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Phase 2 Trial (POLA Study) of Lurbinectedin plus Olaparib in Patients with Advanced Solid Tumors: Results of Efficacy, Tolerability, and the Translational Study

Publicated to:Cancers. 14 (4): - 2022-02-01 14(4), DOI: 10.3390/cancers14040915

Authors: Poveda A; Lopez-Reig R; Oaknin A; Redondo A; Rubio MJ; Guerra E; Fariñas-Madrid L; Gallego A; Rodriguez-Freixinos V; Fernandez-Serra A; Juan O; Romero I; Lopez-Guerrero JA

Affiliations

Catholic Univ Valencia San Vicente Martir, Sch Med, Dept Pathol, Valencia 46001, Spain - Author
Centro de Investigacion Principe Felipe , Instituto Valenciano de Oncologia - Author
Fdn Inst Valenciano Oncol, Lab Mol Biol, Valencia 46009, Spain - Author
Fdn Inst Valenciano Oncol, Med Oncol, Valencia 46009, Spain - Author
Hosp Quironsalud, Initia Oncol, Oncogynecol Dept, Avda Blasco Ibanez 14, Valencia 46010, Spain - Author
Hosp Univ Ramon & Cajal, Med Oncol, Madrid 28034, Spain - Author
Hospital Quirónsalud Valencia - Author
Hospital Ramón y Cajal - Author
Hospital Universitari Vall d'Hebron - Author
Hospital Universitari Vall d'Hebron , Odette Cancer Centre - Author
Hospital Universitario La Paz - Author
Hospital Universitario Reina Sofía - Author
Instituto Valenciano de Oncologia - Author
Pivotal SLU, Med Oncol, Madrid 28023, Spain - Author
Principe Felipe Res Ctr CIPF, CIPF, IVO, Joint Res Unit Canc, Valencia 46012, Spain - Author
Saint Louis University, Madrid Campus - Author
Sunnybrook Hlth Sci Ctr, Odette Canc Ctr, Dept Med Oncol & Hematol, Toronto, ON M4N 3M5, Canada - Author
Univ Autonoma Madrid UAM, Hosp Univ La Paz IdiPAZ, Med Oncol Dept, Madrid 28049, Spain - Author
Univ Hosp Reina Sofia, Med Oncol Dept, Cordoba 14004, Spain - Author
Universidad Católica de Valencia San Vicente Mártir , Centro de Investigacion Principe Felipe , Instituto Valenciano de Oncologia - Author
Vall Hebron Univ Hosp, Vall Hebron Inst Oncol VHIO, Med Oncol Dept, Barcelona 08035, Spain - Author
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Abstract

We hypothesized that the combination of olaparib and lurbinectedin maximizes DNA damage, thus increasing its efficacy. The POLA phase 1 trial established the recommended phase 2 dose of lurbinectedin as being 1.5 mg (day 1) and that of olaparib as being 250 mg/12 h (days 1–5) for a 21-day cycle. In phase 2, we explore the efficacy of the combination in terms of clinical response and its correlation with mutations in the HRR genes and the genomic instability (GI) parameters. Results: A total of 73 patients with high-grade ovarian (n = 46), endometrial (n = 26), and triple-negative breast cancer (n = 1) were treated with lurbinectedin and olaparib. Most patients (62%) received ≥3 lines of prior therapy. The overall response rate (ORR) and disease control rate (DCR) were 9.6% and 72.6%, respectively. The median progression-free survival (PFS) was 4.54 months (95% CI 3.0–5.2). Twelve (16.4%) patients were considered long-term responders (LTR), with a median PFS of 13.3 months. No clinical benefit was observed for cases with HRR gene mutation. In ovarian LTRs, although a direct association with GI and a total loss of heterozygosity (LOH) events was observed, the association did not reach statistical significance (p = 0.055). Globally, the total number of LOHs might be associated with the ORR (p =0.074). The most common grade 3–4 toxicities were anemia and thrombocytopenia, in 6 (8.2%) and 3 (4.1%) patients, respectively. Conclusion: The POLA study provides evidence that the administration of lurbinectedin and olaparib is feasible and tolerable, with a DCR of 72.6%. Different GI parameters showed associations with better responses.

Keywords

endometrial cancergenomic instabilitylurbinectedinolaparibEndometrial cancerGenomic instabilityLurbinectedinOlaparibOvarian cancer

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Cancers due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2022, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Oncology.

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 2.6, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions Jun 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-06-27, the following number of citations:

  • WoS: 1
  • Scopus: 4

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-06-27:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 26.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 26 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 3.75.
  • The number of mentions on the social network X (formerly Twitter): 2 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
  • Assignment of a Handle/URN as an identifier within the deposit in the Institutional Repository: https://repositorio.uam.es/handle/10486/703782

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Canada.