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#881 The NUVOLA TRIAL: neoadjuvant chemoteraphy in unresectable ovarian cancer with olaparib and weekly carboplatin plus paclitaxel. A phase II open-label multi-centre study
  1. Vanda Salutari1,
  2. Claudia Marchetti1,2,
  3. Viola Ghizzoni1,
  4. Elena Giudice2,
  5. Diana Giannarelli1,
  6. Riccardo Tudisco2,
  7. Maria Vittoria Carbone1,
  8. Barbara Costantini1,3,
  9. Angelica Naldini1,
  10. Caterina Ricci1,
  11. Carolina Maria Sassu1,
  12. Giulia Ponti1,
  13. Domenica Lorusso1,2,
  14. Anna Fagotti1,2 and
  15. Giovanni Scambia1,2
  1. 1Fondazione Policlinico Agostino Gemelli IRCCS, Rome, Italy
  2. 2Università Cattolica del Sacro Cuore, Rome, Italy
  3. 3Unicamillus, International Medical University in Rome, Rome, Italy


Introduction/Background Neoadjuvant chemotherapy (NACT) and subsequent interval debulking surgery (IDS) represent an alternative treatment for advanced ovarian cancer (AOC) patients not suitable for primary debulking surgery (PDS). BRCA mutated (BRCAmut) patients are known to benefit from PARP inhibition as maintenance in terms of response rate and survival. In this trial, we investigated Olaparib in combination with standard carboplatin-paclitaxel chemotherapy as NACT for BRCAmut AOC patients..

Methodology This phase II, single-arm, open-label trial enrolled BRCAmut, FIGO stage III-IV high-grade serous or endometrioid AOC patients, not suitable for PDS. Patients received 3 cycles of NACT with weekly Carboplatin AUC2 - Paclitaxel 60mg/m2 in combination with intermittent Olaparib 150 mg bid orally, days 1 to 3. After NACT, patients were evaluated for IDS (figure 1). The primary endpoint was pathological complete response (pCR) in almost 20% of cases, considering a reported reference rate of PCR at 6% [Petrillo et al., Am J Obstet Gynecol. 2014].

Results Out of 37 patients screened, 35 met the eligibility criteria and were included in the study. pCR was found in 11.4% of cases. Interestingly, 28.6% of patients achieved a chemotherapy response score (CRS) 3, while a CRS2 was found in 40% of participants, and CRS1 in 17.1%. Treatment-Related Adverse Events (TRAEs)≥3 were reported in 83.3% of patients; specifically, neutropenia in 66.7%, anemia in 13.9%, and thrombocytopenia in 11.1% of cases. Grade ≥3 non-hematological TRAEs were not reported.

Conclusion Despite the higher prevalence of pCR rate with the addition of Olaparib to NACT relative to historical controls, the trial did not meet its primary endpoint. Olaparib in combination with chemotherapy reported higher hematological toxicity compared to chemotherapy alone; nevertheless, the tolerability profile of the combination was manageable.

Disclosures V.S. reports Honoraria/consultation fees from AstraZeneca, MSD, GSK, Pharmamar and Novocure; C.M. reports Honoraria/consultation fees from AstraZeneca and Pharmamar, research grants/supports from AstraZeneca, Pharmamar, MSD, GSK, and Menarini; D.L. reports consulting or advisory role at PharmaMar, Merck Serono, Novartis; speakers’ bureau fees from AstraZeneca, Clovis Oncology, PharmaMar, and Tesaro/GSK; research funding (to institution) from Clovis Oncology, Merck, PharmaMar, and Tesaro/GSK; personal financial interest in AstraZeneca, Clovis Oncology, PharmaMar, Roche, and Tesaro/GSK; Honoraria from AstraZeneca, Clovis Oncology, Genmab, Immunogen, Merck, Roche, and Tesaro/GSK; Expert testimony on behalf of Clovis Oncology; A.F. reports Honoraria/consultation fees from Johnson&Johnson, research grants/supports from AstraZeneca, speakers’ bureau fees from Fondazione Interazionale Menarini; G.S. reports Honoraria/consultation fees from Covidien AG, AstraZeneca, MSD, speakers’ bureau fees from Olympus Europa, Baxter Healthcare, Intuitive Surgical Inc., GlaxoSmithKline; V.G., E.G, D.G, R.T., M.V.C., B.C., A.N., C.R., C.M.S., G.P. have nothing to disclose.

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