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In breast cancer coverage this year, topline results from the phase 3 NATALEE trial made waves in March, with our other most-read content in the space covering an expanded indication for abemaciclib, revised screening recommendations, a new potential treatment to reduce radiation exposure, and the benefits of diet and exercise on patient outcomes.
For 2023, our top breast cancer coverage ran the spectrum, starting with the March release of topline results from the NATALEE trial of ribociclib in patients with stage II/III hormone receptor–positive (HR+)/HER2-negative (HER2–) or triple-negative disease. Our other most-read content covered a new indication for abemaciclib, revised screening recommendations, a new potential treatment to reduce radiation exposure, and results from the LEANer study of an adjuvant diet and exercise intervention for patients undergoing chemotherapy.
Please enjoy these 2023 highlights, and click on over to our breast cancer page for other developments from the past year.
5. Diet and Exercise Intervention Associated With Better pCR in TNBC or HR+, HER2– BC
Data from the LEANer (Lifestyle, Exercise, and Nutrition Early After Diagnosis) study show patients undergoing chemotherapy were interested in a diet- and exercise-based intervention, and that participating in it led to better diet quality, physical activity, and pathological complete response (pCR). First published by CancerNetwork®, a sister site to The American Journal of Managed Care®, this article notes there was a pCR rate among these patients with HR+/HER2– or triple-negative disease of 53% vs 28% in the usual-care arm. Further, fruit, vegetable, and fiber intake all rose among the patients in the intervention arm, while the usual care cohort experienced adverse changes, and weekly exercise amounts rose to 143.4 vs 47.7 minutes, respectively.
4. Condensed Proton Therapy Schedule Shows Promise for Patients With Breast Cancer
Hypofractionated proton postmastectomy radiotherapy has potential to reduce radiation exposure to the heart and lungs, according to these study findings published in The Lancet Oncology in September. With off-target effects of radiation being heart and lung complications, “proton therapy offers a precise alternative by using proton beams to target cancer cells while sparing surrounding healthy tissues.” Among the study’s 82 adult patients (median [IQR] age, 52 [44-64] years), those in the hypofractionation group experienced fewer protocol-defined complications vs the conventional fractionation group, 8 vs 14. The study authors said their findings overall indicate similar tolerability between the 2 approaches.
3. In Reversal, USPSTF Draft Recommendation Calls for Breast Cancer Screening at Age 40
In May, the US Preventive Services Task Force (USPSTF) updated its breast cancer screening recommendation to say this should start at age 40, and take place every other year, reversing the then-current recommendation to initiate screening at age 50. Having a grade of B means the service is recommended and carries with it a high certainty of a moderate benefit or “moderate certainty that the net benefit is moderate to substantial.” This decision was spurred by the rise in breast cancer among younger women and the sizable gap in deadly disease between Black and White women, and the USPSTF believes 19% more lives could be saved from earlier screening.
2. FDA Expands Abemaciclib Indication in HR+/HER2–, Node+, High-Risk Breast Cancer
Based on 4-year findings from the phase monarchE trial, this new indication for the kinase inhibitor abemaciclib (Verzenio, Eli Lilly and Company) means it can now be administered in combination with endocrine therapy (ET) as adjuvant treatment. The 4-year data show recurrence-free rates of 85.5% in the patients who received abemaciclib plus physician’s choice of ET (tamoxifen or an aromatase inhibitor) compared with 78.6% among those who received just ET, and there were no new safety signals. Patient eligibility for the treatment will be determined by nodal status and tumor size and grade, and not the Ki-67 score, which was removed as a criterion for patient selection.
On March 27, Novartis announced these findings from the ongoing NATALEE trial, which is investigating the CDK4/6 inhibitor ribociclib (Kisqali) plus ET for use among patients with stage II/III HR+/HER2– early breast cancer. The primary study end point is invasive disease–free survival, and outcomes are being compared between patients receiving the combination treatment vs ET alone. More than 90% of patients who have breast cancer have early-stage disease, according to Novartis, and this trial’s protocol includes their long-term follow-up evaluation, including overall survival. Estimated completion date is May 29, 2026.