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.

Reference

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

Source

NEWSLETTER

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

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like
57ΑκόλουθοιΑκολουθήστε

Διαβαστε Επίσης

Καρκίνος και Κορωνοϊός (COVID-19) ΜΕΡΟΣ Α

Εάν είστε καρκινοπαθής, το ανοσοποιητικό σας σύστημα μπορεί να μην είναι τόσο ισχυρό όσο κανονικά, έτσι μπορεί να ανησυχείτε για τους κινδύνους που σχετίζονται...

ΠΑΓΚΟΣΜΙΑ ΗΜΕΡΑ ΚΑΡΚΙΝΟΥ

Η Παγκόσμια Ημέρα Κατά του Καρκίνου καθιερώθηκε με πρωτοβουλία της Διεθνούς Ένωσης κατά του Καρκίνου (UICC), που εκπροσωπεί 800 οργανώσεις σε 155 χώρες του...

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ)

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...
- Advertisment -

Ροή Ειδήσεων

Foodie Friday: It’s Berry Season!

July is National Berry Month! If berries aren’t part of your daily diet, now is the perfect time to start eating more of these...

No Link Between Viral Vector in Zynteglo and Acute Myeloid Leukaemia

On 23 July 2021, the European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) has endorsed findings of...

Expecting Mom Finds Pregnant Stray Cat And Gives Her A Home

A woman was 9 months pregnant when she found a pregnant stray cat. Unable to bear the thought of the fellow mom giving birth...

3 Questions Cancer Caregivers Can Ask Themselves to Help Prevent Burnout

Karen Warner Schueler is the president of her own executive coaching firm and author of The Sudden Caregiver: A Roadmap for Resilient Caregiving. For...

FDA Approval of Rylaze Will Address Drug Shortage for Childhood ALL

July 29, 2021, by NCI Staff FDA's approval of Rylaze is expected to help address a long-running shortage of the drug Erwinia asparaginase for kids...

EMA Recommends Granting a Marketing Authorisation for the Hybrid Medicine Imatinib

On 22 July 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting...