Use of Ibrutinib Via Nasogastric (NG) Tube & Percutaneous Endoscopic Gastrostomy (PEG) Tube

Abstract

We describe the successful administration of ibrutinib via nasogastic (NG) tube & percutaneous endoscopic gastrostomy (PEG)tube. It was not previously known by the manufacturer if this route of administration was possible. Our patient was a 71 year old man diagnosed with a leukaemic variant mantle cell lymphoma. He was commenced on R-CHOP (rituximab, cyclophospahmide, doxorubicin, vincristine, prednisolone) chemotherapy however after 3 cycles of chemotherapy there was no reduction in his lymphadenopathy or splenomegaly despite a reduction in the peripheral blood lymphocytosis. During the R-CHOP chemotherapy, the patient suffered left-sided facial shingles causing Ramsay Hunt syndrome. He was left with a residual neurological swallowing deficit requiring nasogastric feeding. Due to the lack of response to R-CHOP chemotherapy, we felt that ibrutinib could be a useful second line treatment, however we were not sure if the capsule could be opened to allow administration via his nasogastric tube. We contacted the manufacturer who said that there was no data about this method of administration and therefore it was not recommended. Our own research identified one ongoing clinical trial comparing suspension and sprinkle formulations of ibrutinib to the capsule formulation (NCT02390609). This trial was unreported however we felt encouraged that this method of administration did seem feasible. It was felt that ibrutinib represented the best chance of a useful disease response so full dose treatment was commenced via the nasogastric tube. This was later changed to a percutaneous endoscopic gastrostomy (PEG) tube. The patient opened the capsule and flushed the contents down the tube with water. A follow up blood count 2 weeks later showed a marked lymphocytosis (baseline lymphocyte count 0.4 x109/L, risen to 40.8 x 109/L), as would be expected with ibrutinib therapy. This reduced to near normal values over the following 3 months, accompanied by an improvement in the haemoglobin and platelet counts. Imaging at 3 months confirmed compete resolution of all pre-existing lymphadenopathy and the previous 25.6 cm splenomegaly. Our patients' dramatic response suggests that capsule formulation ibrutinib can be successfully administered by NG or PEG tubes. Disclosures Maddox: Janssen: Other: Funding to attend ASH 2016 (travel, accommodation, registration); Boehringer-Ingelheim: Other: Funding to attend ASH 2014 (travel, accommodation, registration).

Enteral tube administration of oral chemotherapy drugs

“…For example, of the five drugs in our review where data for NG tube administration is available (ibrutinib, imatinib, tretinoin, vemurafenib, vismodegib), they are supported exclusively by case reports, which did not always provide preparation or administration instructions or lacked detailed information on administration or resulting outcomes. [64][65][66][67][68][69][70][71][72][73][74][75] Additionally, aside from one case report, all of the data described gastric administration, either through an NG, PEG, or gastrostomy tube. This limits some applicability to alternative sites of delivery (i.e.…”

“…Two case reports describe successful use of ibrutinib through an NG tube or PEG tube; method of administration not described. 64,65 One report noted that the capsule was opened and flushed down the feeding tube with water. 65 Imatinib X Not available.…”

Ibrutinib Treatment through Nasogastric Tube in a Comatose Patient with Central Nervous System Localization of Mantle Cell Lymphoma

“…To the best of our knowledge, this is the first case published describing the administration of ibrutinib through a nasogastric tube to a comatose patient. It is worth noting, however, that one case was reported describing the administration of ibrutinib capsule content through the nasogastric tube in a conscious patient with a swallowing disorder [ 8 ].…”

Ibrutinib treatment via alternative administration in a patient with chronic lymphocytic leukemia and dysphagia

“…A literature review revealed only two case reports of patients opening the capsule formulation and administration via NG or PEG tube. 3,6 It was decided to extrapolate this data and direct the assisted living facility to open the capsules and sprinkle over soft food. The caregiver donned appropriate PPE including gloves and mask while administering to the patient.…”

“…5 To date, there are only 2 published case reports of capsule contents being opened and given via nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube. 3,6 For patients who cannot swallow, and who are not candidates for alternative intravenous therapies, the safety and efficacy of alternative oral administration of ibrutinib remains unknown.…”