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Table 5 Adverse drug reactions related to different initial afatinib dosages

From: Lower starting dose of afatinib for the treatment of metastatic lung adenocarcinoma harboring exon 21 and exon 19 mutations

Adverse events All patients Afatinib 30 mg daily Afatinib 40 mg daily P value
Maximal grade of events     < 0.0001
 No 8 (4%) 2 (2%) 6 (8%)  
 Grade 1 62 (35%) 50 (49%) 12 (16%)  
 Grade 2 78 (44%) 43 (42%) 35 (45%)  
 Grade 3 31 (17%) 7 (7%) 24 (31%)  
Presence of any moderate and severe (≥ grade 2) adverse events 109 (61%) 50 (49%) 59 (77%) 0.0002
Details of moderate and severe (≥ grade 2) adverse events
 Diarrhea 49 (27%) 13 (13%) 36 (47%) < 0.0001
 Stomatitis 14 (8%) 4 (4%) 10 (13%) 0.0253
 Paronychia 50 (28%) 29 (28%) 21 (27%) 0.8642
 Acne and/or skin rash 61 (34%) 17 (17%) 44 (57%) < 0.0001
 Dry skin 9 (5%) 1 (1%) 8 (10%) 0.0043
 Pruritus 9 (5%) 1 (1%) 8 (10%) 0.0043
 Adverse events involving skin a 62 (35%) 18 (18%) 44 (57%) < 0.0001
 Hepatitis 4 (2%) 1 (1%) 3 (4%) 0.1913
 Interstitial lung disease 0 (0%) 0 (0%) 0 (0%)  
Presence of any severe (≥ grade 3) adverse events 31 (17%) 7 (7%) 24 (31%) < 0.0001
Details of severe (≥ grade 3) adverse events
 Diarrhea 14 (8%) 2 (2%) 12 (16%) 0.0008
 Stomatitis 3 (2%) 2 (2%) 1 (1%) 0.7326
 Paronychia 6 (3%) 2 (2%) 4 (5%) 0.2340
 Acne and/or skin rash 11 (6%) 0 (0%) 11 (14%) < 0.0001
 Dry skin 0 (0%) 0 (0%) 0 (0%)  
 Pruritus 1 (1%) 0 (0%) 1 (1%) 0.2484
 Adverse events involving skin a 11 (6%) 0 (0%) 11 (14%) < 0.0001
 Hepatitis 1 (1%) 1 (1%) 0 (0%) 0.3836
 Interstitial lung disease 0 (0%) 0 (0%) 0 (0%)  
Details of adverse events
 Diarrhea     < 0.0001
  No 47 (26%) 33 (32%) 14 (18%)  
  Grade 1 83 (46%) 56 (55%) 27 (35%)  
  Grade 2 35 (20%) 11 (11%) 24 (31%)  
  Grade 3 14 (8%) 2 (2%) 12 (16%)  
 Stomatitis     0.0214
  No 125 (70%) 70 (69%) 55 (71%)  
  Grade 1 40 (22%) 28 (27%) 12 (16%)  
  Grade 2 11 (6%) 2 (2%) 9 (12%)  
  Grade 3 3 (2%) 2 (2%) 1 (1%)  
 Paronychia     0.6304
  No 87 (49%) 49 (48%) 38 (49%)  
  Grade 1 42 (23%) 24 (24%) 18 (23%)  
  Grade 2 44 (25%) 27 (26%) 17 (22%)  
  Grade 3 6 (3%) 2 (2%) 4 (5%)  
 Acne and/or skin rash     < 0.0001
  No 34 (19%) 22 (22%) 12 (16%)  
  Grade 1 84 (47%) 63 (62%) 21 (27%)  
  Grade 2 50 (28%) 17 (17%) 33 (43%)  
  Grade 3 11 (6%) 0 (0%) 11 (14%)  
 Dry skin     0.0171
  No 69 (39%) 41 (40%) 28 (36%)  
  Grade 1 101 (56%) 60 (59%) 41 (53%)  
  Grade 2 9 (5%) 1 (1%) 8 (10%)  
 Pruritus     0.0381
  No 112 (63%) 68 (67%) 44 (57%)  
  Grade 1 58 (32%) 33 (32%) 25 (32%)  
  Grade 2 8 (4%) 1 (1%) 7 (9%)  
  Grade 3 1 (1%) 0 (0%) 1 (1%)  
 Adverse events involving skin a     < 0.0001
  No 24 (13%) 16 (16%) 8 (10%)  
  Grade 1 93 (52%) 68 (67%) 25 (32%)  
  Grade 2 51 (28%) 18 (18%) 33 (43%)  
  Grade 3 11 (6%) 0 (0%) 11 (14%)  
 Hepatitis     0.1382
  No 172 (96%) 100 (98%) 72 (94%)  
  Grade 1 3 (2%) 1 (1%) 2 (3%)  
  Grade 2 3 (2%) 0 (0%) 3 (4%)  
  Grade 3 1 (1%) 1 (1%) 0 (0%)  
 Interstitial lung disease     0.2166
  Grade 1 2 (1%) 2 (2%) 0 (0%)  
  1. aAdverse events involving included acne, skin rash, dry skin, and pruritus