Korean Journal of Clinical Oncology (대한종양외과학회지)

Korean Society of Surgical Oncology (대한종양외과학회)
권호 표지
DOI QR코드

DOI QR Code

Nine months versus 12 months of adjuvant trastuzumab for patients with HER2-positive breast cancer

  • Received : 2018.08.06
  • Accepted : 2018.11.12
  • Published : 2018.12.31
⟨ Previous Next ⟩

Abstract

Purpose: This study aimed to compare the results of treatment with adjuvant trastuzumab for 9 months versus 12 months in human epidermal growth factor 2 (HER2)-positive breast cancer patients. The primary endpoint was disease-free survival. Secondary endpoints included cardiac safety, tolerability, and overall survival. Methods: The study included 60 non-metastatic HER2-positive breast cancer patients. All study patients underwent surgery, received adjuvant chemotherapy, radiotherapy and hormonal therapy if indicated. Thirty patients were randomized in each group. Group I patients received adjuvant trastuzumab for 12 months, while group II patients received adjuvant trastuzumab for 9 months. Patients were assessed by clinical examination and Echocardiography during treatment. Results: After median follow-up of 12 months, 90% of the patients in group I were disease free and 83.3% of patients in group II were disease free (P=0.402). All studied population in both groups I and II were alive at the end of the 1-year follow-up period after the completion of adjuvant trastuzumab treatment thus overall survival is 100%. Conclusion: Trastuzumab is tolerable and its side effects are reversible. Nine months of adjuvant trastuzumab treatment is more cost effective than the standard 12 months.

Keywords

References

  1. Morrow M, Burstein HJ, Harris JR. Malignant tumors of the breast. In: DeVita VT, Lawrence TS, Rosenberg SA, editors. Cancer principles & practice of oncology. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. p. 1117-56.
  2. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet]. Lyon (FR): International Agency for Research on Cancer; c2012 [cited 2018 Dec 17]. Available from: http://globocan.iarc.fr/
  3. Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in Egypt: results of the national population-based cancer registry program. J Cancer Epidemiol 2014;2014:437971.
  4. Zeeneldin AA, Ramadan M, Gaber AA, Taha FM. Clinico-pathological features of breast carcinoma in elderly Egyptian patients: a comparison with the non-elderly using population-based data. J Egypt Natl Canc Inst 2013;25:5-11. https://doi.org/10.1016/j.jnci.2012.10.003
  5. Esserman LJ, Joe BN, Gralow JR, Duda RB. Clinical features, diagnosis, and staging of newly diagnosed breast cancer [Internet]. Updated 2013 Jan 28 [cited 2018 Dec 17]. Available from: http://ultra-medica.net/Uptodate21.6/contents/mobipreview.htm?9/49/10009?source=see_link
  6. Varshney D, Zhou YY, Geller SA, Alsabeh R. Determination of HER-2 status and chromosome 17 polysomy in breast carcinomas comparing HercepTest and PathVysion FISH assay. Am J Clin Pathol 2004;121:70-7. https://doi.org/10.1309/FUQH92B039025LHG
  7. Burstein HJ, Harris LN, Gelman R, Lester SC, Nunes RA, Kaelin CM, et al. Preoperative therapy with trastuzumab and paclitaxel followed by sequential adjuvant doxorubicin/cyclophosphamide for HER2 overexpressing stage II or III breast cancer: a pilot study. J Clin Oncol 2003;21:46-53. https://doi.org/10.1200/JCO.2003.03.124
  8. Moja L, Tagliabue L, Balduzzi S, Parmelli E, Pistotti V, Guarneri V, et al. Trastuzumab containing regimens for early breast cancer. Cochrane Database Syst Rev 2012;(4):CD006243.
  9. Burstein H, Hayes DF, Dizon DS. Adjuvant medical therapy for HER2-positive breast cancer. Updated 2013 Apr 4 [cited 2018 Dec 17]. Available from: http://ultra-medica.net/Uptodate21.6/contents/UTD.htm?11/7/11384/abstract/1,2#H1133979075
  10. Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, et al. 6 Months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol 2013;14:741-8. https://doi.org/10.1016/S1470-2045(13)70225-0
  11. Bloom HJ, Richardson WW. Histological grading and prognosis in breast cancer; a study of 1409 cases of which 359 have been followed for 15 years. Br J Cancer 1957;11:359-77. https://doi.org/10.1038/bjc.1957.43
  12. Cavallo J. 2018 ASCO: shortening adjuvant trastuzumab to 6 months in patients with HER2-positive early breast cancer is effective and reduces cardiac toxicities. Huntington (NY): The ASCO Post; Updated 2018 Sep 17 [cited 2018 Dec 17]. Available from: http://www.ascopost.com/News/58848
  13. Conte PF, Bisagni G, Frassoldati A, Brandes AA, Anselmi E, Giotta F, et al. 9 weeks vs 1 year adjuvant trastuzumab in combination with chemotherapy: results of the phase III multicentric Italian study Short-HER [abstract]. J Clin Oncol 2017;35(No 15_suppl):501. https://doi.org/10.1200/JCO.2017.35.15_suppl.501
  14. Joensuu H, Fraser J, Wildiers H, Huovinen R, Auvinen P, Utriainen M, et al. SABCS 2017: SOLD trial data support current standard 12-month adjuvant trastuzumab for HER2-positive breast cancer. Proceedings of the San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio (TX); GS3-04.
  15. Sendur MA, Aksoy S, Ozdemir N, Yazici O, Zengin N, Altundag MK. Comparison of the efficacy of 9-weeks versus 52-weeks of adjuvant trastuzumab treatment in HER-2 positive early-stage breast cancer with axillary lymph nodemetastases. Ann Oncol 2014;25:99.
  16. Tonyali O, Coskun U, Sener N, Inanc M, Akman T, Oksuzoglu B, et al. Nine-week trastuzumab treatment versus 52-week trastuzumab treatment for HER2-positive early-stage breast cancer. J Cancer Res Clin Oncol 2012;138:2145-51. https://doi.org/10.1007/s00432-012-1296-x
  17. Icli F, Altundag K, Coskun U, Paydas S, Basaran G, Saip P, et al. Nine versus 52 weeks of adjuvant trastuzumab in early breast cancer: an observational study of the Turkish Oncology Group. J Clin Oncol 2011;29:629.
  18. Ozen M, Aksoy S, Dizdar O, Sener Dede D, Dogan E, Arslan C, et al. Addition of nine weeks of trastuzumab to adjuvant chemotherapy in operable HER2-positive breast cancer patients: retrospective analysis [abstract]. J Clin Oncol 2010;28(No 15_suppl):e13664. https://doi.org/10.1200/jco.2010.28.15_suppl.e13664
  19. Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, et al. 2 Years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet 2013;382:1021-8. https://doi.org/10.1016/S0140-6736(13)61094-6
  20. Romond EH, Suman VJ, Jeong JH, Sledge GW Jr, Geyer CE Jr, Martino S, et al. Trastuzumab plus adjuvant chemotherapy for HER2-positive breast cancer: final planned joint analysis of overall survival (OS) from NSABP B-31 and NCCTG N9831 [abstract]. Cancer Res 2012; 72(No 24_suppl): S5-5.
  21. Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006;354:809-20. https://doi.org/10.1056/NEJMoa053028
  22. Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, et al. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial. J Clin Oncol 2009;27:5685-92. https://doi.org/10.1200/JCO.2008.21.4577
  23. Russell SD, Blackwell KL, Lawrence J, Pippen JE Jr, Roe MT, Wood F, et al. Independent adjudication of symptomatic heart failure with the use of doxorubicin and cyclophosphamide followed by trastuzumab adjuvant therapy: a combined review of cardiac data from the National Surgical Adjuvant breast and Bowel Project B-31 and the North Central Cancer Treatment Group N9831 clinical trials. J Clin Oncol 2010;28:3416-21. https://doi.org/10.1200/JCO.2009.23.6950
  24. Bowles EJ, Wellman R, Feigelson HS, Onitilo AA, Freedman AN, Delate T, et al. Risk of heart failure in breast cancer patients after anthracycline and trastuzumab treatment: a retrospective cohort study. J Natl Cancer Inst 2012;104:1293-305. https://doi.org/10.1093/jnci/djs317
  25. Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, et al. Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the North Central Cancer Treatment Group N9831 adjuvant breast cancer trial. J Clin Oncol 2008;26:1231-8. https://doi.org/10.1200/JCO.2007.13.5467
  26. Beauclair S, Formento P, Fischel JL, Lescaut W, Largillier R, Chamorey E, et al. Role of the HER2 [Ile655Val] genetic polymorphism in tumorogenesis and in the risk of trastuzumab-related cardiotoxicity. Ann Oncol 2007;18:1335-41. https://doi.org/10.1093/annonc/mdm181
  27. Halyard MY, Pisansky TM, Dueck AC, Suman V, Pierce L, Solin L, et al. Radiotherapy and adjuvant trastuzumab in operable breast cancer: tolerability and adverse event data from the NCCTG Phase III Trial N9831. J Clin Oncol 2009;27:2638-44. https://doi.org/10.1200/JCO.2008.17.9549
  28. Ng T, Chan M, Khor CC, Ho HK, Chan A. The genetic variants underlying breast cancer treatment-induced chronic and late toxicities: a systematic review. Cancer Treat Rev 2014;40:1199-214. https://doi.org/10.1016/j.ctrv.2014.10.001
  29. Schneider BP, O'Neill A, Shen F, Sledge GW, Thor AD, Kahanic SP, et al. Pilot trial of paclitaxel-trastuzumab adjuvant therapy for early stage breast cancer: a trial of the ECOG-ACRIN cancer research group (E2198). Br J Cancer 2015;113:1651-7. https://doi.org/10.1038/bjc.2015.405