Trastuzumab without chemotherapy in the adjuvant treatment of breast cancer: subgroup results from a large observational study

Dall, P.; Koch, Thorsten; Göhler, Thomas; Selbach, Johannes; Ammon, A.; Eggert, Jochen; Gazawi, N; Rezek, D.; Wischnik, A.; Hielscher, Carsten; Schleif, Nicolas; Cirrincione, Ursula; Hinke, Axel; Feisel-Schwickardi, Gabriele

doi:10.1186/s12885-017-3857-5

Cited by 17 publications

(12 citation statements)

References 26 publications

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“…Dual HER2 blockade therapies without chemotherapy have demonstrated efficacy in the preoperative setting in patients with HER2-positive breast cancer 24 . However, data about non-chemotherapy HER2 blockade including single agent trastuzumab is limited in the adjuvant setting 25 . Future trials are warranted to explore this option in smaller HER positive breast cancer.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of adjuvant trastuzumab in women with HER2-positive T1a or bN0M0 breast cancer: a population-based cohort study

Ali

Hendry

et al. 2022

Sci Rep

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Adjuvant trastuzumab has been associated with superior survival in women with ≥ T1c or node-positive HER2-positive early-stage breast cancer; however, there is a lack of phase III trials in women with T1a/bN0 disease. Our study aimed to assess the outcomes of women with HER2-positive T1a/bN0 breast cancer who received adjuvant trastuzumab in Saskatchewan, Canada. We evaluated all women diagnosed with HER2-positive T1a/bN0 breast cancer in Saskatchewan between 2008 and 2017. We performed Cox proportional multivariable analysis to determine factors correlated with survival. In addition, inverse probability treatment weighting (IPTW) using propensity score was performed to assess benefit of adjuvant trastuzumab. Ninety-one eligible women with a median age of 61 years (range 30–89) were identified. Thirty-nine (43%) women received adjuvant trastuzumab. Women who received trastuzumab were younger and had a higher rate of T1b disease. Overall, 3% of women who received trastuzumab compared to 12% of women who did not receive trastuzumab developed breast cancer recurrence (p = 0.23). Five-year disease-free survival (DFS) of women who received adjuvant trastuzumab was 94.8% compared to 82.7% of women who did not receive trastuzumab (p = 0.22). Five-year overall survival was 100% of women who received trastuzumab compared to 90.4% of women who did not receive adjuvant trastuzumab (p = 0.038). In the multivariable analysis, grade III tumors were correlated with inferior DFS (hazard ratio [HR] 5.5, 95% CI [1.7–17.7]). The propensity score using the inverse probability of treatment weighting showed that lack of adjuvant trastuzumab was correlated inferior DFS, with an HR of 4 (95% CI 1.05–15.5). Women with HER2-positive T1a/bN0 breast cancer had overall low recurrence of breast cancer. However, the results of this exploratory analysis indicate that women who received adjuvant trastuzumab had better survival.

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Section: Discussionmentioning

confidence: 99%

Efficacy of adjuvant trastuzumab in women with HER2-positive T1a or bN0M0 breast cancer: a population-based cohort study

Ali

Hendry

et al. 2022

Sci Rep

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“…During these 6–8 cycles, there are potential cost savings with respect to healthcare professional time and consumables with IV trastuzumab administration by piggy backing on the costs that must be applied for IV chemotherapy administration during concurrent or sequential administration. The combination of trastuzumab with chemotherapy is usual practice (94%) during adjuvant therapy across German hospitals [ 21 ], whereas trastuzumab monotherapy is the norm in the Southeast Netherlands (100%) [ 22 ] and most common in Southeast Wales (83%) [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

Simulating Costs of Intravenous Biosimilar Trastuzumab vs. Subcutaneous Reference Trastuzumab in Adjuvant HER2-Positive Breast Cancer: A Belgian Case Study

Simoens

Vulto

Dylst³

2021

Pharmaceuticals

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This study aimed to compare drug costs and healthcare costs of a 1 year adjuvant course with intravenous biosimilar trastuzumab vs. subcutaneous reference trastuzumab in HER2-positive breast cancer from the Belgian hospital perspective. Our simulation is based on the methodology used by Tjalma and colleagues, and considered costs of drugs, healthcare professional time and consumables. We calculated intravenous drug costs for different body weights, and computed drug costs and healthcare costs to treat 100 patients with either trastuzumab formulation, assuming a binomial body weight distribution in this sample. Scenarios were run to account for drug discounts and intravenous vial sharing. Drug costs amounted to €1,431,282 with intravenous biosimilar trastuzumab and €1,522,809 with subcutaneous reference trastuzumab for a sample of 100 patients in the base case analysis. When healthcare professional time and consumables were also considered, healthcare costs with intravenous biosimilar trastuzumab were similar to those with subcutaneous reference trastuzumab. Differences in healthcare costs between intravenous biosimilar trastuzumab and subcutaneous reference trastuzumab depended on the level of discounts on these formulations and on intravenous vial sharing. Our case study demonstrates that comparing costs of intravenous vs. subcutaneous formulations is complex and multifactorial, and entails more than a simple cost comparison of products.

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“…Data from a large observational study suggested that trastuzumab-plus-chemotherapy should remain the preferred option for all patients indicated for adjuvant treatment, and that a low proportion of patients need an alternative treatment approach, either because of contraindications or the patient's preference. Trastuzumab monotherapy might be a reasonable option [10], but to our knowledge, no prospective data exist to suggest that prospective adjuvant trastuzumab alone can offer a bene t over no adjuvant therapy.…”

Section: Discussionmentioning

confidence: 99%

Adjuvant Trastuzumab Without Chemotherapy For Treating Early HER2-Positive Breast Cancer In Older Patients: A Cohort Study Accompanying With The RESPECT Trial

Sawaki¹,

Taira²,

Uemura³

et al. 2021

Preprint

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Purpose To gauge the effects of treatment practices on prognosis for all older patients with HER2-positive breast cancer, particularly to determine whether adjuvant trastuzumab alone can offer benefit over no adjuvant therapy. This report accompanies the RESPECT study, a randomized-controlled trial (RCT) comparing trastuzumab monotherapy with trastuzumab-plus-chemotherapy for early HER2-positive breast cancer.Patients and methods Patients who declined the RCT were treated based on the physician’s discretion. We studied the (1) trastuzumab-plus-chemotherapy group, (2) trastuzumab-monotherapy group, and (3) non-trastuzumab group (no therapy or anticancer therapy without trastuzumab). The primary endpoint was disease-free survival (DFS), which was compared using the propensity-score method.Results We enrolled 398 eligible patients, aged over 70 years, with HER2-positive invasive breast cancer, of whom 275 (69%) were in the RCT, and 123 (31%) were in this cohort group. The median age was 74.5 years. Among cohort group treatment categories were as follows: (1) trastuzumab-plus-chemotherapy group (n = 36, 30%), (2) trastuzumab-monotherapy group (n = 52, 43%), and (3) non-trastuzumab group (n = 32, 27%). A total of 73% of patients received trastuzumab-containing regimens, with or without chemotherapy. The 3-year DFS was 92.3% in the trastuzumab-plus-chemotherapy group, 89.2% in the trastuzumab-monotherapy group, and 82.5% in the non-trastuzumab group. DFS in the non-trastuzumab group was lower than in the trastuzumab-plus-chemotherapy and trastuzumab-monotherapy groups (propensity-adjusted HR: 3.29; 95% CI: 1.15–9.39; P = 0.026). The relapse-free survival in the non-trastuzumab group was lower than in the trastuzumab-plus-chemotherapy and trastuzumab monotherapy groups (propensity-adjusted HR = 7.80; 95% CI: 2.32–26.2, P < 0.0001). Chemotherapy with trastuzumab or trastuzumab monotherapy did not affect health-related quality of life (HRQoL) at 36 months.Conclusions Trastuzumab-treated patients had better prognoses than patients not treated with trastuzumab without deterioration of HRQoL. Thus, trastuzumab monotherapy can be considered for patients who reject chemotherapy.Trial registration number The protocol was registered on the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID: UMIN 000028476).

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Trastuzumab without chemotherapy in the adjuvant treatment of breast cancer: subgroup results from a large observational study

Abstract: Background: The topic of trastuzumab therapy without chemotherapy in early breast cancer (EBC) has been repeatedly discussed at international consensus meetings, but is compromised by the lack of solid evidence from clinical studies.

Cited by 17 publications

References 26 publications

Efficacy of adjuvant trastuzumab in women with HER2-positive T1a or bN0M0 breast cancer: a population-based cohort study

Efficacy of adjuvant trastuzumab in women with HER2-positive T1a or bN0M0 breast cancer: a population-based cohort study

Simulating Costs of Intravenous Biosimilar Trastuzumab vs. Subcutaneous Reference Trastuzumab in Adjuvant HER2-Positive Breast Cancer: A Belgian Case Study

Adjuvant Trastuzumab Without Chemotherapy For Treating Early HER2-Positive Breast Cancer In Older Patients: A Cohort Study Accompanying With The RESPECT Trial

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