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- W4236859423 abstract "5577 Background : Combination of GC chemotherapy is active and has a favorable safety profile in some several solid tumors, including advanced squamous cell head and neck cancers. We evaluated the efficacy and toxicity of this combination in advanced or recurrent NPC. Methods : In a two-center phase II study, patients with histologically confirmed advanced or recurrent NPC, measurable disease, WHO PS 0–2, age 19–70 years, adequate organ function, and written informed consent, were treated with Gemcitabine 1250 mg/m2 day 1 and day 8; Cisplatin 80 mg/m2 day 1 every 3 weeks. Primary endpoint was objective response rate. Results : Thirty five patients were enrolled between 12/01 and 11/03. There were 27 male and 8 female, 33 with Javanese ethnicity and 2 Caucasian;. with a mean age was 45 years (19–68). All but 3 patients (91.4%) had undifferentiated histology. Twenty-two patients had metastatic or recurrent disease, 13 patients had locally advanced disease. All patients were chemonaive, and 10 patients had recurrent disease after radiotherapy. There were 2 complete responses and 22 partial responses, yielding an 83% overall response rate from in 29 evaluable patients (95 CI, 68% - 97%). Grade 4 liver toxicity was found in 2 of 166 (1.2%) cycles analyzed. Grade III/IV anemia, neutropenia and thrombocytopenia were found in 1.8%, 8.2% and 1.2% of cycles respectively. Two patients are still on treatment. With a median follow-up of 9 months (1–21), the median progression-free survival and overall survival are 9 and 19 months, respectively. Conclusion : Gemcitabine and cisplatin combination is effective and has a safe toxicity profile for advanced and recurrent NPC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Elli Lily" @default.
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- W4236859423 date "2004-07-15" @default.
- W4236859423 modified "2023-09-26" @default.
- W4236859423 title "Combination of gemcitabine and cisplatin (GC) chemotherapy for advanced or recurrent nasopharyngeal cancer (NPC): A phase II study" @default.
- W4236859423 doi "https://doi.org/10.1200/jco.2004.22.14_suppl.5577" @default.
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