Improvements in Survival and Clinical Benefit With Gemcitabine as First-Line Therapy for Patients With Advanced Pancreas Cancer: A Randomized Trial.

Autor:	Burris HA 3rd; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Moore MJ; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Andersen J; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Green MR; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Rothenberg ML; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Modiano MR; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Cripps MC; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Portenoy RK; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Storniolo AM; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Tarassoff P; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Nelson R; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Dorr FA; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Stephens CD; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA., Von Hoff DD; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78245, USA.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Dec 20; Vol. 41 (36), pp. 5482-5492.
DOI:	10.1200/JCO.22.02777
Abstrakt:	Purpose: Most patients with advanced pancreas cancer experience pain and must limit their daily activities because of tumor-related symptoms. To date, no treatment has had a significant impact on the disease. In early studies with gemcitabine, patients with pancreas cancer experienced an improvement in disease-related symptoms. Based on those findings, a definitive trial was performed to assess the effectiveness of gemcitabine in patients with newly diagnosed advanced pancreas cancer. Patients and Methods: One hundred twenty-six patients with advanced symptomatic pancreas cancer completed a lead-in period to characterize and stabilize pain and were randomized to receive either gemcitabine 1,000 mg/m2 weekly x 7 followed by 1 week of rest, then weekly x 3 every 4 weeks thereafter (63 patients), or to fluorouracil (5-FU) 600 mg/m2 once weekly (63 patients). The primary efficacy measure was clinical benefit response, which was a composite of measurements of pain (analgesic consumption and pain intensity), Karnofsky performance status, and weight. Clinical benefit required a sustained (> or = 4 weeks) improvement in at least one parameter without worsening in any others. Other measures of efficacy included response rate, time to progressive disease, and survival. Results: Clinical benefit response was experienced by 23.8% of gemcitabine-treated patients compared with 4.8% of 5-FU-treated patients (P = .0022). The median survival durations were 5.65 and 4.41 months for gemcitabine-treated and 5-FU-treated patients, respectively (P = .0025). The survival rate at 12 months was 18% for gemcitabine patients and 2% for 5-FU patients. Treatment was well tolerated. Conclusion: This study demonstrates that gemcitabine is more effective than 5-FU in alleviation of some disease-related symptoms in patients with advanced, symptomatic pancreas cancer. Gemcitabine also confers a modest survival advantage over treatment with 5-FU.
Databáze:	MEDLINE
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