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  • 388 Short-course HIPEC at the time of interval debulking surgery for high tumor burden ovarian cancer: preliminary results of a pioneering clinical trial in brazil

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E-Poster viewings
Trials in Progress
IGCS19-0755
388 Short-course HIPEC at the time of interval debulking surgery for high tumor burden ovarian cancer: preliminary results of a pioneering clinical trial in brazil
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  1. T Batista1,2,
  2. V Carneiro1,3,
  3. R Tancredi4,
  4. L Badiglian-Filho5,
  5. B Sarmento6,
  6. R Costa7,
  7. A Lopes7,
  8. M Vieira8,
  9. F Lissa9 and
  10. C Leão10
  1. 1Instituto de Medicina Integral Professor Fernando Figueira IMIP, Department of Surgery/Oncology, Recife, Brazil
  2. 2Universidade Federal de Pernambuco UFPE, Department of Surgery, Recife, Brazil
  3. 3Hospital de Câncer de Pernambuco HCP, Department of Gynecology, Recife, Brazil
  4. 4Hospital de Câncer de Pernambuco HCP, Department of Clinical Oncology, Recife, Brazil
  5. 5AC Camargo Cancer Center, Department of Gynecology, São Paulo, Brazil
  6. 6Instituto Hospital de Base do Distrito Federal IHBDF, Service of Surgical Oncology, Brasília, Brazil
  7. 7Instituto Brasileiro de Controle do Cancer IBCC, Department of Gynecology, São Paulo, Brazil
  8. 8Hospital de Câncer de Barretos, Department of Gynecologic Oncology, Barretos, Brazil
  9. 9Hospital São José, Department of Surgery/Oncology, Criciúma, Brazil
  10. 10Instituto de Medicina Integral Professor Fernando Figueira IMIP, Department of Surgery, Recife, Brazil

Abstract

Objectives To present the postoperative outcomes in our ongoing clinical trial.

Methods Cross-sectional analysis of early data from our phase 2 trial – an open-label, multicenter, single-arm trial on the safety and efficacy of neoadjuvant chemotherapy (NACT) followed by fast-track cytoreductive surgery (CRS) plus short-course HIPEC in advanced ovarian cancer (ClinicalTrials.gov: NCT02249013).

Results Fifteen patients with stage IIIB (n=1) or IIIC (n=14) epithelial malignancies were enrolled until July, 2019. The median (range) age was 46 years (19–67), with preoperative serum CA125 levels of 737.7U/mL (161.6–6550). The median number of NACT cycles was 3 (2–4), resulting in PCI scores of 11 (3–18) at the time of CRS/HIPEC – developed after 29 days (26–43) from the last NACT cycle. Time to restarts i.v. chemotherapy was 39 days (31–74). Median operation time was 490 minutes (235–865), with 9 patients requiring major bowel resection as rectosigmoidectomy (n=8) or partial colectomy (n=1). Median length of hospital stay was 5 days (3–10), with ICU stay of 1 day (1–5). Four patients experienced no postoperative complications, whereas 5 suffered only minor G1/G2 complications, and 6 suffered major G3 complications, according to the NCI/CTCAE classification. The most common complications were electrolytes imbalance and anemia. Two patients experienced reoperation because of G3 postoperative hemorrhage or peritoneal infection, whereas no deaths were recorded.

Conclusions Our protocol seems to be feasible and safe, with manageable low rates of short- and middle-term complications. Recruitment to this pioneering clinical trial in Brazil is ongoing.

http://dx.doi.org/10.1136/ijgc-2019-IGCS.388

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