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Moderate hypofractionated helical tomotherapy for older patients with localized prostate cancer: long-term outcomes of a phase I–II trial Cover

Moderate hypofractionated helical tomotherapy for older patients with localized prostate cancer: long-term outcomes of a phase I–II trial

Radiology and Oncology
Volume 56 (2022): Issue 2 (June 2022)
By: ,  ,  ,  ,  ,  ,  ,   and    
Open Access
|Mar 2022
Figures & tables

Figures & Tables

Figure 1

Consort diagram of the trial.

Figure 2

Kaplan-Meier curves of (A) progression-free survival (PFS), (B) biochemical failure free survival (BFFS), (C) prostate cancer specific survival (PCSS), and (D) overall survival (OS) in patients received hypofractionated radiation therapy (HFRT).

Table 1

Demographic characteristics of patients and baseline risk assessment

Group-1 (76.0 Gy/34 F, N = 33)Group-2 (71.6 Gy/28 F, N = 34)p-value
Age, y (mean ± SD)79.7 ± 3.977.3 ± 5.10.284
Median time of follow-up, y (range)8.9 (1.5–11.4)6.8 (2.6–8.4)0.002
AJCC T stage, no. (%)0.121
   T1c/T1x1 (3.0)0
   T2a/T2b/T2c/T2x29 (87.9)27 (79.4)
   T3a/T3b/T3x3 (9.1)6 (17.6)
   T401 (2.9)
Risk stage, no. (%)0.204
   low risk3 (9.1)1 (2.9)
   intermediate risk11 (33.3)10 (29.4)
   high risk15 (45.5)18 (53.0)
   very high risk4 (12.1)5 (14.7)
Gleason score, no. (%)0.775
   5–612 (36.4)13 (38.2)
   710 (30.3)13 (38.2)
   8–98 (24.2)5 (14.7)
   unknown3 (9.1)3 (8.8)
Pre-treatment PSA, no. (%)0.442
   < 10 ng/mL11 (33.3)7 (20.6)
   10–20 ng/mL8(24.2)8 (23.5)
   > 20 ng/mL14 (42.4)19 (55.9)
   Comorbidity
   Diabetes4 (12%)3 (8.8%)0.659
   Hypertension7 (21.2%)8 (23.5%)0.820
   Symptomatic haemorrhoids3 (9.1%)1 (2.9%)0.288
Intended androgen deprivation therapy0.288
   LHRH plus short-term AA30 (90.9%)33 (97.1%)
   Other3 (9.1%)1 (2.9%)
Radiotherapy (mean ± SD) treatment time, w6.8 ± 0.45.8 ± 0.5< 0.001
Result by Roach formula, no. (%)0.791
   > 15%23 (69.7)25 (73.5)
   ≤ 15%10 (30.3)9 (26.5)
Elective (%) lymph node irradiation, no.025 (73.5)

[i] Data are presented as mean ± SD or median (range), categorial data are described as number (percentage).

AA = anti-androgen; AJCC = American Joint Committee on Cancer; F = fractions; LHRH = luteinising-hormone-releasing hormone; PSA = prostate-specific antigen; y = year

Table 2

Survival analysis of PC patients according to the data obtained during the last follow-up

Total (n = 67)Group-1 (n = 33)Group-2 (n = 34)p-value
Full analysis set
   BF, no. (%)16 (23.9)9 (27.3)7 (20.6)0.521
   BCDF, no. (%)26 (38.8)15 (45.5)11 (32.4)0.271
   Overall deaths, no. (%)18 (26.9)12 (36.4)6 (17.6)0.164
Deaths of PC in overall death, no. (%)5 (27.8)3 (25.0)2 (33.3)0.638
   nPC deaths, no. (%)13 (72.2)9 (75.0)4 (66.7)0.213
   PFS, %71.668.674.80.591
   BFFS, %77.674.080.30.915
   PCSS, %91.989.993.80.605
   OS, %77.071.987.50.376
Total (n = 48)Group-1 (n = 23)Group-2 (n = 25)p-value
Subgroup analysis (LNI > 15%)
   BF, no. (%)15 (31.3)9 (39.1)6 (24.0)0.259
   BCDF, no. (%)21 (43.8)12 (52.1)9 (36.0)0.259
   Overall deaths, no. (%)14 (29.2)9 (39.1)5 (20.0)0.145
   Deaths of PC in overall death, no. (%)5 (10.4)3 (13.0)2 (8.0)0.568
   nPC deaths, no. (%)9 (18.8)6 (26.1)3 (12.0)0.212
   PFS, %61.758.760.10.667
   BFFS, %62.656.457.30.643
   PCSS, %88.385.191.30.552
   OS, %72.063.670.80.433

[i] Categorial data are described as number (percentage).

BCDF = biochemical and clinical disease failure; BF = biochemical failure; BFFS = biochemical failure free survival; OS = overall survival; PC = prostate cancer; PCSS = prostate cancer specific survival; PFS = progression-free survival; nPC = non-prostate cancer

Figure 3

Kaplan-Meier curves of (A) progression-free survival (PFS), (B) biochemical failure free survival (BFFS), (C) prostate cancer specific survival (PCSS), and (D) overall survival (OS) in patients with pelvic lymph nodes involvement (LNI) risk > 15% in Group-1 who had no elective pelvic node irradiation (blue line), and in Group-2 who had an irradiation of 50.4 Gy/28 fractions (F) (green line).

Table 3

Univariate and multivariate analysis for OS, PFS

FactorUnivariate analysisMultivariate analysis
HR95% CIp-valueHR95% CIp-value
OS
   HFRT regimens0.8460.083–2.2860.3261.6810.533–5.3050.375
   Age > 80y0.6310.170–2.0210.3980.5360.161–1.7860.310
   iPSA > 20ng/ml1.1510.088–8.0150.8801.0080.992–1.0250.303
   Gleason ≥ 80.8350.177–4.6700.9080.8850.252–3.1040.849
   T > 3b1.0620.219–14.0690.5962.9410.505–17.1370.230
   High and very high risk1.3400.072–13.7420.9960.8750.196–3.9040.861
   Roach > 15%0.7870.426–9.3050.3815.5810.623–49.9690.124
   RT time > 42 d0.8830.218–6.9490.8130.267-0.605
PFS
   HFRT regimens1.8430.347–9.7940.4731.659-0.198
   Age > 80y1.2240.371–4.0350.7400.517-0.472
   iPSA > 20ng/ml0.3310.023–4.8060.4180.277-0.598
   Gleason ≥ 80.7490.140–4.0010.7350.851-0.356
   T > 3b0.1190.010–1.3630.0870.1970.065–0.5940.004
   High and very high risk2.6390.135–51.7180.5230.169-0.681
   Roach > 15%0.6600.156–2.7960.8371.075-0.300
   RT time > 42 d0.8320.144–4.8070.3240.257-0.605

[i] Data are presented as HR with 95% CI.

CI = confidence interval; cT stage = clinical T stage; GS = Gleason score; HFRT = hypofractionated radiotherapy; HR = hazard ratio; iPSA = initial (pretreatment) prostate-specific antigen; OS = overall survival; RT = radiotherapy; PFS = progression-free survival.

Table 4

Late genitourinary and gastrointestinal toxicities after a median follow-up of 7.2 years

Group-1 (n = 32)Group-2 (n = 32)p-value
GU0.127
   Grade 015 (46.9%)17 (53.1%)
   Grade 115 (46.9%)13 (40.6%)
   Grade 21 (3.1%)0
   Grade 3 or 41 (3.1%)2 (6.3%)
GI0.554
   Grade 024 (75.0%)24 (75.0%)
   Grade 15 (15.6%)3 (9.4%)
   Grade 23 (9.4%)2 (6.2%)
   Grade 3 or 40 (0%)3 (9.4%)

[i] GI = gastrointestinal; GU = genitourinary

Figure 4

Late grade ≥ 2 genitourinary and gastrointestinal toxicity-free survival in patients received hypofractionated radiation therapy (HFRT).

DOI: https://doi.org/10.2478/raon-2022-0011 | Journal eISSN: 1581-3207 | Journal ISSN: 1318-2099
Journal RSS Feed
Language: English
Page range: 216 - 227
Submitted on: Aug 2, 2021
Accepted on: Feb 11, 2022
Published on: Mar 28, 2022
Published by: Association of Radiology and Oncology
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
Keywords:
helical tomotherapy,
radiation dose hypofractionation,
progression-free survival,
follow-up studies,
prostatic neoplasms,
adenocarcinoma
Related subjects:
Medicine,
Clinical medicine,
Radiology

© 2022 Di Cui, Lei Du, Wei Yu, Boning Cai, Lingling Meng, Jun Yang, Yanrong Luo, Jing Chen, Lin Ma, published by Association of Radiology and Oncology
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Volume 56 (2022): Issue 2 (June 2022)
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