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Impact of addition of immune checkpoint inhibitors to neoadjuvant chemotherapy in triple-negative breast cancer

Impact of addition of immune checkpoint inhibitors to neoadjuvant chemotherapy in triple-negative breast cancer
Study (reference) Chemotherapy regimen Subgroup IT agent (target) Control EFS results (IT versus control)
Number pCR* (%) Number pCR* (%)
  Pembrolizumab
(PD-1)		 Placebo  
KEYNOTE-522[1,2] Weekly paclitaxel with carboplatin (weekly or every 3 weeks) for 12 weeks followed by doxorubicin or epirubicin and cyclophosphamide for 4 cycles All 784 65 390 51 At median follow-up of 39 months, 3-year EFS 84 versus 77% (HR 0.63, 95% CI 0.48-0.82)
PD-L1+ 656 69 317 55
PD-L1– 127 45 69 30
I-SPY2[3] Weekly paclitaxel for 12 weeks followed by doxorubicin and cyclophosphamide for 4 cycles All 28 60 80 22 Not reported
  Atezolizumab
(PD-L1)		 Placebo  
Impassion031[4] Weekly nabpaclitaxel for 12 weeks followed by doxorubicin and cyclophosphamide for 4 cycles All 165 58 168 41 At approximately 20 months' median follow-up, EFS not reached (HR 0.76, 95% CI 0.4-1.44)
PD-L1+ 77 69 75 49
PD-L1– 88 48 93 34
  Atezolizumab
(PD-L1)		 None  
NeoTRIPaPDL1[5] Nabpaclitaxel and carboplatin days 1 and 8 every 21 days for 8 cycles All 138 44 142 41 Not reported
PD-L1+ 79 52 77 48
PD-L1– 59 32 65 32
  Durvalumab
(PD-L1)		 Placebo  
GeparNUEVO[6,7] Weekly nabpaclitaxel for 12 weeks followed epirubicin and cyclophosphamide for 4 cycles All 88 53 86 44 At median follow-up of 42 months, 3-year iDFS 85 versus 77% (HR 0.54, 95% CI 0.27-1.09)
PD-L1+ 69 58 69 51
PD-L1– 11 44 9 18
Window 59 61 58 41
IT: immunotherapy; pCR: pathologic complete response; PD-1: programmed cell death protein 1; EFS: event-free survival; PD-L1: programmed cell death ligand 1; HR: hazard ratio; iDFS: invasive disease-free survival.
* pCR: ypT0/isN0.
¶ The first 117 patients treated on GeparNeuvo received a single dose of either durvalumab or placebo two weeks before starting neoadjuvant chemotherapy with the same agent; this was omitted after the study's independent data monitoring committee expressed concern about the delay in the start of chemotherapy; another 57 patients were subsequently treated without this "window" treatment.
References:
  1. Schmid P, Cortes J, Pusztai L, et al. Pembrolizumab for early triple-negative breast cancer. N Engl J Med 2020; 382:810.
  2. Schmid P, Cortes J, Dent R, et al.KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy versus placebo + chemotherapy, followed by adjuvant pembrolizumab versus. placebo for early-stage TNBC. Ann Oncol 2021; ESMO #VP7-2021.
  3. Nanda R, Liu MC, Yau C, et al. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: An analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol 2020; 6:676.
  4. Mittendorf EA, Zhang H, Barrios CH, et al. Neoadjuvant atezolizumab in combination with sequential nabpaclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): A randomised, double-blind, phase 3 trial. Lancet 2020; 396:1090.
  5. Gianni L, Huang CS, Egle D, et al. Pathologic complete response (pCR) to neoadjuvant treatment with or without atezolizumab in triple-negative, early high-risk and locally advanced breast cancer. NeoTRIPaPDL1 Michelangelo randomized study. Cancer Res 2019; 80S: SABCS #GS3-04.
  6. Loibl S, Untch M, Burchardi N, et al. A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: Clinical results and biomarker analysis of GeparNuevo study. Ann Oncol 2019; 30:1279.
  7. Loibl S, Schneeweiss A, Huober JB, et al. Durvalumab improves long-term outcome in TNBC: Results from the phase II randomized GeparNUEVO study investigating neoadjuvant durvalumab in addition to an anthracycline/taxane based neoadjuvant chemotherapy in early triple-negative breast cancer (TNBC). J Clin Oncol 2021; 39S: ASCO #506.
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