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. 2013 Jun;104(6):718-24.
doi: 10.1111/cas.12148. Epub 2013 Apr 15.

Early tumor shrinkage in metastatic colorectal cancer: retrospective analysis from an irinotecan-based randomized first-line trial

Clemens Giessen  1 , Ruediger P Laubender, Ludwig Fischer von Weikersthal, Andreas Schalhorn, Dominik P Modest, Sebastian Stintzing, Michael Haas, Ulrich R Mansmann, Volker Heinemann
Affiliations

Early tumor shrinkage in metastatic colorectal cancer: retrospective analysis from an irinotecan-based randomized first-line trial

Clemens Giessen et al. Cancer Sci. 2013 Jun.

Abstract

Early tumor shrinkage (ETS) has been highlighted as a favorable prognostic factor related to progression-free survival (PFS) and overall survival (OS) in cytotoxic treatment of metastatic colorectal cancer. Data from a randomized phase III study comparing infusional 5-fluorouracil plus irinotecan (FUFIRI) versus irinotecan plus oxaliplatin (mIROX) were evaluated. Patient groups were analyzed according to the relative change in maximum tumor diameter between baseline and after 7 weeks of treatment. The ETS cohort was defined as a decrease of ≥20%. Additionally, the non-ETS cohort was subdivided into "minor shrinkage" (0-19%), "tumor progression" (any increase) and development of "new metastatic lesions". Progression-free survival and OS were estimated in all patient subgroups. Assessment of ETS was possible in 201 patients. Early tumor shrinkage was observed in 47% (94/201) and non-ETS in 53% (107/201) of patients. Patients with ETS had a more favorable outcome with regard to PFS (9.9 months vs 6.1 months, P = 0.029) and OS (27.5 months vs 17.8 months, P = 0.002). In the non-ETS subgroups, patients with "minor shrinkage" (PFS 8.4 months, OS 21.6 months) showed a markedly better outcome than patients with "early tumor progression" (PFS 4.0 months, OS 15.3 months) or with "new metastatic lesions (PFS 2.2 months, OS 7.6 months). In conclusion, ETS assessment offers accelerated response evaluation when compared to RECIST. In patients treated with chemotherapy alone, ETS ≥20% is associated with excellent outcome. Non-ETS is a heterogeneous subgroup where patients with minor shrinkage clearly benefit from treatment, and patients with early progression or development of new lesions have an unfavorable prognosis.

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Figures

Figure 1
Figure 1
CONSORT diagram.ETS, early tumor shrinkage; FUFIRI, 5‐fuorouracil/folinic acid/irinotecan; mIROX, modified irinotecan plus oxaliplatin; RECIST, Response Evaluation Criteria in Solid Tumors.
Figure 2
Figure 2
Waterfall plot of relative changes in maximum tumor diameter after 7 weeks on treatment (early tumor shrinkage [ETS]) and characterization of best overall response according to RECIST 1.1 Response evaluation according to RECIST 1.1: CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease
Figure 3
Figure 3
Progression‐free survival (PFS) in early tumor shrinkage (ETS) and non‐ETS patients. Progression‐free survival‐FIRE‐1 trial according to early tumor shrinkage.
Figure 4
Figure 4
Progression‐free survival (PFS) in early tumor shrinkage (ETS) and non‐ETS subgroups. Progression‐free survival‐ FIRE‐1 trial according to early tumor shrinkage subgroups.
Figure 5
Figure 5
Overall survival (OS) in early tumor shrinkage (ETS) and non‐ETS patients. Overall survival‐ FIRE‐1 trial according to early tumor shrinkage.
Figure 6
Figure 6
Overall survival (OS) in early tumor shrinkage (ETS) and non‐ETS subgroups. Overall survival‐ FIRE‐1 according to early tumor shrinkage subgroups.
See this image and copyright information in PMC

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