Efficacy and safety of oral pyrotinib in HER2 positive metastatic breast cancer: real-world practice / 北京大学学报(医学版)

OBJECTIVE@#Pyrotinib, a novel irreversible pan-ErbB receptor tyrosine kinase inhibitor, showed promising antitumor activity and acceptable tolerability in phase II and phase III randomized clinical trials. We assessed the activity and safety of oral pyrotinib for human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer patients in the real world.@*METHODS@#We retrospectively analyzed 72 HER2 positive metastatic breast cancer (MBC) patients who received oral pyrotinib based regimens at Beijing Cancer Hospital and other four hospitals (Peking University First Hospital, China-Japan Friendship Hospital, General Hospital of PLA, Peking University Third Hospital) from August 2018 to September 2019. Progression free survival (PFS), objective response rate (ORR), adverse events (AE) of pyrotinib were investigated.@*RESULTS@#Seventy-two patients with HER2 positive MBC were enrolled. The median age of the patients was 55 years (range: 32-79 years). Sixty-nine (95.8%) patients had received anti-HER2 treatment in the metastatic and/or (neo) adjuvant settings; 61 (84.7%) patients had received anti-HER2 treatments in the metastatic setting in terms of trastuzumab 56 (77.8%) patients, lapatinib 36 (50.0%) patients, and T-DM1 4 (5.6%) patients. Among these 72 patients who received oral pyrotinib based regimens, 62 (86.1%) patients received pyrotinib (±trastuzumab) in combination with chemotherapy, 6 (8.3%) patients received pyrotinib (± trastuzumab) in combination with endocrine therapy and 4 (5.6%) patients received pyrotinib (±trastuzumab). Sixty-five (90.3%) patients received 400 mg pyrotinib once daily as initial dose, and 7 (9.7%) patients received 320 mg. OBJECTIVE response and safety to pyrotinib based therapy were evaluable in all the 72 patients. One (1.4%) patient achieved complete response (CR), 18 (25.0%) patients achieved partial response (PR), 41 (56.9%) patients had stable disease (SD), and 12 (16.7%) patients had progressive disease (PD). The ORR (CR+PR) was 26.4% and the median PFS was 7.6 months (95%CI: 5.5-9.7 months). Among the 36 patients with prior lapatinib therapy, the median PFS was 7.9 months (95%CI: 4.1-11.7 months). Among the 15 patients with brain metastasis, the median PFS was 6.0 months (95%CI: 2.2-9.8 months). The main toxicities related to pyrotinib were diarrhea in 57 (79.2%) cases, and 48 (66.7%) cases with grade 1-2 as well as 9 (12.5%) cases with grade 3.@*CONCLUSION@#Pyrotinib based therapy is an effective treatment for patients with HER2 positive MBC, including patients with lapatinib treatment failure and brain metastasis, and the toxicities can be tolerated.

Clinical study of albumin-bound paclitaxel-based chemotherapy in treatment of advanced breast cancer / 肿瘤

Objective: To evaluate the efficacy and safety of albumin-bound paclitaxel-based chemotherapy for patients with advanced breast cancer. Methods: A total of 33 patients with advanced breast cancer were enrolled into this study from July 2009 to April 2012. All patients received albuminbound paclitaxel-based chemotherapy. The adverse reactions were evaluated every cycle, and the shortterm response was evaluated every two cycles. The patients were followed-up, and the survival was analyzed. Results: Of twenty-eight patients who could be evaluated for short-term response, one patient achieved complete response, six patients achieved partial response, and fourteen patients had stable disease. The objective response rate was 25.0% (7/28), and the disease control rate was 75.0% (21/28). Twenty-seven of the 33 patients were analyzed for the survival. The median progression-free survival was 4.5 months [95% confidence interval (CI ): 3.0-6.0], and the median overall survival was 15.0 months (95% CI : 7.9-22.1). The main toxicity was myelosuppression (grades 3 and 4 neutropenia and anemia were seen in 69.7% (23/33) and 21.2% (7/33) of patients, respectively). Hypersensitivity reactions occurred in 21.2% (7/33) of patients. The most frequent hypersensitivity reactions were drug fever and (or) skin rash, and no serious hypersensitivity reaction occurred. Conclusion: Albumin-bound paclitaxel is effective and tolerable in patients with advanced breast cancer, and there is no need for premedication. Copyright © 2013 by TUMOR.

Concurrent versus sequential systemic chemotherapy and whole brain radiation therapy for brain matastases in non-small-cell lung cancer patients / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy, survival and toxicity in patients with brain metastases from non-small cell lung cancer (NSCLC), treated with concurrent systemic chemotherapy and whole brain radiation therapy (WBRT) or sequential systemic chemotherapy/WBRT.</p><p><b>METHODS</b>A total of 60 NSCLC patients with brain metastases were divided into two groups in this prospective clinical study: concurrent systemic chemotherapy and WBRT group (concurrent group) and sequential systemic chemotherapy/WBRT group (sequential group).</p><p><b>RESULTS</b>Of 59 assessable patients, the overall response rate was 22.0%, and the brain response rate was 35.6%; the median progression-free survival time was 3.0 months, and the overall 1- and 2-year survival rates were 55% and 24.4%, respectively, with a median survival time of 16.0 months. The overall response rate was 20.0% in the concurrent group and 24.1% in sequential group (P > 0.05). The brain response rates of 43.3% in concurrent group and 27.6% in sequential group were also not significantly different (P > 0.05). The median progression-free survival time for the patients in the concurrent group was 3.0 months versus 4.0 months in the sequential group, and the median survival time was 16.0 months versus 13.0 months (all P > 0.05). The 1- and 2-year survival rates were 58.5% and 37.2% versus 52.9% and 18.9%, respectively, with a significant difference in the 2-year survival rate between the two groups (P = 0.011). In the sequential group, leukopenia was more frequent during chemotherapy than that in the concurrent group (P = 0.029).</p><p><b>CONCLUSION</b>Concurrent systemic chemotherapy and WBRT is effective with tolerable adverse events in treating brain metastasis from NSCLC with an encouraging survival, and deserves further large sample and randomized multicenter clinical trials.</p>