Ronald L. Koretz, MD
In patients with resected colorectal cancer at low risk for recurrence, does adjuvant chemotherapy increase survival?
Randomized controlled trial (Quick and Simple and Reliable [QUASAR] trial).
Median 5.5 years.
150 centers in 19 countries in Europe, Asia, Australia/New Zealand, and Africa.
3239 patients 23 to 86 years of age (median age 63 y, 61% men) with complete colon (71% of patients) or rectal (29%) cancer resection and an uncertain indication for adjuvant chemotherapy (as determined by consultation between attending physician and patient). 91% of patients had stage II (lymph node–negative) disease, 8% had stage III (node-positive) disease, and 0.5% had stage I disease.
Chemotherapy (n = 1622) or observation alone (n = 1617). All patients in the chemotherapy group received 30 doses of fluorouracil (370 mg/m2 intravenously [IV]), either in six 5-d courses every 4 wk or once/wk for 30 wk. In the first 3 y of the trial, chemotherapy patients were also randomized to receive either high-dose (175 mg) or low-dose (25 mg) L-folinic acid IV combined with fluorouracil, plus levamisole (50 mg) or placebo 3 times daily for 3 d every 2 wk for 12 courses. In the last 6 y of the trial, all chemotherapy patients received fluorouracil plus low-dose folinic acid.
All-cause mortality, death from colorectal cancer, and recurrence.
97% (intention-to-treat analysis).
Chemotherapy reduced risk for all outcomes compared with observation (Table). Most of the benefit was seen in the first 2 years. Taking into account the reduction in quality of life during treatment, chemotherapy increased the quality-adjusted life span by about 10 months for a 55-year-old patient and by about 2 months for a 70-year-old patient. In stage II colon cancer, this translates into an absolute improvement in survival of 3.6%.
In patients with resected colorectal cancer at low risk for recurrence, adjuvant chemotherapy prevented recurrence and increased survival.
Chemotherapy (Chemo) vs observation (Obs) for colorectal cancer with low recurrence risk†
†Abbreviations defined in Glossary. RRR, NNT, and CI calculated from data in article.
Koretz RL. Adjuvant chemotherapy increased survival in colorectal cancer patients with low recurrence risk. Ann Intern Med. ;148:JC3–6. doi: 10.7326/0003-4819-148-10-200805200-02006
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Published: Ann Intern Med. 2008;148(10):JC3-6.
Colorectal Cancer, Gastroenterology/Hepatology, Gastrointestinal Cancer, Hematology/Oncology.
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