PURPOSE Pyrotinib, an irreversible pan-ErbB inhibitor, showed promising antitumor activity and acceptable tolerability in a phase I trial. We assessed the efficacy and tolerability of pyrotinib versus lapatinib, both in combination with capecitabine, in women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer in an open-label, multicenter, randomized phase II study. PATIENTS AND METHODS Chinese patients with HER2-positive relapsed or metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab were assigned (1:1) to receive 400 mg pyrotinib or lapatinib 1,250 mg orally once per day for 21-day cycles in combination with capecitabine (1,000 mg/m2 orally twice per day on days 1 to 14). The primary end point was investigator-assessed overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. RESULTS Between May 29, 2015, and March 15, 2016, 128 eligible patients were randomly assigned to the pyrotinib (n = 65) or lapatinib (n = 63) treatment groups. The overall response rate was 78.5% (95% CI, 68.5% to 88.5%) with pyrotinib and 57.1% (95% CI, 44.9% to 69.4%) with lapatinib (treatment difference, 21.3%; 95% CI, 4.0% to 38.7%; P = .01). The median progression-free survival was 18.1 months (95% CI, 13.9 months to not reached) with pyrotinib and 7.0 months (95% CI, 5.6 to 9.8 months) with lapatinib (adjusted hazard ratio, 0.36; 95% CI, 0.23 to 0.58; P < .001). The most frequent grade 3 to 4 adverse events were hand-foot syndrome in 16 of 65 patients (24.6%) in the pyrotinib group versus 13 of 63 (20.6%) in the lapatinib group; diarrhea in 10 patients (15.4%) versus three patients (4.8%), respectively; and decreased neutrophil count in six patients (9.2%) versus two patients (3.2%), respectively. CONCLUSION In women with HER2-positive metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab, pyrotinib plus capecitabine yielded statistically significant better overall response rate and progression-free survival than lapatinib plus capecitabine in this randomized phase II trial.
PURPOSE Standard adjuvant chemotherapy for triple-negative breast cancer (TNBC) includes a taxane and an anthracycline. Concomitant capecitabine may be beneficial, but robust data to support this are lacking. The efficacy and safety of the addition of capecitabine into the TNBC adjuvant treatment regimen was evaluated. PATIENTS AND METHODS This randomized, open-label, phase III trial was conducted in China. Eligible female patients with early TNBC after definitive surgery were randomly assigned (1:1) to either capecitabine (3 cycles of capecitabine and docetaxel followed by 3 cycles of capecitabine, epirubicin, and cyclophosphamide) or control treatment (3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide). Randomization was centralized without stratification. The primary end point was disease-free survival (DFS). RESULTS Between June 2012 and December 2013, 636 patients with TNBC were screened, and 585 were randomly assigned to treatment (control, 288; capecitabine, 297). Median follow-up was 67 months. The 5-year DFS rate was higher for capecitabine than for control treatment (86.3% v 80.4%; hazard ratio, 0.66; 95% CI, 0.44 to 0.99; P = .044). Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%). Overall, 39.1% of patients had capecitabine dose reductions, and 8.4% reported grade ≥ 3 hand-foot syndrome. The most common grade ≥ 3 hematologic toxicities were neutropenia (capecitabine, 136 [45.8%]; control, 118 [41.0%]) and febrile neutropenia (capecitabine, 50 [16.8%]; control, 46 [16.0%]). Safety data were similar to the known capecitabine safety profile and generally comparable between arms. CONCLUSION Capecitabine when added to 3 cycles of docetaxel followed by 3 cycles of a 3-drug anthracycline combination containing capecitabine instead of fluorouracil significantly improved DFS in TNBC without new safety concerns.
BackgroundThe purpose of this study was to compare the clinical outcomes of elderly patients undergoing surgery for treatment of unstable trochanteric fractures receiving either proximal femoral nails anti-rotation-Asia (PFNA-IIs) or InterTan nails (ITs).MethodsBetween January 1, 2012, and June 31, 2015, 168 elderly patients with unstable intertrochanteric femur fractures enrolled in this study. The only intervention was ITs or PFNA-IIs of the unstable trochanteric femur fractures. Follow-up was at 1, 3, 6, and 12 months postoperatively and yearly thereafter. Intraoperative variables and postoperative complications were compared between the two groups.ResultsEight patients died, six were too infirmed for follow-up, and seven were lost during follow-up, leaving 147 patients meeting the criteria were evaluated at a mean follow-up of 20 months (range 16–26 months). Significant differences were observed between the two groups regarding local complications (IT, n = 10 vs. PFNA-II, n = 20), varus collapse of the head/neck or femoral shaft fractures at the tip of the nail (IT, n = 1 vs. PFNA-II, n = 8), femoral neck shortening (IT, 4.4 ± 1.1 mm vs. PFNA-II, 7.4 ± 2.4 mm), fracture healing time (IT, 14.7 ± 2.1 weeks vs. PFNA-II, 15.7 ± 2.4 weeks), femoral shaft fractures (IT, n = 0 vs. PFNA-II, n = 4), rotational loss of reduction (IT, n = 0 vs. PFNA-II, n = 9), lateral cortex fractures of the proximal femur or lateral greater trochanter fractures (IT, n = 8 vs. PFNA-II, n = 1), operative time (IT, 71.9 ± 6.8 min vs. PFNA-II, 52.3 ± 4.0 min), intraoperative blood loss (IT, 190.6 ± 6.0 mL vs. PFNA-II, 180.9 ± 10.8 mL), fluoroscopy time (IT, 5.0 ± 0.48 min vs. PFNA-II, 2.8 ± 0.33 min), hospital stay (IT, 9.65 ± 0.95 days vs. PFNA-II, 8.58 ± 0.93 days), cut-out (IT, n = 0 vs. PFNA-II, n = 6), and tip-apex distance (IT, 26.7 ± 0.91 mm vs. PFNA-II, 23.2 ± 1.22 mm). No significant differences existed for the other observation indexes (p > 0.05).ConclusionsThe IT nail may have more advantage for patients with unstable intertrochanteric fractures of the femur. However, for those complicated with lateral greater trochanter fractures, lateral cortex fractures of the proximal femurs, or unfit for surgery, the PFNA-II nail could be a good option. In addition, a large-sample, multicenter observational study is required for evaluation of its long-term efficacy, and optimal management strategies for specific unstable fracture patterns, different sorts of bone quality, and different levels of patient demand.
Background: Cancer patients had been profoundly affected by the outbreak of COVID-19 especially after quarantine restrictions in China. We aimed to explore the treatment changes and delays of early breast cancer (EBC) during the first quarter of 2020. Methods: We did this retrospective, multicentre, cohort study at 97 cancer centres in China. EBC patients who received treatment regardless of preoperative therapy, surgery or postoperative therapy during first quarter of 2020 were included. Findings: 8397 patients were eligible with a median age of 50 (IQR 43À56). 0¢2% (15/8397) of EBC patients were confirmed as COVID-19 infection. Only 5¢2% of breast cancer diagnosis occurred after quarantine in Hubei compared with 15¢3% in other provinces (OR= 0¢30, 95%CI 0¢24À0¢38). postoperative endocrine
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