Αρχική World News Olaparib Maintenance Fails in Platinum Sensitive Advanced Non-Small Cell Lung Cancer

Olaparib Maintenance Fails in Platinum Sensitive Advanced Non-Small Cell Lung Cancer

Despite sound rationale that patients with platinum sensitive non-small cell lung cancer (NSCLC) should also be sensitive to poly (ADP-ribose) polymerase inhibitors (PARPi), olaparib maintenance did not improve survival in a small under-enrolled phase II study. These findings were presented at the European Lung Cancer Virtual Congress 2021 (25-27 March).

Sophie Postel-Vinay of the Drug Development Department, Institut Gustave Roussy in Villejuif, France explained that DNA damage response (DDR) defects occur in NSCLC and that the DDR defects leading to platinum sensitivity widely overlap with those underlying sensitivity to PARP inhibitors, such as olaparib. Therefore, Dr. Postel-Vinay and co-investigators evaluated whether olaparib could be an effective maintenance treatment in patients with platinum-sensitive advanced NSCLC.

Olaparib as maintenance treatment was assessed in the randomised double-blind phase II PIPSeN (NCT02679963) study, which enrolled 180 chemonaïve patients with ECOG performance status (PS) 0-1, stage IIIB-IV NSCLC. The patients had no EGFR or ALK/ROS alterations.

After 4 to 6 cycles of platinum-based chemotherapy 60 patients achieving partial or complete response were randomly assigned to olaparib maintenance at 300 mg twice daily or placebo. Randomisation was stratified according to age, histology, and country.

The primary study objective was progression-free survival (PFS) from randomisation per RECIST v1.1. and secondary objectives included overall survival (OS) and safety.

The PIPSeN study was halted prematurely

PIPSeN required enrollment of 500 patients for randomisation of 144 patients to reach the anticipated hazard ratio (HR) of 0.65. However, due to the registration of anti-PD-L1 agents in the first-line setting, the study was closed prematurely.

Following randomisation, 33 patients were treated with olaparib maintenance and 27 received placebo. Their median age was 64 years, 64% had adenocarcinoma, and 3% of patients were never-smokers. Patient and tumour characteristics were well-balanced between arms, with the exception that 14 versus 8 patients had bone metastases and 11 versus 4 patients had peripheral lymphadenopathy in the olaparib and placebo arms, respectively.

Survival was not improved with olaparib as maintenance therapy

Median PFS was similar between arms at 2.3 months with olaparib maintenance versus 2.1 months with placebo (HR 0.89, 95% confidence interval [CI] 0.51-1.55; p = 0.68), as was median OS of 9.5 versus 14.1 months in the respective arms (HR 1.29; 95% CI 0.68-2.45; p = 0.44).

Subsequent systemic therapy was administered to 38 patients overall; of these, 23 were on olaparib and 15 were on placebo. Subsequent therapy included anti-PD(L)1 immune checkpoint blockers in 19 and 11 patients, and other immunotherapies in one and two patients of these respective arms.

Grade ≥3 adverse events (AEs) occurred in 20 patients receiving olaparib compared to 8 on placebo. Of 10 AEs leading to treatment discontinuation or treatment interruption, eight occurred in the olaparib arm.

Conclusions

The investigators noted that the PIPSeN study was terminated early due to being statistically underpowered, with only 50% of the pre-planned patient population available for analysis.

Although olaparib maintenance was well tolerated, neither median PFS nor median OS was improved by olaparib in this sample of patients with platinum-sensitive NSCLC.

This study was funded by AstraZeneca.

Reference

100MO – Postel-Vinay S, Planchard D, Antigny M, et al. Olaparib maintenance vs placebo in platinum-sensitive non-small cell lung cancer: The phase II randomized PIPSeN trial. European Lung Cancer Virtual Congress 2021 (25-27 March).

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

Dad Creates Inclusive Children’s Book For Daughter With Disability And Others Like Her

Danny Jordan is a television producer and father of a child with an upper limb difference. Since there aren’t many children’s books out there...

Atlantic rowing trio smash world record and raise thousands for cancer charities

Abby, Charlotte and Kat (left to right) in English Harbour after breaking the world record. Three British women, including one with an incurable cancer, have...

Artificial Intelligence for Diagnosis and Gleason Grading of Prostate Cancer

A global artificial intelligence (AI) competition, the Prostate cANcer graDe Assessment (PANDA) challenge, compiled and publicly released a European cohort for AI development, the...

Daughter And Her Terminally Ill Dad Go On Bucket List Adventures In His Final Days

72-year-old Patrick Mitchell loves life and always wanted to live past 100, but everything changed when he found out that he had terminal stage...

A new year of expanding research horizons

As a new year of research gets underway, we ask two of our Research Committee Chairs to take stock of the incredible science done...

Young Women At Increased Risk Of Aggressive Breast Cancer

Breast cancer is on the rise among younger women. According to a study published in the Journal of the American Medical Association, there has been...