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

Table 5

Results (toxicity) comparison with randomized studies.

Study	Number of pts	Adjuvant therapy	Toxicity scores	Acute toxicity		Late toxicity
				GI	GU	GI	GU
Thompson et al.,; 2006 [5]	214	RT: 60–64 Gy (2 Gy/fraction) to prostatic fossa and periprostatic tissue	NR	NR	NR	Proctitis and/or rectal bleeding: 3.3%; *	Urethral stricture: 17.8%; total urinary incontinence: 6.5%; *
Wiegel et al.,; 2009 [3]; (ARO 96-02/AUO AP 09/95)	114	RT: 60 Gy (2 Gy/fraction) to prostatic fossa and region of seminal vesicles with 1 cm margin	Acute: RTOG; Late: RTOG-EORTC	NR	NR	G2: 1.4%; G3: 0%; †	G2: 2%; G3: 0.7%; urethral stricture: 1.4%; †
Bolla et al.,; 2012 [4]; (EORTC 22911)	502	RT: 50 Gy (2 Gy/fraction) to prostatic fossa and region of seminal vesicles and periprostatic area + 10 Gy to prostatic fossa	NR	NR	NR	G ≥ 2: 2.5%; ‡	G ≥ 2: 21.3%; ‡
						Late GI-GU G ≥ 1: 70.8%
						Late GI-GU G3: 5.3%
						Late GI-GU G4: 0%
						‡
Present series	123	RT: 64.8–70.2 Gy (1.8 Gy/fraction) to prostatic fossa and region of seminal vesicles with 1 cm margin ± ENI,; 45 Gy ± AHT	Acute: RTOG; Late: RTOG-EORTC	G3: 2.4%; G4: 0.0%	G3: 3.3%; G4: 0.0%	G ≥ 2: 3.7%; G ≥ 3: 0.0%; G ≥ 4: 0.0%; §	G ≥ 2: 12.7%; G ≥ 3: 5.8%; G ≥ 4: 0.0%; §

ENI: elective nodal irradiation; GI: gastrointestinal; GU: genitourinary; AHT: adjuvant hormonal therapy; NR: not reported; pts: patients; *: crude (median follow-up: 10.6 years); †: crude (median follow-up: 53.7 months); ‡: 10-year cumulative incidence; and §: 5-year actuarial cumulative incidence.