Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial.

The excellent outcomes seen in patients treated with adjuvant trastuzumab emtansine (T-DM1) in the ATEMPT trial and the favorable toxicity profile associated with this agent make T-DM1 a potential therapeutic option for select patients with stage I HER2-positive breast cancer. Moreover, T-DM1 is an established adjuvant treatment for patients with HER2-positive breast cancer with the residual invasive disease after neoadjuvant therapy. Given that cardiotoxicity is the most significant adverse event of trastuzumab, which is a main molecular component of T-DM1, we conducted a sub-analysis of the ATEMPT trial to determine the cardiac safety of adjuvant T-DM1. In this analysis, the incidence of grade 3-4 left ventricular systolic dysfunction (LVSD) in T-DM1 or trastuzumab plus paclitaxel arms were respectively 0.8 and 1.8%. In addition, three (0.8%) patients in the T-DM1 arm and six (5.3%) patients in the adjuvant paclitaxel with trastuzumab (TH) arm experienced a significant asymptomatic left ventricular ejection fraction (LVEF) decline that per-protocol required holding T-DM1 or trastuzumab. All patients with available follow-up data experienced full resolution of cardiac symptoms and LVEF normalization. Furthermore, we performed an exploratory analysis to assess the relationship between age, baseline LVEF, and body mass index with cardiac outcomes. No significant association between these baseline characteristics and the incidence of significant asymptomatic LVEF decline or symptomatic LVSD was identified. The low incidence of significant cardiac adverse events in this population during therapy with adjuvant T-DM1 suggests that studies on the cost-effectiveness of cardiac monitoring during adjuvant therapy using anthracycline-free regimens are needed.Clinical Trial Registration: ClinicalTrials.gov, NCT01853748.

Cancer Survivorship in Latin America: Current Status and Opportunities.

PURPOSE: The number of cancer survivors is increasing globally although the status of cancer survivorship care provision and research in developing countries is limited. This study aimed to review published literature and available guidelines and/or recommendations to inform cancer survivorship care in Latin America. METHODS: Embase, Web of Science, Scopus, PubMed, and SciELO were systematically searched for articles and guidelines and/or recommendations published through December 31, 2020. Our search terms included cancer, survivors, neoplasm, cancer, survivorship, survivor, follow-up studies, and the name of the countries. We categorized the articles by country, year, cancer type(s), language, and domain of cancer survivorship care. We also searched governmental health agencies websites in all Latin American countries. RESULTS: Our literature review found 664 articles for inclusion. The number of publications increased over time. Brazil had most of the survivorship research (n = 483, 72.7%). The most common topics included surveillance and management of psychosocial effects (n = 237, 35.7%) and physical effects (n = 230, 34.6%). Prevention and surveillance for recurrences and health promotion and disease prevention were each addressed by about 10% (n = 71) of the publications. Although close to half of the publications included more than one cancer, 28.9% (n = 192) focused solely on breast cancer. We found no guidelines and/or recommendations explicitly focusing on Latin America in the reviews of the literature or the national governmental institutions' websites. CONCLUSION: We found a growing body of cancer survivorship publications, mainly focusing on psychosocial and physical effects, although no cancer survivorship guidance and/or recommendations focused on Latin America were identified. Expanding research across Latin American countries and covering a broader spectrum of cancer survivorship care is needed. Development of guidelines may further promote provision of quality care for this growing population of cancer survivors.

Psychosocial needs of young breast cancer survivors in Mexico City, Mexico.

OBJECTIVE: Young breast cancer survivors in Mexico face distinct psychosocial challenges that have not been characterized. This study aims to describe the psychosocial needs of young breast cancer survivors in Mexico at 5 or more years of survivorship, identifying areas of focus for early interventions. METHODS: Breast cancer patients diagnosed at age 40 or prior with 5 or more years since diagnosis were invited to participate in one-on-one 30-60 minute semi-structured audio-recorded interviews at the Instituto Nacional de Cancerología in Mexico City. Transcripts were coded using thematic analysis with NVivo software. RESULTS: 25 women participated. Five major phenomena emerged from analysis: (1) minimization of fertility concerns; (2) persistence of body image disturbance over time; (3) barriers to employment during survivorship; (4) impact on family relationships and social networks; & (5) unmet psychological care and informational needs. CONCLUSIONS: Early interventions with a focus on fertility loss education, access to reconstructive surgery and body image support, guidance during return-to-work, assistance with childcare, integration of psychological care and the fulfillment of informational needs could ameliorate long-term psychological and social distress for young breast cancer survivors in Mexico.

Fertility concerns among breast cancer patients in Mexico.

OBJECTIVE: Young women represent a high proportion of the total number of breast cancer (BC) patients in Mexico; however, no previous studies addressing their attitudes regarding the risk of chemotherapy-induced infertility and its contributing factors are available. The aim of this study was to evaluate the concerns of young women with BC towards the risk of infertility in two referral centers in Mexico with access to public health services. METHODS: A cross-sectional study including women with newly or previously detected BC aged 40 years or younger at diagnosis was conducted. Variables regarding concerns about fertility were collected from an adapted version of the Fertility Issues Survey. RESULTS: 134 consecutive eligible women responded to the in-person paper survey. 55% were partnered, 35.1% had no children, and 48% reported willingness to have children prior to BC diagnosis. Only 3% of patients considered to be able to afford extra expenses. At diagnosis, 44% of women expressed some level of concern about infertility risk. The only factor significantly associated with fertility concern was the desire of having children prior to diagnosis (OR 11.83, p = 0.006). Only 30.6% patients recalled having received information regarding infertility risk from their physicians. CONCLUSION: A minority of young women with breast cancer in Mexico is informed about the risk of BC treatment-induced infertility, despite substantial interest. Informing all patients about infertility risk and available options for fertility preservation should be an essential aspect of the supportive care of young women with BC, even in low-middle income countries such as Mexico.

Prospective study of fertility concerns and preservation strategies in young women with breast cancer.

PURPOSE: Most research regarding fertility in young women with breast cancer has focused on long-term survivors. Little is known about how fertility concerns affect treatment decisions or fertility preservation strategies at the time of initial cancer diagnosis. PATIENTS AND METHODS: As part of an ongoing prospective multicenter cohort study, we surveyed women with newly diagnosed early-stage breast cancer at age ≤ 40 years. The baseline survey included sociodemographic, medical, and treatment data as well as a modified Fertility Issues Survey, including fertility concern and preservation items. Univariable and multivariable modeling were used to investigate predictors of greater fertility concern. RESULTS: Among the first 620 eligible respondents included in this analysis, median age was 37 years (range, 17 to 40 years); 425 women (68%) discussed fertility issues with their physicians before starting therapy, and 319 (51%) were concerned about becoming infertile after treatment. Because of concerns about fertility, four women (1%) chose not to receive chemotherapy, 12 (2%) chose one chemotherapy regimen over another, six (1%) considered not receiving endocrine therapy, 19 (3%) decided not to receive endocrine therapy, and 71 (11%) considered receiving endocrine therapy for < 5 years; 65 (10%) used fertility preservation strategies. Greater concern about fertility was associated with younger age, nonwhite race, not having children, and receipt of chemotherapy. CONCLUSION: Many young women with newly diagnosed breast cancer have concerns about fertility, and for some, these substantially affect their treatment decisions. Only a minority of women currently pursue available fertility preservation strategies in this setting.