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Chemotherapy after cancer resection near pancreas may improve survival
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Patients with periampullary cancer who undergo resection followed by chemotherapy experienced significantly longer OS than patients who did not receive chemotherapy, according to results of a phase 3 study.
About 80% of periampullary carcinomas are resectable, and they comprise 30% to 40% of all resections for cancers at the head of the pancreas. Five-year survival rates after resection range from 37% to 51% for ampullary cancers, 23% to 30% for bile duct cancers, and 25% to 59% for duodenal cancers, according to background information in the study.
John P. Neoptolemos, MD, head of the division of surgery and oncology at the University of Liverpool, and colleagues conducted the randomized controlled trial to determine whether adjuvant chemotherapy (fluorouracil or gemcitabine) improved OS after resection. The trial involved patients from 100 centers in 18 countries between July 2000 and May 2008.
Researchers evaluated 428 patients with ampullary carcinoma (n=297), bile duct cancer (n=96) or other types of cancer (n=35).
Neoptolemos and colleagues assigned 144 patients to an observation group. One hundred forty-three patients received 20 mg/m2 folinic acid via IV bolus injection followed by 425 mg/m² fluorouracil via injection, administered 1 to 5 days every 28 days. The other 141 patients received 1,000 mg/m² of IV infusion of gemcitabine once a week for 3 of every 4 weeks for 6 months, according to the study.
At the time of analysis, 244 patients (57%) had died. The deaths included 88 patients (61%) in the observation group, 83 patients (58%) in the fluorouracil plus folinic acid group and 73 patients (52%) in the gemcitabine group.
The median survival was 35.2 months for the observation group (95% CI, 27.2-43), 38.9 months for patients treated with fluorouracil plus folinic acid (95% CI, 24.6-56) and 45.7 months for patients treated with gemcitabine (95% CI, 36.5-infinity).
Unadjusted analysis of OS did not reveal a significant benefit for adjuvant therapy, according to Neoptolemos and colleagues.
Once adjusted for prognostic variables, researchers found a statistically significant survival benefit, specifically gemcitabine compared with observation.
The HR for chemotherapy compared with observation was 0.75 (95% CI, 0.57-0.98) after adjusting for independent prognostic variables (age, bile duct cancer, poor tumor differentiation and positive lymph nodes) and conducting multiple regression analysis, according to the study findings.
“Although this study found support for the use of adjuvant chemotherapy to improve survival in patients with periampullary cancers, this effect was modest, indicating a need for further improvements and warranting the testing of combination chemotherapies,” the researchers concluded.
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