Current status of the adjuvant therapy in uterine sarcoma: A literature review

Table 1 Summary of chief trials investigating the role of adjuvant chemotherapy and radiotherapy in uterine sarcomas

	n patients	Trial population	Trial desing	% relapse	PFS (mo)	OS (mo)	2-yr DFS	3-yr DFS	3-yr OS
51 Gy in 28 fractions vs observation (Reed et al[23], 2008)	224	US, stage I-II (103 uLMS)	Randomised, phase 3		6.2 vs 4.9 (P = 0.35)	8.5 vs 6.7 (P = 0.92)
Doxorubicin 60 mg/m2 (8 cycles) vs observation (Omura et al[40], 1985)	225	US, stage I-II (48 uLMS)	Randomised, phase 3	41% vs 53%	NR vs 40.2	73.7 vs 55 (P > 0.5)
Ifosfamide 1.5 g/m2/d (Kushner et al[41], 2000)	13	US, stage I-IV	Single-arm		26	41
Gemcitabine 900 mg/m2 d1, d8 + Docetaxel 75 mg/m2 d8 q21d, 4 cycles (Hensley et al[11], 2009)	25	uLMS, stage I-IV	Single-arm		13 (FU > 49)	NR	All pts 45% Stage I-II 59%
Gemcitabine 900 mg/m2 d1, d8 + Docetaxel 75 mg/m2 d8 q21d 4 cycles followed by doxorubicin 60 mg/m2 q21d 4 cycles (SARC-005) (Hensley et al[46], 2013)	47	uLMS, stage I-IIIa	Phase 2		NR (FU > 39)	NR	78%	57%
Doxorubicin 50 mg/m2 d1, ifosfamide 3 g/m2 d1 d2, cisplatin 75 mg/m2 d3 (4 cycles) + G-CSF + RT vs RT alone (SARCGYN) (Pautier et al[47], 2013)	81	US, stage I-III	Randomised, Phase 3	38.5% vs 62%				55% vs 41% (P = 0.048)	81% vs 69% (P = 0.92)

RT: Radiotherapy; US: Uterine sarcomas; DFS: Disease-free survival; PFS: Progression-free survival; OS: Overall survival; uLMS: Uterine leiomyosarcoma.