Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer

Y. Z. Patt, D. V. Jones, A. Hoque, R. Lozano, Avi Markowitz, I. Raijman, P. Lynch, C. Charnsangavej

    Research output: Contribution to journalArticle

    124 Citations (Scopus)

    Abstract

    Purpose: To assess the efficacy of systemic intravenous-fluorouracil (5-FU) and subcutaneous recombinant human interferon alfa-2b (rIFNα-2b) in patients with measurable cancer of the biliary tree. Patients and Methods: Thirty-five patients (25 with cholangiocarcinoma and 10 with gallbladder carcinoma) were registered onto this phase II protocol between 1992 and 1995. Patients received a continuous infusion of 750 mg/m2/d of 5-FU on days 1 through 5 through a centrally placed venous catheter and a subcutaneous injection of 5 MU/m2 of rIFNα-2b on days 1, 3, and 5. Treatment cycles were repeated every 14 days; one course of therapy included four treatment cycles. Disease status was assessed every 8 weeks. Dosages were lowered for grade III mucositis. Fourteen patients had prior treatment and, before initiating this therapy, 17 patients required decompression of the biliary tree. Results: Eleven of 32 (34%) assessable patients had a partial response. The median time to disease progression was 9.5 months, and the median survival time 12 months. Grade III to IV toxic effects were granulocytopenia (14%), mucositis (20%), diarrhea (9%), and dermatitis (11%). Grade III to IV asthenia and fatigue were observed in 6% of patients. Conclusion: Drug tolerance was better among previously untreated patients. To achieve a complete response, additional chemotherapy or radiotherapy should be considered when liver resection or transplantation is not feasible. However, if these results can be reproduced by other investigators, the regimen should be studied for adjuvant treatment of gallbladder carcinoma incidentally identified in patients undergoing cholecystectomy.

    Original languageEnglish (US)
    Pages (from-to)2311-2315
    Number of pages5
    JournalJournal of Clinical Oncology
    Volume14
    Issue number8
    StatePublished - 1996

    Fingerprint

    interferon alfa-2b
    Biliary Tract Neoplasms
    Fluorouracil
    Mucositis
    Biliary Tract
    Gallbladder
    Therapeutics
    Drug Tolerance
    Carcinoma
    Asthenia
    Agranulocytosis

    ASJC Scopus subject areas

    • Cancer Research
    • Oncology

    Cite this

    Patt, Y. Z., Jones, D. V., Hoque, A., Lozano, R., Markowitz, A., Raijman, I., ... Charnsangavej, C. (1996). Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. Journal of Clinical Oncology, 14(8), 2311-2315.

    Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. / Patt, Y. Z.; Jones, D. V.; Hoque, A.; Lozano, R.; Markowitz, Avi; Raijman, I.; Lynch, P.; Charnsangavej, C.

    In: Journal of Clinical Oncology, Vol. 14, No. 8, 1996, p. 2311-2315.

    Research output: Contribution to journalArticle

    Patt, YZ, Jones, DV, Hoque, A, Lozano, R, Markowitz, A, Raijman, I, Lynch, P & Charnsangavej, C 1996, 'Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer', Journal of Clinical Oncology, vol. 14, no. 8, pp. 2311-2315.
    Patt YZ, Jones DV, Hoque A, Lozano R, Markowitz A, Raijman I et al. Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. Journal of Clinical Oncology. 1996;14(8):2311-2315.
    Patt, Y. Z. ; Jones, D. V. ; Hoque, A. ; Lozano, R. ; Markowitz, Avi ; Raijman, I. ; Lynch, P. ; Charnsangavej, C. / Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. In: Journal of Clinical Oncology. 1996 ; Vol. 14, No. 8. pp. 2311-2315.
    @article{6c7e69c417b0474fae78a2981c82f8ed,
    title = "Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer",
    abstract = "Purpose: To assess the efficacy of systemic intravenous-fluorouracil (5-FU) and subcutaneous recombinant human interferon alfa-2b (rIFNα-2b) in patients with measurable cancer of the biliary tree. Patients and Methods: Thirty-five patients (25 with cholangiocarcinoma and 10 with gallbladder carcinoma) were registered onto this phase II protocol between 1992 and 1995. Patients received a continuous infusion of 750 mg/m2/d of 5-FU on days 1 through 5 through a centrally placed venous catheter and a subcutaneous injection of 5 MU/m2 of rIFNα-2b on days 1, 3, and 5. Treatment cycles were repeated every 14 days; one course of therapy included four treatment cycles. Disease status was assessed every 8 weeks. Dosages were lowered for grade III mucositis. Fourteen patients had prior treatment and, before initiating this therapy, 17 patients required decompression of the biliary tree. Results: Eleven of 32 (34{\%}) assessable patients had a partial response. The median time to disease progression was 9.5 months, and the median survival time 12 months. Grade III to IV toxic effects were granulocytopenia (14{\%}), mucositis (20{\%}), diarrhea (9{\%}), and dermatitis (11{\%}). Grade III to IV asthenia and fatigue were observed in 6{\%} of patients. Conclusion: Drug tolerance was better among previously untreated patients. To achieve a complete response, additional chemotherapy or radiotherapy should be considered when liver resection or transplantation is not feasible. However, if these results can be reproduced by other investigators, the regimen should be studied for adjuvant treatment of gallbladder carcinoma incidentally identified in patients undergoing cholecystectomy.",
    author = "Patt, {Y. Z.} and Jones, {D. V.} and A. Hoque and R. Lozano and Avi Markowitz and I. Raijman and P. Lynch and C. Charnsangavej",
    year = "1996",
    language = "English (US)",
    volume = "14",
    pages = "2311--2315",
    journal = "Journal of Clinical Oncology",
    issn = "0732-183X",
    publisher = "American Society of Clinical Oncology",
    number = "8",

    }

    TY - JOUR

    T1 - Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer

    AU - Patt, Y. Z.

    AU - Jones, D. V.

    AU - Hoque, A.

    AU - Lozano, R.

    AU - Markowitz, Avi

    AU - Raijman, I.

    AU - Lynch, P.

    AU - Charnsangavej, C.

    PY - 1996

    Y1 - 1996

    N2 - Purpose: To assess the efficacy of systemic intravenous-fluorouracil (5-FU) and subcutaneous recombinant human interferon alfa-2b (rIFNα-2b) in patients with measurable cancer of the biliary tree. Patients and Methods: Thirty-five patients (25 with cholangiocarcinoma and 10 with gallbladder carcinoma) were registered onto this phase II protocol between 1992 and 1995. Patients received a continuous infusion of 750 mg/m2/d of 5-FU on days 1 through 5 through a centrally placed venous catheter and a subcutaneous injection of 5 MU/m2 of rIFNα-2b on days 1, 3, and 5. Treatment cycles were repeated every 14 days; one course of therapy included four treatment cycles. Disease status was assessed every 8 weeks. Dosages were lowered for grade III mucositis. Fourteen patients had prior treatment and, before initiating this therapy, 17 patients required decompression of the biliary tree. Results: Eleven of 32 (34%) assessable patients had a partial response. The median time to disease progression was 9.5 months, and the median survival time 12 months. Grade III to IV toxic effects were granulocytopenia (14%), mucositis (20%), diarrhea (9%), and dermatitis (11%). Grade III to IV asthenia and fatigue were observed in 6% of patients. Conclusion: Drug tolerance was better among previously untreated patients. To achieve a complete response, additional chemotherapy or radiotherapy should be considered when liver resection or transplantation is not feasible. However, if these results can be reproduced by other investigators, the regimen should be studied for adjuvant treatment of gallbladder carcinoma incidentally identified in patients undergoing cholecystectomy.

    AB - Purpose: To assess the efficacy of systemic intravenous-fluorouracil (5-FU) and subcutaneous recombinant human interferon alfa-2b (rIFNα-2b) in patients with measurable cancer of the biliary tree. Patients and Methods: Thirty-five patients (25 with cholangiocarcinoma and 10 with gallbladder carcinoma) were registered onto this phase II protocol between 1992 and 1995. Patients received a continuous infusion of 750 mg/m2/d of 5-FU on days 1 through 5 through a centrally placed venous catheter and a subcutaneous injection of 5 MU/m2 of rIFNα-2b on days 1, 3, and 5. Treatment cycles were repeated every 14 days; one course of therapy included four treatment cycles. Disease status was assessed every 8 weeks. Dosages were lowered for grade III mucositis. Fourteen patients had prior treatment and, before initiating this therapy, 17 patients required decompression of the biliary tree. Results: Eleven of 32 (34%) assessable patients had a partial response. The median time to disease progression was 9.5 months, and the median survival time 12 months. Grade III to IV toxic effects were granulocytopenia (14%), mucositis (20%), diarrhea (9%), and dermatitis (11%). Grade III to IV asthenia and fatigue were observed in 6% of patients. Conclusion: Drug tolerance was better among previously untreated patients. To achieve a complete response, additional chemotherapy or radiotherapy should be considered when liver resection or transplantation is not feasible. However, if these results can be reproduced by other investigators, the regimen should be studied for adjuvant treatment of gallbladder carcinoma incidentally identified in patients undergoing cholecystectomy.

    UR - http://www.scopus.com/inward/record.url?scp=0029830677&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=0029830677&partnerID=8YFLogxK

    M3 - Article

    VL - 14

    SP - 2311

    EP - 2315

    JO - Journal of Clinical Oncology

    JF - Journal of Clinical Oncology

    SN - 0732-183X

    IS - 8

    ER -