Table 3.
Adjuvant setting.
| Author | Period | Study | Tumor Stage (No of Patients) |
Median Age, Years | DFS | LRC | OS | Toxicity (G > 2) |
Median FU, Months | Main Results |
|---|---|---|---|---|---|---|---|---|---|---|
| Logar [30] | 1997–2004 | Mo. | Stage II: 4 Stage III: 33 Stage IVa: 11 n.a.: 3 |
74.4 | 10-y: 34.5% | 10-y: 41.1% | 10-y: 22.7% | n.a. | 22.5 (2–203) | Factors that contribute to lower outcome in stage I and II were higher age (mean age 79.9 ± 6.5, p = 0.04). ECE had a negative impact on LC (p = 0.02). If N+, LC decreased by 60% (p = 0.03), and OS as well as DFS decreased by 50% (p = 0.2). There was a trend to a better LC with doses > 54.0 Gy (p = 0.05). |
| Kunos [31] | 2009 | Mo. Randomized |
Adjuvant RT III–IV: 59 No Adjuvant RT III–IV: 55 |
70 (23–89) | n.a. | Adjuvant RT 6y: 59% No Adjuvant RT III–IV: 48% |
Adjuvant RT 6y: 36% No Adjuvant RT III–IV: 13% |
74 | At 6 years, the cumulative incidence of cancer-related death was 29% for RT compared with 51% for pelvic node resection (hazard ratio 0.49, 95% CI 0.28–0.87, p = 0.015) Significant univariable association between greater than 20% positive ipsilateral groin nodes and the number of contralateral lymph node metastases (p = 0.02), pelvic node metastasis (p = 0.06), recurrence (p = 0.03), cancer-related deaths (p = 0.02), and all-cause deaths (p = 0.01) |
|
| Tagliaferri [8] | 2013–2017 | Mo. | Stage II: 2 Stage III: 24 |
70 (18–87) | 2-y: 82% 3-y: 72.4% |
2-y: 88.6% 3-y: 79.3% |
2-y: 91% 3-y: 91% |
14.2% | 32 (6–72) | Loco-regional and systemic disease control are favorable, not only in node-negative patients, but also in node-positive patients |
| Gill [32] | 1998–2011 | Mu. | Stage III–IV 1797 | 69 (21–90) | n.a. | n.a. | CT 3-y: 46.9% No CT 3-y: 53.9% |
28.3 (11.6–70.6) | Older patients (age > 75 years: HR 4.32, 95% CI 2.94–6.33, p < 0.001), patients with greater Charlson–Deyo comorbidity scores (≥2: HR 1.58, 95% CI 1.06-2.35, p = 0.026), and higher lymph node involvement (≥4 lymph nodes involved: HR 2.84, 95% CI 2.20–3.67, p < 0.001) had a greater risk of death Delivery of adjuvant CT resulted in a 38% reduction in the risk of death (HR 0.62, 95% CI 0.48–0.79, p < 0.001) |
|
| Mahner [33] | 1998–2008 | Mu. | Adjuvant RT III–IV: 244 No Adjuvant RT III–IV: 169 |
67 (30–87) | Adjuvant RT 3-y: 39.6% No Adjuvant RT 3-y: 39.6% p = 0.004 |
n.a. | Adjuvant RT 3-y: 57.1% No Adjuvant RT 3-y: 51.4% p = 0.17 |
n.a. | 39.4 (11.8–71.4) | DFS and OS reduction in pts with increasing numbers of N+ (p < 0.001). 3-year DFS in N+ receiving adjuvant RT was statistically significantly better compared with N+ patients without adjuvant RT (39.6% vs. 25.9%, p = 0.004). 3-year OS rate was statistically not significant (57.7% vs. 51.4%, p = 0.17). Adjuvant RT was a statistically significant predictor for cancer-related DFS and OS (adjuvant RT vs. none DFS: p = 0.001; OS: p = 0.04) |
| Laliscia [34] | 1999–2016 | Mo. | IB–II: 17 III–IV: 34 |
71 (38–86) | 5-y: 52% | n.a. | 5-y: 63% | n.a. | 31 (3–204) | Age < 76 year and RT total dose >54 Gy were significantly associated with better DFS (p = 0.0444 and 0.012, respectively) and OS (p = 0.015 and 0.015, respectively) |
| Rydzewski [15] | 2004–2014 | Mu. | Adjuvant RT III–IV: 974 Adjuvant RCT III–IV: 744 No Adjuvant RT III–IV: 1061 |
n.a. | n.a. | n.a. | Adjuvant RT 5-y: 29.4–55.9% Adjuvant RCT 5-y: 49.1–68.1% No Adjuvant RT 5-y: 21.2–46.1% p < 0.001 |
n.a. | n.a. | More nodes examined, higher T stage, older age, and more co-morbidities were also associated with worse OS. OS was highest for the RCT group for both patients with one N+ and those with two or more N+. Significantly decreased mortality for patients with 1 N+ who received EBRT (p = 0.001), patients with 2 or more N+ receiving EBRT (p < 0.001), patients with 1 N+ receiving RCT (p = 0.004), and patients with 2 or more N+ receiving RCT (p < 0.001). |
| Parthasarathy [11] | 1998–2001 | Mu. | Adjuvant RT III–IV: 102 No Adjuvant RT III–IV: 106 |
65 (29–87) 71 (31–100) |
Adjuvant RT 5-y: 77% No Adjuvant RT 5-y: 61.2% p = 0.02 |
n.a. | n.a. | n.a. | n.a. | RT improved the OS of those patients who had a less extensive lymphadenectomy (≤12 lymph nodes removed) from 55.1% to 76.6% (p = 0.035). Younger age (p = 0.008) is a significant independent prognostic factor after controlling for factors such as year of diagnosis, percent positive nodes, grade of disease, and use of adjuvant RT. |
Abbreviation. RCT: radio-chemotherapy; DFS: disease free survival; EBRT: external beam radiotherapy; ECE: extracapsular extension; G: grade; LC: local control; Mo: monocentric; mu: multicentric; N+: positive nodes; na: not available; RT: radiotherapy; OS: overall survival; y: years; FU: follow-up.