Secondary cytoreduction and carboplatin hyperthermic intraperitoneal chemotherapy for platinum-sensitive recurrent ovarian cancer: An MSK Team Ovary phase II study Journal Article


Authors: Zivanovic, O.; Chi, D. S.; Zhou, Q.; Iasonos, A.; Konner, J. A.; Makker, V.; Grisham, R. N.; Brown, A. K.; Nerenstone, S.; Diaz, J. P.; Schroeder, E. D.; Langstraat, C. L.; Paroder, V.; Lakhman, Y.; Soldan, K.; Su, K.; Gardner, G. J.; Andikyan, V.; Guo, J.; Jewell, E. L.; Long Roche, K.; Troso-Sandoval, T.; Lichtman, S. M.; Moukarzel, L. A.; Dessources, K.; Abu-Rustum, N. R.; Aghajanian, C.; Tew, W. P.; Beumer, J.; Sonoda, Y.; O'Cearbhaill, R. E.
Article Title: Secondary cytoreduction and carboplatin hyperthermic intraperitoneal chemotherapy for platinum-sensitive recurrent ovarian cancer: An MSK Team Ovary phase II study
Abstract: PURPOSE The purpose of this phase II study was to evaluate hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin for recurrent ovarian cancer during secondary cytoreductive surgery. MATERIALS AND METHODS Patients were intraoperatively randomly assigned to carboplatin HIPEC (800 mg/m(2) for 90 minutes) or no HIPEC, followed by five or six cycles of postoperative IV carboplatin-based chemotherapy, respectively. Based on a binomial single-stage pick-the-winner design, an arm was considered winner if >= 17 of 49 patients were without disease progression at 24 months post-surgery. Secondary objectives included postoperative toxicity and HIPEC pharmacokinetics. RESULTS Of 98 patients, 49 (50%) received HIPEC. Complete gross resection was achieved in 82% of the HIPEC patients and 94% of the standard-arm patients. Bowel resection was performed in 37% of patients in the HIPEC arm compared with 65% in the standard (P = .008). There was no perioperative mortality and no difference in use of ostomies, length of stay, or postoperative toxicity. At 24 months, eight patients (16.3%; 1-sided 90% CI, 9.7 to 100) were without progression or death in the HIPEC arm and 12 (24.5%; 1-sided 90% CI, 16.5 to 100) in the standard arm. With a medium follow-up of 39.5 months, 82 patients progressed and 37 died. The median progression-free survival in the HIPEC and standard arms were 12.3 and 15.7 months, respectively (hazard ratio, 1.54; 95% CI, 1 to 2.37; P = .05). There was no significant difference in median overall survival (52.5 v 59.7 months, respectively; hazard ratio, 1.39; 95% CI, 0.73 to 2.67; P = .31). These analyses were exploratory. CONCLUSION HIPEC with carboplatin was well tolerated but did not result in superior clinical outcomes. This study does not support the use of HIPEC with carboplatin during secondary cytoreductive surgery for platinum-sensitive recurrent ovarian cancer.
Keywords: cisplatin; maintenance therapy; carcinoma; surgery; solid tumors; double-blind; primary peritoneal; fallopian-tube; epithelial ovarian; open-label
Journal Title: Journal of Clinical Oncology
Volume: 39
Issue: 23
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2021-08-10
Start Page: 2594
End Page: 2604
Language: English
ACCESSION: WOS:000708050000010
DOI: 10.1200/jco.21.00605
PROVIDER: wos
PMCID: PMC8330970
PUBMED: 34019431
Notes: Article -- Source: Wos
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MSK Authors
  1. Ginger J Gardner
    270 Gardner
  2. Vicky Makker
    265 Makker
  3. Yuliya Lakhman
    96 Lakhman
  4. Elizabeth Jewell
    131 Jewell
  5. Dennis S Chi
    707 Chi
  6. Yukio Sonoda
    472 Sonoda
  7. Jason Konner
    156 Konner
  8. Oliver Zivanovic
    291 Zivanovic
  9. Qin Zhou
    254 Zhou
  10. Stuart Lichtman
    228 Lichtman
  11. Alexia Elia Iasonos
    363 Iasonos
  12. Rachel Nicole Grisham
    170 Grisham
  13. William P Tew
    245 Tew
  14. Viktoriya Paroder
    60 Paroder
  15. Krysten Nicole Soldan
    10 Soldan
  16. Katy Su
    3 Su