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

다국어 초록 (Multilingual Abstract)

Purpose: This study aimed to compare the results of treatment with adjuvant trastuzumab for 9 months versus 12 months in human epider�mal 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 adju�vant 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 dis�ease 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 effec�tive than the standard 12 months.

참고문헌 (Reference)

1 Romond EH, "Trastuzumab plus adjuvant chemotherapy for HER2-positive breast cancer: final planned joint analysis of overall survival (OS) from NSABP B-31 and NCCTG N9831" 72 (72): S5-S5, 2012

2 Moja L, "Trastuzumab containing regimens for early breast cancer" (4) : CD006243-, 2012

3 Ng T, "The genetic variants underlying breast cancer treatment-induced chronic and late toxicities:a systematic review" 40 : 1199-1214, 2014

4 Joensuu H, "SABCS 2017: SOLD trial data support current standard 12-month adjuvant trastuzumab for HER2-positive breast cancer" 3-, 2017

5 Beauclair S, "Role of the HER2 [Ile655Val] genetic polymorphism in tumorogenesis and in the risk of trastuzumab-related cardiotoxicity" 18 : 1335-1341, 2007

6 Bowles EJ, "Risk of heart failure in breast cancer patients after anthracycline and trastuzumab treatment: a retrospective cohort study" 104 : 1293-1305, 2012

7 Halyard MY, "Radiotherapy and adjuvant trastuzumab in operable breast cancer: tolerability and adverse event data from the NCCTG Phase III Trial N9831" 27 : 2638-2644, 2009

8 Burstein HJ, "Preoperative therapy with trastuzumab and paclitaxel followed by sequential adjuvant doxorubicin/cyclophosphamide for HER2 overexpressing stage II or III breast cancer: a pilot study" 21 : 46-53, 2003

9 Schneider BP, "Pilot trial of paclitaxel-trastuzumab adjuvant therapy for early stage breast cancer: a trial of the ECOG-ACRIN cancer research group (E2198)" 113 : 1651-1657, 2015

10 Tonyali O, "Nine-week trastuzumab treatment versus 52-week trastuzumab treatment for HER2-positive early-stage breast cancer" 138 : 2145-2151, 2012

11 Icli F, "Nine versus 52 weeks of adjuvant trastuzumab in early breast cancer:an observational study of the Turkish Oncology Group" 29 : 629-, 2011

12 Russell SD, "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" 28 : 3416-3421, 2010

13 Bloom HJ, "Histological grading and prognosis in breast cancer; a study of 1409 cases of which 359 have been followed for 15 years" 11 : 359-377, 1957

14 Ferlay J, "GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide:IARC Cancer Base No. 10" International Agency for Research on Cancer

15 Joensuu H, "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" 27 : 5685-5692, 2009

16 Varshney D, "Determination of HER-2 status and chromosome 17 polysomy in breast carcinomas comparing HercepTest and PathVysion FISH assay" 121 : 70-77, 2004

17 Sendur MA, "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" 25 : 99-, 2014

18 Zeeneldin AA, "Clinico-pathological features of breast carcinoma in elderly Egyptian patients: a comparison with the non-elderly using population-based data" 25 : 5-11, 2013

19 Esserman LJ, "Clinical features, diagnosis, and staging of newly diagnosed breast cancer"

20 Perez EA, "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" 26 : 1231-1238, 2008

21 Morrow M, "Cancer principles & practice of oncology" Wolters Kluwer Health 1117-1156, 2015

22 Ibrahim AS, "Cancer incidence in Egypt: results of the national population-based cancer registry program" 2014 : 437971-, 2014

23 Burstein H, "Adjuvant medical therapy for HER2-positive breast cancer"

24 Joensuu H, "Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer" 354 : 809-820, 2006

25 Ozen M, "Addition of nine weeks of trastuzumab to adjuvant chemotherapy in operable HER2-positive breast cancer patients: retrospective analysis" 28 (28): e13664-, 2010

26 Conte PF, "9 weeks vs 1 year adjuvant trastuzumab in combination with chemotherapy: results of the phase III multicentric Italian study Short-HER" 35 (35): 501-, 2017

27 Pivot X, "6 Months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial" 14 : 741-748, 2013

28 Cavallo J, "2018 ASCO: shortening adjuvant trastuzumab to 6months in patients with HER2-positive early breast cancer is effective and reduces cardiac toxicities" The ASCO Post

29 Goldhirsch A, "2 Years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial" 382 : 1021-1028, 2013