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.
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.
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%.
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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