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Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial

Holtan, Shernan G ; Steen, Preston D ; Foster, Nathan R ; Erlichman, Charles ; Medeiros, Fabiola ; Ames, Matthew M ; Safgren, Stephanie L ; Graham, David L ; Behrens, Robert J ; Goetz, Matthew P Perez-Gracia, Jose Luis

PloS one, 2012-07, Vol.7 (7), p.e39285 [Periódico revisado por pares]

United States: Public Library of Science

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Título:
Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial
Autor: Holtan, Shernan G ; Steen, Preston D ; Foster, Nathan R ; Erlichman, Charles ; Medeiros, Fabiola ; Ames, Matthew M ; Safgren, Stephanie L ; Graham, David L ; Behrens, Robert J ; Goetz, Matthew P
Perez-Gracia, Jose Luis
Assuntos: Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Bone marrow ; Camptothecin - adverse effects ; Camptothecin - analogs & derivatives ; Camptothecin - therapeutic use ; Cancer ; Cancer metastasis ; Cancer therapies ; Carcinoma ; Care and treatment ; Chemotherapy ; Clinical outcomes ; Clinical trials ; Cohort Studies ; Colorectal cancer ; Consortia ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Diagnostic systems ; Dose-Response Relationship, Drug ; Female ; Gemcitabine ; Gene expression ; Glucuronosyltransferase ; Health aspects ; Hematology ; Humans ; Irinotecan ; Lymphatic system ; Male ; Maris, Roger ; Medical diagnosis ; Medical imaging ; Medical prognosis ; Medical research ; Medicine ; Metastases ; Metastasis ; Middle Aged ; Neoplasms, Unknown Primary - drug therapy ; Oncology ; Patients ; Pearl, Minnie ; Polymorphism ; Product development ; Prognosis ; Stem cells ; Survival ; Therapy ; Toxicity ; Treatment Outcome
É parte de: PloS one, 2012-07, Vol.7 (7), p.e39285
Notas: Conceived and designed the experiments: NRF CE FM MPG. Performed the experiments: SLS. Analyzed the data: SGH NRF CE FM MPG. Contributed reagents/materials/analysis tools: SGH PDS NRF CE FM MMA SLS DLG RJB MPG. Wrote the paper: SGH PDS NRF CE FM MMA SLS DLG RJB MPG.
Descrição: Metastatic carcinoma of unknown primary (CUP) has a very poor prognosis, and no standard first-line therapy currently exists. Here, we report the results of a phase II study utilizing a combination of gemcitabine and irinotecan as first-line therapy. Treatment was with gemcitabine 1000 mg/m(2) and irinotecan 75 mg/m(2) weekly times four on a six week cycle (Cohort I). Due to excessive toxicity, the dose and schedule were modified as follows: gemcitabine 750 mg/m(2) and irinotecan 75 mg/m(2) given weekly times three on a four week cycle (Cohort II). The primary endpoint was the confirmed response rate (CR + PR). Secondary endpoints consisted of adverse events based upon the presence or absence of the UDP glucuronosyltransferase 1 family, polypeptide A1*28 (UGT1A1*28) polymorphism, time to progression, and overall survival. Thirty-one patients were enrolled with a median age of 63 (range: 38-94), and 26 patients were evaluable for efficacy. Significant toxicity was observed in Cohort 1, characterized by 50% (7/14) patients experiencing a grade 4+ adverse event, but not in cohort II. The confirmed response rate including patients from both cohorts was 12% (95% CI: 2-30%), which did not meet the criteria for continued enrollment. Overall median survival was 7.2 months (95% CI: 4.0 to 11.6) for the entire cohort but notably longer in cohort II than in cohort I (9.3 months (95% CI: 4.1 to 12.1) versus 4.0 months (95% CI: 2.2 to 15.6)). Gemcitabine and irinotecan is not an active combination when used as first line therapy in patients with metastatic carcinoma of unknown primary. Efforts into developing novel diagnostic and therapeutic approaches remain important for improving the outlook for this heterogeneous group of patients. ClinicalTrials.gov NCT00066781.
Editor: United States: Public Library of Science
Idioma: Inglês

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Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial

Holtan, Shernan G ; Steen, Preston D ; Foster, Nathan R ; Erlichman, Charles ; Medeiros, Fabiola ; Ames, Matthew M ; Safgren, Stephanie L ; Graham, David L ; Behrens, Robert J ; Goetz, Matthew P Perez-Gracia, Jose Luis

United States: Public Library of Science

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