Αρχική World News Rucaparib Extends PFS in the Maintenance Treatment of Recurrent EOC Without Detrimental...

Rucaparib Extends PFS in the Maintenance Treatment of Recurrent EOC Without Detrimental Effects on Patient Health Status

A post hoc exploratory analysis of the phase III ARIEL3 study conducted in patients with platinum-sensitive, recurrent epithelial ovarian carcinoma (EOC) showed significant differences in quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST), thus confirming the benefit of rucaparib versus placebo in all predefined study cohorts. Rucaparib provided significant benefits to patient health status even when accounting for toxicities; these benefits were observed in the intention-to-treat (ITT) population and irrespective of BRCA mutation status. Amit M. Oza of the Princess Margaret Cancer Centre, University Health Network and Sinai Health System, University of Toronto in Toronto, Ontario, Canada and colleagues reported on 24 August 2020 in the Journal of Clinical Oncology that taken together, their findings demonstrated that rucaparib extended PFS in the maintenance setting without detrimental effects on patient health status.

Although most women with EOC respond to first-line treatment, many experience relapse. Maintenance treatment with a targeted agent such as bevacizumab or a poly(ADP-ribose) polymerase (PARP) inhibitor has become the standard of care for patients with EOC after a response to chemotherapy. It is important to evaluate whether adding maintenance treatment to a patient’s therapeutic regimen prolongs survival at the expense of toxicities that compromise the patient’s overall health status.

In the ARIEL3 trial, the primary efficacy endpoint of investigator-assessed PFS was significantly improved with a PARP inhibitor, rucaparib maintenance treatment versus placebo in all 3 prespecified cohorts: patients with BRCA-mutated tumour (germline, somatic, or unknown origin), patients with a homologous recombination deficient (HRD) tumour (BRCA mutation plus BRCA wild-type/high loss of heterozygosity (LOH), and the ITT population. Based on the study results, rucaparib is approved for the maintenance treatment of adult patients with recurrent EOC, fallopian tube or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.

To further evaluate the clinical benefits of rucaparib maintenance treatment from a patient-centred perspective, the ARIEL3 investigators performed QA-PFS and Q-TWiST analyses. It is the first report of the Q-TWiST analysis for a PARP inhibitor in ovarian cancer and the first report of quality-adjusted outcomes for a PARP inhibitor that includes patients with ovarian cancer without a known deleterious BRCA mutation.

Patients completed the 3-level version of the EQ-5D questionnaire (EQ-5D-3L) at screening, on day 1 of each treatment cycle, at the treatment discontinuation visit, and at the 28-day follow-up visit. QA-PFS was calculated as PFS function x EQ-5D-3L index score function. Q-TWiST analyses were performed defining toxicity as the mean duration in which a patient experienced grade ≥3 treatment-emergent adverse events (TEAEs) or the mean duration in which a patient experienced grade ≥2 TEAEs of nausea, vomiting, fatigue, and asthenia. The visit cut-off was 15 April 2017.

Mean QA-PFS was significantly longer with rucaparib versus placebo in the ITT population (difference 6.28 months, 95% confidence interval [CI] 4.85 to 7.47 months), BRCA-mutated cohort (9.37 months, 95% CI 6.65 to 11.85 months), HRD cohort (7.93 months, 95% CI 5.93 to 9.53 months) and BRCA wild-type/LOH low patient subgroup (2.71 months, 95% CI 0.31 to 4.44 months).

With toxicity defined using grade ≥3 TEAEs, the difference in mean Q-TWiST for rucaparib versus placebo was 6.88 months (95% CI 5.71 to 8.23 months), 9.73 months (95% CI 7.10 to 11.94 months), 8.11 months (95% CI 6.36 to 9.49 months), and 3.35 months (95% CI 1.66 to 5.40 months) in the ITT population, BRCA-mutated cohort, HRD cohort, and BRCA wild-type/LOH low patient subgroup, respectively. Q-TWiST with toxicity defined using select grade ≥2 TEAEs also consistently favoured rucaparib.

The authors concluded that in their analyses, rucaparib provided significant benefits to patient health status even when accounting for toxicities, as demonstrated by QA-PFS and Q-TWiST analyses. These benefits were observed in the ITT population and in subgroups of patients with a BRCA-mutated tumour and those with a BRCA wild-type tumour. Across analysis groups, rucaparib maintenance treatment provided a significant benefit despite the impact of toxicities on patients’ health status, and patients treated with rucaparib had longer periods without clinically relevant symptoms compared with those receiving placebo. These findings demonstrated that rucaparib extended PFS in the maintenance setting without detrimental effects on patient health status.

The study was supported by Clovis Oncology.


Oza AM, Lorusso D, Aghajanian C, et al. Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma. JCO; Published online 24 August 2020. DOI: 10.1200/JCO.19.03107.



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

Targeted Therapy Based on Molecular Profiling of Malignant Mesothelioma Tumours Is Feasible

Targeted therapy recommendations can be made based on the molecular profiles of tumour samples from patients with metastatic malignant mesothelioma (MM) according to findings...

News digest – targeted radiation beam, precision medicine and our early detection roadmap

<img width="620" height="348" src="https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1.jpg" class="attachment-hero size-hero" alt srcset="https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1.jpg 620w, https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1-300x168.jpg 300w, https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1-220x123.jpg 220w, https://zniup3zx6m0ydqfpv9y6sgtf-wpengine.netdna-ssl.com/wp-content/uploads/2020/10/Radiation_hero-1-150x84.jpg 150w" sizes="(max-width: 620px) 100vw, 620px" data-attachment-id="18059" data-permalink="https://scienceblog.cancerresearchuk.org/2020/10/17/news-digest-targeted-radiation-beam-precision-medicine-and-our-early-detection-roadmap/radiation_hero-3/" data-orig-file="https://scienceblog.cancerresearchuk.org/wp-content/uploads/2020/10/Radiation_hero-1.jpg" data-orig-size="620,348" data-comments-opened="1"...

A Pet Pug Helped Two Sisters Realize They Both Had Breast Cancer

Sisters Amanda Tasca and Amy Niosi are grateful for one very perceptive pug. Amanda’s dog Daisy, a gift from her husband Steve and one...

Woman with Breast Cancer May Have Saved Her Twin’s Life by Revealing Her Lumpectomy Scar

When Meagan McCallum was diagnosed with breast cancer, she had no idea that her experience might actually save her sister’s life. Meagan underwent a...

Lo que debe saber sobre el cáncer de pulmón

La Dra. Jyoti D. Patel es profesora de Medicina y directora de Oncología Torácica de la Universidad de Chicago y es editora asociada para...

Alternatives for Outdoor Foods

Autumn has arrived, but that doesn’t mean outdoor dining has to end! You might be wondering what foods you could prepare that are healthy...