PURPOSE: This three-armed phase III study in adults with advanced soft tissue sarcomas was planned as a comparison of objective regression rates, toxicity, and survival of patients receiving doxorubicin alone, ifosfamide plus doxorubicin, and mitomycin plus doxorubicin plus cisplatin. PATIENTS AND METHODS: Between December 1987 and July 1990, 279 patients with histologically confirmed sarcomas were enrolled to receive treatment A (doxorubicin 80 mg/m2), treatment B (ifosfamide 7.5 g/m2 plus doxorubicin 60 mg/m2), or treatment C (mitomycin 8 mg/m2 plus doxorubicin 40 mg/m2 plus cisplatin 60 mg/m2). RESULTS: Of 262 assessable patients, 74 (29%) achieved objective tumor regression. Objective regression occurred in 20% of the 90 patients who received doxorubicin alone (complete remission [CR] rate, 2%), in 34% of the 88 who received ifosfamide plus doxorubicin (CR rate, 3%), and in 32% of the 84 who received mitomycin plus doxorubicin plus cisplatin (CR rate, 7%). With grade 3 or greater myelosuppression in 53% of group A, 80% of group B, and 55% of group C, regimen B was significantly more myelosuppressive than either regimen A or C (P = .01) with two, three, and one treatment-related deaths, respectively. Synovial sarcomas were responsive to ifosfamide plus doxorubicin, especially among patients younger than 40 years of age. CONCLUSION:Ifosfamide plus doxorubicin produced a significantly higher regression rate (P = .03) than did doxorubicin alone; however, this was achieved at a level of myelosuppression significantly more intense than that produced by the single agent or by the three-drug combination. Mitomycin, doxorubicin, and cisplatin also appeared to be more active than the single agent; however, at a myelosuppression level similar to that of doxorubicin alone, this trend (P = .07) did not attain the usual level for significance. No significant survival differences were observed.
RCT Entities:
PURPOSE: This three-armed phase III study in adults with advanced soft tissue sarcomas was planned as a comparison of objective regression rates, toxicity, and survival of patients receiving doxorubicin alone, ifosfamide plus doxorubicin, and mitomycin plus doxorubicin plus cisplatin. PATIENTS AND METHODS: Between December 1987 and July 1990, 279 patients with histologically confirmed sarcomas were enrolled to receive treatment A (doxorubicin 80 mg/m2), treatment B (ifosfamide 7.5 g/m2 plus doxorubicin 60 mg/m2), or treatment C (mitomycin 8 mg/m2 plus doxorubicin 40 mg/m2 plus cisplatin 60 mg/m2). RESULTS: Of 262 assessable patients, 74 (29%) achieved objective tumor regression. Objective regression occurred in 20% of the 90 patients who received doxorubicin alone (complete remission [CR] rate, 2%), in 34% of the 88 who received ifosfamide plus doxorubicin (CR rate, 3%), and in 32% of the 84 who received mitomycin plus doxorubicin plus cisplatin (CR rate, 7%). With grade 3 or greater myelosuppression in 53% of group A, 80% of group B, and 55% of group C, regimen B was significantly more myelosuppressive than either regimen A or C (P = .01) with two, three, and one treatment-related deaths, respectively. Synovial sarcomas were responsive to ifosfamide plus doxorubicin, especially among patients younger than 40 years of age. CONCLUSION:Ifosfamide plus doxorubicin produced a significantly higher regression rate (P = .03) than did doxorubicin alone; however, this was achieved at a level of myelosuppression significantly more intense than that produced by the single agent or by the three-drug combination. Mitomycin, doxorubicin, and cisplatin also appeared to be more active than the single agent; however, at a myelosuppression level similar to that of doxorubicin alone, this trend (P = .07) did not attain the usual level for significance. No significant survival differences were observed.
Authors: George D Demetri; Laurence H Baker; Derrick Beech; Robert Benjamin; Ephraim S Casper; Ernest U Conrad; Thomas F DeLaney; David S Ettinger; Martin J Heslin; Ray J Hutchinson; Krystyna Kiel; William G Kraybill; G Douglas Letson; James Neff; Richard J O'Donnell; I Benjamin Paz; Raphael E Pollock; R Lor Randall; Karen D Schupak; Douglas S Tyler; Margaret von Mehren; Jeffrey Wayne Journal: J Natl Compr Canc Netw Date: 2005-03 Impact factor: 11.908
Authors: A Italiano; O Mir; A Cioffi; E Palmerini; S Piperno-Neumann; C Perrin; L Chaigneau; N Penel; F Duffaud; J E Kurtz; O Collard; F Bertucci; E Bompas; A Le Cesne; R G Maki; I Ray Coquard; J Y Blay Journal: Ann Oncol Date: 2013-10-07 Impact factor: 32.976
Authors: Jérôme Fayette; Nicolas Penel; Christine Chevreau; Jean-Yves Blay; Didier Cupissol; Antoine Thyss; Cécile Guillemet; Maria Rios; Frédéric Rolland; Pierre Fargeot; Jacques Olivier Bay; Simone Mathoulin-Pelissier; Jean Michel Coindre; Binh Bui-Nguyen Journal: Invest New Drugs Date: 2009-01-16 Impact factor: 3.850
Authors: Alberto Bongiovanni; Manuela Monti; Flavia Foca; Federica Recine; Nada Riva; Valentina Di Iorio; Chiara Liverani; Alessandro De Vita; Giacomo Miserocchi; Laura Mercatali; Dino Amadori; Toni Ibrahim Journal: Support Care Cancer Date: 2016-08-27 Impact factor: 3.603