Ординатура / Офтальмология / Английские материалы / Ocular Oncology_Albert, Polans_2003
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Clinical Trials in Uveal Melanoma |
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389 |
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Table 4 Continued |
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Standard |
Pre-enucleation |
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enucleation |
radiation |
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Tumor characteristic |
(N ¼ 506) |
(N ¼ 497) |
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Post to equator |
60 |
(12) |
65 |
(14) |
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Indeterminate, not reported |
6 |
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17 |
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Peaked |
12 |
(2) |
10 |
(2) |
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Flat |
4 |
(1) |
5 |
(1) |
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Other |
2 |
(<1) |
2 |
(<1) |
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Indeterminate |
3 |
(1) |
3 |
(1) |
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Internal reflectivity |
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Very low |
22 |
(4) |
17 |
(3) |
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Low |
193 |
(38) |
189 |
(38) |
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Low–medium |
172 |
(34) |
167 |
(34) |
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Medium |
55 |
(11) |
55 |
(11) |
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Medium–high |
10 |
(2) |
18 |
(4) |
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High or very high |
3 |
(1) |
2 (<1) |
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Irregular |
34 |
(7) |
36 |
(7) |
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Indeterminate |
17 |
(3) |
13 |
(3) |
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Source: Ref. 17.
choroidal melanoma to determine best treatment practices [2]. Utilizing this study infrastructure, overall study compliance was excellent, with compliance rates in excess of 90% in each of the study arms including patient eligibility, treatment application including external-beam radiotherapy, iodine-125 brachytherapy and enucleation, confirmation of tumor pathology, standardization of echography and photography, documentation of follow-up, and confirmation of vital status (Tables 12 and 13). This quality assurance, over a 17-year study interval, is a testament to the study design and the focus of the study participants.
Table 5 Histopathological Assessment of Metastatic Status: Large Choroidal Melanoma Treatment Trial
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Standard |
Pre-enucleation |
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enucleation |
radiation |
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Status at death |
(N ¼ 238) |
(N ¼ 219) |
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Melanoma metastasis |
130 |
(57) |
139 |
(67) |
Malignant tumor present, primary uncertain |
51 |
(22) |
41 |
(20) |
Malignant tumor present, not metastatic melanoma |
18 |
(8) |
4 |
(2) |
No evidence of malignancy |
21 |
(9) |
17 |
(8) |
Insufficient evidence to establish presence of malignancy |
8 |
(4) |
6 |
(3) |
Not yet assessed |
10 |
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12 |
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Source: Ref. 17.
390 |
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Murray et al. |
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Table 6 Baseline Visual Acuity: Large Choroidal Melanoma Treatment Trial |
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No. (%) of patients |
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Eligible patients |
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Ineligible |
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Enrolled |
Not enrolled |
Total eligible |
patients |
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Visual acuity |
(n ¼ 1317) |
(n ¼ 2882) |
(n ¼ 2882) |
(n ¼ 2164) |
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Eye with choroidal melanoma |
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20/20 or better |
413 |
(32) |
592 |
(38) |
1005 |
(35) |
368 |
(17) |
20/25 to 20/32 |
343 |
(26) |
409 |
(26) |
752 |
(26) |
487 |
(23) |
20/40 to 20/50 |
236 |
(18) |
228 |
(15) |
464 |
(16) |
360 |
(17) |
20/63 to 20/80 |
92 |
(7) |
130 |
(8) |
222 |
(8) |
254 |
(12) |
20/100 to 20/125 |
62 |
(5) |
44 |
(3) |
106 |
(4) |
104 |
(5) |
20/160 to 20/200 |
50 |
(4) |
61 |
(4) |
111 |
(4) |
161 |
(8) |
Worse than 20/200 |
110 |
(8) |
85 |
(6) |
195 |
(7) |
376 |
(18) |
Not reported |
11 |
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16 |
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27 |
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54 |
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Median |
20/32 |
20/25 |
20/32 |
20/50 |
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Fellow eye |
917 |
(70) |
1000 |
(64) |
1917 |
(67) |
999 |
(47) |
20/20 or better |
294 |
(22) |
403 |
(26) |
697 |
(24) |
645 |
(30) |
20/25 to 20/32 |
77 |
(6) |
104 |
(7) |
181 |
(6) |
233 |
(11) |
20/40 to 20/50 |
14 |
(1) |
32 |
(2) |
46 |
(2) |
83 |
(4) |
20/63 to 20/80 |
6 |
(<1) |
7 |
(<1) |
13 |
(<1) |
13 |
(1) |
20/100 to 20/125 |
3 |
(<1) |
5 |
(<1) |
8 |
(<1) |
41 |
(2) |
20/160 to 20/200 |
. . . a |
. . . |
. . . |
110 |
(5) |
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Worse than 20/200 |
6 |
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14 |
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20 |
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40 |
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Not reported |
520/20 |
520/20 |
520/20 |
20/25 |
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Median |
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a Ellipses indicate ‘‘not applicable.’’ Source: Ref. 14.
Single-institution clinical trials also play a role in our understanding of treatment benefits for patients with choroidal melanoma. Char and colleagues evaluated, in a prospective, randomized clinical trial, the application of helium ion charged-particle radiotherapy compared with iodine-125 brachytherapy [24]. This trial enrolled patients with medium choroidal/ciliary body melanoma and evaluated melanoma-specific mortality, local tumor recurrence, rates of enucleation, and treatment-related complications. Eighty-six patients were treated with helium ion charged-particle radiotherapy applied to a target 70 GyE to the tumor apex, with a 2-mm treatment margin, while 98 patients received iodine-125 brachytherapy applied to a target dose of 85 Gy to the tumor apex, with an initial treatment margin of 1 mm (later expanded to 2 mm after documentation of high local tumor failure rates). Char and colleagues reported high local tumor failure rates for iodine-125 brachytherapy with an event rate of 13.3% and an enucleation rate of 17.3% (mean follow-up 48 months) compared with helium ion charged particle radiotherapy with a local tumor failure rate of 0% and an enucleation rate of 9.3%. Metastatic ocular melanoma was noted in 8.2% of iodine-125 brachytherapy treated patients and in 9.3% of helium
Clinical Trials in Uveal Melanoma |
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391 |
Table 7 Echographic Baseline Characteristics: Medium Choroidal Melanoma Treatment |
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Trial |
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No. (%) of eligible patients |
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Enrolled |
Not enrolled |
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Characteristic |
(n ¼ 1317) |
(n ¼ 1565) |
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Tumor shape/configuration |
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Dome |
1014 |
(77) |
327 |
(77) |
Collar button |
207 |
(16) |
55 |
(13) |
Lobulated or irregular |
61 |
(5) |
29 |
(7) |
Peaked |
31 |
(2) |
9 |
(2) |
Flat |
3 |
(<1) |
2 |
(<1) |
Other |
1 |
(<1) |
0 |
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Not availablea |
. . . b |
1143 |
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Internal reflectivity |
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Very low |
75 |
(6) |
8 |
(10) |
Low |
503 |
(39) |
49 |
(59) |
Low–medium |
523 |
(40) |
17 |
(2) |
Medium |
85 |
(7) |
7 |
(8) |
Medium–high, high, or very high |
37 |
(3) |
2 |
(<1) |
Irregular |
75 |
(6) |
0 |
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Indeterminate |
19 |
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. . . |
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Not available |
. . . |
1482 |
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a Not assessed after November 1989 for patients who did not enroll. b Ellipses indicate ‘‘not applicable.’’
Source: Ref. 14.
ion treated patients. Melanoma related mortality was 8% in both treatment arms. Helium ion charged-particle radiotherapy was associated with lower tumor recurrence rates and lower enucleation rates than iodine-125 brachytherapy. Rates of local tumor recurrence and enucleation were significantly higher than reported within the COMS Medium Choroidal Melanoma Trial.
Gragoudas and colleagues evaluated, in a prospective randomized clinical trial, the application of proton-beam charged-particle radiotherapy at two different radiation doses to determine the effect on melanoma-specific mortality, local tumor control, visual acuity and visual field conservation, and treatment related complications [25]. A total of 188 patients were randomized to receive protonbeam radiotherapy at a targeted treatment dose of either 70 or 50 GyE to the tumor apex, with a treatment margin of 2 mm or greater. No difference in outcomes was noted for either treatment group with the exception of less loss of visual field noted for the lower-dose treatment arm. Melanoma metastatic disease was noted in 8% of treated patients, tumor recurrence was noted in 3% of treated eyes, while 55% of patients retained visual acuity of at least, 20/200. This single-institution clinical trial documented minimal benefit (and no significant risk) to a reduction in treatment dose to 50 GyE to the tumor apex for charged-particle radiotherapy for posterior uveal melanoma.
392 |
Murray et al. |
Table 8 Demographics of Ineligible, Eligible, Enrolled Eligible, and Not Enrolled but Eligible Patients (Evaluation of Internal and External Study Validity): Large Choroidal Melanoma Treatment Trial
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No. (%) of patients |
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Eligible patients |
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Ineligible |
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Enrolled |
Not enrolled |
Total eligible |
patients |
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Characteristic |
(n ¼ 1003) |
(n ¼ 299) |
(n ¼ 1302) |
(n ¼ 558) |
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Age (years) |
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<40 |
90 |
(9) |
31 |
(11) |
121 |
(9) |
30 |
(5) |
40–49 |
135 |
(13) |
46 |
(16) |
181 |
(14) |
46 |
(8) |
50–59 |
210 |
(21) |
54 |
(18) |
264 |
(20) |
75 |
(13) |
60–69 |
286 |
(29) |
63 |
(21) |
349 |
(27) |
147 |
(26) |
70–79 |
228 |
(23) |
68 |
(23) |
296 |
(23) |
161 |
(29) |
580 |
54 |
(5) |
33 |
(11) |
87 |
(7) |
99 |
(18) |
Not reported |
0 |
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4 |
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4 |
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0 |
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Mean age (years) |
60.1 |
60.5 |
60.2 |
66.1 |
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Sex |
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Male |
576 |
(57) |
155 |
(53) |
731 |
(56) |
275 |
(49) |
Female |
427 |
(43) |
140 |
(47) |
567 |
(44) |
283 |
(51) |
Not reported |
0 |
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4 |
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4 |
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0 |
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Race/ethnicity |
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White, not Hispanic |
970 |
(97) |
288 |
(98) |
1258 |
(97) |
540 |
(97) |
Hispanic |
24 |
(2) |
2 |
(1) |
26 |
(2) |
8 |
(1) |
Black, not Hispanic |
5 |
(<1) |
4 |
(1) |
9 |
(1) |
8 |
(1) |
Asian or Pacific Islander |
2 |
(<1) |
1 |
(<1) |
3 |
(<1) |
2 |
(<1) |
American Indian or Eskimo |
2 |
(<1) |
0 |
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2 |
(<1) |
0 |
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Not reported |
0 |
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4 |
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4 |
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0 |
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Source: Ref. 16.
Clinical trials data approximate the ‘‘gold standard’’ for determination of treatment benefits particularly when the study design incorporates a clinically important question, standardizes inclusion and exclusion criteria, and maintains excellent study compliance, allowing for extrapolation of the study data to patients outside of the study. Clinical trials using this classic design tend to be expensive endeavors and require widespread participation of the medical community and eligible patients [26,27]. The Collaborative Ocular Melanoma Study has definitively answered the question of pre-enucleation radiotherapy as an unnecessary adjunctive treatment to primary enucleation alone in the management of large choroidal melanoma, has definitively answered the question of safety and efficacy of iodine-125 brachytherapy in the treatment of medium choroidal melanoma, and has noted no difference in mortality between this globe-conserving therapy and primary enucleation. Of significant import is the development of a national infrastructure that established standards of excellence within participating clinical centers of the
Clinical Trials in Uveal Melanoma |
393 |
COMS for patients with choroidal melanoma, further broadening access of care for patients with this life-threatening ocular malignancy [28]. Further application of clinical trials methodology would play a significant role in evaluating evolving technologies in the management of posterior uveal melanoma, particularly treatment advances focused at enhanced globe conservation coupled with improved functional preservation of vision. Additionally, the COMS has defined a framework for a future clinical trial to evaluate the timing and treatment outcomes for patients with small choroidal melanoma.
Table 9 Tumor Characteristics for Ineligible, Eligible, Enrolled Eligible, and Not Enrolled but Eligible Patients: Large Choroidal Melanoma Treatment Trial
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No. (%) of patients |
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Eligible patients |
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Ineligible |
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Enrolled |
Not enrolled |
Total eligible |
patients |
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Characteristic |
(n ¼ 1003) |
(n ¼ 299) |
(n ¼ 1302) |
(n ¼ 558) |
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Time since initial diagnosis (days) |
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430 |
864 |
(86) |
244 |
(82) |
1108 |
(85) |
431 |
(77) |
31–180 |
106 |
(11) |
40 |
(13) |
146 |
(11) |
63 |
(11) |
181–365 |
8 |
(1) |
4 |
(1) |
12 |
(1) |
16 |
(3) |
>365 |
25 |
(2) |
9 |
(3) |
34 |
(3) |
48 |
(9) |
Not reported |
0 |
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2 |
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2 |
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0 |
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Median days |
7 |
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7 |
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7 |
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7 |
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Laterality |
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Right eye |
507 |
(51) |
148 |
(49) |
655 |
(50) |
275 |
(49) |
Left eye |
496 |
(49) |
151 |
(51) |
647 |
(50) |
283 |
(51) |
Apical height (mm) |
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45.0 |
90 |
(9) |
22 |
(7) |
112 |
(9) |
48 |
(9) |
5.1–7.0 |
109 |
(11) |
26 |
(9) |
135 |
(10) |
46 |
(8) |
7.1–9.0 |
230 |
(23) |
64 |
(21) |
294 |
(23) |
103 |
(19) |
9.1–11.0 |
281 |
(28) |
100 |
(33) |
381 |
(29) |
153 |
(28) |
11.1–13.0 |
191 |
(19) |
65 |
(22) |
256 |
(20) |
115 |
(21) |
13.1–15.0 |
73 |
(7) |
18 |
(6) |
91 |
(7) |
61 |
(11) |
>15.0 |
28 |
(3) |
4 |
(1) |
32 |
(2) |
30 |
(5) |
Not reported |
1 |
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0 |
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1 |
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2 |
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Mean (mm) |
9.5 |
9.6 |
9.5 |
10.1 |
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Longest basal diameter (mm) |
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<13.0 |
78 |
(8) |
34 |
(12) |
112 |
(9) |
49 |
(9) |
13.0–14.9 |
82 |
(8) |
37 |
(13) |
119 |
(9) |
38 |
(7) |
15.0–16.9 |
215 |
(22) |
66 |
(23) |
281 |
(22) |
89 |
(17) |
17.0–18.9 |
334 |
(34) |
84 |
(29) |
418 |
(32) |
166 |
(31) |
19.0–20.9 |
183 |
(18) |
52 |
(18) |
235 |
(18) |
119 |
(22) |
21.0–22.9 |
73 |
(7) |
14 |
(5) |
87 |
(7) |
41 |
(8) |
523.0 |
30 |
(3) |
6 |
(2) |
36 |
(3) |
29 |
(5) |
Indeterminate, not reported |
8 |
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6 |
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14 |
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27 |
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Mean (mm) |
17.3 |
16.7 |
17.2 |
17.6 |
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Location of posterior tumor border |
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Posterior to equator |
885 |
(89) |
281 |
(95) |
1166 |
(90) |
389 |
(79) |
Between ora serrata and equator |
31 |
(3) |
8 |
(3) |
39 |
(3) |
64 |
(13) |
Ciliary body |
0 |
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0 |
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0 |
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8 |
(2) |
394 |
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Murray et al. |
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Table 9 Continued |
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No. (%) of patients |
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Eligible patients |
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Ineligible |
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Enrolled |
Not enrolled |
Total eligible |
patients |
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Characteristic |
(n ¼ 1003) |
(n ¼ 299) |
(n ¼ 1302) |
(n ¼ 558) |
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Indeterminate |
79 |
(8) |
7 |
(2) |
86 |
(7) |
32 |
(6) |
Not reported, not requested |
8 |
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3 |
|
11 |
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65a |
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Location of anterior tumor border |
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Posterior to equator |
125 |
(12) |
30 |
(10) |
155 |
(12) |
41 |
(8) |
Between ora serrata and equator |
357 |
(36) |
121 |
(41) |
478 |
(37) |
129 |
(26) |
Pars plana |
211 |
(21) |
70 |
(23) |
281 |
(22) |
60 |
(12) |
Pars plicata |
230 |
(23) |
64 |
(21) |
294 |
(23) |
128 |
(26) |
Anterior chamber angle |
57 |
(6) |
8 |
(3) |
65 |
(5) |
42 |
(9) |
Iris |
0 |
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0 |
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0 |
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70 |
(14) |
Indeterminate |
21 |
(2) |
5 |
(2) |
26 |
(2) |
22 |
(4) |
Not reported, not requested |
2 |
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1 |
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3 |
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66a |
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aData requested for patients in this category only until March 1994. Source: Ref. 16.
Table 10 Baseline Echographic Characteristics: Large Choroidal Melanoma Treatment
Trial
No. (%) of eligible patients
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Enrolled |
Not enrolled |
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Characteristic |
(n ¼ 1003) |
(n ¼ 299) |
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Tumor shape/configuration |
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Collar button |
426 |
(43) |
61 |
(47) |
Dome |
383 |
(38) |
47 |
(36) |
Lobulated or irregular |
153 |
(15) |
20 |
(15) |
Peaked |
22 |
(2) |
2 |
(2) |
Flat |
9 |
(1) |
0 |
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Other |
4 (<1) |
0 |
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Indeterminate, not reported |
6 |
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169a |
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Internal reflectivity |
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Very low |
39 |
(4) |
20b |
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Low |
382 |
(39) |
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Low–medium |
339 |
(35) |
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Medium |
110 |
(11) |
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Medium–high |
28 |
(3) |
4c |
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High |
4 (<1) |
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Very high |
1 (<1) |
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Irregular |
70 |
(7) |
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Indeterminate, not assessed |
30 |
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275 |
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a Not classified after November 1989 for patients not enrolled. b Total of very low, low, low–medium, and medium.
c Total of medium-high, high, very high, and irregular. Source: Ref. 16.
Clinical Trials in Uveal Melanoma |
395 |
Table 11 Baseline Visual Acuity: Large Choroidal Melanoma Treatment Trial
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No. (%) of patients |
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Eligible patients |
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Ineligible |
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Enrolled |
Not enrolled |
Total eligible |
patients |
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Visual Acuity |
(n ¼ 1003) |
(n ¼ 299) |
(n ¼ 1302) |
(n ¼ 558) |
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Eye with choroidal melanoma |
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20/20 or better |
123 |
(12) |
39 |
(16) |
162 |
(13) |
30 |
(6) |
20/25–20/32 |
136 |
(14) |
49 |
(20) |
185 |
(15) |
74 |
(16) |
20/40–20/50 |
149 |
(15) |
31 |
(12) |
180 |
(14) |
55 |
(12) |
20/63–20/80 |
116 |
(12) |
27 |
(11) |
143 |
(12) |
55 |
(12) |
20/100–20/125 |
86 |
(9) |
18 |
(7) |
104 |
(8) |
20 |
(4) |
20/160–20/200 |
58 |
(6) |
15 |
(6) |
73 |
(6) |
31 |
(7) |
Worse than 20/200 |
324 |
(33) |
71 |
(28) |
395 |
(32) |
204 |
(43) |
Not reported |
11 |
|
49 |
|
60 |
|
89 |
|
Median visual acuity |
20/80 |
20/63 |
20/80 |
20/160 |
||||
Fellow Eye |
|
|
|
|
|
|
|
|
20/20 or better |
690 |
(69) |
146 |
(49) |
836 |
(66) |
218 |
(44) |
20/25–20/32 |
229 |
(23) |
71 |
(29) |
300 |
(23) |
148 |
(30) |
20/40–20/50 |
47 |
(5) |
17 |
(6) |
64 |
(5) |
62 |
(13) |
20/63–20/80 |
15 |
(1) |
10 |
(3) |
25 |
(2) |
34 |
(7) |
20/100–20/125 |
5 (<1) |
4 |
(1) |
9 |
(1) |
4 |
(1) |
|
20/160–20/200 |
4 (<1) |
1 (<1) |
5 (<1) |
11 |
(2) |
|||
Worse than 20/200 |
8 |
(1) |
3 |
(1) |
11 |
(1) |
17 |
(3) |
Not reported |
5 |
|
47 |
|
52 |
|
64 |
|
Median visual acuity |
520/20 |
520/20 |
520/20 |
20/25 |
||||
Source: Ref. 16.
396 |
|
|
|
|
|
|
Murray et al. |
|
Table 12 Patient Baseline Demographics Medium Choroidal Melanoma Treatment Trial |
||||||||
|
|
|
|
|
|
|||
|
|
|
No. % of patients |
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
Eligible patients |
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|
Not |
Total |
Ineligible |
|||
|
Enrolled |
enrolled |
eligible |
patients |
||||
Characteristic |
(n ¼ 1317) |
(n ¼ 1565) |
(n ¼ 2882) |
(n ¼ 2164) |
||||
Age (year) |
|
|
|
|
|
|
|
|
<40 |
125 |
(9) |
176 |
(11) |
301 |
(10) |
162 |
(7) |
40–49 |
178 |
(14) |
262 |
(17) |
440 |
(15) |
236 |
(11) |
50–59 |
268 |
(20) |
328 |
(21) |
596 |
(21) |
346 |
(16) |
60–69 |
408 |
(31) |
382 |
(24) |
790 |
(27) |
526 |
(24) |
70–79 |
282 |
(21) |
320 |
(20) |
602 |
(21) |
622 |
(29) |
580 |
56 |
(4) |
91 |
(6) |
147 |
(5) |
271 |
(13) |
Not reported |
0 |
|
6 |
|
6 |
|
1 |
|
Mean age (years) |
60 |
|
59 |
|
59 |
|
64 |
|
Sex |
|
|
|
|
|
|
|
|
Men |
665 |
(50) |
813 |
(52) |
1478 |
(51) |
1056 |
(49) |
Women |
652 |
(50) |
746 |
(48) |
1398 |
(49) |
1107 |
(51) |
Not reported |
0 |
|
6 |
|
6 |
|
1 |
|
Race/ethnicity |
|
|
|
|
|
|
|
|
White, not Hispanic |
1289 |
(98) |
1534 |
(98) |
2823 |
(98) |
2117 |
(98) |
Hispanic |
14 |
(1) |
14 |
(1) |
28 |
(1) |
29 |
(1) |
Black, not Hispanic |
8 |
(1) |
7 (<1) |
15 |
(1) |
13 |
(1) |
|
Asian or Pacific Islander |
5 (<1) |
4 (<1) |
9 (<1) |
3 (<1) |
||||
Native American |
1 (<1) |
0 |
|
1 (<1) |
1 (<1) |
|||
Not reported |
0 |
|
6 |
|
6 |
|
1 |
|
|
|
|
|
|
|
|
|
|
Source: Ref. 14.
Clinical Trials in Uveal Melanoma |
|
|
|
|
|
397 |
||
Table 13 Tumor Baseline Characteristics: Medium Choroidal Melanoma Treatment Trial |
||||||||
|
|
|
|
|
|
|||
|
|
|
No. (%) of patients |
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
Eligible patients |
|
|
|
|
|
|
|
|
|
|
|
|
Ineligible |
|
|
|
|
|
|
|
|
||
|
Enrolled |
Not enrolled |
Total eligible |
patients |
||||
Characteristic |
(n ¼ 1317) |
(n ¼ 1565) |
(n ¼ 2882) |
(n ¼ 2164) |
||||
Time since initial diagnosis, days |
|
|
|
|
|
|
|
|
430 |
944 |
(72) |
1190 |
(76) |
2134 |
(74) |
1572 |
(73) |
31–180 |
188 |
(14) |
170 |
(11) |
358 |
(12) |
254 |
(12) |
181–365 |
67 |
(5) |
56 |
(4) |
123 |
(4) |
78 |
(4) |
>365 |
117 |
(9) |
148 |
(9) |
265 |
(9) |
246 |
(11) |
Not reported |
1 |
|
1 |
|
2 |
|
13 |
|
Median time, days |
9 |
|
8 |
|
8 |
|
7 |
|
Laterality |
|
|
|
|
|
|
|
|
Right eye |
663 |
(50) |
821 |
(52) |
1484 |
(51) |
1075 |
(50) |
Left eye |
654 |
(50) |
744 |
(48) |
1398 |
(49) |
1084 |
(50) |
Both eyes |
. . . a |
. . . |
. . . |
5 (<1) |
||||
Apical height, mm |
|
|
|
|
|
|
|
|
2.5–3.0 |
162 |
(12) |
297 |
(19) |
459 |
(16) |
294 |
(14) |
3.1–4.0 |
430 |
(33) |
472 |
(30) |
902 |
(31) |
613 |
(28) |
4.1–5.0 |
243 |
(18) |
268 |
(17) |
511 |
(18) |
372 |
(17) |
5.1–6.0 |
154 |
(12) |
199 |
(13) |
353 |
(12) |
288 |
(13) |
6.1–7.0 |
139 |
(11) |
138 |
(9) |
277 |
(10) |
233 |
(11) |
7.1–8.0 |
114 |
(9) |
104 |
(7) |
218 |
(8) |
192 |
(9) |
8.1–10.0 |
75 |
(6) |
87 |
(6) |
162 |
(6) |
171 |
(8) |
Not reported |
. . . |
. . . |
. . . |
1 |
|
|||
Mean height, mm |
4.8 |
4.7 |
4.7 |
5.0 |
||||
Longest basal diameter, mm |
|
|
|
|
|
|
|
|
48.0 |
185 |
(14) |
252 |
(16) |
437 |
(15) |
378 |
(18) |
8.1–10.0 |
275 |
(21) |
378 |
(24) |
653 |
(23) |
797 |
(23) |
10.1–12.0 |
371 |
(28) |
426 |
(27) |
797 |
(28) |
539 |
(25) |
12.1–14.0 |
276 |
(21) |
302 |
(19) |
578 |
(20) |
378 |
(18) |
14.1–16.0 |
210 |
(16) |
207 |
(13) |
417 |
(15) |
348 |
(16) |
Indeterminate |
. . . |
. . . |
. . . |
24 |
|
|||
Mean diameter, mm |
11.4 |
11.1 |
11.2 |
11.2 |
||||
Location of posterior |
|
|
|
|
|
|
|
|
tumor border |
|
|
|
|
|
|
|
|
Posterior to equator |
1279 |
(97) |
1487 |
(97) |
2766 |
(97) |
1108 |
(85) |
Between equator and |
38 |
(3) |
46 |
(3) |
84 |
(3) |
145 |
(11) |
ora serrata |
|
|
|
|
|
|
|
|
Ciliary body |
. . . |
. . . |
. . . |
36 |
(3) |
|||
Anterior chamber |
. . . |
. . . |
. . . |
2 |
(<1) |
|||
angle |
|
|
|
|
|
|
|
|
Indeterminate |
. . . |
2 |
|
2 |
|
11 |
|
|
Not available |
. . . |
30 |
|
30 |
|
862 |
|
|
398 |
|
|
|
|
|
|
Murray et al. |
|
Table 13 Continued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|
No. (%) of patients |
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
Eligible patients |
|
|
|
|
|
|
|
|
|
|
|
|
Ineligible |
|
|
|
|
|
|
|
|
||
|
Enrolled |
Not enrolled |
Total eligible |
patients |
||||
Characteristic |
(n ¼ 1317) |
(n ¼ 1565) |
(n ¼ 2882) |
(n ¼ 2164) |
||||
Location of anterior tumor border |
|
|
|
|
|
|
|
|
Posterior to equator |
728 |
(55) |
757 (49) |
1485 |
(51) |
725 |
(57) |
|
Between equator and |
446 |
(34) |
604 (39) |
1050 |
(37) |
270 |
(21) |
|
ora serrata |
|
|
|
|
|
|
|
|
Ciliary body |
143 |
(11) |
172 (11) |
315 |
(11) |
167 |
(13) |
|
Anterior chamber |
. . . |
. . . |
. . . |
55 |
(4) |
|||
angle |
|
|
|
|
|
|
|
|
Iris |
. . . |
. . . |
. . . |
67 |
(5) |
|||
Indeterminate |
. . . |
2 |
|
2 |
|
18 |
|
|
Not available |
. . . |
30 |
|
30 |
|
862 |
|
|
Location of tumor apex relative to fovea |
|
|
|
|
|
|
||
Centered over fovea |
9 |
(1) |
4 |
(<1) |
13 |
(<1) |
32 |
(2) |
Temporal |
632 |
(48) |
328 |
(40) |
960 |
(45) |
379 |
(29) |
Superior |
262 |
(20) |
202 |
(25) |
464 |
(22) |
301 |
(23) |
Inferior |
255 |
(19) |
167 |
(20) |
422 |
(20) |
285 |
(22) |
Nasal |
159 |
(12) |
116 |
(14) |
275 |
(13) |
298 |
(23) |
Not available{ |
. . . |
748 |
|
748 |
|
869 |
|
|
Distance from closest tumor border to edge of optic disc, mm |
|
|
|
|
||||
42.0 |
216 |
(16) |
27 |
(17) |
. . . |
. . . |
||
2.1–4.0 |
423 |
(32) |
41 |
(26) |
. . . |
. . . |
||
4.1–6.0 |
311 |
(24) |
33 |
(21) |
. . . |
. . . |
||
6.1–8.0 |
156 |
(12) |
23 |
(14) |
. . . |
. . . |
||
>8.0 |
207 |
(16) |
35 |
(22) |
. . . |
. . . |
||
Not availableb |
4 |
|
1406 |
|
. . . |
. . . |
||
Median, mm |
4.0 |
4.5 |
|
|
|
|
|
|
Closest distance between tumor and FAZ center, mm |
|
|
|
|
|
|||
0 |
190 |
(15) |
17 |
(11) |
. . . |
. . . |
||
0.1–2.0 |
345 |
(26) |
33 |
(21) |
. . . |
. . . |
||
2.1–5.0 |
342 |
(26) |
41 |
(26) |
. . . |
. . . |
||
5.1–8.0 |
226 |
(17) |
33 |
(21) |
. . . |
. . . |
||
>8.0 |
201 |
(15) |
35 |
(22) |
. . . |
. . . |
||
Not available6 |
13 |
|
1406 |
|
|
|
|
|
Median, mm |
3.0 |
4.5 |
|
|
|
|
||
a Ellipses indicate ‘‘not applicable’’ or ‘‘inappropriate calculation’’; FAZ, foveal avascular zone. b Requested only during early years for patients not enrolled. Missing data for enrolled patients. Source: Ref. 14.