A Multicenter Randomized Controlled Study of Paclitaxel plus Carboplatin versus Oral Uracil-Tegafur as the Adjuvant Chemotherapy in Resected Non-Small Cell Lung Cancer
| Autor: | Shinichi Toyooka, Hiroshi Date, Shinsuke Kajiwara, Keitaro Matsuo, Hiroshige Nakamura, Morihito Okada, Motohiro Yamashita, Hirohito Tada, Katsuyuki Hotta, Junichi Sakamoto, Motoi Aoe, Shinichiro Miyoshi, Masao Nakata, Norihito Okumura, Naoki Watanabe, Junichi Soh |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine Adult Male medicine.medical_specialty Lung Neoplasms Paclitaxel Gastroenterology law.invention Carboplatin 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Internal medicine Multicenter trial Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Humans Prospective Studies Lung cancer Survival rate Aged Tegafur Aged 80 and over business.industry Area under the curve Middle Aged medicine.disease Survival Analysis 030104 developmental biology Oncology chemistry Chemotherapy Adjuvant 030220 oncology & carcinogenesis Toxicity Female business |
| Zdroj: | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 13(5) |
| ISSN: | 1556-1380 |
| Popis: | Introduction We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC. Methods In an open-label multicenter trial, patients with pathological stage IB to IIIA NSCLC were randomized into a group receiving paclitaxel (175 mg/m 2 ) plus carboplatin (area under the curve 5) every 3 weeks for four cycles (arm A) or a group receiving orally administered UFT (250 mg/m 2 ) daily for 2 years (arm B). The primary and secondary end points were overall survival and relapse-free survival and toxicity, respectively. Results Between November 2004 and November 2010, 402 patients from 40 institutions were included (201 in each arm). The median follow-up period was 6.5 years. The 5-year overall survival rate was 70% (95% confidential interval [CI]: 63–76] in arm A versus 73% (95% CI: 66–78) in arm B (hazard ratio = 0.92, 95% CI: 0.55–1.41, p = 0.69 ). There was no significant difference in the 5-year relapse-free survival rate between arms A and B (56% versus 57% [hazard ratio = 0.92, 95% CI: 0.63–1.34, p = 0.50]). Toxicities were well tolerated and there was no treatment-related death. Toxicities of any grade or grade 4 were significantly more frequent in the paclitaxel plus carboplatin group (95.7% and 22.1%, respectively) than in the UFT group (76.5% and 1.0%, respectively [ p Conclusions As adjuvant chemotherapy, paclitaxel plus carboplatin was no better than UFT in terms of survival among patients with stage IB to IIIA NSCLC tumors who underwent complete resection (UMIN000000810). |
| Databáze: | OpenAIRE |
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