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Evaluation of Pegylated Liposomal Doxorubicin Dose on the Adverse Drug Event Profile and Outcomes in Treatment of Recurrent Endometrial Cancer
  1. Justin M. Julius, PharmD*,
  2. Janos L. Tanyi, MD, PhD,
  3. Graciela M. Nogueras-Gonzalez, MPH,
  4. Jack L. Watkins, PharmD*,
  5. Robert L. Coleman, MD§,
  6. Judith K. Wolf, MD and
  7. Judith A. Smith, PharmD, BCOP, CPHQ, FCCP, FISOPP*,§,
  1. *Division of Pharmacy, The University of Texas MD Anderson Cancer Center;
  2. Department of Obstetrics and Gynecology, Baylor College of Medicine;
  3. Department of Biostatistics, The University of Texas MD Anderson Cancer Center; and
  4. §Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX;
  5. MD Anderson–Banner, Phoenix, AZ; and
  6. Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Sciences Center, Houston, TX.
  1. Address correspondence and reprint requests to Judith A. Smith, PharmD, BCOP, CPHQ, FCCP, FISOPP, Department Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, CPB6.3244 1155 Herman Pressler, Unit 1362 Houston, TX 77230. E-mail: jasmith@mdanderson.org.

Abstract

Objective This study aims to determine factors that may increase the likelihood of adverse drug events (ADEs) in patients with recurrent endometrial cancer treated with pegylated liposomal doxorubicin (PLD) as well as this agent’s impact on clinical outcomes.

Methods The treatment records of patients with endometrial cancer who received PLD at The University of Texas, MD Anderson Cancer Center, from 1996 to 2006 were reviewed. Patient demographics, PLD dose, ADEs, use of supportive care interventions, disease progression, and survival were extracted. Logistical regression analysis was used to identify factors that were associated with higher incidence of ADEs and that influenced survival.

Results A total of 60 patients with recurrent endometrial cancer were identified who experienced 122 ADEs. The most commonly reported ADEs were nausea (18.9%), palmar-plantar erythrodysesthesia (PPE; 16.4%), muscle weakness (12.3%), mucositis (10.7%), and peripheral neuropathy (9.8%). Seventeen patients (28%) required a dose reduction because of ADEs. However, only 5 (8.3%) patients discontinued therapy because of toxicity. Cooling mechanisms were used in 19 patients to prevent PPE, although 9 of these patients still experienced PPE. Treatment with 6 or more cycles of PLD was associated with increased incidence of neutropenia (P = 0.045), peripheral neuropathy (P = 0.004), and PPE (P < 0.001). No differences in progression-free survival or time to progression were found between the doses of PLD; however, there was an assessable trend toward increased survival with doses of 40 mg/m2.

Conclusions Although there was no association with dose level and ADEs, more cycles received increased the incidence of toxicities, including PPE and neuropathy. There was no association between different doses of PLD and progression-free survival or time to progression.

  • Adverse effects
  • Dose intensity
  • Doxil
  • Endometrial cancer

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Footnotes

  • This work was supported in part by the Cancer Center Support Grant (NCI Grant P30 Ca016672). R.L.C. is supported by the Ann Rife Cox Chair in Gynecology.

  • The authors declare no conflicts of interest.

  • Author Contributions: Conception and design: Judith K. Wolf, Judith A. Smith, Robert Coleman; collection and assembly of data: Justin M. Julius, Janos L. Tanyi, Judith A. Smith, Lafit R. Mora; data analysis and interpretation: Justin M. Julius, Judith A. Smith, Judith K. Wolf, Graciela M. Nogueras-Gonzalez, Robert Coleman, Jack Watkins; manuscript writing: Justin M. Julius, Judith A. Smith, Judith K. Wolf, Robert Coleman, Jack Watkins.

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