Significant<i>p</i> values for the association between gene expression and clinic-pathological characteristics of triple negative breast cancer patients (univariate analysis, categorization based on tertiles).

<p>Significant<i>p</i> values for the association between gene expression and clinic-pathological characteristics of triple negative breast cancer patients (univariate analysis, categorization based on tertiles).</p

Real Time PCR primers.

<p>Real Time PCR primers.</p

Kaplan-Meier estimates for event-free survival (panel A) and overall survival (panel B) in TNBC patients stratifies by the different level of<i>FANCA</i> expression (univariate analysis, categorization based on tertiles).

<p>Kaplan-Meier estimates for event-free survival (panel A) and overall survival (panel B) in TNBC patients stratifies by the different level of<i>FANCA</i> expression (univariate analysis, categorization based on tertiles).</p

Normalized and calibrated values (mean± SD and median) of the different DNA repair genes in tumor samples.

*<p><i>p</i> value indicate the difference of the gene expression levels between TNBC anl LABC; <i>p</i> value in bold are significant.</p

Baseline patients' demographic.

<p>SD: standard deviation; IDC: invasive ductal carcinoma; ILC: invasive lobular carcinoma.</p

Overall survival and event-free survival in triple negative breast cancer patients by expression of the different genes (univariate analysis, categorization based on tertiles).

<p>The mRNA expression distribution of all the genes was split into three groups, as described in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0066243#s2" target="_blank">Materials and Methods</a>. <i>p</i> value in bold are significant.</p

Randomised Phase II Trial (NCT00637975) Evaluating Activity and Toxicity of Two Different Escalating Strategies for Pregabalin and Oxycodone Combination Therapy for Neuropathic Pain in Cancer Patients

<div><p>Purpose</p><p>Neuropathic pain is commonly associated with cancer. Current treatments include combination opioid and adjuvant therapies, but no guidelines are available for dose escalation strategies. This phase II study compared the efficacy and tolerability of two dose escalation strategies for oxycodone and pregabalin combination therapy.</p><p>Methods</p><p>Patients (N = 75) with oncological neuropathic pain, previously untreated with pregabalin, were recruited in 5 Italian institutions between 2007 and 2010. Patients were randomised to two different dose escalation strategies (arm A; N = 38) oxycodone at a fixed dose with increasing pregabalin doses; (arm B; N = 37) pregabalin at a fixed dose with increasing oxycodone doses. Patients were evaluated from daily diaries and follow-ups at 3, 7, 10, and 14 days after beginning treatment with a numerical rating scale (NRS), neuropathic pain scale (SDN), and well-being scale (ESAS). The primary endpoint was a ≥1/3 reduction in pain (NRS); secondary endpoints included the time to analgesia and adverse effects. The study had a 90% probability of detecting the best strategy for a true difference of at least 15%.</p><p>Results</p><p>More patients in arm A (76%) than arm B (64%) achieved ≥1/3 overall pain reduction even after controlling for baseline factors (gender, baseline pain). Group A reported fewer side effects than group B; constipation 52.8% vs. 66.7%; nausea: 27.8% vs. 44.4%; drowsiness: 44.4% vs. 55.6%; confusion: 16.7% vs. 27.8%; itching: 8.3% vs. 19.4%.</p><p>Conclusions</p><p>Both strategies effectively controlled neuropathic pain, but according to the adopted selection design arm A is preferable to arm B for pain control.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="http://clinicaltrials.gov/ct2/show/NCT00637975" target="_blank">NCT00637975</a></p></div

Patient CONSORT Diagram.

<p>Patient CONSORT Diagram.</p

Study design.

<p>Study design.</p

Evaluation of toxicity.

<p>Evaluation of toxicity.</p