Positive bone marrow biopsy is associated with a decreased disease-free survival in patients with operable breast cancer.

Background: Bone marrow (BM) biopsy has been suggested as an independent prognostic factor in patients with breast cancer.

Methods: Patients operated for breast cancer from June 2000 to April 2008 were enrolled in this protocol after signing an informed consent. After primary surgery, BM aspirate from the iliac crest was obtained and 5-10 cc of blood collected. Since 2002 a peripheral blood (PB) sample was also obtained. Both carcinoembryonic antigen (CEA) and Mammaglobin-specific nested reverse-transcription polymerase chain reaction (RT-PCR) were used to examine BM and PB samples. Physicians and patients were blinded to results.

Results: Two hundred seventy-three patients underwent BM and/or PB test. The median age of the patients was 63 years (31-80 years), and the median tumor diameter was 1.5 cm (0.1-6 cm). BM aspirates were unsuccessful in nine patients, and RT-PCR was not technically feasible in 18 women, leaving 246 patients available for analysis of results and follow-up. Among them, 110 patients (45%) had either a BM or a PB test positive for CEA or Mammaglobin (Test+). At median follow-up of 60 months, 31 events (deaths or relapse) occurred (13%). Disease-free survival (DFS) was significantly lower in the Test+ group (BP and/or PB) (P<0.001). This effect was independent of nodal status. At 5 years, event-free survival for Node-/Test- patients was 46/49 (94%) and for Node+/Test+ patients was 21/33 (64%), while patients with only one status positive (Node-/Test+ or Node+/Test-) had an intermediate disease-free survival (35/43, 81%) (P=0.005). In a subgroup analysis, RT-PCR results for BM and Mammaglobin retained statistical significance on DFS (P<0.001), while those for PB and CEA did not.

Conclusions: This study confirms that RT-PCR of the BM is an independent prognostic factor for disease-free survival of breast cancer patients, and may improve their staging, allowing better strategies for therapy and follow-up.