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Table 11 Prospective clinical trials evaluating concurrent external beam radiation therapy and taxane-based chemotherapy for high-risk prostate cancer

From: Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial

Study

Design

N patients

EBRT technique

EBRT dosage (Gy)

Taxane drug

Taxane dosage (mg/m2)

ADT duration (months)

Toxicity scoring system

Highest acute GU toxicity §

Highest acute GI toxicity §

Highest late toxicity §

Biochemical recurrence

Follow-up, median (months)

Kumar [14]

Phase I

22

3D-CRT

70.2

Docetaxel

5 (n=3), 8 (n=3),

None

CTC v2.0, RTOG †

Grade 2

Grade 3

Urinary

5/8

8

12 (n=3), 16 (n=5),

Frequency/urgency

Diarrhea (n=2)

Retention (n=1)

20 (n=6), 25(n=2)

(n=8)

Sanfilippo [23]

Phase I/II

22

3D-CRT

63 (n=3), 66.6

Paclitaxel

30

9

CTC v2.0

Grade 2

Grade 3

Grade 1

6/22

38

(n=7), 70.2 (n=4),

Frequency/urgency

Diarrhea (n=4)

Frequency

73.8 (n=8)

(n=4)

(n=2)

Perrotti [15]

Phase I/II

20

IMRT

72

Docetaxel

20

None

CTC,

Grade 2

Grade 2

none

3/20

11.7

RTOG †

Frequency (n=7)

Diarrhea (n=8)

Bolla [16]

Phase II

50

3D-CRT (n=45),

70

Docetaxel

20

<36 (n=6),

CTC v2.0,

Grade 3

Grade 4

Grade 3

NR ‡

54

IMRT (n=5)

36 (n=43),

RTOG †

Dysuria (n=2)

Proctitis (n=1)

Proctitis (n=1)

>36 (n=1)

Hussain [24]

Phase I

59

3D-CRT

70.2 (n=29),

Paclitaxel

40 (n=10),

4 (n=29),

CTC v2.0

Grade 2

Grade 3

NA

13/29, 11/30*

76.3, 74.9*

64.8 (n=30)*

50 (n=31),

24 (n=30)

Frequency/urgency/

Diarrhea (n=9)

60 (n=18)

Incontinence (n=5)

Chen [25]

Phase I

18

IMRT

78

Docetaxel

10 (n=9),

24

CTCAE v3.0

Grade 2

Grade 3

NA

3/18

26

15 (n=6),

Frequency (n=2)

Diarrhea (n=2)

20 (n=3)

Present series

Phase II

35

IMRT

80 (n=17),

Docetaxel

30 mg (n=8),

24

CTCAE v3.0

Grade 3

Grade 3

Grade 2 urinary

6/17, 8/18*

63

70 (n=18)*

40 mg (n=27)

Urinary retention

Diarrhea

Retention

         

(n=1)

(n=2)

(n=2)

  
  1. 3D-CRT = three-dimensional conformal radiation therapy; ADT = androgen deprivation therapy; CTC = Common Toxicity Criteria of the National Cancer Institute; CTCAE = Common Terminology Criteria for Adverse Events of the National Cancer Institute; EBRT = external beam radiation therapy; GI = gastrointestinal symptoms; GU = genitourinary symptoms; IMRT = intensity-modulated radiation therapy; NA = not assessed; NR = not reported; RTOG = Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer toxicity criteria.
  2. *Patients with previous radical prostatectomy; † late toxicity; ‡ clinical disease-free survival was 66.72% at 5 years; § when two or more events, only the most common was reported.