BackgroundIn the Trastuzumab for GAstric cancer (ToGA) study, trastuzumab plus chemotherapy improved median overall survival by 2.7 months in patients with human epidermal growth factor receptor 2 (HER2)-positive [immunohistochemistry (IHC) 3+/fluorescence in situ hybridization-positive] gastric/gastroesophageal junction cancer compared with chemotherapy alone (hazard ratio 0.74). Post hoc exploratory analyses in patients expressing higher HER2 levels (IHC 2+/fluorescence in situ hybridization-positive or IHC 3+) demonstrated a 4.2-month improvement in median overall survival with trastuzumab (hazard ratio 0.65). The ToGA study provides the largest screening dataset available on HER2 overexpression/amplification in this indication. We further analyzed correlation(s) of HER2 overexpression/amplification with clinical and epidemiological factors.MethodsHER2-positivity was analyzed by histological subtype, tumor location, geographic region, and specimen type. Exploratory efficacy analyses were performed.ResultsThe HER2-positivity rate was 22.1 % across analyzed tumor samples. Rates were similar between European and Asian patients (23.6 % vs. 23.9 %), but higher in intestinal- vs. diffuse-type (31.8 % vs. 6.1 %), and gastroesophageal junction cancer versus gastric tumors (32.2 % vs. 21.4 %). Across all IHC scores, variability in HER2 staining (≤30 % stained cells) was observed in almost 50 % of cases, with increasing rates in lower IHC categories, and did not affect treatment outcome. The polysomy rate was 4 %.ConclusionsHER2 expression varies by tumor location and type. All patients with advanced gastric or gastroesophageal junction cancer should be tested for HER2 status, preferably using IHC initially. Due to the unique characteristics of gastric cancer, specific testing/scoring guidelines should be adhered to.Electronic supplementary materialThe online version of this article (doi:10.1007/s10120-014-0402-y) contains supplementary material, which is available to authorized users.
Chidamide was generally well tolerated in patients with advanced solid tumors or lymphomas in the tested regimens. Favorable PK and PD profiles, as well as encouraging preliminary anti-tumor activity, were demonstrated.
The lungs are the second most common site of metastasis for colorectal cancer (CRC) after the liver. Rectal cancer is associated with a higher incidence of lung metastases compared to colon cancer. In China, the proportion of rectal cancer cases is around 50%, much higher than that in Western countries (nearly 30%). However, there is no available consensus or guideline focusing on CRC with lung metastases. We conducted an extensive discussion and reached a consensus of management for lung metastases in CRC based on current research reports and the experts’ clinical experiences and knowledge. This consensus provided detailed approaches of diagnosis and differential diagnosis and provided general guidelines for multidisciplinary therapy (MDT) of lung metastases. We also focused on recommendations of MDT management of synchronous lung metastases and initial metachronous lung metastases. This consensus might improve clinical practice of CRC with lung metastases in China and will encourage oncologists to conduct more clinical trials to obtain high-level evidences about managing lung metastases. Electronic supplementary material The online version of this article (10.1186/s13045-019-0702-0) contains supplementary material, which is available to authorized users.
Aim: In a previous study, a 130-nm nanoparticle albumin-bound paclitaxel (nab-paclitaxel) demonstrated improved efficacy and safety profile compared with solvent-based paclitaxel (sb-paclitaxel) in Caucasian patients with metastatic breast cancer (MBC). The aim of the present randomized study was to compare the response rates and safety profile of nab-paclitaxel with sb-paclitaxel in Chinese patients with MBC. Methods:In the present open-label, multicenter study, 210 patients with MBC were randomly assigned to receive nab-paclitaxel 260 mg/m 2 intravenously (i.v.) over 30 min every 3 weeks (q3w) with no premedication or sb-paclitaxel 175 mg/m 2 i.v. over 3 h q3w with standard premedication. Results:The overall response rate was 54 and 29% in patients treated with nab-paclitaxel and sb-paclitaxel, respectively (P < 0.001). nab-paclitaxel induced a higher response rate in patients who were <65 years old, patients who were receiving first-line therapy, patients who had no prior anthracycline therapy, patients who had Յ or >3 metastatic lesions, and patients who had visceral disease. The progression-free survival (PFS) period was 7.6 months for nab-paclitaxel and 6.2 months for sb-paclitaxel (P = 0.118). Despite the 49% higher paclitaxel dose in patients receiving nab-paclitaxel compared with patients receiving sb-paclitaxel, the safety profile was similar in both treatment groups. The most common grades 3 and 4 adverse event (AE) in both arms was neutropenia. The most common grade 3 nonhematologic AE was peripheral neuropathy, and no grade 4 peripheral neuropathy was observed. Conclusion: Compared with sb-paclitaxel, nab-paclitaxel demonstrated superior efficacy, an acceptable safety profile, and a trend toward increased PFS in patients with MBC.
The aim of the present study was to investigate the association between the prognosis of lymph node-negative breast cancer patients and clinicopathological factors, as well as the association between tumor-associated gene expression and prognosis. Clinical data and survival information was collected for 341 patients with lymph node-negative breast cancer, admitted to the Cancer Hospital of the Chinese Academy of Medical Sciences (Beijing, China) from 1995 to 1999. Kaplan-Meier survival analysis and Log-rank tests were used to evaluate the association of clinical parameters and prognosis. In addition, the gene expression of HER2, TOP2A and CCND1 in patients with good [disease-free survival (DFS), ≥5 years] and poor (DFS, <5 years) prognoses was analyzed. The clinicopathological factors of the 341 lymph node-negative breast cancer patients were determined. The 5-year DFS and overall survival rate (OS) in patients >35 years old was higher as compared with those of patients under the age of 35. Tumor size significantly affected the 5-year DFS. Patients with smaller tumors (≤2 cm) had a significantly higher DFS rate as compared with patients with larger tumors (>2 cm). Estrogen receptor (ER)-positive patients had a significantly higher 5-year DFS and OS rate as compared with ER-negative patients. By contrast, there were no significant differences in the 5-year DFS and OS rates between progesterone receptor-positive and -negative patients. The 5-year DFS and OS rates were significantly higher in patients treated with adjuvant hormone therapy, as compared with patients without hormone therapy. The expression of HER2 protein was higher in patients with a poor prognosis as compared with those with a good prognosis; however, there were no differences in the protein expression of CCND1 and TOP2A between patients with a good and poor prognosis. The results of quantitative polymerase chain reaction showed that the gene expression of HER2 and CCND1 was higher in patients with a poor prognosis as compared with that in patients with a good prognosis. TOP2A gene expression was not significantly different between patients with a poor and good prognosis. The age at diagnosis, tumor size, ER status and hormone therapy were associated with prognosis in patients with lymph node-negative breast cancer. The molecular biomarker, HER2, but not CCND1 or TOP2A, may be a critical factor for predicting prognosis.
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