Health-related quality of life (QoL) in platinum-resistant ovarian cancer patients treated with olaparib and pegylated liposomal doxorubicin (PLD), a multicenter single-arm phase II clinical trial (ROLANDO, GEICO-1601).

Authors

null

José Alejandro Perez-Fidalgo

Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Valencia, Spain

José Alejandro Perez-Fidalgo , Alfonso Cortés Salgado , Yolanda García , María Iglesias , Uriel Bohn Sarmiento , Elisa Calvo García , Luis Manso Sánchez , Ana Santaballa , Ana Oaknin , Andrés Redondo , María Jesus Rubio , Antonio González-Martín

Organizations

Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Valencia, Spain, Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain, Department of Medical Oncology, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain, Department of Medical Oncology, Hospital Son Llatzer, Palma De Mallorca, Spain, Department of Medical Oncology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas De Gran Canaria, Spain, Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain, Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain, Department of Medical Oncology, Hospital Universitari i Politècnic La Fe, Valencia, Spain, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, Hospital Universitario La Paz – IdiPAZ, Madrid, Spain, Department of Medical Oncology, Hospital Universitario Reina Sofia, Córdoba, Spain, Department of Medical Oncology, Clínica Universidad de Navarra, Madrid, Spain

Research Funding

Other
AstraZeneca

Background: The prognosis for patients with platinum-resistant/refractory ovarian cancer (PROC) is poor, and the aim of treatment is focused primarily on symptom control and maintenance of QoL. The objective of this study was to assess the impact on QoL of the combination of pegylated liposomal doxorubicin (PLD) with olaparib (OLA) in PROC patients (pts). Methods: ROLANDO is a single arm phase II trial that enrolled pts with high-grade serous or endometrioid and at least one previous PROC recurrence (between 28 days - 6 months after last platinum). Up to 4 previous lines (up to 5 in BRCA-mut) were allowed. Pts received 6 cycles of PLD 40 mg/m2 intravenously every 28 days + OLA 300 mg b.i.d. followed by OLA 300 mg b.i.d. monotherapy until progression or unacceptable toxicity. QoL was measured by European Organization for Research and Treatment of Cancer QLQ C30 questionnaire evaluating functional status, and symptom intensity and QLQ OV-28 ovarian cancer specific module, both filled out by pts every 4 months (mo) regardless of disease progression. Questionnaire compliance was reported as percentage of the initial number of pts. Changes between baseline and subsequent visits (Wilcoxon rank test) were evaluated. P values < 0.05 were considered significant. Results: From 2017 to 2020, 31 pts were recruited. Median age was 57 y.o., ECOG 0/1: 32.3%/67.7%. Median of prior lines was 2 (range 1-5) and pts were on study treatment for a median of 5 mo (range 1.4-19.5) for OLA and 5 cycles (range 2 - 6) for PLD. QoL information was available at baseline for 30 (97%) pts and decayed to 22 (71%), 13 (42%), 6 (19%) and 4 (13%) pts at 4, 8, 12, and 16 mo respectively. Global health status measured by QLQ C30 and QLQ OV-28 scores was maintained throughout all time points with no significant differences. Significant transient improvement was seen in social functioning after 12 mo (p = 0.013). Nausea-vomiting (p = 0.02), hair loss (p = 0.012) and constipation (p = 0.037) showed a significant increase at 4 mo overlapping with PLD administration, and returned to baseline levels afterwards. This was in line with the reported adverse reactions frequency of nausea (58.1%) and vomiting (45.2%). Dyspnea showed a transient significant increase at 12 mo (p = 0.012), whereas insomnia (p = 0.038) and attitude towards disease (p = 0.007) improved at 16 mo. Symptoms such as appetite and constipation did not change after 12 mo. Most functional scales (physical, role, emotional, cognitive, body, sexuality) and symptom scales (fatigue, pain, appetite loss, diarrhoea, neurologic, hormonal and economic burden) had no statistically significant changes. Conclusions: Pts treated with OLA+PLD combination reported no signs of clinically relevant deterioration of QoL while on treatment. All QoL items changes were transient in no more than 1 time-point. Clinical trial information: NCT03161132

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT03161132

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 5549)

DOI

10.1200/JCO.2021.39.15_suppl.5549

Abstract #

5549

Poster Bd #

Online Only

Abstract Disclosures