Annals of oncology : official journal of the European Society for Medical Oncology · 2025
A phase II, randomized, open-label study to evaluate low-dose pembrolizumab plus chemotherapy versus chemotherapy as neoadjuvant therapy for localized triple-negative breast cancer (TNBC) (PLANeT trial-Pembrolizumab Low dose in Addition to NACT in TNBC).
СтатьяКлиническое исследование II фазыРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Arora A, Bhaskarane H, Tansir G, Bakhshi S, Gogia A, Kumar A, Jain R, Kalra K, Vishvam D, Mathur S, Rathore R, Shamim S A, Dhamija E, Rangarajan K, Tanwar P, Prasad C P, Kumar S, Gupta I, Mani K, Upadhyay A D, Divakar M K, Vasudeva P, Verma N, Agstam S, Vuthaluru S, Parshad R, Bansal V K, Dhar A, Krishna A, Ranjan P, Suhani S, Prakash O, Kataria K, Kumar B, Mishra A, Sharma J, Bansal B, Saikia J, Bhasker S, Haresh K P, Gupta S, Saini S K, Mallick S, Batra A
Аннотация
BACKGROUND: Addition of pembrolizumab to neoadjuvant chemotherapy (NACT) is a standard-of-care treatment in non-metastatic triple-negative breast cancer (TNBC). Trials employing reduced doses of immune checkpoint inhibitors have yielded encouraging activity in several tumor types. Whether low-dose pembrolizumab enhances pathological complete response when added to NACT in TNBC remains uncertain.
PATIENTS AND METHODS: A phase II, open-label, randomized controlled study was conducted at a tertiary cancer center in New Delhi, India. Eligible participants had previously untreated stage II-III TNBC and lacked access to standard-dose pembrolizumab. Patients were randomly assigned (1 : 1) to receive dose-dense NACT-four cycles of doxorubicin-cyclophosphamide followed by four cycles of paclitaxel with or without a low dose of pembrolizumab (50 mg every 6 weeks for three cycles). The primary endpoint was pathological complete response.
RESULTS: Between February 2024 and February 2025, 157 patients were enrolled. Baseline characteristics were comparable between study arms. Surgery was completed in 152 patients. In the intention-to-treat population, pathological complete response was achieved in 53.8% [90% confidence interval (CI) 43.9% to 63.5%] of patients receiving low-dose pembrolizumab + NACT versus 40.5% (90% CI 31.1% to 50.4%) with NACT alone, corresponding to an absolute difference of 13.3% (90% CI 0.3% to 26.3%, one-sided P = 0.047). Among those who underwent surgery, the respective pathological complete response rates were 56.7% and 41.0% (absolute difference 15.7%, one-sided P = 0.031). Grade ≥3 toxicities occurred in 50% of patients in the low-dose pembrolizumab arm and in 59.5% in the control arm.
CONCLUSIONS: Addition of low-dose immunotherapy to NACT led to a statistically significant increase in pathological complete response rates, and the benefit appears to be numerically similar to that seen in the KEYNOTE-522 trial. In settings where access to the standard regimen is restricted, a low-dose approach may offer a feasible and cost-effective treatment option for patients with TNBC.
PATIENTS AND METHODS: A phase II, open-label, randomized controlled study was conducted at a tertiary cancer center in New Delhi, India. Eligible participants had previously untreated stage II-III TNBC and lacked access to standard-dose pembrolizumab. Patients were randomly assigned (1 : 1) to receive dose-dense NACT-four cycles of doxorubicin-cyclophosphamide followed by four cycles of paclitaxel with or without a low dose of pembrolizumab (50 mg every 6 weeks for three cycles). The primary endpoint was pathological complete response.
RESULTS: Between February 2024 and February 2025, 157 patients were enrolled. Baseline characteristics were comparable between study arms. Surgery was completed in 152 patients. In the intention-to-treat population, pathological complete response was achieved in 53.8% [90% confidence interval (CI) 43.9% to 63.5%] of patients receiving low-dose pembrolizumab + NACT versus 40.5% (90% CI 31.1% to 50.4%) with NACT alone, corresponding to an absolute difference of 13.3% (90% CI 0.3% to 26.3%, one-sided P = 0.047). Among those who underwent surgery, the respective pathological complete response rates were 56.7% and 41.0% (absolute difference 15.7%, one-sided P = 0.031). Grade ≥3 toxicities occurred in 50% of patients in the low-dose pembrolizumab arm and in 59.5% in the control arm.
CONCLUSIONS: Addition of low-dose immunotherapy to NACT led to a statistically significant increase in pathological complete response rates, and the benefit appears to be numerically similar to that seen in the KEYNOTE-522 trial. In settings where access to the standard regimen is restricted, a low-dose approach may offer a feasible and cost-effective treatment option for patients with TNBC.