保健食品又称膳食补充剂、饮食补充剂、营养补充剂，包括维生素、矿物质、蛋白质、氨基酸、糖类、脂类、可食用植物、药食两用中药等营养辅助成分以及健康辅助成分口服产品，具有特定保健功能，适宜特定人群食用，可以调节机体功能，不可用于治疗疾病。虽然根据既往研究报告，保健食品被广泛用于癌症治疗期间，但是关于其安全性或有效性的研究数据寥寥无几，尤其某些保健食品（例如维生素A、C、E，类胡萝卜素，辅酶Q10等抗氧化剂）可能削弱化疗对肿瘤细胞的毒性作用。
2019年12月19日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表罗斯威尔帕克综合癌症中心、波士顿大学、弗雷德哈钦森癌症研究中心、俄亥俄州立大学、哥伦比亚大学、克利夫兰医学中心、马萨诸塞州医疗中心、乔治城大学、梅奥医学中心、德克萨斯大学MD安德森癌症中心、西雅图抗癌联盟、芝加哥洛约拉大学、加拿大阿伦布莱尔癌症中心的西南肿瘤学协作组SWOG乳腺癌化疗研究S0221关联研究DELCaP分析报告，探讨了保健食品与乳腺癌患者生存结局的相关性。
S0221 (Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer): Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer (NCT00070564)
DELCaP: Diet, Exercise, Lifestyle and Cancer Prognosis
DELCaP研究从S0221研究入组高风险早期乳腺癌环磷酰胺＋多柔比星＋紫杉醇化疗之前和期间补充保健食品患者1134例，于化疗之前和化疗开始之后大约6个月时完成调查问卷。通过多因素比例风险回归模型，对临床和生活方式等其他影响因素进行校正后，分析入组后6个月的复发和生存。
结果发现，无论临床和生活方式等其他影响因素如何，化疗之前且期间补充与从未补充任何抗氧化剂的患者相比：
复发风险高1.41倍（95%置信区间：0.98～2.04，P=0.06）
死亡风险高1.40倍（95%置信区间：0.90～2.18，P=0.14）
化疗之前且期间补充与从未补充维生素B12的患者相比：
复发或死亡风险高1.83倍（95%置信区间：1.15～2.92，P<0.01）
死亡风险高2.04倍（95%置信区间：1.22～3.40，P<0.01）
补充与从未补充铁的患者相比：
化疗期间补充：复发风险高1.79倍（95%置信区间：1.20～2.67，P<0.01）
化疗之前且期间补充：复发风险高1.91倍（95%置信区间：0.98～3.70，P=0.06）
死亡风险相似
补充与从未补充多种维生素的患者相比，生存结局相似。
因此，该研究结果表明，对于高风险早期乳腺癌环磷酰胺＋多柔比星＋紫杉醇化疗患者，化疗之前和化疗期间补充任何抗氧化剂、维生素B12、铁等保健食品可能影响生存结局，该结果与化疗期间谨慎补充保健食品的指南推荐意见一致，除了多种维生素。
J Clin Oncol. 2019 Dec 19. [Epub ahead of print]
Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221).
Ambrosone CB, Zirpoli GR, Hutson AD, McCann WE, McCann SE, Barlow WE, Kelly KM, Cannioto R, Sucheston-Campbell LE, Hershman DL, Unger JM, Moore HCF, Stewart JA, Isaacs C, Hobday TJ, Salim M, Hortobagyi GN, Gralow JR, Budd GT, Albain KS.
Roswell Park Comprehensive Cancer Center, Buffalo, NY; Boston University, Boston, MA; Fred Hutchinson Cancer Research Center, Seattle, WA; The Ohio State University, Columbus, OH; Columbia University, New York, NY; Cleveland Clinic, Cleveland, OH; Baystate Medical Center, Springfield, MA; Georgetown University, Washington, DC; Mayo Clinic, Rochester, MN; Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; The University of Texas MD Anderson Cancer Center, Houston, TX; Seattle Cancer Care Alliance, Seattle, WA; Loyola University Chicago Stritch School of Medicine, Chicago, IL.
PURPOSE: Despite reported widespread use of dietary supplements during cancer treatment, few empirical data with regard to their safety or efficacy exist. Because of concerns that some supplements, particularly antioxidants, could reduce the cytotoxicity of chemotherapy, we conducted a prospective study ancillary to a therapeutic trial to evaluate associations between supplement use and breast cancer outcomes.
METHODS: Patients with breast cancer randomly assigned to an intergroup metronomic trial of cyclophosphamide, doxorubicin, and paclitaxel were queried on their use of supplements at registration and during treatment (n =1,134). Cox proportional hazards regression adjusting for clinical and lifestyle variables was used. Recurrence and survival were indexed at 6 months after enrollment using a landmark approach.
RESULTS: There were indications that use of any antioxidant supplement (vitamins A, C, and E; carotenoids; coenzyme Q10) both before and during treatment was associated with an increased hazard of recurrence (adjusted hazard ratio [adjHR], 1.41; 95% CI, 0.98 to 2.04; P = .06) and, to a lesser extent, death (adjHR, 1.40; 95% CI, 0.90 to 2.18; P = .14). Relationships with individual antioxidants were weaker perhaps because of small numbers. For nonantioxidants, vitamin B12 use both before and during chemotherapy was significantly associated with poorer disease-free survival (adjHR, 1.83; 95% CI, 1.15 to 2.92; P < .01) and overall survival (adjHR, 2.04; 95% CI, 1.22 to 3.40; P < .01). Use of iron during chemotherapy was significantly associated with recurrence (adjHR, 1.79; 95% CI, 1.20 to 2.67; P < .01) as was use both before and during treatment (adjHR, 1.91; 95% CI, 0.98 to 3.70; P = .06). Results were similar for overall survival. Multivitamin use was not associated with survival outcomes.
CONCLUSION: Associations between survival outcomes and use of antioxidant and other dietary supplements both before and during chemotherapy are consistent with recommendations for caution among patients when considering the use of supplements, other than a multivitamin, during chemotherapy.
PMID: 31855498
DOI: 10.1200/JCO.19.01203
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