Salvage surgical resection after high-dose ifosfamide (HDIF) based regimens in advanced soft tissue sarcoma (ASTS): a potential positive selection bias--a study of the Spanish group for research on sarcomas (GEIS).
OBJECTIVE
To assess the impact of different factors on response rate (RR), time to tumor progression (TTP), and overall survival time (OS) in patients with locally advanced or metastatic soft tissue sarcoma (ASTS), included in three protocols with high-dose ifosfamide (HDIF).


METHODS
One hundred fifty six ASTS patients included in three consecutive phase II trials with HDIF (>10 g/m(2)), alone or in combination with doxorubicin (DX), were analyzed. Cofactors were institution, trial, gender, age, performance status, histologic type, grade of malignancy, prior radiotherapy, presence of locoregional disease, metastatic site, salvage surgery, number of organs involved, and disease-free interval.


RESULTS
By multivariate analysis performance status >0 and lack of salvage surgery correlated with a poorer survival. A good-risk and a poor-risk group were identified, with median survival time (OS) of 29, 5, and 10 months, respectively (P = 0.00001). The 1-, 2-, and 3-year OS for 83 good-risk patients (either with PS = 0 or receiving salvage surgery) was 83, 44, and 29%, respectively, those figures being 37, 7, and 3% for 73 poor-risk patients.


CONCLUSIONS
The design of randomized trials in ASTS including HDIF should consider those prognostic factors as stratification variables.
Maurel
Joan
J
Department of Medical Oncology, Hospital Clínic, Barcelona, Spain. jmaurel@clinic.ub.es
Buesa
José
J
López-Pousa
Antonio
A
del Muro
Xavier García
XG
Quintana
María Jesús
MJ
Martín
Javier
J
Casado
Antonio
A
Martínez-Trufero
Javier
J
de Las Peñas
Ramón
R
Balañá
Carmen
C
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage*; D015982:Bias; D017322:Clinical Trials, Phase II as Topic; D003131:Combined Modality Therapy; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005354:Fibrosarcoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery; D018219:Histiocytoma, Benign Fibrous / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage*; D007890:Leiomyosarcoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery; D008080:Liposarcoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D018319:Neurofibrosarcoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery; D018579:Patient Selection; D016016:Proportional Hazards Models; D012107:Research Design; D016879:Salvage Therapy; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D013030:Spain; D016019:Survival Analysis
D000903:Antibiotics, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D004317:Doxorubicin; D007069:Ifosfamide