135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522

Dent, Rebecca; Cortés, Javier; Pusztai, Lajos; McArthur, Heather L.; Küemmel, Sherko; Bergh, Jonas; Denkert, C.; Park, Y.H.; Hui, Rita L.; Harbeck, N.; Takahashi, M.; Untch, M.; Fasching, Peter A.; Cardoso, Fátima; Haiderali, Amin; Jia, Liyi; Nguyen, Allison Martin; Pan, Wei‐Jian; O’Shaughnessy, Joyce; Schmid, Patrick

doi:10.1016/j.annonc.2022.07.170

Cited by 6 publications

(5 citation statements)

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“…Quality of life (QoL) data were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) and EORTC QLQ-BR23 questionnaires, which were collected from over 80% of patients at week 21 of preoperative treatment and after 24 weeks of postoperative treatment. There were no significant differences between the study groups according to quality-of-life outcomes (global health status, emotional functioning, physical functioning, and breast symptoms, including skin problems) [13].…”

Section: Introductionmentioning

confidence: 80%

Recent advances in the treatment of triple-negative breast cancer

et al. 2023

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Triple-negative is the rarest breast cancer biological subtype of breast cancer, but has the most aggressive course. The resuls of chemotherapy, especially in advanced disease, are unsatisfactory. Numerous clinical trials have been conducted, that resulted in registrations of new drugs decreasing the risk of recurrence and improving the outcome of patients with metastatic disease. The article summarizes the data on modern therapies registered in recent years. The role of pembrolizumab in perioperative treatment in the early stage was indicated, as well as the importance of olaparib in BRCA mutation carriers. Additionally, in patients with metastatic the indication for immunotherapy (pembrolizumab and atezolizumab), sacituzumab govitecan and PARP inhibitors (olaparib and talazoparib) in BRCA mutation carriers were highlighted.

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Section: Introductionmentioning

confidence: 80%

Recent advances in the treatment of triple-negative breast cancer

et al. 2023

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“…As additional drugs are incorporated into our treatment portfolio, understanding the patient experience is critical to guiding each patient in evaluating the pros and cons of escalating therapy. In KEYNOTE‐522, there was no meaningful difference in the change in HRQoL between the pembrolizumab and placebo arms during both neoadjuvant and adjuvant study treatment 28 . Most toxicities in KEYNOTE‐522 occurred during the neoadjuvant phase, 13 suggesting attribution to chemoimmunotherapy and emphasizing the importance of evaluating the patient experience with escalation of therapy for TNBC.…”

Section: Discussionmentioning

confidence: 97%

“…In KEYNOTE-522, there was no meaningful difference in the change in HRQoL between the pembrolizumab and placebo arms during both neoadjuvant and adjuvant study treatment. 28 Most toxicities in KEYNOTE-522 occurred during the neoadjuvant phase, 13 suggesting attribution to chemoimmunotherapy and emphasizing the importance of evaluating the patient experience with escalation of therapy for TNBC. Although platinum and taxane therapy were not administered concurrently in EA1131, these PROs provide insight into the additive side effects from platinums when incorporated into TNBC treatment.…”

Section: Smith Et Almentioning

confidence: 99%

Adjuvant platinum versus capecitabine for residual, invasive, triple‐negative breast cancer: Patient‐reported outcomes in ECOG‐ACRIN EA1131

Smith,

Zhao,

Mayer

et al. 2024

Cancer

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BackgroundPatient‐reported outcomes (PROs) are a better tool for evaluating the experiences of patients who have symptomatic, treatment‐associated adverse events (AEs) compared with clinician‐rated AEs. The authors present PROs assessing health‐related quality of life (HRQoL) and treatment‐related neurotoxicity for adjuvant capecitabine versus platinum on the Eastern Cooperative Oncology Group‐American College of Radiology Imaging Network (ECOG‐ACRIN) EA1131 trial (ClinicalTrials.gov identifier NCT02445391).MethodsParticipants completed the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy–Breast Cancer Symptom Index (NFBSI‐16) and the Functional Assessment of Cancer Therapy–Gynecologic Oncology Group neurotoxicity subscale (platinum arm only) at baseline, cycle 3 day 1 (C3D1), 6 months, and 15 months. Because of early termination, power was insufficient to test the hypothesis that HRQoL, as assessed by the NFBSI‐16 treatment side‐effect (TSE) subscale, would be better at 6 and 15 months in the capecitabine arm; all analyses were exploratory. Means were compared by using t‐tests or the Wilcoxon rank‐sum test, and proportions were compared by using the χ2 test.ResultsTwo hundred ninety‐six of 330 eligible patients provided PROs. The mean NFBSI‐16 TSE subscale score was lower for the platinum arm at baseline (p = .02; absolute difference, 0.6 points) and for the capecitabine arm at C3D1 (p = .04; absolute difference, 0.5 points), but it did not differ at other times. The mean change in TSE subscale scores differed between the arms from baseline to C3D1 (platinum arm, 0.15; capecitabine arm, −0.72; p = .03), but not from baseline to later time points. The mean decline in Functional Assessment of Cancer Therapy–Gynecologic Oncology Group neurotoxicity subscale scores exceeded the minimal meaningful change (1.38 points) from baseline to each subsequent time point (all p < .05).ConclusionsDespite the similar frequency of clinician‐rated AEs, PROs identified greater on‐treatment symptom burden with capecitabine and complemented clinician‐rated AEs by characterizing patients’ experiences during chemotherapy.

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“…At ESMO 2022, results for the secondary endpoints assessing patient-reported outcomes (PROs) in KEYNOTE-522 were reported [88]. The study analyzed the completion of EORTC QLQ-30 and QLQ-BR23 questionnaires during the neoadjuvant and adjuvant stages and found no significant differences in PRO scores, including global health status, quality of life, emotional functioning, physical functioning, and breast symptoms, between the treatment groups.…”

Section: Immune-related Adverse Event (Iraes)mentioning

confidence: 99%

Hope and Hype around Immunotherapy in Triple-Negative Breast Cancer

Jacobs

Agostinetto

Miggiano

et al. 2023

Cancers

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Triple-negative breast cancer (TNBC) holds a poor prognosis compared to other breast cancer subtypes, and the development of new effective treatment strategies is an unmet medical need. TNBC has traditionally been considered not amenable to treatment with targeted agents due to a lack of actionable targets. Therefore, chemotherapy has remained the mainstay of systemic treatment for many decades. The advent of immunotherapy raised very hopeful expectations in TNBC, possibly due to higher levels of tumor-infiltrating lymphocytes, PD-L1 expression and tumor mutational burden compared to other breast cancer subtypes, that predict an effective anti-tumor immune-engagement. The results of clinical trials testing immunotherapy in TNBC led to the approval of the combination of immune checkpoint inhibitors and chemotherapy in both early and advanced settings. However, some open questions about the use of immunotherapy in TNBC still exist. These include a deeper understanding of the heterogeneity of the disease, identification of reliable predictive biomarkers of response, determination of the most appropriate chemotherapy backbone and appropriate management of potential long-term immune-related adverse events. In this review we aim to examine the available evidence on the use of immunotherapy strategies in both early and advanced TNBC, to critically discuss some of the limitations encountered in clinical research and to summarize data on novel promising immunotherapeutic strategies beyond PD-(L)1 blockade that have been investigated in the most recent trials.

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135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522

Cited by 6 publications

References 0 publications

Recent advances in the treatment of triple-negative breast cancer

Recent advances in the treatment of triple-negative breast cancer

Adjuvant platinum versus capecitabine for residual, invasive, triple‐negative breast cancer: Patient‐reported outcomes in ECOG‐ACRIN EA1131

Hope and Hype around Immunotherapy in Triple-Negative Breast Cancer

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