Table 3. Acute and Late Treatment-Related Adverse Events Occurring in at Least 5% of Patients in Either Arma.
| Adverse event | Estimate (95% CI), % | P value | |
|---|---|---|---|
| CRT plus lapatinib | CRT plus placebo | ||
| Acute events (60 lapatinib patients and 59 placebo patients) | |||
| Grade 5 overall | 0.0 (0.0-0.0) | 3.4 (0.0-8.0) | .64 |
| Grade 3-4 overall | 83.3 (73.9-92.8) | 79.7 (69.4-89.9) | |
| Grade 3 dysphagiab | 31.7 (19.9-43.4) | 45.8 (33.1-58.5) | |
| Grade 3-4 decreased lymphocyte count | 26.7 (15.5-37.9) | 18.6 (8.7-28.6) | |
| Grade 2-3 dry mouthc | 25.0 (14.0-36.0) | 32.2 (20.3-44.1) | |
| Grade 3-4 anorexia | 18.3 (8.5-28.1) | 16.9 (7.4-26.5) | |
| Grade 3 nauseac | 16.7 (7.2-26.1) | 16.9 (7.4-26.5) | |
| Grade 3 mucositis oralb | 16.7 (7.2-26.1) | 11.9 (3.6-20.1) | |
| Grade 3 vomitingb | 16.7 (7.2-26.1) | 10.2 (2.5-17.9) | |
| Grade 3 dehydrationb | 13.3 (4.7-21.9) | 16.9 (7.4-26.5) | |
| Grade 3-4 decreased neutrophil count | 13.3 (4.7-21.9) | 10.2 (2.5-17.9) | |
| Grade 3 acute kidney injuryb | 11.7 (3.5-19.8) | 8.5 (1.4-15.6) | |
| Grade 3 hyponatremiab | 10.0 (2.4-17.6) | 10.2 (2.5-17.9) | |
| Grade 3-4 decreased white blood cell | 8.3 (1.3-15.3) | 13.6 (4.8-22.3) | |
| Grade 3 weight lossc | 8.3 (1.3-15.3) | 6.8 (0.4-13.2) | |
| Grade 3-4 hypokalemia | 6.7 (0.4-13.0) | 5.1 (0.0-10.7) | |
| Grade 3 sore throatc | 5.0 (0.0-10.5) | 8.5 (1.4-15.6) | |
| Grade 3 anemiab | 5.0 (0.0-10.5) | 6.8 (0.4-13.2) | |
| Grade 3 radiation dermatitisb | 5.0 (0.0-10.5) | 6.8 (0.4-13.2) | |
| Grade 3 pharyngeal mucositisb | 5.0 (0.0-10.5) | 5.1 (0.0-10.7) | |
| Grade 3 painc | 5.0 (0.0-10.5) | 3.4 (0.0-8.0) | |
| Grade 3-4 increased creatinine | 3.3 (0.0-7.9) | 6.8 (0.4-13.2) | |
| Grade 3-4 laryngeal edema | 3.3 (0.0-7.9) | 5.1 (0.0-10.7) | |
| Grade 3 dyspneab | 1.7 (0.0-4.9) | 5.1 (0.0-10.7) | |
| Grade 3 hoarsenessc | 1.7 (0.0-4.9) | 5.1 (0.0-10.7) | |
| Grade 3 fatiguec | 0.0 (0.0-0.0) | 5.1 (0.0-10.7) | |
| Late events (n = 50 lapatinib patients and 49 placebo patients) | |||
| Grade 5 overall | 0.0 (0.0-0.0) | 4.1 (0.0-9.6) | .84 |
| Grade 3-4 overall | 44.0 (30.2-57.8) | 40.8 (27.1-54.6) | |
| Grade 2-3 dry mouthc | 36.0 (22.7-49.3) | 28.6 (15.9-41.2) | |
| Grade 3 dysphagiab | 26.0 (13.8-38.2) | 24.5 (12.4-36.5) | |
| Grade 3 weight lossc | 8.0 (0.5-15.5) | 12.2 (3.1-21.4) | |
| Grade 3-4 decreased lymphocyte count | 8.0 (0.5-15.5) | 4.1 (0.0-9.6) | |
| Grade 3 hyponatremiab | 8.0 (0.5-15.5) | 2.0 (0.0-6.0) | |
| Grade 3 hoarsenessc | 8.0 (0.5-15.5) | 0.0 (0.0-0.0) | |
| Grade 3 esophageal stenosisb | 6.0 (0.0-12.6) | 6.1 (0.0-12.8) | |
| Grade 3 impaired hearingb | 6.0 (0.0-12.6) | 2.0 (0.0-6.0) | |
| Grade 3 pharyngeal mucositisb | 2.0 (0.0-5.9) | 8.2 (0.5-15.8) | |
Abbreviation: CRT, chemoradiotherapy.
a
Adverse events were graded with Common Terminology Criteria for Adverse Events, version 4. Treatment related is defined as definitely, probably, or possibly related to treatment. Acute is defined as 180 days or less from the end of radiation therapy and late as more than 180 days from the end of radiation therapy. P values are from the Fisher exact test.
b
No grade 4 events were reported for this term.
c
Grade 4 does not exist for this term in Common Terminology Criteria for Adverse Events, version 4.