Neoadjuvant chemotherapy followed by fast-track cytoreductive surgery plus short-course hyperthermic intraperitoneal chemotherapy (HIPEC) in advanced ovarian cancer: preliminary results of a promising all-in-one approach

Thales Paulo Batista, Vandré Cabral G Carneiro, Rodrigo Tancredi, Ana Ligia Bezerra Teles, Levon Badiglian-Filho, Cristiano Souza Leão, Thales Paulo Batista, Vandré Cabral G Carneiro, Rodrigo Tancredi, Ana Ligia Bezerra Teles, Levon Badiglian-Filho, Cristiano Souza Leão

Abstract

Purpose: Hyperthermic intraperitoneal chemotherapy (HIPEC) has been considered a promising treatment option for advanced or recurrent ovarian cancer, but there is no clear evidence based on randomized controlled trials to advocate this approach as a standard therapy. In this study, we aim to present the early outcomes and insights after an interim analysis of a pioneering clinical trial in Brazil.

Methods: This study was a cross-sectional analysis of early data from our ongoing clinical trial - an open-label, double-center, single-arm trial on the safety and efficacy of using HIPEC for advanced ovarian cancer (ClinicalTrials.gov: NCT02249013). A fast-track recovery strategy was also applied to improve patient outcomes.

Results: Nine patients with stage IIIB (n=1) or IIIC (n=8) epithelial malignancies were enrolled until February 2017. The median (range) serum CA125 level at diagnosis was 692 (223.7-6550) U/mL. The median number of preoperative cycles of intravenous (i.v.) chemotherapy was 3 (2-4), resulting in peritoneal cancer index scores of 9 (3-18) at the time of HIPEC. Time of restarting i.v. chemotherapy was 37 (33-50) days with all patients completing 6 cycles as planned. The median operation time was 395 (235-760) minutes, the length of hospital stay was 4 (3-10) days, and all the patients left the ICU on the morning after the procedure. Two patients experienced no postoperative complications, whereas 91% of the complications were minor G1/G2 events. Preliminary assessment also suggested no impairment of the patient's quality of life.

Conclusion: Our comprehensive protocol might represent a promising all-in-one approach for advanced ovarian cancer. The patient recruitment for this trial is ongoing.

Keywords: hyperthermia; ovarian neoplasms; peritoneal carcinomatosis; peritoneal neoplasms; peritoneal surface malignancy.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flow diagram summarizing the number of patients who were assessed for eligibility, recruited to participate, assigned to HIPEC, and included in the analyses. Abbreviations: HIPEC, hyperthermic intraperitoneal chemotherapy; NACT, neoadjuvant chemotherapy.
Figure 2
Figure 2
Course of the patient-reported health-related quality of life over time, according to EORTC QLQ-C30 functioning scales. All subscale responses were converted to 0–100 scales (according to the EORTC guidelines). Abbreviations: EORTC, European Organisation for Research and Treatment of Cancer; HIPEC, hyperthermic intraperitoneal chemotherapy.

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