A single-arm, phase 2 study of adjuvant chemotherapy with oral tegafur-uracil for pathologically lymphovascular invasion positive stage IA non-small cell lung cancer: LOGIK0602 study.

Abstract

BACKGROUND:

Lymphovascular invasion (LVI), which includes vascular or lymphatic invasions, is a representative prognostic factor even in patients with resected stage IA non-small cell lung cancer (NSCLC). Because tegafur-uracil is effective on cancers with LVI, we conducted a multi-center single-arm phase II study to estimate the efficacy of adjuvant tegafur-uracil in patients with LVI-positive stage IA NSCLC.

METHODS:

Patients with completely resected LVI-positive stage IA NSCLC were registered. LVI was diagnosed by consensus of two of three pathologists. Adjuvant chemotherapy consisted of 2 years of oral tegafur-uracil at 250 mg/m2/day. Fifty-five patients from 7 institutions were enrolled from June 2007 to September 2012.

RESULTS:

Among the 52 eligible patients, 36 (69.2%) completed the treatment course. There were 39 male and 13 female patients. The observation period was calculated as 562 to 3107 days using the reverse Kaplan-Meier method. The 5-year overall and relapse free survival rates were 94.2 and 88.5% respectively, which were significantly better than that of any other studies conducted on patients with LVI-positive stage IA NSCLC. Notably, the overall survival rate was 15% better than that of our prior retrospective study. The retrospective analysis of stage IA NSCLC patients who had received an operation in the same period revealed that the 5-year overall survival rate of the LVI positive group was 73.6% when adjuvant chemotherapy was not applied. Among 55 safety analysis sets, 4 cases of grade 3 hepatic function disorder (9.1%) and 5 cases of grade 2 anorexia (10.9%) were most frequently observed. No grade 4 adverse effects were encountered.

CONCLUSION:

A 2-year course of oral tegafur-uracil administration is feasible and might have a significant benefit in the adjuvant treatment of LVI-positive stage IA NSCLC.

TRIAL REGISTRATION:

UMIN identifier: UMIN000005921 ; Date of enrolment of the first participant to the trial: 19 June 2007; Date of registration: 5 July 2011 (retrospectively registered).

• Authors: Tomoshi Tsuchiya, Ryotaro Kamohara, Masashi Muraoka, Takeshi Nagayasu, Sho Saeki, Mitsuhiro Takenoyama, Makoto Suzuki, Kazuo Inada, Shoji Tokunaga, Tomayoshi Hayashi, Shogo Urabe, Takaomi Koga, Shinji Akamine, Kenji Sugio
• Journal: BMC cancer (BMC Cancer) Vol. 20 Issue 1 Pg. 1192 (Dec 04 2020) ISSN: 1471-2407 [Electronic] England
• PMID: 33276755 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Prodrugs
• Tegafur
• Uracil

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Blood Vessels (pathology)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology, surgery)
• Chemotherapy, Adjuvant (adverse effects)
• Combined Modality Therapy
• Disease-Free Survival
• Female
• Gastrointestinal Diseases (chemically induced)
• Humans
• Kaplan-Meier Estimate
• Lung Neoplasms (drug therapy, pathology, surgery)
• Lymphatic Vessels (pathology)
• Male
• Middle Aged
• Neoplasm Invasiveness
• Neutropenia (chemically induced)
• Patient Compliance
• Pneumonectomy
• Prodrugs (administration & dosage, adverse effects)
• Prospective Studies
• Tegafur (administration & dosage, adverse effects)
• Uracil (administration & dosage, adverse effects)