Introduction
Early HER2-positive breast cancer requires timely initiation of anti-HER2 therapy to optimize outcomes. In low- and middle-income countries (LMICs), health-system constraints—ranging from diagnostic delays to treatment access barriers—can slow this process. This retrospective cohort study examines whether a structured Patient Navigation Program (PNP) can reduce the time from diagnosis to initiation of anti-HER2 therapy and improve adherence to recommended treatment timelines.
Methods
We conducted a retrospective cohort study at a tertiary care center serving a LMIC. Patients diagnosed with HER2-positive early breast cancer between January 2018 and December 2021 were included. The study compared two cohorts: (1) before the PNP implementation (usual care) and (2) after PNP implementation (navigation-supported care). The PNP involved trained navigators who coordinated referrals, appointments, imaging, pathology, and therapy scheduling, while also addressing transportation, social support, and education needs.
Main outcomes included time from diagnostic biopsy to first anti-HER2 therapy, proportion initiating therapy within guideline-recommended windows, treatment completion rates, and overall survival where data allowed. We used multivariable Cox and logistic regression to adjust for age, stage, receptor status, comorbidities, and treatment facility factors.
Results
A total of 312 patients met inclusion criteria (pre-PNP: n=142; post-PNP: n=170). Median time from diagnostic biopsy to first anti-HER2 therapy decreased from 48 days in the pre-PNP period to 28 days post-PNP (p<0.001). The proportion starting therapy within 60 days of diagnosis increased from 42% to 75% with navigation support (odds ratio 3.9, 95% CI 2.5–6.2). Completion rates for the prescribed anti-HER2 regimen were higher in the navigation cohort, with fewer missed appointments and faster resolution of insurance or logistical barriers.
Subgroup analyses suggested greater benefits among patients with longer transport times and those living in rural or peri-urban areas. After adjustment, navigation support remained independently associated with timelier therapy initiation (adjusted HR for time-to-therapy: 0.58, 95% CI 0.44–0.76) and higher odds of guideline-concordant initiation (adjusted OR 3.6, 95% CI 2.2–5.9). Follow-up duration varied, but early disease-free survival trends favored the navigation cohort, consistent with faster access to therapy.
Discussion
Our retrospective cohort demonstrates that a patient navigation program can substantially shorten the time to anti-HER2 therapy in a LMIC setting. The reduction in diagnostic-to-treatment interval translated into higher rates of timely therapy initiation and improved adherence to therapy plans. Several mechanisms likely underlie these improvements: proactive scheduling, patient education, transportation assistance, and streamlining of laboratory and imaging referrals. Importantly, navigators acted as liaisons among patients, clinicians, and payers, mitigating common bottlenecks that delay treatment.
The findings align with broader evidence that care coordination improves cancer treatment timeliness and outcomes in resource-constrained settings. While the study design cannot definitively prove causality, the magnitude of observed improvements, consistency across subgroups, and robust adjustment for potential confounders support the program’s effectiveness. Limitations include retrospective data collection, potential unmeasured confounders, and single-center generalizability. Future work should explore cost-effectiveness, long-term oncologic outcomes, and scalability across diverse LMIC health systems.
Conclusion
Implementing a Patient Navigation Program markedly reduced the time to initiation of anti-HER2 therapy for patients with early HER2-positive breast cancer in a LMIC. By addressing logistical, educational, and access barriers, navigation-led care improves timely treatment delivery and adherence to guideline-concordant regimens. This approach offers a practical pathway to bridge care gaps and enhance outcomes for patients with HER2-positive breast cancer in resource-limited settings.
Implications for practice
– Integrate trained patient navigators into breast cancer care teams in LMICs to coordinate complex care pathways.
– Prioritize navigation programs that address transportation, appointment scheduling, and payer-related barriers.
– Monitor time-to-therapy metrics and adherence rates as key quality indicators to guide program refinement.
Keywords: patient navigation, anti-HER2 therapy, early breast cancer, LMIC, timely treatment, retrospective cohort, health systems optimization
