PMID- 36734294 OWN - NLM STAT- MEDLINE DCOM- 20230510 LR - 20230511 IS - 2045-7634 (Electronic) IS - 2045-7634 (Linking) VI - 12 IP - 8 DP - 2023 Apr TI - Combined all-trans retinoic acid with low-dose apatinib in treatment of recurrent/metastatic head and neck adenoid cystic carcinoma: A single-center, secondary analysis of a phase II study. PG - 9144-9155 LID - 10.1002/cam4.5653 [doi] AB - BACKGROUND: Treatment options are limited for recurrent/metastatic adenoid cystic carcinoma of the head and neck (R/M ACCHN). We aimed to evaluate the preliminary results of the efficacy and safety of all-trans retinoic acid (ATRA) combined with low-dose apatinib in patients with R/M ACCHN according to a secondary analysis of a phase II study. METHODS: Patients from a phase II study (NCT02775370) who orally administered 500 milligram (mg) apatinib daily until treatment-related adverse events (AEs) intolerance or progression occurred were eligible for inclusion. Patients were further treated with combination therapy of ATRA (25 mg/m(2) /day) and apatinib (250 mg/day) between March 2019 and October 2021 until progression of disease (PD). RESULTS: A total of 16 patients were included with nine (56.3%) males and aged 35-69 years old. All recruited patients previously received anti-angiogenic therapy then withdrew due to toxicities or progression occurred. The objective response rate (ORR) and disease control rate (DCR) were 18.8% and 100%, respectively. During a median follow-up of 23.9 months (range:17.8-31.7 months), 11 (68.8%) patients developed PD and one of them died in 20.9 months. The median of progression-free survival (PFS) was 16.3 months (95% CI: 7.2-25.4 months), and the 6-month, 12-month, and 24-month PFS rates were 100%, 81.3%, and 33.3%, respectively. The grade 3 adverse events were albuminuria (n = 2, 12.5%) and hand-foot syndrome (n = 1, 6.25%). CONCLUSION: All-trans retinoic acid combined with low-dose apatinib might be a potential efficacy therapeutic option for patients with R/M ACCHN. This finding will be further confirmed by our registered ongoing trial, the APLUS study (NCT04433169). CI - (c) 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. FAU - Ye, Lulu AU - Ye L AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. FAU - Zhang, Lin AU - Zhang L AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. FAU - Li, Rongrong AU - Li R AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. FAU - Pan, Xinhua AU - Pan X AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. FAU - Li, Jiang AU - Li J AD - Department of Oral Pathology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. FAU - Dou, Shengjin AU - Dou S AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. FAU - Jiang, Wen AU - Jiang W AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. FAU - Wang, Chong AU - Wang C AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. FAU - Chen, Wantao AU - Chen W AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. FAU - Zhu, Guopei AU - Zhu G AUID- ORCID: 0000-0003-4770-9458 AD - Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China. AD - National Center for Stomatology, Shanghai, China. AD - National Clinical Research Center for Oral Diseases, Shanghai, China. AD - Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai, China. LA - eng SI - ClinicalTrials.gov/NCT02775370 PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230203 PL - United States TA - Cancer Med JT - Cancer medicine JID - 101595310 RN - 5S371K6132 (apatinib) RN - 0 (Antineoplastic Agents) RN - 5688UTC01R (Tretinoin) SB - IM MH - Male MH - Humans MH - Adult MH - Middle Aged MH - Aged MH - Female MH - *Antineoplastic Agents/adverse effects MH - *Carcinoma, Adenoid Cystic/drug therapy MH - Tretinoin/adverse effects MH - *Carcinoma/drug therapy MH - *Head and Neck Neoplasms/drug therapy MH - *Lung Neoplasms/pathology PMC - PMC10166967 OTO - NOTNLM OT - adenoid cystic carcinoma OT - all-trans retinoic acid OT - apatinib OT - head and neck cancer OT - oncological outcomes COIS- All authors declare that they have no conflict of interest. EDAT- 2023/02/04 06:00 MHDA- 2023/05/10 06:42 PMCR- 2023/02/03 CRDT- 2023/02/03 05:44 PHST- 2023/01/12 00:00 [revised] PHST- 2022/07/29 00:00 [received] PHST- 2023/01/17 00:00 [accepted] PHST- 2023/05/10 06:42 [medline] PHST- 2023/02/04 06:00 [pubmed] PHST- 2023/02/03 05:44 [entrez] PHST- 2023/02/03 00:00 [pmc-release] AID - CAM45653 [pii] AID - 10.1002/cam4.5653 [doi] PST - ppublish SO - Cancer Med. 2023 Apr;12(8):9144-9155. doi: 10.1002/cam4.5653. Epub 2023 Feb 3.