Table 11.
Prospective clinical trials evaluating concurrent external beam radiation therapy and taxane-based chemotherapy for high-risk prostate cancer
| Study | Design | N patients | EBRT technique | EBRT dosage (Gy) | Taxane drug | Taxane dosage (mg/m 2 ) | 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) |
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.
*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.