The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.
Phase II, Open-Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of Olaparib, a Poly (ADP-Ribose) Polymerase Inhibitor, and Pegylated Liposomal Doxorubicin in Patients With BRCA1 or BRCA2 Mutations and Recurrent Ovarian Cancer
Abstract
Purpose: Olaparib (AZD2281), an orally active poly (ADP-ribose) polymerase inhibitor that induces synthetic lethality in BRCA1- or BRCA2-deficient cells, has shown promising clinical efficacy in nonrandomized phase II trials in patients with ovarian cancer with BRCA1 or BRCA2 deficiency. We assessed the comparative efficacy and safety of olaparib and pegylated liposomal doxorubicin (PLD) in this patient population. Patients and Methods: In this multicenter, open-label, randomized, phase II study, patients with ovarian cancer that recurred within 12 months of prior platinum therapy and with confirmed germline BRCA1 or BRCA2 mutations were enrolled. Patients were assigned in a 1:1:1 ratio to olaparib 200 mg twice per day or 400 mg twice per day continuously or PLD 50 mg/m 2 intravenously every 28 days. The primary efficacy end point was Response Evaluation Criteria in Solid Tumors (RECIST) –assessed progression-free survival (PFS). Secondary end points included objective response rate (ORR) and safety. Results: Ninety-seven patients were randomly assigned. Median PFS was 6.5 months (95% CI, 5.5 to 10.1 months), 8.8 months (95% CI, 5.4 to 9.2 months), and 7.1 months (95% CI, 3.7 to 10.7 months) for the olaparib 200 mg, olaparib 400 mg, and PLD groups, respectively. There was no statistically significant difference in PFS (hazard ratio, 0.88; 95% CI, 0.51 to 1.56; P = .66) for combined olaparib doses versus PLD. RECIST-assessed ORRs were 25%, 31%, and 18% for olaparib 200 mg, olaparib 400 mg, and PLD, respectively; differences were not statistically significant. Tolerability of both treatments was as expected based on previous trials. Conclusion: The efficacy of olaparib was consistent with previous studies. However, the efficacy of PLD was greater than expected. Olaparib 400 mg twice per day is a suitable dose to explore in further studies in this patient population.
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New Guidelines to Evaluate the Response to Treatment in Solid Tumors
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Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy
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“7) for the olaparib 200 mg, olaparib 400 mg, and PLD cohorts, respectively [17].”
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Liu, J. F., Barry, W. T., Birrer, M., Lee, J.-M., Buckanovich, R. J., Fleming, G. F., Rimel, B., Buss, M. K., Nattam, S., Hurteau, J., et al. (2014) · The Lancet Oncology · doi:10.1016/s1470-2045(14)70391-2 · Cited by 585
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Metadata
- Authors
- Kaye, S. B., Lubinski, J., Matulonis, U., Ang, J. E., Gourley, C., Karlan, B. Y., Amnon, A., Bell-McGuinn, K. M., Chen, L.-M., Friedlander, M., Safra, T., Vergote, I., Wickens, M., Lowe, E. S., Carmichael, J., & Kaufman, B.
- Venue
- Journal of Clinical Oncology
- Published
- 2012-02-01
- Volume
- 30
- Issue
- 4
- Pages
- 372-379
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2147071985
- Cited by
- 470
- References
- 22
- FWCI
- 17.10
- Type
- journal article
- Language
- en
- Open access
- closed
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- Kaye, S. B., Lubinski, J., Matulonis, U., Ang, J. E., Gourley, C., Karlan, B. Y., Amnon, A., Bell-McGuinn, K. M., Chen, L.-M., Friedlander, M., Safra, T., Vergote, I., Wickens, M., Lowe, E. S., Carmichael, J., & Kaufman, B. (2012). Phase II, Open-Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of Olaparib, a Poly (ADP-Ribose) Polymerase Inhibitor, and Pegylated Liposomal Doxorubicin in Patients With BRCA1 or BRCA2 Mutations and Recurrent Ovarian Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2011.36.9215
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