Table 1. . Patient baseline characteristics.
| Baseline characteristics | All patients | Adjuvant therapy‡ | Watch-and-wait§ | p-value¶ |
|---|---|---|---|---|
| N = 380 | N = 129 | N = 251 | ||
| Demographics | ||||
| Country of residence N, (%) | < 0.001† | |||
| – Argentina | 20 (5.3) | 0 (0.0) | 20 (8.0) | |
| – Brazil | 8 (2.1) | 7 (5.4) | 1 (0.4) | |
| – Canada | 15 (3.9) | 12 (9.3) | 3 (1.2) | |
| – France | 67 (17.6) | 17 (13.2) | 50 (19.9) | |
| – Germany | 120 (31.6) | 31 (24.0) | 89 (35.5) | |
| – Spain | 80 (21.1) | 46 (35.7) | 34 (13.5) | |
| – UK | 10 (2.6) | 1 (0.8) | 9 (3.6) | |
| – USA | 60 (15.8) | 15 (11.6) | 45 (17.9) | |
| Age at index date (years) | ||||
| – Mean ± SD [median] | 57.2 ± 14.2 [57] | 52.9 ± 11.6 [52] | 59.3 ± 14.9 [61] | < 0.001† |
| – 65 years or older, N (%) | 127 (33.4) | 22 (17.1) | 105 (41.8) | < 0.001† |
| Males, N (%) | 211 (55.5) | 73 (56.6) | 138 (55.0) | 0.849 |
| Insurance coverage at the time of stage III melanoma, N (%)# | ||||
| Public insurance plan only | 265 (69.7) | 95 (73.6) | 170 (67.7) | 0.284 |
| Private insurance plan only | 42 (11.1) | 12 (9.3) | 30 (12.0) | 0.544 |
| Mix of public/private insurance plan | 9 (2.4) | 5 (3.9) | 4 (1.6) | 0.303 |
| Unknown | 64 (16.8) | 17 (13.2) | 47 (18.7) | 0.221 |
| Employment status at the time of stage III melanoma, N (%) | ||||
| Full time | 160 (42.1) | 67 (51.9) | 93 (37.1) | 0.008† |
| Part time | 17 (4.5) | 6 (4.7) | 11 (4.4) | 1 |
| Voluntary work | 2 (0.5) | 1 (0.8) | 1 (0.4) | 1 |
| Sick leave | 5 (1.3) | 3 (2.3) | 2 (0.8) | 0.445 |
| Unemployed | 23 (6.1) | 10 (7.8) | 13 (5.2) | 0.442 |
| Early retirement | 2 (0.5) | 1 (0.8) | 1 (0.4) | 1 |
| Normal retirement | 99 (26.1) | 16 (12.4) | 83 (33.1) | < 0.001† |
| Other (e.g., disabled, student) | 7 (1.8) | 2 (1.6) | 5 (2.0) | 1 |
| Unknown | 65 (17.1) | 23 (17.8) | 42 (16.7) | 0.901 |
| Comorbidity | ||||
| CCI | ||||
| – Mean ± SD [median] | 2.3 ± 0.8 [2] | 2.2 ± 0.6 [2] | 2.4 ± 0.9 [2] | 0.002† |
| – CCI ≤2, N (%) | 292 (76.8) | 112 (86.8) | 180 (71.7) | 0.001† |
| Tumor stage at initial diagnosis, N (%) | ||||
| Stage I | 64 (16.8) | 11 (8.5) | 53 (21.1) | < 0.001† |
| Stage II | 146 (38.4) | 54 (41.9) | 92 (36.7) | |
| Stage III | 145 (38.2) | 61 (47.3) | 84 (33.5) | |
| Unknown | 25 (6.6) | 3 (2.3) | 22 (8.8) | |
| Stage III characteristics | ||||
| Substage at stage III diagnosis, N (%) | 0.157 | |||
| – Stage IIIA | 146 (38.4) | 55 (42.6) | 91 (36.3) | |
| – Stage IIIB | 168 (44.2) | 58 (45.0) | 110 (43.8) | |
| – Stage IIIC | 66 (17.4) | 16 (12.4) | 50 (19.9) | |
| Lymph node involvement, N (%) | 0.070 | |||
| –Yes | 377 (99.2) | 126 (97.7) | 251 (100.0) | |
| – No | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| –Unknown | 3 (0.8) | 3 (2.3) | 0 (0.0) | |
| Tumor ulceration or mitoses ≥1/mm2, N (%) | 0.274 | |||
| – Absent | 207 (54.5) | 63 (48.8) | 144 (57.4) | |
| – Present | 145 (38.2) | 56 (43.4) | 89 (35.5) | |
| – Unknown | 28 (7.4) | 10 (7.8) | 18 (7.2) | |
| Tumor thickness, N (%) | 0.153 | |||
| – ≤1 mm | 39 (10.3) | 10 (7.8) | 29 (11.6) | |
| – 1.01–2.0 mm | 95 (25.0) | 39 (30.2) | 56 (22.3) | |
| – 2.01–4.0 mm | 106 (27.9) | 28 (21.7) | 78 (31.1) | |
| – >4.0 mm | 112 (29.5) | 42 (32.6) | 70 (27.9) | |
| – Unknown | 28 (7.4) | 10 (7.8) | 18 (7.2) | |
| Primary location of melanoma, N (%) | 0.154 | |||
| – Legs | 132 (34.7) | 45 (34.9) | 87 (34.7) | |
| – Back | 81 (21.3) | 37 (28.7) | 44 (17.5) | |
| – Trunk | 69 (18.2) | 22 (17.1) | 47 (18.7) | |
| – Arms | 54 (14.2) | 16 (12.4) | 38 (15.1) | |
| – Head | 28 (7.4) | 5 (3.9) | 23 (9.2) | |
| – Other | 12 (3.2) | 3 (2.3) | 9 (3.6) | |
| – Unknown | 4 (1.1) | 1 (0.8) | 3 (1.2) | |
| Stage III surgery characteristics | ||||
| Days from stage III diagnosis to surgery, mean ± SD [median] | 30.7 ± 89.7 [8] | 28.4 ± 56.2 [10] | 31.9 ± 102.8 [7] | 0.856 |
| Year of surgery, N (%) | < 0.001† | |||
| – 2011 | 73 (19.2) | 19 (14.7) | 54 (21.5) | |
| – 2012 | 65 (17.1) | 31 (24.0) | 34 (13.5) | |
| – 2013 | 72 (18.9) | 39 (30.2) | 33 (13.1) | |
| – 2014 | 101 (26.6) | 25 (19.4) | 76 (30.3) | |
| – 2015 | 64 (16.8) | 15 (11.6) | 49 (19.5) | |
| – 2016 | 5 (1.3) | 0 (0.0) | 5 (2.0) | |
| BRAF mutation test | ||||
| Tested for BRAF mutation, N (%) | 0.492 | |||
| – Yes | 245 (64.5) | 80 (62.0) | 165 (65.7) | |
| – No | 125 (32.9) | 44 (34.1) | 81 (32.3) | |
| – Unknown | 10 (2.6) | 5 (3.9) | 5 (2.0) | |
| Timing of first BRAF test, N (% tested) | ||||
| – Before relapse | 182 (74.3) | 67 (83.8) | 115 (69.7) | 0.028† |
| – At/after relapse†† | 63 (25.7) | 13 (16.3) | 50 (30.3) | |
| – Mutation identified, N (% tested) | 136 (55.5) | 47 (58.8) | 89 (53.9) | 0.566 |
| Type of mutation, N (% with BRAF) | 0.302 | |||
| – V600E only | 108 (79.4) | 34 (72.3) | 74 (83.1) | |
| – V600K only | 9 (6.6) | 3 (6.4) | 6 (6.7) | |
| – V600R only | 1 (0.7) | 0 (0.0) | 1 (1.1) | |
| – V600K and V600E | 7 (5.1) | 5 (10.6) | 2 (2.2) | |
| – V600, not specified | 3 (2.2) | 1 (2.1) | 2 (2.2) | |
| – Unknown | 8 (5.9) | 4 (8.5) | 4 (4.5) | |
Statistical significance at the 5% level.
The adjuvant therapy cohort was defined as patients who received systemic therapy following initial surgery for stage III (but prior to relapse).
The watch-and-wait cohort was defined as patients who did not receive any systemic therapy following initial surgery for stage III (i.e., watch-and-wait/observation) (prior to relapse).
Statistical comparisons between the adjuvant therapy and watch-and-wait cohorts were performed using Wilcoxon rank-sum tests for continuous variables and Chi-square tests for categorical variables.
Other type of plan and no insurance plan categories for insurance coverage at the time of stage III melanoma are not shown, as no patient in the study sample was included in either of these categories.
During the follow up period, a relapse (loco-regional, unresectable/metastatic, or secondary primary melanoma) was observed for 168 patients (43 in adjuvant therapy cohort and 125 in watch-and-wait cohort).
CCI: Charlson Comorbidity Index; N: Sample size; SD: Standard deviation.