Is the Fixed-Dose Intravenous Trastuzumab Policy Warranted in Limited-Resource Settings?

Kassem, Loay; Shohdy, Kyrillus S.; Abdel-Azeez, Ahmad M; Attia, Hazem Ali

doi:10.1200/jgo.18.00155

Cited by 2 publications

(3 citation statements)

References 9 publications

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“…The median age of our cohort is 48 years, which is 14 years younger than the Western population median (62 years) [ 5 ]. This is a consistent observation with other national data [ 5 , 6 ]. For example, in a study comparing Egypt’s Gharbia Cancer Registry (GCR) and the United States Surveillance, Epidemiology, and End Results (SEER) registries, Egyptian GCR cases were, on average, over 10 years younger than US SEER cases, with nearly 19% of GCR cases ≤ 40 years of age as compared to only 6% of US SEER cases [ 5 ].…”

Section: Discussionsupporting

confidence: 93%

Pathological responses and survival outcomes in patients with locally advanced breast cancer after neoadjuvant chemotherapy: a single-institute experience

Shohdy

Almeldin

Fekry

et al. 2021

J Egypt Natl Canc Inst

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Background Pathological complete response (pCR) is a surrogate for the efficacy of neoadjuvant chemotherapy (NCT) in locally advanced breast cancer (LABC). We analyzed the predictive clinical factors for pathological responses and survival outcomes in a cohort of Egyptian patients. Methods We evaluated the medical records of patients with breast cancer who received NCT in our academic institute. Survival curves were estimated with the Kaplan-Meier method. Cox proportional models were used for multiple regression analysis. Results Our cohort included 368 patients with a median age of 48 years (range 21–70). The median follow-up time was 3 years. The clinical tumor stage (T3–4) represented 58%, with 80% having positive axillary nodes. The luminal subgroup prevailed by 68%. The objective response rate (ORR) reached 78%, and 16% of patients achieved pCR. The clinical node stage and optimal chemotherapy were associated with higher ORR (p = 0.035 and p = 0.001, respectively). Predictors of pCR were clinical T-stage (p = 0.026), high Ki-67 index > 20 (p = 0.05), and receiving optimal chemotherapy (p = 0.014). The estimated 3-year disease free-survival (DFS) was 53%. Receptor status, achieving ORR, and pCR were associated with better DFS with hazard ratios of 0.56, p = 0.008; 0.38, p = 0.04; and 0.28, p = 0.007, respectively. Conclusions Luminal tumors still draw benefit from neoadjuvant chemotherapy in terms of clinical response and breast conservative surgery. Treatment escalation to those who did not achieve pCR requires more investigation, given a higher recurrence rate in real-world experience.

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Section: Discussionsupporting

confidence: 93%

Pathological responses and survival outcomes in patients with locally advanced breast cancer after neoadjuvant chemotherapy: a single-institute experience

Shohdy

Almeldin

Fekry

et al. 2021

J Egypt Natl Canc Inst

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“…Indeed, Joensuu et al 8 reported that a 9-week course was noninferior to the 1-year course and was associated with a better cardiac safety profile 8 . The dosage is also can vary in RLS, our group previously showed that adopting a fixed dose is a questionable approach, and more studies are needed to evaluate that point 9 .…”

Section: Introductionmentioning

confidence: 99%

“…Previously, our group showed that the fixed-dose approach leads to significant per-label deviations in patients treated in RLS 9 . However, the impact of TRA deviations on the long-term clinical outcomes of HER2-positive localized breast cancer is still unclear.…”

Section: Introductionmentioning

confidence: 99%

The Impact of Trastuzumab Administration Patterns on the Long-Term Clinical Outcomes of Patients with Non-Metastatic Breast Cancer in a Resource-Limited Setting

Abd-Elhafeez,

Hassan,

Almeldin

et al. 2024

Kasr-Al-Aini J.of Clin. Onc. and Nuc. Med.

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Background: Administration of trastuzumab (TRA) in resource-limited settings (RLS) is associated with significant deviations from per-label recommendations such as fixed-dose instead of weight-based, interruptions, and a reduced number of cycles. The impact of these deviations on the clinical outcomes of HER2-positive non-metastatic breast cancer is unclear. Methods: We retrospectively reviewed the records of patients with operable HER2-positive breast cancer treated at our center from 2013 to 2018 for TRA dose deviations. The standard protocol for TRA administration includes a one-year course of TRA with one intravenous dose every three weeks for 17 cycles. We assessed the number of cycles, underdosing based on body weight calculation, and low relative dose intensity (RDI). Cox regression analysis was used to identify predictors of survival and was adjusted for baseline clinical variables. Results: This analysis included 208 patients with a median age of 45 years. A total of 175 (84%) patients showed at least one per label deviation. Fifty-four patients (26%) were underdosed with a mean maintenance dose defect of 54 ±107 mg, 64 (31%) received a reduced number of courses (≤ 9 cycles), and 103 patients (49.5%) received TRA at low RDI. Reduced number of cycles was the only factor associated with a worse hazard of recurrence-free survival and overall survival (HR: 2.25, 95% CI: 1.35-3.75, adjusted p =0.002) and (HR: 2.48, 95% CI: 1.36-4.52, adjusted p =0.003), respectively. Conclusion: In our cohort, not all the deviations had adverse impacts on clinical outcomes. Only a reduced number of cycles was associated with a worse recurrence-free and overall survival hazard. Improving access to anti-HER2 therapies in RLS is crucial. Ensuring the full course of TRA in RLS is needed.

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Is the Fixed-Dose Intravenous Trastuzumab Policy Warranted in Limited-Resource Settings?

Cited by 2 publications

References 9 publications

Pathological responses and survival outcomes in patients with locally advanced breast cancer after neoadjuvant chemotherapy: a single-institute experience

Pathological responses and survival outcomes in patients with locally advanced breast cancer after neoadjuvant chemotherapy: a single-institute experience

The Impact of Trastuzumab Administration Patterns on the Long-Term Clinical Outcomes of Patients with Non-Metastatic Breast Cancer in a Resource-Limited Setting

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