A phase 2 study of adjuvant chemotherapy with 5-fluorouracil/leucovorin and oxaliplatin after lung metastasectomy for colorectal cancer (WJOG5810G).

ABSTRACT:

Background

The clinical significance of adjuvant chemotherapy after lung metastasectomy for colorectal cancer remains unknown. This phase 2 study evaluated adjuvant chemotherapy with modified 5-fluorouracil/leucovorin and oxaliplatin (mFOLFOX6) after lung metastasectomy.

Methods

Eligibility criteria included colorectal adenocarcinoma, first curative resection of ≤4 lung metastases, and no prior chemotherapy. Treatment consisted of 12 cycles of mFOLFOX6. The primary endpoint was the 5-year overall survival (OS) rate, with the expectation of 50% (threshold, 35%) and a planned sample size of 100 (90% power; alpha error, 5%).

Results

Fifty-two patients were enrolled between July 2011 and July 2014; patient enrollment was closed prematurely because of slow accrual. Excludi

SUBMITTER: Machida N 

PROVIDER: S-EPMC11934843 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature