Asian Pacific Journal of Cancer Prevention

Asian Pacific Journal of Cancer Prevention (아시아태평양암예방학회)
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Safety and Management of Toxicity Related to Aflibercept in Combination with Fluorouracil, Leucovorin and Irinotecan in Malaysian Patients with Metastatic Colorectal Cancer

  • Yusof, Mastura Md (Pantai Cancer Institute, Pantai Hospital Kuala Lumpur) ;
  • Abdullah, Nik MA (Department of Oncology, Pusat Perubatan Universiti Kebangsaan Malaysia) ;
  • Sharial, MSN Mohd (Department of Oncology, Pantai Hospital Ipoh) ;
  • Zaatar, Adel (Department of Oncology, Gleneagles Medical Center, Oncology Clinic)
  • Published : 2016.04.11
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Abstract

Background: Between October 2012 and February 2015, 25 patients with metastatic colorectal cancer (mCRC) (mean age, $57.0{\pm}12.1years$) were granted access to aflibercept via the Aflibercept Named Patient Program at four centers. Materials and Methods: Here we reported the initial experience of aflibercept / FOLFIRI in combination. We evaluated treatment-related adverse events (AEs), progression-free survival (PFS) and overall survival (OS). Results: The majority of the patients experienced gastrointestinal toxicity (grade 1-2), with diarrhea (52%), mucositis (52%), and nausea/vomiting (20%) being largely observed. Neutropenia (16%) and febrile neutropenia (8%) were common grade 3-4 hematological events. Aflibercept-related toxicity was managed as per practice guidelines. No grade 5 event was reported. Median PFS was 6.12 months (95% CI, 4.80-7.20) and OS was 12 months (95% CI, 9.80-14.18). The partial response (PR), stable disease (SD), and progressive disease (PD) rates were 25% (95% CI: 23.4-27.0), 37.5% (95% CI: 31.6-43.3), and 37.5% (95% CI: 22.5-52.5), respectively. Conclusions: Aflibercept/FOLFIRI can be administered safely in a second line setting to Malaysian patients with mCRC, as the AEs experienced were generally reversible and manageable. The safety and efficacy outcomes were consistent with those observed in Western populations.

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References

  1. Bai L, Zhang DS, Wu WJ, et al (2015). Clinical outcomes of Chinese patients with metastatic colorectal cancer receiving first-line bevacizumab-containing treatment. Med Oncol, 32, 469.
  2. Chiron M, Bagley RG, Pollard J (2014). Differential antitumor activity of aflibercept and bevacizumab in patient-derived xenograft models of colorectal cancer. Mol Cancer Ther, 13, 1636-44. https://doi.org/10.1158/1535-7163.MCT-13-0753
  3. Chiron M, Bagley RG, Pollard J, et al (2014). Differential antitumor activity of aflibercept and bevacizumab in patient-derived xenograft models of colorectal cancer. Mol Cancer Ther, 13, 1636-44. https://doi.org/10.1158/1535-7163.MCT-13-0753
  4. Common Terminology Criteria for Adverse Events v4.0 (CTCAE 2009). U.S department of health and human services.
  5. Do K, Cao L, Kang Z, et al (2015). A phase II study of sorafenib combined with cetuximab in EGFR-expressing, KRAS-mutated metastatic colorectal cancer. Clin Colorectal Cancer, 14, 154-61. https://doi.org/10.1016/j.clcc.2015.02.007
  6. Garcia-Alfonso P, Ferrer A, Gil S, et al (2015). Neoadjuvant and conversion treatment of patients with colorectal liver metastasis: the potential role of bevacizumab and other antiangiogenic agents. Target Oncol, 10, 453-65. https://doi.org/10.1007/s11523-015-0362-0
  7. Grothey A, Van Cutsem E, Sobrero A, et al (2013). Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet, 38, 303-12.
  8. Jitawatanarat P, Wee W (2013). Update on antiangiogenic therapy in colorectal cancer: aflibercept and regorafenib. J Gastrointest Oncol, 4, 231-8.
  9. Lee JJ, Chu E (2014). Sequencing of antiangiogenic agents in the treatment of metastatic colorectal cancer. Clin Colorectal Cancer, 13, 135-44. https://doi.org/10.1016/j.clcc.2014.02.001
  10. Lim KG (2014). A review of colorectal cancer research in malaysia. Med J Malaysia, 69, 23-32.
  11. Majid N, Ghissassi I, Mrabti H, et al (2015). Bevacizumab in clinical practice. Gulf J Oncol, 1, 33-7.
  12. Malaysia cancer statistics- Data and figure (2007). National Cancer Registry Report.
  13. Muhammad S, Jiang Z, Liu Z, Kaur K, Wang X (2013). The role of EGFR monoclonal antibodies (MoABs) cetuximab/panitumab, and BRAF inhibitors in BRAF mutated colorectal cancer. J Gastrointest Oncol, 4, 72-81.
  14. Nishino M, Jagannathan JP, Ramaiya NH, et al (2010). Revised RECIST guideline version 1.1: What oncologists want to know and what radiologists need to know. AJR Am J Roentgeno. 195, 281-9. https://doi.org/10.2214/AJR.09.4110
  15. Norwati D, Harmy MY, Norhayati MN, Amry AR (2014). Colorectal cancer screening practices of primary care providers: results of a national survey in Malaysia. Asian Pac J Cancer Prev, 15, 2901-4. https://doi.org/10.7314/APJCP.2014.15.6.2901
  16. Papadopoulos N, Martin J, Ruan Q (2012). Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis, 15, 171-85. https://doi.org/10.1007/s10456-011-9249-6
  17. Passardi A, Nanni O, Tassinari D, et al (2015). Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: final results for first-line treatment from the ITACa randomized clinical trial. Ann Oncol, 26, 1201-7. https://doi.org/10.1093/annonc/mdv130
  18. Patel A, Sun W (2014). Ziv-aflibercept in metastatic colorectal cancer. Biologics, 8, 13-25.
  19. Pourhoseingholi MA (2012). Increased burden of colorectal cancer in Asia. World J Gastrointest Oncol, 4, 68-70. https://doi.org/10.4251/wjgo.v4.i4.68
  20. Product Information (2012). ZALTRAP(R) intravenous injection, ziv-aflibercept intravenous injection. sanofi-aventis U.S.LLC (per FDA), Bridgewater, NJ.
  21. Syed YY, McKeage K (2015). Aflibercept: a review in metastatic colorectal cancer. Drugs, 75, 1435-45. https://doi.org/10.1007/s40265-015-0444-4
  22. Tang PA, Moore MJ (2013). Aflibercept in the treatment of patients with metastatic colorectal cancer: latest findings and+ interpretations. Therap Adv Gastroenterol, 6, 459-73. https://doi.org/10.1177/1756283X13502637
  23. Van Cutsem E, Tabernero J, Lakomy R, et al (2012) Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol, 30, 3499-506. https://doi.org/10.1200/JCO.2012.42.8201
  24. Wong NA, Gonzalez D, Salto-Tellez M (2014). RAS testing of colorectal carcinoma-a guidance document from the association of clinical pathologists molecular pathology and diagnostics group. J Clin Pathol, 67, 751-7. https://doi.org/10.1136/jclinpath-2014-202467
  25. Yoshida M, Muro K, Tsuji A (2015). Combination chemotherapy with bevacizumab and S-1 for elderly patients with metastatic colorectal cancer (BASIC trial). Eur J Cancer, 51, 935-41. https://doi.org/10.1016/j.ejca.2015.03.007

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