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The immune system is regulated by a delicate balance of factors that initiate antitumor immune responses and inhibit excessive inflammation and autoimmunity. Cells from both the innate and adaptive immune systems work to eradicate pathogens and other threats, including cancer. A number (https://dirilishurdacilik.com/content/uploads/files/download/delphi-2020-completo-serial-number.zip) of investigations1-3 over the past decade suggest that a proportion of breast cancers are immunogenically active and that some breast tumors have a substantial lymphocytic infiltrate. Lymphocyte-predominant breast cancers are characterized by tumor-infiltrating lymphocytes comprising 50% or more of the tumor bed. Primary breast tumors with a robust immune infiltrate are associated with a better response to neoadjuvant chemotherapy.
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Participants in the control arm received standard NACT: 80 mg/m2 intravenous paclitaxel weekly for 12 weeks, followed by 4 cycles of 60 mg/m2 doxorubicin plus 600 mg/m2 intravenous cyclophosphamide every 2 to 3 weeks (AC). Participants in the pembrolizumab arm received standard NACT plus 200 mg intravenous pembrolizumab every 3 weeks for 4 cycles (weeks 1, 4, 7, and 10) concurrently with paclitaxel. Steroid premedication was standardized across sites. For the first infusion, pembrolizumab was given first, followed by 20 mg of dexamethasone received orally after a 30-minute waiting period, followed by paclitaxel 30 minutes later. If no infusion reaction occurred, dexamethasone was reduced to 10 mg for week 2. If participants did not experience an infusion reaction with the first 2 doses of paclitaxel, dexamethasone was discontinued. If patients had an infusion reaction despite corticosteroid premedications, switching to nab-paclitaxel was allowed. If infusion reactions were manageable with dexamethasone, the premedications remained unchanged.
Importance Approximately 25% of patients with early-stage breast cancer who receive (neo)adjuvant chemotherapy experience a recurrence within 5 years. Improvements in therapy are greatly needed.
The trial was designed by the I-SPY2 study investigators. Merck provided study drug but played no role in the study design, collection/analysis of data or manuscript preparation. All participating sites received institutional review board approval, and patients provided written informed consent. The I-SPY2 DSMB meets monthly to review patient safety and study progress.
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Initial concerns that steroid premedications required for paclitaxel might interfere with the efficacy of pembrolizumab appear unfounded. Although steroid premedications were discontinued after 2 doses of (weekly) paclitaxel if no infusion reactions were observed, they were routinely used per physician discretion for infusion reactions and management of irAEs. Because median time to response with pembrolizumab monotherapy in advanced breast cancer was reportedly 18 weeks,5 there was initial concern that the 20- to 24-week duration of NACT would be too short to see the benefit of neoadjuvant pembrolizumab. Although we observed no complete responses on the week 3 MRI, 16 of 31 (52%) of those who eventually achieved a pCR showed greater than 95% reduction in tumor volume by week 12, with the rest achieving a pCR by 24 weeks.
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The immune checkpoint inhibitor pembrolizumab, when added to standard NACT, was associated with improvement in pCR rates over chemotherapy alone in women with high-risk, early-stage, ERBB2-negative breast cancer. Randomized phase 3 registrational trials evaluating pembrolizumab in combination with standard NACT for TNBC (KEYNOTE 522) and high-risk, HR-positive/ERBB2-negative breast cancer (KEYNOTE 756) are ongoing. Preliminary reports that the addition of pembrolizumab to standard NACT in TNBC is associated with improved pCR rates in the KEYNOTE 522 randomized phase 3 trial provides validation of the I-SPY2 concept, which aims to accelerate drug development by efficiently identifying effective agents and the signatures in which they are most effective.
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Patients with ERBB2-negative breast cancer who enrolled in I-SPY2 between November 26, 2021, and November 5, 2021, were eligible for randomization to pembrolizumab. A total of 69 patients were adaptively randomized to pembrolizumab and were evaluable for the primary end point (40 HR-positive/ERBB2-negative, 29 TNBC).