Abstract
Background: Sensorial peripheral neuropathy (SPN) is a common adverse event occurred patients (pts) treated with microtubule targeting agent, including paclitaxel (P). P neurotoxicity is determined by microtubule structure destruction, resulting in an assoplasmic transport system alteration with subsequent cellular death. Three-four grade (G) SPN incidence in weekly P ranges approximately from 9-24% in metastatic breast cancer pts to 4-8% in adjuvant setting. Furthermore, SPN recovery can be long and not completely solved. To date, there is no a standard of care for chemotherapy induced SPN. Recently, an oral liquid (R)-&agr;-Lipoic acid (ALA) formulation proved efficacy in SPN, diabetic polyneuropathy and radiculopathy opposing oxygen free radicals damage on peripheral nerve fibers. Material (patients) and methods: Based on clinical data observed in diabetic polyneuropathy, we conducted a pilot study to evaluate the effect of an innovative oral liquid ALA formulation (300 mg vial once a day) on SPN, occurred in breast cancer pts treated with adjuvant/neoadjuvant weekly P. ALA was administered until clinical evidence of SPN deterioration or complete resolution. SPN was evaluated according to NCI CTcriteria, version 4.0. Results: From December 2014 to March 2015, we collected data from 20 breast cancer women (median age 58 years, range 35-74) treated with adjuvant (16 patients) or neoadjuvant (4 patients) epirubicin combined to cyclophosphamide followed by weekly P (80 mg/mq for 12 weeks). All pts had a negative medical history for neuropathy and/or diabetes. During P treatment, 12 (60%) pts developed a G1 SPN, 6 (30%) a G2 PN and 2 (10%) a G3 SPN, respectively. SPN median time onset from the beginning of P was 35 days (range 14-84). Pts started to intake ALA at SPN onset. G1/2/3 PN improved in 5 (42%)/3 (50%)/1 (50%), respectively, stabilized in 5 (42%)/ 2 (33%)/1 (50%) respectively and worsened in 2 (16%)/1 (17%)/0 pts respectively. Overall, 16 (80%) of 20 treated women had a SPN relied. Median time to response was 21 days (range 7-84). Seventeen (85%) pts completed P chemotherapy; 1 needed a P dose reduction and 2 stopped P (at IX and X cycle, respectively), due to SPN worsening. ALA treatment was well tolerated, excepting 2 pts who experienced heartburn, resolved after ALA withdrawal. Conclusions: Although preliminary, ALA appears to have a role in reducing SPN induced by weekly P. Further studies are needed to prospectively evaluate these promising findings.
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