Real-World Evidence of Trastuzumab, Pertuzumab, and Docetaxel Combination as a First-Line Treatment for Korean Patients with HER2-Positive Metastatic Breast Cancer
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Purpose: Trastuzumab has markedly improved the survival outcomes of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and dual blockade of HER2 using trastuzumab and pertuzumab in combination with taxanes (THP) has become a standard of care for HER2-positive metastatic breast cancer (MBC) worldwide since the CLEOPATRA trial. We assessed the outcomes of THP as a first-line treatment for Korean HER2-positive MBC patients in the real-world setting. Materials and methods: Between August 2008 and October 2020, we identified 228 HER2-positive MBC patients who received THP as a first-line palliative chemotherapy. We analyzed survival outcomes, efficacy, and adverse events of THP retrospectively. Results: After a median follow-up duration of 28.7 months, median overall survival and progression-free survival were 58.3 months (95% confidence interval [CI], 36.6 to 80.0) and 19.1 months (95% CI, 16.2 to 21.9), respectively. Better survival outcomes were observed in patient who received docetaxel for more than six cycles. Patients exposed to anti-HER2 directed therapies in a perioperative setting had poor survival outcomes. The overall response rate was 86.8% with a complete response (CR) rate of 17.7%. Among responders, 16.7% of patients sustained THP over 35 months and showed better survivals and higher CR rates. Adverse events were comparable to those reported in previous studies. Conclusion: In a real-world context, clinical outcomes of Korean HER2-positive MBC patients treated with THP were similar to those of patients in the CLEOPATRA trial. Much longer follow-up results would be warranted.
Abstract
Purpose: Trastuzumab has markedly improved the survival outcomes of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and dual blockade of HER2 using trastuzumab and pertuzumab in combination with taxanes (THP) has become a standard of care for HER2-positive metastatic breast cancer (MBC) worldwide since the CLEOPATRA trial. We assessed the outcomes of THP as a first-line treatment for Korean HER2-positive MBC patients in the real-world setting. Materials and methods: Between August 2008 and October 2020, we identified 228 HER2-positive MBC patients who received THP as a first-line palliative chemotherapy. We analyzed survival outcomes, efficacy, and adverse events of THP retrospectively. Results: After a median follow-up duration of 28.7 months, median overall survival and progression-free survival were 58.3 months (95% confidence interval [CI], 36.6 to 80.0) and 19.1 months (95% CI, 16.2 to 21.9), respectively. Better survival outcomes were observed in patient who received docetaxel for more than six cycles. Patients exposed to anti-HER2 directed therapies in a perioperative setting had poor survival outcomes. The overall response rate was 86.8% with a complete response (CR) rate of 17.7%. Among responders, 16.7% of patients sustained THP over 35 months and showed better survivals and higher CR rates. Adverse events were comparable to those reported in previous studies. Conclusion: In a real-world context, clinical outcomes of Korean HER2-positive MBC patients treated with THP were similar to those of patients in the CLEOPATRA trial. Much longer follow-up results would be warranted.
참고문헌 (32)
- Bray F, "Global cancer statistics 2018 : GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries", CA Cancer J Clin, 68, pp.394~424 (2018)
- Ross JS, "The HER-2 receptor and breast cancer : ten years of targeted anti-HER-2 therapy and personalized medicine", Oncologist, 14, pp.320~368 (2009)
- Slamon DJ, "Human breast cancer : correlation of relapse and survival with amplification of the HER-2", neu oncogene, 1987, pp.235, 177~182
- Hudis CA, "Trastuzumab : mechanism of action and use in clinical practice", N Engl J Med, 357, pp.39~51 (2007)
- Slamon DJ, "Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2", N Engl J Med, 344, pp.783~792 (2001)
- Baselga J, "Novel anticancer targets : revisiting ERBB2 and discovering ERBB3", Nat Rev Cancer, 9, pp.463~475 (2009)
- Lee-Hoeflich ST, "A central role for HER3 in HER2-amplified breast cancer : implications for targeted therapy", Cancer Res, 68, pp.5878~5887 (2008)
- Baselga J, "Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer", N Engl J Med, 366, pp.109~119 (2011)
- Swain SM, "Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in CLEOPATRA : a randomized, double-blind, placebo-controlled phase III study", Oncologist, 18, pp.257~264 (2013)
- Swain SM, "Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer(CLEOPATRA study) : overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study", Lancet Oncol, 14, pp.461~471 (2013)
- Swain SM, "Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer", N Engl J Med, 372, pp.724~734 (2015)
- Swain SM, "Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer(CLEOPATRA) : end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study", Lancet Oncol, 21, pp.519~530 (2020)
- Schwartz LH, "RECIST 1.1-Update and clarification: From the RECIST committee", Eur J Cancer, 62, pp.132~137 (2016)
- "Common Terminology Criteria for Adverse Events (CTCAE), version 5.0" (2017)[URL]
- Takahashi M, "The efficacy and safety of pertuzumab plus trastuzumab and docetaxel as a first-line therapy in Japanese patients with inoperable or recurrent HER2-positive breast cancer : the COMACHI study", Breast Cancer Res Treat, 185, pp.125~134 (2021)
- Gamucci T, "A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study", Cancer Biol Ther, 20, pp.192~200 (2019)
- Ramagopalan SV, "Association of pertuzumab, trastuzumab, and docetaxel combination therapy with overall survival in patients with metastatic breast cancer", JAMA Netw Open, 4, pp.e2027764~ (2021)
- Wong Y, "Long-term survival of de novo stage IV human epidermal growth receptor 2(HER2)positive breast cancers treated with HER2-targeted therapy", Oncologist, 24, pp.313~318 (2019)
- Dieras V, "Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer(EMILIA) : a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial", Lancet Oncol, 18, pp.732~742 (2017)
- Verma S, "Trastuzumab emtansine for HER2-positive advanced breast cancer", N Engl J Med, 367, pp.1783~1791 (2012)
- Uncu D, "Efficacy of trastuzumab-based therapy after disease progression on lapatinib based therapy in heavily pretreated HER2-positive metastatic breast cancer patients", J Clin Oncol, 32(15 Suppl), pp.e11586~ (2014)
- Lang I, "Trastuzumab retreatment after relapse on adjuvant trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancer : final results of the Retreatment after HErceptin Adjuvant trial", Clin Oncol(R Coll Radiol), 26, pp.81~89 (2014)
- Xu B, "Outcomes of re-treatment with first-line trastuzumab plus taxane in patients (pts) with metastatic breast cancer (mBC) who relapsed after (neo)adjuvant trastuzumab: a prospective multicenter study", J Clin Oncol, 34(15 Suppl), pp.e12068~ (2016)
- Rier HN, "First-line palliative HER2-targeted therapy in HER2-positive metastatic breast cancer is less effective after previous adjuvant trastuzumab-based therapy", Oncologist, 22, pp.901~909 (2017)
- von Minckwitz G, "Trastuzumab emtansine for residual invasive HER2-positive breast cancer", N Engl J Med, 380, pp.617~628 (2019)
- Tripathy D, "De novo versus recurrent HER2-positive metastatic breast cancer : patient characteristics, treatment, and survival from the SystHERs Registry", Oncologist, 25, pp.e214~e222 (2020)
- Gradishar WJ, "Taxanes for the treatment of metastatic breast cancer", Breast Cancer(Auckl), 6, pp.159~171 (2012)
- Martin M, "Adjuvant docetaxel for node-positive breast cancer", N Engl J Med, 352, pp.2302~2313 (2005)
- Stubblefield MD, "A prospective surveillance model for physical rehabilitation of women with breast cancer : chemotherapy-induced peripheral neuropathy", Cancer, 118, pp.2250~2260 (2012)
- Modi S, "Trastuzumab deruxtecan in previously treated HER2-positive breast cancer", N Engl J Med, 382, pp.610~621 (2020)
- Murthy RK, "Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer", N Engl J Med, 382, pp.597~609 (2020)
- Rugo HS, "Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2-positive advanced breast cancer : a phase 3 randomized clinical trial", JAMA Oncol, 7, pp.573~584 (2021)
