Breast Cancer

Key clinical point: A regimen consisting of docetaxel and capecitabine (TX) followed by cyclophosphamide, epirubicin, and capecitabine (CEX) prolonged survival in patients with early breast cancer (BC) vs. a regimen containing of only docetaxel followed by cyclophosphamide, epirubicin, and fluorouracil (T-CEF).

Major finding: Patients assigned to TX-CEX vs. T-CEF arms had significantly higher 15-year survival rate (77.6% vs. 73.3%; hazard ratio [HR] 0.81; log-rank P = .037) with patients in the triple-negative subgroup benefitting the most (HR 0.59; 95% CI 0.36-0.97).

Study details: Findings are from the open-label, phase 3 FinXX study including 1,495 patients with axillary node-positive or high-risk node-negative early BC, who were randomly assigned to the TX-CEX or T-CEF arms.

Disclosures: This study was supported by Roche, Sanofi, AstraZeneca, the Cancer Society of Finland, and others. The authors declared serving as consultants, advisors, or on the speaker’s bureau or receiving honoraria and research funding from several sources.

Source: Joensuu H et al. J Clin Oncol. 2022 (Jan 12). Doi: 10.1200/JCO.21.02054.

Key clinical point: A regimen consisting of docetaxel and capecitabine (TX) followed by cyclophosphamide, epirubicin, and capecitabine (CEX) prolonged survival in patients with early breast cancer (BC) vs. a regimen containing of only docetaxel followed by cyclophosphamide, epirubicin, and fluorouracil (T-CEF).

Major finding: Patients assigned to TX-CEX vs. T-CEF arms had significantly higher 15-year survival rate (77.6% vs. 73.3%; hazard ratio [HR] 0.81; log-rank P = .037) with patients in the triple-negative subgroup benefitting the most (HR 0.59; 95% CI 0.36-0.97).

Study details: Findings are from the open-label, phase 3 FinXX study including 1,495 patients with axillary node-positive or high-risk node-negative early BC, who were randomly assigned to the TX-CEX or T-CEF arms.

Disclosures: This study was supported by Roche, Sanofi, AstraZeneca, the Cancer Society of Finland, and others. The authors declared serving as consultants, advisors, or on the speaker’s bureau or receiving honoraria and research funding from several sources.

Source: Joensuu H et al. J Clin Oncol. 2022 (Jan 12). Doi: 10.1200/JCO.21.02054.

Key clinical point: A regimen consisting of docetaxel and capecitabine (TX) followed by cyclophosphamide, epirubicin, and capecitabine (CEX) prolonged survival in patients with early breast cancer (BC) vs. a regimen containing of only docetaxel followed by cyclophosphamide, epirubicin, and fluorouracil (T-CEF).

Major finding: Patients assigned to TX-CEX vs. T-CEF arms had significantly higher 15-year survival rate (77.6% vs. 73.3%; hazard ratio [HR] 0.81; log-rank P = .037) with patients in the triple-negative subgroup benefitting the most (HR 0.59; 95% CI 0.36-0.97).

Study details: Findings are from the open-label, phase 3 FinXX study including 1,495 patients with axillary node-positive or high-risk node-negative early BC, who were randomly assigned to the TX-CEX or T-CEF arms.

Disclosures: This study was supported by Roche, Sanofi, AstraZeneca, the Cancer Society of Finland, and others. The authors declared serving as consultants, advisors, or on the speaker’s bureau or receiving honoraria and research funding from several sources.

Source: Joensuu H et al. J Clin Oncol. 2022 (Jan 12). Doi: 10.1200/JCO.21.02054.

Key clinical point: Fosnetupitant showed a favorable safety profile with a low risk of causing injection-site reactions in patients with breast cancer receiving chemotherapy with doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide (AC/EC).

Major finding: Treatment-related adverse events (TRAE) were reported by 21.2% vs. 22.0% of patients in fosnetupitant vs. fosaprepitant group with adverse events relevant to injection site reactions observed in 5.8% vs. 26.0% of patients in fosnetupitant vs. fosaprepitant groups. Grade 3 or higher TRAEs occurred in 9.6% vs. 0% patients in fosnetupitant vs. fosaprepitant groups, with none leading to death or treatment discontinuation.

Study details: Findings are from a phase 3 study including 102 patients with breast cancer receiving AC/EC chemotherapy who were randomly assigned to receive fosnetupitant or fosaprepitant, both in combination with intravenous palonosetron and dexamethasone.

Disclosures: This study was funded by Taiho Pharmaceutical Co, Ltd. The authors declared receiving grants, consulting fees, payments, honoraria, travel support, or contracts from several sources including Taiho Pharmaceutical Co, Ltd.

Source: Matsuura K et al. Cancer. 2022 (Jan 19). Doi: 10.1002/cncr.34088.

Key clinical point: Fosnetupitant showed a favorable safety profile with a low risk of causing injection-site reactions in patients with breast cancer receiving chemotherapy with doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide (AC/EC).

Major finding: Treatment-related adverse events (TRAE) were reported by 21.2% vs. 22.0% of patients in fosnetupitant vs. fosaprepitant group with adverse events relevant to injection site reactions observed in 5.8% vs. 26.0% of patients in fosnetupitant vs. fosaprepitant groups. Grade 3 or higher TRAEs occurred in 9.6% vs. 0% patients in fosnetupitant vs. fosaprepitant groups, with none leading to death or treatment discontinuation.

Study details: Findings are from a phase 3 study including 102 patients with breast cancer receiving AC/EC chemotherapy who were randomly assigned to receive fosnetupitant or fosaprepitant, both in combination with intravenous palonosetron and dexamethasone.

Disclosures: This study was funded by Taiho Pharmaceutical Co, Ltd. The authors declared receiving grants, consulting fees, payments, honoraria, travel support, or contracts from several sources including Taiho Pharmaceutical Co, Ltd.

Source: Matsuura K et al. Cancer. 2022 (Jan 19). Doi: 10.1002/cncr.34088.

Key clinical point: Fosnetupitant showed a favorable safety profile with a low risk of causing injection-site reactions in patients with breast cancer receiving chemotherapy with doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide (AC/EC).

Major finding: Treatment-related adverse events (TRAE) were reported by 21.2% vs. 22.0% of patients in fosnetupitant vs. fosaprepitant group with adverse events relevant to injection site reactions observed in 5.8% vs. 26.0% of patients in fosnetupitant vs. fosaprepitant groups. Grade 3 or higher TRAEs occurred in 9.6% vs. 0% patients in fosnetupitant vs. fosaprepitant groups, with none leading to death or treatment discontinuation.

Study details: Findings are from a phase 3 study including 102 patients with breast cancer receiving AC/EC chemotherapy who were randomly assigned to receive fosnetupitant or fosaprepitant, both in combination with intravenous palonosetron and dexamethasone.

Disclosures: This study was funded by Taiho Pharmaceutical Co, Ltd. The authors declared receiving grants, consulting fees, payments, honoraria, travel support, or contracts from several sources including Taiho Pharmaceutical Co, Ltd.

Source: Matsuura K et al. Cancer. 2022 (Jan 19). Doi: 10.1002/cncr.34088.

Key clinical point: Aromatase inhibitor vs. tamoxifen reduced the risk for breast cancer (BC) recurrence in premenopausal women with early-stage, estrogen receptor-positive (ER+) BC receiving ovarian suppression.

Major finding: Aromatase inhibitor vs. tamoxifen was associated with significantly reduced rates of BC recurrence during the first 4 years of follow-up (risk ratio [RR] 0.68; P < .0001) and distant recurrence (RR 0.83; P = .018). No significant differences in breast cancer mortality, death without recurrence, or all-cause mortality were observed between the treatment groups.

Study details: Findings are a meta-analysis of 4 phase 3 trials (ABCSG-XII, TEXT, SOFT, and HOBOE) including 7,030 premenopausal women with ER+ BC who were randomly assigned to aromatase inhibitors (anastrozole, exemestane, or letrozole) or tamoxifen for 3 or 5 years, all in combination with ovarian suppression or ablation.

Disclosures: This study was funded by the Cancer Research UK and UK Medical Research Council. The authors declared serving as leaders and fiduciaries or receiving grants, consulting fees, travel support, or honoraria from several sources.

Source: Early Breast Cancer Trialists' Collaborative Group. Lancet Oncol. 2022 (Feb 3). Doi: 10.1016/S1470-2045(21)00758-0.

Key clinical point: Aromatase inhibitor vs. tamoxifen reduced the risk for breast cancer (BC) recurrence in premenopausal women with early-stage, estrogen receptor-positive (ER+) BC receiving ovarian suppression.

Major finding: Aromatase inhibitor vs. tamoxifen was associated with significantly reduced rates of BC recurrence during the first 4 years of follow-up (risk ratio [RR] 0.68; P < .0001) and distant recurrence (RR 0.83; P = .018). No significant differences in breast cancer mortality, death without recurrence, or all-cause mortality were observed between the treatment groups.

Study details: Findings are a meta-analysis of 4 phase 3 trials (ABCSG-XII, TEXT, SOFT, and HOBOE) including 7,030 premenopausal women with ER+ BC who were randomly assigned to aromatase inhibitors (anastrozole, exemestane, or letrozole) or tamoxifen for 3 or 5 years, all in combination with ovarian suppression or ablation.

Disclosures: This study was funded by the Cancer Research UK and UK Medical Research Council. The authors declared serving as leaders and fiduciaries or receiving grants, consulting fees, travel support, or honoraria from several sources.

Source: Early Breast Cancer Trialists' Collaborative Group. Lancet Oncol. 2022 (Feb 3). Doi: 10.1016/S1470-2045(21)00758-0.

Key clinical point: Aromatase inhibitor vs. tamoxifen reduced the risk for breast cancer (BC) recurrence in premenopausal women with early-stage, estrogen receptor-positive (ER+) BC receiving ovarian suppression.

Major finding: Aromatase inhibitor vs. tamoxifen was associated with significantly reduced rates of BC recurrence during the first 4 years of follow-up (risk ratio [RR] 0.68; P < .0001) and distant recurrence (RR 0.83; P = .018). No significant differences in breast cancer mortality, death without recurrence, or all-cause mortality were observed between the treatment groups.

Study details: Findings are a meta-analysis of 4 phase 3 trials (ABCSG-XII, TEXT, SOFT, and HOBOE) including 7,030 premenopausal women with ER+ BC who were randomly assigned to aromatase inhibitors (anastrozole, exemestane, or letrozole) or tamoxifen for 3 or 5 years, all in combination with ovarian suppression or ablation.

Disclosures: This study was funded by the Cancer Research UK and UK Medical Research Council. The authors declared serving as leaders and fiduciaries or receiving grants, consulting fees, travel support, or honoraria from several sources.

Source: Early Breast Cancer Trialists' Collaborative Group. Lancet Oncol. 2022 (Feb 3). Doi: 10.1016/S1470-2045(21)00758-0.

Key clinical point: Protein-truncating variants (PTV) of 9 breast cancer (BC) risk genes showed substantial differences in tumor pathology and were generally associated with triple-negative (TN) or high-grade disease.

Major finding: BRCA1 showed the highest association for TN disease (odds ratio [OR] 55.32; 95% CI 40.51-75.55) and ATM variants for the hormone receptor-positive (HR+) erb-b2 receptor tyrosine kinase 2-negative (ERBB2−) high-grade subtype (OR 4.99; 95% CI 3.68-6.76). RAD51C (OR 6.19; 95% CI 3.17-12.12), RAD51D (OR 6.19; 95% CI 2.99-12.79), and BARD1 (OR 10.05; 95% CI 5.27-19.19) were most strongly associated with TN disease. PALB2 PTVs showed higher ORs for HR+ERBB2− high-grade subtype (OR 9.43; 95% CI 6.24- 14.25) and TN disease (OR 8.05; 95% CI 5.17-12.53).

Study details: This was a case-control analysis of the BRIDGES study including 42,680 patients with BC who were matched with 46,387 healthy controls.

Disclosures: This study was funded by the European Union Horizon 2020 research and innovation program, Wellcome Trust, and several other sources. The authors declared receiving grants, honorariums, personal fees, or awards from several sources.

Source: Breast Cancer Association Consortium. JAMA Oncol. 2022 (Jan 27). Doi: 10.1001/jamaoncol.2021.6744.

Key clinical point: Protein-truncating variants (PTV) of 9 breast cancer (BC) risk genes showed substantial differences in tumor pathology and were generally associated with triple-negative (TN) or high-grade disease.

Major finding: BRCA1 showed the highest association for TN disease (odds ratio [OR] 55.32; 95% CI 40.51-75.55) and ATM variants for the hormone receptor-positive (HR+) erb-b2 receptor tyrosine kinase 2-negative (ERBB2−) high-grade subtype (OR 4.99; 95% CI 3.68-6.76). RAD51C (OR 6.19; 95% CI 3.17-12.12), RAD51D (OR 6.19; 95% CI 2.99-12.79), and BARD1 (OR 10.05; 95% CI 5.27-19.19) were most strongly associated with TN disease. PALB2 PTVs showed higher ORs for HR+ERBB2− high-grade subtype (OR 9.43; 95% CI 6.24- 14.25) and TN disease (OR 8.05; 95% CI 5.17-12.53).

Study details: This was a case-control analysis of the BRIDGES study including 42,680 patients with BC who were matched with 46,387 healthy controls.

Disclosures: This study was funded by the European Union Horizon 2020 research and innovation program, Wellcome Trust, and several other sources. The authors declared receiving grants, honorariums, personal fees, or awards from several sources.

Source: Breast Cancer Association Consortium. JAMA Oncol. 2022 (Jan 27). Doi: 10.1001/jamaoncol.2021.6744.

Key clinical point: Protein-truncating variants (PTV) of 9 breast cancer (BC) risk genes showed substantial differences in tumor pathology and were generally associated with triple-negative (TN) or high-grade disease.

Major finding: BRCA1 showed the highest association for TN disease (odds ratio [OR] 55.32; 95% CI 40.51-75.55) and ATM variants for the hormone receptor-positive (HR+) erb-b2 receptor tyrosine kinase 2-negative (ERBB2−) high-grade subtype (OR 4.99; 95% CI 3.68-6.76). RAD51C (OR 6.19; 95% CI 3.17-12.12), RAD51D (OR 6.19; 95% CI 2.99-12.79), and BARD1 (OR 10.05; 95% CI 5.27-19.19) were most strongly associated with TN disease. PALB2 PTVs showed higher ORs for HR+ERBB2− high-grade subtype (OR 9.43; 95% CI 6.24- 14.25) and TN disease (OR 8.05; 95% CI 5.17-12.53).

Study details: This was a case-control analysis of the BRIDGES study including 42,680 patients with BC who were matched with 46,387 healthy controls.

Disclosures: This study was funded by the European Union Horizon 2020 research and innovation program, Wellcome Trust, and several other sources. The authors declared receiving grants, honorariums, personal fees, or awards from several sources.

Source: Breast Cancer Association Consortium. JAMA Oncol. 2022 (Jan 27). Doi: 10.1001/jamaoncol.2021.6744.

Key clinical point: A regimen consisting of docetaxel and capecitabine (TX) followed by cyclophosphamide, epirubicin, and capecitabine (CEX) vs. only docetaxel followed by cyclophosphamide, epirubicin, and fluorouracil (T-CEF) prolonged recurrence-free survival (RFS) in patients with non- BRCA1-like early triple-negative breast cancer (TNBC).

Major finding: Overall, patients assigned to TX-CEX vs. T-CEF arms had higher RFS (hazard ratio [HR] 0.39; P = .01), with the capecitabine-containing chemotherapy being significantly more effective than conventional chemotherapy in patients with non-BRCA1-like tumor (HR 0.23; P < .01) but not in patients with BRCA1-like tumor (HR 0.66; P = .42).

Study details: Findings are from the open-label, phase 3 FinXX study including 202 patients with early TNBC who were randomly assigned to TX-CEX or T-CEF arms.  BRCA1-like status was obtained for 129 patients.

Disclosures: This work was supported by the Dutch Cancer Society. The authors declared serving as board members and employees or receiving fees, grants, nonfinancial, and research support from several sources.

Source: de Boo LW et al. Br J Cancer. 2022 (Feb 5). Doi: 10.1038/s41416-022-01711-y.

Key clinical point: A regimen consisting of docetaxel and capecitabine (TX) followed by cyclophosphamide, epirubicin, and capecitabine (CEX) vs. only docetaxel followed by cyclophosphamide, epirubicin, and fluorouracil (T-CEF) prolonged recurrence-free survival (RFS) in patients with non- BRCA1-like early triple-negative breast cancer (TNBC).

Major finding: Overall, patients assigned to TX-CEX vs. T-CEF arms had higher RFS (hazard ratio [HR] 0.39; P = .01), with the capecitabine-containing chemotherapy being significantly more effective than conventional chemotherapy in patients with non-BRCA1-like tumor (HR 0.23; P < .01) but not in patients with BRCA1-like tumor (HR 0.66; P = .42).

Study details: Findings are from the open-label, phase 3 FinXX study including 202 patients with early TNBC who were randomly assigned to TX-CEX or T-CEF arms.  BRCA1-like status was obtained for 129 patients.

Disclosures: This work was supported by the Dutch Cancer Society. The authors declared serving as board members and employees or receiving fees, grants, nonfinancial, and research support from several sources.

Source: de Boo LW et al. Br J Cancer. 2022 (Feb 5). Doi: 10.1038/s41416-022-01711-y.

Key clinical point: A regimen consisting of docetaxel and capecitabine (TX) followed by cyclophosphamide, epirubicin, and capecitabine (CEX) vs. only docetaxel followed by cyclophosphamide, epirubicin, and fluorouracil (T-CEF) prolonged recurrence-free survival (RFS) in patients with non- BRCA1-like early triple-negative breast cancer (TNBC).

Major finding: Overall, patients assigned to TX-CEX vs. T-CEF arms had higher RFS (hazard ratio [HR] 0.39; P = .01), with the capecitabine-containing chemotherapy being significantly more effective than conventional chemotherapy in patients with non-BRCA1-like tumor (HR 0.23; P < .01) but not in patients with BRCA1-like tumor (HR 0.66; P = .42).

Study details: Findings are from the open-label, phase 3 FinXX study including 202 patients with early TNBC who were randomly assigned to TX-CEX or T-CEF arms.  BRCA1-like status was obtained for 129 patients.

Disclosures: This work was supported by the Dutch Cancer Society. The authors declared serving as board members and employees or receiving fees, grants, nonfinancial, and research support from several sources.

Source: de Boo LW et al. Br J Cancer. 2022 (Feb 5). Doi: 10.1038/s41416-022-01711-y.

Key clinical point: Adding carboplatin to neoadjuvant paclitaxel followed by doxorubicin and cyclophosphamide improved long-term event-free survival (EFS) along with a manageable safety profile in patients with triple-negative breast cancer (TNBC).

Major finding: Patients receiving carboplatin+veliparib+paclitaxel vs. paclitaxel showed significant improvements in EFS (hazard ratio [HR] 0.63; P = .02), whereas EFS was not significntly different among patients assigned to carboplatin+veliparib+paclitaxel vs. carboplatin+paclitaxel (HR 1.12; P = .62). Rates of treatment-emergent and post-treatment-emergent adverse events and secondary malignancies were similar across treatment groups.

Study details: Findings are based on the 4.5-year follow-up data from the phase 3 BrighTNess trial including 634 patients with stage II-III TNBC who were randomly assigned to receive carboplatin+veliparib, carboplatin+veliparib placebo, or carboplatin placebo+veliparib placebo, all in combination with paclitaxel.

Disclosures: This study was supported by AbbVie. Some authors declared serving on the advisory board and speaker’s bureau or receiving travel funds, writing support, honoraria, research funds, and consulting fees from several sources including AbbVie. D Maag declared being an employee or stockholder of AbbVie.

Source: Geyer CE Jr et al. Ann Oncol. 2022 (Jan 27). Doi: 10.1016/j.annonc.2022.01.009.

Key clinical point: Adding carboplatin to neoadjuvant paclitaxel followed by doxorubicin and cyclophosphamide improved long-term event-free survival (EFS) along with a manageable safety profile in patients with triple-negative breast cancer (TNBC).

Major finding: Patients receiving carboplatin+veliparib+paclitaxel vs. paclitaxel showed significant improvements in EFS (hazard ratio [HR] 0.63; P = .02), whereas EFS was not significntly different among patients assigned to carboplatin+veliparib+paclitaxel vs. carboplatin+paclitaxel (HR 1.12; P = .62). Rates of treatment-emergent and post-treatment-emergent adverse events and secondary malignancies were similar across treatment groups.

Study details: Findings are based on the 4.5-year follow-up data from the phase 3 BrighTNess trial including 634 patients with stage II-III TNBC who were randomly assigned to receive carboplatin+veliparib, carboplatin+veliparib placebo, or carboplatin placebo+veliparib placebo, all in combination with paclitaxel.

Disclosures: This study was supported by AbbVie. Some authors declared serving on the advisory board and speaker’s bureau or receiving travel funds, writing support, honoraria, research funds, and consulting fees from several sources including AbbVie. D Maag declared being an employee or stockholder of AbbVie.

Source: Geyer CE Jr et al. Ann Oncol. 2022 (Jan 27). Doi: 10.1016/j.annonc.2022.01.009.

Key clinical point: Adding carboplatin to neoadjuvant paclitaxel followed by doxorubicin and cyclophosphamide improved long-term event-free survival (EFS) along with a manageable safety profile in patients with triple-negative breast cancer (TNBC).

Major finding: Patients receiving carboplatin+veliparib+paclitaxel vs. paclitaxel showed significant improvements in EFS (hazard ratio [HR] 0.63; P = .02), whereas EFS was not significntly different among patients assigned to carboplatin+veliparib+paclitaxel vs. carboplatin+paclitaxel (HR 1.12; P = .62). Rates of treatment-emergent and post-treatment-emergent adverse events and secondary malignancies were similar across treatment groups.

Study details: Findings are based on the 4.5-year follow-up data from the phase 3 BrighTNess trial including 634 patients with stage II-III TNBC who were randomly assigned to receive carboplatin+veliparib, carboplatin+veliparib placebo, or carboplatin placebo+veliparib placebo, all in combination with paclitaxel.

Disclosures: This study was supported by AbbVie. Some authors declared serving on the advisory board and speaker’s bureau or receiving travel funds, writing support, honoraria, research funds, and consulting fees from several sources including AbbVie. D Maag declared being an employee or stockholder of AbbVie.

Source: Geyer CE Jr et al. Ann Oncol. 2022 (Jan 27). Doi: 10.1016/j.annonc.2022.01.009.

Key clinical point: Pyrotinib+capecitabine showed intracranial objective response and was well tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases in the PERMEATE phase 2 study.

Major finding: The intracranial objective response rate was 74.6% (95% CI 61.6%-85.0%) in radiotherapy-naive patients and 42.1% (95% CI 20.3%-66.5%) in patients with progressive disease after whole-brain radiotherapy. Common grade 3 treatment-emergent adverse events were diarrhea and decreased white blood cell count. No treatment-related deaths were reported.

Study details: Findings are from the single-arm, phase 2 PERMEATE study including 78 patients with HER2+ BC and brain metastases who were either radiotherapy-naive or had progressive disease after radiotherapy. Patients received 400 mg pyrotinib once daily and 1000 mg/m² capecitabine twice daily for 14 days, followed by 7 days off during each 21-day cycle.

Disclosures: This study was funded by the National Cancer Centre Climbing Foundation Key Project of China and Jiangsu Hengrui Pharmaceuticals. The authors declared no conflicts of interest.

Source: Yan M et al. Lancet Oncol. 2022 (Jan 24). Doi: 10.1016/S1470-2045(21)00716-6.

Key clinical point: Pyrotinib+capecitabine showed intracranial objective response and was well tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases in the PERMEATE phase 2 study.

Major finding: The intracranial objective response rate was 74.6% (95% CI 61.6%-85.0%) in radiotherapy-naive patients and 42.1% (95% CI 20.3%-66.5%) in patients with progressive disease after whole-brain radiotherapy. Common grade 3 treatment-emergent adverse events were diarrhea and decreased white blood cell count. No treatment-related deaths were reported.

Study details: Findings are from the single-arm, phase 2 PERMEATE study including 78 patients with HER2+ BC and brain metastases who were either radiotherapy-naive or had progressive disease after radiotherapy. Patients received 400 mg pyrotinib once daily and 1000 mg/m² capecitabine twice daily for 14 days, followed by 7 days off during each 21-day cycle.

Disclosures: This study was funded by the National Cancer Centre Climbing Foundation Key Project of China and Jiangsu Hengrui Pharmaceuticals. The authors declared no conflicts of interest.

Source: Yan M et al. Lancet Oncol. 2022 (Jan 24). Doi: 10.1016/S1470-2045(21)00716-6.

Key clinical point: Pyrotinib+capecitabine showed intracranial objective response and was well tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases in the PERMEATE phase 2 study.

Major finding: The intracranial objective response rate was 74.6% (95% CI 61.6%-85.0%) in radiotherapy-naive patients and 42.1% (95% CI 20.3%-66.5%) in patients with progressive disease after whole-brain radiotherapy. Common grade 3 treatment-emergent adverse events were diarrhea and decreased white blood cell count. No treatment-related deaths were reported.

Study details: Findings are from the single-arm, phase 2 PERMEATE study including 78 patients with HER2+ BC and brain metastases who were either radiotherapy-naive or had progressive disease after radiotherapy. Patients received 400 mg pyrotinib once daily and 1000 mg/m² capecitabine twice daily for 14 days, followed by 7 days off during each 21-day cycle.

Disclosures: This study was funded by the National Cancer Centre Climbing Foundation Key Project of China and Jiangsu Hengrui Pharmaceuticals. The authors declared no conflicts of interest.

Source: Yan M et al. Lancet Oncol. 2022 (Jan 24). Doi: 10.1016/S1470-2045(21)00716-6.

A number of clinical trials in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled.

• Menopausal women at moderate risk of developing breast cancer. A phase 2 study sponsored by the National Cancer Institute is seeking women aged 45-60 in late menopause or post menopause who are at “moderate” risk of developing breast cancer. Examples of criteria for moderate risk include prior proliferative disease on breast biopsy or having a first- or second-degree relative who developed breast cancer at aged 60 or younger. Researchers are looking for a signal that bazedoxifene plus conjugated estrogens (Duavee), a hot-flash therapy, could prevent breast cancer in at-risk people. Participants in the active-therapy group will receive once-daily oral medication for 6 months. The control patients will have the option of taking the medication after 6 months. The trial aims to enroll 120 participants. It began recruiting on Dec. 2, 2021, at the University of Kansas Medical Center; sites in California, Illinois, and Massachusetts are planned. The primary outcome is the change in fibroglandular volume. Overall survival (OS) and quality of life (QOL) will not be measured. More details at clinicaltrials.gov.

• Early high-risk nonmetastatic HER2+ breast cancer with no prior treatment. Adults with this type of breast cancer are invited to join a phase 3 trial of trastuzumab deruxtecan (T-DXd; Enhertu) as neoadjuvant therapy. T-DXd is currently approved for patients with advanced disease, so this study could lead to a new indication. Participants will receive standard intravenous regimens of either T-DXd monotherapy; T-DXd followed by paclitaxel (Taxol), trastuzumab (Herceptin), and pertuzumab (Perjeta), referred to as the THP regime; or doxorubicin plus cyclophosphamide followed by THP. The primary outcome is rate of pathologic complete response, and a secondary outcome is OS over approximately 5 years. QOL won’t be measured. The study opened on Oct. 25, 2021, and eventually hopes to recruit 624 participants in 19 countries and 15 U.S. states. More details at clinicaltrials.gov.

“[This is an] important early trial to move trastuzumab deruxtecan to early disease. If successful as monotherapy, this would be a big win for patients,” commented Kathy Miller, MD, professor of oncology and medicine at Indiana University, Indianapolis, a contributor to this news organization. She cautioned that monitoring rates of pneumonitis will be important in this curable setting.

• Locally advanced unresectable or metastatic HER2+ breast cancer with no prior tyrosine-kinase inhibitor therapy. Adult patients with these clinical features are eligible for a phase 3 study that is also testing a drug in an earlier setting than its current label – tucatinib (Tukysa) as first-line anti-HER2 therapy in advanced disease. Tucatinib was approved in April 2020 by the U.S. Food and Drug Administration as second-line therapy in such patients, so this study could also lead to a new indication. Participants in the experimental arm will receive tucatinib tablets twice daily and a combination of trastuzumab and pertuzumab intravenously or subcutaneously every 3 weeks for up to approximately 3 years. Patients in the control arm will take a placebo instead of tucatinib. Seven sites across Florida, Kentucky, Maryland, and South Carolina aim to start recruiting 650 participants on Feb. 28, 2022. The primary outcome is progression-free survival (PFS). OS and QoL will be tracked. More details at clinicaltrials.gov.

“Tucatinib has real activity,” commented Dr. Miller, adding that “we haven’t [yet] found the best way to exploit that activity for our patients.”

• Inoperable or metastatic HR+ HER2– breast cancer after one or two lines of systemic chemotherapy. Adults with this type of breast cancer are being recruited for a phase 3 study to compare datopotamab deruxtecan (Dato-DXd), an experimental antibody-drug conjugate (ADC), against a range of standard single-agent chemotherapies. Participants will receive either intravenous Dato-DXd or investigator’s choice of one of four chemotherapies: oral capecitabine (Xeloda), IV gemcitabine (Gemzar), IV eribulin (Halaven), or IV vinorelbine (Navelbine). The trial began recruiting for 700 participants at sites worldwide on Oct. 18, 2021. U.S. sites are in Michigan and California; trial centers in 15 other states are planned. Primary outcomes are OS over approximately 3.5 years and PFS over approximately 2 years. QOL is tracked. More details at clinicaltrials.gov.

Commenting on this trial, Dr. Miller said: “ADCs will play an expanded role in our management. This may be one of the first to move into the ER+ population.”

• Advanced ER+, HER2– breast cancer. Adult patients with this type of cancer can join a phase 3 trial testing oral imlunestrant, an experimental selective estrogen-receptor degrader (SERD), against standard endocrine therapy. For up to 3 years, people in the study will take either daily tablets of imlunestrant or once-daily pills of imlunestrant and another SERD, abemaciclib (Verzenio). A third group of participants will receive their investigator’s choice of either daily tablets of exemestane (Aromasin) or monthly intramuscular injections of fulvestrant (Faslodex). The study opened to 800 participants on Oct. 4, 2021, at sites in 11 U.S. states and worldwide. The primary outcome is PFS over approximately 3 years; 5-year OS is a secondary outcome. QOL is not assessed. More details at clinicaltrials.gov

Dr. Miller predicted that “oral SERDs will replace fulvestrant in the future: We already have positive phase 3 data with elacestrant.”

Dr. Miller has a regular column with this news organization, Miller on Oncology. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

A number of clinical trials in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled.

• Menopausal women at moderate risk of developing breast cancer. A phase 2 study sponsored by the National Cancer Institute is seeking women aged 45-60 in late menopause or post menopause who are at “moderate” risk of developing breast cancer. Examples of criteria for moderate risk include prior proliferative disease on breast biopsy or having a first- or second-degree relative who developed breast cancer at aged 60 or younger. Researchers are looking for a signal that bazedoxifene plus conjugated estrogens (Duavee), a hot-flash therapy, could prevent breast cancer in at-risk people. Participants in the active-therapy group will receive once-daily oral medication for 6 months. The control patients will have the option of taking the medication after 6 months. The trial aims to enroll 120 participants. It began recruiting on Dec. 2, 2021, at the University of Kansas Medical Center; sites in California, Illinois, and Massachusetts are planned. The primary outcome is the change in fibroglandular volume. Overall survival (OS) and quality of life (QOL) will not be measured. More details at clinicaltrials.gov.

• Early high-risk nonmetastatic HER2+ breast cancer with no prior treatment. Adults with this type of breast cancer are invited to join a phase 3 trial of trastuzumab deruxtecan (T-DXd; Enhertu) as neoadjuvant therapy. T-DXd is currently approved for patients with advanced disease, so this study could lead to a new indication. Participants will receive standard intravenous regimens of either T-DXd monotherapy; T-DXd followed by paclitaxel (Taxol), trastuzumab (Herceptin), and pertuzumab (Perjeta), referred to as the THP regime; or doxorubicin plus cyclophosphamide followed by THP. The primary outcome is rate of pathologic complete response, and a secondary outcome is OS over approximately 5 years. QOL won’t be measured. The study opened on Oct. 25, 2021, and eventually hopes to recruit 624 participants in 19 countries and 15 U.S. states. More details at clinicaltrials.gov.

“[This is an] important early trial to move trastuzumab deruxtecan to early disease. If successful as monotherapy, this would be a big win for patients,” commented Kathy Miller, MD, professor of oncology and medicine at Indiana University, Indianapolis, a contributor to this news organization. She cautioned that monitoring rates of pneumonitis will be important in this curable setting.

• Locally advanced unresectable or metastatic HER2+ breast cancer with no prior tyrosine-kinase inhibitor therapy. Adult patients with these clinical features are eligible for a phase 3 study that is also testing a drug in an earlier setting than its current label – tucatinib (Tukysa) as first-line anti-HER2 therapy in advanced disease. Tucatinib was approved in April 2020 by the U.S. Food and Drug Administration as second-line therapy in such patients, so this study could also lead to a new indication. Participants in the experimental arm will receive tucatinib tablets twice daily and a combination of trastuzumab and pertuzumab intravenously or subcutaneously every 3 weeks for up to approximately 3 years. Patients in the control arm will take a placebo instead of tucatinib. Seven sites across Florida, Kentucky, Maryland, and South Carolina aim to start recruiting 650 participants on Feb. 28, 2022. The primary outcome is progression-free survival (PFS). OS and QoL will be tracked. More details at clinicaltrials.gov.

“Tucatinib has real activity,” commented Dr. Miller, adding that “we haven’t [yet] found the best way to exploit that activity for our patients.”

• Inoperable or metastatic HR+ HER2– breast cancer after one or two lines of systemic chemotherapy. Adults with this type of breast cancer are being recruited for a phase 3 study to compare datopotamab deruxtecan (Dato-DXd), an experimental antibody-drug conjugate (ADC), against a range of standard single-agent chemotherapies. Participants will receive either intravenous Dato-DXd or investigator’s choice of one of four chemotherapies: oral capecitabine (Xeloda), IV gemcitabine (Gemzar), IV eribulin (Halaven), or IV vinorelbine (Navelbine). The trial began recruiting for 700 participants at sites worldwide on Oct. 18, 2021. U.S. sites are in Michigan and California; trial centers in 15 other states are planned. Primary outcomes are OS over approximately 3.5 years and PFS over approximately 2 years. QOL is tracked. More details at clinicaltrials.gov.

Commenting on this trial, Dr. Miller said: “ADCs will play an expanded role in our management. This may be one of the first to move into the ER+ population.”

• Advanced ER+, HER2– breast cancer. Adult patients with this type of cancer can join a phase 3 trial testing oral imlunestrant, an experimental selective estrogen-receptor degrader (SERD), against standard endocrine therapy. For up to 3 years, people in the study will take either daily tablets of imlunestrant or once-daily pills of imlunestrant and another SERD, abemaciclib (Verzenio). A third group of participants will receive their investigator’s choice of either daily tablets of exemestane (Aromasin) or monthly intramuscular injections of fulvestrant (Faslodex). The study opened to 800 participants on Oct. 4, 2021, at sites in 11 U.S. states and worldwide. The primary outcome is PFS over approximately 3 years; 5-year OS is a secondary outcome. QOL is not assessed. More details at clinicaltrials.gov

Dr. Miller predicted that “oral SERDs will replace fulvestrant in the future: We already have positive phase 3 data with elacestrant.”

Dr. Miller has a regular column with this news organization, Miller on Oncology. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

A number of clinical trials in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled.

• Menopausal women at moderate risk of developing breast cancer. A phase 2 study sponsored by the National Cancer Institute is seeking women aged 45-60 in late menopause or post menopause who are at “moderate” risk of developing breast cancer. Examples of criteria for moderate risk include prior proliferative disease on breast biopsy or having a first- or second-degree relative who developed breast cancer at aged 60 or younger. Researchers are looking for a signal that bazedoxifene plus conjugated estrogens (Duavee), a hot-flash therapy, could prevent breast cancer in at-risk people. Participants in the active-therapy group will receive once-daily oral medication for 6 months. The control patients will have the option of taking the medication after 6 months. The trial aims to enroll 120 participants. It began recruiting on Dec. 2, 2021, at the University of Kansas Medical Center; sites in California, Illinois, and Massachusetts are planned. The primary outcome is the change in fibroglandular volume. Overall survival (OS) and quality of life (QOL) will not be measured. More details at clinicaltrials.gov.

• Early high-risk nonmetastatic HER2+ breast cancer with no prior treatment. Adults with this type of breast cancer are invited to join a phase 3 trial of trastuzumab deruxtecan (T-DXd; Enhertu) as neoadjuvant therapy. T-DXd is currently approved for patients with advanced disease, so this study could lead to a new indication. Participants will receive standard intravenous regimens of either T-DXd monotherapy; T-DXd followed by paclitaxel (Taxol), trastuzumab (Herceptin), and pertuzumab (Perjeta), referred to as the THP regime; or doxorubicin plus cyclophosphamide followed by THP. The primary outcome is rate of pathologic complete response, and a secondary outcome is OS over approximately 5 years. QOL won’t be measured. The study opened on Oct. 25, 2021, and eventually hopes to recruit 624 participants in 19 countries and 15 U.S. states. More details at clinicaltrials.gov.

“[This is an] important early trial to move trastuzumab deruxtecan to early disease. If successful as monotherapy, this would be a big win for patients,” commented Kathy Miller, MD, professor of oncology and medicine at Indiana University, Indianapolis, a contributor to this news organization. She cautioned that monitoring rates of pneumonitis will be important in this curable setting.

• Locally advanced unresectable or metastatic HER2+ breast cancer with no prior tyrosine-kinase inhibitor therapy. Adult patients with these clinical features are eligible for a phase 3 study that is also testing a drug in an earlier setting than its current label – tucatinib (Tukysa) as first-line anti-HER2 therapy in advanced disease. Tucatinib was approved in April 2020 by the U.S. Food and Drug Administration as second-line therapy in such patients, so this study could also lead to a new indication. Participants in the experimental arm will receive tucatinib tablets twice daily and a combination of trastuzumab and pertuzumab intravenously or subcutaneously every 3 weeks for up to approximately 3 years. Patients in the control arm will take a placebo instead of tucatinib. Seven sites across Florida, Kentucky, Maryland, and South Carolina aim to start recruiting 650 participants on Feb. 28, 2022. The primary outcome is progression-free survival (PFS). OS and QoL will be tracked. More details at clinicaltrials.gov.

“Tucatinib has real activity,” commented Dr. Miller, adding that “we haven’t [yet] found the best way to exploit that activity for our patients.”

• Inoperable or metastatic HR+ HER2– breast cancer after one or two lines of systemic chemotherapy. Adults with this type of breast cancer are being recruited for a phase 3 study to compare datopotamab deruxtecan (Dato-DXd), an experimental antibody-drug conjugate (ADC), against a range of standard single-agent chemotherapies. Participants will receive either intravenous Dato-DXd or investigator’s choice of one of four chemotherapies: oral capecitabine (Xeloda), IV gemcitabine (Gemzar), IV eribulin (Halaven), or IV vinorelbine (Navelbine). The trial began recruiting for 700 participants at sites worldwide on Oct. 18, 2021. U.S. sites are in Michigan and California; trial centers in 15 other states are planned. Primary outcomes are OS over approximately 3.5 years and PFS over approximately 2 years. QOL is tracked. More details at clinicaltrials.gov.

Commenting on this trial, Dr. Miller said: “ADCs will play an expanded role in our management. This may be one of the first to move into the ER+ population.”

• Advanced ER+, HER2– breast cancer. Adult patients with this type of cancer can join a phase 3 trial testing oral imlunestrant, an experimental selective estrogen-receptor degrader (SERD), against standard endocrine therapy. For up to 3 years, people in the study will take either daily tablets of imlunestrant or once-daily pills of imlunestrant and another SERD, abemaciclib (Verzenio). A third group of participants will receive their investigator’s choice of either daily tablets of exemestane (Aromasin) or monthly intramuscular injections of fulvestrant (Faslodex). The study opened to 800 participants on Oct. 4, 2021, at sites in 11 U.S. states and worldwide. The primary outcome is PFS over approximately 3 years; 5-year OS is a secondary outcome. QOL is not assessed. More details at clinicaltrials.gov

Dr. Miller predicted that “oral SERDs will replace fulvestrant in the future: We already have positive phase 3 data with elacestrant.”

Dr. Miller has a regular column with this news organization, Miller on Oncology. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

A drop-off in cancer screening during the first year of the COVID-19 pandemic has led to a marked increase in people presenting with advanced breast and colon cancer at Moores Cancer Center in La Jolla, Calif., according to a research letter in JAMA Network Open.

“The number of patients presenting at late, incurable stages is increasing,” say the authors, led by Jade Zifei Zhou, MD, PhD, a hematology/oncology fellow at the center, which is affiliated with the University of California, San Diego.

As the pandemic unfolded and much of routine medicine was put on hold, the postponement or delay in mammograms, colonoscopies, and other screenings led many cancer experts to warn of trouble ahead. In June 2020, for instance, the National Cancer Institute predicted tens of thousands of excess cancer deaths through 2030 because of missed screenings and delays in care.

The message now, Dr. Zhou and colleagues say, is that “patients who have delayed preventative care during the pandemic should be encouraged to resume treatment as soon as possible.”

The team compared the number of people presenting to their cancer center with stage I and IV disease, either for a new diagnosis or a second opinion, during 2019 and with the number during 2020, the first year of the pandemic. The review included over 500 patients, almost 90% of whom were women aged 58 years on average.

While 63.9% of patients with breast cancer presented with stage I disease in 2019, 51.3% did so in 2020. Conversely, while just 1.9% presented with stage IV breast cancer in 2019, the number went up to 6.2% in 2020.

The numbers were even worse from January through March 2021, with only 41.9% of women presenting with stage I and 8% presenting with stage IV breast cancer.

It was the same story for colon cancer, but because of smaller numbers, the findings were not statistically significant.

After the start of the pandemic, the number of patients presenting with stage I colon cancer fell from 17.8% (eight patients) to 14.6% (six patients), while stage IV presentations climbed from 6.7% (three) to 19.5% (eight).

Across all cancer types, stage I presentations fell from 31.9% in 2019 to 29% in 2020, while stage IV presentations rose from 26% to 26.4%.

One of the study limitations is that the patients who came in for a second opinion could have been newly diagnosed but might also have been referred for refractory disease, the authors comment.

No funding for this study was reported. Senior author Kathryn Ann Gold, MD, reported personal fees from AstraZeneca, Takeda, Rakuten, and Regeneron as well as grants from Pfizer and Pharmacyclics.

A version of this article first appeared on Medscape.com.

A drop-off in cancer screening during the first year of the COVID-19 pandemic has led to a marked increase in people presenting with advanced breast and colon cancer at Moores Cancer Center in La Jolla, Calif., according to a research letter in JAMA Network Open.

“The number of patients presenting at late, incurable stages is increasing,” say the authors, led by Jade Zifei Zhou, MD, PhD, a hematology/oncology fellow at the center, which is affiliated with the University of California, San Diego.

As the pandemic unfolded and much of routine medicine was put on hold, the postponement or delay in mammograms, colonoscopies, and other screenings led many cancer experts to warn of trouble ahead. In June 2020, for instance, the National Cancer Institute predicted tens of thousands of excess cancer deaths through 2030 because of missed screenings and delays in care.

The message now, Dr. Zhou and colleagues say, is that “patients who have delayed preventative care during the pandemic should be encouraged to resume treatment as soon as possible.”

The team compared the number of people presenting to their cancer center with stage I and IV disease, either for a new diagnosis or a second opinion, during 2019 and with the number during 2020, the first year of the pandemic. The review included over 500 patients, almost 90% of whom were women aged 58 years on average.

While 63.9% of patients with breast cancer presented with stage I disease in 2019, 51.3% did so in 2020. Conversely, while just 1.9% presented with stage IV breast cancer in 2019, the number went up to 6.2% in 2020.

The numbers were even worse from January through March 2021, with only 41.9% of women presenting with stage I and 8% presenting with stage IV breast cancer.

It was the same story for colon cancer, but because of smaller numbers, the findings were not statistically significant.

After the start of the pandemic, the number of patients presenting with stage I colon cancer fell from 17.8% (eight patients) to 14.6% (six patients), while stage IV presentations climbed from 6.7% (three) to 19.5% (eight).

Across all cancer types, stage I presentations fell from 31.9% in 2019 to 29% in 2020, while stage IV presentations rose from 26% to 26.4%.

One of the study limitations is that the patients who came in for a second opinion could have been newly diagnosed but might also have been referred for refractory disease, the authors comment.

No funding for this study was reported. Senior author Kathryn Ann Gold, MD, reported personal fees from AstraZeneca, Takeda, Rakuten, and Regeneron as well as grants from Pfizer and Pharmacyclics.

A version of this article first appeared on Medscape.com.

A drop-off in cancer screening during the first year of the COVID-19 pandemic has led to a marked increase in people presenting with advanced breast and colon cancer at Moores Cancer Center in La Jolla, Calif., according to a research letter in JAMA Network Open.

“The number of patients presenting at late, incurable stages is increasing,” say the authors, led by Jade Zifei Zhou, MD, PhD, a hematology/oncology fellow at the center, which is affiliated with the University of California, San Diego.

As the pandemic unfolded and much of routine medicine was put on hold, the postponement or delay in mammograms, colonoscopies, and other screenings led many cancer experts to warn of trouble ahead. In June 2020, for instance, the National Cancer Institute predicted tens of thousands of excess cancer deaths through 2030 because of missed screenings and delays in care.

The message now, Dr. Zhou and colleagues say, is that “patients who have delayed preventative care during the pandemic should be encouraged to resume treatment as soon as possible.”

The team compared the number of people presenting to their cancer center with stage I and IV disease, either for a new diagnosis or a second opinion, during 2019 and with the number during 2020, the first year of the pandemic. The review included over 500 patients, almost 90% of whom were women aged 58 years on average.

While 63.9% of patients with breast cancer presented with stage I disease in 2019, 51.3% did so in 2020. Conversely, while just 1.9% presented with stage IV breast cancer in 2019, the number went up to 6.2% in 2020.

The numbers were even worse from January through March 2021, with only 41.9% of women presenting with stage I and 8% presenting with stage IV breast cancer.

It was the same story for colon cancer, but because of smaller numbers, the findings were not statistically significant.

After the start of the pandemic, the number of patients presenting with stage I colon cancer fell from 17.8% (eight patients) to 14.6% (six patients), while stage IV presentations climbed from 6.7% (three) to 19.5% (eight).

Across all cancer types, stage I presentations fell from 31.9% in 2019 to 29% in 2020, while stage IV presentations rose from 26% to 26.4%.

One of the study limitations is that the patients who came in for a second opinion could have been newly diagnosed but might also have been referred for refractory disease, the authors comment.

No funding for this study was reported. Senior author Kathryn Ann Gold, MD, reported personal fees from AstraZeneca, Takeda, Rakuten, and Regeneron as well as grants from Pfizer and Pharmacyclics.

A version of this article first appeared on Medscape.com.