Publications by authors named "Fedro A Peccatori"

86 Publications

Early Breast Cancers During Pregnancy Treated With Breast-Conserving Surgery in the First Trimester of Gestation: A Feasibility Study.

Front Oncol 2021 24;11:723693. Epub 2021 Aug 24.

Division of Breast Surgery, IEO, European Institute of Oncology IRCCS, Milan, Italy.

Breast cancer is the most common malignancy occurring during gestation. In early-stage breast cancer during pregnancy (PrBC), breast-conserving surgery (BCS) with delayed RT is a rational alternative to mastectomy, for long considered the standard-of-care. Regrettably, no specific guidelines on the surgical management of these patients are available. In this study, we investigated the feasibility and safety of BCS during the first trimester of pregnancy in women with early-stage PrBC. All patients with a diagnosis of PrBC during the first trimester of pregnancy jointly managed in two PrBC-specialized Centers were included in this study. All patients underwent BCS followed by adjuvant radiotherapy to the ipsilateral breast after delivery. Histopathological features and biomarkers were first profiled on pre-surgical biopsies. The primary outcome was the isolated local recurrence (ILR). Among 168 PrBC patients, 67 (39.9%) were diagnosed during the first trimester of gestation. Of these, 30 patients (age range, 23-43 years; median=36 years; gestational age, 2-12 weeks; median=7 weeks; median follow-up time=6.5 years) met the inclusion criteria. The patients that were subjected to radical surgery (n=14) served as controls. None of the patients experienced perioperative surgical complications. No ILR were observed within three months (n=30), 1 year (n=27), and 5 years (n=18) after surgery. Among the study group, 4 (12.3%) patients experienced ILR or new carcinomas after 6-13 years, the same number (n=4) had metastatic dissemination after 3-7 years. These patients are still alive and disease-free after 14-17 years of follow-up. The rate of recurrences and metastasis in the controls were not significantly different. The findings provide evidence that BCS in the first trimester PrBC is feasible and reasonably safe for both the mother and the baby.
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http://dx.doi.org/10.3389/fonc.2021.723693DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8421851PMC
August 2021

Who are the women who enrolled in the POSITIVE trial: A global study to support young hormone receptor positive breast cancer survivors desiring pregnancy.

Breast 2021 Oct 3;59:327-338. Epub 2021 Aug 3.

Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA. Electronic address:

Background: Premenopausal women with early hormone-receptor positive (HR+) breast cancer receive 5-10 years of adjuvant endocrine therapy (ET) during which pregnancy is contraindicated and fertility may wane. The POSITIVE study investigates the impact of temporary ET interruption to allow pregnancy.

Methods: POSITIVE enrolled women with stage I-III HR + early breast cancer, ≤42 years, who had received 18-30 months of adjuvant ET and wished to interrupt ET for pregnancy. Treatment interruption for up to 2 years was permitted to allow pregnancy, delivery and breastfeeding, followed by ET resumption to complete the planned duration.

Findings: From 12/2014 to 12/2019, 518 women were enrolled at 116 institutions/20 countries/4 continents. At enrolment, the median age was 37 years and 74.9 % were nulliparous. Fertility preservation was used by 51.5 % of women. 93.2 % of patients had stage I/II disease, 66.0 % were node-negative, 54.7 % had breast conserving surgery, 61.9 % had received neo/adjuvant chemotherapy. Tamoxifen alone was the most prescribed ET (41.8 %), followed by tamoxifen + ovarian function suppression (OFS) (35.4 %). A greater proportion of North American women were <35 years at enrolment (42.7 %), had mastectomy (59.0 %) and received tamoxifen alone (59.8 %). More Asian women were nulliparous (81.0 %), had node-negative disease (76.2%) and received tamoxifen + OFS (56.0 %). More European women had received chemotherapy (69.3 %).

Interpretation: The characteristics of participants in the POSITIVE study provide insights to which patients and doctors considered it acceptable to interrupt ET to pursue pregnancy. Similarities and variations from a regional, sociodemographic, disease and treatment standpoint suggest specific sociocultural attitudes across the world.
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http://dx.doi.org/10.1016/j.breast.2021.07.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8365381PMC
October 2021

Breast cancer diagnosed in the post-weaning period is indicative for a poor outcome.

Eur J Cancer 2021 Sep 27;155:13-24. Epub 2021 Jul 27.

Department of Oncology, Laboratory of Gynecological Oncology, KU Leuven, Leuven, Belgium; Department of Gynecology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands; Department of Gynecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium; Department of Gynecological Oncology, Amsterdam University Medical Centers, Amsterdam, the Netherlands. Electronic address:

Background: In young women, a breast cancer diagnosis after childbirth increases the risk for metastasis and death. Studies in rodents suggest that post-weaning mammary gland involution contributes to the poor prognosis of postpartum breast cancers. However, this association has not been investigated in humans, mainly because of missing information on the patient's lactation status at diagnosis.

Patients And Methods: Clinicopathological data of 1180 young women with primary invasive breast cancer, diagnosed within 2 years postpartum (PP-BC), during pregnancy (Pr-BC), or nulliparous (NP-BC), were collected. For PP-BC patients, breastfeeding history was retrieved to differentiate breast cancers identified during lactation (PP-BC) from those diagnosed post-weaning (PP-BC). Differences in prognostic parameters, first site of distant metastasis, and risks for metastasis and death were determined between patient groups.

Results: Cox proportional hazard models pointed to a twofold increased the risk of metastasis and death in PP-BC patients compared with PP-BC (hazard ratio [HR] 2.1 [P = 0.021] and 2.9 [P = 0.004]), Pr-BC (HR 2.1 [P<0.001] and 2.3 [P<0.001]) and NP-BC (HR 2.1 [P<0.001] and 2.0 [P<0.001]) patients. Prognosis was poorest for PP-BC patients who did not breastfeed or only for ≤ 3 months before diagnosis. This could not fully be attributed to differences in standard prognostic characteristics. In addition, PP-BC tumours showed a 3- to 8-fold increased risk to metastasise to the liver, yet this did not correlate with the poor outcome of this patient cohort.

Conclusions: Breast cancer diagnosed shortly after weaning specifically adds to the poor prognosis in women diagnosed with PP-BC. Apart from the importance of an increased awareness, these data show that detailed lactation data need to be registered when breast cancer outcome in young women is investigated.
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http://dx.doi.org/10.1016/j.ejca.2021.06.009DOI Listing
September 2021

The Contribution of the European School Of Oncology Education to the Central Asian and Caucasian Regions.

J Cancer Educ 2021 Jul 22. Epub 2021 Jul 22.

European School of Oncology, Milan, Italy.

The European School of Oncology (ESO) organizes educational activities within Europe, the Mediterranean region, Central Asia, and the Caucasus. In this paper, we report on the participation of oncologists from Uzbekistan, Kazakhstan, Kirgizstan, Tajikistan, Azerbaijan, Georgia, and Armenia in various ESO activities including the masterclass, courses, refresher courses, conventions, conferences, consensus conferences, clinical training centers fellowship program, and the medical students' courses in oncology. Over the last 15 years, 428 oncologists and medical students have successfully attended one or more of the above activities organized in various European countries. This article details the implementation and coordination of the ESO educational events in the Central Asian and the Caucasian regions.
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http://dx.doi.org/10.1007/s13187-021-02072-5DOI Listing
July 2021

Pregnancy After Breast Cancer: A Systematic Review and Meta-Analysis.

J Clin Oncol 2021 Jul 1:JCO2100535. Epub 2021 Jul 1.

Fertility and Procreation Unit, Gynecologic Oncology Department, European Institute of Oncology IRCCS, Milan, Italy.

Purpose: Many patients and physicians remain concerned about the potential detrimental effects of pregnancy after breast cancer (BC) in terms of reproductive outcomes and maternal safety. This systematic review and meta-analysis aimed at providing updated evidence on these topics.

Methods: A systematic literature review was conducted to identify studies including patients with a pregnancy after BC (PROSPERO number CRD42020158324). Likelihood of pregnancy after BC, their reproductive outcomes, and maternal safety were assessed. Pooled relative risks, odds ratios (ORs), and hazard ratios (HRs) with 95% CIs were calculated using random effects models.

Results: Of 6,462 identified records, 39 were included involving 8,093,401 women from the general population and 112,840 patients with BC of whom 7,505 had a pregnancy after diagnosis. BC survivors were significantly less likely to have a subsequent pregnancy compared with the general population (relative risk, 0.40; 95% CI, 0.32 to 0.49). Risks of caesarean section (OR, 1.14; 95% CI, 1.04 to 1.25), low birth weight (OR, 1.50; 95% CI, 1.31 to 1.73), preterm birth (OR, 1.45; 95% CI, 1.11 to 1.88), and small for gestational age (OR, 1.16; 95% CI, 1.01 to 1.33) were significantly higher in BC survivors, particularly in those with previous chemotherapy exposure, compared with the general population. No significantly increased risk of congenital abnormalities or other reproductive complications were observed. Compared to patients with BC without subsequent pregnancy, those with a pregnancy had better disease-free survival (HR, 0.66; 95% CI, 0.49 to 0.89) and overall survival (HR, 0.56; 95% CI, 0.45 to 0.68). Similar results were observed after correcting for potential confounders and irrespective of patient, tumor, and treatment characteristics, pregnancy outcome, and timing of pregnancy.

Conclusion: These results provide reassuring evidence on the safety of conceiving in BC survivors. Patients' pregnancy desire should be considered a crucial component of their survivorship care plan.
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http://dx.doi.org/10.1200/JCO.21.00535DOI Listing
July 2021

Educational contribution of the College of the European School of Oncology to the Latin American Oncologists.

Future Oncol 2021 Aug 8;17(23):2981-2987. Epub 2021 Jun 8.

European School of Oncology, Via Turati 29, 20121, Milan, Italy.

The European School of Oncology (ESO) offers a wide range of educational activities in Europe, the Middle East and Latin America. International experts are invited to provide proper education in the diagnosis and treatment of patients with cancer according to a holistic model of care. This activity is currently structured in the ESO College (ESCO) through masterclasses in clinical oncology, international conferences, clinical training centers fellowship programs, certificate of competence and advanced studies, patients' advocacy events, e-learning sessions and medical students' courses in oncology. This institutional profile highlights the ESO-ESCO educational activities dedicated to Latin American oncologists and reports on the experience of the 869 participants that have attended these programs.
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http://dx.doi.org/10.2217/fon-2021-0421DOI Listing
August 2021

First Case Report of Pregnancy on Alectinib in a Woman With Metastatic ALK-Rearranged Lung Cancer: A Case Report.

J Thorac Oncol 2021 05 30;16(5):873-877. Epub 2021 Mar 30.

Department of Oncology, Mario Negri Institute for Pharmacological Research IRCCS, Milan, Italy.

This is the first case report of a patient with ALK-rearranged metastatic lung adenocarcinoma who became pregnant during treatment with alectinib. A multidisciplinary team of gynecologists, neonatologists, oncologists, psychologists, and pharmacologists was set up to handle the case. According to patient's preference, the study drug was continued throughout pregnancy and the woman delivered a healthy baby girl at 35 weeks and 5 days of gestation. Fetal parameters remained normal during pregnancy. At birth, alectinib levels were 14 times higher in maternal plasma than in the fetus (259 versus 18 ng/mL). The average concentration of alectinib in the placenta was 562 ng/g. The baby was followed during her first 20 months, and no developmental anomalies were observed. After 32 months from diagnosis, the mother is well and in partial remission.
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http://dx.doi.org/10.1016/j.jtho.2021.02.005DOI Listing
May 2021

Live European School of Oncology e-Sessions (e-ESO).

Crit Rev Oncol Hematol 2021 Jul 16;163:103301. Epub 2021 Mar 16.

European School of Oncology, Milan, Italy.

The European School of Oncology (ESO) embarked on an online educational project, starting with live sessions in 2008 (e-ESO). Our scholars and young oncologists identified the need to be offered independent high-level online education with contributions from experts around the world, free of charge and available at any moment. We report on various types of e-sessions, such as grand-rounds, highlights, debates, clinical cases and other sessions. Our audience has grown over the last decade, reaching 11,123 users who have viewed a total of 77,041 sessions since the beginning of 2008. Moreover, our activities on social media platforms have enhanced our visibility, reaching more physicians around the globe. Due to the recent events surrounding the COVID-19 pandemic, online education has proven to be of great value in offering long-distance teaching. We have analyzed the growth of our audience and its attendance over the last 12 years.
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http://dx.doi.org/10.1016/j.critrevonc.2021.103301DOI Listing
July 2021

Clinical behavior and outcomes of breast cancer in young women with germline BRCA pathogenic variants.

NPJ Breast Cancer 2021 Feb 12;7(1):16. Epub 2021 Feb 12.

Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.

Young breast cancer (BC) patients carrying a germline BRCA pathogenic variant (mBRCA) have similar outcomes as non-carriers. However, the impact of the type of gene (BRCA1 vs. BRCA2) and hormone receptor status (positive [HR+] vs. negative [HR-]) on clinical behavior and outcomes of mBRCA BC remains largely unknown. This is an international, multicenter, hospital-based, retrospective cohort study that included mBRCA patients diagnosed, between January 2000 and December 2012, with stage I-III invasive early BC at age ≤40 years. From 30 centers worldwide, 1236 young mBRCA BC patients were included. Among 808 and 428 patients with mBRCA1 or mBRCA2, 191 (23.6%) and 356 (83.2%) had HR+tumors, respectively (P < 0.001). Median follow-up was 7.9 years. Second primary BC (P = 0.009) and non-BC malignancies (P = 0.02) were more frequent among mBRCA1 patients while distant recurrences were less frequent (P = 0.02). Irrespective of hormone receptor status, mBRCA1 patients had worse disease-free survival (DFS; adjusted HR = 0.76, 95% CI = 0.60-0.96), with no difference in distant recurrence-free interval (DRFI) and overall survival (OS). Patients with HR+ disease had more frequent distant recurrences (P < 0.001) and less frequent second primary malignancies (BC: P = 0.005; non-BC: P = 0.18). No differences in DFS and OS were observed according to hormone receptor status, with a tendency for worse DRFI (adjusted HR = 1.39, 95% CI = 0.94-2.05) in patients with HR+ BC. Type of mBRCA gene and hormone receptor status strongly impact BC clinical behavior and outcomes in mBRCA young patients. These results provide important information for patients' counseling on treatment, prevention, and surveillance strategies.
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http://dx.doi.org/10.1038/s41523-021-00224-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880991PMC
February 2021

Discussing motherhood when the oncological prognosis is dire: ethical considerations for physicians.

ESMO Open 2020 11;5(6):e000956

Department of Gynaecologic Oncology, European Institute of Oncology IRCCS, Milano, Italy. Electronic address:

Physicians are increasingly open to discussing and supporting pregnancy after cancer treatment. However, counselling patients who are seeking pregnancy despite advanced oncological disease and/or uncertain prognosis is still challenging. Two paradigmatic cases are presented and analysed to illustrate the ethical uneasiness faced by treating physicians when seriously ill patients seek fertility preservation and/or pregnancy. Review of ethical issues is built around the four principles of biomedical ethics. Respect for patients autonomy in relation to managing realistic expectations and avoiding giving patients false hopes opens the analysis. It is followed by considering fair allocation of resources and meaningful distinction between protecting patients from harm and contributing to their welfare. Responsibilities towards the unborn child are discussed in a light of maternal and fetal interdependency. Respecting personal autonomy requires abstaining from controlling inferences to the individual patient's choices, but it does not mean that patients should be left on their own to pick and choose their disease management approaches without advice and guidance from healthcare professionals. Physicians should reason evaluating the potential harms and checking if benefits will outweigh the risks and if costs will produce the best overall results. Responsibilities towards the unborn child can be managed by balancing the respect for maternal autonomy and beneficence for pregnant woman and her fetus. The oncologist cannot determine how patients should view their disease but with empathy and compassion can help them understand the logical rationale behind clinical advice.
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http://dx.doi.org/10.1136/esmoopen-2020-000956DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656910PMC
November 2020

Pregnancy and Lactation: Risk or Protective Factors for Breast Cancer?

Adv Exp Med Biol 2020 ;1252:195-197

Department of Medical and Surgical Sciences and Biotechnology, Sapienza University of Rome, Rome, Italy.

Pregnancy and lactation represent the most effective protective elements against breast cancer; counter-intuitively breast cancer incidence shows a small but noticeable increase up to 5 years after delivery. The cumulative effect is however favourable and women show a reduction in breast cancer risk which is proportional to the total duration of lactation and to the number of full-term pregnancies.
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http://dx.doi.org/10.1007/978-3-030-41596-9_27DOI Listing
September 2020

Lactation during and after Breast Cancer.

Adv Exp Med Biol 2020 ;1252:159-163

Private Lactation Consultant Practice, Lerici, La Spezia, Italy.

Breastfeeding is an important aspect of mother-newborn relationship and is of great benefit for the baby. Unfortunately, many drugs taken by the mother may pass into her milk and exert an effect on the newborn. Very limited data is available and a cautionary approach is warranted especially when the woman receives anticancer treatment including chemotherapy , hormonal treatment and the recently introduced target agents as well as monoclonal antibodies. In all these conditions breastfeeding should be put on hold.More and more often physicians are faced with women that are pregnant years after the diagnosis of cancer: this has long been considered dangerous for the mother, but data show that prognosis is definitely not worse. If the woman is no longer being actively treated, breastfeeding is advisable every time it is possible, even if patients that received breast radiation may be unable to produce a sufficient amount of milk on that side.
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http://dx.doi.org/10.1007/978-3-030-41596-9_22DOI Listing
September 2020

Management of HER2-positive breast cancer during pregnancy: a case report.

Tumori 2020 Dec 30;106(6):NP33-NP35. Epub 2020 Jul 30.

Department of Gynecology, Justo José de Urquiza Hospital, Concepción del Uruguay, Entre Ríos, Argentina.

Introduction: Breast cancer is one of the most common malignancies diagnosed during pregnancy, with an incidence of 1:3000 pregnancies. Its rising incidence is related to the trend to postpone childbearing during the last 30 years. Breast cancer during pregnancy should not be managed differently from the nonpregnant setting. Chemotherapy is reported to be safe after the first trimester, whereas trastuzumab and tamoxifen are contraindicated regardless of the trimester.

Case Description: A patient diagnosed with breast cancer recurrence during pregnancy was exposed to both tamoxifen and trastuzumab during the first two trimesters of pregnancy. In addition, docetaxel was administered during the second and third trimesters, without subsequent fetal malformations or obstetric complications.

Conclusions: When conception occurs inadvertently during assumption of tamoxifen or anti-HER2 agents, their effects on the fetus and on the course of pregnancy are not completely understood. Further studies are needed in this setting, highlighting the importance to share clinical experiences.
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http://dx.doi.org/10.1177/0300891620944218DOI Listing
December 2020

Pregnancy After Breast Cancer in Patients With Germline Mutations.

J Clin Oncol 2020 09 16;38(26):3012-3023. Epub 2020 Jul 16.

Department of Medical Oncology, Institut Jules Bordet and Université Libre de, Brussels, Belgium.

Purpose: Young women with germline mutations have unique reproductive challenges. Pregnancy after breast cancer does not increase the risk of recurrence; however, very limited data are available in patients with mutations. This study investigated the impact of pregnancy on breast cancer outcomes in patients with germline mutations.

Patients And Methods: This is an international, multicenter, hospital-based, retrospective cohort study. Eligible patients were diagnosed between January 2000 and December 2012 with invasive early breast cancer at age ≤ 40 years and harbored deleterious germline mutations. Primary end points were pregnancy rate, and disease-free survival (DFS) between patients with and without a pregnancy after breast cancer. Pregnancy outcomes and overall survival (OS) were secondary end points. Survival analyses were adjusted for guarantee-time bias controlling for known prognostic factors.

Results: Of 1,252 patients with germline mutations (, 811 patients; , 430 patients; , 11 patients) included, 195 had at least 1 pregnancy after breast cancer (pregnancy rate at 10 years, 19%; 95% CI, 17% to 22%). Induced abortions and miscarriages occurred in 16 (8.2%) and 20 (10.3%) patients, respectively. Among the 150 patients who gave birth (76.9%; 170 babies), pregnancy complications and congenital anomalies occurred in 13 (11.6%) and 2 (1.8%) cases, respectively. Median follow-up from breast cancer diagnosis was 8.3 years. No differences in DFS (adjusted hazard ratio [HR], 0.87; 95% CI, 0.61 to 1.23; = .41) or OS (adjusted HR, 0.88; 95% CI, 0.50 to 1.56; = .66) were observed between the pregnancy and nonpregnancy cohorts.

Conclusion: Pregnancy after breast cancer in patients with germline mutations is safe without apparent worsening of maternal prognosis and is associated with favorable fetal outcomes. These results provide reassurance to patients with -mutated breast cancer interested in future fertility.
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http://dx.doi.org/10.1200/JCO.19.02399DOI Listing
September 2020

ESGO-SIOPE guidelines for the management of adolescents and young adults with non-epithelial ovarian cancers.

Lancet Oncol 2020 07;21(7):e360-e368

Paediatric Oncology, University Hospital Bonn, Bonn, Germany.

The European Society of Gynaecological Oncology and the European Society for Paediatric Oncology jointly developed clinically relevant and evidence-based guidelines for the management of adolescents and young adults aged 15 to 25 years with non-epithelial ovarian cancers, including malignant ovarian germ cell tumours, sex cord-stromal tumours, and small cell carcinoma of the ovary of hypercalcaemic type. The developmental process of these guidelines is based on a systematic literature review and critical appraisal process involving an international multidisciplinary developmental group consisting of experts from relevant disciplines (paediatric oncology, paediatric surgery, medical oncology, pathology, psycho-oncology, gynaecological oncology, and reproductive endocrinology). Given the specific and often complex issues involved in treating this group of patients, fertility sparing surgery and decrease of acute and long-term toxicities from treatment were important criteria for guidelines definition. Prior to publication, the guidelines were reviewed by 54 independent international practitioners in cancer care delivery.
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http://dx.doi.org/10.1016/S1470-2045(20)30091-7DOI Listing
July 2020

The clinical training centers fellowships: a European School of Oncology career development program (2013-2019).

Future Oncol 2020 Sep 21;16(26):1969-1976. Epub 2020 Jun 21.

European School of Oncology, Milan, Italy.

This article refers to the European School of Oncology Clinical Training Centers (CTCs) program, which is a granted Fellowships program dedicated to young oncologists in training. A total of 74 fellowships were offered by several CTCs during the last 7 years. Candidates were enrolled for 3-6 months of training rotations as fellows or observers in more than 30 training programs in well known Cancer Centers around Europe. Fellowships were covering medical, surgical, radiation and pediatric oncology specialties, laboratory diagnostic training and experimental, translational and clinical research. Fellows originated from Europe, Latin America and Mediterranean Africa. Analysis of the questionnaire assessment showed that 95.5% of the fellows evaluated CTC programs with an 'excellent' or 'very good' score, while 100% declare that they had reached their objectives. The European School of Oncology CTC program designed for an additional practical education abroad meets the needs of young oncologists.
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http://dx.doi.org/10.2217/fon-2020-0193DOI Listing
September 2020

Estimation of historical control rate for a single arm de-escalation study - Application to the POSITIVE trial.

Breast 2020 Oct 2;53:1-7. Epub 2020 Jun 2.

International Breast Cancer Study Group Statistical Center, Department of Data Sciences, Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, 450 Brookline Ave, Boston, MA, 02215, USA. Electronic address:

Background: Although randomized controlled clinical trials are optimal to evaluate the effect of an experimental therapy, single-arm trials are required whenever randomization is unethical or not feasible, such as de-escalation studies. We propose using prospectively identified historical controls to place results of single-arm, de-escalation trials into context.

Methods: POSITIVE is a prospective, single-arm study in young women with hormone-receptor-positive early breast cancer to determine if temporarily interrupting adjuvant endocrine therapy in order to become pregnant increases the risk of a breast cancer event. After 272 women enrolled in POSITIVE, we identified a cohort of 1499 SOFT/TEXT patients potentially eligible to enroll in POSITIVE who did not interrupt endocrine therapy. Method I used the SOFT/TEXT cohort to calculate annualized hazard rates by a piecewise exponential model. Method II used the SOFT/TEXT cohort to group-match SOFT/TEXT patients to POSITIVE patients; sample sets of SOFT/TEXT patients were randomly drawn 5000 times to obtain sets having patient, disease, and treatment characteristics more balanced with POSITIVE participants.

Results: Compared with SOFT/TEXT, POSITIVE participants were younger, less likely to be overweight/obese, had fewer positive nodes, and fewer received aromatase inhibitor or chemotherapy. The estimated 3-year breast cancer free interval event rates were 9.5% (95% CI: 7.9%,11.1%) for Method I and 9.4% (95% CI: 7.8%,10.9%) for Method II, compared with 5.8% initially assumed when POSITIVE was designed.

Conclusion: External control datasets should be identified before launching single-arm, de-escalation trials and methods applied during their conduct to provide context for interim monitoring and interpretation of the final analysis.
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http://dx.doi.org/10.1016/j.breast.2020.05.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7375555PMC
October 2020

Frequency of Pregnancy-Associated Cancer: A Systematic Review of Population-Based Studies.

Cancers (Basel) 2020 May 26;12(6). Epub 2020 May 26.

Department of Clinical Sciences and Community Health, University of Milan, 20122 Milan, Italy.

Despite numerous available resources of evidence, the results about the frequency of pregnancy-associated cancer (PAC) still show poor comparability due to dissimilarities in the study design and methodology, inclusion criteria, incoherent duration of follow-up and a heterogeneous reference population. We conducted a systematic review of population-based studies on PAC published up to December 2019, to provide updated research on this topic, highlighting strengths and limitations. Of the 24 papers included, 11 considered all types of tumors and 13 dealt with specific types of cancer. Differences in the procedures for estimating the frequency of PAC emerged even among population studies. However, we found consistent results for overall frequency of PAC- around 1/1000 pregnancies. Our review suggests that about 25% of PAC cases are diagnosed during pregnancy, confirming the hypothesis of an excess of diagnosis in the postpregnancy period. Sparse and inconsistent results were found regarding a potential increase in the frequency of PAC over calendar years. Alignments in the strategy to identify PAC are needed to overcome methodological weaknesses.
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http://dx.doi.org/10.3390/cancers12061356DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352408PMC
May 2020

Uterine irradiation as a determinant of infertility and pregnancy losses in young cancer survivors.

Ecancermedicalscience 2020 6;14:1032. Epub 2020 May 6.

Fertility and Procreation Unit, Division of Gynaecologic Oncology, European Institute of Oncology IRCCS, Milan, Italy.

Several concerns exist regarding the impact of anticancer treatments on fertility and pregnancy outcome. The detrimental effects of both chemotherapy and radiotherapy on the ovaries are well reported in the available literature. Fewer data are focused on the importance of a functioning uterus to conceive and carry on a healthy pregnancy. The aim of this paper is to provide a narrative review of the current literature to assess the role of uterine irradiation as a potential determinant of infertility and poor obstetrical outcomes. This review addresses the need for multidisciplinary counselling in order to face the poor reproductive and obstetrical outcomes of women who had uterine radiation, according to the different backgrounds (radiotherapy during adulthood versus childhood; total body irradiation versus pituitary, spinal and/or abdominal-pelvic irradiation).
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http://dx.doi.org/10.3332/ecancer.2020.1032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7221126PMC
May 2020

The impact of the European School of Oncology masterclass in clinical oncology on self-professional development.

Crit Rev Oncol Hematol 2020 Jul 28;151:102976. Epub 2020 Apr 28.

European School of Oncology, Milan, Italy.

We investigated the impact of the European School of Oncology's (ESO) Masterclass (MCO) in Clinical Oncology on the career development of young participants. MCO represents the flagship educational activity of ESO and is organized annually, mostly in collaboration with the European Society for Medical Oncology (ESMO) in five different geographical regions. A questionnaire consisting of 21 questions was sent to all doctors who attended the ESO MCOs from 2009 to 2016. The 228 responders were mostly from European countries and hold the specialty of Medical Oncology. Ninety-five percent of them evaluated ESO MCOs as "extremely useful" or "useful" for their professional career. Around 60% were trained at University Hospitals or Cancer Institutes and currently, one-third of them are employed in Academic Centers. Eighty percent have performed translational or clinical research and 77.5% were able to publish in pertinent international journals. The contribution of ESO MCOs to trainees' career development in different oncology disciplines around the world is discussed.
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http://dx.doi.org/10.1016/j.critrevonc.2020.102976DOI Listing
July 2020

Clinical Case Presentation and Discussion During ESO-ESMO Masterclass: a 10-Year Interactive Educational Experience.

J Cancer Educ 2020 Apr 17. Epub 2020 Apr 17.

European School of Oncology, Milan, Italy.

In this article, we report on the clinical case presentations that have been delivered during the ESO or ESO-ESMO Masterclasses in Clinical Oncology in the last 10 years. Masterclasses have been held in three different geographical continents including Europe, Middle East, and Latin America, in which participants had to submit a clinical case and present it either in front of a tumor board (multidisciplinary-like sessions) or in small groups. Clinical case presentation is a unique part of the educational program preparing young oncologists to present and discuss their own patients with distinguished experts. In each Masterclass, between 40 and 55 clinical cases-depending on the number of participants-are presented. All presentations are assessed and evaluated by faculty members as well as by the rest of the participants.
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http://dx.doi.org/10.1007/s13187-020-01744-yDOI Listing
April 2020

Fertility preservation strategies in borderline ovarian tumor recurrences: different sides of the same coin.

J Assist Reprod Genet 2020 05 18;37(5):1217-1219. Epub 2020 Mar 18.

Fertility and Procreation Unit in Oncology, Gynecologic Oncology Program, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.

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http://dx.doi.org/10.1007/s10815-020-01738-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7244678PMC
May 2020

Can we trust tumour markers in pregnancy after breast cancer? A case of elevated CA 15-3 in the third trimester of pregnancy normalising after delivery.

Ecancermedicalscience 2019 26;13:979. Epub 2019 Nov 26.

Fertility and Procreation Unit, Division of Gynecologic Oncology, European Institute of Oncology IRCCS, 20141 Milan, Italy.

We realized a narrative review of the current literature starting from the case of a patient with raised CA15-3 during an uncomplicated pregnancy after breast cancer. The aim of our paper was to assess specificity, physiological changes and clinical utility of CA 15-3 monitoring during pregnancy after breast cancer, starting from clinical practice and retrieving the most relevant evidence in the literature.
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http://dx.doi.org/10.3332/ecancer.2019.979DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6946420PMC
November 2019

Breastfeeding After Breast Cancer: Feasibility, Safety, and Ethical Perspectives.

J Hum Lact 2020 Feb 15;36(1):40-43. Epub 2019 Nov 15.

IEO European Institute of Oncology IRCCS, Milan, Italy.

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http://dx.doi.org/10.1177/0890334419887723DOI Listing
February 2020

Breastfeeding during R-CHOP chemotherapy: please abstain!

Eur J Cancer 2019 09 19;119:107-111. Epub 2019 Aug 19.

European Institute of Oncology IRCCS, Division of Gynecologic Oncology, Milan, Italy.

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http://dx.doi.org/10.1016/j.ejca.2019.07.012DOI Listing
September 2019

Chemotherapy and anti-HER2 therapy in metastatic breast cancer in pregnancy followed by surgical treatment.

Ecancermedicalscience 2019 14;13:930. Epub 2019 May 14.

Fertility and Procreation Unit, European Institute of Oncology, IRCCS, 20141 Milan, Italy.

Between 5% and 10% of women have distant metastases when they receive a breast cancer (BC) diagnosis. Metastatic BC is associated with poor prognosis but advances in systemic treatments have improved survival rates in recent decades. Debates about local primary tumour management in metastatic stages continue, but multiple studies have shown that primary tumour surgery can be beneficial. BC is one of the most commonly diagnosed neoplasias during pregnancy. Treatment of pregnant BC patients should follow the standard treatment of young, non-pregnant patients as closely as possible. We present the case of a young, pregnant patient with metastatic BC with a complete clinical response to chemotherapy followed by surgical treatment.
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http://dx.doi.org/10.3332/ecancer.2019.930DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6592705PMC
May 2019

Knowledge, attitudes and practice of physicians towards fertility and pregnancy-related issues in youngBRCA-mutated breast cancer patients.

Reprod Biomed Online 2019 May 10;38(5):835-844. Epub 2019 Jan 10.

Fertility Clinic, Research Laboratory on Human Reproduction, CUB-Erasme and Université Libre de Bruxelles, Brussels, Belgium.

Research Question: This study explored the knowledge, attitudes and practice of physicians towards fertility and pregnancy-related issues in young BRCA-mutated breast cancer patients.

Design: Physicians attending two international breast cancer conferences completed a 26-item questionnaire exploring fertility preservation, pregnancy during (BCP) or after breast cancer. A statistical comparison was carried out of the responses exploring the same issues in young breast cancer patients overall or specifically in those with BRCA mutations.

Results: The survey was completed by 273 physicians. Ovarian tissue cryopreservation (33% versus 40%; P = 0.009) and gonadotrophin-releasing hormone analogues during chemotherapy (74% versus 81%; P = 0.001) were less commonly suggested in BRCA-mutated patients than in the overall breast cancer population. 42% of respondents agreed or were neutral on the statement that ovarian stimulation should not be considered safe in BRCA-mutated breast cancer patients. 45% and 30% agreed or were neutral on the statement that pregnancy in breast cancer survivors may increase the risk of recurrence in BRCA-mutated patients or in the overall breast cancer population, respectively (P < 0.001). 15% and 3% disagreed that transplanting the cryopreserved ovarian tissue can be considered safe in BRCA-mutated patients or in the overall breast cancer population, respectively (P < 0.001). 33.3% were against the addition of platinum agents as neoadjuvant chemotherapy in BRCA-mutated patients with BCP.

Conclusions: Several misconceptions on fertility preservation and pregnancy-related issues in breast cancer patients persist even among physicians directly involved in breast cancer care. Focused research efforts to address these issues in BRCA-mutated breast cancer patients and education to improve physicians' knowledge and adherence to available guidelines are urgently needed.
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http://dx.doi.org/10.1016/j.rbmo.2018.11.031DOI Listing
May 2019

The BCY3/BCC 2017 survey on physicians' knowledge, attitudes and practice towards fertility and pregnancy-related issues in young breast cancer patients.

Breast 2018 Dec 22;42:41-49. Epub 2018 Aug 22.

Fertility and Procreation Unit, Gynecologic Oncology Department, IRCCS European Institute of Oncology, European School of Oncology (ESO), Milan, Italy.

Background: Fertility and pregnancy-related issues are major concerns for young breast cancer patients. Limited data are available on physicians' knowledge, attitudes and practice in these fields.

Methods: A 26-item questionnaire exploring 3 different topics (fertility preservation, pregnancy after breast cancer and breast cancer during pregnancy) was sent by email to physicians attending the 2016 3rd European School of Oncology (ESO) - European Society for Medical Oncology (ESMO) Breast Cancer in Young Women Conference (BCY3) and the 15th St. Gallen International Breast Cancer Conference 2017 (BCC 2017). Given the selected sample, survey respondents were expected to have a higher than average interest in the management of breast cancer patients. Descriptive analyses were performed.

Results: A total of 273 physicians (105 at BCY3 and 168 at BCC 2017) completed the survey; 37.0%, 46.9% and 34.8% reported never having consulted the available international guidelines on fertility preservation, pregnancy after breast cancer and management of breast cancer during pregnancy, respectively. Up to 18.3% of respondents did not know if the different fertility preservation options were available in their country; 22.3% suggested that controlled ovarian stimulation should not be considered safe in patients with hormone receptor-positive disease. A total of 30.4% of respondents agreed or were neutral on the statement that pregnancy in breast cancer survivors may increase the risk of recurrence. Regarding breast cancer during pregnancy, 23.8% and 38.1% disagreed or were neutral on the statements that endocrine therapy and anti-HER2 agents should be avoided during pregnancy, respectively.

Conclusions: Further educational initiatives are needed to improve physicians' knowledge and adherence to available guidelines when addressing fertility and pregnancy-related issues in young breast cancer patients.
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http://dx.doi.org/10.1016/j.breast.2018.08.099DOI Listing
December 2018

Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients.

Lancet Oncol 2018 03 26;19(3):337-346. Epub 2018 Jan 26.

Department of Oncology, KU Leuven, Leuven, Belgium; Division of Gynaecologic Oncology, University Hospitals Leuven, Leuven, Belgium; Center for Gynaecologic Oncology Amsterdam, Antoni van Leeuwenhoek-Netherlands Cancer Institute, Amsterdam, Netherlands; Centre for Gynaecologic Oncology Amsterdam, Academical Medical Center, Amsterdam, Netherlands. Electronic address:

Background: Awareness is growing that cancer can be treated during pregnancy, but the effect of this change on maternal and neonatal outcomes is unknown. The International Network on Cancer, Infertility and Pregnancy (INCIP) registers the incidence and maternal, obstetric, oncological, and neonatal outcomes of cancer occurring during pregnancy. We aimed to describe the oncological management and obstetric and neonatal outcomes of patients registered in INCIP and treated in the past 20 years, and assess associations between cancer type or treatment modality and obstetric and neonatal outcomes.

Methods: This descriptive cohort study included pregnant patients with cancer registered from all 37 centres (from 16 countries) participating in the INCIP registry. Oncological, obstetric, and neonatal outcome data of consecutive patients diagnosed with primary invasive cancer during pregnancy between Jan 1, 1996, and Nov 1, 2016, were retrospectively and prospectively collected. We analysed changes over time in categorical patient characteristics, outcomes, and treatment methods with log-binomial regression. We used multiple logistic regression to analyse preterm, prelabour rupture of membranes (PPROM) or preterm contractions, small for gestational age, and admission to the neonatal intensive care unit (NICU). The INCIP registry study is registered with ClinicalTrials.gov, number NCT00330447, and is ongoing.

Findings: 1170 patients were included in the analysis and 779 (67%) received treatment during pregnancy. Breast cancer was the most common malignant disease (462 [39%]). Every 5 years, the likelihood of receiving treatment during pregnancy increased (relative risk [RR] 1·10, 95% CI 1·05-1·15), mainly related to an increase of chemotherapeutic treatment (1·31, 1·20-1·43). Overall, 955 (88%) of 1089 singleton pregnancies ended in a livebirth, of which 430 (48%) of 887 pregnancies ended preterm. Each 5 years, we observed more livebirths (RR 1·04, 95% CI 1·01-1·06) and fewer iatrogenic preterm deliveries (0·91, 0·84-0·98). Our data suggest a relationship between platinum-based chemotherapy and small for gestational age (odds ratio [OR] 3·12, 95% CI 1·45-6·70), and between taxane chemotherapy and NICU admission (OR 2·37, 95% CI 1·31-4·28). NICU admission seemed to depend on cancer type, with gastrointestinal cancers having highest risk (OR 7·13, 95% CI 2·86-17·7) and thyroid cancers having lowest risk (0·14, 0·02-0·90) when compared with breast cancer. Unexpectedly, the data suggested that abdominal or cervical surgery was associated with a reduced likelihood of NICU admission (OR 0·30, 95% CI 0·17-0·55). Other associations between treatment or cancer type and outcomes were less clear.

Interpretation: Over the years, the proportion of patients with cancer during pregnancy who received antenatal treatment increased, especially treatment with chemotherapy. Our data indicate that babies exposed to antenatal chemotherapy might be more likely to develop complications, specifically small for gestational age and NICU admission, than babies not exposed. We therefore recommend involving hospitals with obstetric high-care units in the management of these patients.

Funding: Research Foundation-Flanders, European Research Council, Charles University, Ministry of Health of the Czech Republic.
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http://dx.doi.org/10.1016/S1470-2045(18)30059-7DOI Listing
March 2018

Response.

J Natl Cancer Inst 2018 08;110(8):919-920

Department of Internal Medicine, Division of Hematology-Oncology, American University of Beirut (AUB), Beirut, Lebanon.

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http://dx.doi.org/10.1093/jnci/djx292DOI Listing
August 2018
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