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Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab.

ABSTRACT: The evidence emerged from the TOURANDOT trial encourages evaluating the role of anthropometric determinants on treatment outcomes in HER2-negative metastatic breast cancer patients treated with bevacizumab-including regimens. We thus analyzed data from a subgroup of these patients from a larger cohort previously assessed for treatment outcomes. Patients were included in the present analysis if body mass index values had been recorded at baseline. Clinical benefit rates, progression free survival and overall survival were assessed for the overall study population and subgroups defined upon molecular subtype. One hundred ninety six patients were included (N:196). Body mass index showed no impact on clinical benefit rates in the overall study sample and in the luminal cancer subset (p = 0.12 and p = 0.79, respectively), but did so in the triple negative subgroup, with higher rates in patients with body mass index ?25 (p = 0.03). In the overall study sample, body mass index did no impact progression free or overall survival (p = 0.33 and p = 0.67, respectively). Conversely, in triple negative patients, progression free survival was significantly longer with body mass index ?25 (6 vs 14 months, p = 0.04). In this subset, overall survival was more favorable (25 vs 19 months, p = 0.02). The impact of the molecular subtype was confirmed in multivariate models including the length of progression free survival, and number of metastatic sites (p < 0.0001). Further studies are warranted to confirm our findings in more adequately sized, ad hoc, prospective studies.

SUBMITTER: Pizzuti L

PROVIDER: S-EPMC5902232 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab.

Pizzuti Laura L Sergi Domenico D Sperduti Isabella I Lauro Luigi Di LD Mazzotta Marco M Botti Claudio C Izzo Fiorentino F Marchetti Luca L Tomao Silverio S Marchetti Paolo P Natoli Clara C Grassadonia Antonino A Gamucci Teresa T Mentuccia Lucia L Magnolfi Emanuela E Vaccaro Angela A Cassano Alessandra A Rossi Ernesto E Botticelli Andrea A Sini Valentina V Sarobba Maria G MG Fabbri Maria Agnese MA Moscetti Luca L Astone Antonio A Michelotti Andrea A De Angelis Claudia C Bertolini Ilaria I Angelini Francesco F Ciliberto Gennaro G Maugeri-Saccà Marcello M Giordano Antonio A Barba Maddalena M Vici Patrizia P

Cancer biology & therapy 20180216 4

The evidence emerged from the TOURANDOT trial encourages evaluating the role of anthropometric determinants on treatment outcomes in HER2-negative metastatic breast cancer patients treated with bevacizumab-including regimens. We thus analyzed data from a subgroup of these patients from a larger cohort previously assessed for treatment outcomes. Patients were included in the present analysis if body mass index values had been recorded at baseline. Clinical benefit rates, progression free survival ...[more]

PMID: 29336662

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Project description:We conducted an open-label, randomized, two-arm multi-center study to assess the efficacy and safety of paclitaxel versus paclitaxel + sorafenib in patients with locally advanced or metastatic HER2-negative breast cancer.Patients were randomly assigned to receive either paclitaxel monotherapy (80 mg/m2) weekly (3 weeks on, 1 week off) plus sorafenib 400 mg orally, twice a day taken continuously throughout 28 day cycles. Sorafenib dose was gradually escalated from a starting dose of 200 mg twice a day. The primary endpoint was progression free survival (PFS).A pre-planned efficacy interim analysis was performed on the data of 60 patients, 30 patients in each treatment arm. Median PFS was estimated at 6.6 months (95% CI: 5.1 to 9.0) in patients randomized to single-agent paclitaxel (Arm A) and 5.6 months (95% CI: 3.8 to 6.5) in patients randomized to paclitaxel-sorafenib combination (Arm B) therapy. Contrary to the hypothesis, the treatment effect was statistically significant in favor of paclitaxel monotherapy (hazard ratio 1.80, 95% CI: 1.02 to 3.20; log-rank test P = 0.0409). It was decided to stop the trial early for futility. Median OS was also in favor of Arm A (20.7 months (95% CI: 16.4 to 26.7) versus 12.1 months (95% CI: 5.8 to 20.4) in Arm B. Clinical control was achieved in 28 patients (93.3%) in Arm A and in 21 patients 70.0% in Arm B. Overall response rate was met in 43.3% of patients in Arm A and in 40.0% in Arm B. Toxicities were increased in Arm B with higher rates of diarrhea, nausea, neutropenia, hand-foot skin reaction (HFSR) and anorexia, Grad 3 and 4 toxicities were rare.In this pre-planned interim analysis, paclitaxel-sorafenib combination therapy was not found to be superior to paclitaxel monotherapy with regard to the primary end point, progression-free survival. The trial was therefore discontinued early. There was no indication of more favorable outcomes for combination therapy in secondary efficacy end points. As expected, the safety and toxicity profile of the combination therapy was less favorable compared to monotherapy. Overall, this trial did not demonstrate that adding sorafenib to second- or third-line paclitaxel provides any clinical benefit to patients with HER2-negative advanced or metastatic breast cancer. Cautious dosing using a sorafenib ramp up schedule might have contributed to negative results.The study was registered at EudraCT (No 2009-018025-73) and retrospectively registered at Clinical trials.gov on March 17, 2011 ( NCT01320111 ).

Dataset Information

Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab.

Publications

Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab.

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