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P118 European, non-interventional, phase IV NIMES-ROC trial of trabectedin plus pegylated liposomal doxorubicin in patients with platinum-sensitive recurrent ovarian cancer: an interim analysis
  1. LM de Sande González1,
  2. G Scambia2,
  3. A Villanucci3,
  4. E Naglieri4,
  5. M Arruti Ibarbia5,
  6. F Brusa6,
  7. H Bourgeois7,
  8. R Sorio8,
  9. A Casado Herraez9,
  10. D Reichert10,
  11. C Dopchie11 and
  12. S Pignata12
  1. 1Hospital Universitario de León, León, Spain
  2. 2Policlinico Universitario Agostino Gemelli I.R.C.C.S. Universita Cattolica Di Roma, Roma
  3. 3Azienda Ospedaliero-Universitaria Careggi, Firenze
  4. 4Istituto Oncologico Giovanni Paolo II, Bari, Italy
  5. 5Hospital de Galdakao, Galdakao, Spain
  6. 6Ospedale Cardinal Massaia, Asti-Piemonte, Italy
  7. 7Centre Jean Bernard-Clinique Victor Hugo, Le Mans, France
  8. 8Centro di Riferimento Oncologico di Aviano (IRCCS), Aviano, Italy
  9. 9University Hospital San Carlos, Madrid, Spain
  10. 10Onkologie Westerstede, Medizinische Studiengesellschaft NORD-WEST GmbH, Westerstede, Germany
  11. 11CHWapi Site IMC, Centre Hospitalier Wallonie Picarde, Tournai, Belgium
  12. 12Istituto Nazionale Tumori Pascale – I.R.C.C.S. – Fondazione Pascale, Napoli, Italy


Introduction/Background The non-interventional NIMES-ROC phase IV trial (NCT02825420) evaluated trabectedin (Yondelis®)+pegylated liposomal doxorubicin (PLD) in real-life clinical practice, given in accordance with the marketing authorization to women with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of prior anti-angiogenic treatment.

Methodology We report the results of an interim analysis of the data from patients with PSROC treated with trabectedin+PLD within the approved schedule (PLD 30 mg/m² followed by 1.1 mg/m² trabectedin as 3-h/every 3 weeks). Eligible were adults with PSROC who have received ≥1 cycle of trabectedin+PLD before inclusion. The primary endpoint was to assess the progression-free survival (PFS) according to investigator criteria.

Results Overall, 158 adult patients from 50 sites across Spain, Italy, Germany, France and Belgium were evaluated. Median number of trabectedin+PLD cycles received per patient was 6, with 95 patients (50.6%) receiving ≥6 cycles and up 34 cycles. Median treatment duration and cycle duration were 22.2 weeks (range: 3–124) and 25.5 days (range: 21.0–73.0), respectively, with ≥63% of patients treated on an outpatient basis. Twenty-two patients received prior PLD or doxorubicin with no reported safety issues due to retreatment with trabectedin+PLD. With 73 PFS events and 32 deaths recorded, median PFS and overall survival were 11.4 months (95% CI: 10–14) and not reached (16.8-nr), respectively. The objective response rate was 38%, while 28.5% of patients had disease stabilization for a disease control rate of 66.5%. A total of 108 trabectedin-emergent adverse reactions (TEARs) occurred. Most common grade 3/4 TEARs were neutropenia (25%) and asthenia (4%).

Conclusion Acknowledging the interim results from observational studies need to be interpreted with caution, our preliminary data confirm that trabectedin+PLD is effective and safe in patients with PSROC. Our data favourably compare with those of the pivotal OVA-301 trial (NCT00113607; i.e. median PFS 9.2 months), even with more pretreated patient population (NIMES-ROC: 39.9% with ≥3 prior chemotherapy lines).

Disclosure Nothing to disclose.

Abstract P118 Table 1


Abstract P118 Table 2

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