Impact of baseline BMI and weight change in CCTG adjuvant breast cancer trials.
Impact of baseline BMI and weight change in CCTG adjuvant breast cancer trials.
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CCTG 辅助乳腺癌试验中基线 BMI 和体重变化的影响。
DOI：
10.1093/annonc/mdx152
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Gelmon,KA
中科院分区：
文献类型：
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作者：
Yerushalmi,R;Dong,B;Chapman,JW;Goss,PE;Pollak,MN;Burnell,MJ;Levine,MN;Bramwell,VHC;Pritchard,KI;Whelan,TJ;Ingle,JN;Shepherd,LE;Parulekar,WR;Han,L;Ding,K;Gelmon,KA
背景我们假设基线 BMI 和 BMI 变化的增加会对辅助乳腺癌全身治疗的临床结果产生负面影响。方法数据来自化疗试验 MA.5 和 MA.21；内分泌治疗MA.12、MA.14和MA.27；和曲妥珠单抗 HERA/MA.24 进行了分析。主要目的是检查 BMI 变化对 5 年无乳腺癌间隔 (BCFI) 的影响；次要目标包括 1 年和 3 年的 BMI 变化； BMI 变化对疾病特异性生存 (DSS) 和总生存 (OS) 的影响；和基线 BMI 的影响。分层分析包括试验治疗和复合试验分层因素。 结果在绝经前/围绝经期/绝经后早期化疗试验（N=2793）中，基线BMI不会影响任何终点，并且BMI较基线增加不会显着影响5年后的BCFI（P=0.85），尽管它与1年后较差的BCFI（P=0.03）和DSS（P=0.07）相关。 BMI 增加 3 年和 5 年与更好的 DSS (P= 0.01; 0.01) 和 OS (P= 0.003; 0.05) 相关。在绝经前内分泌治疗试验MA.12（N=672）中，基线BMI较高的患者1年后BCFI较差（P=0.02），1年和5年后DSS较差（P=0.05；0.004），5年后OS较差（P=0.01）。 BMI 增加不会影响 5 年后的 BCFI (P= 0.90)，尽管它与 1 年后较差的 BCFI (P= 0.01) 相关。在绝经后内分泌治疗试验 MA.14 和 MA.27 (N= 8236) 中，基线 BMI 并未显着影响任何终点的结果。 BMI 变化不会影响 1 或 3 年后的 BCFI 或 DSS，尽管 BMI 平均增加 0.3 与 1 年后更好的 OS (P= 0.02) 相关。使用曲妥珠单抗 (N= 1395) 时，基线 BMI 和 BMI 的变化并未显着影响结果。结论 较高的基线 BMI 和 BMI 增加仅对绝经前/围绝经期/绝经后早期试验患者的结果产生负面影响。否则，BMI 的增加与健康女性的预期类似，要么不会影响结果，要么与更好的结果相关。临床试验编号 CAN-NCIC-MA5；美国国家癌症研究所 (NCI)-V90-0027； MA.12-NCT00002542； MA.14-NCT00002864； MA.21-NCT00014222； HERA，NCT00045032；CAN-NCIC-MA24； MA-27-NCT00066573。
BackgroundWe hypothesized that increased baseline BMI and BMI change would negatively impact clinical outcomes with adjuvant breast cancer systemic therapy.MethodsData from chemotherapy trials MA.5 and MA.21; endocrine therapy MA.12, MA.14 and MA.27; and trastuzumab HERA/MA.24 were analyzed. The primary objective was to examine the effect of BMI change on breast cancer-free interval (BCFI) landmarked at 5 years; secondary objectives included BMI changes at 1 and 3 years; BMI changes on disease-specific survival (DSS) and overall survival (OS); and effects of baseline BMI. Stratified analyses included trial therapy and composite trial stratification factors.ResultsIn pre-/peri-/early post-menopausal chemotherapy trials (N= 2793), baseline BMI did not impact any endpoint and increased BMI from baseline did not significantly affect BCFI (P= 0.85) after 5 years although it was associated with worse BCFI (P= 0.03) and DSS (P= 0.07) after 1 year. BMI increase by 3 and 5 years was associated with better DSS (P= 0.01; 0.01) and OS (P= 0.003; 0.05). In pre-menopausal endocrine therapy trial MA.12 (N= 672), patients with higher baseline BMI had worse BCFI (P= 0.02) after 1 year, worse DSS (P= 0.05; 0.004) after 1 and 5 years and worse OS (P= 0.01) after 5 years. Increased BMI did not impact BCFI (P= 0.90) after 5 years, although it was associated with worse BCFI (P= 0.01) after 1 year. In post-menopausal endocrine therapy trials MA.14 and MA.27 (N= 8236), baseline BMI did not significantly impact outcome for any endpoint. BMI change did not impact BCFI or DSS after 1 or 3 years, although a mean increased BMI of 0.3 was associated with better OS (P= 0.02) after 1 year. With the administration of trastuzumab (N= 1395) baseline BMI and BMI change did not significantly impact outcomes.ConclusionsHigher baseline BMI and BMI increases negatively affected outcomes only in pre-/peri-/early post-menopausal trial patients. Otherwise, BMI increases similar to those expected in healthy women either did not impact outcome or were associated with better outcomes.Clinical Trials numbersCAN-NCIC-MA5; National Cancer Institute (NCI)-V90-0027; MA.12-NCT00002542; MA.14-NCT00002864; MA.21-NCT00014222; HERA, NCT00045032;CAN-NCIC-MA24; MA-27-NCT00066573.