Docetaxel and fluorouracil as first-line therapy for gastric cancer with bone marrow metastasis and disseminated intravascular coagulation.

Gastric cancer with bone marrow metastasis and disseminated intravascular coagulation constitutes a highly aggressive gastric cancer subtype which presents a peculiar biological behavior and very poor prognosis. Retrospective studies have shown chemotherapy could prolong survival, but a prospective trial is still unavailable. This study is the first prospective clinical trial to evaluate the safety and efficacy of chemotherapy for advanced gastric cancer patients with bone marrow metastasis.

Highly aggressive gastric cancer is a special subtype gastric cancer with highly aggressive biological behavior and very poor prognosis. This is a multicenter phase II clinical trial. Infusional fluorouracil of 200 mg/m² on days 1­21 with docetaxel 25 mg/m² on days 1, 8 and 15 will be administered as the first-line therapy to highly aggressive gastric cancer with platelet lower than 50 × 10⁹/l, every 4 weeks. The primary end point is the hematological response rate, which is defined as the percentage of participants whose platelet count restores to normal range. The secondary end points are time to hematological response, 1-month mortality, overall survival, toxicity and quality of life. This study will provide high-level evidence to guide clinical practice for highly aggressive gastric cancer. Clinical Trial Registration: NCT04547153 (ClinicalTrials.gov).

Safety and efficacy analysis on modified FOLFOXIRI as first-line treatment for advanced colorectal cancer in China-single center experience / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate the safety and preliminary efficacy of modified FOLFOXIRI (combination of reducing dosage irinotecan, oxaliplatin and fluorouracil) in first-line treatment for patients with metastatic colorectal cancer.</p><p><b>METHOD</b>A total of 53 patients with advanced colorectal cancer receiving modified FOLFOXIRI regimen were recruited continuously from January 2010 to January 2014. Safety profile was recorded based on NCI Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0). Objective response was evaluated by Response Evaluation Criteria in Solid Tumors version1.1 (RECIST 1.1) after administration of at least 4 cycles chemotherapy. Kras and Braf gene sequencing was tested by dideoxy chain-termination method. Relation between efficacy and two genes was examined.</p><p><b>RESULTS</b>Among 53 patients, no treatment-related mortality was presented. The rate of grade 3 to 4 adverse event was 32.1% (17/53), including neutropenia 13.2%(7/53), anemia 11.3% (6/53) and fatigue 9.4% (5/53). Overall response rate (ORR) and disease control rate (DCR) were respectively 65.9% (29/44) and 90.0% (40/44). Radical resection rate (R0) was 29.5% (13/44). Efficacy of mFOLFOXIRI regimen plus targeting therapy was assessed in 44 patients. mFOLFOXIRI regimen plus targeting therapy achieved an ORR of 72.7% (8/11), which was higher than the ORR 65.9% (21/33) of triplet regimen alone, but the difference was not statistically significant (P=0.198). Paraffin specimens of 48 colorectal cancer cases were tested. Twenty-one cases were Kras mutant (43.75%), 3 cases were Braf mutant (6.25%). There were no significant differences between two groups (P>0.05).</p><p><b>CONCLUSION</b>Reducing dosage mFOLFOXIRI can be safely used in advanced colorectal cancer and can achieve promising results in terms of short term efficacy.</p>