Publications by authors named "Maria T Bourlon"

48 Publications

Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma.

N Engl J Med 2021 03;384(9):829-841

From the Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Harvard Medical School, Boston (T.K.C.); the Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London (T.P.); the Bradford Hill Clinical Research Center, Santiago, Chile (M.B.); the Department of Medical Oncology, Gustave Roussy, Villejuif, France (B.E.); the Department of Hemato-Oncology, Urologic Oncology Clinic, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.T.B.), the Department of Medical Oncology, Centro Universitario contra el Cáncer, Hospital Universitario "Dr. José Eleuterio González," Universidad Autónoma de Nuevo León, Nuevo León (V.M.O.J.), and the Department of Medical Oncology, Hospital H+ Querétaro, Querétaro (J.P.F.) - all in Mexico; the Department of Outpatient Chemotherapy, Professor Franciszek Lukaszczyk Oncology Center, Bydgoszcz (B.Z.), and the Department of Clinical Oncology and Hematology, Regional Specialist Hospital, Biała Podlaska (J. Żołnierek) - both in Poland; the Division of Oncology, Department of Medicine, Siteman Cancer Center, Washington University School of Medicine, St. Louis (J.J.H.); Oncology Unit 1, Department of Oncology, Istituto Oncologico Veneto IRCCS, Padua (U.B.), the Department of Medical Oncology, Ospedale San Donato, Istituto Toscano i, Arezzo (A.H.), the Department of Internal Medicine, University of Pavia, Pavia (C.P.), and the University of Bari "A. Moro," Bari (C.P.) - all in Italy; the Department of Genitourinary Medical Oncology, M.D. Anderson Cancer Center, Houston (A.Y.S.); the Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona (C.S.); the Department of Medical Oncology, Royal Brisbane and Women's Hospital, Herston, QLD (J.C.G.), and Cabrini Monash University Department of Medical Oncology, Cabrini Health, Malvern, VIC (D.P.) - both in Australia; the Oncology Research Center, Hospital São Lucas, Porto Alegre, Brazil (C.B.); Fundacion Richardet Longo, Instituto Oncologico de Cordoba, Cordoba (M.R.), and Instituto Multidisciplinario de Oncología, Clínica Viedma, Viedma (R.K.) - both in Argentina; the Division of Medical Oncology, Department of Internal Medicine, University of Colorado School of Medicine, Aurora (E.R.K.); the Departments of Urology and Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata (Y.T.), and the Department of Urology, Keio University School of Medicine, Tokyo (R.M.) - both in Japan; the Department of Urology, Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); the Departments of Clinical Research (J. Zhang.), Clinical Oncology (M.A.M.), Biostatistics (B.S.), and Health Economics and Outcomes Research (F.E.), Bristol Myers Squibb, Princeton, NJ; the Department of Clinical Oncology, Exelixis, Alameda, CA (G.M.S.); the Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD (A.B.A.); and the Department of Medicine, Memorial Sloan Kettering Cancer Center, New York (R.J.M.).

Background: The efficacy and safety of nivolumab plus cabozantinib as compared with those of sunitinib in the treatment of previously untreated advanced renal-cell carcinoma are not known.

Methods: In this phase 3, randomized, open-label trial, we randomly assigned adults with previously untreated clear-cell, advanced renal-cell carcinoma to receive either nivolumab (240 mg every 2 weeks) plus cabozantinib (40 mg once daily) or sunitinib (50 mg once daily for 4 weeks of each 6-week cycle). The primary end point was progression-free survival, as determined by blinded independent central review. Secondary end points included overall survival, objective response as determined by independent review, and safety. Health-related quality of life was an exploratory end point.

Results: Overall, 651 patients were assigned to receive nivolumab plus cabozantinib (323 patients) or sunitinib (328 patients). At a median follow-up of 18.1 months for overall survival, the median progression-free survival was 16.6 months (95% confidence interval [CI], 12.5 to 24.9) with nivolumab plus cabozantinib and 8.3 months (95% CI, 7.0 to 9.7) with sunitinib (hazard ratio for disease progression or death, 0.51; 95% CI, 0.41 to 0.64; P<0.001). The probability of overall survival at 12 months was 85.7% (95% CI, 81.3 to 89.1) with nivolumab plus cabozantinib and 75.6% (95% CI, 70.5 to 80.0) with sunitinib (hazard ratio for death, 0.60; 98.89% CI, 0.40 to 0.89; P = 0.001). An objective response occurred in 55.7% of the patients receiving nivolumab plus cabozantinib and in 27.1% of those receiving sunitinib (P<0.001). Efficacy benefits with nivolumab plus cabozantinib were consistent across subgroups. Adverse events of any cause of grade 3 or higher occurred in 75.3% of the 320 patients receiving nivolumab plus cabozantinib and in 70.6% of the 320 patients receiving sunitinib. Overall, 19.7% of the patients in the combination group discontinued at least one of the trial drugs owing to adverse events, and 5.6% discontinued both. Patients reported better health-related quality of life with nivolumab plus cabozantinib than with sunitinib.

Conclusions: Nivolumab plus cabozantinib had significant benefits over sunitinib with respect to progression-free survival, overall survival, and likelihood of response in patients with previously untreated advanced renal-cell carcinoma. (Funded by Bristol Myers Squibb and others; CheckMate 9ER ClinicalTrials.gov number, NCT03141177.).
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http://dx.doi.org/10.1056/NEJMoa2026982DOI Listing
March 2021

A View from the past into our collective future: the oncofertility consortium vision statement.

Authors:
Teresa K Woodruff Lauren Ataman-Millhouse Kelly S Acharya Teresa Almeida-Santos Antoinette Anazodo Richard A Anderson Leslie Appiah Joy Bader Kerri Becktell Robert E Brannigan Lesley Breech Maria T Bourlon Žana Bumbuliene Karen Burns Lisa Campo-Engelstein Jacira R Campos Grace M Centola Mauricio Barbour Chehin Diane Chen Michel De Vos Francesca E Duncan Ahmed El-Damen Douglas Fair Yemi Famuyiwa Patricia Y Fechner Paula Fontoura Olivia Frias Sabrina A Gerkowicz Jill Ginsberg Clarisa R Gracia Kara Goldman Veronica Gomez-Lobo Brent Hazelrigg Michael H Hsieh Luis R Hoyos Alfonso Hoyos-Martinez Robert Jach Jacek Jassem Murid Javed Yasmin Jayasinghe Roohi Jeelani Jacqueline S Jeruss Nalini Kaul-Mahajan Jessica Keim-Malpass Tyler G Ketterl Mohamed Khrouf Dana Kimelman Atsuko Kusuhara William H Kutteh Monica M Laronda Jung Ryeol Lee Vicky Lehmann Joseph M Letourneau Lynda K McGinnis Eileen McMahon Lillian R Meacham Monserrat Fabiola Velez Mijangos Molly Moravek Leena Nahata George Moses Ogweno Kyle E Orwig Mary Ellen Pavone Fedro Alessandro Peccatori Romina Ileana Pesce Hanna Pulaski Gwendolyn Quinn Ramiro Quintana Tomas Quintana Bruno Ramalho de Carvalho Rosalind Ramsey-Goldman Joyce Reinecke Fernando M Reis Julie Rios Alice S Rhoton-Vlasak Kenny A Rodriguez-Wallberg Cassandra Roeca Seth J Rotz Erin Rowell Mahmoud Salama Amanda J Saraf Anibal Scarella Tara Schafer-Kalkhoff Deb Schmidt Suneeta Senapati Divya Shah Ariella Shikanov Margarett Shnorhavorian Jodi L Skiles James F Smith Kristin Smith Fabio Sobral Kyle Stimpert H Irene Su Kouhei Sugimoto Nao Suzuki Mili Thakur David Victorson Luz Viale Wendy Vitek W Hamish Wallace Ellen A Wartella Lynn M Westphal Stacy Whiteside Lea H Wilcox Christine Wyns Shuo Xiao Jing Xu Mary Zelinski

J Assist Reprod Genet 2021 Jan 6;38(1):3-15. Epub 2021 Jan 6.

Division of Reproductive & Developmental Sciences, Oregon National Primate Research Center, Oregon Health & Science University, Beaverton, OR, USA.

Purpose: Today, male and female adult and pediatric cancer patients, individuals transitioning between gender identities, and other individuals facing health extending but fertility limiting treatments can look forward to a fertile future. This is, in part, due to the work of members associated with the Oncofertility Consortium.

Methods: The Oncofertility Consortium is an international, interdisciplinary initiative originally designed to explore the urgent unmet need associated with the reproductive future of cancer survivors. As the strategies for fertility management were invented, developed or applied, the individuals for who the program offered hope, similarly expanded. As a community of practice, Consortium participants share information in an open and rapid manner to addresses the complex health care and quality-of-life issues of cancer, transgender and other patients. To ensure that the organization remains contemporary to the needs of the community, the field designed a fully inclusive mechanism for strategic planning and here present the findings of this process.

Results: This interprofessional network of medical specialists, scientists, and scholars in the law, medical ethics, religious studies and other disciplines associated with human interventions, explore the relationships between health, disease, survivorship, treatment, gender and reproductive longevity.

Conclusion: The goals are to continually integrate the best science in the service of the needs of patients and build a community of care that is ready for the challenges of the field in the future.
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http://dx.doi.org/10.1007/s10815-020-01983-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786868PMC
January 2021

Patient Navigation to Improve Early Access to Supportive Care for Patients with Advanced Cancer in Resource-Limited Settings: A Randomized Controlled Trial.

Oncologist 2021 Feb 12;26(2):157-164. Epub 2020 Dec 12.

Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Background: The early integration of supportive care in oncology improves patient-centered outcomes. However, data are lacking regarding how to achieve this in resource-limited settings. We studied whether patient navigation increased access to multidisciplinary supportive care among Mexican patients with advanced cancer.

Materials And Methods: This randomized controlled trial was conducted between August 2017 and April 2018 at a public hospital in Mexico City. Patients aged ≥18 years with metastatic tumors ≤6 weeks from diagnosis were randomized (1:1) to a patient navigation intervention or usual care. Patients randomized to patient navigation received personalized supportive care from a navigator and a multidisciplinary team. Patients randomized to usual care obtained supportive care referrals from treating oncologists. The primary outcome was the implementation of supportive care interventions at 12 weeks. Secondary outcomes included advance directive completion, supportive care needs, and quality of life.

Results: One hundred thirty-four patients were randomized: 67 to patient navigation and 67 to usual care. Supportive care interventions were provided to 74% of patients in the patient navigation arm versus 24% in usual care (difference 0.50, 95% confidence interval [CI] 0.34-0.62; p < .0001). In the patient navigation arm, 48% of eligible patients completed advance directives, compared with 0% in usual care (p < .0001). At 12 weeks, patients randomized to patient navigation had less moderate/severe pain (10% vs. 33%; difference 0.23, 95% CI 0.07-0.38; p = .006), without differences in quality of life between arms.

Conclusion: Patient navigation improves access to early supportive care, advance care planning, and pain for patients with advanced cancer in resource-limited settings.

Implications For Practice: The early implementation of supportive care in oncology is recommended by international guidelines, but this might be difficult to achieve in resource-limited settings. This randomized clinical trial including 134 Mexican patients with advanced cancer demonstrates that a multidisciplinary patient navigation intervention can improve the early access to supportive and palliative care interventions, increase advance care planning, and reduce symptoms compared with usual oncologist-guided care alone. These results demonstrate that patient navigation represents a potentially useful solution to achieve the adequate implementation of supportive and palliative care in resource-limited settings globally.
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http://dx.doi.org/10.1002/onco.13599DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7873328PMC
February 2021

Access to Palliative Care Services and Clinical Outcomes of Patients With Solid Malignancy-Associated Myelophthisis in a Resource-Limited Setting.

Am J Hosp Palliat Care 2020 Nov 9:1049909120969963. Epub 2020 Nov 9.

Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Background: Myelophthisis (MPT) has been associated with a dreadful prognosis. Patients' access to palliative care (PC) and factors influencing its clinical outcomes are poorly described. Our aim was to analyze the impact of patient- and disease-specific characteristics on survival of patients with MPT and describe their use of PC in a resource-limited setting.

Methods: Retrospective study including patients with solid tumor MPT, diagnosed between 1996 and 2018.

Results: Seventy patients ( 58 years) were included. 58% were synchronously diagnosed with MPT at time of primary tumor diagnosis. Most common oncologic diagnoses were prostate (25.7%), gastrointestinal (20%), and breast (18.6%) neoplasms. Median overall survival (OS) was 1.9 months. Primaries other than prostate, breast, and lung (HR 1.37, 95% CI 1.15 - 1.8; = 0.02) and transfusion requirements (HR 2.8, 95% CI 1.01 - 7.9; = 0.04) were independently associated with decreased OS. Administration of multiple systemic therapeutic interventions (HR 0.15, 95% CI 0.06 - 0.39; = 0.01) was the sole factor improving OS. Assessment by PC was pursued in 51.4% of patients. The median number of consults per patient was two, with no difference in assessment rate or consult number across different primaries ( = 0.96). Four cases of palliative sedation were reported, all performed by the primary care team.

Conclusion: MPT is highly heterogeneous and risk stratification to optimize the use of therapeutic interventions in unison with palliative interventions is needed to maximize efforts toward improving patient quality of life. There is an alarming need of PC services in the multidisciplinary management of patients within developing regions.
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http://dx.doi.org/10.1177/1049909120969963DOI Listing
November 2020

Recommendations from the ASCO Academic Global Oncology Task Force.

JCO Glob Oncol 2020 10;6:1666-1673

American Society of Clinical Oncology, Alexandria, VA.

In recognition of the rising incidence and mortality of cancer in low- and middle-resource settings, as well as the increasingly international profile of its membership, ASCO has prioritized efforts to enhance its engagement at a global level. Among the recommendations included in the 2016 Global Oncology Leadership Task Force report to the ASCO Board of Directors was that ASCO should promote the recognition of global oncology as an academic field. The report suggested that ASCO could serve a role in transitioning global oncology from an informal field of largely voluntary activities to a more formal discipline with strong research and well-defined training components. As a result of this recommendation, in 2017, ASCO formed the Academic Global Oncology Task Force (AGOTF) to guide ASCO's contributions toward formalizing the field of global oncology. The AGOTF was asked to collect and analyze key issues and barriers toward the recognition of global oncology as an academic discipline, with an emphasis on training, research, and career pathways, and produce a set of recommendations for ASCO action. The outcome of the AGOTF was the development of recommendations designed to advance the status of global oncology as an academic discipline.
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http://dx.doi.org/10.1200/GO.20.00497DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7713550PMC
October 2020

Disorders of Sex Development and Malignant Germ Cell Tumors.

Oncology (Williston Park) 2020 Oct;34(10):421-426

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

A woman, aged 44 years, presented at the general oncology outpatient clinic with bloating, abdominal pain, and significant unintended weight loss. Her past medical history included a bilateral inguinal hernia surgical repair at age 6, and primary amenorrhea since age 15. The patient never underwent additional studies to identify the cause of the primary amenorrhea.
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http://dx.doi.org/10.46883/ONC.2020.3410.0421DOI Listing
October 2020

Immunosenescence profile and expression of the aging biomarker (p16) in testicular cancer survivors treated with chemotherapy.

BMC Cancer 2020 Sep 14;20(1):882. Epub 2020 Sep 14.

Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Background: Cytotoxic chemotherapy can cure advanced germ cell tumors. Nevertheless, cancer treatment may induce cellular senescence and accelerate molecular aging. The aging process implies an increase of cells expressing p16 and changes in lymphocyte subpopulations. Our aim was to study the potential induction of premature immunosenescence in testicular cancer survivors (TCS) exposed to chemotherapy.

Methods: Case-control exploratory study of TCS treated with chemotherapy (≥3 BEP cycles, disease-free ≥3 months) compared with age matched healthy controls. Peripheral blood mononuclear cells were isolated, and lymphocyte subpopulations were analyzed by flow cytometry. CDKN2A/p16 expression in T cells was measured using qPCR. The percentage of lymphocyte subpopulations and the CDKN2A/p16 expression in TCS were compared with the control group using the Wilcoxon signed-rank test.

Results: We included 16 cases and 16 controls. The median age was 27 years (minimum 24, maximum 54) and the median time on surveillance was 26.5 months (minimum 3, maximum192). TCS had a lower percentage of total T cells and CD4+ T cells in total lymphocytes. Among the CD4+ T lymphocytes, TCS had less naïve CD4+ and increased memory CD4+ cells. Within the CD8+ T lymphocytes, TCS exhibited a decrease in the percentage of naïve cells and an increase in CD8 + CD45RA + CD57+ cells. TCS also exhibited decreased memory CD19+ B cells compared to the controls. The relative expression of CDKN2A/p16 in T cells was increased in TCS (mean 1.54; 95% CI of the mean: 1.074-2.005; p = 0.048).

Conclusion: In this exploratory study, TCS showed increased expression of CDKN2A/p16 and a lymphocyte phenotype that has been associated with immunosenescence. Further studies are warranted to define the clinical implications of these alterations in TCS.
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http://dx.doi.org/10.1186/s12885-020-07383-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7491179PMC
September 2020

Challenges of Treating a Patient With Advanced Prostate Cancer During the COVID-19 Pandemic.

Oncology (Williston Park) 2020 08;34(8):317-319

Department of Hematology and Oncology, Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

A 78-year-old man had a medical history of hypertension, atrial fibrillation, chronic kidney disease, and metastatic castration-resistant prostate cancer (CRPC). He had progressed to first-line therapy for CRPC with abiraterone plus androgen-deprivation therapy (ADT) and as second-line therapy he was being treated with docetaxel, with biochemical progression in his last prostate specific antigen measurement. He was admitted to the hospital on April 2020, in the middle of the coronavirus disease 2019 (COVID-19) pandemic, because of painful bone lesions and deterioration of renal function.
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http://dx.doi.org/10.46883/ONC.2020.3408.0317DOI Listing
August 2020

Creative Approaches to Global Cancer Research and Control.

JCO Glob Oncol 2020 07;6:4-7

Institute of Human Virology, Department of Epidemiology and Public Health, Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore, MD.

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http://dx.doi.org/10.1200/GO.20.00237DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846070PMC
July 2020

The Value of PD-L1 Expression as Predictive Biomarker in Metastatic Renal Cell Carcinoma Patients: A Meta-Analysis of Randomized Clinical Trials.

Cancers (Basel) 2020 Jul 17;12(7). Epub 2020 Jul 17.

Medical Oncology Department, University Hospital 12 de Octubre, 28041 Madrid, Spain.

Immune checkpoint inhibitors (ICIs) are soluble antibodies that have dramatically changed the outcomes including overall survival in a subset of kidney tumors, specifically in renal cell carcinoma (RCC). To date, there is no a single predictive biomarker approved to be used to select the patients that achieve benefit from ICIs targeting. It seems reasonable to analyze whether the programmed death-ligand 1 (PD-L1) expression could be useful. To assess the role of PD-L1 expression as a potential predictive biomarker for benefit of ICIs in RCC patients, we performed a search of randomized clinical trials (RCTs) comparing ICIs (monotherapy or in combination with other therapies) to standard of care in metastatic RCC patients according to PRISMA guidelines. Trials must have included subgroup analyses evaluating the selected outcomes (progression-free survival (PFS) and overall survival (OS)) in different subsets of patients according to PD-L1 expression on tumor samples. Hazard ratios with confidence intervals were used as the measure of efficacy between groups. A total of 4635 patients (six studies) were included (ICIs arm: 2367 patients; standard of care arm: 2268 patients). Globally, PFS and OS results favored ICIs. Differential expression of PD-L1 on tumor samples could select a subset of patients who could benefit more in terms of PFS (those with higher levels; -value for difference between subgroups: <0.0001) but it did not seem to impact in OS results (-value for difference: 0.63). As different methods to assess PD-L1 positivity were used among trials, this heterogeneity could have an influence on the results. PD-L1 could represent a biomarker to test PFS in clinical trials but its value for OS is less clear. In this meta-analysis, the usefulness of PD-L1 expression as a predictive biomarker to select treatment in metastatic RCC patients was not clearly shown.
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http://dx.doi.org/10.3390/cancers12071945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7409133PMC
July 2020

Outcomes and Challenges of Reproductive Health in Hematopoietic Stem Cell Transplantation Survivors.

Biol Blood Marrow Transplant 2020 11 10;26(11):2127-2131. Epub 2020 Jul 10.

Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Long-term therapy-related reproductive health side effects impact the quality of life of hematopoietic stem cell transplantation (HSCT) survivors. In this study, we evaluated the prevalence of gonadal dysfunction (GD) pre- and post-HSCT, analyzed factors associated with GD, and explored rates of fertility assessment (FA) and fertility preservation (FP) in a resource-limited setting. FA and outcomes of patients age ≤45 years undergoing HSCT between June 2000 and May 2018 were collected retrospectively. We included 213 patients with a median age of 26 years. Pre-HSCT FA was performed in 71.8%, with a GD rate of 17%. The rate of GD was not different between the sexes (females, 19.5% versus males, 16.1%; P = .616) and was only associated with increasing age. The rate of cryopreservation in the cohort was 3.3%. Almost one-half (47.7%) of post-HSCT patients completed FA and evidenced an increase in GD rate to 48.9%. Comparing pre-HSCT and post-HSCT GD rates, women had a significant increase (19.5% versus 81.4%; P < .001), whereas men did not (16.1% versus 20.4%; P = .76). These results were confirmed by a multiple imputation analysis accounting for missing data. Female sex, pre-HSCT cytotoxic therapy, myeloablative conditioning, and germ cell tumor (GCT) diagnosis were associated with post-HSCT GD. Reproductive health preservation can be positively impacted when FA and FP are prioritized at the initial diagnosis in HSCT candidates, particularly in women of older age and men with a diagnosis of GCT. The low FP success observed urges implementation of strategies that favor accessibility and improve quality of life of HSCT survivors in low- and middle-income countries.
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http://dx.doi.org/10.1016/j.bbmt.2020.07.007DOI Listing
November 2020

Immune-Related Adverse Events Involving Multiple Organ Sites in a Patient Treated With Nivolumab Plus Ipilimumab.

Oncology (Williston Park) 2020 May;34(5):171-174

Associate Professor, Hematology and Medical Oncology Department. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Mexico City, Mexico.

A 56-year-old white man with a 74 pack-year smoking history presented with macroscopic hematuria and a significant weight loss of 45 pounds in 6 months. His clinical laboratory tests indicated iron defi ciency anemia and a computed tomography (CT) scan showed a left kidney tumor, mediastinal lymph nodes, and multiple lung metastases. A percutaneous CT-guided kidney biopsy revealed grade 3 clear cell renal carcinoma based on World Health Organization/International Society of Urologic Pathology classifi cation. The patient started first line systemic treatment for intermediate-risk metastatic renal cell carcinoma (mRCC) with combination immunotherapy with nivolumab plus ipilimumab.1 After 10 days of the first cycle, he presented with a pruritic maculopapular rash covering 20% of his body surface.
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May 2020

Oncofertility Knowledge Among Internal Medicine Residents in an Academic Center in Mexico.

J Cancer Educ 2020 May 28. Epub 2020 May 28.

Hemato-Oncology Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.

Guidelines recommend discussing fertility preservation with patients with cancer. In Mexico, internists frequently are the primary care provider (PCP) for adults in reproductive age. The knowledge of oncofertility among PCPs in low and middle income countries is poorly known. Internal medicine residents in a tertiary care hospital in Mexico City participated in a survey regarding fertility concepts in cancer patients. Sixty-three residents participated; their median age was 27. Thirty percent reported 0% self-perceived confidence for providing counseling about fertility issues, and 26% reported more than 50% self-perceived confidence. Twenty-eight percent reported not asking patients in reproductive age about satisfied parity/paternity. Eighty-one percent correctly identified patients that should receive fertility counseling, and 68% identified alkylating chemotherapy as having the highest risk of infertility. Fifty-four percent were able to name at least one fertility preservation (FP) strategy for males, whereas 49% were able to name at least one strategy in females. Residents who reported at least 50% self-perceived confidence for providing fertility counseling were more likely to name at least one FP strategy for men (64.7%) versus those who reported less than 50% self-perceived confidence (52.1%), but this result was not statistically significant (p = 0.378). This was similar for FP strategies in women, with 64.7% of more confident residents naming at least one, compared with 43.4% of less confident residents (p = 0.134). Knowledge of FP in patients with cancer is insufficient among internal medicine residents in our institution. Inclusion of oncofertility concepts in the internal medicine program is needed.
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http://dx.doi.org/10.1007/s13187-020-01771-9DOI Listing
May 2020

69-Year-Old Man With Castration-Resistant Prostate Cancer Progressing After Docetaxel and Androgen Receptor-Targeting Agent.

Oncology (Williston Park) 2020 Apr 10;34(4). Epub 2020 Apr 10.

KEY POINTS • The prognosis for patients with mCRPC has improved over the last few years due to the introduction of novel agents. • The optimal sequence of administering these therapeutic agents remains as a moving target and is not well established. Decisions are usually made according to patients' clinical conditions and disease characteristics, and the safety profile and availability of new drugs. • Recently, cabazitaxel improved outcomes in the third-line setting after docetaxel and an ARTA. Olaparib is an additional option for second- and third-line treatment in those with alterations in BRCA1, BRCA2, and ATM. • Understanding the mechanisms of resistance may provide a rationale for suggesting specific strategies. • A subset of patients may benefit from molecularly targeted therapies, which highlights the importance of genomic testing in the castration-resistant setting. • Immunotherapy may provide benefit to some subsets of patients, such as those with MSI-high tumors. Studies regarding combination therapy with immune checkpoint inhibitors are ongoing.
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April 2020

Survey of Fertility Preservation Options Available to Patients With Cancer Around the Globe.

JCO Glob Oncol 2020 2;6. Epub 2020 Mar 2.

Northwestern University, Chicago, IL.

Purpose: Oncofertility focuses on providing fertility and endocrine-sparing options to patients who undergo life-preserving but gonadotoxic cancer treatment. The resources needed to meet patient demand often are fragmented along disciplinary lines. We quantify assets and gaps in oncofertility care on a global scale.

Methods: Survey-based questionnaires were provided to 191 members of the Oncofertility Consortium Global Partners Network, a National Institutes of Health-funded organization. Responses were analyzed to measure trends and regional subtleties about patient oncofertility experiences and to analyze barriers to care at sites that provide oncofertility services.

Results: Sixty-three responses were received (response rate, 25%), and 40 were analyzed from oncofertility centers in 28 countries. Thirty of 40 survey results (75%) showed that formal referral processes and psychological care are provided to patients at the majority of sites. Fourteen of 23 respondents (61%) stated that some fertility preservation services are not offered because of cultural and legal barriers. The growth of oncofertility and its capacity to improve the lives of cancer survivors around the globe relies on concentrated efforts to increase awareness, promote collaboration, share best practices, and advocate for research funding.

Conclusion: This survey reveals global and regional successes and challenges and provides insight into what is needed to advance the field and make the discussion of fertility preservation and endocrine health a standard component of the cancer treatment plan. As the field of oncofertility continues to develop around the globe, regular assessment of both international and regional barriers to quality care must continue to guide process improvements.
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http://dx.doi.org/10.1200/JGO.2016.008144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7853877PMC
March 2020

Survey of Third-Party Parenting Options Associated With Fertility Preservation Available to Patients With Cancer Around the Globe.

JCO Glob Oncol 2020 2;6. Epub 2020 Mar 2.

Northwestern University, Chicago, IL.

Purpose: In the accompanying article, "Survey of Fertility Preservation Options Available to Patients With Cancer Around the Globe," we showed that specific fertility preservation services may not be offered at various sites around the world because of cultural and legal barriers. We assessed global and regional experiences as well as the legal status of third-party reproduction and adoption to serve as a comprehensive international data set and resource for groups that wish to begin oncofertility interventions.

Methods: We provide data on the legalities of third-party assisted reproductive technologies and other family-building options in the 28 oncofertility-practicing countries surveyed.

Results: We found regional and country differences that will be important in the development of tailored resources for physicians and for patient brochures that are sensitive to these local restrictions and cultural norms.

Conclusion: Because many patients first consult Web-based materials, the formal assessment of the availability of these options provides members of the global oncofertility community with data to which they might otherwise not have ready access to better serve their patients.
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http://dx.doi.org/10.1200/JGO.2017.009944DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7853875PMC
March 2020

Barriers and Opportunities of Oncofertility Practice in Nine Developing Countries and the Emerging Oncofertility Professional Engagement Network.

JCO Glob Oncol 2020 2;6. Epub 2020 Mar 2.

Northwestern University, Chicago, IL.

Purpose: Oncofertility practice continues to grow in developing countries despite the lack of health care services, especially those related to cancer care. The purpose of this study is to further explore oncofertility practice in these countries and identify opportunities for field-wide coalescence.

Methods: We generated a survey to learn more about oncofertility practice in nine developing countries within our Oncofertility Consortium Global Partners Network-Mexico, Colombia, Guatemala, Argentina, Chile, Nigeria, South Africa, Saudi Arabia, and India. Their responses were collected, reviewed, and discussed.

Results: Surveyed centers from the nine developing countries continue to experience a similar set of common challenges, including a lack of awareness among providers and patients, cultural and religious constraints, lack of insurance coverage and funding to help to support oncofertility programs, and high out-of-pocket costs for patients. Despite these barriers, many opportunities exist and there is great potential for the future.

Conclusion: The current need is to unify the new technologies and best practices that emerge from rural communities and developing countries with those in large metropolitan cities, both domestically (US based) and abroad, into a functional unit: the Oncofertility Professional Engagement Network. The Oncofertility Professional Engagement Network will bridge the gap between domestic and international programs to establish a strong global network in which members share resources, methodologies and experiences and further build cultural competency.
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http://dx.doi.org/10.1200/JGO.18.00180DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7853876PMC
March 2020

Latent Tuberculosis in Hematopoietic Stem Cell Transplantation: Diagnostic and Therapeutic Strategies to Prevent Disease Activation in an Endemic Population.

Biol Blood Marrow Transplant 2020 07 19;26(7):1350-1354. Epub 2020 Mar 19.

Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Latent tuberculosis infection (LTBI) affects one-fourth of the world´s population. Hematopoietic stem cell transplantation (HSCT) recipients are at an elevated risk of developing active tuberculosis infection (ATBI). In this retrospective study of donors and HSCT recipients who underwent transplantation between February 2000 and June 2018, our aim was to determine the prevalence of LTBI and ATBI and to describe diagnostic and therapeutic strategies in an HSCT population in an endemic region. The cohort of 409 participants included 125 allogeneic HSCT (allo-HSCT) recipients, 165 autologous HSCT (auto-HSCT) recipients, and 119 HSCT donors. Patients were evaluated pre-HSCT with tuberculin skin test and thoracic imaging. LTBI was diagnosed in 26.2% of the cohort. Cases represented 20% of the auto-HSCT population, 20% of the allo-HSCT population, and 41.2% of the donor population. Pre-HSCT evaluation to rule out ATBI was performed in 62.6% of the cohort; all results were negative. Isoniazid was administered to 73.3% of those with LTBI. Within subgroups, 91.7% of HSCT recipients and 51% of donors received treatment. The median duration of therapy pre-HSCT was 70 days in recipients and 48 days in donors. The incidence of post-HSCT ATBI was 0 at 1-year follow-up. The incidence of LTBI in our population was higher than expected and still might have been underestimated owing to diagnostic test limitations. The absence of incident ATBI suggests that recipients, as opposed to donors, must receive LTBI treatment. Prevention of infectious complications in the HSCT population should be prioritized to improve clinical outcomes. Prospective data from collaborative working groups is needed to determine the best diagnostic and therapeutic approaches in this vulnerable patient population.
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http://dx.doi.org/10.1016/j.bbmt.2020.03.013DOI Listing
July 2020

Oncofertility as a Universal Right and a Global Oncology Priority.

JCO Glob Oncol 2020 03;6:314-316

Monash Health and Monash University, Clayton, Victoria, Australia.

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http://dx.doi.org/10.1200/GO.19.00337DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7113082PMC
March 2020

Determining the risk factors associated with the development of infection in patients with hematological diseases.

Blood Res 2019 Jun 25;54(2):120-124. Epub 2019 Jun 25.

Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Background: infection (CDI) is a nosocomial condition prevalent in patients with hematological disorders. We aimed to identify the risk factors associated with the development of CDI and assess the mortality rate at 15 and 30 days among hematologic patients admitted to a tertiary care center.

Methods: We conducted a retrospective case-control study from January 2010 to December 2015. Forty-two patients with hematologic malignancy and CDI, and 84 with hematologic disease and without history of CDI were included in the case and control groups, respectively.

Results: Univariate analysis revealed that episodes of febrile eutropenia [odds ratio (OR), 5.5; 95% confidence interval (CI), 2.3-12.9; <0.001], admission to intensive care unit (OR, 3.8; 95% CI, 1.4-10.2; =0.009), gastrointestinal surgery (OR, 1.2; 95% CI, 1.1-1.4; <0.001), use of therapeutic (OR, 6.4; 95% CI, 2.5-15.9; <0.001) and prophylactic antibiotics (OR, 4.2; 95% CI, 1.6-10.7; =0.003) in the last 3 months, and >1 hospitalization (OR, 5.6; 95% CI, 2.5-12.6; <0.001) were significant risk factors. Multivariate analysis showed that use of therapeutic antibiotics in the last 3 months (OR, 6.3; 95% CI, 2.1-18.8; =0.001) and >1 hospitalization (OR, 4.3; 95% CI, 1.7-11.0; =0.002) were independent risk factors. Three (7.1%) and 6 (14.2%) case patients died at 15 and 30 days, respectively.

Conclusion: The risk factors for developing CDI were exposure to therapeutic antibiotics and previous hospitalization. Hematological patients who developed CDI had higher early mortality rates, suggesting that new approaches for prevention and treatment are needed.
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http://dx.doi.org/10.5045/br.2019.54.2.120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6614093PMC
June 2019

Caring for Our Trainees: Lessons From Around the World.

Am Soc Clin Oncol Educ Book 2019 Jan 17;39:599-608. Epub 2019 May 17.

3 Hemato-Oncology Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Continuing progress in the science of oncology must be matched by an increased responsibility toward providing oncology trainees around the world with the academic guidance, emotional support, and lifelong mentoring needed to navigate an increasingly complex environment. Although the realities on the ground determine the practicalities, there are important universal lessons to be learned from heeding diverse experiences. In this paper, three faculty at different stages of their careers from countries with different resources and infrastructure share their insights into caring for trainees.
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http://dx.doi.org/10.1200/EDBK_238577DOI Listing
January 2019

Impact of Additional Cytogenetic Abnormalities on the Clinical Behavior of Patients With Chronic Myeloid Leukemia: Report on a Latin American Population.

Clin Lymphoma Myeloma Leuk 2019 06 21;19(6):e299-e306. Epub 2019 Feb 21.

Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Introduction: Additional cytogenetic abnormalities (ACA) in patients with chronic myeloid leukemia (CML) are related to an increased risk of treatment failure, leukemic progression, and decreased survival. Currently, there are scarce data available for the Latin American population. The aim of this study was to outline the impact of ACA emergence in Mexican patients with CML.

Methods: We retrospectively analyzed clinical data from adult patients with CML treated with upfront imatinib between January 2001 and December 2016. Two groups were defined for comparison according to the presence or absence of ACA.

Results: Ninety-seven patients were included. ACAs were found in 30 patients, 20% at diagnosis and 80% during follow-up. In 90% of the patients, ACA emergence was detected in the CML-chronic phase. Regarding clinical outcomes, the complete cytogenetic response rate (16.5% vs. 59.8%; P < .001), progression-free survival (PFS) at 10 years (76% vs. 95%; P = .009), and failure-free survival (FFS) at 10 years (16% vs. 73%; P < .001) were significantly inferior in the ACA group. Multivariate analysis confirmed that ACA emergence was a deleterious independent prognostic factor for PFS (hazard ratio [HR] 8.9; 95% confidence interval [CI] 1.35-58.4; P = .023) and FFS (HR 3.7; 95% CI 1.54-8.58; P = .003).

Conclusions: This study confirms previously reported data regarding the adverse impact of ACA over clinical outcomes in a Latin American population.
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http://dx.doi.org/10.1016/j.clml.2019.02.007DOI Listing
June 2019

Clinical significance of sunitinib-associated macrocytosis in metastatic renal cell carcinoma.

Cancer Med 2016 12 19;5(12):3386-3393. Epub 2016 Oct 19.

Division of Medical Oncology, Department of Medicine, School of Medicine, University of Colorado, Aurora, Colorado.

Increases in the mean corpuscular volume (MCV) have been observed in patients with metastatic renal cell carcinoma (mRCC) on tyrosine kinase inhibitor (TKI) treatment; however, its association with progression-free-survival (PFS) is unknown. We aimed to characterize TKI-associated macrocytosis in mRCC and its relationship with PFS. Retrospective review of data on macrocytosis and thyroid dysfunction on mRCC patients treated with sunitinib and/or sorafenib. These results are evaluated in the context of our previous report on the association of hypothyroidism in this setting. We assessed PFS as clinically defined by the treating physician. Seventy-four patients, 29 of whom received both drugs, were included. A treatment period was defined as time from initiation to discontinuation of either sunitinib or sorafenib; 103 treatment periods [sorafenib (47), sunitinib (56)] were analyzed. Macrocytosis was found in 55 and 8% of sunitinib- and sorafenib-treated patients, respectively, P < 0.001. The median time to developing macrocytosis was 3 months (m, range 1-7). Median PFS in sunitinib-treated patients was 11 m (95% CI: 6-19). Median PFS was higher among those with macrocytosis compared to normocytosis (21 m [95% CI: 11-25] vs. 4 m [95% CI: 3-8] P = 0.0001). Macrocytosis and hypothyroidism were two significant predictors of PFS. The greatest difference in PFS among all patients was observed in patients with both macrocytosis and hypothyroidism (25 m), compared to the normocytic and euthyroid patients (5 m) (P < 0.0001). Sunitinib-related macrocytosis was associated with prolonged PFS, and concurrent development of hypothyroidism and macrocytosis further prolonged PFS. Increased MCV may have a role as a predictive biomarker for sunitinib. Prospective studies accounting for other known prognostic factors are needed to confirm this finding.
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http://dx.doi.org/10.1002/cam4.919DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5224865PMC
December 2016

Fluorescent In Situ Hybridization Monitoring and Effect of Detected Early Responses in the Outcome of Patients With Chronic Phase Chronic Myeloid Leukemia: A Report From a Latin American Country.

Clin Lymphoma Myeloma Leuk 2016 08 5;16(8):453-9. Epub 2016 May 5.

Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, México. Electronic address:

Introduction: The cytogenetic hallmark of chronic myeloid leukemia (CML) is the Philadelphia chromosome. Monitoring the response in patients receiving therapy is a standard of care. The present study was conducted to assess the monitoring adherence and reliableness of fluorescent in situ hybridization (FISH) as a monitoring tool and the effect of a complete cytogenetic response (CCyR) assessed by FISH on the prognosis of patients in a chronic phase (CP)-CML cohort.

Materials And Methods: We retrospectively analyzed the data from 63 newly diagnosed CP-CML patients treated with imatinib mesylate at a dose of 400 mg/day as frontline therapy. The clinical data and cytogenetic test results at diagnosis and during monitoring were collected. The cytogenetic monitoring adherence assessment rates were measured. A correlation between chromosome banding analysis (CBA) and FISH was performed. The CCyR assessed by FISH was defined as < 1% BCR-ABL1(+) nuclei. The Kaplan-Meier method was used for overall survival analysis and time-to-event estimates.

Results: The cytogenetic monitoring assessment adherence was 50.8% at 3 months, 93.5% at 6 months, 96.7% at 12 months, and 88.6% at 18 months. The Pearson correlation coefficient showed a significantly positive association (r = 0.84; P < .001) between CBA and FISH. The median follow-up duration after imatinib mesylate initiation was 60 months. A CCyR was achieved in 90.4% of patients within the first 18 months of therapy. At 3 months, 31 patients underwent a FISH evaluation, and 13 (41.9%) had achieved a CCyR. The patients who did not achieve a CCyR at 3 months had a significantly inferior probability of 5-year failure-free survival (38% vs. 94%; P = .001) and progression-free survival (80% vs. 100%; P = .043) compared with those with a CCyR.

Conclusion: We found improved monitoring adherence compared with the previous reports of Latin American populations. In countries with a high incidence of failure for CBA and a lack of real-time polymerase chain reaction standardization, FISH is a sensitive monitoring tool. In our cohort, patients not achieving an early CCyR, as tested by FISH, were a poor prognosis subgroup with worse rates of failure-free survival and progression-free survival.
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http://dx.doi.org/10.1016/j.clml.2016.04.002DOI Listing
August 2016