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Purpose: Only a minority of patients with early breast cancer (EBC) treated with adjuvant or neoadjuvant chemotherapy have sufficient baseline vitamin D. The current recommendations regarding daily vitamin D supplementation appears too low to correct this deficiency in this population. Optimal vitamin D dosing has yet to be determined in this setting. The current randomized phase III study address the issue of the effectiveness and safety of a tailored high dose oral vitamin D supplementation as a means for restoring normal 25-hydroxy vitamin D (25OHD) levels in a large population of chemotherapy-treated EBC patients. Methods: Chemotherapy-treated EBC patients were stratified according to the degree of Vitamin D deficiency, time between chemotherapy initiation and inclusion (0 to 6 months versus 6 to 12 months), hormone receptors status and menopausal status. Participants were randomly assigned to receive a 6-months conventional (C) vitamin D and calcium supplementation or a 6-months high dose oral vitamin D regimen tailored on the degree of deficiency (T) associated with a conventional calcium supplementation. Primary endpoint was the efficacy (6-months percentage of 25OHD serum levels normalization) in the T arm compared with the C arm. Statistical analyses were performed on an intent to treat basis. Results: The trial accrued 215 patients, among which 197 patients presented with vitamin D deficiency, and randomized 195 patients (T, 100; C, 95) from July 2011 to January 2013. The groups were well balanced in regard to the stratification characteristics, as well as in regard of median weight and neoadjuvant or adjuvant chemotherapy status. Compliance to the daily oral supplementation was low in both arms, 64% of the patients in both arms taking less than 80% of the planned oral supplementation dose. Compliance to the tailored high dose vitamin D schedule appeared better (78%). After 6 months of treatment, at the primary endpoint analysis time, significantly more patients in the T arm presented with normalised serum vitamin D levels compared to the C arm (30% vs. 12.6%; p = 0.003). Vitamino-calcic supplementation was well tolerated, with no difference in the treatment-related toxicity between the 2 arms. Conclusion: In this randomized phase III study, a tailored high dose oral vitamin D supplementation allowed a statistically higher percentage of serum 25OHD levels normalization compared to a conventional regimen, without any increase in side effects, in a large population of chemotherapy-treated EBC patients. Observance of a daily oral supplementation remains poor in this setting, advocating for an adaptation of the schedule and dosage of this supplementation in a population of patients subject to chemotherapy-induced emesis. Clinical trial number NCT01480869. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-09-10.

It is a randomised cross-over multicenter study comparing the efficacy and the tolerance of granisetron (Gra) 1 mg and ondansetron (Ond) 8 mg, oral, given during two consecutive cycles to 188 naive patients scheduled to receive a moderately emetogenic chemotherapy. The antiemetic treatment is given one day per course, 1 hour before chemotherapy and the second administration from 8 to 12 hours after the beginning, during each of the two cycles; alternatively according to the randomisation. Five criteria are assessed; nausea (ordinal and visual analogic scales), emeric episodes (vomiting orland retching), complete response (minor or no nausea, no emetic episode and no rescue treatment), patient preference and tolerance. The intent to treat analysis showed no significant difference at cycle 1 between Gra and Ond; at cycle 2, there is no significant difference in the number of emetic episodes; for the prevention of nausea, the ordinal scale shows a significant difference (p = 0.028 in favour of Gra at day 1 (D1) but not from D2 to D5. Gra induced more complete response than Ond at D1 (p = 0.028), but not from D2 to D5. The cross-over study did not show any period or order effect, whereas a treatment effect on Ond was significant in favour of Gra (p = 0.01). There is no significant patients preference in favour of Gra or Ond. In conclusion, Gra was more efficient in preventing nausea and obtaining complete response on the first day of treatment, significantly at the second cycle. Both Gra and Ond had a good antiemetic activity for moderately emetogenic chemotherapy with complete response rates always over 50% on day 1; delayed emesis remain less weli controlled.

4628 Background: D is a small molecule that inhibits Aurora kinases, proteins regulating mitosis, implicated in tumorigenesis and overexpressed in prostate cancer. After D administration, tumor reg...