Phase 2 non-randomised trial of secondary cytoreduction and hyperthermic intraperitoneal chemotherapy in recurrent platinum-sensitive ovarian cancer.

Autor:	Raj H; Department of Surgical Oncology, Cancer Institute (WIA), 38, Sardar Patel Road, Chennai 600036, Tamil Nadu, India.; Hemanth Raj and Marri Sri Santosh Keerthi contributed equally., Keerthi MSS; Department of Surgical Oncology, Cancer Institute (WIA), 38, Sardar Patel Road, Chennai 600036, Tamil Nadu, India.; Hemanth Raj and Marri Sri Santosh Keerthi contributed equally., Palaniappan R; Department of Surgical Oncology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry 605102, India., Prakash U; Department of Surgical Oncology, Cancer Institute (WIA), 38, Sardar Patel Road, Chennai 600036, Tamil Nadu, India., Dhanushkodi M; Department of Medical Oncology, Cancer Institute (WIA), 38, Sardar Patel Road, Chennai 600036, Tamil Nadu, India.; https://orcid.org/0000-0002-8192-3856., Ganesan TS; Department of Medical Oncology, Cancer Institute (WIA), 38, Sardar Patel Road, Chennai 600036, Tamil Nadu, India.
Jazyk:	angličtina
Zdroj:	Ecancermedicalscience [Ecancermedicalscience] 2021 Jul 05; Vol. 15, pp. 1260. Date of Electronic Publication: 2021 Jul 05 (Print Publication: 2021).
DOI:	10.3332/ecancer.2021.1260
Abstrakt:	Background: The role of secondary cytoreduction with hyperthermic intraperitoneal chemotherapy (HIPEC) is not clearly defined in recurrent platinum-sensitive ovarian cancer (PSOC). There is a paucity of studies on secondary cytoreduction with HIPEC in PSOC from developing countries like India. This study was done to assess the feasibility and safety of secondary cytoreduction and HIPEC in recurrent PSOC. Methods: This was a prospective, non-randomised, open-label, phase 2 trial of secondary cytoreduction and HIPEC (Cisplatin 75 mg/m2 43°C over 60 minutes) in patients with recurrent platinum-sensitive epithelial carcinoma of ovary/fallopian tube/peritoneum done in a tertiary cancer centre from February 2016 to August 2019. The primary outcome was to assess the overall survival (OS) and the secondary outcomes were to assess the progression-free survival (PFS) and toxicity. Results: Twenty-seven patients were screened and among them, 15 patients were included in this analysis with a median follow-up of 25 months. The mean cancer antigen (CA) 125 at the time of recurrence was 149 U/mL (range: 10-2,030 U/mL) and the median platinum-free interval was 21 months. The perioperative chemotherapy used was paclitaxel + carboplatin 53.3% (8/15), liposomal doxorubicin + carboplatin 40% (6/15) and none 6.5% (1/15). The median Peritoneal Carcinomatosis Index score was 8 (range: 3-25). The Clavien Dindo score was I, II and III in 6.7%, 26.7% and 13.3% patients, respectively. Recurrence was radiological and biochemical in 60% (9/15) and 7% (1/15), respectively. The most common site of recurrence was intra-abdominal (peritoneal). The median PFS and OS were 15 months (range: 0-34) and 26 months (range: 23-29), respectively. The grade 3 or 4 toxicity was 40%. Conclusion: Secondary cytoreduction with HIPEC is feasible and safe in recurrent PSOC. Conclusive evidence that secondary cytoreduction with HIPEC is essential awaits the results from ongoing randomised controlled trials. Competing Interests: The authors declare that they have no conflicts of interest. (© the authors; licensee ecancermedicalscience.)
Databáze:	MEDLINE
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