caa a22 4500 465789293 CHVBK 20180323112018.0 cr unu---uuuuu 170327e19900201xx s 000 0 eng 10.1007/BF00216936 doi (NATIONALLICENCE)springer-10.1007/BF00216936 Phase II trial of 6-diazo-5-oxo-L-norleucine versus aclacinomycin-A in advanced sarcomas and mesotheliomas [Elektronische Daten] [Robert Earhart, David Amato, Alex Yuang-Chi Chang, Ernest Borden, Masanori Shiraki, Melissa Dowd, Robert Comis, Thomas Davis, Thomas Smith] Summary: Ninety-eight patients with previously-treated advanced soft tissue sarcoma, bone sarcoma, or mesothelioma were randomly assigned to one of two intravenous single-agent treatment regimens, either 6-diazo-5-oxo-l-norleucine (DON; brief infusions of 50 mg/m2/day for 5 consecutive days every 4 weeks) or aclacinomycinA (ACM-A, as 30-min infusions of 100 mg/m2 or 85 mg/m2, administered every 3 weeks). Of 43 patients who were evaluable for response, survival and toxicity, there were two responses (5%) produced by ACM-A; one in a male with mesothelioma, and one in a female with malignant fibrous histiocytoma. None of the 36 evaluable patients treated with DON developed an objective tumor response. Median survival was 4.8 months in the DON treatment arm, and 6.8 months in the ACM-A treatment arm. No patients on the DON arm experienced lethal or life-threatening toxicities, and severe toxicities resulting from this treatment included nausea and emesis (10%), stomatitis (2%), gastrointestinal toxicity (2%), and anemia (2%). Moderate toxicities included vomiting (24%), hematologic toxicity (24%), neurologic toxicity (7%), diarrhea (7%), mucositis (5%), fever (5%), palpitations (2%), hepatotoxicity (2%), bleeding (2%) and edema (2%). Fifteen percent experienced at least one severe reaction, and 63% experienced at least one moderate or greater toxicity. ACM-A was associated with four cases of life-threatening myelosuppression (7%); severe toxicities included myelosuppression (11%), neurologic toxicity (4%), diarrhea (2%), respiratory toxicity (2%), pain and muscle spasms (2%), edema (2%), and ulceration following extravasation (2%). Moderate toxicities included diarrhea (9%), mucositis (7%), hepatotoxicity (7%), infection (5%), fever (7%), gastrointestinal toxicity (4%), respiratory (2%), dehydration (2%), cardiac (2%), alopecia (2%), ulceration following extravasation (7%), and edema (2%). Thirty-eight percent of patients on the ACM-A arm developed one or more severe or worse toxicity, and 76% had at least one moderate or worse toxicity. Neither regimen produces useful clinical results in patients with advanced sarcomas or mesotheliomas. Kluwer Academic Publishers, 1990 6-diazo-5-oxo-L-norleucine nationallicence aclacinomycin-A nationallicence phase II nationallicence sarcoma nationallicence mesothelioma nationallicence Earhart Robert University of Wisconsin Clinical Cancer Center, CA 21076, Madison, WI, USA aut Amato David Dana-Farber Cancer Institute, Harvard School of Public Health, CA 23318, Boston, MA, USA aut Yuang-Chi Chang Alex University of Rochester Cancer Center, CA 11083, Rochester, NY, USA aut Borden Ernest University of Wisconsin Clinical Cancer Center, CA 21076, Madison, WI, USA aut Shiraki Masanori Tufts University School of Medicine, CA 07183, Boston, MA, USA aut Dowd Melissa Dana-Farber Cancer Institute, Harvard School of Public Health, CA 23318, Boston, MA, USA aut Comis Robert Fox Chase Cancer Center, CA 18281, Philadelphia, PA, USA aut Davis Thomas University of Wisconsin Clinical Cancer Center, CA 21076, Madison, WI, USA aut Smith Thomas Tufts University School of Medicine, CA 07183, Boston, MA, USA aut Investigational New Drugs Kluwer Academic Publishers 8/1(1990-02-01), 113-119 0167-6997 8:1<113 1990 8 10637 https://doi.org/10.1007/BF00216936 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF00216936 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Earhart Robert University of Wisconsin Clinical Cancer Center, CA 21076, Madison, WI, USA aut NATIONALLICENCE 700 1- Amato David Dana-Farber Cancer Institute, Harvard School of Public Health, CA 23318, Boston, MA, USA aut NATIONALLICENCE 700 1- Yuang-Chi Chang Alex University of Rochester Cancer Center, CA 11083, Rochester, NY, USA aut NATIONALLICENCE 700 1- Borden Ernest University of Wisconsin Clinical Cancer Center, CA 21076, Madison, WI, USA aut NATIONALLICENCE 700 1- Shiraki Masanori Tufts University School of Medicine, CA 07183, Boston, MA, USA aut NATIONALLICENCE 700 1- Dowd Melissa Dana-Farber Cancer Institute, Harvard School of Public Health, CA 23318, Boston, MA, USA aut NATIONALLICENCE 700 1- Comis Robert Fox Chase Cancer Center, CA 18281, Philadelphia, PA, USA aut NATIONALLICENCE 700 1- Davis Thomas University of Wisconsin Clinical Cancer Center, CA 21076, Madison, WI, USA aut NATIONALLICENCE 700 1- Smith Thomas Tufts University School of Medicine, CA 07183, Boston, MA, USA aut NATIONALLICENCE 773 0- Investigational New Drugs Kluwer Academic Publishers 8/1(1990-02-01), 113-119 0167-6997 8:1<113 1990 8 10637 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer