146
Analyzed patients
Stefano observational study
A Meaningful Signal of Benefit in Established CIPN
The study evaluated OnLife®—the formulation available in the United States as Novilora™—following paclitaxel treatment for breast cancer or oxaliplatin treatment for colon cancer.
21
Oncology centers
3 months
Treatment / evaluation
Prospective
Single-arm observational
Study population
Two cohorts, assessed separately.
Paclitaxel
Breast cancer cohort
The strongest signal was observed among patients with paclitaxel-induced neuropathy.
Oxaliplatin
Colon cancer cohort
Outcomes were also evaluated among patients with oxaliplatin-induced neuropathy.
Paclitaxel cohort
Physician-assessed outcomes
Benefit is defined by the study authors as improvement or stabilization of peripheral neuropathy severity.
Physician-assessed
85.1%
benefit
Sensory benefit
Improvement or stabilization of physician-assessed neuropathy severity.
31.1% improved54.1% stabilized
Physician-assessed
87.5%
benefit
Motor benefit
Improvement or stabilization of physician-assessed neuropathy severity.
85.1% and 87.5% do not mean “improved.” They represent improvement or stabilization.
Patient-reported outcomes
45.9%
Reported fewer sensory symptoms and functional limitations
37.5%
Reported fewer motor symptoms and functional limitations
Quality-of-life outcomes
+13.1
Global Health Status / Quality of Life points
+15.5
Physical Functioning points
Paclitaxel cohort; mean changes during three months of OnLife® treatment.
Understanding the evidence
Promising findings, with important limits.
STEFANO was a prospective, multicenter, single-arm observational study.
It was not a randomized, placebo-controlled clinical trial. Therefore, the study cannot establish how much of the observed improvement was attributable to OnLife® versus treatment-independent recovery after chemotherapy.
The authors concluded that the findings were promising—particularly for taxane-induced neuropathy—and that prospective randomized multicenter research is warranted to further confirm benefit.
Primary study source
Zaiss M, Uhlig J, Zahn M-O, et al. Improving Chemotherapy-Induced Peripheral Neuropathy in Patients with Breast or Colon Cancer after End of (Neo)adjuvant Therapy: Results from the Observational Study STEFANO. Oncology Research and Treatment. 2021. DOI: 10.1159/000519000.