Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis

 

Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis

by Paul Stewart, Phillip Blanchette, Prakesh S. Shah, Xiang Y. Ye, R. Gabriel Boldt, Ricardo Fernandes, Ted Vandenberg, Jacques Raphael

The Breast: Open Access: Published: October 21, 2020

One year of adjuvant trastuzumab is considered the standard treatment for patients with HER2 positive breast cancer. However, a shorter duration of trastuzumab may be associated with reduced costs and side effects. Results from randomized trials with diverse non-inferiority margins comparing one year to a shorter duration of adjuvant trastuzumab are not consistent and have not been systematically reviewed using a non-inferiority meta-analysis approach.We conducted a systematic review and meta-analysis of randomized trials to assess whether a shorter duration of adjuvant trastuzumab was non-inferior to one year of treatment or not.

HER2 positivity is not associated with adverse prognosis in high-risk estrogen receptor-positive early breast cancer patients treated with chemotherapy and trastuzumab

 

HER2 positivity is not associated with adverse prognosis in high-risk estrogen receptor-positive early breast cancer patients treated with chemotherapy and trastuzumab

 

by Shuai Li, Jiayi Wu, Ou Huang, Jianrong He, Li Zhu, Weiguo Chen, Yafen Li, Xiaosong Chen, Kunwei Shen 

 

The Breast: Open Access: Published: October 14, 2020

 

Co-expression of human epidermal growth factor receptor-2 (HER2) and hormone receptor (HR) predicted worse prognosis in early breast cancer before trastuzumab was developed. We aimed to investigate whether HER2 positivity was still associated with worse outcome in high-risk estrogen receptor (ER) positive patients treated with trastuzumab and chemotherapy. In the present study, 227 ER+/HER2+ patients treated with trastuzumab and chemotherapy (HER2-pos-T group) and 1097 ER+/HER2-patients treated with chemotherapy alone (HER2-neg group) during 2009 and 2015 were retrospectively enrolled for the comparison of disease-free survival (DFS) and overall survival (OS).

Hospital-based or home-based administration of oncology drugs? A micro-costing study comparing healthcare and societal costs of hospital-based and home-based subcutaneous administration of trastuzumab

Hospital-based or home-based administration of oncology drugs? A micro-costing study comparing healthcare and societal costs of hospital-based and home-based subcutaneous administration of trastuzumab

by Margreet Franken, Tim Kanters, Jules Coenen, Paul de Jong, Agnes Jager, Carin Uyl-de Groot 

The Breast: VOLUME 52, P71-77, AUGUST 01, 2020

Highlights

• Home-based administration of SC trastuzumab almost triples the time of healthcare professionals.
• Healthcare costs are almost twice as much for home-based than for hospital-based administration.
• Patient and family costs are almost five times lower for home-based than for hospital-based administration.

Abstract

Objective

To investigate resource use and time investments of healthcare professionals, patients and their family and to compare healthcare and societal costs of one single hospital-based and one single home-based subcutaneous administration of trastuzumab in The Netherlands.

Method

We conducted a bottom-up micro-costing study. Patients diagnosed with HER2+ early or metastatic breast cancer were recruited in four Dutch hospitals. For healthcare costs, data were collected on drug use, consumables, use of healthcare facilities, time of healthcare professionals, and travelling distance of the nurse. For societal costs, data were collected on patient and family costs (including travelling expenses and time of informal caregivers) and productivity losses of paid and unpaid work.

Results

Societal costs of one single administration of SC trastuzumab were €1753 within the home-based and €1724 within the hospital-based setting. Drug costs of trastuzumab were identical in both settings (€1651). Healthcare costs were higher for home-based administration (€91 versus €47) mainly because of more time of healthcare professionals (110 versus 38 minutes). Costs for patient and family were, however, lower for home-based administration due to travelling expenses (€7 versus €0) and time of informal caregivers (€14 versus €4). Costs for productivity losses were similar for both settings.

Conclusions

Home-based subcutaneous administration of trastuzumab is more time consuming for healthcare professionals and therefore more costly than hospital-based administration. The total budget impact can be large considering that a large number of patients receive a large number of cycles of oncology treatments. If home-based administration is the way forward, novel approaches are crucial for ensuring efficiency of home-based care.

Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: a phase 1 dose-escalation and dose-expansion study

[Articles] Trastuzumab duocarmazine in locally advanced and metastatic solid tumours and HER2-expressing breast cancer: a phase 1 dose-escalation and dose-expansion study

by Udai Banerji, Carla M L van Herpen, Cristina Saura, Fiona Thistlethwaite, Simon Lord, Victor Moreno, Iain R Macpherson, Valentina Boni, Christian Rolfo, Elisabeth G E de Vries, Sylvie Rottey, Jill Geenen, Ferry Eskens, Marta Gil-Martin, Ellen C Mommers, Norbert P Koper, Philippe Aftimos

The Lancet Oncology: Articles| volume  20, issue  8, p1124-1135, August  01, 2019

Trastuzumab duocarmazine shows notable clinical activity in heavily pretreated patients with HER2-expressing metastatic cancer, including HER2-positive trastuzumab emtansine-resistant and HER2-low breast cancer, with a manageable safety profile. Further investigation of trastuzumab duocarmazine for HER2-positive breast cancer is ongoing and trials for HER2-low breast cancer and other HER2-expressing cancers are in preparation.

T-DM1 for residual, invasive, HER2-positive breast cancer

[News] T-DM1 for residual, invasive, HER2-positive breast cancer

by Talha Khan Burki  

The Lancet Oncology: Volume 20, Issue 1, PE13, January 01, 2019

A new study has concluded that adjuvant trastuzumab emtansine (T-DM1) reduces the risk of recurrence or death in patients with HER2-positive breast cancer who have residual disease after neoadjuvant therapy and surgery. In the phase 3, open-label trial, women with HER2-positive, early-stage breast cancer had received neoadjuvant therapy consisting of at least six cycles of chemotherapy, including a taxane, and trastuzumab for at least 9 weeks. Patients were randomly assigned to receive 14 cycles of either T-DM1 or trastuzumab (n=743 per group).

Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial

 by Gunter von Minckwitz, Marco Colleoni, Hans-Christian Kolberg, Serafin Morales, Patricia Santi, Zorica Tomasevic, Nan Zhang, Vladimir Hanes  

The Lancet Oncology, Vol 19, No. 7, p987-998, July 2018

Although the lower bounds of the 90% CIs for RR and risk difference showed non-inferiority, the upper bounds exceeded the predefined equivalence margins when based on local laboratory review of tumour samples, meaning that non-superiority was non-conclusive. In our sensitivity analyses based on central laboratory evaluation of tumour samples, estimates for the two drugs were contained within the predefined equivalence margins, indicating similar efficacy. ABP 980 and trastuzumab had similar safety outcomes in both the neoadjuvant and adjuvant phases of the study.

Duration of trastuzumab for HER2-positive breast cancer

Duration of trastuzumab for HER2-positive breast cancer. The lancet oncology, July 2013, Vol.14(8), p.678-79.

Montemurro, F. and Aglietta, M.

http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70273-0/fulltext?rss=yes

Several large randomised trials completed in the mid-2000s produced overwhelming evidence that the anti-HER2 monoclonal antibody trastuzumab, administered either concomitantly or sequentially with adjuvant chemotherapy for 12 months, increases the cure rate for women with HER2-positive operable breast cancer. One surprising aspect of this success story is that the choice of 12-month treatment duration was mostly as a result of a best guess, rather than on the basis of pre-existing evidence. 

Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable HER2 positive breast cancer

Four year follow-up of trastuzumab plus adjuvant chemotherpy for operable HER2 positive breast cancer: Joint analysis of NNCTG N9831 and NSABP B-31. J Clin Oncol published online before print July 18, 2011

Wan, Y. (summary)

http://www.nelm.nhs.uk/en/NeLM-Area/News/2011---July/19/Four-year-follow-up-of-trastuzumab-plus-adjuvant-chemotherapy-for-operable-HER2-positive-breast-cancer-Joint-analysis-of-NCCTG-N9831-and-NSABP-B-31/

Four large trials evaluating adjuvant trastuzumab for HER2-positive breast cancer demonstrated significant improvements in disease-free survival (DFS; 36% to 52% reduction in DFS events) and overall survival (OS; 33% to 37% reduction in deaths). These data has led adjuvant trastuzumab becoming the foundation of care for HER2-positive early breast cancer.