Cancer · 2025
A phase 2 study of adjuvant chemotherapy with 5-fluorouracil/leucovorin and oxaliplatin after lung metastasectomy for colorectal cancer (WJOG5810G).
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Machida Nozomu, Okumura Takehiro, Boku Narikazu, Kishimoto Junji, Nishina Tomohiro, Suyama Koichi, Ohde Yasuhisa, Shinozaki Katsunori, Baba Hideo, Tokunaga Shinya, Kawakami Hisato, Tsuda Takashi, Kotaka Masahito, Okuda Hiroyuki, Yasui Hisateru, Yamazaki Kentaro, Hironaka Shuichi, Muro Kei, Hyodo Ichinosuke
Аннотация
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. Excluding four ineligible patients, the characteristics of the 48 patients in the efficacy analysis set were a median age of 62 years (range, 43-75 years), Eastern Cooperative Oncology Group performance status of 0 in 45 patients, prior resection of extrathoracic metastasis in four patients, and postoperative carcinoembryonic antigen within normal range in 43 patients; the status of lung metastasis was single in 34 patients, unilateral in 40 patients, and metachronous in 41 patients; and a disease-free interval between primary tumor resection and diagnosis of lung metastasis of <2 years in 33 patients. The 5-year OS rate was 85.2% (95% confidence interval [CI], 71.4%-92.6%), and the 5-year disease-free survival rate was 60.2% (95% CI, 44.9%-72.4%). Forty-one of the 52 patients (78.8%) in the safety analysis set completed 12 cycles of mFOLFOX6. Grade ≥3 adverse events were neutropenia (50.0%), fatigue (7.7%), peripheral sensory neuropathy (7.7%), and other (<5%).
CONCLUSIONS: Adjuvant chemotherapy with mFOLFOX6 is feasible, and may be effective after lung metastasectomy for colorectal cancer.
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. Excluding four ineligible patients, the characteristics of the 48 patients in the efficacy analysis set were a median age of 62 years (range, 43-75 years), Eastern Cooperative Oncology Group performance status of 0 in 45 patients, prior resection of extrathoracic metastasis in four patients, and postoperative carcinoembryonic antigen within normal range in 43 patients; the status of lung metastasis was single in 34 patients, unilateral in 40 patients, and metachronous in 41 patients; and a disease-free interval between primary tumor resection and diagnosis of lung metastasis of <2 years in 33 patients. The 5-year OS rate was 85.2% (95% confidence interval [CI], 71.4%-92.6%), and the 5-year disease-free survival rate was 60.2% (95% CI, 44.9%-72.4%). Forty-one of the 52 patients (78.8%) in the safety analysis set completed 12 cycles of mFOLFOX6. Grade ≥3 adverse events were neutropenia (50.0%), fatigue (7.7%), peripheral sensory neuropathy (7.7%), and other (<5%).
CONCLUSIONS: Adjuvant chemotherapy with mFOLFOX6 is feasible, and may be effective after lung metastasectomy for colorectal cancer.