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A Randomized Trial of Prophylactic Extended Carboplatin Infusion to Reduce Hypersensitivity Reactions in Recurrent Ovarian Cancer
  1. Katherine LaVigne, MD*,
  2. David M. Hyman, MD,,
  3. Qin C. Zhou, MA§,
  4. Alexia Iasonos, PhD§,
  5. William P. Tew, MD,,
  6. Carol Aghajanian, MD,,
  7. Vicky Makker, MD,,
  8. Martee L. Hensley, MD,,
  9. Jason Konner, MD,,
  10. Rachel N. Grisham, MD,,
  11. Nicholas Cangemi, BS,
  12. Krysten Soldan, BS,
  13. David R. Spriggs, MD,,
  14. Paul J. Sabbatini, MD, and
  15. Roisin E. O'Cearbhaill, MD,
  1. *Gynecology Service, Department of Surgery, and
  2. Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center;
  3. Department of Medicine, Weill Cornell Medical College; and
  4. §Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.
  1. Address correspondence and reprint requests to Roisin E. O'Cearbhaill, MD, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065. E-mail: ocearbhr@mskcc.org.

Abstract

Objective Hypersensitivity with repeated exposure to platinum agents is common and can preclude continued treatment, even in patients with disease that remains platinum sensitive. We sought to compare the effects of prophylactic, extended carboplatin infusion versus standard infusion on the rate of carboplatin hypersensitivity reactions (HSRs) in women with recurrent ovarian cancer.

Methods This was a single-institution, randomized, nonblinded trial comparing a graded, 3-hour extended infusion of carboplatin with a standard 30-minute infusion in patients with recurrent ovarian cancer who were enrolled from January 2011 to April 2015. The study was designed to detect a decrease in the HSR rate from 20% (standard infusion) to 5% (extended infusion) assuming a type 1 error of 10% and power of 80% using a 1-sided test.

Results Of 146 enrolled patients, 114 were evaluable. Fifteen (13%) had an HSR—11% (6/56) in the extended-infusion and 16% (9/58) in the standard-infusion groups (P = 0.582). Planned treatment completion was achieved in 50 (89%) of 56 patients and 49 (84%) of 58 patients, respectively. Of 25 patients who received single-agent carboplatin, 8 (32%) had an HSR (53% of all patients who had an HSR [8/15]). Of 23 patients who received carboplatin with gemcitabine, 4 (17%) had an HSR (27% of all patients who had an HSR [4/15]). Of 8 patients who received carboplatin with paclitaxel, 3 (38%) had an HSR (20% of all patients who had an HSR [3/15]). There were no HSRs with pegylated liposomal doxorubicin, the most commonly given concurrent chemotherapy (46% of all patients).

Conclusions A prophylactic, extended carboplatin infusion was not associated with a decreased HSR rate. The overall low HSR rate suggests that premedication may help reduce HSRs.

  • Carboplatin
  • Extended infusion
  • Hypersensitivity
  • Hypersensitivity reactions
  • Ovarian cancer

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Footnotes

  • This work was supported in part by the National Institutes of Health/National Cancer Institute Cancer Center support grant P30 CA008748 and the Kaleidoscope of Hope Ovarian Cancer Foundation.

  • The authors declare no conflicts of interest.

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