Table 4A.
Overall, Progression-Free, and Disease-Free Survival (in Months) for Planned Subgroup Analyses
| Patient Status | OS | PFS | DFS | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
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| Deaths/n | Median (95% CI) | P-Value | Events/n | Median (95% CI) | P-Value | Events/n | Median (95% CI) | P-Value | ||
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| All Patients | 78/89 | 17.2 (14.4, 21.3) | 78/89 | 11.2 (8.7, 13.8) | 46/57 | 11.0 (8.5, 15.8) | ||||
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| Pretreatment BMI | 0.47 | 0.35 | 0.68 | |||||||
| Normal/Underweight | 32/37 | 20.9 (14.2, 35.4) | 32/37 | 13.8 (8.7, 18.1) | 21/26 | 11.2 (8.5, 27.0) | ||||
| Overweight/Obese | 46/52 | 16.0 (13.2, 19.4) | 46/52 | 10.9 (5.8, 12.8) | 25/31 | 9.7 (7.1, 15.6) | ||||
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| Pretreatment Sarcopenia | 0.08 | 0.20 | 0.13 | |||||||
| Yes | 42/46 | 16.8 (12.8, 20.9) | 42/46 | 10.6 (6.4, 14.2) | 25/29 | 9.8 (7.5, 15.6) | ||||
| No | 31/38 | 20.4 (14.9, 40.7) | 31/38 | 12.6 (6.5, 17.8) | 18/25 | 20.2 (7.6, 75.0) | ||||
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| Pretreatment Sarcopenia and Overweight/Obese | 0.04 | 0.11 | 0.54 | |||||||
| Yes | 19/21 | 12.9 (10.0, 17.1) | 19/21 | 6.5 (5.4, 12.0) | 8/10 | 8.6 (0.1, 15.6) | ||||
| No | 57/66 | 20.7 (15.1, 28.5) | 57/66 | 12.6 (9.4, 14.9) | 37/46 | 11.2 (8.5, 20.2) | ||||
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| Post-treatment Sarcopenia | 0.30 | 0.89 | 0.38 | |||||||
| Yes | 45/51 | 17.1 (12.9, 23.5) | 45/51 | 12.0 (6.7, 14.2) | 28/34 | 10.5 (7.3, 15.6) | ||||
| No | 30/35 | 19.4 (14.9, 35.4) | 30/35 | 11.0 (5.7, 14.9) | 16/21 | 20.0 (7.6, 27.0) | ||||
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| Weight Loss | 0.14 | 0.34 | 0.39 | |||||||
| Yes | 49/54 | 16.0 (13.2, 19.4) | 49/54 | 11.0 (7.5, 12.9) | 28/33 | 11.0 (7.1, 15.8) | ||||
| No | 27/33 | 21.3 (13.8, 37.9) | 27/33 | 12.6 (6.1, 15.4) | 17/23 | 11.5 (7.6, 33.2) | ||||
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| Pre/Post-treatment Sarcopenia | 0.46 | 0.56 | 0.40 | |||||||
| No/No | 25/30 | 20.4 (14.9, 44.4) | 25/30 | 11.3 (5.7, 24.5) | 13/18 | 22.3 (7.6, 75.0) | ||||
| No/Yes | 6/8 | 22.5 (5.4, NR) | 6/8 | 14.6 (5.4, NR) | 5/7 | 12.1 (0.4, NR) | ||||
| Yes/No | 4/4 | 25.1 (9.1, 55.9) | 4/4 | 10.6 (4.4, 23.9) | 3/3 | 9.5 (0.1, 20.0) | ||||
| Yes/Yes | 36/40 | 16.7 (12.8, 20.9) | 36/40 | 10.6 (6.5, 14.0) | 21/25 | 10.0 (7.5, 15.8) | ||||
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| HR (95% CI) | HR (95% CI) | HR (95% CI) | ||||||||
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| Adjusted SKM | ||||||||||
| Pretreatment | 73/84 | 0.99 (0.97, 1.02) | 0.47 | 73/84 | 1.00 (0.97, 1.03) | 0.93 | 43/54 | 1.01 (0.97, 1.04) | 0.75 | |
| Post-treatment | 75/86 | 0.99 (0.96, 1.01) | 0.29 | 75/86 | 0.99 (0.97, 1.02) | 0.71 | 44/55 | 1.00 (0.96, 1.03) | 0.84 | |
| Difference* | 71/82 | 0.95 (0.88, 1.03) | 0.22 | 71/82 | 0.95 (0.88, 1.03) | 0.19 | 42/53 | 0.89 (0.80, 1.00) | 0.04 | |
| Percent Difference | 71/82 | 0.98 (0.94, 1.01) | 0.24 | 71/82 | 0.98 (0.94, 1.02) | 0.25 | 42/53 | 0.95 (0.90, 1.01) | 0.08 | |
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| Adjusted VAT | ||||||||||
| Pretreatment | 73/84 | 1.01 (1.00, 1.01) | 0.09 | 73/84 | 1.01 (1.00, 1.01) | 0.10 | 43/54 | 1.01 (1.00, 1.02) | 0.14 | |
| Post-treatment | 75/86 | 1.00 (0.99, 1.01) | 0.96 | 75/86 | 1.00 (0.99, 1.01) | 0.74 | 44/55 | 1.00 (0.99, 1.01) | 0.53 | |
| Difference* | 71/82 | 0.97 (0.95, 0.99) | 0.001 | 71/82 | 0.98 (0.96, 0.99) | 0.01 | 42/53 | 0.98 (0.95, 1.00) | 0.07 | |
| Percent Difference | 71/82 | 1.00 (1.00, 1.00) | 0.37 | 71/82 | 1.00 (1.00, 1.00) | 0.38 | 42/53 | 1.00 (1.00, 1.00) | 0.63 | |
OS=Overall Survival; PFS=Progression-Free Survival; DFS=Disease-Free Survival; CI=Confidence Interval; NR=Median or CI limit is Not Reached
*
The difference was calculated as the difference between post- minus pre-treatment measures. Positive values mean patients gained SKM following treatment. For example, an increase of one unit indicates either a gain of one unit or a smaller loss by one unit.