Relationships Between Köhne Category/Baseline Tumor Load and Early Tumor Shrinkage, Depth of Response, and Outcomes in Metastatic Colorectal Cancer,Clinical Colorectal Cancer

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Relationships Between Köhne Category/Baseline Tumor Load and Early Tumor Shrinkage, Depth of Response, and Outcomes in Metastatic Colorectal Cancer
Clinical Colorectal Cancer ( IF 3.3 ) Pub Date : 2021-05-25 , DOI: 10.1016/j.clcc.2021.05.007
Andrea Sartore-Bianchi ₁ , Pilar García-Alfonso ₂ , Michael Geissler ₃ , Claus-Henning Köhne ₄ , Marc Peeters ₅ , Timothy Price ₆ , Manuel Valladares-Ayerbes ₇ , Ying Zhang ₈ , Peter Burdon ₉ , Julien Taieb ₁₀ , Dominik P Modest ₁₁

Affiliation

Department of Oncology and Hemato-Oncology, Niguarda Cancer Center/University of Milan (La Statale), Milan, Italy.
Department of Oncology, General Universitario Gregorio Marañón, Madrid, Spain.
Geschäftsführung, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.
Department of Oncology and Haematology, Klinikum Oldenburg, Oldenburg, Germany.
Department of Oncology, Antwerp University Hospital/Antwerp University, Edegem, Belgium.
Haematology and Medical Oncology Unit, Queen Elizabeth Hospital/University of Adelaide, Adelaide, Australia.
Department of Medical Oncology, Hospital Universitario Reina Sofia, IMIBIC, CIBERONC, Córdoba, Spain.
Biostatistics, Amgen Inc., Thousand Oaks, California, USA.
European Medical, Amgen (Europe) GmbH, Rotkreuz, Switzerland.
Sorbonne Paris Cité, Paris Descartes University, Georges Pompidou European Hospital, Paris, France.
Medical Department, Division of Hematology, Oncology and Tumor Immunology, Charité University Medicine Berlin, Campus Virchow Klinikum (CVK), Berlin, Germany.

Background

In metastatic colorectal cancer (mCRC), there are limited data on associations between early tumor shrinkage (ETS), depth of response (DpR), and patient characteristics.

Methods

Data from patients with RAS wild-type mCRC who had participated in the PRIME (NCT00364013) and PEAK (NCT00819780) studies were analyzed retrospectively. ETS and DpR were assessed by baseline Köhne category/BRAF status (PRIME) and baseline tumor load (pooled PRIME and PEAK).

Results

Analysis populations included 436 to 665 patients. Patients’ chances of achieving ETS of 30% or greater were 63.8%, 50.4%, and 41.9% in the low-, medium-, and high-risk Köhne categories, and 21.7% in those with BRAF mutations. Corresponding percentages for the highest DpR classification (71%-100%) were 47.7% (low risk), 23.6% (medium risk), 10.0% (high risk), and 4.2% (BRAF mutant). No clear relationship was observed between baseline tumor load and ETS or DpR. An ETS of 30% or greater and higher DpR values were associated with statistically significant prolongation of median progression-free survival and overall survival.

Conclusion

Patients with mCRC categorized at baseline by the Köhne criteria as high risk or with BRAF mutations have lower chances of achieving an ETS of 30% or greater or a high DpR. Baseline tumor load was not predictive of ETS or DpR. Favorable ETS or DpR is associated with improved progression-free and overall survival.

中文翻译：

Köhne 类别/基线肿瘤负荷与转移性结直肠癌早期肿瘤缩小、反应深度和结果之间的关系

背景

在转移性结直肠癌 (mCRC) 中，关于早期肿瘤缩小 (ETS)、反应深度 (DpR) 和患者特征之间关联的数据有限。

方法

回顾性分析了参与 PRIME (NCT00364013) 和 PEAK (NCT00819780) 研究的RAS野生型 mCRC患者的数据。ETS 和 DpR 通过基线 Köhne 类别/ BRAF状态 (PRIME) 和基线肿瘤负荷（合并的 PRIME 和 PEAK）进行评估。

结果

分析人群包括 436 至 665 名患者。在低、中和高风险 Köhne 类别中，患者实现 30% 或更高的 ETS 的机会分别为 63.8%、50.4% 和 41.9%，在BRAF突变患者中为 21.7%。最高 DpR 分类（71%-100%）的相应百分比为 47.7%（低风险）、23.6%（中等风险）、10.0%（高风险）和 4.2%（BRAF突变体）。在基线肿瘤负荷和 ETS 或 DpR 之间没有观察到明确的关系。30% 或更高的 ETS 和更高的 DpR 值与中位无进展生存期和总生存期的统计学显着延长相关。