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【medical-news】Gemcitabine/Cisplatin Combo Improves Survival in Biliary Tract Cancers吉西他滨联合顺铂延长胆道癌生存期

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Gemcitabine/Cisplatin Combo Improves Survival in Biliary Tract Cancers
吉西他滨联合顺铂延长胆道癌生存期
Elsevier Global Medical News. 2009 May 14, K Wachter
The combination of cisplatin and gemcitabine improved overall survival and progression-free survival by 30% over gemcitabine alone in patients with advanced biliary tract cancers, offering what could become the standard of care for this difficult-to-treat cancer.
The results come from the phase III ABC-02 study involving 410 patients with advanced biliary tract, gallbladder, or ampullary carcinoma, which Dr. Juan W. Valle reported during a teleconference held May 14, by the American Society of Clinical Oncology.
Patients on the combination therapy had a 30% reduction in risk of death (Hazard ratio 0.70), compared with those who received gemcitabine (Gemzar) alone. Median survival for the combination therapy group reached 11.7 months, compared with 8.3 months for gemcitabine alone group (P = .002).
"We consider cisplatin and gemcitabine to now be the worldwide standard of care and the backbone for further studies of patients with advanced biliary tract cancers," said Dr. Valle, who is a senior lecturer and medical oncologist at the University of Manchester in the United Kingdom and the Christie NHS Foundation Trust in Manchester.
ASCO President Dr. Richard L. Schilsky, who co-moderated the session, welcomed the results. "As one who treats these patients in my own clinic, it's very comforting to now have a clear standard of care to offer," he said.
The combination therapy also significantly improved progression-free survival, reducing the risk of progression by 30%. The benefit of combining the two drugs comes without adding clinically significant toxicity, said Dr. Valle. Progression-free survival data will be presented along with toxicity data at the ASCO annual meeting.
For this study, patients had to be at least 16 years old with histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma. Intra- or extra-hepatic disease was allowed. Disease could be unresectable locally advanced, recurrent, or metastatic. Patients with brain metastases were excluded.
Patients had to have a life expectancy of least 3 months. At least 6 months had to have passed since prior adjuvant chemotherapy. Patients could not have had prior chemotherapy with gemcitabine or cisplatin.
Prior radiotherapy for localized disease was allowed provided there was clear evidence of disease progression afterward. Likewise, prior curative surgery was allowed provided there was evidence of nonresectable disease relapse requiring systemic chemotherapy.
Eligible patients were randomized to either treatment with gemcitabine alone (204 participants) or in combination with cisplatin (206). Patients were stratified by center, primary site, performance status, prior therapy, and locally advanced vs. metastatic disease.
In the gemcitabine-only arm, the drug was administered at a dose of 1,000 mg/m² on days 1, 8, and 15 out of a 28-day cycle. Patients in this arm underwent 6 cycles (24 weeks). Patients in the combination arm received 1,000 mg/m² gemcitabine and 25 mg/m² cisplatin on days 1 and 8 of a 21-day cycle. Patients in the combination arm underwent 8 cycles (24 weeks).
In both groups, management upon disease progression was at the clinician's discretion, though this was primarily supportive care.
Gemcitabine is manufactured by Eli Lilly and Co., and is indicated for the treatment of breast cancer, non-small cell lung, and pancreatic cancer. Cisplatin is indicated for the treatment of metastatic testicular tumors, metastatic ovarian tumors, and advanced bladder cancer.
The study was funded by Cancer Research UK, under the auspices of the National Cancer Research Network.
http://www.acep.org/ElsevierRSSfeed.aspx?feed=1

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2009-05-16 20:06 浏览 : 831 回复 : 2

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