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Article: Pembrolizumab for early triple-negative breast cancer

TitlePembrolizumab for early triple-negative breast cancer
Authors
Issue Date2020
Citation
New England Journal of Medicine, 2020, v. 382, n. 9, p. 810-821 How to Cite?
AbstractBackground: Previous trials showed promising antitumor activity and an acceptable safety profile associated with pembrolizumab in patients with early triple-negative breast cancer. Whether the addition of pembrolizumab to neoadjuvant chemotherapy would significantly increase the percentage of patients with early triple-negative breast cancer who have a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery is unclear. Methods: In this phase 3 trial, we randomly assigned (in a 2:1 ratio) patients with previously untreated stage II or stage III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) every 3 weeks plus paclitaxel and carboplatin (784 patients; the pembrolizumab-chemotherapy group) or placebo every 3 weeks plus paclitaxel and carboplatin (390 patients; the placebo-chemotherapy group); the two groups then received an additional four cycles of pembrolizumab or placebo, and both groups received doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, the patients received adjuvant pembrolizumab or placebo every 3 weeks for up to nine cycles. The primary end points were a pathological complete response at the time of definitive surgery and event-free survival in the intention-to-treat population. Results: At the first interim analysis, among the first 602 patients who underwent randomization, the percentage of patients with a pathological complete response was 64.8% (95% confidence interval [CI], 59.9 to 69.5) in the pembrolizumab-chemotherapy group and 51.2% (95% CI, 44.1 to 58.3) in the placebo-chemotherapy group (estimated treatment difference, 13.6 percentage points; 95% CI, 5.4 to 21.8; P<0.001). After a median follow-up of 15.5 months (range, 2.7 to 25.0), 58 of 784 patients (7.4%) in the pembrolizumab-chemotherapy group and 46 of 390 patients (11.8%) in the placebo-chemotherapy group had disease progression that precluded definitive surgery, had local or distant recurrence or a second primary tumor, or died from any cause (hazard ratio, 0.63; 95% CI, 0.43 to 0.93). Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively. Conclusions: Among patients with early triple-negative breast cancer, the percentage with a pathological complete response was significantly higher among those who received pembrolizumab plus neoadjuvant chemotherapy than among those who received placebo plus neoadjuvant chemotherapy.
Persistent Identifierhttp://hdl.handle.net/10722/326494
ISSN
2023 Impact Factor: 96.2
2023 SCImago Journal Rankings: 20.544
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorSchmid, P.-
dc.contributor.authorCortes, J.-
dc.contributor.authorPusztai, L.-
dc.contributor.authorMcArthur, H.-
dc.contributor.authorKümmel, S.-
dc.contributor.authorBergh, J.-
dc.contributor.authorDenkert, C.-
dc.contributor.authorPark, Y. H.-
dc.contributor.authorHui, R.-
dc.contributor.authorHarbeck, N.-
dc.contributor.authorTakahashi, M.-
dc.contributor.authorFoukakis, T.-
dc.contributor.authorFasching, P. A.-
dc.contributor.authorCardoso, F.-
dc.contributor.authorUntch, M.-
dc.contributor.authorJia, L.-
dc.contributor.authorKarantza, V.-
dc.contributor.authorZhao, J.-
dc.contributor.authorAktan, G.-
dc.contributor.authorDent, R.-
dc.contributor.authorO'Shaughnessy, J.-
dc.date.accessioned2023-03-10T02:19:41Z-
dc.date.available2023-03-10T02:19:41Z-
dc.date.issued2020-
dc.identifier.citationNew England Journal of Medicine, 2020, v. 382, n. 9, p. 810-821-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/326494-
dc.description.abstractBackground: Previous trials showed promising antitumor activity and an acceptable safety profile associated with pembrolizumab in patients with early triple-negative breast cancer. Whether the addition of pembrolizumab to neoadjuvant chemotherapy would significantly increase the percentage of patients with early triple-negative breast cancer who have a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery is unclear. Methods: In this phase 3 trial, we randomly assigned (in a 2:1 ratio) patients with previously untreated stage II or stage III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) every 3 weeks plus paclitaxel and carboplatin (784 patients; the pembrolizumab-chemotherapy group) or placebo every 3 weeks plus paclitaxel and carboplatin (390 patients; the placebo-chemotherapy group); the two groups then received an additional four cycles of pembrolizumab or placebo, and both groups received doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, the patients received adjuvant pembrolizumab or placebo every 3 weeks for up to nine cycles. The primary end points were a pathological complete response at the time of definitive surgery and event-free survival in the intention-to-treat population. Results: At the first interim analysis, among the first 602 patients who underwent randomization, the percentage of patients with a pathological complete response was 64.8% (95% confidence interval [CI], 59.9 to 69.5) in the pembrolizumab-chemotherapy group and 51.2% (95% CI, 44.1 to 58.3) in the placebo-chemotherapy group (estimated treatment difference, 13.6 percentage points; 95% CI, 5.4 to 21.8; P<0.001). After a median follow-up of 15.5 months (range, 2.7 to 25.0), 58 of 784 patients (7.4%) in the pembrolizumab-chemotherapy group and 46 of 390 patients (11.8%) in the placebo-chemotherapy group had disease progression that precluded definitive surgery, had local or distant recurrence or a second primary tumor, or died from any cause (hazard ratio, 0.63; 95% CI, 0.43 to 0.93). Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively. Conclusions: Among patients with early triple-negative breast cancer, the percentage with a pathological complete response was significantly higher among those who received pembrolizumab plus neoadjuvant chemotherapy than among those who received placebo plus neoadjuvant chemotherapy.-
dc.languageeng-
dc.relation.ispartofNew England Journal of Medicine-
dc.titlePembrolizumab for early triple-negative breast cancer-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1056/NEJMoa1910549-
dc.identifier.pmid32101663-
dc.identifier.scopuseid_2-s2.0-85080089288-
dc.identifier.volume382-
dc.identifier.issue9-
dc.identifier.spage810-
dc.identifier.epage821-
dc.identifier.eissn1533-4406-
dc.identifier.isiWOS:000518581500007-
dc.identifier.f1000737441116-

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