Publications by authors named "Dario Trapani"

74 Publications

Evolution of low HER2 expression between early and advanced-stage breast cancer.

Eur J Cancer 2022 Jan 12;163:35-43. Epub 2022 Jan 12.

European Institute of Oncology IRCCS, Milan, Italy; University of Milan, Milan, Italy. Electronic address:

Background: Low human epidermal growth factor receptor 2 (HER2) expression is emerging as an actionable biomarker for the treatment of breast cancer (BC) with novel anti-HER2 drugs. However, the evolution of this biomarker during the course of disease is still poorly characterised, and controversial data exist on its prognostic implications.

Methods: We reviewed data of patients with HER2-negative BC according to the latest ASCO/CAP guidelines referred between January 2014 and December 2020. We grouped patients based on the immunohistochemistry (IHC) expression of HER2, HER2-zero (IHC 0) and HER2-low subgroup (IHC 1+ or 2+/ISH-negative) and evaluated the evolution of HER2 expression between the primary tumour and the first biopsy collected in the advanced setting. Disease-free survival, overall survival and progression-free survival were compared between patients with HER2-zero and HER2-low expression on the primary tumour.

Results: 232 patients were included in the analysis. Among the overall population, there was a relevant discordance in HER2 expression between the primary tumour and the matched biopsy (K = 0.33, 95%CI 0.21-0.44): 44% of the HER2-zero primary tumour showed an increased HER2 score on biopsy, and 22% of the HER2-low primary tumours turned into HER2-IHC 0. The findings in the sub-populations of hormone-receptors positive (K = 0.32, 95%CI 0.19-0.45) and triple-negative tumours (K = 0.18, 95%CI -0.09-0.46) were consistent with the primary analysis. No difference in survival outcomes was observed between HER2-low and HER2-zero primary tumours.

Conclusions: HER2-low expression is dynamic in BC and may be enriched in the advanced-stage setting. No prognostic significance was demonstrated for HER2-low expression.
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http://dx.doi.org/10.1016/j.ejca.2021.12.022DOI Listing
January 2022

Knowledge, Practice, and Attitudes of Physicians in Low- and Middle-Income Countries on Fertility and Pregnancy-Related Issues in Young Women With Breast Cancer.

JCO Glob Oncol 2022 Jan;8:e2100153

Department of Medical Oncology, U.O. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genova, Italy.

Purpose: Fertility and pregnancy-related issues are highly relevant for young (≤ 40 years) patients with breast cancer. Limited evidence exists on knowledge, practice, and attitudes of physicians from low- and middle-income countries (LMICs) regarding these issues.

Methods: A 19-item questionnaire adapted from an international survey exploring issues about fertility preservation and pregnancy after breast cancer was sent by e-mail between November 2019 and January 2020 to physicians from LMICs involved in breast cancer care. Descriptive analyses were performed.

Results: A total of 288 physicians from Asia, Africa, America, and Europe completed the survey. Median age was 38 years. Responders were mainly medical oncologists (44.4%) working in an academic setting (46.9%). Among responders, 40.2% and 53.8% reported having never consulted the available international guidelines on fertility preservation and pregnancy after breast cancer, respectively. 25.0%, 19.1%, and 24.3% of responders answered to be not at all knowledgeable about embryo, oocyte, or ovarian tissue cryopreservation, respectively; 29.2%, 23.6%, and 31.3% declared that embryo, oocyte, and ovarian tissue cryopreservation were not available in their countries, respectively. 57.6% of responders disagreed or were neutral on the statement that controlled ovarian stimulation can be considered safe in patients with breast cancer. 49.7% and 58.6% of responders agreed or were neutral on the statement that pregnancy in breast cancer survivors may increase the risk of recurrence overall or only in those with hormone receptor-positive disease, respectively.

Conclusion: This survey showed suboptimal knowledge, practice, and attitudes of physicians from LMICs on fertility preservation and pregnancy after treatment completion in young women with breast cancer. Increasing awareness and education on these aspects are needed to improve adherence to available guidelines and to promote patients' oncofertility counseling.
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http://dx.doi.org/10.1200/GO.21.00153DOI Listing
January 2022

Accelerating progress in early triple-negative breast cancer: A viewpoint on antibody-drug conjugates, back from St Gallen breast cancer conference 2021.

Breast 2021 Dec 13. Epub 2021 Dec 13.

European Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hematology, University of Milan, Milan, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.breast.2021.12.012DOI Listing
December 2021

Age-Based Disparities in Metastatic Melanoma Patients Treated in the Immune Checkpoint Inhibitors (ICI) Non-ICI Era: A Population-Based Study.

Front Immunol 2021 16;12:609728. Epub 2021 Nov 16.

Department of Oncology, First Affiliated Hospital of Dalian Medical University, Dalian, China.

Immune checkpoint inhibitors (ICIs) have revolutionized metastatic melanoma treatment, but our knowledge of ICI activity across age groups is insufficient. Patients in different age groups with advanced melanoma were selected based on the ICI approval time in this study. Patients with melanoma were identified in the Surveillance, Epidemiology, and End Result (SEER) database program 2004-2016. The results showed that 4,040 patients had advanced melanoma before the advent of ICI (referred to as the "non-ICI era"), whereas there were 6,188 cases after ICI approval (referred to as the "ICI era"). In all age groups, the cases were dominated by men. The differences between the first (20-59 years) and second (60-74 years) age groups in both eras were significant in terms of surgery performance and holding of insurance policies ( = 0.05). The first and second groups (20-59 and 60-70 years old, respectively) showed no difference in survival (median = 8 months) during the non-ICI era, but the difference was evident in the first, second, and third age groups in the ICI era, with the younger group (20-59 years) having significantly better survival (median = 18, 14, and 10 months, respectively, = 0.0001). Multivariate analysis of the first group (the youngest) in the ICI era revealed that surgery was significantly associated with an increase in survival among patients compared with those who did not undergo surgery ( < 0.0001). Furthermore, having an insurance policy among all age groups in the ICI era was associated with favorable survival in the first (20-59 years) and second (60-74 years) age groups ( = 0.0001), while there were no survival differences in the older ICI group (>74 years). Although there were differences in survival between the ICI era and the non-ICI era, these results demonstrate that ICI positively affected the survival of younger patients with advanced melanoma (first age group) than it had beneficial effects on older patients. Moreover, having had cancer surgery and holding an insurance policy were positive predictors for patient survival. This study emphasizes that adequate clinical and preclinical studies are important to enhance ICI outcomes across age groups.
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http://dx.doi.org/10.3389/fimmu.2021.609728DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8650702PMC
November 2021

Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials.

Cancers (Basel) 2021 Nov 20;13(22). Epub 2021 Nov 20.

Division of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.

Pivotal trials of COVID-19 vaccines did not include cancer patients, with questions remaining about their safety and efficacy in this population. Patients enrolled in early-phase clinical trials receive novel treatments with unknown efficacy and safety profiles. Studies on the safety of COVID-19 vaccines in these patients are urgently required. This is a retrospective, real-world, cohort study of patients receiving anticancer treatments and COVID-19 vaccines between 1 February and 25 June 2021 at the Division of New Drugs Development for Innovative Therapies of the European Institute of Oncology. One hundred thirteen patients were enrolled, 40 in early-phase clinical trials, and 20 under novel immunotherapy agents. Nearly three-quarters of the patients experienced at least one adverse event (AE) after the first dose (1D) (74.3%) and second dose (2D) (72.6%). Most of the AEs were local (67.3% 1D and 61.9% after 2D), while 31.8% (1D) and 38.1% (2D) of the patients had systemic AEs. No AEs above grade 2 were observed. Therefore, COVID-19 vaccines appear to be safe in patients enrolled in early-phase clinical trials, including patients receiving novel immunotherapy compounds. All cancer patients should be prioritized for COVID-19 vaccination, regardless of ongoing treatments or enrollment in early-phase trials.
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http://dx.doi.org/10.3390/cancers13225829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8616209PMC
November 2021

The ESSO core curriculum committee update on surgical oncology.

Eur J Surg Oncol 2021 11 13;47(11):e1-e30. Epub 2021 Oct 13.

Visceral Sarcoma Surgery Unit, Città della Salute e della Scienza, Turin, Italy.

Introduction: Surgical oncology is a defined specialty within the European Board of Surgery within the European Union of Medical Specialists (UEMS). Variation in training and specialization still occurs across Europe. There is a need to align the core knowledge needed to fulfil the criteria across subspecialities in surgical oncology.

Material And Methods: The core curriculum, established in 2013, was developed with contributions from expert advisors from within the European Society of Surgical Oncology (ESSO), European Society for Radiotherapy and Oncology (ESTRO) and European Society of Medical Oncology (ESMO) and related subspeciality experts.

Results: The current version reiterates and updates the core curriculum structure needed for current and future candidates who plans to train for and eventually sit the European fellowship exam for the European Board of Surgery in Surgical Oncology. The content included is not intended to be exhaustive but, rather to give the candidate an idea of expectations and areas for in depth study, in addition to the practical requirements. The five elements included are: Basic principles of oncology; Disease site specific oncology; Generic clinical skills; Training recommendations, and, lastly; Eligibility for the EBSQ exam in Surgical Oncology.

Conclusions: As evidence-based care for cancer patients evolves through research into basic science, translational research and clinical trials, the core curriculum will evolve, mature and adapt to deliver continual improvements in cancer outcomes for patients.
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http://dx.doi.org/10.1016/j.ejso.2021.10.003DOI Listing
November 2021

National health system characteristics, breast cancer stage at diagnosis, and breast cancer mortality: a population-based analysis.

Lancet Oncol 2021 11 13;22(11):1632-1642. Epub 2021 Oct 13.

Breast Health Global Initiative, Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; World Health Organization, Geneva, Switzerland; Departments of Surgery and Global Health, University of Washington, Seattle, WA, USA. Electronic address:

Background: In some countries, breast cancer age-standardised mortality rates have decreased by 2-4% per year since the 1990s, but others have yet to achieve this outcome. In this study, we aimed to characterise the associations between national health system characteristics and breast cancer age-standardised mortality rate, and the degree of breast cancer downstaging correlating with national age-standardised mortality rate reductions.

Methods: In this population-based study, national age-standardised mortality rate estimates for women aged 69 years or younger obtained from GLOBOCAN 2020 were correlated with a broad panel of standardised national health system data as reported in the WHO Cancer Country Profiles 2020. These health system characteristics include health expenditure, the Universal Health Coverage Service Coverage Index (UHC Index), dedicated funding for early detection programmes, breast cancer early detection guidelines, referral systems, cancer plans, number of dedicated public and private cancer centres per 10 000 patients with cancer, and pathology services. We tested for differences between continuous variables using the non-parametric Kruskal-Wallis test, and for categorical variables using the Pearson χ test. Simple and multiple linear regression analyses were fitted to identify associations between health system characteristics and age-standardised breast cancer mortality rates. Data on TNM stage at diagnosis were obtained from national or subnational cancer registries, supplemented by a literature review of PubMed from 2010 to 2020. Mortality trends from 1950 to 2016 were assessed using the WHO Cancer Mortality Database. The threshold for significance was set at a p value of 0·05 or less.

Findings: 148 countries had complete health system data. The following variables were significantly higher in high-income countries than in low-income countries in unadjusted analyses: health expenditure (p=0·0002), UHC Index (p<0·0001), dedicated funding for early detection programmes (p=0·0020), breast cancer early detection guidelines (p<0·0001), breast cancer referral systems (p=0·0030), national cancer plans (p=0·014), cervical cancer early detection programmes (p=0·0010), number of dedicated public (p<0·0001) and private (p=0·027) cancer centres per 10 000 patients with cancer, and pathology services (p<0·0001). In adjusted multivariable regression analyses in 141 countries, two health system characteristics were significantly associated with lower age-standardised mortality rates: higher UHC Index levels (β=-0·12, 95% CI -0·16 to -0·08) and increasing numbers of public cancer centres (β=-0·23, -0·36 to -0·10). These findings indicate that each unit increase in the UHC Index was associated with a 0·12-unit decline in age-standardised mortality rates, and each additional public cancer centre per 10 000 patients with cancer was associated with a 0·23-unit decline in age-standardised mortality rate. Among 35 countries with available breast cancer TNM staging data, all 20 that achieved sustained mean reductions in age-standardised mortality rate of 2% or more per year for at least 3 consecutive years since 1990 had at least 60% of patients with invasive breast cancer presenting as stage I or II disease. Some countries achieved this reduction without most women having access to population-based mammographic screening.

Interpretation: Countries with low breast cancer mortality rates are characterised by increased levels of coverage of essential health services and higher numbers of public cancer centres. Among countries achieving sustained mortality reductions, the majority of breast cancers are diagnosed at an early stage, reinforcing the value of clinical early diagnosis programmes for improving breast cancer outcomes.

Funding: None.
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http://dx.doi.org/10.1016/S1470-2045(21)00462-9DOI Listing
November 2021

Access to cancer medicines deemed essential by oncologists in 82 countries: an international, cross-sectional survey.

Lancet Oncol 2021 10 21;22(10):1367-1377. Epub 2021 Sep 21.

Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, Kingston, ON, Canada; Departments of Oncology, Queen's University, Kingston, ON, Canada; Public Health Sciences, Queen's University, Kingston, ON, Canada. Electronic address:

Background: The WHO Essential Medicines List (EML) identifies priority medicines that are most important to public health. Over time, the EML has included an increasing number of cancer medicines. We aimed to investigate whether the cancer medicines in the EML are aligned with the priority medicines of frontline oncologists worldwide, and the extent to which these medicines are accessible in routine clinical practice.

Methods: This international, cross-sectional survey was developed by investigators from a range of clinical practice settings across low-income to high-income countries, including members of the WHO Essential Medicines Cancer Working Group. A 28-question electronic survey was developed and disseminated to a global network of oncologists in 89 countries and regions by use of a hierarchical snowball method; each primary contact distributed the survey through their national and regional oncology associations or personal networks. The survey was open from Oct 15 to Dec 7, 2020. Fully qualified physicians who prescribe systemic anticancer therapy to adults were eligible to participate in the survey. The primary question asked respondents to select the ten cancer medicines that would provide the greatest public health benefit to their country; subsequent questions explored availability and cost of cancer medicines. Descriptive statistics were used to compare access to medicines between low-income and lower-middle-income countries, upper-middle-income countries, and high-income countries.

Findings: 87 country-level contacts and two regional networks were invited to participate in the survey; 46 (52%) accepted the invitation and distributed the survey. 1697 respondents opened the survey link; 423 were excluded as they did not answer the primary study question and 326 were excluded because of ineligibility. 948 eligible oncologists from 82 countries completed the survey (165 [17%] in low-income and lower-middle-income countries, 165 [17%] in upper-middle-income countries, and 618 [65%] in high-income countries). The most commonly selected medicines were doxorubicin (by 499 [53%] of 948 respondents), cisplatin (by 470 [50%]), paclitaxel (by 423 [45%]), pembrolizumab (by 414 [44%]), trastuzumab (by 402 [42%]), carboplatin (by 390 [41%]), and 5-fluorouracil (by 386 [41%]). Of the 20 most frequently selected high-priority cancer medicines, 19 (95%) are currently on the WHO EML; 12 (60%) were cytotoxic agents and 13 (65%) were granted US Food and Drug Administration regulatory approval before 2000. The proportion of respondents indicating universal availability of each top 20 medication was 9-54% in low-income and lower-middle-income countries, 13-90% in upper-middle-income countries, and 68-94% in high-income countries. The risk of catastrophic expenditure (spending >40% of total consumption net of spending on food) was more common in low-income and lower-middle-income countries, with 13-68% of respondents indicating a substantial risk of catastrophic expenditures for each of the top 20 medications in lower-middle-income countries versus 2-41% of respondents in upper-middle-income countries and 0-9% in high-income countries.

Interpretation: These data demonstrate major barriers in access to core cancer medicines worldwide. These findings challenge the feasibility of adding additional expensive cancer medicines to the EML. There is an urgent need for global and country-level policy action to ensure patients with cancer globally have access to high priority medicines.

Funding: None.
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http://dx.doi.org/10.1016/S1470-2045(21)00463-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8476341PMC
October 2021

Fed or fasted state for oral therapies in breast cancer treatment? A comprehensive review of clinical practice recommendations.

Cancer Treat Rev 2021 Nov 18;100:102281. Epub 2021 Aug 18.

Division of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. Electronic address:

In the last decades several anti-cancer drugs have been developed to treat patients with breast cancer, many of them orally administered, with ongoing efforts to substitute parenteral drugs with oral therapy. The latter is attractive because of its convenience and ease of administration, finally improving quality of life. The drawback of oral administration is that exposure to the drug is affected by different factors and the high variability, combined with the relatively narrow therapeutic index of most of these agents, would predispose some individuals to risk for treatment inefficacy or increase toxicity. Among these factors, food plays a central role since it can influence the pharmacokinetic profile of several drugs. Consequently, health care providers and patients should be aware of possible interaction to optimize treatment. In this review a systematic evaluation of package inserts and literature have been performed to analyse the effect of fed or fasted state on pharmacokinetic of all oral drugs currently approved for breast cancer, offering clear recommendations for their use daily practice.
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http://dx.doi.org/10.1016/j.ctrv.2021.102281DOI Listing
November 2021

Brain and heart-specific death in cancer patients: Population-based study.

Cancer Med 2021 09 10;10(17):5739-5747. Epub 2021 Aug 10.

Department of Oncology, First Affiliated Hospital of Dalian Medical University, Dalian, China.

Background: The occurrence of cardiovascular events is a major cause of death in patients with cancer. Small studies have documented a connection between specific brain alterations and autonomic cardiac dysfunctions, possibly resulting in a worse prognosis. We aimed to refine the knowledge of fatal cardiac events in patients with brain metastasis (BM).

Methods: We performed a Surveillance, Epidemiology, and End Results SEER registry-based investigation (timeline: 2010-2016) and extracted all the advanced patients who had experienced fatal cardiac outcomes. Populations were compared according to the presence or not BM. Kaplan-Meier (KM) methodology was used for survival analysis and a multivariate model was developed by adjusting for multiple possible confounders.

Results: Most related BM and cardiac death were observed at the site of lung cancer (81.4%). We extracted 3187 patients with lung cancer site, including 417 patients who had experienced fatal heart-specific with a history of BM, which is considered a BM group. The second group of heart-specific death included 2770 patients was stated as a non-BM group. Patients who had experienced heart-specific death in the BM group were predominately male, right side, upper site, and non-small type (62.11%, 54.92%, 51.56%, 69.78%), respectively. The survival outcomes between BM and the non- BM was significantly prominent (p = 0.003; median: 2 months vs. 3 months).The negative prognostic independent significance of heart-fatal events was confirmed after adjusting for multiple variables (HR = 0.76, CI = 0.68-84, p < 0.0001). The metastatic liver site was significantly associated with poorer survival rates (HR = 0.68; CI = 0.52-0.88, p = 0.005). We revealed a possible connection between the brain and heart functions.

Conclusions: The prognosis of heart-specific death patients in BM is unfavorable compared to non-BM settings in lung cancer. We may be at the gates of a new field of neurocardiooncology.
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http://dx.doi.org/10.1002/cam4.4069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419745PMC
September 2021

Uro-oncologic patient management during the COVID-19 pandemic: survey findings from an Italian oncologic hub.

Future Oncol 2021 Sep 19;17(27):3615-3625. Epub 2021 Jul 19.

Department of Urology, IEO European Institute of Oncology, IRCCS, Via Ripamonti 435, Milan, Italy.

 Patient and worker satisfaction at an oncologic hub during the COVID-19 pandemic has never been reported. We addressed this topic. We conducted a survey to test the views of patients (n = 64) and healthcare professionals (n = 52) involved with our operative protocol.  A moderate/severe grade of concern due to the COVID-19 emergency was recorded in 63% of patients versus 75% of hospital staff. High/very high versus low satisfaction grade about preventive strategies to reduce the risk of SARS-CoV-2 contagion was identified in the patients compared with the hospital staff group. Surgical treatment at a hub center of uro-oncologic patients coming from spoke centers is well accepted and should, therefore, be recommended. Preventive strategies to reduce the risk of SARS-CoV-2 contagion in hospital staff members should be implemented.
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http://dx.doi.org/10.2217/fon-2021-0145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8288285PMC
September 2021

No Overall Survival Difference in the Immunotherapy Era for Rare Subtypes of Melanoma.

Pathol Oncol Res 2021 17;27:639004. Epub 2021 Jun 17.

Department of Oncology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.

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http://dx.doi.org/10.3389/pore.2021.639004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8262132PMC
June 2021

First line treatment of BRAF mutated advanced melanoma: Does one size fit all?

Cancer Treat Rev 2021 Sep 18;99:102253. Epub 2021 Jun 18.

Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.

In the last decade, immunotherapy and target therapy have revolutionized the prognosis of patients with BRAF-V600 mutation-positive metastatic melanoma. To date, three different combinations of BRAF/MEK inhibitors have been approved for this population, showing comparable efficacy and unique toxicity profiles. Several immune-checkpoint inhibitors, including pembrolizumab, nivolumab and the combination of nivolumab plus ipilimumab, are also available options for untreated metastatic melanoma patients. A novel approach has emerged by combining immune-checkpoint inhibitors and targeted agents, based on preclinical hints of synergy, prompting clinical results from large randomized trials. Specifically, the triplet of atezolizumab, vemurafenib and cobimetinib has been recently approved by FDA for patients with untreated BRAF-mutant metastatic melanoma. With a wide variety of available treatment options in this setting, it is paramount to establish criteria to select the most effective and safe frontline tailored approaches, for each patient. Results from ongoing studies are awaited, to maximise the benefits in survival outcomes and quality of life for patients, balancing adverse events and clinical benefit. The purpose of this review is to summarize the current landscape of standard and experimental treatment strategies for the first line treatment of patients with BRAF-mutated advanced melanoma and discuss the best patient-centered tailored strategies in the first-line setting.
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http://dx.doi.org/10.1016/j.ctrv.2021.102253DOI Listing
September 2021

Knowledge and attitudes of Italian medical oncologists and palliative care physicians toward medical use of cannabis in cancer care: a national survey.

Support Care Cancer 2021 Dec 26;29(12):7845-7854. Epub 2021 Jun 26.

Medical Oncology Unit, Azienda Ospedaliero Universitaria Sant'Andrea, Via di Grottarossa, 1035-39 00189, Rome, Italy.

Purpose: Despite advances in supportive care, cancer-related symptoms tend to be persistent regardless of cancer type, stage of disease, or treatment received. There is an increasing prescription for complementary and alternative medicines, such as medical cannabis (MC). Knowledge and attitudes of Italian medical oncologists and palliative care physicians toward medical cannabis in cancer care remain unknown.

Methods: We conducted a cross-sectional study to investigate the knowledge and attitude toward MC prescription among cancer care professionals in Italy. All invited participants received an email with the electronic questionnaire accessible through a direct link.

Results: Among the 2616 members who received the invitation, 475 replied to the questionnaire and were considered for the survey analysis. The most prescribed formulations among those available in Italy were cannabis FM2. The most frequent clinical indications for the use of MC were pain, gastrointestinal, and mood disorders. Only 9 responders reported MC-related side effects like anxiety insomnia and muscle spasms. The question regarding the normative references for MC prescription and use in Italy had conflicting results: only 14% indicated the exact legislative reference.

Conclusion: Our study highlights a significant discrepancy between personal attitudes, prescription levels, and actual knowledge on MC. This represent a critical issue that should be systemically faced, building educational programs and national guidelines that sublimate personal physicians' beliefs and predispositions, resulting in a robust science-based MC practice. Only through coordinated interventions on science and health policy of MC, there will be success of safety and efficacy, ensuring the best knowledge for the best outcomes.
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http://dx.doi.org/10.1007/s00520-021-06383-7DOI Listing
December 2021

Assessing population diversity in phase III trials of cancer drugs supporting Food and Drug Administration approval in solid tumors.

Int J Cancer 2021 10 5;149(7):1455-1462. Epub 2021 Jul 5.

Department of Medical Oncology, Ankara University School of Medicine, Ankara, Turkey.

Our study aimed to assess inequities in the clinical trial participation for the selected patient groups. We searched the Food and Drug Administration (FDA) database and extracted phase-III clinical trial data from MEDLINE for each approved drug by the FDA between January 1, 2006, and June 30, 2020. We analyzed the inclusion/exclusion criteria, participation according to gender, ethnic group, performance score, the positivity of HBV and HCV, and HIV, having comorbidities and brain metastasis. We compared the findings with that of the general population by retrieving data from the Surveillance, Epidemiology and End Results (SEER) database. We identified 142 phase III pivotal oncology trials that enrolled 105 397 patients. The proportion of female patients in trials was lower than their relative prevalence in the general population from SEER region (36% vs 49.6%, P < .001). The rates of black patients included were lower than their relative prevalence from SEER region (2.1% vs 9.8%, P < .001). 1.3% and 0.8% of patients had HBV and HCV infections, respectively. The patients' numbers with organ dysfunction were not established due to insufficient data from clinical trials. 1.6% of all patients had controlled brain metastasis. Black patients, women and patients with brain metastasis or with HBV and HCV were underrepresented. Our study underscores the importance of expanding the inclusion/exclusion criteria of pivotal oncology trials to be more representative of patients seen in clinical practice.
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http://dx.doi.org/10.1002/ijc.33708DOI Listing
October 2021

COVID-19 vaccines in patients with cancer.

Lancet Oncol 2021 06;22(6):738-739

European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy; Department of Oncology and Hematology, University of Milan, Milan, Italy. Electronic address:

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http://dx.doi.org/10.1016/S1470-2045(21)00250-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8169039PMC
June 2021

Mastering the Use of Novel Anti-HER2 Treatment Options.

JCO Oncol Pract 2021 10 2;17(10):605-606. Epub 2021 Jun 2.

Division of New Drugs and Early Drug Development, European Institute of Oncology, IRCCS, Milan, Italy.

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http://dx.doi.org/10.1200/OP.21.00216DOI Listing
October 2021

The Emerging Role of Liquid Biopsy in Gastric Cancer.

J Clin Med 2021 May 13;10(10). Epub 2021 May 13.

School of Medicine and Health Sciences, Hawassa University, Hawassa 1560, Ethiopia.

(1) Background: Liquid biopsy (LB) is a novel diagnostic method with the potential of revolutionizing the prevention, diagnosis, and treatment of several solid tumors. The present paper aims to summarize the current knowledge and explore future possibilities of LB in the management of metastatic gastric cancer. (2) Methods: This narrative review examined the most recent literature on the use of LB-based techniques in metastatic gastric cancer and the current LB-related clinical trial landscape. (3) Results: In gastric cancer, the detection of circulating cancer cells (CTCs) has been recognized to have a prognostic role in all the disease stages. In the setting of localized disease, cell-free DNA (cfDNA) and circulating tumor DNA (ctDNA) qualitative and quantitative detection have the potential to inform on the risk of cancer recurrence and metastatic dissemination. In addition, gastric cancer-released exosomes may play an essential part in metastasis formation. In the metastatic setting, the levels of cfDNA show a positive correlation with tumor burden. There is evidence that circulating tumor microemboli (CTM) in the blood of metastatic patients is an independent prognostic factor for shorter overall survival. Gastric cancer-derived exosomal microRNAs or clonal mutations and copy number variations detectable in ctDNA may contribute resistance to chemotherapy or targeted therapies, respectively. There is conflicting and limited data on CTC-based PD-L1 verification and cfDNA-based Epstein-Barr virus detection to predict or monitor immunotherapy responses. (4) Conclusions: Although preliminary studies analyzing LBs in patients with advanced gastric cancer appear promising, more research is required to obtain better insights into the molecular mechanisms underlying resistance to systemic therapies. Moreover, validation and standardization of LB methods are crucial before introducing them in clinical practice. The feasibility of repeatable, minimally invasive sampling opens up the possibility of selecting or dynamically changing therapies based on prognostic risk or predictive biomarkers, such as resistance markers. Research is warranted to exploit a possible transforming area of cancer care.
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http://dx.doi.org/10.3390/jcm10102108DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8153353PMC
May 2021

Immune-Checkpoint Inhibitors in Platinum-Resistant Ovarian Cancer.

Cancers (Basel) 2021 Apr 1;13(7). Epub 2021 Apr 1.

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Giacomo Venezian 1, 20133 Milano, Italy.

Platinum-resistant ovarian cancer (OC) has limited treatment options and is associated with a poor prognosis. There appears to be an overlap between molecular mechanisms responsible for platinum resistance and immunogenicity in OC. Immunotherapy with single agent checkpoint inhibitors has been evaluated in a few clinical trials with disappointing results. This has prompted exploration of immunotherapy combination strategies with chemotherapy, anti-angiogenics, poly (ADP-ribose) polymerase (PARP) inhibitors and other targeted agents. The role of immunotherapy in the treatment of platinum-resistant OC remains undefined. The aim of this review is to describe the immunobiology of OC and likely benefit from immunotherapy, discuss clinical trial data and biomarkers that warrant further exploration, as well as provide an overview of future drug development strategies.
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http://dx.doi.org/10.3390/cancers13071663DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037571PMC
April 2021

How to Best Exploit Immunotherapeutics in Advanced Gastric Cancer: Between Biomarkers and Novel Cell-Based Approaches.

J Clin Med 2021 Apr 1;10(7). Epub 2021 Apr 1.

Department of Medicine, Royal Marsden Hospital, London and Surrey, Sutton SM25PT, UK.

Despite extensive research efforts, advanced gastric cancer still has a dismal prognosis with conventional treatment options. Immune checkpoint inhibitors have revolutionized the treatment landscape for many solid tumors. Amongst gastric cancer subtypes, tumors with microsatellite instability and Epstein Barr Virus positive tumors provide the strongest rationale for responding to immunotherapy. Various predictive biomarkers such as mismatch repair status, programmed death ligand 1 expression, tumor mutational burden, assessment of tumor infiltrating lymphocytes and circulating biomarkers have been evaluated. However, results have been inconsistent due to different methodologies and thresholds used. Clinical implementation therefore remains a challenge. The role of immune checkpoint inhibitors in gastric cancer is emerging with data from monotherapy in the heavily pre-treated population already available and studies in earlier disease settings with different combinatorial approaches in progress. Immune checkpoint inhibitor combinations with chemotherapy (CT), anti-angiogenics, tyrosine kinase inhibitors, anti-Her2 directed therapy, poly (ADP-ribose) polymerase inhibitors or dual checkpoint inhibitor strategies are being explored. Moreover, novel strategies including vaccines and CAR T cell therapy are also being trialed. Here we provide an update on predictive biomarkers for response to immunotherapy with an overview of their strengths and limitations. We discuss clinical trials that have been reported and trials in progress whilst providing an account of future steps needed to improve outcome in this lethal disease.
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http://dx.doi.org/10.3390/jcm10071412DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037391PMC
April 2021

Impact of Baseline and On-Treatment Glycemia on Everolimus-Exemestane Efficacy in Patients with Hormone Receptor-Positive Advanced Breast Cancer (EVERMET).

Clin Cancer Res 2021 06 30;27(12):3443-3455. Epub 2021 Mar 30.

Department of Medical Oncology, IRCCS Centro di Riferimento Oncologico di Aviano (CRO), Aviano, Italy.

Purpose: The mTOR complex C1 (mTORC1) inhibitor everolimus in combination with the aromatase inhibitor exemestane is an effective treatment for patients with hormone receptor-positive (HR), HER2-negative (HER2), advanced breast cancer (HR/HER2 aBC). However, everolimus can cause hyperglycemia and hyperinsulinemia, which could reactivate the PI3K/protein kinase B (AKT)/mTORC1 pathway and induce tumor resistance to everolimus.

Experimental Design: We conducted a multicenter, retrospective, Italian study to investigate the impact of baseline and on-treatment (i.e., during first 3 months of therapy) blood glucose levels on progression-free survival (PFS) in patients with HR/HER2 aBC treated with everolimus-exemestane.

Results: We evaluated 809 patients with HR/HER2 aBC treated with everolimus-exemestane as any line of therapy for advanced disease. When evaluated as dichotomous variables, baseline and on-treatment glycemia were not significantly associated with PFS. However, when blood glucose concentration was evaluated as a continuous variable, a multivariable model accounting for clinically relevant patient- and tumor-related variables revealed that both baseline and on-treatment glycemia are associated with PFS, and this association is largely attributable to their interaction. In particular, patients who are normoglycemic at baseline and experience on-treatment diabetes have lower PFS compared with patients who are already hyperglycemic at baseline and experience diabetes during everolimus-exemestane therapy (median PFS, 6.34 vs. 10.32 months; HR, 1.76; 95% confidence interval, 1.15-2.69; = 0.008).

Conclusions: The impact of on-treatment glycemia on the efficacy of everolimus-exemestane therapy in patients with HR/HER2 aBC depends on baseline glycemia. This study lays the foundations for investigating novel therapeutic approaches to target the glucose/insulin axis in combination with PI3K/AKT/mTORC1 inhibitors in patients with HR/HER2 aBC.
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http://dx.doi.org/10.1158/1078-0432.CCR-20-4928DOI Listing
June 2021

The evolving paradigm of biomarker actionability: Histology-agnosticism as a spectrum, rather than a binary quality.

Cancer Treat Rev 2021 Mar 20;94:102169. Epub 2021 Feb 20.

European Institute of Oncology IRCCS, Milan, Italy; University of Milan, Milan, Italy. Electronic address:

Precision medicine is progressively revolutionizing oncology, through the identification of biomarkers predictive of treatment response in cancer patients. For three of such biomarkers, namely NTRK-fusions, microsatellite instability and high tumor mutational burden, drugs have been approved by regulatory agencies regardless of tumor histology, realizing the paradigm of histology-agnostic actionability. Several additional biomarkers are being studied in a histology-agnostic manner, and may in the future expand this list. However, most available evidence suggest that histology-agnosticism may be the extreme of a continuous spectrum of actionability, rather than a binary quality. The present review recapitulates such evidence, highlighting opportunities and challenges posed by the emergence of the spectrum of biomarker actionability in the context of a prevalently histology-based oncology.
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http://dx.doi.org/10.1016/j.ctrv.2021.102169DOI Listing
March 2021

The Emergence of Immune-checkpoint Inhibitors in Colorectal Cancer Therapy.

Curr Drug Targets 2021 ;22(9):1021-1033

Medical Oncology Unit, Ospedale del Mare, Naples, Italy.

Immunotherapy has revolutionized the treatment landscape in a number of solid tumors. In colorectal cancer, evidence suggests that microsatellite high (MSI-H) tumors are the most responsive to immune checkpoint blockade due to increased neo-antigen load and a favorable tumor microenvironment. Indeed, Pembrolizumab now represents a first-line option in such patients. However, MSI-H tumors represent the minority and a proportion of patients' progress despite initially responding. Trials are investigating different immunotherapy combinatorial strategies to enhance immune response in less immunogenic colorectal tumors. Such strategies include dual immune checkpoint blockade, combining immune checkpoint inhibitors with other treatment modalities such as radiotherapy, chemotherapy or other biological or targeted agents. Moreover, there is an increasing drive to identify biomarkers to better select patients most likely to respond to immunotherapy and understand intrinsic and acquired resistance mechanisms. Apart from MSI-H tumors, there is a strong rationale to suggest that tumors with alterations in DNA polymerase epsilon and DNA polymerase delta are also likely to respond to immunotherapy and trials in this subpopulation are underway. Other strategies such as priming O6-methylguanineDNA methyltransferase silenced tumors with alkylating agents to make them receptive to immune checkpoint blockade are also being investigated. Here we discuss different colorectal subpopulations together with their likelihood of response to immune checkpoint blockade and strategies to overcome barriers to a successful clinical outcome. We summarize evidence from published clinical trials and provide an overview of trials in progress whilst discussing newer immunotherapy strategies such as adoptive cell therapies and cancer vaccines.
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http://dx.doi.org/10.2174/1389450122666210204204415DOI Listing
November 2021

The Global Landscape of Treatment Standards for Breast Cancer.

J Natl Cancer Inst 2021 Sep;113(9):1143-1155

Department of Noncommunicable Diseases, World Health Organization, Geneva, Switzerland.

Background: Breast cancer (BC) is a leading cause of morbidity, mortality, and disability for women worldwide. There is substantial variation in treatment outcomes, which is function of multiple variables, including access to treatment. Treatment standards can promote quality and improve survival; thus, their development should be a priority for the cancer-control planning.

Methods: We extracted the guidelines for the treatment of BC from a systematic review of the literature. We evaluated the development process, the methodology, and the recommendations formulated and surveyed the country resource stratification. Metrics of health-system capacity were selected to study the guidelines context appropriateness.

Results: We analyzed 49 distinct guidelines for BC, mostly in English language (n = 23), developed in upper-middle and high-income countries of the European and American regions (n = 39). A resource-stratified approach was identified in a quarter of the guidelines (n = 11), mostly from resource-constrained settings. Only one-half of the guidelines reached a gender balance of the authorship, and 10.2% were based on a multidisciplinary steering committee. A number of efforts and solutions of resource adaptations were recognized, mostly in low- and middle-income countries. Overall, the national guidelines appeared not sensitive enough of the local health-system capacity in formulating recommendations, with possible exception for the radiation therapy availability.

Conclusion: This global landscape of treatment standards for BC demonstrates that the majority is not context appropriate. Research on the formulation of cancer treatment standards is highly warranted, along with novel platforms for developing and disseminating resource-appropriate guidance.
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http://dx.doi.org/10.1093/jnci/djab011DOI Listing
September 2021

Immunotherapy addition to neoadjuvant chemotherapy for early triple negative breast cancer: A systematic review and meta-analysis of randomized clinical trials.

Crit Rev Oncol Hematol 2021 Mar 19;159:103223. Epub 2021 Jan 19.

Division of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, Milan, Italy; Departement of Hematology and Oncology, University of Milan, Milan, Italy. Electronic address:

Importance: Several randomized trials of neoadjuvant chemo-immunotherapy in early triple negative breast cancer (TNBC) have been recently reported, showing conflicting results.

Methods: We systematically searched PubMed, Cochrane CENTRAL, Embase and key oncological meetings for trials of neoadjuvant chemo-immunotherapy in TNBC. The primary endpoint was pCR, with sub-analyses based on PD-L1 expression and risk of relapse.

Results: Five randomized trials enrolling 1496 TNBC patients were included. We observed a statistically significant association between PD1/PD-L1 blockade addition and pCR (SOR = 1.72, 95 %CI: 1.22-2.42). The benefit was significant in the PD-L1 positive subgroup (SOR = 1.65; 95 %CI: 1.06-2.57). pCR was also significantly increased in the high-risk subgroup (SOR = 2.39; 95 %CI: 1.09-5.22), when restricting to patients receiving an anthracycline-based NACT. We found no significant association between immunotherapy addition and toxicity, and no evidence of publication bias.

Conclusions: The addition of PD1/PD-L1 blockade to NACT significantly improves pCR rates in TNBC patients, particularly in patients at high-risk of relapse.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103223DOI Listing
March 2021

Examining policy cohesion for cervical cancer worldwide: analysis of WHO country reports.

ESMO Open 2020 11;5(6):e000878

Organisation mondiale de la Sante, Geneve, Switzerland.

Introduction: Cervical cancer is controllable through appropriate interventions such as vaccination, screening, treatment, early diagnosis and palliative care. The greatest burden of cervical cancer lies in low-income countries (LIC) where most of these services are missing or developed asymmetrically. Indeed, it is important to have not just an expansion, but a symmetric and concordant development of each service. Therefore, policies of countries should be aligned to provide concordant services and achieve the best outcomes with available resources. This is called 'policy cohesion' and for the first time in literature we will analyse cervical cancer policy coherence in all the 194 WHO member states.

Methods: The study is based on the 2017 WHO Non-Communicable Disease Country Capacity Surveys (NCD CCS). Although the survey covers multiple non-communicable diseases, in this report we will only discuss those results pertaining to cervical cancer, analysing the cervical cancer policy cohesion of 194 WHO member states, divided by WHO region and World Bank income group.

Results: Human papilloma virus vaccination exists in 53% of countries. 76% of countries offer cervical screening: among these countries, treatment, early diagnosis guidelines and palliative care are missing in 13%, 13% and 40%, respectively. In the African region, this discord is even more profound: 32%, 17% and 60%, respectively.

Conclusion: Especially in those settings where resources are limited, early detection guidelines, treatment and palliative care should be implemented along with secondary prevention strategies. Symmetric development of concordant cervical cancer services maximises cervical cancer control efficacy.
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http://dx.doi.org/10.1136/esmoopen-2020-000878DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7783605PMC
November 2020

Circulating Tumor DNA as a Biomarker for Outcomes Prediction in Colorectal Cancer Patients.

Curr Drug Targets 2021 ;22(9):1010-1020

Oncology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Circulating tumour DNA (ctDNA) is a novel tool that has been investigated in several types of tumours, including colorectal cancer (CRC). In fact, the techniques based on liquid biopsies are proposed as appealing non-invasive alternatives to tissue biopsy, adding more insights into tumour molecular profile, heterogeneity and for cancer detection and monitoring. Additionally, some analysis showed that in CRC patients, ctDNA seems to act as a biomarker able to predict the outcome (prognostic role) and the response to treatments (predictive role). In particular, in the early stage CRC (stage I-III), it could represent a time marker of adjuvant therapy as well as a marker of minimal residual disease and recurrence risk in addition to the already recognized risk factors. In metastatic CRC, the analysis of molecular tumour profile by ctDNA has shown to have high concordance with the tissue biopsy at diagnosis. Additionally, some studies demonstrated that ctDNA level during the treatment was linked with the early response to treatment and prognosis. Finally, the quantitative analysis of ctDNA and copy number alterations may be useful in order to detect resistance to therapy at the time of progression of disease and to help in finding new therapeutic targets.
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http://dx.doi.org/10.2174/1389450121999201103194248DOI Listing
November 2021

Repurposing anticancer drugs for the management of COVID-19.

Eur J Cancer 2020 12 22;141:40-61. Epub 2020 Sep 22.

Department of Medical Oncology, Mohammed VI University Hospital, Oujda, Morocco.

Since its outbreak in the last December, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has rapidly spread worldwide at a pandemic proportion and thus is regarded as a global public health emergency. The existing therapeutic options for COVID-19 beyond the intensive supportive care are limited, with an undefined or modest efficacy reported so far. Drug repurposing represents an enthusiastic mechanism to use approved drugs outside the scope of their original indication and accelerate the discovery of new therapeutic options. With the emergence of COVID-19, drug repurposing has been largely applied for early clinical testing. In this review, we discuss some repurposed anticancer drugs for the treatment of COVID-19, which are under investigation in clinical trials or proposed for the clinical testing.
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http://dx.doi.org/10.1016/j.ejca.2020.09.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508523PMC
December 2020

Practical classification of triple-negative breast cancer: intratumoral heterogeneity, mechanisms of drug resistance, and novel therapies.

NPJ Breast Cancer 2020 16;6:54. Epub 2020 Oct 16.

Division of Early Drug Development for Innovative Therapies, IEO, European Institute of Oncology IRCCS, Via Ripamonti, 435, 20141 Milan, Italy.

Triple-negative breast cancer (TNBC) is not a unique disease, encompassing multiple entities with marked histopathological, transcriptomic and genomic heterogeneity. Despite several efforts, transcriptomic and genomic classifications have remained merely theoretic and most of the patients are being treated with chemotherapy. Driver alterations in potentially targetable genes, including PIK3CA and AKT, have been identified across TNBC subtypes, prompting the implementation of biomarker-driven therapeutic approaches. However, biomarker-based treatments as well as immune checkpoint inhibitor-based immunotherapy have provided contrasting and limited results so far. Accordingly, a better characterization of the genomic and immune contexture underpinning TNBC, as well as the translation of the lessons learnt in the metastatic disease to the early setting would improve patients' outcomes. The application of multi-omics technologies, biocomputational algorithms, assays for minimal residual disease monitoring and novel clinical trial designs are strongly warranted to pave the way toward personalized anticancer treatment for patients with TNBC.
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http://dx.doi.org/10.1038/s41523-020-00197-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7568552PMC
October 2020

Frequency and types of mutations in Moroccan patients with non-small cell lung cancer.

Tumori 2021 Aug 20;107(4):335-340. Epub 2020 Oct 20.

Department of Medical Oncology, National Institute of Oncology, Faculty of Medicine and Pharmacy, Mohamed V University, Rabat, Morocco.

Background: Mutations in the epidermal growth factor receptor () gene are commonly observed in non-small cell lung cancer (NSCLC), particularly in adenocarcinoma histology. The frequency of mutations is ethnicity-dependent, with a higher proportion reported in Asian populations than Caucasian populations. There is a lack of data on these mutations in north Africa.

Methods: Tumor specimens from Moroccan patients with NSCLC were collected from five pathology laboratories between November 2010 and December 2017 to determine frequency and types of mutations. Tumors were tested in a reference center for by polymerase chain reaction and sequencing of exons 18, 19, 20, and 21.

Results: A total of 334 patients were enrolled: 242 (72.5%) males and 92 females (27.5%). A total of 56.9% had a history of smoking. testing of the 334 lung adenocarcinoma samples demonstrated a wild-type in 261 (78.1%) and mutated in 73 (21.9%). Mutations were mainly detected in the exon 19 deletion (65.8%), followed by exon 21 L858 (17.8%) and other exon 21 codon mutations (5.5%) and exon 18 (6.8%), whereas primary mutations of exon 20 were less frequent (4.1%). In patients with advanced NSCLC, the detection of mutation was independently associated with sex (41.3% female vs 14.5% male; < 0.001) and smoking status (34.8% nonsmokers vs 12.9% active smokers; < 0.001). The mean age was significantly different between the two groups ( = 0.041).

Conclusion: Our findings confirm the genetic heterogeneity of NSCLC worldwide, reporting frequency of mutations in Moroccan patients with NSCLC between those of Asian and Caucasian populations.
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http://dx.doi.org/10.1177/0300891620964571DOI Listing
August 2021
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