Yue Chen1, Yu-Ying Xu2, Hai-Jun Jiang3, Lei Wang2, Jia-Wei Zhai1, Tong Zhang2, Yu-Fei Yang4. 1. Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China. 2. Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. 3. Department of Oncology, Central Hospital of Ankang City, Ankang, Shaanxi Province, 725000, China. 4. Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. yyf93@vip.sina.com.
Abstract
OBJECTIVE: To evaluate the effect and safety of low-dose of apatinib and S-1 combined with Jianpi Bushen Jiedu Decoction (JBJD) in patients with metastatic colorectal cancer (mCRC) who have failed second or above lines treatment, in order to provide more treatment option for mCRC patients by integrated medicine. METHODS: Thirteen patients were selected from a single-arm, open-label clinical study from April 2019 to September 2020. The patients were treated with low-dose apatinib (250 mg, once a day) and S-1 (20 mg, twice a day) combined with JBJD for at least one cycle and were followed up to August 2021. The primary endpoint was disease progression-free survival (PFS). Disease control rate (DCR), objective response rate (ORR), and overall survival (OS) of patients were observed as the secondary endpoints. Adverse events were recorded as well. RESULTS: The average age of the 13 patients was 56.5 ±13.0 years and 76.9% were male. The median PFS and median OS were 4.6 and 8.3 months, respectively. The ORR was 7.7% (1/13) while the DCR was 61.5% (8/13). The common adverse events were hypertension, proteinuria, elevated transaminase, and thrombocytopenia. One patient experienced thrombocytopenia of grade 3. CONCLUSIONS: Patients with mCRC after failure of the second or above lines of treatment may potentially benefit from the treatment of low-dose apatinib and S-1 combined with JBJD because of its similar effect as the standard dose of target therapy and relatively better safety. (Registration No. ChiCTR1900022673).
OBJECTIVE: To evaluate the effect and safety of low-dose of apatinib and S-1 combined with Jianpi Bushen Jiedu Decoction (JBJD) in patients with metastatic colorectal cancer (mCRC) who have failed second or above lines treatment, in order to provide more treatment option for mCRC patients by integrated medicine. METHODS: Thirteen patients were selected from a single-arm, open-label clinical study from April 2019 to September 2020. The patients were treated with low-dose apatinib (250 mg, once a day) and S-1 (20 mg, twice a day) combined with JBJD for at least one cycle and were followed up to August 2021. The primary endpoint was disease progression-free survival (PFS). Disease control rate (DCR), objective response rate (ORR), and overall survival (OS) of patients were observed as the secondary endpoints. Adverse events were recorded as well. RESULTS: The average age of the 13 patients was 56.5 ±13.0 years and 76.9% were male. The median PFS and median OS were 4.6 and 8.3 months, respectively. The ORR was 7.7% (1/13) while the DCR was 61.5% (8/13). The common adverse events were hypertension, proteinuria, elevated transaminase, and thrombocytopenia. One patient experienced thrombocytopenia of grade 3. CONCLUSIONS: Patients with mCRC after failure of the second or above lines of treatment may potentially benefit from the treatment of low-dose apatinib and S-1 combined with JBJD because of its similar effect as the standard dose of target therapy and relatively better safety. (Registration No. ChiCTR1900022673).
Patients with Metastatic Colorectal Cancer after Failure of Second-Line Treatment May Benefit from Low-Dose Apatinib and S-1 Combined with Jianpi Bushen Jiedu Decoction
Authors: Al B Benson; Alan P Venook; Mahmoud M Al-Hawary; Mustafa A Arain; Yi-Jen Chen; Kristen K Ciombor; Stacey Cohen; Harry S Cooper; Dustin Deming; Linda Farkas; Ignacio Garrido-Laguna; Jean L Grem; Andrew Gunn; J Randolph Hecht; Sarah Hoffe; Joleen Hubbard; Steven Hunt; Kimberly L Johung; Natalie Kirilcuk; Smitha Krishnamurthi; Wells A Messersmith; Jeffrey Meyerhardt; Eric D Miller; Mary F Mulcahy; Steven Nurkin; Michael J Overman; Aparna Parikh; Hitendra Patel; Katrina Pedersen; Leonard Saltz; Charles Schneider; David Shibata; John M Skibber; Constantinos T Sofocleous; Elena M Stoffel; Eden Stotsky-Himelfarb; Christopher G Willett; Kristina M Gregory; Lisa A Gurski Journal: J Natl Compr Canc Netw Date: 2021-03-02 Impact factor: 11.908
Authors: Evelien Dekker; Pieter J Tanis; Jasper L A Vleugels; Pashtoon M Kasi; Michael B Wallace Journal: Lancet Date: 2019-10-19 Impact factor: 79.321
Authors: Nelleke P M Brouwer; Dave E W van der Kruijssen; Niek Hugen; Ignace H J T de Hingh; Iris D Nagtegaal; Rob H A Verhoeven; Miriam Koopman; Johannes H W de Wilt Journal: Ann Surg Oncol Date: 2019-12-02 Impact factor: 5.344