medwireNews: Here we provide top-line summaries of results from three phase III breast cancer trials, evaluating nab-paclitaxel and a trastuzumab biosimilar in the nonmetastatic HER2-negative and -positive settings, respectively, and quality of life (QoL) with the addition of palbociclib in the advanced or metastatic setting.
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Finding no significant improvement in pathologic complete response (pCR) rates with neoadjuvant nab-paclitaxel versus the solvent-based formulation, Luca Gianni (San Raffaele Scientific Institute, Milan, Italy) and co-investigators do not recommend a “direct substitution of paclitaxel with nab-paclitaxel at the doses and schedule adopted in the ETNA trial” for women with treatment-naïve HER2-negative breast cancer.
The pCR rate was 22.5% among the 346 patients who were randomly assigned to receive nab-paclitaxel 125 mg/m2 and 18.6% for their 349 counterparts given paclitaxel 90 mg/m2, but the difference was not statistically significant.
As described in JAMA Oncology, both drugs were given on a 3 weeks on, 1 week off schedule for four cycles, followed by four cycles of anthracycline-based chemotherapy.
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The trastuzumab biosimilar SB3 has equivalent efficacy and tolerability to the reference drug in women with early-stage HER2-positive breast cancer in the neoadjuvant setting, report Xavier Pivot (Institut Régional du Cancer, Strasbourg, France) and team in the Journal of Clinical Oncology.
In the randomized trial, a breast pCR was achieved by 51.7% of 402 women treated with SB3 and 42.0% of the 398 given trastuzumab, where both were administered alongside chemotherapy. The adjusted difference of 10.7% and the breast pCR ratio of 1.259 met the predefined equivalence criteria.
And any-grade treatment-emergent adverse events (AEs) occurred in 96.6% and 95.2% of participants in the SB3 and trastuzumab groups, respectively, while the corresponding serious AE rates were 10.5% and 10.7%.
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Among postmenopausal women with newly diagnosed estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer, adding the CDK4/6 inhibitor palbociclib to letrozole does not adversely affect QoL, and in fact significantly improves pain, shows an analysis of the PALOMA-2 trial.
Hope Rugo (University of California San Francisco Comprehensive Cancer Center, USA) and colleagues found that QoL – as measured by changes from baseline in the Functional Assessment of Cancer Therapy–Breast and EuroQOL 5 dimensions scores – did not differ significantly between women who did and did not receive palbociclib alongside letrozole over a median 23 months of follow-up.
But palbociclib-treated patients reported a significantly greater improvement in pain than their placebo-treated counterparts, with an average reduction of 0.256 versus 0.098 points, they report in the Annals of Oncology.
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