Objective: Gemcitabine combined with carboplatin (GC) is a widely used regimen for advanced non-small cell lung cancer (NSCLC), but clinical outcome is still hampered by its toxicity. We conducted a randomized phase II study of GC and compared biweekly versus standard schedules in patients with advanced NSCLC with respect to toxicity and outcome. Methods: Forty patients with stage IIIB or IV NSCLC were randomized to receive either a biweekly regimen of GC [gemcitabine (1,000 mg/m2 on days 1 and 14) and carboplatin (area under the concentration-time curve, AUC = 3 on days 1 and 14)] every 28 days or a standard regimen of GC [gemcitabine (1,000 mg/m2 on days 1 and 8) and carboplatin (AUC = 5 on day 1)] every 21 days. These cycles were repeated until disease progression. Results: Response rates were 55% for the biweekly regimen and 40% for the standard regimen. Median overall and progression-free survival times were 19.7 and 6.2 months, respectively, for the biweekly regimen, and 11.8 and 2.8 months, respectively, for the standard GC regimen. Hematologic toxicity was prominent. However, the incidence of grade 1 or 2 thrombocytopenia was significantly lower in the biweekly than in the standard GC regimen (p < 0.05). Nonhematologic toxicity was mild. Conclusion: A biweekly GC regimen was better tolerated than a standard GC regimen in patients with advanced NSCLC.
A 72-year-old male with effort angina pectoris and old myocardial infarction underwent percutaneous coronary intervention (PCI). A 4 Fr sheath was inserted in the radial artery. After diagnostic angiography, a guidewire was inserted from the diagnostic catheter. The diagnostic catheter is removed, and the distal tip of the guidewire remains in the coronary artery. Intravascular ultrasound (IVUS) could be performed via the 4 Fr sheath without guiding catheters. IVUS-guide PCI was successfully performed with 4 Fr sheath, although IVUS requires at least a 5 Fr or larger system. This technique is called "The Emperor's New Clothes Technique" because PCI is performed as if an invisible guiding catheter was being used.
Background: Zoledronic acid (ZOL) is a nitrogen-containing bisphosphonate, and it induces osteoclast apoptosis and inhibits bone resorption by inhibiting the mevalonate pathway. ZOL has also been found to have antitumor effects that include an angiogenesis inhibiting action, an inhibitory effect on tumor cell adhesion to bone, an inhibitory effect on invasion of the extracellular matrix, and activation of a gdT cells. In addition, it has been found to have a synergistic anti-proliferative effect when used in combination with antitumor drugs. In this study we investigated the pathological complete response (pCR) rate when ZOL is added to anthracycline followed by taxane to treat T2 and T3 breast cancer patients as a neoadjuvant chemotherapy. Methods: Women with resectable invasive StageIIA-IIIB (T ≥3 cm or T ≥2 cm and lymph node positive) breast cancer who are HER-2-negative, between 20 and 70 years of age, and ECOG PS 0–1 were eligible. Patients with distant metastasis, patients who have had received chemotherapy, hormone therapy, or radiotherapy for breast cancer, patients with serious complications, such as heart disease or an infection, patients with a complicating dental or jaw infection or traumatic condition of the teeth, and patients with a history of treatment with a bisphosphonate within the previous 12 months were excluded. A total of 4 courses of FEC100 were administered every 3 weeks followed by weekly paclitaxel for 12 courses. ZOL 4mg was administered every 3–4 weeks a total of 7 times. Patients were randomized 1:1 to chemotherapy + ZOL group or chemotherapy alone group, according to the presence or absence of lymph node metastasis, estrogen receptor (ER) status, and their menopausal status. The primary endpoint was the rate of pCR defined as absence of invasive disease in the breast at surgery. Secondary endpoints were tumor response rate (RECIST ver1.0), the breast-conserving surgery ratio, and disease-free survival (DFS). We calculated the sample size on the basis of a pCR rate of 18% in the chemotherapy alone group and 35% in the chemotherapy + ZOL group, at 5% significance level based on the one-sided chi-square test with the statistical power of 80%, and as a result we targeted a patient sample size of 180 patients. Results: 188 patients were recruited between March 2010 and April 2012. Results of the primary analysis of efficacy and safety will be presented. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr PD07-05.
━━ Objective. We herein report the comprehensive genome profiles obtained by next-generation sequencing (MINtS) using cytological samples (following cell samples) in our hospital. Method. After having registered various kinds of cell samples gathered by examinations performed for cases suspected of being lung cancer at our hospital with the North East Japan Study Group 021A study, we sent the samples to a genetic testing facility. Analyses of EGFR, KRAS, BRAF, and HER2 gene mutations were performed, and ALK, RET, and ROS1 fusion was done. Results. The 1298 samples sent to the facility from December 2015 to June 2019 were all cell samples. The most common EGFR gene mutation was lung adenocarcinoma, which was found in 164 (27.2%) out of 602 samples. The EGFR mutation was more found in 97 (48%) samples with never smoker and in 97 (47%) samples with female, significantly (P<0.01). The KRAS gene mutation was found in 89 samples (15%), and 1 was more found in 72 samples (20%), significantly (P<0.01). The Cobas Ⓡ EGFR Mutation Test version 2.0 of the available EGFR genetic test was performed in 380 patients with lung adenocarcinoma, and the positive conformity ratio was 82.6%, with a negative coincidence rate of 95.2% for MINtS. Conclusion. These findings suggest that MINtS performed using cell samples, which are easier to acquire than tumor tissue, is a promising comprehensive gene variation laboratory procedure for next-generation sequencing in lung cancer patients.
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