Table 2.
Mean change from baseline in EORTC QLQ-C30 GHS, physical functioning, pain and fatigue and EQ-5D-5L VAS scores up to 36 months by age and ECOG performance status at baseline
| Months | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 3 | 6 | 12 | 24 | 36 | ||||||
| LS mean change from baseline (95% CI) | VMP | D-VMP | VMP | D-VMP | VMP | D-VMP | VMP | D-VMP | VMP | D-VMP |
| EORTC QLQ-C30 GHS | ||||||||||
| < 75 years | (n = 178) | (n = 193) | (n = 156) | (n = 171) | (n = 143) | (n = 163) | (n = 64) | (n = 115) | (n = 21) | (n = 68) |
| 6.5 | 10.7 | 12.4 | 11.9 | 13.7 | 15.2 | 14.7 | 14 | 12.1 | 16.4 | |
| (4.1–8.9) | (8.4–13) | (9.9–15) | (9.4–14.3) | (11.1–16.4) | (12.7–17.7) | (11–18.4) | (11.1–16.9) | (6–18.2) | (12.8–19.9) | |
| ≥ 75 years | (n = 65) | (n = 69) | (n = 56) | (n = 64) | (n = 42) | (n = 59) | (n = 18) | (n = 37) | (n = 10) | (n = 12) |
| 4.2 | 5.5 | 6.2 | 6.2 | 9.8 | 7.5 | 9.9 | 3.6 | 4.4 | 8.5 | |
| (−0.3 to 8.7) | (1–10) | (1.3–11.1) | (1.6–10.8) | (4.2–15.3) | (2.8–12.3) | (2.1–17.8) | (−2.2 to 9.4) | (−6.1 to 15) | (−1.1 to 18.2) | |
| ECOG performance status 0 | (n = 68) | (n = 56) | (n = 57) | (n = 46) | (n = 51) | (n = 51) | (n = 25) | (n = 34) | (n = 11) | (n = 16) |
| −0.7 | 8.5 | 4.8 | 7.5 | 1.7 | 8.5 | 6 | 7.4 | 1.3 | 10.3 | |
| (−4.9 to 3.5) | (3.8–13.1) | (0.3–9.3) | (2.5–12.5) | (−3 to 6.4) | (3.7–13.3) | (−0.5 to 12.5) | (1.7–13.1) | (−8.2 to 10.8) | (2.3–18.3) | |
| ECOG performance status 1 | (n = 123) | (n = 138) | (n = 108) | (n = 126) | (n = 95) | (n = 115) | (n = 38) | (n = 73) | (n = 13) | (n = 43) |
| 5.6 | 7.8 | 9.5 | 8.7 | 12.2 | 11.6 | 11 | 7.4 | 9.3 | 11.8 | |
| (2.7–8.6) | (5–10.6) | (6.4–12.7) | (5.8–11.6) | (9–15.5) | (8.6–14.6) | (6.1–15.8) | (3.8–11) | (1.4–17.1) | (7.3–16.3) | |
| ECOG performance status 2 | (n = 54) | (n = 68) | (n = 48) | (n = 63) | (n = 39) | (n = 56) | (n = 20) | (n = 45) | (n = 7) | (n = 21) |
| 11.6 | 14.7 | 18 | 17.9 | 24.2 | 21.5 | 24.2 | 23.3 | 19.3 | 24.7 | |
| (6.9–16.3) | (10.5–18.9) | (13.1–23) | (13.6–22.2) | (18.8–29.6) | (17–26) | (17.2–31.3) | (18.4–28.2) | (8.1–30.6) | (18–31.4) | |
| EORTC QLQ-C30 physical functioning | ||||||||||
| < 75 years | (n = 178) | (n = 193) | (n = 156) | (n = 171) | (n = 143) | (n = 163) | (n = 64) | (n = 115) | (n = 21) | (n = 68) |
| 8.4 | 10 | 12.7 | 14.1 | 14.9 | 17.2 | 16.8 | 16.9 | 14.6 | 16.9 | |
| (6.1–10.7) | (7.7–12.2) | (10.3–15.1) | (11.8–16.4) | (12.5–17.4) | (14.8–19.5) | (13.5–20) | (14.3–19.5) | (9.5–19.8) | (13.7–20) | |
| ≥ 75 years | (n = 65) | (n = 69) | (n = 56) | (n = 64) | (n = 42) | (n = 59) | (n = 18) | (n = 37) | (n = 10) | (n = 12) |
| 2.9 | 3 | 8 | 4.4 | 4.1 | 4.9 | 5.1 | 5.9 | 3.9 | 3.5 | |
| (−2 to 7.9) | (−1.9 to 7.8) | (2.8–13.1) | (−0.5 to 9.4) | (−1.6 to 9.8) | (− 0.2 to 9.9) | (− 2.4 to 12.6) | (0.1–11.7) | (− 5.8 to 13.6) | (− 5.5 to 12.5) | |
| ECOG performance status 0 | (n = 68) | (n = 56) | (n = 57) | (n = 46) | (n = 51) | (n = 51) | (n = 25) | (n = 34) | (n = 11) | (n = 16) |
| −1.2 | 2.8 | 3.1 | 6.1 | 2.3 | 4.6 | 1.3 | 2 | −0.6 | 2.4 | |
| (−4.5 to 2.1) | (−0.8 to 6.5) | (−0.4 to 6.6) | (2.8–10.4) | (−1.3 to 5.9) | (0.9–8.4) | (−3.3 to 5.9) | (−2.3 to 6.2) | (−7.1 to 5.8) | (−3.2 to 8) | |
| ECOG performance status 1 | (n = 123) | (n = 138) | (n = 108) | (n = 126) | (n = 95) | (n = 115) | (n = 38) | (n = 73) | (n = 13) | (n = 43) |
| 5.2 | 4.6 | 9.5 | 7.3 | 8.7 | 11 | 13.6 | 10.1 | 9.9 | 8.5 | |
| (2.1–8.3) | (1.7–7.6) | (6.3–12.7) | (4.3–10.3) | (5.3–12) | (7.9–14.1) | (9–18.2) | (6.6–13.7) | (2.8–16.9) | (4.2–12.7) | |
| ECOG performance status 2 | (n = 54) | (n = 68) | (n = 48) | (n = 63) | (n = 39) | (n = 56) | (n = 20) | (n = 45) | (n = 7) | (n = 21) |
| 16.8 | 21.4 | 22.4 | 26.5 | 29.3 | 29.4 | 27.1 | 33.4 | 27.9 | 35.3 | |
| (11.3–22.3) | (16.5–26.2) | (16.7–28.1) | (21.6–31.5) | (23.3–35.3) | (24.3–34.6) | (19.8–34.4) | (28–38.8) | (17.1–38.8) | (28.4–42.1) | |
| EORTC QLQ-C30 pain* | ||||||||||
| < 75 years | (n = 178) | (n = 193) | (n = 156) | (n = 171) | (n = 143) | (n = 163) | (n = 64) | (n = 115) | (n = 21) | (n = 68) |
| −12.9 | −16.4 | −22.1 | −20.2 | −21.8 | −21.7 | −24.8 | − 23.3 | −26.4 | − 27 | |
| (− 16 to − 9.9) | (− 19.3 to − 13.4) | (−25.3 to − 18.8) | (−23.3 to − 17.1) | (− 25.2 to − 18.5) | (− 24.8 to − 18.5) | (− 29.5 to − 20.1) | (− 26.9 to − 19.7) | (−34.1 to − 18.8) | (− 31.5 to − 22.6) | |
| ≥ 75 years | (n = 65) | (n = 69) | (n = 56) | (n = 64) | (n = 42) | (n = 59) | (n = 18) | (n = 37) | (n = 10) | (n = 12) |
| −9.6 | − 12.4 | − 14.1 | − 13.7 | −13.2 | − 14.5 | − 14.3 | −8.1 | − 8.8 | − 17.9 | |
| (− 15.4 to − 3.8) | (− 18.2 to − 6.7) | (− 20.3 to − 7.8) | (− 19.6 to − 7.8) | (− 20.2 to − 6.1) | (− 20.6 to − 8.4) | (− 24.4 to − 4.3) | (− 15.5 to − 0.7) | (− 22.3 to 4.7) | (− 30.3 to − 5.6) | |
| ECOG performance status 0 | (n = 68) | (n = 56) | (n = 57) | (n = 46) | (n = 51) | (n = 51) | (n = 25) | (n = 34) | (n = 11) | (n = 16) |
| − 1.6 | − 0.7 | − 10 | − 7.3 | − 6.5 | − 5.2 | − 9.5 | −8.5 | − 11.7 | − 12.8 | |
| (− 6.3 to 3) | (− 5.9 to 4.4) | (− 15.1 to − 5) | (− 12.9 to − 1.7) | (− 11.7 to − 1.2) | (− 10.6 to 0.1) | (− 16.7 to − 2.3) | (− 14.8 to − 2.1) | (− 22.2 to − 1.2) | (− 21.6 to − 3.9) | |
| ECOG performance status 1 | (n = 123) | (n = 138) | (n = 108) | (n = 126) | (n = 95) | (n = 115) | (n = 38) | (n = 73) | (n = 13) | (n = 43) |
| − 9.6 | − 15.5 | − 18.8 | − 16.6 | − 16.3 | − 18.6 | −19 | − 16.2 | − 14.8 | − 23 | |
| (− 13.6 to − 5.6) | (− 19.2 to − 11.7) | (− 23 to − 14.6) | (− 20.5 to − 12.7) | (− 20.7 to − 11.9) | (− 22.6 to − 14.5) | (− 25.4 to − 12.5) | (− 21 to − 11.3) | (− 25.3 to − 4.4) | (− 29.1 to − 17) | |
| ECOG performance status 2 | (n = 54) | (n = 68) | (n = 48) | (n = 63) | (n = 39) | (n = 56) | (n = 20) | (n = 45) | (n = 7) | (n = 21) |
| − 26.6 | − 29 | − 31.4 | − 33.5 | − 40 | − 36.4 | − 40.8 | − 36.4 | − 41.1 | − 39.9 | |
| (−32.7 to − 20.4) | (− 34.5 to − 23.5) | (− 37.9 to − 24.9) | (− 39.2 to − 27.9) | (− 47.1 to − 33) | (− 42.3 to − 30.5) | (− 50 to − 31.6) | (− 42.8 to − 29.9) | (− 55.8 to − 26.5) | (− 48.7 to − 31.1) | |
| EORTC QLQ-C30 fatiguea | ||||||||||
| < 75 years | (n = 178) | (n = 193) | (n = 156) | (n = 171) | (n = 143) | (n = 163) | (n = 64) | (n = 115) | (n = 21) | (n = 68) |
| −7.3 | − 7.5 | −12.9 | − 13.5 | −14.1 | − 14.9 | − 13.6 | −13.2 | − 12.3 | −14.7 | |
| (− 9.9 to − 4.7) | (− 10.1 to − 5) | (− 15.7 to − 10.2) | (− 16.1 to − 10.9) | (− 16.9 to − 11.2) | (− 17.6 to − 12.2) | (− 17.5 to − 9.7) | (− 16.2 to − 10.1) | (− 18.6 to − 5.9) | (− 18.5 to − 11) | |
| ≥ 75 years | (n = 65) | (n = 69) | (n = 56) | (n = 64) | (n = 42) | (n = 59) | (n = 18) | (n = 37) | (n = 10) | (n = 12) |
| 0 | 0 | −4.3 | − 3.1 | − 4.7 | − 4.8 | −1.5 | − 0.6 | − 2.2 | − 2.9 | |
| (− 5 to 5) | (− 4.8 to 4.9) | (− 9.6 to 0.9) | (− 8.1 to 1.9) | (− 10.6 to 1.3) | (− 10 to 0.4) | (− 9.7 to 6.7) | (− 6.7 to 5.6) | (− 13 to 8.6) | (− 12.8 to 7) | |
| ECOG performance status 0 | (n = 68) | (n = 56) | (n = 57) | (n = 46) | (n = 51) | (n = 51) | (n = 25) | (n = 34) | (n = 11) | (n = 16) |
| 5.5 | −2.1 | −2.9 | − 6.3 | − 0.7 | − 6 | 1 | − 3.8 | −1.2 | − 0.9 | |
| (1.2–9.9) | (− 6.9 to 2.7) | (−7.5 to 1.7) | (− 11.4 to − 1.2) | (− 5.4 to 4) | (− 11 to − 1.1) | (− 5.1 to 7.1) | (−9.4 to 1.8) | (− 9.7 to 7.3) | (−8.3 to 6.5) | |
| ECOG performance status 1 | (n = 123) | (n = 138) | (n = 108) | (n = 126) | (n = 95) | (n = 115) | (n = 38) | (n = 73) | (n = 13) | (n = 43) |
| − 5.6 | − 5.3 | − 11.4 | −8.7 | − 11.1 | − 10.8 | − 8.9 | −8.3 | − 7.4 | − 11.1 | |
| (− 8.9 to − 2.2) | (− 8.5 to − 2.2) | (− 14.9 to − 7.9) | (− 12 to − 5.5) | (− 14.8 to − 7.4) | (− 14.2 to − 7.5) | (− 14.2 to − 3.7) | (− 12.3 to − 4.4) | (− 15.9 to 1) | (− 16 to − 6.2) | |
| ECOG performance status 2 | (n = 54) | (n = 68) | (n = 48) | (n = 63) | (n = 39) | (n = 56) | (n = 20) | (n = 45) | (n = 7) | (n = 21) |
| − 15 | − 10.2 | − 15.4 | − 20 | − 23.7 | − 21.7 | − 25 | − 19.5 | − 19.5 | − 23.7 | |
| (− 20.3 to − 9.7) | (− 14.9 to − 5.5) | (− 20.9 to − 9.8) | (− 24.8 to − 15.1) | (− 29.7 to − 17.8) | (− 26.8 to − 16.7) | (− 32.8 to − 17.3) | (− 25 to − 14.1) | (− 31.7 to − 7.4) | (− 31.1 to − 16.4) | |
| EQ-5D-5L VAS | ||||||||||
| < 75 years | (n = 178) | (n = 193) | (n = 156) | (n = 171) | (n = 143) | (n = 163) | (n = 64) | (n = 115) | (n = 21) | (n = 68) |
| 6.8 | 9.7 | 9.7 | 10.9 | 12.8 | 12.5 | 15.3 | 13.2 | 13.9 | 15.6 | |
| (4.7–8.8) | (7.7–11.6) | (7.5–11.8) | (8.8–12.9) | (10.6–15) | (10.4–14.6) | (12.2–18.3) | (10.8–15.6) | (9–18.9) | (12.7–18.6) | |
| ≥ 75 years | (n = 65) | (n = 69) | (n = 56) | (n = 64) | (n = 42) | (n = 59) | (n = 18) | (n = 37) | (n = 10) | (n = 12) |
| 2 | 5.7 | 4.5 | 6 | 8.1 | 2.9 | 3.4 | 5.1 | 3.8 | 2.6 | |
| (−1.9 to 5.9) | (1.9–9.5) | (0.3–8.6) | (2.1–9.9) | (3.5–12.8) | (−1.1 to 6.9) | (−3.1 to 10) | (0.3–9.8) | (−4.7 to 12.3) | (− 5.1 to 10.4) | |
| ECOG performance status 0 | (n = 68) | (n = 56) | (n = 57) | (n = 46) | (n = 51) | (n = 51) | (n = 25) | (n = 34) | (n = 11) | (n = 16) |
| − 0.5 | 6.8 | 2.6 | 7.9 | 4.4 | 4 | 5.4 | 6 | 1.4 | 4.9 | |
| (−3.7 to 2.7) | (3.3–10.3) | (−0.9 to 6) | (4.1–11.8) | (0.9–8) | (0.4–7.7) | (0.6–10.3) | (1.7–10.3) | (−5.5 to 8.2) | (−0.9 to 10.8) | |
| ECOG performance status 1 | (n = 123) | (n = 138) | (n = 108) | (n = 126) | (n = 95) | (n = 115) | (n = 38) | (n = 73) | (n = 13) | (n = 43) |
| 5.1 | 6.8 | 6.8 | 6.7 | 10.7 | 8.5 | 10.4 | 7.4 | 11.8 | 10.1 | |
| (2.4–7.7) | (4.3–9.3) | (4–9.6) | (4.1–9.3) | (7.8–13.6) | (5.9–11.2) | (6.2–14.6) | (4.3–10.6) | (5–18.5) | (6.2–14.1) | |
| ECOG performance status 2 | (n = 54) | (n = 68) | (n = 48) | (n = 63) | (n = 39) | (n = 56) | (n = 20) | (n = 45) | (n = 7) | (n = 21) |
| 11.4 | 15.2 | 16.3 | 18.5 | 20 | 19.2 | 22.8 | 23.3 | 20.3 | 26.1 | |
| (7.6–15.3) | (11.7–18.7) | (12.2–20.4) | (15–22.1) | (15.6–24.4) | (15.5–22.9) | (17.1–28.5) | (19.3–27.3) | (11.3–29.2) | (20.7–31.5) | |
aFor pain and fatigue, a negative change equates to greater symptom improvement