Table 3.
CIPN measures | Samples | Baseline | Cycle1 | Cycle2 | Cycle3 | Cycle4 | Cycle5 | Cycle6 | 6mFU | 9mFU | 12mFU |
---|---|---|---|---|---|---|---|---|---|---|---|
n/N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | N (%) | ||
NCI motor 1 (> = grade2) |
Docetaxel | 2/122 (1.6) | 3/122 (2.7) | 4/109 (3.7) | 13/105 (12.4) | 21/95 (22.1) | 9/41 (22) | 8/38 (21.1) | 20/96 (20.8) | 19/89 (21.3) | 12/84 (14.3) |
Paclitaxel | 0/33 (0) | 3/33 (9.1) | 2/31 (6.6) | 2/31 (6.4) | 0/28 (0) | 0/13 (0) | 1/13 (7.7) | 5/27 (18.5) | 3/21 (14.3) | 1/15 (6.7) | |
Cisplatin/Carboplatin | 1/80 (1.2) | 2/65 (3.1) | 5/57 (8.8) | 6/46 (13) | 4/32 (12.5) | 1/9 (11.1) | 0/6 (0) | 3/43 (7) | 3/39 (7.7) | 2/32 (6.2) | |
Oxaliplatin | 0/28 (0) | 2/26 (7.7) | 2/25 (8) | 0/22 (0) | 0/22 (0) | 0/16 (0) | 1/11 (9.1) | 1/21 (4.8) | 0/17 (0) | 0/12 (0) | |
Carboplatin+paclitaxel | 0/49 (0) | 3/44 (6.8) | 2/42 (4.8) | 6/42 (14.3) | 6/38 (15.8) | 6/30 (20) | 5/24 (20.8) | 14/24 (58.3) | 5/40 (12.5) | 2/24 (8.3) | |
Carboplatin+docetaxel | 0/29 (0) | 1/28 (3.6) | 2/26 (7.7) | 2/27 (7.4) | 2/27 (7.4) | 5/26 (17.9) | 6/28 (21.4) | 1/28 (3.6) | 0/28 (0) | 0/27 (0) | |
NCI sensory1 (> = grade2) |
Docetaxel | 0/122 (0) | 1/122 (0.9) | 4/109 (3.7) | 7/105 (6.7) | 10/95 (10.5) | 5/41 (12.2) | 4/38 (10.5) | 17/96 (17.7) | 17/89 (19.1) | 9/84 (10.7) |
Paclitaxel | 0/33 (0) | 3/33 (9.1) | 3/31 (9.7) | 2/31 (6.14) | 0/28 (0) | 0/18 (0) | 3/13 (23.1) | 7/27 (25.9) | 4/21 (19) | 2/15 (13.4) | |
Cisplatin/Carboplatin | 1/80 (1.2) | 0/65 (0) | 4/57 (7.0) | 4/46 (8.7) | 2/32 (6.3) | 1/9 (11.1) | 0/6 (0) | 2/43 (4.7) | 3/39 (7.7) | 2/32 (6.2) | |
Oxaliplatin | 0/28 (0) | 2/26 (7.7) | 2/25 (8) | 0/22 (0) | 0/22 (0) | 0/16 (0) | 1/11 (9.1) | 1/21 (4.8) | 1/17 (5.9) | 0/12 (0) | |
Carboplatin+paclitaxel | 0/49 (0) | 5/44 (11.4) | 3/42 (7.1) | 5/42 (11.9) | 7/38 (18.4) | 7/30 (23.3) | 7/27 (29.2) | 6/40 (15) | 4/40 (10) | 3/24 (12.5) | |
Carboplatin+docetaxel | 0/29 (0) | 0/28 (0) | 1/26 (3.8) | 1/27 (3.7) | 1/27 (3.7) | 3/28 (10.7) | 2/28 (7.1) | 0/28 (0) | 0/28 (0) | 0/27 (0) | |
WHO-CIPN 2 (> = grade 1) |
Docetaxel | 1/122 (0.8) | 3/122 (2.7) | 5/109 (4.6) | 8/105 (7.6) | 11/95 (11.6) | 7/41 (17.1) | 5/38 (13.2) | 16/96 (16.7) | 15/89 (16.9) | 9/84 (10.7) |
Paclitaxel | 2/33 (6.1) | 9/33 (27.3) | 10/31 (32.3) | 16/31 (51.6) | 16/28 (57.1) | 0/18 (0) | 7/13 (53.8) | 14/27 (51.9) | 8/21 (38.1) | 2/15 (13.3) | |
Cisplatin/Carboplatin | 1/80 (1.2) | 2/65 (3) | 6/57 (10.5) | 3/46 (6.5) | 1/32 (3.1) | 0/9 (0) | 0/6 (0) | 2/43 (4.7) | 1/39 (2.6) | 1/32 (3.1) | |
Oxaliplatin | 2/28 (7.1) | 6/26 (23.1) | 9/25 (36) | 14/22 (63.6) | 12/22 (54.5) | 9/16 (56.3) | 3/11 (27.3) | 4/21 (19) | 6/17 (35.3) | 1/12 (8.3) | |
Carboplatin+paclitaxel | 2/49 (4) | 11/44 (25) | 12/42 (28.6) | 15/42 (35.7) | 19/38 (50) | 13/30 (43.3) | 5/19 (20.8) | 7/40 (17.5) | 7/40 (17.5) | 1/24 (4.2) | |
Carboplatin+docetaxel | 0/29 (0) | 0/28 (0) | 0/26 (0) | 0/27 (0) | 1/27 (3.7) | 2/28 (7.1) | 3/28 (10.7) | 2/28 (7.1) | 0/28 (0) | 0/27 (0) | |
Cotton wool(+)3 | Docetaxel | 1/113 (0.9) | 2/104 (1.9) | 2/104 (1.9) | 2/100 (1.2) | 1/84 (1.2) | 1/38 (2.6) | 2/31 (6.5) | 6/82 (7.3) | 4/64 (6.3) | 2/57 (3.5) |
Paclitaxel | 0/31 (0) | 3/33 (9.1) | 1/29 (3.4) | 5/29 (17.2) | 0/28 (0) | 2/18 (11.1) | 1/13 (7.7) | 7/25 (28) | 7/20 (35) | 2/14 (14.3) | |
Cisplatin/Carboplatin | 0/65 (0) | 1/55 (1.8) | 0/48 (0.0) | 0/43 (0) | 0/16 (0) | 0/8 (0) | 0/3 (0) | 1/29 (3.4) | 2/26 (7.7) | 0/19 0) | |
Oxaliplatin | 0/27 (0) | 3/25 (12.0) | 3/25 (12) | 5/22 (22.7) | 3/16 (18.8) | 2/12 (16.7) | 8/20 (40) | 3/16 (18.8) | 1/12 (8.3) | 1/12 (8.3) | |
Carboplatin+paclitaxel | 0/49 (0) | 6/36 (8.3) | 4/35 (11.4) | 8/36 (22.2) | 6/29 (17.1) | 4/27 (14.8) | 1/20 (5) | 6/33 (18.2) | 4/31 (12.9) | 0/16 (0) | |
Carboplatin+docetaxel | 0/29 (0) | 0/28 (0) | 0/26 (0) | 0/27 (0) | 0/27 (0) | 1/28 (3.6) | 1/28 (3.6) | 1/28 (3.6) | 0/26 (0) | 0/25 (0) | |
Monofilame-nt(+)3 | Docetaxel | 1/116 (0.9) | 2/109 (1.8) | 4/109 (3.7) | 5/105 (4.8) | 7/88 (8) | 5/41 (12.2) | 5/31 (16.1) | 16/85 (18.8) | 12/68 (17.6) | 4/57 (7.0) |
Paclitaxel | 1/33 (3.0) | 9/33 (27.3) | 3/31 (9.7) | 5/31 (16.1) | 0/31 (0) | 1/18 (5.6) | 1/13 (7.7) | 7/27 (25.9) | 8/21 (38.1) | 3/15 (20.0) | |
Cisplatin/Carboplatin | 0/77 (0) | 1/63 (1.6) | 2/57 (3.5) | 2/46 (4.3) | 1/17 (5.9) | 1/9 (0) | 0/3 (0) | 3/33 (9.1) | 3/29 (10.3) | 0/21 (0) | |
Oxaliplatin | 0/28 (0) | 2/26 (7.7) | 3/25 (12) | 4/22 (18.2) | 2/22 (9.1) | 3/16 (18.8) | 1/11 (9.1) | 7/21 (33.3) | 4/17 (23.5) | 1/12 (8.3) | |
Carboplatin+paclitaxel | 0/49 (0) | 4/43 (9.3) | 6/42 (14.3) | 11/42 (26.2) | 11/38 (28.9) | 9/30 (30) | 4/20 (20) | 10/38 (26.3) | 7/35 (20) | 2/17 (11.8) | |
Carboplatin+docetaxel | 0/29 (0) | 0/28 (0) | 0/26 (0) | 0/27 (0) | 1/27 (3.7) | 2/28 (7.1) | 3/28 (10.7) | 2/28 (7.1) | 0/26 (0) | 0/25 (0) | |
FACTGOG-Ntx Numbness/tingling in hands 5 (>grade = 1) |
Docetaxel | 21/122 (17.2) | 20/113 (17.7) | 26/109 (23.9) | 29/105 (27.6) | 36/96 (37.5) | 19/41 (46.3) | 17/38 (44.7) | 41/96 (42.7) | 36/90 (40) | 22/84 (26.2) |
Paclitaxel | 7/33 (21.2) | 11/32 (34.4) | 13/31 (41.9) | 15/31 (41.9) | 13/28 (48.4) | 8/18 (44.4) | 9/13 (69.2) | 17/27 (63) | 11/21 (52.4) | 10/15 (66.7) | |
Cisplatin/Carboplatin | 11/81 (13.6) | 7/66 (10.6) | 9/57 (15.8) | 9/47 (19.1) | 6/32 (18.7) | 2/9 (22.2) | 3/6 (50) | 11/43 (25.6) | 7/39 (17.9) | 3/32 (9.4) | |
Oxaliplatin | 2/28 (7.1) | 10/24 (41.7) | 15/26 (65.2) | 15/20 (75) | 15/20 (75) | 8/14 (57.1) | 5/9 (55.6) | 15/21 (71.4) | 11/17 (64.7) | 10/12 (83.3) | |
Carboplatin+paclitaxel | 5/50 (10) | 23/44 (52.4) | 25/41 (61.0) | 22/41 (53.7) | 22/37 (59.5) | 18/28 (64.3) | 13/25 (52) | 22/40 (55) | 16/40 (40) | 8/25 (32) | |
Carboplatin+docetaxel | 1/29 (3.4) | 1/28 (3.6) | 5/26 (19.2) | 3/27 (11.1) | 4/27 (14.8) | 8/28 (28.6) | 12/28 (42.9) | 10/28 (35.7) | 6/28 (21.4) | 5/27 (18.5) | |
FACTGOG-Ntx Numbness/tingling in feet 5 (>grade = 1) |
Docetaxel | 6/122 (4.9) | 10/113 (8.8) | 12/109 (11) | 22/105 (21) | 29/96 (30.2) | 12/41 (29.3) | 9/38 (23.7) | 37/96 (38.5) | 31/90 (34.4) | 21/84 (25.0) |
Paclitaxel | 5/32 (15.6) | 11/31 (35.5) | 13/31 (41.9) | 15/31 (8.4) | 14/28 (50) | 8/18 (44.4) | 7/13 (53.8) | 16/27 (59.3) | 10/21 (47.6) | 7/15 (46.7) | |
Cisplatin/Carboplatin | 5/81 (6.2) | 7/66 (10.6) | 5/57 (8.8) | 7/47 (14.9) | 7/32 (21.9) | 3/9 (33.3) | 3/6 (50) | 14/43 (32.6) | 8/39 (20.5) | 2/32 (6.2) | |
Oxaliplatin | 2/28 (7.2) | 9/27 (37.5) | 16/23 (69.6) | 13/20 (65) | 15/20 (75) | 8/14 (57.1) | 3/9 (33.3) | 15/21 (71.4) | 5/21 (23.8) | 9/12 (75.0) | |
Carboplatin+paclitaxel | 5/50 (10) | 20/44 (45.5) | 22/41 (53.7) | 26/41 (63.4) | 23/37 (62.2) | 20/28 (71.4) | 13/25 (52) | 26/40 (75) | 19/40 (47.5) | 8/25 (32) | |
Carboplatin+docetaxel | 1/29 (3.4) | 2/28 (7.1) | 4/26 (15.4) | 5/27 (18.5) | 6/27 (22.2) | 8/28 (28.6) | 13/28 (46.4) | 10/28 (35.7) | 6/28 (21.4) | 5/27 (18.5) | |
ECIPN-20 (item 3) Numbness inhands/fingers 4 (> = grade 2) |
Docetaxel | 26/122 (21.3) | 22/113 (19.5) | 24/109 (22) | 31/105 (29.5) | 36/96 (37.5) | 17/41 (41.5) | 18/38 (47.4) | 41/96 (42.7) | 36/89 (40.4) | 25/84 (29.8) |
Paclitaxel | 6/33 (18.2) | 11/31 (35.5) | 13/31 (41.9) | 14/31 (45.2) | 13/28 (46.4) | 6/18 (33.3) | 10/13 (76.9) | 10/27 (59.3) | 10/21 (47.6) | 8/15 (53.3) | |
Cisplatin/Carboplatin | 12/81 (14.8) | 5/66 (7.6) | 9/57 (15.8) | 9/47 (19.1) | 6/32 (18.7) | 3/9 (33.3) | 3/6 (50) | 11/43 25.6) | 8/39 (20.5) | 4/32 (22.5) | |
Oxaliplatin | 6/28 (21.4) | 14/24 (58.8) | 17/23 (73.9) | 14/20 (70.0) | 14/20 (70.0) | 8/14 (57.1) | 6/9 (66.6) | 14/21 (66.7) | 10/17 (38.1) | 8/12 (66.7) | |
Carboplatin+paclitaxel | 5/50 (10) | 20/44 (45.5) | 22/41 (53.7) | 23/41 (56.1) | 23/37 (62.2) | 15/28 (53.6) | 13/24 (54.2) | 22/40 (55) | 16/40 (40) | 10/25 (40) | |
Carboplatin+docetaxel | 2/29 (6.9) | 2/28 (7.1) | 4/26 (15.4) | 4/27 (14.8) | 4/27 (14.8) | 7/28 (25) | 11/28 (39.3) | 9/28 (32.1) | 7/28 (25) | 6/27 (22.2) | |
ECIPN-20 (item 4) Numbness in feet/toes 4 (> = grade 2) |
Docetaxel | 8/122 (6.6) | 12/113 (10.6) | 15/109 (13.8) | 23/105 (21.9) | 30/96 (31.2) | 10/41 (24.4) | 11/38 (29.0) | 37/96 (38.5) | 31/90 (34.4) | 24/84 (28.6) |
Paclitaxel | 7/33 (21.2) | 12/32 (37.5) | 11/31 (35.5) | 11/31 (35.5) | 14/28 (50.0) | 9/18 (50.0) | 8/13 (61.5) | 15/27 (55.6) | 6/15 (40) | ||
Cisplatin/Carboplatin | 8/81 (9.9) | 4/66 (6.1) | 6/57 (10.5) | 7/47 (14.9) | 5/32 (15.6) | 3/9 (33.3) | 3/6 (50) | 11/43 (25.6) | 9/39 (23.1) | 3/32 (9.4) | |
Oxaliplatin | 3/28 (10.7) | 10/24 (41.7) | 14/9 (60.1) | 14/20 (70.0) | 14/20 (70) | 7/14 (50.0) | 4/9 (44.4) | 13/21 (61.9) | 10/17 (58.8) | 8/12 (66.7) | |
Carboplatin+paclitaxel | 7/50 (14) | 23/44 (52.3) | 21/41951.2) | 24/41 (58.5) | 25/37 (67.6) | 20/28 (71.4) | 15/24 (62.5) | 27/40 (67.5) | 21/40 (52.5) | 11/25 (440 | |
Carboplatin+docetaxel | 2/29 (6.9) | 2/28 (7.1) | 3/26 (11.5) | 4/27 (14.8) | 6/27 (22.2) | 8/28 (28.6) | 13/28 (46.4) | 10/28 (35.7) | 6/28 (21.4) | 5/27 (18.5) |
1NCI motor/sensory (>grade 2 = Moderate symptoms limiting instrumental ADL); 2 WHO CIPN (> = Grade 1 = Paresthesias and/or decreased tendon reflexes); 3 cotton wool/monofilament (+) = (abnormal sensation, a lot/a little/no sensation); 4 ECIPN-20 (> = grade 2 = A little); 5 FACTGOG-Ntx (> = 1 = a little bit)