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Background <p>Timely initiation of therapy is critical for patients with HER2-positive early breast cancer, especially in low- and middle-income countries (LMICs) where health-system constraints delay care. We evaluated whether a Patient Navigation Program could reduce time from registration to initiation of dual anti-HER2 therapy in Egypt.</p> Methods <p>Retrospective cohort study at the Breast Cancer Comprehensive Center (BCCC). Trained navigators tracked diagnostics, scheduled multidisciplinary tumor board (MDT), prepared/submitted Ministry of Health (MOH) approval files, monitored approval, and booked the earliest infusion slot. The primary endpoint was time from registration to therapy start; secondary endpoints were prespecified intervals—T1 (registration→MDT), T2 (MDT→MOH submission), T3 (MOH submission→MOH approval), and T4 (MOH approval→therapy start), time to surgery, and pathological complete response (pCR). The primary analysis compared symmetric six-month windows: July–December 2022 (without navigation) vs. January–June 2023 (with navigation). A sensitivity analysis included all eligible patients: May–December 2022 vs. January–December 2023. Two-sided <i>p</i> &lt; 0.05 was significant.</p> Results <p>In the primary analysis, navigation significantly shortened MOH approval → therapy start (T4) (<i>p</i> = 0.008), while T1–T3 and total time showed non-significant differences (total: <i>p</i> = 0.127). pCR was similar (78/115 [67.8%] vs. 81/117 [69.2%], <i>p</i> = 0.818). In the sensitivity analysis (<i>N</i> = 441), total time decreased from 146.2 ± 76.6 to 121.6 ± 50.4 days (–24.6 days, <i>p</i> &lt; 0.001), driven by a large improvement in T4 (32.4→20.8 days; − 11.6 days, <i>p</i> &lt; 0.001) while pCR remained comparable, although not statistically significant (64.1% vs. 69.9%, <i>p</i> = 0.76).</p> Conclusion <p>In an LMIC tertiary center, a Patient Navigation Program significantly accelerated the post-approval step to treatment and, across the full year, shortened the overall time from registration to initiation of dual anti-HER2 therapy despite rising volumes. These system-level gains, support navigation as a scalable, equity-promoting strategy aligned with World Health Organization (WHO)Global Breast Cancer Initiative priorities; prospective multicenter evaluations incorporating patient-reported outcomes and cost-effectiveness are warranted.</p>

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Streamlining care through patient navigation: a retrospective cohort study of timely anti-HER2 therapy in early breast cancer in a low-middle income country

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  • 发表日期：

    2025年11月8日

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  • Emad Shash,
  • Fatema Alaa,
  • Engy Maher,
  • Julia F. Rostom,
  • Alaa Ibrahim,
  • Rania Said,
  • Nada Abou El-Kheir,
  • Mona Elhosary,
  • Reem Eid

摘要

Background

Timely initiation of therapy is critical for patients with HER2-positive early breast cancer, especially in low- and middle-income countries (LMICs) where health-system constraints delay care. We evaluated whether a Patient Navigation Program could reduce time from registration to initiation of dual anti-HER2 therapy in Egypt.

Methods

Retrospective cohort study at the Breast Cancer Comprehensive Center (BCCC). Trained navigators tracked diagnostics, scheduled multidisciplinary tumor board (MDT), prepared/submitted Ministry of Health (MOH) approval files, monitored approval, and booked the earliest infusion slot. The primary endpoint was time from registration to therapy start; secondary endpoints were prespecified intervals—T1 (registration→MDT), T2 (MDT→MOH submission), T3 (MOH submission→MOH approval), and T4 (MOH approval→therapy start), time to surgery, and pathological complete response (pCR). The primary analysis compared symmetric six-month windows: July–December 2022 (without navigation) vs. January–June 2023 (with navigation). A sensitivity analysis included all eligible patients: May–December 2022 vs. January–December 2023. Two-sided p < 0.05 was significant.

Results

In the primary analysis, navigation significantly shortened MOH approval → therapy start (T4) (p = 0.008), while T1–T3 and total time showed non-significant differences (total: p = 0.127). pCR was similar (78/115 [67.8%] vs. 81/117 [69.2%], p = 0.818). In the sensitivity analysis (N = 441), total time decreased from 146.2 ± 76.6 to 121.6 ± 50.4 days (–24.6 days, p < 0.001), driven by a large improvement in T4 (32.4→20.8 days; − 11.6 days, p < 0.001) while pCR remained comparable, although not statistically significant (64.1% vs. 69.9%, p = 0.76).

Conclusion

In an LMIC tertiary center, a Patient Navigation Program significantly accelerated the post-approval step to treatment and, across the full year, shortened the overall time from registration to initiation of dual anti-HER2 therapy despite rising volumes. These system-level gains, support navigation as a scalable, equity-promoting strategy aligned with World Health Organization (WHO)Global Breast Cancer Initiative priorities; prospective multicenter evaluations incorporating patient-reported outcomes and cost-effectiveness are warranted.