Gemcitabine and docetaxel in relapsed and unresectable high-grade osteosarcoma and spindle cell sarcoma of bone.
BACKGROUND
Few new compounds are available for relapsed osteosarcoma. We retrospectively evaluated the activity of gemcitabine (G) plus docetaxel (D) in patients with relapsed high-grade osteosarcoma and high-grade spindle cell sarcoma of bone (HGS).


METHODS
Patients receiving G 900 mg/m(2) d 1, 8; D 75 mg/m(2) d 8, every 21 days were eligible. Primary end-point: progression-free survival (PFS) at 4 months; secondary end-point: overall survival (OS) and response rate.


RESULTS
Fifty-one patients were included, with a median age of 17 years (8-71), 26 (51%) were pediatric patients. GD line of treatment: 2nd in 14 patients, ≥3rd in 37. 25 (49%) patients had metastases limited to lungs, 26 (51%) multiple sites.


RESULTS
40 (78%) osteosarcoma, 11 (22%) HGS. Eight (16%) patients achieved surgical complete response (sCR2) after GD. Four-month PFS rate was 46%, and significantly better for patients with ECOG 0 (ECOG 0: 54% vs ECOG 1: 43% vs ECOG 2: 0%; p = 0.003), for patients undergoing metastasectomy after GD (sCR2 75% vs no-sCR2 40 %, p = 0.02) and for osteosarcoma (osteosarcoma 56% vs HGS 18%; p = 0.05), with no differences according to age, line of treatment, and pattern of metastases. Forty-six cases had RECIST measurable disease: 6 (13%) patients had a partial response (PR), 20 (43%) had stable disease (SD) and 20 (43%) had progressive disease (PD). The 1-year OS was 30%: 67% for PR, 54% for SD and 20% for PD (p = 0.005).


CONCLUSIONS
GD is an active treatment for relapsed high-grade osteosarcoma, especially for ECOG 0 patients, and should be included in the therapeutic armamentarium of metastatic osteosarcoma.
PROMETEO Laboratory/Chemotherapy Unit, Istituto Ortopedico Rizzoli, Bologna, Italy. emanuela.palmerini@ior.it.|PROMETEO Laboratory/Section of Chemotherapy, Research, Innovation & Technology (RIT) Department, Istituto Ortopedico Rizzoli, Via Pupilli, 1, 40136, Bologna, Italy. emanuela.palmerini@ior.it.
E
E
Palmerini
University of Washington/ Fred Hutchinson Cancer Research Center, Seattle, USA.
R L
RL
Jones
PROMETEO Laboratory/Chemotherapy Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.
E
E
Marchesi
PROMETEO Laboratory/Chemotherapy Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.
A
A
Paioli
PROMETEO Laboratory/Chemotherapy Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.
M
M
Cesari
PROMETEO Laboratory/Chemotherapy Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.
A
A
Longhi
Oncoematologia Pediatrica INT, Milan, Italy.
C
C
Meazza
UO Oncoematologia Pediatrica Pisa, Pisa, Italy.
L
L
Coccoli
Oncoematologia Pediatrica Torino, Torino, Italy.
F
F
Fagioli
Oncoematologia Pediatrica Torino, Torino, Italy.
S
S
Asaftei
IRCCS Candiolo, Torino, Italy.
G
G
Grignani
Oncoematologia Azienda Ospedaliera Universitaria Meyer Pediatrica, Firenze, Italy.
A
A
Tamburini
University of Washington/ Fred Hutchinson Cancer Research Center, Seattle, USA.
S M
SM
Pollack
Laboratory Research, Istituto Ortopedico Rizzoli, Bologna, Italy.
P
P
Picci
PROMETEO Laboratory/Chemotherapy Unit, Istituto Ortopedico Rizzoli, Bologna, Italy.
S
S
Ferrari
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D012516:Osteosarcoma / Q000188:drug therapy* / Q000473:pathology; D012008:Recurrence; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine
Chemotherapy; Docetaxel; Gemcitabine; High-grade bone sarcoma; Osteosarcoma