1. Elevated circulating tumor cells (CTCs) prior to or following the first round of chemotherapy for metastatic breast cancer suggested a poor prognosis.
2. Early switch to alternative chemotherapy regimens did not improve progression-free or overall survival among patients with elevated CTCs.
Evidence rating level: 1 (Excellent)
Study rundown: Metastatic breast cancer has a poor prognosis, with a median survival of 28 months following diagnosis. Treatment is focused on patient comfort, and typically involves single-agent chemotherapy. Increased circulating tumor cells (CTC) before initiation of new therapy are associated with a poorer response to therapy. At the conclusion of this trial, the authors confirmed that elevated CTCs prior to initiation of or following the first round of chemotherapy predicted decreased overall survival. Furthermore, in this population, early switching to alternate cytotoxic therapies did not prolong overall or progression-free survival. Based off these results, the authors suggested that elevated CTCs may indicate unlikely significant benefit from any chemotherapy regimen. Rather, these patients may be more strongly considered for novel therapeutic agents, rather than attempting second or third line cytotoxic therapies. These findings are supported by the randomized, controlled design of this study, though it should be noted that different patient responses to individual chemotherapy agents could not be fully evaluated.
In-Depth [randomized controlled trial]: From 2006 to 2012, a total of 595 patients with histologically confirmed metastatic breast cancer were enrolled and included in this prospective clinical trial. They were split into three arms: arm A (276) with normal CTC levels at baseline, arm B (165) who had had elevated CTC levels at baseline but normal at first follow-up after treatment, and arm C (123), who had persistently elevated CTC levels. Patients in arm A remained on their initial single-agent chemotherapy regimen until progression. Women in arm B whose CTCs decreased after 21 days of therapy remained on initial therapy. Women in arm C were randomly assigned to continue initial therapy or change to an alternative chemotherapy. The primary outcomes were overall and progression-free survival measured from randomization date. Patients were blinded to first follow-up CTC results. No difference was seen in median overall survival between the two groups in arm C (10.7 and 12.5 months, P = 0.98). CTCs were confirmed to be strongly prognostic, as median overall survival for arms A, B and C were 35 months, 23 months and 13 months, respectively (p < 0.001).
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