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Poster display session

3613 - Outcomes of the combination trabectedin and pegylated liposomal doxorubicin (T-PLD) in recurrent platinum-sensitive ovarian cancer (OC): a GINECO cohort study

Date

09 Sep 2017

Session

Poster display session

Presenters

Frédéric Selle

Citation

Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372

Authors

F. Selle1, P. Heudel2, Y. Tazi3, A. Pozet4, A. Hardy-Bessard5, J. Meunier6, L. Gladieff7, J. Lotz8, M. Provansal9, P. Augereau10, J. Frenel11, N. Bonichon-Lamichhane12, H. Orfeuvre13, F. Pommeret14, M. Torres-Macque15, E. Kalbacher16, C. Roemer-Becuwe17

Author affiliations

  • 1 Medical Oncology, Groupe Hospitalier Diaconesse Croix Saint Simon, 75020 - PARIS/FR
  • 2 Oncology, Centre Léon Bérard, 69373 - Lyon/FR
  • 3 Oncologie Libérale, Centre de Radiothérapie - Clinique Sainte-Anne, 67000 - Strasbourg/FR
  • 4 Ethodological And Quality Of Life Unit In Oncology (inserm Umr 1098), University Hospital Jean Minjoz, 25000 - Besançon/FR
  • 5 Oncologie, Centre CARIO - HPCA, 22190 - PLERIN-SUR-MER/FR
  • 6 Service Oncologie Médicale, Centre Hospitalier Régional d'Orléans, 45067 - ORLEANS/FR
  • 7 Département D'oncologie Médicale, Institut Claudius Regaud, 31059 - TOULOUSE/FR
  • 8 Service D'oncologie Médicale, Hôpital Tenon, 75970 - PARIS/FR
  • 9 Medical Oncology, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 10 Service D'oncologie Médicale, Centre Paul Papin, 49055 - Angers/FR
  • 11 Oncology, ICO Centre René Gauducheau, 44805 - SAINT-HERBLAIN/FR
  • 12 Oncologie - Radiothérapie, Clinique Tivoli, 33000 - BORDEAUX/FR
  • 13 Service Onco-hématologie, Hôpital Fleyriat, 01012 - BOURG-EN-BRESSE/FR
  • 14 Oncology, Gustave Roussy, 94805 - VILLEJUIF/FR
  • 15 Recherche Clinique, ARCAGY-GINECO, 75004 - Paris/FR
  • 16 Radiothérapie - Oncologie, CHU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 17 Oncology, ORACLE - Centre d'Oncologie de Gentilly, 54100 - NANCY/FR
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Resources

Abstract 3613

Background

T-PLD is an effective alternative for the treatment of recurrent platinum-sensitive OC, especially in the partially platinum-sensitive population with a platinum-free interval (PFI) of 6-12 months. The aim of this work was to assess the clinical impact of the combination when used in routine practice.

Methods

This was a prospective, multicenter study carried out in 25 French centers. Eligible patients (pts) were women ≥18 years old with histologically proven relapsed disease following at least one platinum-based chemotherapy and candidates to receive T (1.1 mg/m2) plus PLD (30 mg/m2). Analysis were performed according to the PFI subgroups (PFI 6-12 and PFI>12 [fully platinum-sensitive]) using Stata and R software.

Results

From 07/2014 to 06/2016, 91 pts with platinum-sensitive OC were included (median age 65 years-old, range: 42-86). Most pts had PFI 6-12 (n = 58; 63.7%) vs. n = 33 with PFI>12. Pts were treated with a median of 6 cycles (range: 1-12) of T-PLD. 47 (51.6%) pts received T-PLD as ≥ 3rd line of chemotherapy (range: 2-8). The toxicity profile in the PFI subgroups was not different from that of the overall population. The number of pts with grade 3/4 hematological toxicities in the PFI 6-12 and PFI>12 cohorts was: neutropenia 29.6%/17.6%, febrile neutropenia 4.4%/3.3%, thrombocytopenia 7.7%/12.1%, anemia 5.5%/2.2%. Grade 3 hand and foot syndrome (1 pt) and mucositis (1 pt) were observed in the PFI 6-12 group. Increases in transaminases (grade 3/4) were experienced by 11 pts (10/1) in the PFI 6-12 group and by 5 pts (4/1) in the PFI>12 group. 3 patients in the PFI 6-12 group and 3 in the PFI>12 group discontinued treatment because of toxicities, 6 and 2 due to premature death. Partial and complete responses were achieved in 43 pts (PFI 6-12: n = 26; PFI>12: n = 17, p = 0.82). Median PFS after T-PLD was 5.9 months (95%CI 4.9-6.7) in the PFI 6-12 group and 5.8 months (95%CI 3.7-8.5, logrank p = 0.37) in the PFI>12 group. OS data were not mature at the time of this analysis.

Conclusions

The safety profile of T-PLD when used in real-life management of non-selected OC pts is similar to that observed in clinical trials. T-PLD remains a valuable option to pts with both partially and fully platinum-sensitive disease.

Clinical trial identification

NCT02163720 May 28, 2014

Legal entity responsible for the study

ARCAGY-GINECO

Funding

PharmaMar

Disclosure

L. Gladieff: PharmaMar fees in 2015 and 2016. All other authors have declared no conflicts of interest.

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