Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention.

OBJECTIVES: This study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico. DESIGN: We conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention's effect on patients' supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention's benefits and barriers and understand its feasibility. PARTICIPANTS: 50 women aged 20-75 diagnosed with stage I-III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers. SETTING: Oncology services in three public hospitals of the Mexican Social Security Institute. INTERVENTION: The ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks. RESULTS: 50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms. CONCLUSIONS: This pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT05925257.

Survival Outcomes of Patients With Breast Cancer in a Mexican Population.

PURPOSE: The Instituto Mexicano del Seguro Social is a tripartite contribution providing care to more than 74 million beneficiaries, representing more than 50% of the country's general population. This study aims to describe the survival outcomes and clinicopathologic characteristics of patients with breast cancer at our Center. METHODS: A retrospective cohort of patients with breast cancer treated between January 2012 and December 2020 was conducted. Survival outcomes were assessed using the Kaplan-Meier method. Univariate and multivariate analyses were performed using a Cox proportional hazards model. RESULTS: There were 5,264 patients included with a median follow-up of 54.9 months. Forty-three percent (n = 2,274) were diagnosed in stage I-IIA, 43.1% (n = 2,269) in stage IIB-III, and 7% (n = 383) in stage IV. At 5 years, disease-free survival was 74.9% (95% CI, 73.5 to 76.3) and overall survival (OS) 90.4% (95% CI, 89.4 to 91.3). For stage IV, it was 22.7% (95% CI, 17.3 to 28.5). High histologic grade (hazard ratio, 1.51 [95% CI, 1.34 to 1.7]; P < .001) and lymphovascular invasion (LVI; hazard ratio, 1.85 [95% CI, 1.62 to 2.1]; P < .001) were associated with a higher risk of recurrence. CONCLUSION: Histologic grade and LVI should be considered in the decision to treat with adjuvant chemotherapy in sites where genomic signatures are not available. Our OS data are comparable with other Mexican series; however, it is lower in stage IV. Much remains to be done at the national level, mainly regarding access to additional therapies for each breast cancer subtype. This work contributes to the evaluation of areas for improvement in outcomes in our population.

Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial.

INTRODUCTION: Nearly 30 000 Mexican women develop breast cancer annually, frequently presenting unmet supportive care needs. In high-income countries, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. This paper presents the study protocol for designing and evaluating an ePRO digital health application combined with proactive follow-up by nurses. METHODS AND ANALYSIS: We designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. We will conduct a pilot test of the intervention with 50 patients with breast cancer for 6 weeks to assess feasibility and adjust the application. We will conduct a parallel arm randomised controlled trial assigning 205 patients each to intervention and control in one of Mexico's largest public oncology hospitals. The intervention will be provided for 6 months, with additional 3 months of post-intervention observation. The control group will receive usual healthcare and a list of breast cancer information sources. Women diagnosed with stages I, II or III breast cancer who initiate chemotherapy and/or radiotherapy will be invited to participate. The primary study outcome will be supportive care needs; secondary outcomes include global quality of life and breast symptoms. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6 and 9 months. ETHICS AND DISSEMINATION: The National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants will sign an informed consent form prior to their inclusion. Findings will be disseminated through a policy brief to the local authorities, a webinar for patients, publications in peer-reviewed journals and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: NCT05925257.

ECOG is as independent predictor of the response to chemotherapy, overall survival and progression-free survival in carcinoma of unknown primary site.

The aim of the present study was to determine whether age, gender, functional status, histology, tumor location, number of metastases, and levels of the tumor markers, lactate dehydrogenase (LDH) and albumin, are poor prognostic factors for the response to chemotherapy in patients with carcinoma of unknown primary site. A total of 149 patients diagnosed with carcinoma of unknown primary site that was histologically confirmed, and treated with chemotherapy in the Oncology Hospital, National Medical Center, 'Century XXI' IMSS, Mexico City, Mexico during the period between January 2002 to December 2009, were carefully selected for the present study. The analysis of 149 patients diagnosed with carcinoma of unknown primary site revealed that the liver was the organ with the highest frequency of metastases (33.5%). The objective response rates to chemotherapy were ~30.2%. Notably, ECOG was an important predictor of response to chemotherapy (P=0.008). The median progression-free survival was 7.1 months. Upon multivariate analysis, the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status was observed as an independent predictor of progression (P<0.0001). The median overall survival was 14.2 months. The ECOG was also an independent predictor of mortality (P<0.0001). In conclusion, the data from the present study have demonstrated that ECOG is an independent predictor of a poor response to chemotherapy, lower overall survival and progression-free survival in carcinoma of unknown primary site.

Treatment of non-resectable and metastatic gastrointestinal stromal tumors: experience with the use of tyrosine kinase inhibitors in a third level hospital in Mexico.

BACKGROUND: Stromal tumors of the digestive tract are uncommon malignant diseases, are subclassified as leiomyosarcomas and Gastrointestinal Stromal Tumors (GIST) depending on the molecular expression of tyrosine kinase receptor KIT (CD117). GISTs represent 1% of malignant tumors affecting this anatomical site. Localized tumours diseases are reasonably well controlled by surgical resection and several criteria define the need for adjuvant therapy. In the case of metastatic disease a poor prognosis has been reported with systemic treatment based on chemotherapy. Recently, significant advances have been shown since tyrosine kinase inhibitors (TKIs) were introduced, with median overall survival close to 5 years. Unfortunately in Mexico, even though the therapy has been long used there are no published data of the experience in the treatment of these tumors. METHODS: We used an electronic data base to obtain clinical, radiological and histological data of patients diagnosed with GIST and treated in the oncological center of the Mexican Institute of Social Security, patients were subclassified by stage, symptoms at diagnosis as well as the initial and subsequent systemic treatment. Finally we made an analysis for progression free survival and overall survival identifying prognostic factors. RESULTS: We obtained information of 71 patients with metastatic, non-resectable or recurrent GIST, treated with a TKI, we observed a predominant relation for women (60.4%) with median age of 58 years. Stage at diagnosis was predominantly metastatic (46.5%), most frequently affected sites were lung, liver and retroperitoneum. Median progression free survival was 30.6 months and overall survival was 81.3 months. All patients were initially treated with imatinib at a dose of 400 mg per day. Treatment was well-tolerated in most cases. CONCLUSIONS: Metastatic GIST evaluated in our center shows a different affection in gender and age, and our population shows a different response to TKIs, compared to those reported in other series with superior overall survival. Poor prognosis is associated with lung affection. Biological studies will be started for the molecular evaluation of these tumors.