Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients

Summary

The international treatment guidelines now include recommendations for the use of CDK 4/6 inhibitors in combination with hormone agents for the treatment of postmenopausal women with hormone-receptor-positive/HER2-negative ABC as the first-line standard therapy in endocrine sensitive patients. Nevertheless, it is generally thought that chemotherapy is associated with greater and earlier tumor response, especially in case of high burden of disease. In a retrospective analysis of real-world clinical practice (2002-2012) from US, only 60% of patients initiated ET as the first treatment following metastatic diagnosis . In the real-life world of China, a large number of HR+/HER2- ABC patients with non-visceral crisis also received chemotherapy in first-line treatment, even though the ORR is similar compared with CDK4/6 inhibitors with endocrine therapy. Zhejiang Cancer Hospital retrospective analysis of 5 cases of advanced breast cancer first-line use of Ibance + ET, they were evaluated within 50 days (from 27days to 50days). Based on the early response time observed in real-world data mentioned above, it is proposed a prospective study to further observe the tumor reduction rate in real-world, including to identify the time of patient symptom improvement according to the quality of life scale.

Timeline

Start

2021-04-22

Primary completion

2022-12-31

Completion

2023-06-30

Publications

• Results Lobbezoo DJ, van Kampen RJ, Voogd AC, Dercksen MW, van den Berkmortel F, Smilde TJ, van de Wouw AJ, Peters FP, van Riel JM, Peters NA, de Boer M, Borm GF, Tjan-Heijnen VC. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res Treat. 2013 Oct;141(3):507-14. doi: 10.1007/s10549-013-2711-y. Epub 2013 Oct 9.
• Results Cardoso F, Senkus E, Costa A, Papadopoulos E, Aapro M, Andre F, Harbeck N, Aguilar Lopez B, Barrios CH, Bergh J, Biganzoli L, Boers-Doets CB, Cardoso MJ, Carey LA, Cortes J, Curigliano G, Dieras V, El Saghir NS, Eniu A, Fallowfield L, Francis PA, Gelmon K, Johnston SRD, Kaufman B, Koppikar S, Krop IE, Mayer M, Nakigudde G, Offersen BV, Ohno S, Pagani O, Paluch-Shimon S, Penault-Llorca F, Prat A, Rugo HS, Sledge GW, Spence D, Thomssen C, Vorobiof DA, Xu B, Norton L, Winer EP. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)dagger. Ann Oncol. 2018 Aug 1;29(8):1634-1657. doi: 10.1093/annonc/mdy192. No abstract available.
• Results Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.
• Results Swallow E, Zhang J, Thomason D, Tan RD, Kageleiry A, Signorovitch J. Real-world patterns of endocrine therapy for metastatic hormone-receptor-positive (HR+)/human epidermal growth factor receptor-2-negative (HER2-) breast cancer patients in the United States: 2002-2012. Curr Med Res Opin. 2014 Aug;30(8):1537-45. doi: 10.1185/03007995.2014.908829. Epub 2014 Apr 14.
• Results Turner NC, Finn RS, Martin M, Im SA, DeMichele A, Ettl J, Dieras V, Moulder S, Lipatov O, Colleoni M, Cristofanilli M, Lu DR, Mori A, Giorgetti C, Iyer S, Bartlett CH, Gelmon KA. Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Ann Oncol. 2018 Mar 1;29(3):669-680. doi: 10.1093/annonc/mdx797.
• Results Piessevaux H, Buyse M, Schlichting M, Van Cutsem E, Bokemeyer C, Heeger S, Tejpar S. Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab. J Clin Oncol. 2013 Oct 20;31(30):3764-75. doi: 10.1200/JCO.2012.42.8532. Epub 2013 Sep 16.
• Results Wei M, Ye Q, Wang X, Wang M, Hu Y, Yang Y, Yang J, Cai J. Early tumor shrinkage served as a prognostic factor for patients with stage III non-small cell lung cancer treated with concurrent chemoradiotherapy. Medicine (Baltimore). 2018 May;97(19):e0632. doi: 10.1097/MD.0000000000010632.
• Results Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
• Results Janni W, Alba E, Bachelot T, Diab S, Gil-Gil M, Beck TJ, Ryvo L, Lopez R, Tsai M, Esteva FJ, Aunon PZ, Kral Z, Ward P, Richards P, Pluard TJ, Sutradhar S, Miller M, Campone M. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018 Jun;169(3):469-479. doi: 10.1007/s10549-017-4658-x. Epub 2018 Feb 5.

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