A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung
Yang J.-J.,Shandong Academy of Sciences |
Huang C.,Fujian Province Cancer Hospital |
Chen G.-Y.,Heilongjiang Province Cancer Hospital |
Song Y.,Nanjing General Hospital |
And 4 more authors.
BMC Cancer | Year: 2014
Background: Recent advances have shown that histology and genetic biomarkers are important in patient selection, which have led to significantly better outcomes for lung cancer patients. However, most new treatments only apply to adenocarcinoma or non-squamous, and in squamous carcinoma there is little breakthrough. In a phase III trial nab-paclitaxel plus carboplatin showed superior response rate over paclitaxel and carboplatin. In subgroup analysis the squamous histology appeared to be a predictive factor to nab-paclitaxel treatment.Methods/Design: This is an open-label, randomized, active controlled phase II trial. A total of 120 untreated advanced squamous lung cancer patients are randomized at a 1:1 ratio to receive nab-paclitaxel (135 mg/m2, d1, 8, q3w) plus carboplatin (AUC 5, d1, q3w) or gemcitabine (1,250 mg/m2, d1, 8, q3w) and carboplatin (AUC 5, d1, q3w). The primary endpoint is objective response rate and the second endpoints are progression free survival, overall survival, safety and biomarkers associated with nab-paclitaxel. The treatment will continue up to six cycles or intolerable toxicity.Discussion: This ongoing trial will be the first prospective randomized trial to explore the efficacy of nab-paclitaxel as the first-line treatment specifically in squamous carcinoma of lung.Study number: CTONG1002. Trial Registration: Clinicaltrials.gov reference: NCT01236716. © 2014 Yang et al.; licensee BioMed Central Ltd.
Deng T.,Tianjin Medical University |
Xu N.,Zhejiang University |
Xiong J.-P.,Nanchang University |
Yan Z.,Tianjin Medical University |
And 13 more authors.
Journal of Chemotherapy | Year: 2013
Purpose: To report the results of a safety analysis from a phase II trial comparing administration of weekly paclitaxel plus S-1 (TS) versus paclitaxel plus 5-fluorouracil (5-FU)/calcium folinate (LV) (TLF) as first-line therapy for advanced gastric cancer. Methods: Patients (n5240) with previously untreated advanced gastric cancer were randomly assigned to receive either TS or TLF in a 28-day cycle for six cycles. Results: The clinical features of both sets of patients were similar, with the exception of the incidence of prior chemotherapy (P>0.05). Most treatment-related adverse events occurred at similar rates in both treatment arms. However, patients receiving TS experienced an increase in all-grade especially grade 3/4 neutropenia, with an incidence of 43.7% in the TS arm and 16.3% in the TLF arm, respectively (P<0.05). Other severe adverse events were infrequent and not significantly different between the groups. Conclusion: The safety and tolerance of weekly paclitaxel plus S-1 or 5-FU/LV is well in untreated advanced gastric cancer patients. © 2013 Edizioni Scientifiche per l'Informazione su Farmaci e Terapia.
Xue C.,State Key Laboratory of Oncology in South China |
Xue C.,Sun Yat Sen University |
Huang Y.,State Key Laboratory of Oncology in South China |
Huang Y.,Sun Yat Sen University |
And 33 more authors.
Annals of Oncology | Year: 2013
Background: We aimed to investigate the efficacy and tolerability of sorafenib combined with cisplatin and 5-fluorouracil (5-FU) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). Patients and methods: It was a Simon two-stage designed trial. Chemotherapy-naive patients with recurrent or metastatic disease were enrolled. The regimen was sorafenib 400 mg orally b.i.d., cisplatin 80 mg/m2 i.v. day 1, and 5-FU 1000 mg/m2/day CIV for 4 days, repeated every 21 days. After a maximum of six cycles of chemotherapy, patients received maintenance of sorafenib. Results: In total, 54 patients were enrolled. The objective response rate reached 77.8%, including 1 complete response and 41 partial responses. The median progression-free survival was 7.2 months (95% CI 6.8-8.4 months), and the median overall survival was 11.8 months (95% CI 10.6-18.7 months). Major toxic effects included hand-foot skin reaction, myelosuppression, and gastrointestinal (GI) reaction. The incidence of hemorrhage was 22.2%, and one patient with liver metastases died of GI bleeding. Contrast-enhanced ultrasonography was carried out in a subset of patients with liver metastases. Conclusion: Combination of sorafenib, cisplatin (80 mg/m2) and 5-FU (3000 mg/m2) was tolerable and feasible in recurrent or metastatic NPC. Further randomized trials to compare sorafenib plus cisplatin and 5-FU with standard dose of cisplatin plus 5-FU in NPC are warranted. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Shi Y.,Fujian Province Cancer Hospital |
Zhou X.,Hunan Province Cancer Hospital |
Yu J.,Hunan Province Cancer Hospital |
Liu H.,Fujian Province Cancer Hospital
Journal of Craniofacial Surgery | Year: 2016
Treatment of malignant periorbital tumors requires radical resection of the tumor, which can result in the creation of major eyelid defects. Reconstruction of such defects with satisfactory restoration of function and aesthetic appearance is difficult. The present patient series describes the satisfactory outcomes achieved with a new surgical approach using a retroauricular flap and palatal mucosal graft. The authors reviewed 19 patients of eyelid defects created upon resection of malignant periorbital tumors between 1994 and 2012. Upon confirmation of the defect size, the eyelid defect was repaired with a palatal mucosal graft. Then a retroauricular flap was prepared at the postauricular region and the flap was used to cover the skin defect. In 1 patient, serious venous congestion of the flap occurred. After emergency surgery, the epidermis of the flap died, but the base of the flap survived. Thus, dermatoplasty was repeated. One-fourth of the flap died in 1 patient with an upper eyelid defect near the inner canthus, and after dressing of the wound, dermoplasty was repeated. No complications occurred in the other 17 patients, and satisfactory results were achieved. Thus, using a retroauricular flap, the authors can obtain good aesthetic results in the reconstruction of eyelids defect including the inner and external canthus. The color and texture of the retroauricular flap are similar to those of the eyelid, and scar contracture has a minimal effect. Copyright © 2016 by Mutaz B. Habal, MD.