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Clinical and molecular signature of survival and resistance to olaparib plus pegylated liposomal doxorubicin in platinum-resistant ovarian cancer: a stratified analysis from the phase II clinical trial ROLANDO, GEICO-1601.
Perez-Fidalgo, José Alejandro; Guerra, Eva; García, Yolanda; Iglesias, María; Hernández-Sosa, María; Estevez-García, Purificación; Manso Sánchez, Luis; Santaballa, Ana; Oaknin, Ana; Redondo, Andres; Rubio, M Jesús; González-Martín, Antonio.
Affiliation
  • Perez-Fidalgo JA; Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Valencia, Spain japfidalgo@msn.com.
  • Guerra E; Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain.
  • García Y; Department of Medical Oncology, Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí I3PT. Universitat Autònoma de Barcelona, Sabadell, Spain.
  • Iglesias M; Department of Medical Oncology, Hospital Son Llatzer, Palma De Mallorca, Palma de Mallorca, Spain.
  • Hernández-Sosa M; Department of Medical Oncology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas De Gran Canaria, Spain.
  • Estevez-García P; Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
  • Manso Sánchez L; Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
  • Santaballa A; Department of Medical Oncology, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
  • Oaknin A; Department of Medical Oncology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
  • Redondo A; Department of Medical Oncology, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.
  • Rubio MJ; Department of Medical Oncology, Hospital Universitario Reina Sofia, Cordoba, Spain.
  • González-Martín A; Department of Medical Oncology, Clínica Universidad de Navarra, Madrid, Spain.
Int J Gynecol Cancer ; 33(6): 929-936, 2023 06 05.
Article in En | MEDLINE | ID: mdl-36759001
ABSTRACT

OBJECTIVE:

To determine the potential prognostic value of clinical and molecular biomarkers in the survival of patients with platinum-resistant ovarian cancer treated with olaparib and pegylated liposomal doxorubicin.

METHODS:

ROLANDO was a single-arm phase II trial that included patients with high-grade serous or endometrioid tumors and at least one previous platinum-resistant recurrence regardless of BRCA status. Patients received 6 cycles of pegylated liposomal doxorubicin every 28 days plus olaparib 300 mg twice daily. followed by olaparib 300 mg twice daily; monotherapy until progression or unacceptable toxicity. Prognostic factors including previous lines (and platinum-containing ones), BRCA mutation status, previous bevacizumab, CA-125 levels, and the neutrophil/lymphocyte ratio, lymphocyte/monocyte ratio, and platelet/lymphocyte ratio calculated at inclusion were analyzed through a multivariate logistic regression and factor analysis of mixed data.

RESULTS:

Thirty-one patients were included. Median age was 57 years (range 43-75), Eastern Cooperative Oncolgy Group performance status 0/1 32.3%/67.7% and BRCA mutated 16.1%. Prior treatment lines were >2 lines 14 (45.2%) patients, ≥2 platinum lines 21 patients (67.7%) and previous bevacizumab 19 (61.3%) patients. CA-125 was >2 upper limit normal in 24 (77.4%) patients. A high neutrophil/lymphocyte ratio was associated with worse overall survival by univariate/multivariate regression model (HR=11.18; 95% CI 1.1 to 114.5; p=0.042). No other factors were associated with overall survival in the multivariate model. A multifactorial signature based on clinical and molecular baseline characteristics was capable of defining six patient clusters. Three of these clusters had significantly better prognosis, with a median overall survival of 21.3 months (95% CI 12.2 to not reached).

CONCLUSIONS:

High neutrophil/lymphocyte ratio at platinum-resistant relapse indicated poor prognosis in patients treated with olaparib plus pegylated liposomal doxorubicin. A multifactorial clinical signature was more precise than single variables for implying the prognosis and may help in therapeutic assignment after further validation in large prospective cohorts.
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Ovarian Neoplasms Type of study: Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Adult / Aged / Female / Humans / Middle aged Language: En Journal: Int J Gynecol Cancer Journal subject: GINECOLOGIA / NEOPLASIAS Year: 2023 Type: Article Affiliation country: Spain

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Ovarian Neoplasms Type of study: Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Adult / Aged / Female / Humans / Middle aged Language: En Journal: Int J Gynecol Cancer Journal subject: GINECOLOGIA / NEOPLASIAS Year: 2023 Type: Article Affiliation country: Spain