Αρχική World News T-DM1 is Active and Well Tolerated in Patients with HER2-positive Metastatic Breast...

T-DM1 is Active and Well Tolerated in Patients with HER2-positive Metastatic Breast Cancer and Brain Metastases

The exploratory subgroup analysis of the KAMILLA trial represents the largest reported cohort of patients with HER2-positive metastatic breast cancer and brain metastases treated with T-DM1 in a prospective setting. The study team observed clinically meaningful antitumor activity in patients with and without prior radiotherapy, suggesting that T-DM1 is active, well tolerated in this difficult to treat population and warrants further exploration. The findings are published by Dr Filippo Montemurro of the Candiolo Cancer Institute, FPO-IRCCS in Candiolo, Torino, Italy and colleagues on 4 July 2020 in the Annals of Oncology.

Systemic treatment with HER2-targeted agents may improve clinical outcomes in patients with HER2-positive metastatic breast cancer and brain metastases. Activity of the HER2-targeted tyrosine kinase inhibitors (TKIs) lapatinib and neratinib alone or in combination with capecitabine and the HER2-specific TKI tucatinib in combination with trastuzumab and capecitabine has been reported in patients with HER2-positive metastatic breast cancer and brain metastases.

The authors wrote in the study background that among other potentially active drugs in these patients, the antibody-drug conjugate T-DM1 has been shown to improve overall survival (OS) in patients with trastuzumab-resistant advanced metastatic breast cancer and asymptomatic brain metastases previously treated with radiotherapy, compared with lapatinib plus capecitabine. Two small additional studies also provided signals of T-DM1 clinical activity in this difficult to treat population.

KAMILLA (NCT01702571) is an ongoing, international, single-arm, open-label, phase IIIb study that evaluates the safety and efficacy of T-DM1 in patients previously treated with HER2-targeted therapy and chemotherapy for HER2-positive locally advanced/metastatic breast cancer. The primary analysis found that T-DM1 was well-tolerated and showed efficacy consistent with that reported in previous studies. In the Annals of Oncology, the study team now reports the results of a post-hoc exploratory analysis describing T-DM1 safety and efficacy in patients with and without baseline brain metastases based on final cohort 1 data.

Patients received T-DM1 until unacceptable toxicity, withdrawal of consent, or disease progression. The main outcome measures were best overall response rate (BOR defined as complete response plus partial response) and clinical benefit rate (CBR defined as complete response plus partial response plus stable disease lasting ≥6 months) by RECIST v1.1, progression-free survival (PFS), OS and safety.

Of 2002 treated patients, 398 had baseline brain metastases. In 126 patients with measurable brain metastases, the BOR was 21.4% (95% confidence interval [CI] 14.6–29.6) and CBR was 42.9% (95% CI 34.1–52.0), respectively.

A reduction in the sum of the major diameters of brain metastases ≥30% occurred in 42.9% (95% CI 34.1–52.0), including 49.3% (95% CI 36.9–61.8) of 67 patients without prior radiotherapy for brain metastases.

In the 398 patients with baseline brain metastases, median PFS was 5.5 months (95% CI 5.3–5.6) and OS was 18.9 months (95% CI 17.1–21.3), respectively.

Adverse events profile was similar in patients with and without baseline brain metastases, although nervous system adverse events were more common in patients with baseline metastases, 208 [52.3%]) versus 701 in those without baseline brain metastases (43.7%).

In summary this exploratory analysis of patients with HER2-positive metastatic breast cancer and brain metastases enrolled in a prospective clinical trial shows that T-DM1 is active and well tolerated in this population. Overall response rate was 21.4% across all organs in patients with HER2-positive metastatic breast cancer and measurable brain metastases. Brain target lesion responses were observed in patients with and without prior radiotherapy. In patients with baseline brain metastases treated with T-DM1, median PFS was 5.5 months. Safety was generally similar in patients with versus without baseline brain metastases, except for nervous system adverse events. The study team concluded that T-DM1 should be explored further in this setting.

The authors thanked the team at Covance Clinical-Biotech for managing this global study. It was supported by F. Hoffmann-La Roche, which participated in the design and conduct of the study, collection, management, analysis, and interpretation of the data, preparation, review, and approval of the manuscript, and decision to submit the manuscript for publication.


Montemurro F, Delaloge S, Barrios CH, et al. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial. Annals of Oncology; Published online 4 July 2020. DOI: https://doi.org/10.1016/j.annonc.2020.06.020



Συμπληρώστε το email σας για να λαμβάνετε τις σημαντικότερες ειδήσεις από το ogkologos.com

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like

Διαβαστε Επίσης


ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ) Γράφει ο Δρ Παπαδούρης Σάββας, Παθόλογος-Ογκολόγος   Ο ΜΜΚΠ βρίσκεται αναλογικά στο 80% και πλέον του συνολικού...

Διατρέχουν όντως οι καρκινοπαθείς μεγαλύτερο κίνδυνο λόγω κοροναϊού;

Σε πρακτικό επίπεδο, τα δεδομένα των σχετικών μελετών υποδηλώνουν ότι η χημειοθεραπεία ή οι άλλες αντι-νεοπλασματικές θεραπείες δεν αυξάνουν σημαντικά τον κίνδυνο θνησιμότητας από...

FDA: Η ακτινοβολία των smartphones δεν προκαλεί καρκίνο

Σε μια νέα έκθεσή της, η Υπηρεσία Τροφίμων και Φαρμάκων (FDA) των ΗΠΑ αναφέρει ότι επανεξέτασε τις σχετικές επιστημονικές έρευνες που δημοσιεύθηκαν τα τελευταία...

Νέα ανακάλυψη, νέα ελπίδα για τον καρκίνο

Ένα νεοανακαλυφθέν τμήμα του ανοσοποιητικού μας συστήματος θα μπορούσε να αξιοποιηθεί για την αντιμετώπιση όλων των ειδών καρκίνου, σύμφωνα με επιστήμονες του πανεπιστημίου Cardiff...

Καρκίνος: Ευεργετική για τους καρκινοπαθείς η άσκηση

Σημαντικά ωφέλη προσφέρει η άσκηση, ακόμη και σε ασθενείς με καρκίνο. Οι περισσότεροι ασθενείς αγνοούν τα οφέλη που μπορεί να έχει γι’ αυτούς η συχνή...

Prostate Cancer

The article is provided by Scientific Communications Officer of NIPD Genetics, Ms Marina Charitou (MSc) Prostate Cancer Awareness Prostate cancer is the second most common cancer...
- Advertisment -

Ροή Ειδήσεων

Mother Spent 14 Weeks Battling Breast Cancer Alone During COVID-19 Lockdown

Battling cancer is difficult for anyone, but it’s even harder when you have to do it alone. That’s what happened to Samantha Currie. Samantha, 27,...

ESMO 2020: New Treatments for Advanced Kidney Cancer, Prostate Cancer, and Bladder Cancer

The 2020 European Society for Medical Oncology (ESMO) Virtual Congress was held online from September 19 to September 21. In this podcast, Neeraj Agarwal,...

The UK Government’s spending review: Time to invest in the future of cancer care

This autumn, the chancellor Rishi Sunak will go to Parliament and set out the UK Government’s spending priorities in the Comprehensive Spending Review...

Nivolumab Improves Survival for Some Patients with Advanced Stomach Cancer

October 20, 2020, by NCI Staff Some people with advanced stomach cancers may live longer if they are initially treated with nivolumab (Opdivo) and chemotherapy. Credit: National Cancer Institute Some...

Sugar and cancer – what you need to know

This post was first published in 2017 but has been reviewed and updated in October 2020. There’s a lot of confusing information and advice out...

FDA Extends Approval of Pembrolizumab for Classical Hodgkin Lymphoma

On 14 October 2020, the US Food and Drug Administration (FDA) extended the approval of pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme Corp.) for the...