Intensified Adjuvant Treatment of Prostate Carcinoma: Feasibility Analysis of a Phase I/II Trial

Table 6

Results (toxicity) comparison with nonrandomized studies using high-dose radiotherapy.

Study	Number of pts	Adjuvant therapy	RT technique	Toxicity scores	Acute toxicity		Late; toxicity		Notes
					GI	GU	GI	GU
Nath et al., 2010 [24]	50	RT (median dose: 68 Gy)	IMRT-IGRT	CTC 3.0	G2: 8%; G3: 0%	G2: 14%; G3: 0%	G2: 2%; *	G2: 16%; G3: 2%; *	IMRT-IGRT may reduce RT-induced toxicity
Cozzarini et al., 2012 [25]	556	RT (median dose: 70.2 Gy) ± ENI	2D or 3D	CTC 3.0	NR	G2: 19%; G3: 8%	NR	G2: 23.9%; G3: 12%; †	Younger and hypertensive pts: higher rate of severe GU late sequelae
van Praet et al., 2013 [26]	48 (pN1)	RT (75 Gy to prostate bed + ENI: 54 Gy) + ADT	IMAT	In-house developed scale	G2: 42%; G3: 0%	G2: 35%; G3: 4%	G2: 25%; G3: 0%; ‡	G2: 36%; G3: 7%; G4: 2%; ‡	Acute and late GI toxicity higher following ENI
Present series	123	RT (64.8–70.2 Gy to prostate bed ± ENI) ± AHT	3D CRT	Acute: RTOG; Late: RTOG-EORTC	G2: 10.6%; G3: 2.4%; G4: 0%	G2: 9.8%; G3: 3.3%; G4: 0%	G ≥ 2: 3.7%; G ≥ 3: 0%; G ≥ 4: 0%; §	G ≥ 2: 12.7%; G ≥ 3: 5.8%; G ≥ 4: 0%; §	No significant effect on toxicity by age, dose, ENI, and AHT

3D CRT: 3-dimensional conformal radiation therapy; ADT: androgen deprivation therapy; AHT: adjuvant hormonal therapy; ENI: elective nodal irradiation; GI: gastrointestinal; GU: genitourinary; IGRT: image guided radiation therapy; IMAT: intensity-modulated arc therapy; IMRT: intensity-modulated radiation therapy; pts: patients; *: crude, median follow-up: 24 months; †: 8-year risk; ‡: crude (only patients with ≥12-month follow-up); and §: 5-year actuarial cumulative incidence.