Table 1.
Patient demographics and efficacy and safety of ceritinib in patients with relapsed/refractory ALK-positive ALCL
| Patient 1 | Patient 2 | Patient 3 | |
|---|---|---|---|
| Age (y) | 40 | 48 | 24 |
| Sex | Male | Female | Male |
| Performance status | 1 | 1 | 1 |
| Disease stage (Ann Arbor) | Stage IV* | Stage III B† | Stage III A‡ |
| ALK testing method§ | FISH | IHC and FISH | FISH |
| ALK fusion partner | NPM | NPM | Unknown |
| Prior treatment (dates) | Hyper-CVAD chemotherapy (June 2012 to November 2012) | CHOP chemotherapy (November 2011 to March 2012) | CHOP chemotherapy (October 2012 to February 2013) |
| Best response to prior chemotherapy (duration) | CR (2.3 mo) | CR (3 mo) | CR (1 mo) |
| Relapsed/refractory | Relapsed and refractory | Relapsed | Relapsed |
| Ceritinib starting dose | 750 mg/d | 750 mg/d | 750 mg/d |
| Best response to ceritinib | CR (still ongoing) | CR (still ongoing) | PR (still ongoing) |
| Duration between initiating ceritinib therapy and achieving best response | 2 mo | 8.3 mo | 3 mo |
| Duration of best response to ceritinib | ≥26 mo | ≥24 mo | ≥20 mo |
| Adverse events during ceritinib treatment | Grade 1-2 diarrhea and abdominal discomfort | Grade 2 fatigue and grade 3 increase in transaminase levels (dose reduction) | Acute pericarditis (sharp chest pain, T-wave inversions, and small pericardial effusion on ECG) (dose reduction) |
| Grade 1 diarrhea and vomiting | |||
| Ceritinib dose modification(s) | Not required | Two dose reductions: | One dose reduction: |
| To 600 mg/d (week 16) | To 450 mg/d (week 9) | ||
| To 450 mg/d (week 35) |
CHOP, cyclophosphamide/doxorubicin/vincristine/prednisolone; ECG, electrocardiogram; FISH, fluorescence in situ hybridization; hyper-CVAD, cyclophosphamide/vincristine/adriamycin/dexamethasone; IHC, immunohistochemistry; NPM; nucleophosmin.
Patient 1 was diagnosed with stage IV disease involving cervical/mediastinal/celiac nodal disease plus bone marrow, focal L4 vertebral body, and skin.
Patient 2 was diagnosed with stage III B disease with lymphomatous involvement of cervical, axillary, inguinal, retroperitoneal, parailiacal, and paraaortal lymph node regions and splenomegaly.
Patient 3 was diagnosed with stage III A disease involving multiple lymph node enlargements from the axillary to inguinal areas.
ALK testing method used for enrolling in the ASCEND-1 trial.