A randomized trial of sodium alginate prevention of esophagitis in LA-NSCLC receiving chemoradiotherapy: OLCSG1401
| Autor: | Kenichiro Kudo, Shinobu Hosokawa, Yoshinobu Maeda, Toshihide Yokoyama, Kiichiro Ninomiya, Toshi Murakami, Toshiyuki Kozuki, Shoichi Kuyama, Isao Oze, Hiroshige Yoshioka, Kuniaki Katsui, Katsuyuki Kiura, Daijiro Harada, Akihiro Bessho, Katsuyuki Hotta, Masamoto Nakanishi, Tae Hata, Nagio Takigawa, Masayuki Yasugi |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Lung Neoplasms Alginates Gastroenterology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Esophagitis Humans 030212 general & internal medicine Adverse effect Lung cancer Sodium alginate Neoplasm Staging business.industry Chemoradiotherapy medicine.disease Oncology 030220 oncology & carcinogenesis Cisplatin business Febrile neutropenia |
| Zdroj: | Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 29(9) |
| ISSN: | 1433-7339 |
| Popis: | Radiation esophagitis is a critical adverse event that needs to be appropriately managed while administering thoracic irradiation. This trial aimed to investigate whether sodium alginate has preventative effects on esophagitis in patients with non-small-cell lung cancer (NSCLC) receiving concurrent chemoradiotherapy (CRT). Patients with untreated stage III NSCLC who were eligible for concurrent CRT were randomly assigned at a 1:1:1 ratio to receive one of the following treatments: initial or late use of oral sodium alginate (arms A and B) or water as control (arm C). The primary endpoint was the proportion of patients developing G3 or worse esophagitis. Overall, 94 patients were randomly assigned between February 2014 and September 2018. The study was prematurely terminated because of slow accrual. The proportions of patients with G3 or worse esophagitis were 12.5%, 9.8%, and 19.4% in arms A, B, and C, respectively. Patients receiving sodium alginate had fewer onsets of G3 esophagitis; however, differences compared with arm C were not significant (A vs. C: p = 0.46; B vs. C: p = 0.28). The rates of grade 3 or worse non-hematologic toxicities besides esophagitis were 29%, 26%, and 43% in arms A, B, and C, respectively. Interestingly, compared with arm C, a low rate of febrile neutropenia was observed in arm A (3.1% vs. 19.4%: p = 0.04). Sodium alginate did not show significant preventative effects on radiation-induced esophagitis in patients with NSCLC. The frequency of CRT-induced febrile neutropenia was lower in the early use sodium alginate arm. ClinicalTrials.gov Identifier Registry number: UMIN000013133 |
| Databáze: | OpenAIRE |
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