respectively, P<0.001), and a significantly higher cancer-specific mortality rate (72.4%, 70.2% and 65.3% in black, white, and other races, respectively, P<0.001). Table: 1324P

Age of diagnosis for patients with metastatic breast cancer at initial diagnosis for different races

Conclusions

Among women with metastatic breast cancer at initial diagnosis, substantial racial differences exist, with black patients having higher prevalence, younger age at diagnosis and shorter overall survival. While genomic profiles maybe a factor driving such difference, disparities in healthcare access may contribute to the highlighted disparities in prevalence and outcomes.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

Clinical trials investigate new diagnosing, treating, and managing cancer to improve the standard of care treatment. However, the economic benefits of running oncologic clinical trials for hospital administrators are often not considered. One potential financial benefit of clinical trials is drug cost avoidance (DCA), resulting when trial subjects receive industry-sponsored treatment drugs that the institution would otherwise fund.

Methods

We performed a cross-sectional, observational, retrospective study of a total of 53 clinical trials with 363 patients enrolled from a third level hospital in Spain, the Hospital Clínico Universitario Virgen de la Arrixaca (HCUVA). We calculated the DCA from the price of the best standard of care (i.e.: drugs that the institution would otherwise fund). A linear regression model was used to determine cost contributors and estimate their impact.

Results

The total DCA was ∼5.1 million euros (31 clinical trials; 177 enrollees), representing 30% and 0,05% approximately of the annual pharmaceutical expenditures at the HCUVA and for the Spanish Health System, respectively. Cancer type analysis showed that lung cancer had the highest average DCA by trial, indicating that treatments in these trials were the most expensive. Linear regression analysis showed that the number of patients in a trial did not significantly affect that trial's DCA. Instead, cancer type, phase trials, and intention of treatment were significant cost contributors to DCA. Compared to digestive cancer trials, breast and lung trials were significantly more expensive, (p < 0.05 and p < 0.1, respectively). Phase III trials were more expensive than Phase II (p < 0.05) and adjuvant trials were less expensive than palliative (p < 0.001).

Conclusions

We identified key cancer clinical trial characteristics that significantly impacted the estimated DCA. Our work provides the groundwork to explore DCA contributors with potential to enhance public relations material and serve as a negotiating tool for budgeting, thus playing an important role to inform decisions about resource allocation.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

Bibliometric indicators are broadly used to assess academic success. Predatory journals (PJs) have infiltrated the Open Access Movement (OA) with promises of fast-track publications. There is limited knowledge on PJs and no global study oncology.

Methods

We developed an online, 29-question survey to investigate knowledge and practice of PJ, with a focus on low- middle-income countries (LMICs). Descriptive statistics and logistic regression were used, to identify risk factors for publishing in PJs. CROSS guidelines were used.

Results

426 complete responses to the survey were reported (M:F ratio 0.98; mean age: 38.5y). Participants were MD (62.9%), MD/PhD (17.1%) and PhD (14.8%), both clinicians and translational cancer researchers; >70% had published oncology papers before. Two-third belonged to LMICs (n=286) Vs high-income (HIC) (n=140). Principal factors to select Journals for publication were: prestige of the publisher, impact factor, Pubmed indexing (93%). A half reported pressure to publish from supervisors, institutions and funding agencies. Email by PJs were reported by 68%, “every day” or “every week”, and 31% via social network: 93% claimed not to reply PJs’ emails. 13.4% (n=57) confirmed past publications on PJs, convinced by fast editorial decision, no-peer review, affordable OA fees, pressure to finalize training programs, career advancements. Less than a third knew PJ-detection tools (Check Think Submit; Beall’s list) and a half had heard about only from our survey. Multivariable model showed a significant correlation of having publications in PJs with email engagements (OR=3.56; 1.73-7.33) and practicing in LMICs (OR=2.11; 1.05-4.21). Having a previous experience in academic publishing was not protective (p=0.008). Proposals for improvement were suggested: educational workshops, awareness in social networks, enhanced research funding in LMICs, surveillance by supervisors and ensure institutional actions against PJs.

Conclusions

Predatory publishing is a significant issue in global oncology. Our survey identified actionable risk factors of vulnerability to PJs, to inform research capacity-building in LMICs. We expect that our study will provide a rationale to build programs to increase awareness and mark a global change.

Legal entity responsible for the study

Khalid El Bairi.

Funding

Has not received any funding.

Disclosure

K. El Bairi: Financial Interests, Personal, Royalties: Elsevier, Springer. C.G. Lengyel: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. A. Petrillo: Financial Interests, Personal, Royalties: Servier, Eli-Lilly, MSD; Financial Interests, Personal, Invited Speaker: Merck. All other authors have declared no conflicts of interest.

Background

Socioeconomic disparities have been identified as a risk factor to cancer screening and survival. Socioeconomic disparities are one of the major challenges for public health in Chin. However, few studies have focused on the association between socioeconomic status (SES) and survival outcomes for nasopharyngeal carcinoma patients. In this cohort study, we assessed the influence of socioeconomic disparities on the survival outcomes of patients with NPC in an endemic area.

Methods

Data were derived from Cancer Registration System of Sun Yat-sen University Cancer Center (SYSUCC) for NPC patients enrolled between January 1, 2000, and December 31, 2012. SES was categorized into three groups according to the China's 4th economic census SES indicator variables as follows: low, medium and high. Survival outcomes were estimated using the Kaplan-Meier method and compared by the log-rank test. Multivariate Cox regression was used to identify independent prognostic factors.

Results

In the cohort, 11069 adult patients with NPC were included in the analysis, 8309 (75.07%) were men, 2760 (24.93%) were women, and the mean (SD) age was 45.98 (11.4) years. The median follow-up time for the whole cohort was 5.52 years. Kaplan-Meier survival analysis revealed that OS was significantly different among SES, with 10-year survival rate of 74.30% in low SES patients, 76.47% in medium SES patients, and 81.60% in high SES patients (P < .001). In a multivariable model, all patient and tumor demographic variables identified as covariates, and SES was a significant independent factor. Compared with low SES patients, medium SES patients (HR, 0.778; 95% CI, 0.701-0.864), high SES patients (HR, 0.569; 95% CI, 0.488-0.664) were associated with decreased hazard ratio (HR) of overall survival.

Conclusions

Our study revealed SES was associated with the outcomes of patients with NPC. Patients with NPC who had high SES had better overall survival compared with those who had low and medium SES. This finding highlights the disparities in access to healthcare for NPC patients in an endemic area, China. Policy change is needed to require the health agencies to expand health insurance coverage, improve access to cancer treatment, and increase diversity in the nursing care.

Legal entity responsible for the study

The authors.

Funding

Shandong Provincial Natural Science Foundation of China (No. ZR2021QH208 to Dr Meng).

Disclosure

All authors have declared no conflicts of interest.

Background

Health Technology Agencies improve their assessment over time. In 2020, the French HAS published an Organizational Impact map, to define and structure organizational impact (OI) for health technologies. As immunotherapies have extended survival and improved quality of life in advanced cancer, we identified OIs that immunotherapies had on health care system and professionals.

Methods

A literature review was conducted to identify the OI induced by immunotherapies and the actors concerned. Then, interviews with various healthcare stakeholders (HS) were performed. They were asked if immunotherapies had OI classified into 3 macrocriteria: impact on care process (6 criteria), impact on capacities and skills required by the actors (6 criteria) and impact on society (4 criteria). If an OI was mentioned for a criterion, details regarding its impact (minor, moderate, major) and its period (learning and/or routine) were asked. We considered that an OI exists when 75% of HS mentioned an impact for a given criterion.

Results

Overall, 27 HS were interviewed. For 12 out of the 16 criteria, the majority of HS mentioned an impact while literature enabled to identify impacts for 11 criteria. Three criteria (HS skills, transferred skills between HS, scheduling capabilities) had consensus among HS and high impact; 3 criteria (rhythm or care duration, working/living conditions, social relationship) showed consensus but moderate impact; 2 criteria (funding, scheduling capabilities cross-structure) had high impact but no consensus. For 8 criteria (environment, health security, inequity…) no consensus and moderate impact was found.

Conclusions

The introduction of immunotherapies for advanced cancer has an important OI in France, regarding capacities and skills. Qualitative analysis of interviews will provide more information regarding all HS perspectives and OI needing further research.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

I. Borget: Financial Interests, Personal, Invited Speaker: Novartis, Allergan, Roche, Astellas, AstraZeneca; Financial Interests, Personal, Advisory Board: Gilead, BMS. C. Chouaid: Financial Interests, Personal, Advisory Board: AstraZeneca, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen; Financial Interests, Institutional, Funding: AstraZeneca, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen. F. Cotté: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. A. Gaudin: Financial Interests, Personal, Full or part-time Employment, Employee: Bristol Myers Squibb. V. Grumberg: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb.

Background

Regional variation in treatment and outcomes of lung cancer (LC) exists in England suggesting a need for more effective and personalised disease management. However, population level data on patterns of multimorbidity (MM) at diagnosis (Dx), early Dx and mortality in LC across English regions by gender and ethnicity is scarce.

Methods

From the National Cancer Registration Dataset 235208 people aged ≥ 15 years (53% male) with incident LC (2014-2019) across 21 Cancer Alliances (CA) were analysed by gender and in White, Black and South Asian (SA) ethnicities. Regional variation in the proportion with early Dx (Stage 1/2), MM (Charlson Index ≥ 1) and 1-year crude mortality rate / 100 person years (PY) was estimated. Average Percent Change (APC, %)) was estimated to assess temporal changes.

Results

The proportion of Early Dx was low but increased over time with regional variation in males (24 to 28%; APC mean (min, max): 2.8 (0.4, 7.5)%), females (28 to 34%; APC mean (min, max): 4.0 (1.2, 8.6)%), White (26 to 31%; APC mean (min, max): 3.6 (1.5, 7.3)%), Black (23 to 31%; APC mean (min, max): 6.3 (1.1, 10.1)%), and SA ethnicities (25 to 31%; APC mean (min, max): 4.6 (-0.3, 12.1)%). MM at Dx increased across all regions in males (19 to 25%; APC mean (min, max): 4.9 (0.7, 8.7)%) and females (15 to 21%; APC mean (min, max): 6.5 (0.2, 10.2)%), with SA having the highest increase in MM burden (22 to 30%; APC mean (min, max): 5.9 (3.3, 20.7)%) among all ethnicities. Crude mortality rates declined in male (124 to 104/100 PY; APC mean (min, max): -3.5 (-1.1, -7.1)%) and female (100 to 81/100 PY; APC mean (min, max): -4.6 (-1.5, -10.6)%), male having significantly higher rate (p<0.05). Correlation of early Dx with death rate reduction was not observed, with 25% regions with >28% early diagnosis but >100/100 PY death rate.

Conclusions

High regional variations in early Dx, MM and death rate were observed across all incident lung cancer population stratum, over the analysed time period. While the early Dx and mortality reduction in lung cancer is marginal and heterogeneous across English regions, there is an urgent need to further optimise early Dx and care management pathways in multi-ethnic society with increasing multimorbidity.

Legal entity responsible for the study

The authors.

Funding

AstraZeneca.

Disclosure

S.K. Paul: Other, Personal and Institutional, Full or part-time Employment: AstraZeneca. S. Hori: Other, Personal and Institutional, Full or part-time Employment: AstraZeneca. A. Krishna: Other, Personal and Institutional, Full or part-time Employment: AstraZeneca. All other authors have declared no conflicts of interest.

Background

The COVID-19 pandemic has led to deviations in all sectors of cancer care. We present multidisciplinarily approved recommendations for ethically and empirically based prioritisation of procedures in times of scarce resources for patients with colorectal and pancreatic cancer.

Methods

The CancerCOVID consortium conducted qualitative and quantitative studies on ethical challenges and psychosocial stress of patients and health care professionals in cancer care. For empirical analyses we obtained data from AOK Plus, the main health insurance in Saxony, AIO (Arbeitsgemeinschaft internistische Onkologie) cancer centers, the institute of Pathology Bochum, the ColoPredict Registry and data of outpatient care from the BNHO (Berufsverband der Hämatologen und Onkologen) and Onkotrakt AG. A selective literature review of international data and guidelines focussing on the effects of the pandemic on cancer care and allocation of resources was conducted. Structured group discussions on justified criteria for prioritisation were held with experts from oncology, ethics, law and health research. Recommendations for prioritisation were formulated as S1 guideline with approval of 9 AWMF Medical Societies, 22 multidisciplinary experts and patient representatives.

Results

The main principle for decisions on prioritisation in times of scarce resources is the minimisation of individual and aggregated harm. In case of relevant risk of harm from a possible low priority classification or postponement prioritization decisions should be made individually for the respective patients according to the multiple-eyes principle. Decision making should involve different disciplines and professions depending on local infrastructure. We concretised recommendations for 5 areas in cancer care.

Conclusions

Guidelines based on a broad multidisciplinary consensus can give ethically and empirically based support in medical decision making when resources are scarce. This can provide relief for decision-makers and facilitate transparency and trust of patients and population.

Legal entity responsible for the study

The authors.

Funding

Bundesministerium für Bildung und Forschung; Germany Förderkennzeichen: 01KI20521A-C.

Disclosure

A. Reinacher-Schick: Financial Interests, Personal, Invited Speaker: Amgen, Roche, Merck Serono, Bristol-Myers Squibb, MSD, MCI Group, AstraZeneca; Financial Interests, Personal, Advisory Board: Amgen, Roche, Merck Serono, Bristol-Myers Squibb, MSD, AstraZeneca, Pierre Fabre; Financial Interests, Personal, Other, Travel support: Roche; Financial Interests, Institutional, Research Grant: BNT, Roche, Ipsen. O. Schoffer: Financial Interests, Personal, Advisory Role: Novartis. A. Kraeft: Financial Interests, Personal, Writing Engagements: Astra. A. Tannapfel: Financial Interests, Institutional, Research Grant: Roche, Biontech. J. Schmitt: Financial Interests, Institutional, Funding: Sanofi, Pfizer, Novartis. All other authors have declared no conflicts of interest.

Background

Solid tumors may occasionally regress even without treatment, either spontaneously or as a result of placebo effect. Such spontaneous regressions or responses are intriguing from both scientific and regulatory standpoints. We conducted an updated systematic review and meta-analysis of clinical trials of anticancer drugs in advanced solid tumors to estimate an updated placebo response rate in the targeted therapy/immunotherapy era.

Methods

Meta-analysis of placebo-controlled RCTs of anticancer drugs for advanced solid tumors published during 2015-2019. Included RCTs: (1) assessed advanced adult solid tumours only; (2) not neo/adjuvant therapy; (3) not local therapies such as surgery or radiation, cell-based therapies, or supportive care; (4) had a sample size greater than 20 participants; (5) randomly allocated patients to either treatment or placebo arms; (6) the placebo arm was a monotherapy or was used in combination with the best supportive care; (7) was not a duplicate trial or subgroup analysis; (8) measured objective response rates as outlined by the Response Evaluation Criteria in Solid Tumours (RECIST). Primary endpoint was to estimate a summary objective response rate of placebo in anti-cancer clinical trials.

Results

31 phase 3 RCTs including 4887 patients on placebo met our inclusion criteria and formed the study cohort. The pooled overall ORR, CR and PR rates in the placebo arm, using random-effects model, were 2% (95% CI, 1% to 3%), 0.01% (95% CI, 0% to 0.15%), and 2% (95% CI, 1% to 4%) respectively. Higher placebo responses were observed in maintenance therapy trials and prostate cancer trials.

Conclusions

Overall, 2% patients with advanced solid tumors can expect to achieve some response even in absence of treatment. However, complete regression without treatment is rare. This data can help clinical and regulatory policy.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

B. Gyawali: Financial Interests, Personal, Invited Speaker, For writing Medscape Columns: Medscape; Financial Interests, Personal, Invited Speaker, For giving invited talks and grand rounds at universities, cancer centers and professional societies: Various academic and professional organizations; Financial Interests, Personal, Other, Consulting services: Vivio Health; Non-Financial Interests, Member: ASCO, IASLC, JSMO. All other authors have declared no conflicts of interest.

Background

Significant survival benefit is seen with pembrolizumab monotherapy for untreated PD-L1-positive metastatic non-small-cell lung cancer and palbociclib for previously untreated, hormone receptor-positive, HER-2 negative, locally advanced, or metastatic breast cancer. However, access and affordability of these drugs remain challenging in low middle-income countries, including India. To improve the access to meaningful treatment options, India’s health insurance scheme, AB-PMJAY, has linked the oncology packages to National Cancer Grid (NCG) resource-stratified guidelines. The survival benefit with these drugs in two of the most prevalent cancers made it relevant to conduct cost-effectiveness (CEA) assessment for their inclusion in NCG guidelines to guide health benefit packages.

Methods

International HTA evidence was leveraged to accelerate the assessment of these drugs by applying an aHTA approach. We developed a scope for the aHTA by defining the population, intervention, and comparator, followed by a rapid literature review for efficacy, safety, and cost-effectiveness data. Subsequently, a price-benchmarking analysis was undertaken to understand the price being paid in India as compared to international prices in selected countries where the medicines are licensed/reimbursed after adjusting for purchasing power parity (PPP). These data were used to estimate treatment cost per year.

Results

There was sufficient evidence on the safety and clinical effectiveness for both the drugs. The evidence for cost-effectiveness supported the recommendation of palbociclib use in the benchmarking countries only after significant price discounts. However, there was only limited CEA evidence on the value for money for pembrolizumab. The PPP-adjusted list prices of palbociclib and pembrolizumab in India were four times and 2-3 times, respectively as compared to other benchmarking countries. The yearly cost of treatment for all eligible patients was estimated to be $2606,567,040 for palbociclib and $3,740,340,100 for pembrolizumab.

Conclusions

As per aHTA, pembrolizumab and palbociclib are not cost-effective in India at the current prices for the assessed clinical indications.

Legal entity responsible for the study

Tata Memorial Centre on behalf of National Cancer Grid.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

Rare cancers (RC) defined as those with incidence <6/100000 per population, constitute a significant proportion of cancers (∼20%) when considered collectively. Challenges in diagnosis, trial recruitment, and non-standardized treatment approaches result in inferior outcomes of RC. The current study aimed to map the epidemiology of RC in SAARC countries, compile the RC list, compare it with the internationally accepted RC list (RARECAREnet)and explore the RC trends based on age, gender, regional differences.

Methods

We collected data from 30 Population-Based Cancer Registries (PBCR) of India and the published national registries of Nepal, Bhutan and Sri Lanka (SL) and compared them with the standard RARECAREnet RC list.

Results

Due to the lower incidence of cancer in SAARC countries, (with the standard definition <6/100000 per population), 67·5%, 68·3%, 62·3% and 37% of all incident cancers were defined as RC in India, Bhutan, Nepal and SL respectively. The use of an arbitrary cut-off of CR<3 included only 43%, 39.5%, 51.8% and 17.2% of incident cancers as RC in these countries. CR< 3 may represent a more appropriate threshold to identify the lead thrust areas for tumor care in this region. There are similarities and notable differences between the RC lists of SAARC region with that of the European RC list. Oral cavity cancers are rare in Europe while pancreas, rectum, urinary bladder and melanomas are common. In addition, uterine, colon and prostatic cancers are rare in India, Nepal and Bhutan. In SL, thyroid cancer is common. Further, there are gender-related and regional differences in the RC trends in SAARC countries. The distinct population characteristics and RC epidemiology may imply towards the differential screening policies including those oriented towards high-risk populations. Nevertheless, PBCR data is based on cancer sites and lacks data on rare histologies which is a limitation.

Conclusions

The first study to map Rare Cancers in SAARC regions highlight that it is an unmet need to capture epidemiological nuances in RC as a first step towards understanding unique issues prevalent in developing world and may guide policymakers to adopt appropriate measures to improve RC care and tailor public health interventions. Regional and Global collaborations are highly warranted to select resource appropriate care for these rare “Forgotten Cancers”.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

J. Bajpai: Financial Interests, Institutional, Invited Speaker, Institutional financial interests for conducted research: Eli Lilly; Financial Interests, Institutional, Invited Speaker, Institutional financial interests for conducted research: Novartis, Roche, Paxman Coolers Ltd,; Financial Interests, Institutional, Invited Speaker, Institutional financial interests for conducted research(completed study): Samsung Bioepis co. Ltd; Financial Interests, Institutional, Invited Speaker, Institutional financial interests for conducted research(completed study): Sun Pharma; Non-Financial Interests, Advisory Role: Novartis; Non-Financial Interests, Leadership Role, Founder General Secretary: Immuno-Oncology Society of India (IOSI); Non-Financial Interests, Leadership Role, Executive Committee Member: Indian Society of Medical and Paediatric Oncology (ISMPO); Non-Financial Interests, Leadership Role, Founder Member and Joint Secretory: Teenage and Young Adult Cancer Foundation (TYAcan); Non-Financial Interests, Leadership Role, Managing Committee Member: Indian cooperative Oncology network (ICON). S. Gupta: Financial Interests, Personal, Other, Member of various committees related to guidelines, drug pricing, others: Indian Council of Medical Research, Government of India; Financial Interests, Personal, Other, Member of Scientific Committee on nano-biosensors for healthcare apllications. Council of Scientific and Industrial Research, Government of India; Financial Interests, Personal, Other, Scientific committee member for appraisal of scientific projects submitted to DBT for funding. Department of Biotechnology, Government of India; Financial Interests, Personal, Other, Scientific committee member for appraisal of scientific projects submitted to India Alliance for funding. India Alliance is a partnership between Wellcome Trust and Department of Biotechnology (Government of India) to fund healthcare related research in India: India Alliance; Financial Interests, Institutional, Other, Steering Committee member for a global clinical trial (CLEE011A2207). Honorarium to institution: Novartis; Financial Interests, Institutional, Other, Steering Committee member for a global clinical trial. Honorarium to institution: AstraZeneca; Financial Interests, Institutional, Advisory Board, Advisory Board member on ovarian cancer. Honorarium to institution.: AstraZeneca UK Limited; Financial Interests, Institutional, Advisory Board, Advisory Board member on metastatic breast cancer. Honorarium to institution.: Eli Lilly & Company (India) Limited; Financial Interests, Institutional, Invited Speaker, Invited speaker on cervical cancer at an academic conference. Honorarium to institution.: SEOUL NATIONAL UNIVERSITY HOSPITAL; Financial Interests, Institutional, Invited Speaker, Chairperson at a conference. Honorarium to institution: Lupin Limited; Financial Interests, Institutional, Invited Speaker, Chairperson, speaker, or panelist at 5 conferences/meetings. Honoraria to institution.: Roche Products (India) Private Limited; Financial Interests, Institutional, Invited Speaker, Chairperson, panelist, or speaker at a 3 meetings/roundtable. Honoraria to institution.: Novartis Healthcare Pvt. Ltd.; Financial Interests, Institutional, Invited Speaker, Chairperson at 2 conferences/meetings. Honoraria to institution.: Eli Lilly & Company (India) Limited; Financial Interests, Institutional, Invited Speaker, Invited speaker in a conference. Nag Foundation is a not-for-profit registered society working in the field of cancer: Nag Foundation; Financial Interests, Institutional, Invited Speaker, Invited panelist in a meeting. Honorarium to institution: Eisai Company Limited; Financial Interests, Institutional, Invited Speaker, Invited speaker. Honorarium to institution: Omnicuris Healthcare Private Limited; Financial Interests, Institutional, Invited Speaker, Invited panelist at a conference. Honorarium to institution: Cipla Limited, Cadila Pharmaceuticals; Financial Interests, Institutional, Invited Speaker, Invited chairperson at a conference. Honorarium to institution.: Intas Pharmaceuticals Limited; Financial Interests, Institutional, Invited Speaker, CO40016 Titled - A Double Blind, Placebo- Controlled, Randomized Phase III Study of IPATASERTIB in combination with Paclitaxel As a treatment for patients with PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple Negative Breast cancer or Hormone Receptor – Positive, HER2 – Negative Breast Cancer: F. Hoffmann-La Roche Ltd; Financial Interests, Institutional, Invited Speaker, National coordinating PI of a multi-omics study in ER positive breast cancer: Department of Biotechnology, Government of India; Financial Interests, Institutional, Invited Speaker, EGC002: Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 (EirGenix Trastuzumab) with Herceptin® as Neoadjuvant Treatment in Combination with Anthracycline/Paclitaxel-based Systemic Therapy in Patients with HER2-positive Early Breast Cancer: EirGenix Inc.; Financial Interests, Institutional, Invited Speaker, Protocol No. - CLEE011A3201C: A phase II randomized study of the combination of Ribociclib plus goserelin acetate with Hormonal Therapy versus physician choice chemotherapy in premenopausal or perimenopausal patients with hormone receptorpositive/HER2-negative inoperable locally advanced or metastatic breast cancer - RIGHT Choice Study: Novartis Healthcare Pvt. Ltd.; Financial Interests, Institutional, Invited Speaker, Protocol No. - D9100C00001 : A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer (CALLA): AstraZeneca Pharma India limited.; Financial Interests, Institutional, Invited Speaker, Protocol No. - CLEE011A2207: A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of 400 mg of ribociclib in combination with non-steroidal aromatase inhibitors for the treatment of pre- and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received no prior therapy for advanced disease: Novartis Healthcare Pvt. Ltd.; Financial Interests, Institutional, Invited Speaker: Glenmark Pharmaceuticals Ltd.; Financial Interests, Institutional, Invited Speaker, Protocol No. - D0816R00025 : A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum Based Chemotherapy and Metastatic Breast Cancer with Germline BRCA1/2 Mutation (SOLI Study): AstraZeneca Pharma India Limited; Financial Interests, Institutional, Invited Speaker, Protocol No. - D3614C00001 : A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC).: AstraZeneca Pharma India Limited; Financial Interests, Institutional, Invited Speaker, PIK3CA Registry- A descriptive study of PIK3CA mutations in patients with HR+/Her2- advanced breast cancer.: Novartis Healthcare Private Limited; Financial Interests, Institutional, Invited Speaker, Protocol No. - D967JC00001 : A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with other Anti-cancer Agents in Patients with HER2-positive Metastatic Breast Cancer (DESTINY-Breast07): AstraZeneca Pharma India Ltd.; Financial Interests, Institutional, Invited Speaker, Protocol No. - D9670C00001 : A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06): AstraZeneca Pharma India Ltd.; Financial Interests, Institutional, Invited Speaker, D9311C00001 ''A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E): AstraZeneca; Financial Interests, Institutional, Invited Speaker, WO42633 A phase III, randomized, double-blind, placebo-controlled clinical trial toevaluate the efficacy and safety of adjuvant atezolizumab or placebo and trastuzumab emtansine forher2-positive breast cancer at high risk of recurrence following preoperative therapy (ASTEFANIA study): Roche Products (India) Pvt. Ltd.; Financial Interests, Institutional, Invited Speaker, MO42921 a multi-country observational retrospective study to evaluate the prevalence of pd-l1 and its role in patients with tnbc treated with systemic therapy (VANESSA): Roche Products India Pvt Ltd.; Financial Interests, Institutional, Invited Speaker, Cost-effectiveness Analysis & Value-Based Pricing for Anti-Cancer Drugs: Implications for Patients, Industry, Insurer and Regulator: Department of Health Research, Ministry of Health and Family Welfare, New Delhi; Financial Interests, Institutional, Invited Speaker, Coordinating PI for Multi-Omics Analysis to Decipher Mechanisms of Hormone Resistance in Breast Cancer: Department of Biotechnology, Government of India; Financial Interests, Institutional, Invited Speaker, Mapping of Breast Cancer: Department of Science and Technology, Government of India; Financial Interests, Institutional, Invited Speaker, Protocol No. - ECTS/16/002 : A multicentric open label phase II safety and efficacy study of ormeloxifene in tamoxifen resistant metastatic/recurrent breast cancer patients: HLL Lifecare Limited (A Government of India Enterprises); Financial Interests, Institutional, Invited Speaker, Protocol No. - D0818R0000 : Protocol no. D0818R00001- A Non-interventional, multicentre study to assess prevalence of BRCA1 and BRCA2 mutation among ovarian, primary peritoneal and fallopian tube cancer patients in India (BRCA study): AstraZeneca Pharma India Ltd.; Financial Interests, Institutional, Invited Speaker, Protocol No. - 1000-16 : An Open Label, Single Arm, Multicentric, Phase IV study to evaluate the safety and efficacy of Bevacizumab of Intas Pharmaceuticals Limited in approved indications: Intas Pharmaceuticals Ltd; Financial Interests, Institutional, Invited Speaker, Protocol No. - Protocol no: 471-13 : A Prospective, Adaptive, Randomized, Open-Label, Multicenter Clinical Trial to assess the Efficacy and Safety of Fixed Dose Combination of Capecitabine & Cyclophosphamide in Patients of Metastatic Breast Cancer with failure of Anthracycline and/or Taxane Chemotherapy: Intas Pharmaceuticals Ltd; Financial Interests, Institutional, Invited Speaker, Protocol No. - MO39196 : A Phase III, Multicentre, randomised, double-blind, placebo controlled study of Atezolizumab ( anti-PD-L1 antibody) in combination with paclitaxel compared with placebo in combination with paclitaxel for patients with previously untreated, inoperable locally advanced or metastatic Triple Negative Breast Cancer.: Roche Products (India) Pvt. Ltd; Financial Interests, Institutional, Invited Speaker, Protocol No. - CBYL719C2301 : A phase III randomized double-blind, placebo controlled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment: Novartis Healthcare Pvt. Ltd.; Non-Financial Interests, , Leadership Role, General Secretary of this non-governmental organization (It is a not-for-profit) which aims to help underprivileged patients with breast and gynecological cancers and promotes research and educational activities in these themes: Women's Cancer Initiative - Tata Memorial Hospital; Non-Financial Interests, Leadership Role, President-Elect of ISMPO which is the largest professional organization of medical oncologists in India. It is a not-for-profit registered society.: Indian Society of Medical and Paediatric Oncology (ISMPO); Non-Financial Interests, , Invited Speaker, This is a not-for-profit registered organization which aims to create large databases of genomic and other 'omic' data in breast and other cancers: Indian Cancer Genome Atlas. All other authors have declared no conflicts of interest.

Background

Two main aspects are leading precision oncology implementation into clinical practice: the adoption of extended genome sequencing technologies and the institutions and activity of Molecular Tumor Boards (MTBs). On behalf of CIPOMO (Italian association of Oncology Departments directors) we promoted a national survey to obtain a picture of the adoption of precision medicine into clinical oncology in Italy, considering the provisions of the National Recovery and Resilience Plan. We report the results of the survey.

Methods

20 questions were sent via Survey Monkey platform (Individual Advantage version) to 169 heads of medical oncology departments, and their answers were collected from the 10^th to 28^th of February 2022.

Results

129 directors participated; 113 sets of answers were analyzed. 19 regions out of 21 participated, as a representative sample of the Italian healthcare system. 67.3% of participants are aware of ESMO recommendations on Next-generation sequencing (NGS) use for advanced cancer. NGS is currently used by 52.2% of the Departments at cancer diagnosis; 47.8% base molecular diagnostic on single gene analysis. Among the ones using NGS, 49.2% adopt tumor specific panels, 30.5% a unique pan-tumor panel, 20.3% didn’t answer. 72.3% of respondents find appropriate to limit molecular analysis on biomarkers indicated by scientific guidelines at diagnosis; 27.7% would use a more extended sequencing upfront. MTBs are present in 13 out of Regions but overall 33.6% of Departments has not access to them. Among the Centers with an active MTB, 23.9% routinely refer cases for consultation, 43.7% haven’t done it yet, 32.4% report that the nowadays organization does not fit their needs.

Conclusions

NGS technologies and MTBs are not homogeneously implemented in Italy. These results could be a starting point for clinicians, scientific societies and health care institutions to outline the best practices, achieve consensus and formulate recommendations for precision oncology implementation in our current clinical practice.

Legal entity responsible for the study

G. Fasola.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.